Doug Brunk

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, and which appear in the Jan. 13, 2011, edition of the New England Journal of Medicine, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

"A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media," Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). "The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk."

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39°C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained "substantial limitations," according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses.* Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear," they said.

Dr. Hoberman and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on all three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.*

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM "affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria."

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child’s condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, "together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial."

Dr. Klein noted in his editorial that since physicians "cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent."

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

* CORRECTION, 3/17/2011: The original version of this article omitted the word "few" from the following sentence: "These include the lack of stringent diagnostic criteria, the inclusion of very few young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses." An earlier version of this story also said that children were required to meet one of three criteria in order to participate in the trial; they were actually required to meet all criteria. This version has been corrected.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

DENVER – Patients on hemodialysis who consumed pomegranate juice for 1 year developed significantly fewer infections compared with those who did not, results from a single-center placebo-controlled study showed.

Photo credit: Wikimedia Commons user SriniG

They also had significant reductions in markers of inflammation and protein oxidation, Dr. Batya Kristal reported during a press briefing at the annual meeting of the American Society of Nephrology.

"Antioxidant-rich pomegranate juice has been shown to improve the lipid profile in patients with diabetes, reduce blood pressure in patients with hypertension, and improve heart function in those with heart disease," said Dr. Kristal, a nephrologist with Western Galilee Hospital, Nahariya, Israel.

She and her associates set out to study the use of pomegranate juice in hemodialysis patients "because they also suffer from oxidative stress, which is caused by excess production of free oxygen radicals in the face of low antioxidants," she said. "Free radicals are involved in the development of chronic diseases such as aging, coronary heart disease, and cancer. The damage of free radicals can be reduced by dietary intake of antioxidants."

During dialysis, she continued, the blood flow through the dialyzer enhances free radical release, which adds to the high levels of oxidative stress and inflammation.

For the study, 101 dialysis patients were randomized to receive 3.38 ounces of pomegranate juice or placebo three times per week for 1 year. "The pomegranate juice and placebo bottles looked the same," Dr. Kristal said. "Even the taste was similar. Both patients and staff were blinded to its content."

The researchers chose a commercial pomegranate juice manufactured in Turkey and marketed in Israel. She said the product was chosen because it had the highest concentration of polyphenols among 14 pomegranate juices tested.

The study’s primary end point was the change from baseline in markers of inflammation and protein oxidation, including neutrophil priming, interleukin-6, albumin, and oxygenized fibrinogen. The main secondary end point was the rate of hospitalization due to infections.

After 1 year, patients in the pomegranate group had significant reductions in neutrophil priming (P = .003), oxidized fibrinogen (P = .001), Il-6 (P less than .001), and albumin (P = .005), while those in the placebo group had no significant change in any of the markers.

Dr. Kristal also reported that patients in the pomegranate group had a lower rate of infection-related hospitalization compared with patients in the placebo group (33 vs. 55 per 1,000 patient-months, respectively), a difference that was not statistically significant (P = .11). However, significantly fewer patients in the pomegranate group developed a second infection-related hospitalization compared with their counterparts in the placebo group (3 vs. 18 per 1,000 patient-months, for a P value of .01).

Since pomegranate juice contains a high amount of potassium, Dr. Kristal emphasized that its intake by dialysis patients should be monitored by a dietician and a nephrologist, to prevent potassium overload. She also noted that pomegranate juice may interfere with the metabolism of certain drugs.

The study was funded by the Chief Scientist Office of the Ministry of Health, Israel; the Jess and Mildred Fisher Family Cardiology Research Fund; and the Office of the Executive Vice President for Research, Technion, Israel.

Dr. Kristal said that she had no relevant financial disclosures.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding "supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone," reported researchers led by Dr. Glenn Haugeberg in the January 2011 issue of Annals of the Rheumatic Diseases.

[Digital X-Ray Radiogrammetry Shows Minute Bone Loss in RA]

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at S?rlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was –0.45% vs. –2.69%, respectively, in digit 2; –0.34% vs. –3.32% in digit 3; –0.39% vs. –2.57% in digit 4, and –0.59% vs. –2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (–1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with –2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

"Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand," the researchers wrote. "This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines."

In discussing their findings, the investigators wrote that the "results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body."

They acknowledged certain limitations of the study, including the small sample size and the fact that "the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss."

The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding "supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone," reported researchers led by Dr. Glenn Haugeberg in the January 2011 issue of Annals of the Rheumatic Diseases.

