Sarah Safranek, MLIS

Evidence summary

A 2005 meta-analysis evaluated the effectiveness of HA injections for osteoarthritis of the knee compared with saline placebo. Researchers identified 22 studies of 8 HA products that used the common end point of pain with movement.¹ (TABLE 1 lists FDA-approved HA products available in the United States.²) A decrease in pain of 15% was deemed clinically meaningful.

Compared with placebo, the mean difference in pain scores with HA products was -4% (95% confidence interval [CI], -9% to 1%) after 2 to 6 weeks; -4% (95% CI, -8% to -1%) after 10 to 14 weeks; and -7% (95% CI, -12% to -2%) after 22 to 30 weeks. The authors note that the small measured effect of HA was magnified by trials that didn’t report intention-to-treat results. The effect of HA was also larger in studies that didn’t conceal allocation. A weakness of the analysis was its inability to assess potential differences between HA products.

In this 2005 meta-analysis, HA injection didn’t improve knee function in any time interval. But in a Cochrane meta-analysis conducted the following year, HA was found to have positive results.³

TABLE 1
FDA-approved hyaluronic acid products

HA relieves pain about as much as NSAIDs

The comprehensive 2006 Cochrane meta-analysis reviewed single- and double-blinded RCTs that evaluated the effect of 12 HA products on osteoarthritis of the knee.³ Studies compared HA products with placebo (40), intra-articular steroids (10), NSAIDs (6), physical therapy (3), exercise (2), and each other (15). Efficacy data for different products couldn’t be combined because the studies measured different sets of outcomes at different time points.

Overall, the authors concluded that HA injections effectively reduced pain scores, with the largest benefit occurring within 5 to 13 weeks (TABLE 2). The authors also noted that the reductions in pain with HA injections, although generally small, were comparable to oral NSAID therapy and intra-articular corticosteroids. The trials reported few adverse events.

Two RCTs show no difference in efficacy among HA products

The Cochrane review determined that not enough evidence existed to evaluate HA products against each other. Two subsequent RCTs compared HA products and found no differences in efficacy. One study compared Synvisc, Orthovisc, and Ostenil therapy in 660 patients over 6 months.⁴ The other compared Synvisc with Euflexxa in 321 patients over 3 months.⁵ Notably, 8% of patients in this study who used Synvisc developed an effusion, compared with 0.6% of patients who used Euflexxa (P=.0015).

Recommendations

A 2007 report from the Agency for Healthcare Research and Quality (AHRQ) states that “viscosupplementation trials generally report positive effects on pain and function scores compared with placebo, but the evidence on clinical benefit is uncertain.”⁶

The 2007 guidelines of the Institute for Clinical Systems Improvement note that synthetic hyaluronates “may be effective” in selected patients with mild to moderate degenerative joint disease (based on evidence of middle quality on a 3-tier grading system).⁷

The American Academy of Orthopaedic Surgeons 2008 guideline on osteoarthritis of the knee indicates that, based on the AHRQ report,⁶ it cannot recommend for or against the use of intra-articular hyaluronic acid for mild to moderate symptomatic OA of the knee.⁸

TABLE 2
How HA products affect pain measures

Evidence summary

A 2005 meta-analysis evaluated the effectiveness of HA injections for osteoarthritis of the knee compared with saline placebo. Researchers identified 22 studies of 8 HA products that used the common end point of pain with movement.¹ (TABLE 1 lists FDA-approved HA products available in the United States.²) A decrease in pain of 15% was deemed clinically meaningful.

Compared with placebo, the mean difference in pain scores with HA products was -4% (95% confidence interval [CI], -9% to 1%) after 2 to 6 weeks; -4% (95% CI, -8% to -1%) after 10 to 14 weeks; and -7% (95% CI, -12% to -2%) after 22 to 30 weeks. The authors note that the small measured effect of HA was magnified by trials that didn’t report intention-to-treat results. The effect of HA was also larger in studies that didn’t conceal allocation. A weakness of the analysis was its inability to assess potential differences between HA products.

