Mary Ann Moon

Tens of thousands of people continue to have asthma and posttraumatic stress symptoms attributed to the Sept. 11, 2001, terrorist attack on the World Trade Center, a report in the JAMA.

Five to six years after the tragedy, an estimated 25,500 rescue/recovery workers, residents, office workers, and even passersby directly exposed to the particulates and fumes at the site have been diagnosed as having new-onset asthma. Even more—an estimated 61,000-have experienced symptoms indicative of PTSD, said Robert M. Brackbill, Ph.D., of the Centers for Disease Control and Prevention, and his associates.

The researchers assessed the long-term impact of the terrorist attack on health using information collected in the World Trade Center Health Registry, “the largest postdisaster exposure registry in U.S. history,” which tracks a cohort of about 71,000 of the estimated 409,000 people who were present during or immediately after the attacks. Asthma and posttraumatic stress (PTS) symptoms were two of the most frequently reported health effects.

A total of 46,322 members of the cohort surveyed in 2006-2007 were included this analysis.

Applying the results to the entire set of exposed persons yielded estimates that some 25,500 (range of 17,000-40,000) have developed postevent asthma and about 61,000 (range of 43,000-88,600) have developed symptoms of posttraumatic stress.

Asthma status was assessed via self-reported first lifetime diagnosis of asthema or reactive airways dysfunction. PTS symptoms in the cohort were assessed with the PTSD Checklist, a 17-item self-report instrument.

The overall postevent incidence of new-onset asthma was 10.2%. “The annualized rate of asthma diagnoses in the 4 months immediately following the attacks was at least 6 times higher than the estimated annual national adult rate of 0.5% for 2002, and in subsequent years it remained at least 2 times higher than national estimates,” the investigators noted.

Asthma rates were nearly as high among passersby who were exposed only during the collapse of the World Trade Center towers as they were among people who returned to live or work near the site for months afterward, suggesting that symptoms often stemmed directly from exposure to the particulates and fumes released during the collapse itself.

Asthma symptoms were most evident among rescue/recovery workers and correlated with longer exposure at the site. However, asthma symptoms were also noted among residents and office workers, particularly those whose homes or work sites received a heavy coating of the dust generated by the collapse of the towers.

The data also suggested that asthma related to intense exposure to the dust cloud is more severe than is other asthma. “Respondents with asthma diagnosed after September 11 were more symptomatic, required more treatment, and reported a lower quality of life than those with asthma diagnosed before September 11,” Dr. Brackbill and his colleagues said (JAMA 2009;302:502-16).

The asthma incidence reported here is likely to be an underestimate, since the study excluded the 40% of new-onset asthma diagnoses in which the exact date of onset could not be determined. In most of those cases, circumstances suggested that the asthma was event related, the researchers noted.

Approximately 10% of the study cohort reported chronic PTS symptoms, and an additional 10% developed late-onset symptoms, highlighting the importance of ongoing mental health surveillance after disasters.

Rescue/recovery workers were the group most likely to have delayed PTS symptoms.

Long-term stress symptoms correlated with intense exposure to the dust cloud, injury during the disaster, and witnessing horror. The risk also was higher for people who lost a spouse, other family member, coworker, or acquaintance in the attacks.

However, postevent experiences were the strongest risk factor for long-term PTS, with people who lost their jobs and had poor social support being the most likely to suffer severe, prolonged stress.

“These findings confirm the general understanding that, over time, evaluation and treatment of individuals with long-term PTSD must address social factors that moderate predisaster and peridisaster experiences,” Dr. Brackbill and his associates said.

“Our findings confirm that, after a terrorist attack, mental health conditions can persist if not identified and adequately treated, and that a substantial number of exposed persons may develop late-onset symptoms,” they noted.

No financial conflicts of interest were reported.

Tens of thousands of people continue to have asthma and posttraumatic stress symptoms attributed to the Sept. 11, 2001, terrorist attack on the World Trade Center, a report in the JAMA.

Five to six years after the tragedy, an estimated 25,500 rescue/recovery workers, residents, office workers, and even passersby directly exposed to the particulates and fumes at the site have been diagnosed as having new-onset asthma. Even more—an estimated 61,000-have experienced symptoms indicative of PTSD, said Robert M. Brackbill, Ph.D., of the Centers for Disease Control and Prevention, and his associates.

The researchers assessed the long-term impact of the terrorist attack on health using information collected in the World Trade Center Health Registry, “the largest postdisaster exposure registry in U.S. history,” which tracks a cohort of about 71,000 of the estimated 409,000 people who were present during or immediately after the attacks. Asthma and posttraumatic stress (PTS) symptoms were two of the most frequently reported health effects.

A total of 46,322 members of the cohort surveyed in 2006-2007 were included this analysis.

Applying the results to the entire set of exposed persons yielded estimates that some 25,500 (range of 17,000-40,000) have developed postevent asthma and about 61,000 (range of 43,000-88,600) have developed symptoms of posttraumatic stress.

Asthma status was assessed via self-reported first lifetime diagnosis of asthema or reactive airways dysfunction. PTS symptoms in the cohort were assessed with the PTSD Checklist, a 17-item self-report instrument.

The overall postevent incidence of new-onset asthma was 10.2%. “The annualized rate of asthma diagnoses in the 4 months immediately following the attacks was at least 6 times higher than the estimated annual national adult rate of 0.5% for 2002, and in subsequent years it remained at least 2 times higher than national estimates,” the investigators noted.

Asthma rates were nearly as high among passersby who were exposed only during the collapse of the World Trade Center towers as they were among people who returned to live or work near the site for months afterward, suggesting that symptoms often stemmed directly from exposure to the particulates and fumes released during the collapse itself.

Asthma symptoms were most evident among rescue/recovery workers and correlated with longer exposure at the site. However, asthma symptoms were also noted among residents and office workers, particularly those whose homes or work sites received a heavy coating of the dust generated by the collapse of the towers.

The data also suggested that asthma related to intense exposure to the dust cloud is more severe than is other asthma. “Respondents with asthma diagnosed after September 11 were more symptomatic, required more treatment, and reported a lower quality of life than those with asthma diagnosed before September 11,” Dr. Brackbill and his colleagues said (JAMA 2009;302:502-16).

The asthma incidence reported here is likely to be an underestimate, since the study excluded the 40% of new-onset asthma diagnoses in which the exact date of onset could not be determined. In most of those cases, circumstances suggested that the asthma was event related, the researchers noted.

Approximately 10% of the study cohort reported chronic PTS symptoms, and an additional 10% developed late-onset symptoms, highlighting the importance of ongoing mental health surveillance after disasters.

Rescue/recovery workers were the group most likely to have delayed PTS symptoms.

Long-term stress symptoms correlated with intense exposure to the dust cloud, injury during the disaster, and witnessing horror. The risk also was higher for people who lost a spouse, other family member, coworker, or acquaintance in the attacks.

However, postevent experiences were the strongest risk factor for long-term PTS, with people who lost their jobs and had poor social support being the most likely to suffer severe, prolonged stress.

“These findings confirm the general understanding that, over time, evaluation and treatment of individuals with long-term PTSD must address social factors that moderate predisaster and peridisaster experiences,” Dr. Brackbill and his associates said.

“Our findings confirm that, after a terrorist attack, mental health conditions can persist if not identified and adequately treated, and that a substantial number of exposed persons may develop late-onset symptoms,” they noted.

No financial conflicts of interest were reported.

Tens of thousands of people continue to have asthma and posttraumatic stress symptoms attributed to the Sept. 11, 2001, terrorist attack on the World Trade Center, a report in the JAMA.

Five to six years after the tragedy, an estimated 25,500 rescue/recovery workers, residents, office workers, and even passersby directly exposed to the particulates and fumes at the site have been diagnosed as having new-onset asthma. Even more—an estimated 61,000-have experienced symptoms indicative of PTSD, said Robert M. Brackbill, Ph.D., of the Centers for Disease Control and Prevention, and his associates.

The researchers assessed the long-term impact of the terrorist attack on health using information collected in the World Trade Center Health Registry, “the largest postdisaster exposure registry in U.S. history,” which tracks a cohort of about 71,000 of the estimated 409,000 people who were present during or immediately after the attacks. Asthma and posttraumatic stress (PTS) symptoms were two of the most frequently reported health effects.

A total of 46,322 members of the cohort surveyed in 2006-2007 were included this analysis.

Applying the results to the entire set of exposed persons yielded estimates that some 25,500 (range of 17,000-40,000) have developed postevent asthma and about 61,000 (range of 43,000-88,600) have developed symptoms of posttraumatic stress.

Asthma status was assessed via self-reported first lifetime diagnosis of asthema or reactive airways dysfunction. PTS symptoms in the cohort were assessed with the PTSD Checklist, a 17-item self-report instrument.

The overall postevent incidence of new-onset asthma was 10.2%. “The annualized rate of asthma diagnoses in the 4 months immediately following the attacks was at least 6 times higher than the estimated annual national adult rate of 0.5% for 2002, and in subsequent years it remained at least 2 times higher than national estimates,” the investigators noted.

Asthma rates were nearly as high among passersby who were exposed only during the collapse of the World Trade Center towers as they were among people who returned to live or work near the site for months afterward, suggesting that symptoms often stemmed directly from exposure to the particulates and fumes released during the collapse itself.