[Digital X-Ray Radiogrammetry Shows Minute Bone Loss in RA]

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at S?rlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was –0.45% vs. –2.69%, respectively, in digit 2; –0.34% vs. –3.32% in digit 3; –0.39% vs. –2.57% in digit 4, and –0.59% vs. –2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (–1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with –2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

"Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand," the researchers wrote. "This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines."

In discussing their findings, the investigators wrote that the "results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body."

They acknowledged certain limitations of the study, including the small sample size and the fact that "the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss."

The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding "supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone," reported researchers led by Dr. Glenn Haugeberg in the January 2011 issue of Annals of the Rheumatic Diseases.

[Digital X-Ray Radiogrammetry Shows Minute Bone Loss in RA]

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at S?rlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was –0.45% vs. –2.69%, respectively, in digit 2; –0.34% vs. –3.32% in digit 3; –0.39% vs. –2.57% in digit 4, and –0.59% vs. –2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (–1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with –2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

"Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand," the researchers wrote. "This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines."

In discussing their findings, the investigators wrote that the "results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body."

They acknowledged certain limitations of the study, including the small sample size and the fact that "the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss."

The researchers stated that they had no relevant financial disclosures to make.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

DENVER – When patients with stage 3 chronic kidney disease develop anemia, they have a worse clinical course, according to results of a multicenter study in Spain.

"Anemia is a very complicated cardiovascular risk factor. It appears early in many (chronic kidney disease) patients, especially in the diabetic population," Dr. Alberto M. Castelao said in an interview during a poster session at the annual meeting of the American Society of Nephrology.

He and his associates evaluated data from 431 patients aged 18-78 years who were enrolled in the Study of Non-Anaemic Stage 3 CKD Patients Who Develop Renal Anaemia (NADIR-3), an epidemiologic, prospective, 3-year trial conducted at 27 centers in Spain. At baseline, the patients had a mean estimated glomerular filtration rate of 30-59 mL/min per 1.73m2 without anemia. They were followed every 6 months until they started renal replacement therapy or died.

If anemia occurred, the researchers conducted a diagnostic study to rule out causes not related to chronic kidney disease. In women, anemia was defined as a hemoglobin of less than 11.5 g/dL. In men, anemia was defined as a hemoglobin of less than 13.5 g/dL in those aged younger than 70 years and a level of less than 12.0 g/dL in men aged 70 and older.

Dr. Castelao, a nephrologist who practices in Bellvitge, Spain, reported that the mean age of the 431 patients was 63 years and 70% were male. Nearly one-third (30%) developed anemia – 85% from a renal cause – over the time period. The probability of developing anemia was 10% at 1 year, 20% at 2 years, and 26% at 3 years. The mean time to onset of anemia was 35 months.

Compared to patients without anemia, those who developed anemia had lower baseline estimated glomerular filtration rate (35.9 mL/min per 1.73m2 vs. 40.0 mL/min per 1.73m2, respectively), greater baseline proteinuria (0.94 g/day vs. 0.62 g/day), lower albumin (4.1 g/dL vs. 4.3 g/dL), greater reduction of estimated glomerular filtration rate (6.8 mL/min per 1.73m2 vs. 1.6 mL/min per 1.73m2 at 3 years), earlier progression to stage 4 CKD (18 months vs. 28 months), and greater rate of major cardiovascular events (16.1% vs. 6.9%), hospitalization (33.7% vs. 19.4%), and mortality (10.3% vs. 6.6%). All differences between the two groups were statistically significant.

"If we can stop anemia early, perhaps we can stabilize the renal function," Dr. Castelao said.

The study was sponsored by the Spanish Group for the Study of Diabetic Nephropathy. It received financial support from Amgen. Dr. Castelao said that he had no relevant financial disclosures.

SAN DIEGO – To date, there are very small associations between state-level taxes on sugar-sweetened beverages and consumption or weight outcomes.

However, if the existing soda tax rates were to jump by 400%-500%, “you'd have a substantially larger potential impact on consumption and weight outcomes,” Lisa Powell, Ph.D., said at the meeting.

Dr. Powell, a senior research scientist at the Institute for Health Research and Policy at the University of Illinois at Chicago, presented empirical findings on the association between state-level soda taxes with consumption and weight outcomes, based on national data including A.C. Nielsen Homescan Data, Early Childhood Longitudinal Study-Kindergarten Cohort, Monitoring the Future, and the National Longitudinal Survey of Youth 1997. The work was conducted as part of the Robert Wood Johnson Foundation–supported Bridging the Gap program (www.bridgingthegapresearch.org

Currently, Dr. Powell said, 34 states have soda sales taxes mostly in the 5%-7% range (mean 5.2%). Additionally, three states (West Virginia, Washington, and Rhode Island) have excise taxes on sugar-sweetened beverages; four states (Virginia, Tennessee, Arkansas, and Alabama) have other license/privilege fees/taxes; and eight states (New York, Rhode Island, North Carolina, Mississippi, Kansas, New Mexico, California, and Hawaii) have sugar-sweetened beverage legislative proposals pending review.