In this 2005 meta-analysis, HA injection didn’t improve knee function in any time interval. But in a Cochrane meta-analysis conducted the following year, HA was found to have positive results.³

TABLE 1
FDA-approved hyaluronic acid products

HA relieves pain about as much as NSAIDs

The comprehensive 2006 Cochrane meta-analysis reviewed single- and double-blinded RCTs that evaluated the effect of 12 HA products on osteoarthritis of the knee.³ Studies compared HA products with placebo (40), intra-articular steroids (10), NSAIDs (6), physical therapy (3), exercise (2), and each other (15). Efficacy data for different products couldn’t be combined because the studies measured different sets of outcomes at different time points.

Overall, the authors concluded that HA injections effectively reduced pain scores, with the largest benefit occurring within 5 to 13 weeks (TABLE 2). The authors also noted that the reductions in pain with HA injections, although generally small, were comparable to oral NSAID therapy and intra-articular corticosteroids. The trials reported few adverse events.

Two RCTs show no difference in efficacy among HA products

The Cochrane review determined that not enough evidence existed to evaluate HA products against each other. Two subsequent RCTs compared HA products and found no differences in efficacy. One study compared Synvisc, Orthovisc, and Ostenil therapy in 660 patients over 6 months.⁴ The other compared Synvisc with Euflexxa in 321 patients over 3 months.⁵ Notably, 8% of patients in this study who used Synvisc developed an effusion, compared with 0.6% of patients who used Euflexxa (P=.0015).

Recommendations

A 2007 report from the Agency for Healthcare Research and Quality (AHRQ) states that “viscosupplementation trials generally report positive effects on pain and function scores compared with placebo, but the evidence on clinical benefit is uncertain.”⁶

The 2007 guidelines of the Institute for Clinical Systems Improvement note that synthetic hyaluronates “may be effective” in selected patients with mild to moderate degenerative joint disease (based on evidence of middle quality on a 3-tier grading system).⁷

The American Academy of Orthopaedic Surgeons 2008 guideline on osteoarthritis of the knee indicates that, based on the AHRQ report,⁶ it cannot recommend for or against the use of intra-articular hyaluronic acid for mild to moderate symptomatic OA of the knee.⁸

TABLE 2
How HA products affect pain measures

Evidence summary

A 2005 meta-analysis evaluated the effectiveness of HA injections for osteoarthritis of the knee compared with saline placebo. Researchers identified 22 studies of 8 HA products that used the common end point of pain with movement.¹ (TABLE 1 lists FDA-approved HA products available in the United States.²) A decrease in pain of 15% was deemed clinically meaningful.

Compared with placebo, the mean difference in pain scores with HA products was -4% (95% confidence interval [CI], -9% to 1%) after 2 to 6 weeks; -4% (95% CI, -8% to -1%) after 10 to 14 weeks; and -7% (95% CI, -12% to -2%) after 22 to 30 weeks. The authors note that the small measured effect of HA was magnified by trials that didn’t report intention-to-treat results. The effect of HA was also larger in studies that didn’t conceal allocation. A weakness of the analysis was its inability to assess potential differences between HA products.

In this 2005 meta-analysis, HA injection didn’t improve knee function in any time interval. But in a Cochrane meta-analysis conducted the following year, HA was found to have positive results.³

TABLE 1
FDA-approved hyaluronic acid products

HA relieves pain about as much as NSAIDs

The comprehensive 2006 Cochrane meta-analysis reviewed single- and double-blinded RCTs that evaluated the effect of 12 HA products on osteoarthritis of the knee.³ Studies compared HA products with placebo (40), intra-articular steroids (10), NSAIDs (6), physical therapy (3), exercise (2), and each other (15). Efficacy data for different products couldn’t be combined because the studies measured different sets of outcomes at different time points.

Overall, the authors concluded that HA injections effectively reduced pain scores, with the largest benefit occurring within 5 to 13 weeks (TABLE 2). The authors also noted that the reductions in pain with HA injections, although generally small, were comparable to oral NSAID therapy and intra-articular corticosteroids. The trials reported few adverse events.