Asthma symptoms were most evident among rescue/recovery workers and correlated with longer exposure at the site. However, asthma symptoms were also noted among residents and office workers, particularly those whose homes or work sites received a heavy coating of the dust generated by the collapse of the towers.

The data also suggested that asthma related to intense exposure to the dust cloud is more severe than is other asthma. “Respondents with asthma diagnosed after September 11 were more symptomatic, required more treatment, and reported a lower quality of life than those with asthma diagnosed before September 11,” Dr. Brackbill and his colleagues said (JAMA 2009;302:502-16).

The asthma incidence reported here is likely to be an underestimate, since the study excluded the 40% of new-onset asthma diagnoses in which the exact date of onset could not be determined. In most of those cases, circumstances suggested that the asthma was event related, the researchers noted.

Approximately 10% of the study cohort reported chronic PTS symptoms, and an additional 10% developed late-onset symptoms, highlighting the importance of ongoing mental health surveillance after disasters.

Rescue/recovery workers were the group most likely to have delayed PTS symptoms.

Long-term stress symptoms correlated with intense exposure to the dust cloud, injury during the disaster, and witnessing horror. The risk also was higher for people who lost a spouse, other family member, coworker, or acquaintance in the attacks.

However, postevent experiences were the strongest risk factor for long-term PTS, with people who lost their jobs and had poor social support being the most likely to suffer severe, prolonged stress.

“These findings confirm the general understanding that, over time, evaluation and treatment of individuals with long-term PTSD must address social factors that moderate predisaster and peridisaster experiences,” Dr. Brackbill and his associates said.

“Our findings confirm that, after a terrorist attack, mental health conditions can persist if not identified and adequately treated, and that a substantial number of exposed persons may develop late-onset symptoms,” they noted.

No financial conflicts of interest were reported.

Over-the-counter analgesics may not contribute to acute liver decompensation or worsen existing decompensation in patients with cirrhosis, Dr. Sakib Karim Khalid and his colleagues reported.

These hepatotoxic agents—specifically, acetaminophen and NSAIDS such as aspirin, ibuprofen, naproxen, and sulindac—have been suspected of causing acute hepatic decompensation or of worsening the condition of an already decompensated patient with cirrhosis, but prospective data are lacking.

Dr. Khalid of Yale University, New Haven, Conn., and his associates performed a case-control study in which 91 consecutive cirrhosis patients hospitalized for acute hepatic decompensation were compared with two groups of control subjects to determine whether use of over-the-counter analgesics during the preceding 30 days could account for the decompensation.

The study was supported in part by Ortho-McNeil Pharmaceuticals Inc.

Acute hepatic decompensation was characterized by variceal hemorrhage, new or worsening ascites, encephalopathy, jaundice, spontaneous bacterial peritonitis, spontaneous bacteremia, or renal dysfunction, they said (Clin. Gastroenterol. Hepatol. 2009 Apr 24. [doi:10.1016/j.cgh.2009.04.015

One control group comprised 153 cirrhosis patients who were not hospitalized; the other comprised 89 patients without cirrhosis who were hospitalized for reasons unrelated to liver failure.

The researchers expected to find that patients with acute hepatic decompensation had taken more OTC analgesics than either control group, but “our results actually show that a lower proportion of patients with cirrhosis use OTC analgesics in general, and that an even lower proportion… had used them in the preceding month,” they wrote.

Only 32 cirrhosis patients with acute liver failure (35%) reported using any OTC analgesics during the preceding 30 days, compared with 80 cirrhotic controls (52%) and 62 noncirrhotic controls (70%). In particular, acetaminophen “was used by only one-fifth of the cirrhotic cases,” was used at daily doses that were equivalent to those used by cirrhotic control subjects, and was never used at a dose that exceeded the therapeutic dose of 4 g/day.

These results suggest that OTC analgesics “do not contribute to acute hepatic decompensation in cirrhosis,” Dr. Khalid and his colleagues wrote.

Specifically, “acetaminophen at a maximal daily dose of 3 g/day (for up to 2 days) or at a daily dose of 1 g/day (for up to 25 days) does not appear to be associated with acute hepatic decompensation,” they said.

No financial conflicts other than the study sponsorship were reported.

Over-the-counter analgesics may not contribute to acute liver decompensation or worsen existing decompensation in patients with cirrhosis, Dr. Sakib Karim Khalid and his colleagues reported.

These hepatotoxic agents—specifically, acetaminophen and NSAIDS such as aspirin, ibuprofen, naproxen, and sulindac—have been suspected of causing acute hepatic decompensation or of worsening the condition of an already decompensated patient with cirrhosis, but prospective data are lacking.

Dr. Khalid of Yale University, New Haven, Conn., and his associates performed a case-control study in which 91 consecutive cirrhosis patients hospitalized for acute hepatic decompensation were compared with two groups of control subjects to determine whether use of over-the-counter analgesics during the preceding 30 days could account for the decompensation.

The study was supported in part by Ortho-McNeil Pharmaceuticals Inc.

Acute hepatic decompensation was characterized by variceal hemorrhage, new or worsening ascites, encephalopathy, jaundice, spontaneous bacterial peritonitis, spontaneous bacteremia, or renal dysfunction, they said (Clin. Gastroenterol. Hepatol. 2009 Apr 24. [doi:10.1016/j.cgh.2009.04.015

One control group comprised 153 cirrhosis patients who were not hospitalized; the other comprised 89 patients without cirrhosis who were hospitalized for reasons unrelated to liver failure.

The researchers expected to find that patients with acute hepatic decompensation had taken more OTC analgesics than either control group, but “our results actually show that a lower proportion of patients with cirrhosis use OTC analgesics in general, and that an even lower proportion… had used them in the preceding month,” they wrote.

Only 32 cirrhosis patients with acute liver failure (35%) reported using any OTC analgesics during the preceding 30 days, compared with 80 cirrhotic controls (52%) and 62 noncirrhotic controls (70%). In particular, acetaminophen “was used by only one-fifth of the cirrhotic cases,” was used at daily doses that were equivalent to those used by cirrhotic control subjects, and was never used at a dose that exceeded the therapeutic dose of 4 g/day.

These results suggest that OTC analgesics “do not contribute to acute hepatic decompensation in cirrhosis,” Dr. Khalid and his colleagues wrote.

Specifically, “acetaminophen at a maximal daily dose of 3 g/day (for up to 2 days) or at a daily dose of 1 g/day (for up to 25 days) does not appear to be associated with acute hepatic decompensation,” they said.

No financial conflicts other than the study sponsorship were reported.

Over-the-counter analgesics may not contribute to acute liver decompensation or worsen existing decompensation in patients with cirrhosis, Dr. Sakib Karim Khalid and his colleagues reported.

These hepatotoxic agents—specifically, acetaminophen and NSAIDS such as aspirin, ibuprofen, naproxen, and sulindac—have been suspected of causing acute hepatic decompensation or of worsening the condition of an already decompensated patient with cirrhosis, but prospective data are lacking.

Dr. Khalid of Yale University, New Haven, Conn., and his associates performed a case-control study in which 91 consecutive cirrhosis patients hospitalized for acute hepatic decompensation were compared with two groups of control subjects to determine whether use of over-the-counter analgesics during the preceding 30 days could account for the decompensation.

The study was supported in part by Ortho-McNeil Pharmaceuticals Inc.

Acute hepatic decompensation was characterized by variceal hemorrhage, new or worsening ascites, encephalopathy, jaundice, spontaneous bacterial peritonitis, spontaneous bacteremia, or renal dysfunction, they said (Clin. Gastroenterol. Hepatol. 2009 Apr 24. [doi:10.1016/j.cgh.2009.04.015

One control group comprised 153 cirrhosis patients who were not hospitalized; the other comprised 89 patients without cirrhosis who were hospitalized for reasons unrelated to liver failure.

The researchers expected to find that patients with acute hepatic decompensation had taken more OTC analgesics than either control group, but “our results actually show that a lower proportion of patients with cirrhosis use OTC analgesics in general, and that an even lower proportion… had used them in the preceding month,” they wrote.

Only 32 cirrhosis patients with acute liver failure (35%) reported using any OTC analgesics during the preceding 30 days, compared with 80 cirrhotic controls (52%) and 62 noncirrhotic controls (70%). In particular, acetaminophen “was used by only one-fifth of the cirrhotic cases,” was used at daily doses that were equivalent to those used by cirrhotic control subjects, and was never used at a dose that exceeded the therapeutic dose of 4 g/day.

These results suggest that OTC analgesics “do not contribute to acute hepatic decompensation in cirrhosis,” Dr. Khalid and his colleagues wrote.

Specifically, “acetaminophen at a maximal daily dose of 3 g/day (for up to 2 days) or at a daily dose of 1 g/day (for up to 25 days) does not appear to be associated with acute hepatic decompensation,” they said.

No financial conflicts other than the study sponsorship were reported.

Researchers have developed a simple scoring method to identify nonalcoholic fatty liver disease using easily available clinical and laboratory data, Dr. Anna Kotronen and her colleagues reported.

The authors also devised an equation containing the same variables as this NAFLD liver fat score that can be used to estimate a patient's individual liver fat content as a percentage.