“Typically, the tax rates that exist right now for soda are for general revenue,” she explained. “Going forward, there is going to be more of a potential concern about reverse causality when you try to model this, because you may have a state which has a particularly high obesity rate, and policy makers may implement a high soda tax as a potential solution to try to deal with obesity in that state.”

The A.C. Nielsen Homescan Data used in the analysis was a cross-section of household purchase information based on scanner data from a variety of stores during the second quarter of 2007. The final sample included 66,211 nonmilitary households. Dr. Powell and her associates calculated the consumption of soda in ounces over the quarter. Preliminary results show that if the existing tax rate on soda were higher by one point for all households, “you'd have a statistically significant lower amount of consumption per household by only 9 ounces relative to the sample mean of 566 ounces over the quarter,” she said. “That's extremely small, less than one can of soda.”

When they applied simulation of an 18% sales tax, soda purchase would fall by about 25%. “If you consider a 1 cent per liquid ounce tax rate, which corresponds roughly to a 25% sales tax, then you'd see a 35% reduction in purchases,” she added.

The Early Childhood Longitudinal Study Kindergarten Cohort was used to examine the association between soda taxes, consumption, and weight of children. The final sample included 7,414 children who reported their food consumption and 7,300 for which height and weight information existed. Outcome variables were soda consumption in the last week, soda purchases at school, and weight change from third to fifth grade.

Analysis of the entire study population revealed a statistically significant but small effect on soda consumption at school and on the change in weight between third and fifth grade. “However, we found larger effects for children who are at risk for being overweight and for those who are at risk of obesity in general, including those from low-income families, minorities, and those who watch more than 9 hours of television per day,” Dr. Powell said. “This gets at the fact that different populations may respond differently to some of these tax policies.”

Assuming a linear extrapolation, she continued, an 18% soda tax would correspond to a −0.23 body mass index units in the change in BMI between third and fifth grade, or a 20% reduction in the excess BMI gain.

Monitoring the Future was a cross-sectional study of behaviors, attitudes, and values of 8th, 10th, and 12th-grade students for 1997-2006; the estimation sample includes 153,673 observations. Dr. Powell and her associates set out to examine the association between soda taxes and the BMI of respondents, and the overall effects they observed were small. “The significant effect was for those who were at risk of overweight,” she said. “In other studies where we've looked at how adolescents respond to pricing of fast food, we found that individuals who are at the upper tail of BMI distribution were much more price sensitive than those at the mean, suggesting that taxes would have a larger effect for more-overweight persons. From a policy standpoint, this is exactly the group whose behavior you want to change.”

National Longitudinal Survey of Youth 1997 is a nationally representative longitudinal data on youth aged 12-17 years in 1997. Four waves are being studied, including 1997, 1998, 1999, and 2000. The estimation sample includes 11,900 person-year observations living at home. Preliminary results show larger associations for adolescents from low-income households.

Dr. Powell said that in the future, jurisdictions that adopt higher taxes on sugar-sweetened beverages “will provide natural experiments for researchers to examine the effectiveness of these efforts in promoting healthier dietary intake and curbing the obesity epidemic.”

Two areas of future research that she called for include issues of applicability to food stamp programs as well as considering the notion of an excise tax instead of a sales tax. “The excise tax would apply prior to purchase and be listed as part of the shelf price,” she said. “If the intended goal is a public health goal, where you're trying to change behavior, that's really the only way to do it. It has to be built into the shelf price.”

Dr. Powell said that she had no relevant financial conflicts to disclose.

SAN DIEGO – To date, there are very small associations between state-level taxes on sugar-sweetened beverages and consumption or weight outcomes.

However, if the existing soda tax rates were to jump by 400%-500%, “you'd have a substantially larger potential impact on consumption and weight outcomes,” Lisa Powell, Ph.D., said at the meeting.