Two RCTs show no difference in efficacy among HA products

The Cochrane review determined that not enough evidence existed to evaluate HA products against each other. Two subsequent RCTs compared HA products and found no differences in efficacy. One study compared Synvisc, Orthovisc, and Ostenil therapy in 660 patients over 6 months.⁴ The other compared Synvisc with Euflexxa in 321 patients over 3 months.⁵ Notably, 8% of patients in this study who used Synvisc developed an effusion, compared with 0.6% of patients who used Euflexxa (P=.0015).

Recommendations

A 2007 report from the Agency for Healthcare Research and Quality (AHRQ) states that “viscosupplementation trials generally report positive effects on pain and function scores compared with placebo, but the evidence on clinical benefit is uncertain.”⁶

The 2007 guidelines of the Institute for Clinical Systems Improvement note that synthetic hyaluronates “may be effective” in selected patients with mild to moderate degenerative joint disease (based on evidence of middle quality on a 3-tier grading system).⁷

The American Academy of Orthopaedic Surgeons 2008 guideline on osteoarthritis of the knee indicates that, based on the AHRQ report,⁶ it cannot recommend for or against the use of intra-articular hyaluronic acid for mild to moderate symptomatic OA of the knee.⁸

TABLE 2
How HA products affect pain measures

Evidence summary

Two prospective cohort studies have looked at the usefulness of clinical characteristics to help differentiate MRSA from MSSA infections. The studies—a 2002 observational study of 144 children and a 2007 study of 180 consecutively enrolled adults—found no clear distinguishing features for MRSA.^1,2 They did note some commonly associated risk factors, however (TABLE).^2,3

Abscess formation was the most common presentation of CA-MRSA, followed by purulent cellulitis.^3,4 The prevalence and incidence of nonpurulent CA-MRSA is not well defined.

TABLE
Is it MRSA? A look at the odds

Best treatment bet: Incision and drainage

Incision and drainage remains the mainstay of abscess treatment.^3,5 A 2007 RCT of 166 indigent, inner-city patients with confirmed MRSA investigated combining incision and drainage with 7 days of therapy using either cephalexin or placebo. The primary outcome was clinical cure or failure 7 days after incision and drainage. The trial found no advantage to adding antibiotics; MRSA would likely be resistant to cephalexin in any case.⁶

A 2006 summary from Clinical Evidence found no RCT support for any outpatient antibiotic.⁷ No evidence exists that intranasal mupirocin or antiseptic body washes reduce the recurrence rate.⁷ We found no studies evaluating the optimal treatment of purulent skin and soft tissue infections without abscesses.

Avoid fluoroquinolones

MRSA isolates demonstrate a high resistance to fluoroquinolones, so this class of drugs isn’t recommended.³

Recommendations

The Centers for Disease Control and Prevention (CDC) recommends the following treatment for CA-MRSA:

• drain all abscesses; incision and drainage alone suffices for immunocompetent patients
• for other patients, consider adjunct treatment with clindamycin, trim-ethoprim and sulfamethoxazole, tetracyclines, or linezolid.

The CDC also recommends consulting an infectious disease specialist before using linezolid and avoiding fluoroquinolone and macrolide antibiotics because resistance develops rapidly.⁸ Rifampin can be used in combination with other standard treatments.⁸

The CDC doesn’t recommend treating nonpurulent skin infections with CA-MRSA-specific antibiotics. These infections are generally caused by Streptococcus pyogenes and remain sensitive to β-lactam antibiotics. When the community prevalence of CA-MRSA is low, a β-lactam antibiotic can be used with close follow-up.⁸

The Infectious Diseases Society of America recommends incision and drainage for abscesses and treatment with CA-MRSA-specific antibiotics for purulent skin infections.⁹

Evidence summary

Two prospective cohort studies have looked at the usefulness of clinical characteristics to help differentiate MRSA from MSSA infections. The studies—a 2002 observational study of 144 children and a 2007 study of 180 consecutively enrolled adults—found no clear distinguishing features for MRSA.^1,2 They did note some commonly associated risk factors, however (TABLE).^2,3

Abscess formation was the most common presentation of CA-MRSA, followed by purulent cellulitis.^3,4 The prevalence and incidence of nonpurulent CA-MRSA is not well defined.