“To our knowledge, the NAFLD liver fat score and equation are the first simple tools allowing prediction of NAFLD and liver fat in humans based on routinely available data,” said Dr. Kotronen of the University of Helsinki and her associates (Gastroenterology 2009; June 12 [doi:10.1053/j.gastro.2009.06.005

The prevalence of NAFLD is estimated to be 20%-30% in the general population, and up to 75% among obese people. Liver function abnormalities are both insensitive and nonspecific markers of the disorder, and the best method for measuring liver fat content—proton magnetic resonance spectroscopy, or 1H-MRS—often is not available in general practice.

The investigators devised their scoring method by characterizing 313 subjects whose liver fat content had been measured using 1H-MRS, and identifying which variables independently predicted NAFLD. They then tested the validity of the method in another 157 subjects who also underwent 1H-MRS.

A total of 359 of the study subjects did not have diabetes, and 111 had type 2 diabetes but had no other known disease except obesity.

The variables of interest were presence of the metabolic syndrome; increased levels of fasting serum insulin, fasting plasma glucose, fasting serum aspartate aminotransferase (AST), and alanine aminotransferase (ALT); and a decreased AST/ALT ratio. The scoring method assigns numerical values to each of these variables and can be calculated online.

The resulting score, if higher than −0.640, predicted NAFLD with a sensitivity of 86% and a specificity of 71%. In the validation group, a cutoff score of −0.640 or higher predicted NAFLD with a sensitivity of 84% and a specificity of 69%.

The data also were used to create a liver fat equation to predict an individual patient's liver fat percentage.

When clinicians use this score to discover which patients with type 2 diabetes have NAFLD, they can better select antihyperglycemic drugs. For example, PPAR-gamma (peroxisome proliferator-activated receptor-gamma) agonists, also known as thiazolidinediones, are known to decrease liver fat content by approximately half, and they also significantly reduce hepatic inflammation, ballooning necrosis, and, possibly, fibrosis in patients who have nonalcoholic steatohepatitis.

No financial conflicts of interest were reported.

Researchers have developed a simple scoring method to identify nonalcoholic fatty liver disease using easily available clinical and laboratory data, Dr. Anna Kotronen and her colleagues reported.

The authors also devised an equation containing the same variables as this NAFLD liver fat score that can be used to estimate a patient's individual liver fat content as a percentage.

“To our knowledge, the NAFLD liver fat score and equation are the first simple tools allowing prediction of NAFLD and liver fat in humans based on routinely available data,” said Dr. Kotronen of the University of Helsinki and her associates (Gastroenterology 2009; June 12 [doi:10.1053/j.gastro.2009.06.005

The prevalence of NAFLD is estimated to be 20%-30% in the general population, and up to 75% among obese people. Liver function abnormalities are both insensitive and nonspecific markers of the disorder, and the best method for measuring liver fat content—proton magnetic resonance spectroscopy, or 1H-MRS—often is not available in general practice.

The investigators devised their scoring method by characterizing 313 subjects whose liver fat content had been measured using 1H-MRS, and identifying which variables independently predicted NAFLD. They then tested the validity of the method in another 157 subjects who also underwent 1H-MRS.

A total of 359 of the study subjects did not have diabetes, and 111 had type 2 diabetes but had no other known disease except obesity.

The variables of interest were presence of the metabolic syndrome; increased levels of fasting serum insulin, fasting plasma glucose, fasting serum aspartate aminotransferase (AST), and alanine aminotransferase (ALT); and a decreased AST/ALT ratio. The scoring method assigns numerical values to each of these variables and can be calculated online.

The resulting score, if higher than −0.640, predicted NAFLD with a sensitivity of 86% and a specificity of 71%. In the validation group, a cutoff score of −0.640 or higher predicted NAFLD with a sensitivity of 84% and a specificity of 69%.

The data also were used to create a liver fat equation to predict an individual patient's liver fat percentage.

When clinicians use this score to discover which patients with type 2 diabetes have NAFLD, they can better select antihyperglycemic drugs. For example, PPAR-gamma (peroxisome proliferator-activated receptor-gamma) agonists, also known as thiazolidinediones, are known to decrease liver fat content by approximately half, and they also significantly reduce hepatic inflammation, ballooning necrosis, and, possibly, fibrosis in patients who have nonalcoholic steatohepatitis.

No financial conflicts of interest were reported.

Researchers have developed a simple scoring method to identify nonalcoholic fatty liver disease using easily available clinical and laboratory data, Dr. Anna Kotronen and her colleagues reported.

The authors also devised an equation containing the same variables as this NAFLD liver fat score that can be used to estimate a patient's individual liver fat content as a percentage.

“To our knowledge, the NAFLD liver fat score and equation are the first simple tools allowing prediction of NAFLD and liver fat in humans based on routinely available data,” said Dr. Kotronen of the University of Helsinki and her associates (Gastroenterology 2009; June 12 [doi:10.1053/j.gastro.2009.06.005

The prevalence of NAFLD is estimated to be 20%-30% in the general population, and up to 75% among obese people. Liver function abnormalities are both insensitive and nonspecific markers of the disorder, and the best method for measuring liver fat content—proton magnetic resonance spectroscopy, or 1H-MRS—often is not available in general practice.

The investigators devised their scoring method by characterizing 313 subjects whose liver fat content had been measured using 1H-MRS, and identifying which variables independently predicted NAFLD. They then tested the validity of the method in another 157 subjects who also underwent 1H-MRS.

A total of 359 of the study subjects did not have diabetes, and 111 had type 2 diabetes but had no other known disease except obesity.

The variables of interest were presence of the metabolic syndrome; increased levels of fasting serum insulin, fasting plasma glucose, fasting serum aspartate aminotransferase (AST), and alanine aminotransferase (ALT); and a decreased AST/ALT ratio. The scoring method assigns numerical values to each of these variables and can be calculated online.

The resulting score, if higher than −0.640, predicted NAFLD with a sensitivity of 86% and a specificity of 71%. In the validation group, a cutoff score of −0.640 or higher predicted NAFLD with a sensitivity of 84% and a specificity of 69%.

The data also were used to create a liver fat equation to predict an individual patient's liver fat percentage.

When clinicians use this score to discover which patients with type 2 diabetes have NAFLD, they can better select antihyperglycemic drugs. For example, PPAR-gamma (peroxisome proliferator-activated receptor-gamma) agonists, also known as thiazolidinediones, are known to decrease liver fat content by approximately half, and they also significantly reduce hepatic inflammation, ballooning necrosis, and, possibly, fibrosis in patients who have nonalcoholic steatohepatitis.

No financial conflicts of interest were reported.

Vertebroplasty was no more beneficial than a sham procedure for painful osteoporotic vertebral fractures in the first two blinded, randomized, controlled trials ever to assess the technique, according to separate reports.

These findings are likely to transform percutaneous vertebroplasty—a widely accepted method of pain relief that has become routine therapy—from “a procedure that is virtually always considered to be successful” into one “considered no better than placebo,” James N. Weinstein, D.O., of Dartmouth-Hitchcock Medical Center, Hanover, N.H., said in an editorial accompanying the reports.

The Centers for Medicare and Medicaid Services and radiologic and neurologic surgery societies have recommended reimbursement of vertebroplasty—endorsements that have boosted a dramatic rise in its popularity. The number of vertebroplasties performed in the United States has more than doubled in the past 6 years, Dr. Weinstein noted (N. Engl. J. Med. 2009;361:619-21).

The procedure involves injecting medical cement directly into a vertebral fracture to stabilize it and relieve pain. Many case series and small, unblinded, nonrandomized, noncontrolled studies have suggested that it is effective, though the precise mechanism of action has never been delineated.

In one of the reports, Rachelle Buchbinder, Ph.D., of Monash University, Malvern, Australia, and her associates randomly assigned 38 patients with 1-2 recent vertebral fractures to vertebroplasty and 40 to a sham procedure.

The primary outcome measure, overall pain score, was no different between the two groups at 1-week, 1-month, 3-month, or 6- month assessments. Pain at rest, pain during the night, physical functioning, and quality of life measures also were not significantly different, nor was the use of opioid analgesics, they said (N. Engl. J. Med. 2009;361:557-68).

These results were consistent regardless of patients' duration of symptoms and history of previous fractures.

One subject who underwent vertebroplasty and could not receive prophylactic cephalothin because of drug allergies developed an adjacent new fracture and osteomyelitis requiring surgery. Some studies have suggested that vertebroplasty raises the risk of subsequent fractures, particularly in vertebrae adjacent to treated areas, sometimes after the medical cement has leaked into those areas.

“Our results show … the hazards of relying on the results of uncontrolled or poorly controlled studies to assess treatment efficacy,” Dr. Buchbinder and her colleagues noted.

Earlier studies may have overestimated the benefit of vertebroplasty “by failing to take into account the favorable natural history of the condition, the tendency of regression to the mean, and the placebo response to treatment, which may be amplified when the treatment is invasive,” they added.

In another study, Dr. David F. Kallmes of the Mayo Clinic, Rochester, Minn., and his associates enrolled patients at 11 medical centers in the United States, the United Kingdon, and Australia. A total of 68 were randomly assigned to vertebroplasty and 63 to a sham procedure.

At 1 month, the two groups did not differ significantly on the 2 primary outcomes, which were separate measures of pain and disability. Secondary outcomes of pain intensity, disability, and quality of life also were not significantly different, Dr. Kallmes and his colleagues said (N. Engl. J. Med. 2009;361:569-79).