Dr. Powell, a senior research scientist at the Institute for Health Research and Policy at the University of Illinois at Chicago, presented empirical findings on the association between state-level soda taxes with consumption and weight outcomes, based on national data including A.C. Nielsen Homescan Data, Early Childhood Longitudinal Study-Kindergarten Cohort, Monitoring the Future, and the National Longitudinal Survey of Youth 1997. The work was conducted as part of the Robert Wood Johnson Foundation–supported Bridging the Gap program (www.bridgingthegapresearch.org

Currently, Dr. Powell said, 34 states have soda sales taxes mostly in the 5%-7% range (mean 5.2%). Additionally, three states (West Virginia, Washington, and Rhode Island) have excise taxes on sugar-sweetened beverages; four states (Virginia, Tennessee, Arkansas, and Alabama) have other license/privilege fees/taxes; and eight states (New York, Rhode Island, North Carolina, Mississippi, Kansas, New Mexico, California, and Hawaii) have sugar-sweetened beverage legislative proposals pending review.

“Typically, the tax rates that exist right now for soda are for general revenue,” she explained. “Going forward, there is going to be more of a potential concern about reverse causality when you try to model this, because you may have a state which has a particularly high obesity rate, and policy makers may implement a high soda tax as a potential solution to try to deal with obesity in that state.”

The A.C. Nielsen Homescan Data used in the analysis was a cross-section of household purchase information based on scanner data from a variety of stores during the second quarter of 2007. The final sample included 66,211 nonmilitary households. Dr. Powell and her associates calculated the consumption of soda in ounces over the quarter. Preliminary results show that if the existing tax rate on soda were higher by one point for all households, “you'd have a statistically significant lower amount of consumption per household by only 9 ounces relative to the sample mean of 566 ounces over the quarter,” she said. “That's extremely small, less than one can of soda.”

When they applied simulation of an 18% sales tax, soda purchase would fall by about 25%. “If you consider a 1 cent per liquid ounce tax rate, which corresponds roughly to a 25% sales tax, then you'd see a 35% reduction in purchases,” she added.

The Early Childhood Longitudinal Study Kindergarten Cohort was used to examine the association between soda taxes, consumption, and weight of children. The final sample included 7,414 children who reported their food consumption and 7,300 for which height and weight information existed. Outcome variables were soda consumption in the last week, soda purchases at school, and weight change from third to fifth grade.

Analysis of the entire study population revealed a statistically significant but small effect on soda consumption at school and on the change in weight between third and fifth grade. “However, we found larger effects for children who are at risk for being overweight and for those who are at risk of obesity in general, including those from low-income families, minorities, and those who watch more than 9 hours of television per day,” Dr. Powell said. “This gets at the fact that different populations may respond differently to some of these tax policies.”

Assuming a linear extrapolation, she continued, an 18% soda tax would correspond to a −0.23 body mass index units in the change in BMI between third and fifth grade, or a 20% reduction in the excess BMI gain.

Monitoring the Future was a cross-sectional study of behaviors, attitudes, and values of 8th, 10th, and 12th-grade students for 1997-2006; the estimation sample includes 153,673 observations. Dr. Powell and her associates set out to examine the association between soda taxes and the BMI of respondents, and the overall effects they observed were small. “The significant effect was for those who were at risk of overweight,” she said. “In other studies where we've looked at how adolescents respond to pricing of fast food, we found that individuals who are at the upper tail of BMI distribution were much more price sensitive than those at the mean, suggesting that taxes would have a larger effect for more-overweight persons. From a policy standpoint, this is exactly the group whose behavior you want to change.”

National Longitudinal Survey of Youth 1997 is a nationally representative longitudinal data on youth aged 12-17 years in 1997. Four waves are being studied, including 1997, 1998, 1999, and 2000. The estimation sample includes 11,900 person-year observations living at home. Preliminary results show larger associations for adolescents from low-income households.

Dr. Powell said that in the future, jurisdictions that adopt higher taxes on sugar-sweetened beverages “will provide natural experiments for researchers to examine the effectiveness of these efforts in promoting healthier dietary intake and curbing the obesity epidemic.”

Two areas of future research that she called for include issues of applicability to food stamp programs as well as considering the notion of an excise tax instead of a sales tax. “The excise tax would apply prior to purchase and be listed as part of the shelf price,” she said. “If the intended goal is a public health goal, where you're trying to change behavior, that's really the only way to do it. It has to be built into the shelf price.”

Dr. Powell said that she had no relevant financial conflicts to disclose.

SAN DIEGO – To date, there are very small associations between state-level taxes on sugar-sweetened beverages and consumption or weight outcomes.

However, if the existing soda tax rates were to jump by 400%-500%, “you'd have a substantially larger potential impact on consumption and weight outcomes,” Lisa Powell, Ph.D., said at the meeting.