TABLE
Is it MRSA? A look at the odds

Best treatment bet: Incision and drainage

Incision and drainage remains the mainstay of abscess treatment.^3,5 A 2007 RCT of 166 indigent, inner-city patients with confirmed MRSA investigated combining incision and drainage with 7 days of therapy using either cephalexin or placebo. The primary outcome was clinical cure or failure 7 days after incision and drainage. The trial found no advantage to adding antibiotics; MRSA would likely be resistant to cephalexin in any case.⁶

A 2006 summary from Clinical Evidence found no RCT support for any outpatient antibiotic.⁷ No evidence exists that intranasal mupirocin or antiseptic body washes reduce the recurrence rate.⁷ We found no studies evaluating the optimal treatment of purulent skin and soft tissue infections without abscesses.

Avoid fluoroquinolones

MRSA isolates demonstrate a high resistance to fluoroquinolones, so this class of drugs isn’t recommended.³

Recommendations

The Centers for Disease Control and Prevention (CDC) recommends the following treatment for CA-MRSA:

• drain all abscesses; incision and drainage alone suffices for immunocompetent patients
• for other patients, consider adjunct treatment with clindamycin, trim-ethoprim and sulfamethoxazole, tetracyclines, or linezolid.

The CDC also recommends consulting an infectious disease specialist before using linezolid and avoiding fluoroquinolone and macrolide antibiotics because resistance develops rapidly.⁸ Rifampin can be used in combination with other standard treatments.⁸

The CDC doesn’t recommend treating nonpurulent skin infections with CA-MRSA-specific antibiotics. These infections are generally caused by Streptococcus pyogenes and remain sensitive to β-lactam antibiotics. When the community prevalence of CA-MRSA is low, a β-lactam antibiotic can be used with close follow-up.⁸

The Infectious Diseases Society of America recommends incision and drainage for abscesses and treatment with CA-MRSA-specific antibiotics for purulent skin infections.⁹

Evidence summary

Two prospective cohort studies have looked at the usefulness of clinical characteristics to help differentiate MRSA from MSSA infections. The studies—a 2002 observational study of 144 children and a 2007 study of 180 consecutively enrolled adults—found no clear distinguishing features for MRSA.^1,2 They did note some commonly associated risk factors, however (TABLE).^2,3

Abscess formation was the most common presentation of CA-MRSA, followed by purulent cellulitis.^3,4 The prevalence and incidence of nonpurulent CA-MRSA is not well defined.

TABLE
Is it MRSA? A look at the odds

Best treatment bet: Incision and drainage

Incision and drainage remains the mainstay of abscess treatment.^3,5 A 2007 RCT of 166 indigent, inner-city patients with confirmed MRSA investigated combining incision and drainage with 7 days of therapy using either cephalexin or placebo. The primary outcome was clinical cure or failure 7 days after incision and drainage. The trial found no advantage to adding antibiotics; MRSA would likely be resistant to cephalexin in any case.⁶

A 2006 summary from Clinical Evidence found no RCT support for any outpatient antibiotic.⁷ No evidence exists that intranasal mupirocin or antiseptic body washes reduce the recurrence rate.⁷ We found no studies evaluating the optimal treatment of purulent skin and soft tissue infections without abscesses.

Avoid fluoroquinolones

MRSA isolates demonstrate a high resistance to fluoroquinolones, so this class of drugs isn’t recommended.³

Recommendations

The Centers for Disease Control and Prevention (CDC) recommends the following treatment for CA-MRSA:

• drain all abscesses; incision and drainage alone suffices for immunocompetent patients
• for other patients, consider adjunct treatment with clindamycin, trim-ethoprim and sulfamethoxazole, tetracyclines, or linezolid.