One patient who underwent vertebroplasty sustained an injury to the thecal sac during the procedure and required hospitalization, they added.

Dr. Buchbinder reports receiving grant support for the trial from Cook Australia, a manufacturer of medical products and devices. Dr. Kallmes reports receiving consulting fees from Zelos Therapeutics and grant support from ArthroCare, Stryker, Cardinal, and Cook and serving as an unpaid consultant to Bone Support. Dr. Weinstein reported no disclosures.

Vertebroplasty was no more beneficial than a sham procedure for painful osteoporotic vertebral fractures in the first two blinded, randomized, controlled trials ever to assess the technique, according to separate reports.

These findings are likely to transform percutaneous vertebroplasty—a widely accepted method of pain relief that has become routine therapy—from “a procedure that is virtually always considered to be successful” into one “considered no better than placebo,” James N. Weinstein, D.O., of Dartmouth-Hitchcock Medical Center, Hanover, N.H., said in an editorial accompanying the reports.

The Centers for Medicare and Medicaid Services and radiologic and neurologic surgery societies have recommended reimbursement of vertebroplasty—endorsements that have boosted a dramatic rise in its popularity. The number of vertebroplasties performed in the United States has more than doubled in the past 6 years, Dr. Weinstein noted (N. Engl. J. Med. 2009;361:619-21).

The procedure involves injecting medical cement directly into a vertebral fracture to stabilize it and relieve pain. Many case series and small, unblinded, nonrandomized, noncontrolled studies have suggested that it is effective, though the precise mechanism of action has never been delineated.

In one of the reports, Rachelle Buchbinder, Ph.D., of Monash University, Malvern, Australia, and her associates randomly assigned 38 patients with 1-2 recent vertebral fractures to vertebroplasty and 40 to a sham procedure.

The primary outcome measure, overall pain score, was no different between the two groups at 1-week, 1-month, 3-month, or 6- month assessments. Pain at rest, pain during the night, physical functioning, and quality of life measures also were not significantly different, nor was the use of opioid analgesics, they said (N. Engl. J. Med. 2009;361:557-68).

These results were consistent regardless of patients' duration of symptoms and history of previous fractures.

One subject who underwent vertebroplasty and could not receive prophylactic cephalothin because of drug allergies developed an adjacent new fracture and osteomyelitis requiring surgery. Some studies have suggested that vertebroplasty raises the risk of subsequent fractures, particularly in vertebrae adjacent to treated areas, sometimes after the medical cement has leaked into those areas.

“Our results show … the hazards of relying on the results of uncontrolled or poorly controlled studies to assess treatment efficacy,” Dr. Buchbinder and her colleagues noted.

Earlier studies may have overestimated the benefit of vertebroplasty “by failing to take into account the favorable natural history of the condition, the tendency of regression to the mean, and the placebo response to treatment, which may be amplified when the treatment is invasive,” they added.

In another study, Dr. David F. Kallmes of the Mayo Clinic, Rochester, Minn., and his associates enrolled patients at 11 medical centers in the United States, the United Kingdon, and Australia. A total of 68 were randomly assigned to vertebroplasty and 63 to a sham procedure.

At 1 month, the two groups did not differ significantly on the 2 primary outcomes, which were separate measures of pain and disability. Secondary outcomes of pain intensity, disability, and quality of life also were not significantly different, Dr. Kallmes and his colleagues said (N. Engl. J. Med. 2009;361:569-79).

One patient who underwent vertebroplasty sustained an injury to the thecal sac during the procedure and required hospitalization, they added.

Dr. Buchbinder reports receiving grant support for the trial from Cook Australia, a manufacturer of medical products and devices. Dr. Kallmes reports receiving consulting fees from Zelos Therapeutics and grant support from ArthroCare, Stryker, Cardinal, and Cook and serving as an unpaid consultant to Bone Support. Dr. Weinstein reported no disclosures.

Vertebroplasty was no more beneficial than a sham procedure for painful osteoporotic vertebral fractures in the first two blinded, randomized, controlled trials ever to assess the technique, according to separate reports.

These findings are likely to transform percutaneous vertebroplasty—a widely accepted method of pain relief that has become routine therapy—from “a procedure that is virtually always considered to be successful” into one “considered no better than placebo,” James N. Weinstein, D.O., of Dartmouth-Hitchcock Medical Center, Hanover, N.H., said in an editorial accompanying the reports.

The Centers for Medicare and Medicaid Services and radiologic and neurologic surgery societies have recommended reimbursement of vertebroplasty—endorsements that have boosted a dramatic rise in its popularity. The number of vertebroplasties performed in the United States has more than doubled in the past 6 years, Dr. Weinstein noted (N. Engl. J. Med. 2009;361:619-21).

The procedure involves injecting medical cement directly into a vertebral fracture to stabilize it and relieve pain. Many case series and small, unblinded, nonrandomized, noncontrolled studies have suggested that it is effective, though the precise mechanism of action has never been delineated.

In one of the reports, Rachelle Buchbinder, Ph.D., of Monash University, Malvern, Australia, and her associates randomly assigned 38 patients with 1-2 recent vertebral fractures to vertebroplasty and 40 to a sham procedure.

The primary outcome measure, overall pain score, was no different between the two groups at 1-week, 1-month, 3-month, or 6- month assessments. Pain at rest, pain during the night, physical functioning, and quality of life measures also were not significantly different, nor was the use of opioid analgesics, they said (N. Engl. J. Med. 2009;361:557-68).

These results were consistent regardless of patients' duration of symptoms and history of previous fractures.

One subject who underwent vertebroplasty and could not receive prophylactic cephalothin because of drug allergies developed an adjacent new fracture and osteomyelitis requiring surgery. Some studies have suggested that vertebroplasty raises the risk of subsequent fractures, particularly in vertebrae adjacent to treated areas, sometimes after the medical cement has leaked into those areas.

“Our results show … the hazards of relying on the results of uncontrolled or poorly controlled studies to assess treatment efficacy,” Dr. Buchbinder and her colleagues noted.

Earlier studies may have overestimated the benefit of vertebroplasty “by failing to take into account the favorable natural history of the condition, the tendency of regression to the mean, and the placebo response to treatment, which may be amplified when the treatment is invasive,” they added.

In another study, Dr. David F. Kallmes of the Mayo Clinic, Rochester, Minn., and his associates enrolled patients at 11 medical centers in the United States, the United Kingdon, and Australia. A total of 68 were randomly assigned to vertebroplasty and 63 to a sham procedure.

At 1 month, the two groups did not differ significantly on the 2 primary outcomes, which were separate measures of pain and disability. Secondary outcomes of pain intensity, disability, and quality of life also were not significantly different, Dr. Kallmes and his colleagues said (N. Engl. J. Med. 2009;361:569-79).

One patient who underwent vertebroplasty sustained an injury to the thecal sac during the procedure and required hospitalization, they added.

Dr. Buchbinder reports receiving grant support for the trial from Cook Australia, a manufacturer of medical products and devices. Dr. Kallmes reports receiving consulting fees from Zelos Therapeutics and grant support from ArthroCare, Stryker, Cardinal, and Cook and serving as an unpaid consultant to Bone Support. Dr. Weinstein reported no disclosures.

Treatment with injectable diacetylmorphine, the active ingredient in heroin, compared favorably with methadone treatment in a phase III clinical trial reported in the the New England Journal of Medicine.

Patients who received diacetylmorphine through the North American Opiate Medication Initiative were more likely to stay in treatment, reduce their use of illegal drugs, and scale back other illegal activities than were those given methadone. They also showed greater improvements in medical, psychiatric, and economic status, and in their family and social relationships, which “suggests a positive treatment effect beyond reduction in illicit-drug use or other illegal activities,” said Eugenia Oviedo-Joekes, Ph.D., of the University of British Columbia, Vancouver, and her associates (N. Engl. J. Med. 2009;361:777-86).

“Methadone, provided according to best-practice guidelines, should remain the treatment of choice for the majority of patients. However, there will continue to be a subgroup of patients who will not benefit even from optimized methadone maintenance.

Prescribed, supervised use of diacetylmorphine appears to be a safe and effective adjunctive treatment for this severely affected population of patients who would otherwise remain outside the health care system,” the investigators said.

Injectable diacetylmorphine has been used in several European countries for many years. To assess its performance in a North American population, Dr. Oviedo-Joekes and her colleagues performed an open-label, randomized, controlled trial in Montreal and Vancouver.

A total of 115 patients were randomly assigned to receive diacetylmorphine, 111 to receive standard oral methadone, and 25 to receive injectable hydromorphone for validation of the self-reported use of illicit heroin by means of urine testing. All the study subjects had long histories of injectable drug use and extensive involvement in criminal activity, and all had undergone multiple attempts at treatment.

The medications were administered daily and under supervision in clinics, and patients were allowed to switch, partially or totally, to oral methadone if they wished. Twenty-three of the diacetylmorphine patients switched to methadone.

To ensure safety, all study subjects who received injectable medications were observed for 30 minutes after each injection.

After 1 year of follow-up, 67% of the diacetylmorphine group improved in illicit drug use and other illegal activities, compared with 48% of the methadone group. Scores improved on more subscales on a measure of this outcome, and they improved to a greater degree, with acetylmorphine than with methadone.