Dr. Powell, a senior research scientist at the Institute for Health Research and Policy at the University of Illinois at Chicago, presented empirical findings on the association between state-level soda taxes with consumption and weight outcomes, based on national data including A.C. Nielsen Homescan Data, Early Childhood Longitudinal Study-Kindergarten Cohort, Monitoring the Future, and the National Longitudinal Survey of Youth 1997. The work was conducted as part of the Robert Wood Johnson Foundation–supported Bridging the Gap program (www.bridgingthegapresearch.org

Currently, Dr. Powell said, 34 states have soda sales taxes mostly in the 5%-7% range (mean 5.2%). Additionally, three states (West Virginia, Washington, and Rhode Island) have excise taxes on sugar-sweetened beverages; four states (Virginia, Tennessee, Arkansas, and Alabama) have other license/privilege fees/taxes; and eight states (New York, Rhode Island, North Carolina, Mississippi, Kansas, New Mexico, California, and Hawaii) have sugar-sweetened beverage legislative proposals pending review.

“Typically, the tax rates that exist right now for soda are for general revenue,” she explained. “Going forward, there is going to be more of a potential concern about reverse causality when you try to model this, because you may have a state which has a particularly high obesity rate, and policy makers may implement a high soda tax as a potential solution to try to deal with obesity in that state.”

The A.C. Nielsen Homescan Data used in the analysis was a cross-section of household purchase information based on scanner data from a variety of stores during the second quarter of 2007. The final sample included 66,211 nonmilitary households. Dr. Powell and her associates calculated the consumption of soda in ounces over the quarter. Preliminary results show that if the existing tax rate on soda were higher by one point for all households, “you'd have a statistically significant lower amount of consumption per household by only 9 ounces relative to the sample mean of 566 ounces over the quarter,” she said. “That's extremely small, less than one can of soda.”

When they applied simulation of an 18% sales tax, soda purchase would fall by about 25%. “If you consider a 1 cent per liquid ounce tax rate, which corresponds roughly to a 25% sales tax, then you'd see a 35% reduction in purchases,” she added.

The Early Childhood Longitudinal Study Kindergarten Cohort was used to examine the association between soda taxes, consumption, and weight of children. The final sample included 7,414 children who reported their food consumption and 7,300 for which height and weight information existed. Outcome variables were soda consumption in the last week, soda purchases at school, and weight change from third to fifth grade.

Analysis of the entire study population revealed a statistically significant but small effect on soda consumption at school and on the change in weight between third and fifth grade. “However, we found larger effects for children who are at risk for being overweight and for those who are at risk of obesity in general, including those from low-income families, minorities, and those who watch more than 9 hours of television per day,” Dr. Powell said. “This gets at the fact that different populations may respond differently to some of these tax policies.”

Assuming a linear extrapolation, she continued, an 18% soda tax would correspond to a −0.23 body mass index units in the change in BMI between third and fifth grade, or a 20% reduction in the excess BMI gain.

Monitoring the Future was a cross-sectional study of behaviors, attitudes, and values of 8th, 10th, and 12th-grade students for 1997-2006; the estimation sample includes 153,673 observations. Dr. Powell and her associates set out to examine the association between soda taxes and the BMI of respondents, and the overall effects they observed were small. “The significant effect was for those who were at risk of overweight,” she said. “In other studies where we've looked at how adolescents respond to pricing of fast food, we found that individuals who are at the upper tail of BMI distribution were much more price sensitive than those at the mean, suggesting that taxes would have a larger effect for more-overweight persons. From a policy standpoint, this is exactly the group whose behavior you want to change.”

National Longitudinal Survey of Youth 1997 is a nationally representative longitudinal data on youth aged 12-17 years in 1997. Four waves are being studied, including 1997, 1998, 1999, and 2000. The estimation sample includes 11,900 person-year observations living at home. Preliminary results show larger associations for adolescents from low-income households.

Dr. Powell said that in the future, jurisdictions that adopt higher taxes on sugar-sweetened beverages “will provide natural experiments for researchers to examine the effectiveness of these efforts in promoting healthier dietary intake and curbing the obesity epidemic.”

Two areas of future research that she called for include issues of applicability to food stamp programs as well as considering the notion of an excise tax instead of a sales tax. “The excise tax would apply prior to purchase and be listed as part of the shelf price,” she said. “If the intended goal is a public health goal, where you're trying to change behavior, that's really the only way to do it. It has to be built into the shelf price.”

Dr. Powell said that she had no relevant financial conflicts to disclose.