The CDC also recommends consulting an infectious disease specialist before using linezolid and avoiding fluoroquinolone and macrolide antibiotics because resistance develops rapidly.⁸ Rifampin can be used in combination with other standard treatments.⁸

The CDC doesn’t recommend treating nonpurulent skin infections with CA-MRSA-specific antibiotics. These infections are generally caused by Streptococcus pyogenes and remain sensitive to β-lactam antibiotics. When the community prevalence of CA-MRSA is low, a β-lactam antibiotic can be used with close follow-up.⁸

The Infectious Diseases Society of America recommends incision and drainage for abscesses and treatment with CA-MRSA-specific antibiotics for purulent skin infections.⁹

Evidence summary

Parent education reduces clinic visits for asthmatic children

A 2001 trial randomized 81 families with a smoking parent and an asthmatic child between 3 and 12 years of age to 3 sessions of behavioral and educational counseling or usual care at an outpatient asthma clinic.¹ Parental education included information on second-hand smoke, basic asthma education, and feedback about urine cotinine levels (a marker of nicotine absorption). Behavioral counseling focused on reducing second-hand smoke exposure by caregivers.

The education group had a significantly reduced risk of 2 or more asthma-related clinic visits in the following 12 months compared with usual care (odds ratio=0.32; P=.03; number needed to treat=5). No significant decrease was noted in mean urine cotinine levels between groups (adjusted mean difference=-0.38 ng/mg favoring education; P=.26).

A similar trial that measured changes in urine cotinine randomized 91 families with a smoking parent and an asthmatic child into 3 groups:²

• A control group received usual care (regular office visits at an asthma clinic and medication management)
• A monitoring group used a parental smoking diary and a children’s asthma symptom diary
• A counseling group received 5 counseling sessions and also kept diaries. An environmental monitor in the home was used to assess exposure to secondhand smoke.

In the counseling group, 21.4% of patients (6 of 28) maintained 0% exposure throughout the 30-month trial period compared with 3.6% and 3.8% in the monitoring and control groups, respectively (P<.05 for comparison of counseling group to monitoring and control).

Banning indoor smoking sharply cuts nicotine exposure

No data are available on education about second-hand smoke in families with nonasthmatic children. However, strong evidence suggests that smoking outside the house reduces exposure generally.

A 2003 cross-sectional survey of 164 households in the United Kingdom with at least 1 smoking parent and 1 bottle-fed infant looked for a correlation between strategies to reduce second-hand smoke and urine cotinine-to-creatinine ratios in the infants.³ Parents were classified into 3 groups according to whether they maintained a strict ban on smoking in the home, a less strict ban (smoking at home but not near the infant), or no ban.

The mean infant urinary cotinine-to-creatinine ratio was 2.43 in the no-ban group and 2.61 in the less-strict ban group (difference not significant). The combined mean for these 2 groups—2.58—was significantly higher than the mean of 1.26 in the strictest group (P<.001).

A later study recruited a convenience sample of 49 interested families with a smoking mother and a nonbreastfeeding infant between 2 and 12 months of age.⁴ Families were classified by smoking history into one of 3 groups: nonsmoking households, smoking households where efforts were made to limit smoke exposure, and smoking households where no efforts were made to limit exposure. Urine samples were obtained 3 times over 1 week. Urine cotinine levels in infants averaged 0.33 ng/mL in nonsmoking households, 2.47 ng/mL in smoking households with limited exposure, and 15.47 ng/mL in smoking households with unlimited exposure (P<.001 for all comparisons).

A case-control study that recruited families with asthmatic and nonasthmatic children assessed the effectiveness of parental behaviors to reduce second-hand smoke in 182 households with 1 smoking parent and a child between 6 and 12 years of age.⁵ Researchers measured room air nicotine and salivary cotinine concentrations.

The nicotine levels on children’s belts and in their bedrooms and the family room were approximately 3 log units lower in houses with strict smoking bans compared with households with any degree of indoor smoking (P<.0001). Similarly, salivary cotinine levels were approximately 4 log units lower in children of households with indoor smoking bans (P<.0001).

Recommendations

The United States Preventive Services Task Force (USPSTF) strongly recommends that physicians help all smoking adults to quit.⁶ The American Academy of Family Physicians endorses the USPSTF position and further advises that smoking parents be counseled about the health effects of environmental tobacco smoke on their children.⁷

The American Academy of Pediatrics⁸ and the Veterans Administration⁹ recommend urging parents to stop smoking to prevent serious health implications for their children; they further encourage pediatric clinicians to offer parents advice on quitting in order to limit children’s exposure to second-hand smoke.