The rate of retention in treatment also was better with diacetylmorphine (88%) than with methadone (54%). Rates of response and retention with hydromorphone were 64% and 88%, respectively.

The mean number of days of illicit heroin use during the preceding month declined from 27 to 5 with diacetylmorphine and from 27 to 12 with methadone. At baseline, both groups had spent a median of $1,200 (U.S.) per month on illicit drugs, which was reduced to $320 with diacetylmorphine and to $400 with methadone.

A total of 54 patients reported 79 serious adverse events–18 with methadone, 51 with diacetylmorphine, and 10 with hydromorphone. Overdoses and seizures were the most common serious adverse events associated with diacetylmorphine.

“Sixteen of the 115 patients randomly assigned to receive diacetylmorphine had a life-threatening overdose or seizure during the study. Because the study included close medical supervision, these serious adverse events were promptly treated, and all patients recovered,” the investigators noted.

No potential conflicts of interest were reported.

Treatment with injectable diacetylmorphine, the active ingredient in heroin, compared favorably with methadone treatment in a phase III clinical trial reported in the the New England Journal of Medicine.

Patients who received diacetylmorphine through the North American Opiate Medication Initiative were more likely to stay in treatment, reduce their use of illegal drugs, and scale back other illegal activities than were those given methadone. They also showed greater improvements in medical, psychiatric, and economic status, and in their family and social relationships, which “suggests a positive treatment effect beyond reduction in illicit-drug use or other illegal activities,” said Eugenia Oviedo-Joekes, Ph.D., of the University of British Columbia, Vancouver, and her associates (N. Engl. J. Med. 2009;361:777-86).

“Methadone, provided according to best-practice guidelines, should remain the treatment of choice for the majority of patients. However, there will continue to be a subgroup of patients who will not benefit even from optimized methadone maintenance.

Prescribed, supervised use of diacetylmorphine appears to be a safe and effective adjunctive treatment for this severely affected population of patients who would otherwise remain outside the health care system,” the investigators said.

Injectable diacetylmorphine has been used in several European countries for many years. To assess its performance in a North American population, Dr. Oviedo-Joekes and her colleagues performed an open-label, randomized, controlled trial in Montreal and Vancouver.

A total of 115 patients were randomly assigned to receive diacetylmorphine, 111 to receive standard oral methadone, and 25 to receive injectable hydromorphone for validation of the self-reported use of illicit heroin by means of urine testing. All the study subjects had long histories of injectable drug use and extensive involvement in criminal activity, and all had undergone multiple attempts at treatment.

The medications were administered daily and under supervision in clinics, and patients were allowed to switch, partially or totally, to oral methadone if they wished. Twenty-three of the diacetylmorphine patients switched to methadone.

To ensure safety, all study subjects who received injectable medications were observed for 30 minutes after each injection.

After 1 year of follow-up, 67% of the diacetylmorphine group improved in illicit drug use and other illegal activities, compared with 48% of the methadone group. Scores improved on more subscales on a measure of this outcome, and they improved to a greater degree, with acetylmorphine than with methadone.

The rate of retention in treatment also was better with diacetylmorphine (88%) than with methadone (54%). Rates of response and retention with hydromorphone were 64% and 88%, respectively.

The mean number of days of illicit heroin use during the preceding month declined from 27 to 5 with diacetylmorphine and from 27 to 12 with methadone. At baseline, both groups had spent a median of $1,200 (U.S.) per month on illicit drugs, which was reduced to $320 with diacetylmorphine and to $400 with methadone.

A total of 54 patients reported 79 serious adverse events–18 with methadone, 51 with diacetylmorphine, and 10 with hydromorphone. Overdoses and seizures were the most common serious adverse events associated with diacetylmorphine.

“Sixteen of the 115 patients randomly assigned to receive diacetylmorphine had a life-threatening overdose or seizure during the study. Because the study included close medical supervision, these serious adverse events were promptly treated, and all patients recovered,” the investigators noted.

No potential conflicts of interest were reported.

Treatment with injectable diacetylmorphine, the active ingredient in heroin, compared favorably with methadone treatment in a phase III clinical trial reported in the the New England Journal of Medicine.

Patients who received diacetylmorphine through the North American Opiate Medication Initiative were more likely to stay in treatment, reduce their use of illegal drugs, and scale back other illegal activities than were those given methadone. They also showed greater improvements in medical, psychiatric, and economic status, and in their family and social relationships, which “suggests a positive treatment effect beyond reduction in illicit-drug use or other illegal activities,” said Eugenia Oviedo-Joekes, Ph.D., of the University of British Columbia, Vancouver, and her associates (N. Engl. J. Med. 2009;361:777-86).

“Methadone, provided according to best-practice guidelines, should remain the treatment of choice for the majority of patients. However, there will continue to be a subgroup of patients who will not benefit even from optimized methadone maintenance.

Prescribed, supervised use of diacetylmorphine appears to be a safe and effective adjunctive treatment for this severely affected population of patients who would otherwise remain outside the health care system,” the investigators said.

Injectable diacetylmorphine has been used in several European countries for many years. To assess its performance in a North American population, Dr. Oviedo-Joekes and her colleagues performed an open-label, randomized, controlled trial in Montreal and Vancouver.

A total of 115 patients were randomly assigned to receive diacetylmorphine, 111 to receive standard oral methadone, and 25 to receive injectable hydromorphone for validation of the self-reported use of illicit heroin by means of urine testing. All the study subjects had long histories of injectable drug use and extensive involvement in criminal activity, and all had undergone multiple attempts at treatment.

The medications were administered daily and under supervision in clinics, and patients were allowed to switch, partially or totally, to oral methadone if they wished. Twenty-three of the diacetylmorphine patients switched to methadone.

To ensure safety, all study subjects who received injectable medications were observed for 30 minutes after each injection.

After 1 year of follow-up, 67% of the diacetylmorphine group improved in illicit drug use and other illegal activities, compared with 48% of the methadone group. Scores improved on more subscales on a measure of this outcome, and they improved to a greater degree, with acetylmorphine than with methadone.

The rate of retention in treatment also was better with diacetylmorphine (88%) than with methadone (54%). Rates of response and retention with hydromorphone were 64% and 88%, respectively.

The mean number of days of illicit heroin use during the preceding month declined from 27 to 5 with diacetylmorphine and from 27 to 12 with methadone. At baseline, both groups had spent a median of $1,200 (U.S.) per month on illicit drugs, which was reduced to $320 with diacetylmorphine and to $400 with methadone.

A total of 54 patients reported 79 serious adverse events–18 with methadone, 51 with diacetylmorphine, and 10 with hydromorphone. Overdoses and seizures were the most common serious adverse events associated with diacetylmorphine.

“Sixteen of the 115 patients randomly assigned to receive diacetylmorphine had a life-threatening overdose or seizure during the study. Because the study included close medical supervision, these serious adverse events were promptly treated, and all patients recovered,” the investigators noted.

No potential conflicts of interest were reported.

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a recent report.

In a prospective, multicenter, observational study, 30-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445-54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005-2007, which was performed by 33 surgeons certified by the LABS consortium.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13%. Another 25% of the patients underwent laparoscopic adjustable gastric banding, and the remaining 4% had other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% with Roux-en-Y gastric bypass, and 7.8% with open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum said he has received grants from Sanofi-Aventis and Covidien AG and served as an expert witness on cases involving adverse events after bariatric surgery.

Patients who had a history of thrombotic disorders were at increased risk of poor outcomes.

Source DR. FLUM

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a recent report.

In a prospective, multicenter, observational study, 30-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445-54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005-2007, which was performed by 33 surgeons certified by the LABS consortium.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13%. Another 25% of the patients underwent laparoscopic adjustable gastric banding, and the remaining 4% had other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% with Roux-en-Y gastric bypass, and 7.8% with open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum said he has received grants from Sanofi-Aventis and Covidien AG and served as an expert witness on cases involving adverse events after bariatric surgery.

Patients who had a history of thrombotic disorders were at increased risk of poor outcomes.

Source DR. FLUM

The most common bariatric surgeries carry low rates of adverse perioperative outcomes when performed by experienced surgeons in established centers, according to a recent report.

In a prospective, multicenter, observational study, 30-day mortality was 0.3% and the rate of major complications was 4.1%, which are comparable to rates for other major operations. Those rates are considered low for bariatric surgery, because most patients are extremely obese and have multiple comorbid conditions, said Dr. David R. Flum of the University of Washington, Seattle, and his associates in the Longitudinal Assessment of Bariatric Surgery (LABS) study (N. Engl. J. Med. 2009;361:445-54).

The investigators evaluated 4,776 consecutive patients who underwent first-time bariatric surgery in 2005-2007, which was performed by 33 surgeons certified by the LABS consortium.

The most common procedure was Roux-en-Y gastric bypass (71% of patients), which was performed laparoscopically in 87% of cases and as an open procedure in 13%. Another 25% of the patients underwent laparoscopic adjustable gastric banding, and the remaining 4% had other bariatric procedures.

The primary outcome of the study was a composite end point of death, deep vein thrombosis, venous thromboembolism, reintervention, or failure to be discharged within 30 days. That occurred in 1% of the patients undergoing laparoscopic adjustable gastric banding, 4.8% with Roux-en-Y gastric bypass, and 7.8% with open Roux-en-Y gastric bypass.

Patients who had a history of thrombotic disorders, had poor functional status, or had sleep apnea were at increased risk of poor outcomes.

“Regardless of the type of procedure, the predicted probability of the composite end point was lowest among patients who did not have a history of deep vein thrombosis or venous thromboembolism or of obstructive sleep apnea, and who were in the middle range of the spectrum of body mass index for the cohort,” Dr. Flum and his colleagues said.

The researchers added that the study focused on perioperative adverse events. Another study that has just completed recruitment (LABS-2) will assess the long-term effects of bariatric surgery on health conditions, quality of life, health care costs, and psychosocial issues.

Dr. Flum said he has received grants from Sanofi-Aventis and Covidien AG and served as an expert witness on cases involving adverse events after bariatric surgery.

Patients who had a history of thrombotic disorders were at increased risk of poor outcomes.

Source DR. FLUM

Antioxidant supplements do not appear to increase the risk of melanoma, according to a large, population-based study.

None of the exposure variables examined—overall antioxidant use, duration of use over the past 10 years, total dosage expressed in pill-years, or years of adult use during adulthood—correlated with melanoma risk in either men or women, said Dr. Maryam M. Asgari of Kaiser Permanente Northern California, Oakland, and her associates.

They undertook this study because the Supplementation in Vitamins and Mineral Antioxidants (SUVIMAX) study, a primary prevention trial published in 2007, found that daily oral supplementation with a combination of antioxidants raised the incidence of melanoma in women. The SUVIMAX findings were alarming, given that an estimated 48%–55% of American adults use supplements regularly, Dr. Asgari and her colleagues wrote.

They further examined the issue in a cohort of 69,671 adults who answered a 24-page questionnaire regarding health history, lifestyle factors, diet, supplement use, and cancer risk factors. They focused on the five antioxidants assessed in the SUVIMAX trial: vitamin C, vitamin E, zinc, beta carotene, and selenium.

Most of the study subjects (66%) were either current or former users of multivitamins. During 7 years of follow-up there were 461 incident cases of cutaneous melanoma.

Antioxidants were not associated with the disease. “Specifically, in the highest dose category of multivitamins … there was no increased risk of melanoma. Results were similar in men and women,” the investigators wrote (Arch. Dermatol. 2009;145:879–82).

Moreover, since many people take multivitamins plus additional beta carotene and selenium supplements, comparably high doses of these two nutrients were tested in a separate analysis. Again, no increased risk of melanoma was found and the results were the same for women and men.

It is likely that the SUVIMAX findings “could be explained by methodological shortcomings,” Dr. Asgari and her associates wrote.

In that study, subjects answered only a single question pertaining to their lifetime sun exposure, and “the analysis was based on only 16 cases” of melanoma. In addition, the incidence of melanoma in the SUVIMAX population was only 25 cases per 100,000 person-years—one-fifth the rate in the current study.

The work of Dr. Asgari and her associates was supported in part by the National Institute of Arthritis, Musculoskeletal and Skin Diseases and the National Cancer Institute. No financial conflicts of interest were reported.

Antioxidant supplements do not appear to increase the risk of melanoma, according to a large, population-based study.

None of the exposure variables examined—overall antioxidant use, duration of use over the past 10 years, total dosage expressed in pill-years, or years of adult use during adulthood—correlated with melanoma risk in either men or women, said Dr. Maryam M. Asgari of Kaiser Permanente Northern California, Oakland, and her associates.

They undertook this study because the Supplementation in Vitamins and Mineral Antioxidants (SUVIMAX) study, a primary prevention trial published in 2007, found that daily oral supplementation with a combination of antioxidants raised the incidence of melanoma in women. The SUVIMAX findings were alarming, given that an estimated 48%–55% of American adults use supplements regularly, Dr. Asgari and her colleagues wrote.

They further examined the issue in a cohort of 69,671 adults who answered a 24-page questionnaire regarding health history, lifestyle factors, diet, supplement use, and cancer risk factors. They focused on the five antioxidants assessed in the SUVIMAX trial: vitamin C, vitamin E, zinc, beta carotene, and selenium.

Most of the study subjects (66%) were either current or former users of multivitamins. During 7 years of follow-up there were 461 incident cases of cutaneous melanoma.

Antioxidants were not associated with the disease. “Specifically, in the highest dose category of multivitamins … there was no increased risk of melanoma. Results were similar in men and women,” the investigators wrote (Arch. Dermatol. 2009;145:879–82).

Moreover, since many people take multivitamins plus additional beta carotene and selenium supplements, comparably high doses of these two nutrients were tested in a separate analysis. Again, no increased risk of melanoma was found and the results were the same for women and men.

It is likely that the SUVIMAX findings “could be explained by methodological shortcomings,” Dr. Asgari and her associates wrote.

In that study, subjects answered only a single question pertaining to their lifetime sun exposure, and “the analysis was based on only 16 cases” of melanoma. In addition, the incidence of melanoma in the SUVIMAX population was only 25 cases per 100,000 person-years—one-fifth the rate in the current study.

The work of Dr. Asgari and her associates was supported in part by the National Institute of Arthritis, Musculoskeletal and Skin Diseases and the National Cancer Institute. No financial conflicts of interest were reported.

Antioxidant supplements do not appear to increase the risk of melanoma, according to a large, population-based study.

None of the exposure variables examined—overall antioxidant use, duration of use over the past 10 years, total dosage expressed in pill-years, or years of adult use during adulthood—correlated with melanoma risk in either men or women, said Dr. Maryam M. Asgari of Kaiser Permanente Northern California, Oakland, and her associates.

They undertook this study because the Supplementation in Vitamins and Mineral Antioxidants (SUVIMAX) study, a primary prevention trial published in 2007, found that daily oral supplementation with a combination of antioxidants raised the incidence of melanoma in women. The SUVIMAX findings were alarming, given that an estimated 48%–55% of American adults use supplements regularly, Dr. Asgari and her colleagues wrote.

They further examined the issue in a cohort of 69,671 adults who answered a 24-page questionnaire regarding health history, lifestyle factors, diet, supplement use, and cancer risk factors. They focused on the five antioxidants assessed in the SUVIMAX trial: vitamin C, vitamin E, zinc, beta carotene, and selenium.

Most of the study subjects (66%) were either current or former users of multivitamins. During 7 years of follow-up there were 461 incident cases of cutaneous melanoma.

Antioxidants were not associated with the disease. “Specifically, in the highest dose category of multivitamins … there was no increased risk of melanoma. Results were similar in men and women,” the investigators wrote (Arch. Dermatol. 2009;145:879–82).

Moreover, since many people take multivitamins plus additional beta carotene and selenium supplements, comparably high doses of these two nutrients were tested in a separate analysis. Again, no increased risk of melanoma was found and the results were the same for women and men.

It is likely that the SUVIMAX findings “could be explained by methodological shortcomings,” Dr. Asgari and her associates wrote.

In that study, subjects answered only a single question pertaining to their lifetime sun exposure, and “the analysis was based on only 16 cases” of melanoma. In addition, the incidence of melanoma in the SUVIMAX population was only 25 cases per 100,000 person-years—one-fifth the rate in the current study.

The work of Dr. Asgari and her associates was supported in part by the National Institute of Arthritis, Musculoskeletal and Skin Diseases and the National Cancer Institute. No financial conflicts of interest were reported.

In patients attending a general dermatology practice, most melanomas diagnosed during a 3-year period were not the presenting complaint, but were only discovered because a dermatologist performed a full-body skin examination, according to a recent report.

Such melanomas, discovered incidentally during an unrelated office visit, were more likely to be thinner or in-situ lesions than those that were inquired about by the patient or someone who observed them on the patient, said Dr. Jonathan Kantor and Deborah E. Kantor, C.R.N.P., of North Florida Dermatology Associates, Jacksonville.

The U.S. Preventive Services Task Force has stated that current evidence is insufficient to recommend either for or against routine full-body melanoma screening, and previous studies of patients in tertiary referral centers have reported that physicians detect only 14%–34% of melanomas.

“Our aim was to determine the proportion of patients in a private dermatology practice in whom melanoma was detected but was not the presenting complaint. If a substantial proportion of melanomas are detected only after a dermatologist's examination, this may suggest that FBSE [full-body skin examination], and not simply a problem-focused approach, should at least be considered for selected patients,” the researchers said (Arch. Dermatol. 2009;145:873–6).

The findings also “may help to promote education and encourage future patients to avail themselves of full-body skin examination,” they added.

The investigators performed a retrospective case series of all patients diagnosed as having melanoma (51 cases) or melanoma in situ (75 cases) during a 3-year period. Patients were aged 15–92 years (mean age, 60 years).

A total of 56% of melanomas were discovered by a dermatologist and had not been noted by the patient, a spouse, a friend, or another physician. Similarly, 60% of the melanomas in situ were discovered by a dermatologist, they said.

“Moreover, we found that dermatologist detection was associated with thinner melanomas and an increasing likelihood of the melanoma being in-situ,” they said.

“Thus, full-body skin examinations confer both an absolute benefit (detecting most melanomas) as well as a clinically significant marginal benefit (detecting melanomas with less tumor thickness). We hope that these findings will help spur large population-based studies in high-risk populations to develop an evidence-based approach to determining appropriate screening practices and intervals,” the investigators added.

The researchers reported no financial disclosures.

In patients attending a general dermatology practice, most melanomas diagnosed during a 3-year period were not the presenting complaint, but were only discovered because a dermatologist performed a full-body skin examination, according to a recent report.

Such melanomas, discovered incidentally during an unrelated office visit, were more likely to be thinner or in-situ lesions than those that were inquired about by the patient or someone who observed them on the patient, said Dr. Jonathan Kantor and Deborah E. Kantor, C.R.N.P., of North Florida Dermatology Associates, Jacksonville.

The U.S. Preventive Services Task Force has stated that current evidence is insufficient to recommend either for or against routine full-body melanoma screening, and previous studies of patients in tertiary referral centers have reported that physicians detect only 14%–34% of melanomas.

“Our aim was to determine the proportion of patients in a private dermatology practice in whom melanoma was detected but was not the presenting complaint. If a substantial proportion of melanomas are detected only after a dermatologist's examination, this may suggest that FBSE [full-body skin examination], and not simply a problem-focused approach, should at least be considered for selected patients,” the researchers said (Arch. Dermatol. 2009;145:873–6).

The findings also “may help to promote education and encourage future patients to avail themselves of full-body skin examination,” they added.

The investigators performed a retrospective case series of all patients diagnosed as having melanoma (51 cases) or melanoma in situ (75 cases) during a 3-year period. Patients were aged 15–92 years (mean age, 60 years).

A total of 56% of melanomas were discovered by a dermatologist and had not been noted by the patient, a spouse, a friend, or another physician. Similarly, 60% of the melanomas in situ were discovered by a dermatologist, they said.

“Moreover, we found that dermatologist detection was associated with thinner melanomas and an increasing likelihood of the melanoma being in-situ,” they said.

“Thus, full-body skin examinations confer both an absolute benefit (detecting most melanomas) as well as a clinically significant marginal benefit (detecting melanomas with less tumor thickness). We hope that these findings will help spur large population-based studies in high-risk populations to develop an evidence-based approach to determining appropriate screening practices and intervals,” the investigators added.

The researchers reported no financial disclosures.

In patients attending a general dermatology practice, most melanomas diagnosed during a 3-year period were not the presenting complaint, but were only discovered because a dermatologist performed a full-body skin examination, according to a recent report.

Such melanomas, discovered incidentally during an unrelated office visit, were more likely to be thinner or in-situ lesions than those that were inquired about by the patient or someone who observed them on the patient, said Dr. Jonathan Kantor and Deborah E. Kantor, C.R.N.P., of North Florida Dermatology Associates, Jacksonville.

The U.S. Preventive Services Task Force has stated that current evidence is insufficient to recommend either for or against routine full-body melanoma screening, and previous studies of patients in tertiary referral centers have reported that physicians detect only 14%–34% of melanomas.

“Our aim was to determine the proportion of patients in a private dermatology practice in whom melanoma was detected but was not the presenting complaint. If a substantial proportion of melanomas are detected only after a dermatologist's examination, this may suggest that FBSE [full-body skin examination], and not simply a problem-focused approach, should at least be considered for selected patients,” the researchers said (Arch. Dermatol. 2009;145:873–6).

The findings also “may help to promote education and encourage future patients to avail themselves of full-body skin examination,” they added.

The investigators performed a retrospective case series of all patients diagnosed as having melanoma (51 cases) or melanoma in situ (75 cases) during a 3-year period. Patients were aged 15–92 years (mean age, 60 years).

A total of 56% of melanomas were discovered by a dermatologist and had not been noted by the patient, a spouse, a friend, or another physician. Similarly, 60% of the melanomas in situ were discovered by a dermatologist, they said.

“Moreover, we found that dermatologist detection was associated with thinner melanomas and an increasing likelihood of the melanoma being in-situ,” they said.

“Thus, full-body skin examinations confer both an absolute benefit (detecting most melanomas) as well as a clinically significant marginal benefit (detecting melanomas with less tumor thickness). We hope that these findings will help spur large population-based studies in high-risk populations to develop an evidence-based approach to determining appropriate screening practices and intervals,” the investigators added.

The researchers reported no financial disclosures.

The glutamate modulator N-acetylcysteine significantly reduces trichotillomania symptoms, according to a study of 50 patients.

In what the investigators described as the first clinical trial assessing a glutamatergic agent for this disorder, N-acetylcysteine was judged effective by both patients and physicians, to a degree comparable with other medications plus cognitive-behavioral therapy.

“N-acetylcysteine is an amino acid, is available in health-food stores, is cheaper than most insurance copayments, and seems to be well tolerated. [It] could be an effective treatment option for people with trichotillomania,” said Dr. Jon E. Grant and his associates at the University of Minnesota, Minneapolis (Arch. Gen. Psychiatry 2009;66:756–63).

Moreover, the study results indicate that “pharmacologic manipulation of the glutamate system (in the nucleus accumbens) may target core symptoms of compulsive behaviors,” they added.

Trichotillomania is the recurrent pulling out of hair—head hair, eyebrows, eyelashes, pubic hair, or other body hair—to obtain relief of tension, which leads to noticeable hair loss. There is no Food and Drug Administration-approved treatment for trichotillomania at present, but glutamatergic dysfunction has been implicated in the pathogenesis of disorders that have a compulsive component, and glutamate modulators like N-acetylcysteine have been used to treat cocaine urges and gambling behavior.

Dr. Grant and his colleagues assessed the agent in 45 women and 5 men (mean age, 34 years) who reported spending a mean of 65 minutes every day pulling out hair, usually from multiple sites. Most of these patients had never sought mental health treatment for hair pulling.

Thirty of the study subjects (60%) reported having at least one clinically important comorbid disorder, such as major depressive disorder; an anxiety disorder; another impulse-control disorder, such as skin picking or nail biting; or an eating disorder. Four patients were receiving psychotherapy, and 28 were taking a psychotropic medication or a stimulant.

Subjects were randomly assigned to receive 12 weeks of N-acetylcysteine or a matching placebo. A significant treatment effect was evident at 9 weeks and persisted for the duration of the study.

At the conclusion of treatment, those who had taken N-acetylcysteine showed significant improvement on both the severity subscale and the “resistance and control” subscale of the Massachusetts General Hospital Hairpulling Scale, as well as on the Psychiatric Institute Trichotillomania Scale.

A total of 56% of those in the active-treatment group said they were “much” or “very much” improved on the Clinical Global Impression (CGI) scale, compared with 16% of the placebo group.

Patients who received N-acetylcysteine did not show a greater improvement in psychosocial functioning than those who received placebo. However, this sample may have been too small to detect a meaningful difference between the two groups, given that at baseline, most of the subjects had only mild psychosocial dysfunction and reported a quality of life in the “average” range, Dr. Grant and his associates said.

Dr. Grant has received research grants from Forest Pharmaceuticals, GlaxoSmithKline, and Somaxon Pharmaceuticals and has served as a consultant to Pfizer Pharmaceuticals and Somaxon. In addition, Dr. Grant, who also is a lawyer, has consulted for law offices as an expert regarding impulse control disorders.

This patient extracted most of the hair from a wide area of the scalp.

Source ©Elsevier 2004, Habif: Clinical Dermatology, 4th ed.

The glutamate modulator N-acetylcysteine significantly reduces trichotillomania symptoms, according to a study of 50 patients.

In what the investigators described as the first clinical trial assessing a glutamatergic agent for this disorder, N-acetylcysteine was judged effective by both patients and physicians, to a degree comparable with other medications plus cognitive-behavioral therapy.

“N-acetylcysteine is an amino acid, is available in health-food stores, is cheaper than most insurance copayments, and seems to be well tolerated. [It] could be an effective treatment option for people with trichotillomania,” said Dr. Jon E. Grant and his associates at the University of Minnesota, Minneapolis (Arch. Gen. Psychiatry 2009;66:756–63).

Moreover, the study results indicate that “pharmacologic manipulation of the glutamate system (in the nucleus accumbens) may target core symptoms of compulsive behaviors,” they added.

Trichotillomania is the recurrent pulling out of hair—head hair, eyebrows, eyelashes, pubic hair, or other body hair—to obtain relief of tension, which leads to noticeable hair loss. There is no Food and Drug Administration-approved treatment for trichotillomania at present, but glutamatergic dysfunction has been implicated in the pathogenesis of disorders that have a compulsive component, and glutamate modulators like N-acetylcysteine have been used to treat cocaine urges and gambling behavior.

Dr. Grant and his colleagues assessed the agent in 45 women and 5 men (mean age, 34 years) who reported spending a mean of 65 minutes every day pulling out hair, usually from multiple sites. Most of these patients had never sought mental health treatment for hair pulling.

Thirty of the study subjects (60%) reported having at least one clinically important comorbid disorder, such as major depressive disorder; an anxiety disorder; another impulse-control disorder, such as skin picking or nail biting; or an eating disorder. Four patients were receiving psychotherapy, and 28 were taking a psychotropic medication or a stimulant.

Subjects were randomly assigned to receive 12 weeks of N-acetylcysteine or a matching placebo. A significant treatment effect was evident at 9 weeks and persisted for the duration of the study.

At the conclusion of treatment, those who had taken N-acetylcysteine showed significant improvement on both the severity subscale and the “resistance and control” subscale of the Massachusetts General Hospital Hairpulling Scale, as well as on the Psychiatric Institute Trichotillomania Scale.

A total of 56% of those in the active-treatment group said they were “much” or “very much” improved on the Clinical Global Impression (CGI) scale, compared with 16% of the placebo group.

Patients who received N-acetylcysteine did not show a greater improvement in psychosocial functioning than those who received placebo. However, this sample may have been too small to detect a meaningful difference between the two groups, given that at baseline, most of the subjects had only mild psychosocial dysfunction and reported a quality of life in the “average” range, Dr. Grant and his associates said.

Dr. Grant has received research grants from Forest Pharmaceuticals, GlaxoSmithKline, and Somaxon Pharmaceuticals and has served as a consultant to Pfizer Pharmaceuticals and Somaxon. In addition, Dr. Grant, who also is a lawyer, has consulted for law offices as an expert regarding impulse control disorders.

This patient extracted most of the hair from a wide area of the scalp.

Source ©Elsevier 2004, Habif: Clinical Dermatology, 4th ed.

The glutamate modulator N-acetylcysteine significantly reduces trichotillomania symptoms, according to a study of 50 patients.

In what the investigators described as the first clinical trial assessing a glutamatergic agent for this disorder, N-acetylcysteine was judged effective by both patients and physicians, to a degree comparable with other medications plus cognitive-behavioral therapy.

“N-acetylcysteine is an amino acid, is available in health-food stores, is cheaper than most insurance copayments, and seems to be well tolerated. [It] could be an effective treatment option for people with trichotillomania,” said Dr. Jon E. Grant and his associates at the University of Minnesota, Minneapolis (Arch. Gen. Psychiatry 2009;66:756–63).

Moreover, the study results indicate that “pharmacologic manipulation of the glutamate system (in the nucleus accumbens) may target core symptoms of compulsive behaviors,” they added.

Trichotillomania is the recurrent pulling out of hair—head hair, eyebrows, eyelashes, pubic hair, or other body hair—to obtain relief of tension, which leads to noticeable hair loss. There is no Food and Drug Administration-approved treatment for trichotillomania at present, but glutamatergic dysfunction has been implicated in the pathogenesis of disorders that have a compulsive component, and glutamate modulators like N-acetylcysteine have been used to treat cocaine urges and gambling behavior.

Dr. Grant and his colleagues assessed the agent in 45 women and 5 men (mean age, 34 years) who reported spending a mean of 65 minutes every day pulling out hair, usually from multiple sites. Most of these patients had never sought mental health treatment for hair pulling.

Thirty of the study subjects (60%) reported having at least one clinically important comorbid disorder, such as major depressive disorder; an anxiety disorder; another impulse-control disorder, such as skin picking or nail biting; or an eating disorder. Four patients were receiving psychotherapy, and 28 were taking a psychotropic medication or a stimulant.

Subjects were randomly assigned to receive 12 weeks of N-acetylcysteine or a matching placebo. A significant treatment effect was evident at 9 weeks and persisted for the duration of the study.

At the conclusion of treatment, those who had taken N-acetylcysteine showed significant improvement on both the severity subscale and the “resistance and control” subscale of the Massachusetts General Hospital Hairpulling Scale, as well as on the Psychiatric Institute Trichotillomania Scale.

A total of 56% of those in the active-treatment group said they were “much” or “very much” improved on the Clinical Global Impression (CGI) scale, compared with 16% of the placebo group.

Patients who received N-acetylcysteine did not show a greater improvement in psychosocial functioning than those who received placebo. However, this sample may have been too small to detect a meaningful difference between the two groups, given that at baseline, most of the subjects had only mild psychosocial dysfunction and reported a quality of life in the “average” range, Dr. Grant and his associates said.

Dr. Grant has received research grants from Forest Pharmaceuticals, GlaxoSmithKline, and Somaxon Pharmaceuticals and has served as a consultant to Pfizer Pharmaceuticals and Somaxon. In addition, Dr. Grant, who also is a lawyer, has consulted for law offices as an expert regarding impulse control disorders.

This patient extracted most of the hair from a wide area of the scalp.

Source ©Elsevier 2004, Habif: Clinical Dermatology, 4th ed.

High plasma adiponectin levels consistently correlate with lower risk for type 2 diabetes across many different populations, according to a literature review.

This finding places adiponectin “among the strongest and most consistent biochemical predictors of type 2 diabetes,” said Dr. Shanshan Li of Harvard School of Public Health, Boston, and associates.

The researchers performed a literature review and meta-analysis of 13 prospective studies that recorded adiponectin levels from blood samples collected before the onset of diabetes and followed study subjects for at least 1 year to track the development of the disease. There were 14,598 subjects all together, of whom 2,623 developed type 2 diabetes.

The pooled analysis showed that the relative risk of type 2 diabetes was 0.72 per 1-log mcg/mL increment in adiponectin levels, a highly significant result. “We observed a substantial inverse association between plasma adiponectin level and incidence of type 2 diabetes. Risk of type 2 diabetes appeared to decrease monotonically with increasing adiponectin levels.

“The association was consistent for whites, East Asians, Asian Indians, African Americans, and Native Americans,” Dr. Li and colleagues reported (JAMA 2009;302:179-88).

The correlation also was consistent despite substantial differences in study populations and methods, remaining strong despite the use of different adiponectin assays, methods of ascertaining diabetes, durations of follow-up, mean body mass index of subjects, and proportions of male and female subjects.

Although this meta-analysis could not determine whether low adiponectin levels exert a causal effect on diabetes or are simply a marker of risk, “the consistency of the association across diverse populations, the dose-response relationship, and the supportive findings in mechanistic studies indicate that adiponectin is a promising target for the reduction of risk of type 2 diabetes,” the investigators noted.

“Recent studies have shown that adiponectin levels can be increased through pharmaceutical and lifestyle interventions,” they added.

The investigators did not disclose any potential financial conflicts of interest.

High plasma adiponectin levels consistently correlate with lower risk for type 2 diabetes across many different populations, according to a literature review.

This finding places adiponectin “among the strongest and most consistent biochemical predictors of type 2 diabetes,” said Dr. Shanshan Li of Harvard School of Public Health, Boston, and associates.

The researchers performed a literature review and meta-analysis of 13 prospective studies that recorded adiponectin levels from blood samples collected before the onset of diabetes and followed study subjects for at least 1 year to track the development of the disease. There were 14,598 subjects all together, of whom 2,623 developed type 2 diabetes.

The pooled analysis showed that the relative risk of type 2 diabetes was 0.72 per 1-log mcg/mL increment in adiponectin levels, a highly significant result. “We observed a substantial inverse association between plasma adiponectin level and incidence of type 2 diabetes. Risk of type 2 diabetes appeared to decrease monotonically with increasing adiponectin levels.

“The association was consistent for whites, East Asians, Asian Indians, African Americans, and Native Americans,” Dr. Li and colleagues reported (JAMA 2009;302:179-88).

The correlation also was consistent despite substantial differences in study populations and methods, remaining strong despite the use of different adiponectin assays, methods of ascertaining diabetes, durations of follow-up, mean body mass index of subjects, and proportions of male and female subjects.

Although this meta-analysis could not determine whether low adiponectin levels exert a causal effect on diabetes or are simply a marker of risk, “the consistency of the association across diverse populations, the dose-response relationship, and the supportive findings in mechanistic studies indicate that adiponectin is a promising target for the reduction of risk of type 2 diabetes,” the investigators noted.

“Recent studies have shown that adiponectin levels can be increased through pharmaceutical and lifestyle interventions,” they added.

The investigators did not disclose any potential financial conflicts of interest.

High plasma adiponectin levels consistently correlate with lower risk for type 2 diabetes across many different populations, according to a literature review.

This finding places adiponectin “among the strongest and most consistent biochemical predictors of type 2 diabetes,” said Dr. Shanshan Li of Harvard School of Public Health, Boston, and associates.

The researchers performed a literature review and meta-analysis of 13 prospective studies that recorded adiponectin levels from blood samples collected before the onset of diabetes and followed study subjects for at least 1 year to track the development of the disease. There were 14,598 subjects all together, of whom 2,623 developed type 2 diabetes.

The pooled analysis showed that the relative risk of type 2 diabetes was 0.72 per 1-log mcg/mL increment in adiponectin levels, a highly significant result. “We observed a substantial inverse association between plasma adiponectin level and incidence of type 2 diabetes. Risk of type 2 diabetes appeared to decrease monotonically with increasing adiponectin levels.

“The association was consistent for whites, East Asians, Asian Indians, African Americans, and Native Americans,” Dr. Li and colleagues reported (JAMA 2009;302:179-88).

The correlation also was consistent despite substantial differences in study populations and methods, remaining strong despite the use of different adiponectin assays, methods of ascertaining diabetes, durations of follow-up, mean body mass index of subjects, and proportions of male and female subjects.

Although this meta-analysis could not determine whether low adiponectin levels exert a causal effect on diabetes or are simply a marker of risk, “the consistency of the association across diverse populations, the dose-response relationship, and the supportive findings in mechanistic studies indicate that adiponectin is a promising target for the reduction of risk of type 2 diabetes,” the investigators noted.

“Recent studies have shown that adiponectin levels can be increased through pharmaceutical and lifestyle interventions,” they added.

The investigators did not disclose any potential financial conflicts of interest.