Evidence summary

Parent education reduces clinic visits for asthmatic children

A 2001 trial randomized 81 families with a smoking parent and an asthmatic child between 3 and 12 years of age to 3 sessions of behavioral and educational counseling or usual care at an outpatient asthma clinic.¹ Parental education included information on second-hand smoke, basic asthma education, and feedback about urine cotinine levels (a marker of nicotine absorption). Behavioral counseling focused on reducing second-hand smoke exposure by caregivers.

The education group had a significantly reduced risk of 2 or more asthma-related clinic visits in the following 12 months compared with usual care (odds ratio=0.32; P=.03; number needed to treat=5). No significant decrease was noted in mean urine cotinine levels between groups (adjusted mean difference=-0.38 ng/mg favoring education; P=.26).

A similar trial that measured changes in urine cotinine randomized 91 families with a smoking parent and an asthmatic child into 3 groups:²

• A control group received usual care (regular office visits at an asthma clinic and medication management)
• A monitoring group used a parental smoking diary and a children’s asthma symptom diary
• A counseling group received 5 counseling sessions and also kept diaries. An environmental monitor in the home was used to assess exposure to secondhand smoke.

In the counseling group, 21.4% of patients (6 of 28) maintained 0% exposure throughout the 30-month trial period compared with 3.6% and 3.8% in the monitoring and control groups, respectively (P<.05 for comparison of counseling group to monitoring and control).

Banning indoor smoking sharply cuts nicotine exposure

No data are available on education about second-hand smoke in families with nonasthmatic children. However, strong evidence suggests that smoking outside the house reduces exposure generally.

A 2003 cross-sectional survey of 164 households in the United Kingdom with at least 1 smoking parent and 1 bottle-fed infant looked for a correlation between strategies to reduce second-hand smoke and urine cotinine-to-creatinine ratios in the infants.³ Parents were classified into 3 groups according to whether they maintained a strict ban on smoking in the home, a less strict ban (smoking at home but not near the infant), or no ban.

The mean infant urinary cotinine-to-creatinine ratio was 2.43 in the no-ban group and 2.61 in the less-strict ban group (difference not significant). The combined mean for these 2 groups—2.58—was significantly higher than the mean of 1.26 in the strictest group (P<.001).

A later study recruited a convenience sample of 49 interested families with a smoking mother and a nonbreastfeeding infant between 2 and 12 months of age.⁴ Families were classified by smoking history into one of 3 groups: nonsmoking households, smoking households where efforts were made to limit smoke exposure, and smoking households where no efforts were made to limit exposure. Urine samples were obtained 3 times over 1 week. Urine cotinine levels in infants averaged 0.33 ng/mL in nonsmoking households, 2.47 ng/mL in smoking households with limited exposure, and 15.47 ng/mL in smoking households with unlimited exposure (P<.001 for all comparisons).

A case-control study that recruited families with asthmatic and nonasthmatic children assessed the effectiveness of parental behaviors to reduce second-hand smoke in 182 households with 1 smoking parent and a child between 6 and 12 years of age.⁵ Researchers measured room air nicotine and salivary cotinine concentrations.

The nicotine levels on children’s belts and in their bedrooms and the family room were approximately 3 log units lower in houses with strict smoking bans compared with households with any degree of indoor smoking (P<.0001). Similarly, salivary cotinine levels were approximately 4 log units lower in children of households with indoor smoking bans (P<.0001).

Recommendations

The United States Preventive Services Task Force (USPSTF) strongly recommends that physicians help all smoking adults to quit.⁶ The American Academy of Family Physicians endorses the USPSTF position and further advises that smoking parents be counseled about the health effects of environmental tobacco smoke on their children.⁷

The American Academy of Pediatrics⁸ and the Veterans Administration⁹ recommend urging parents to stop smoking to prevent serious health implications for their children; they further encourage pediatric clinicians to offer parents advice on quitting in order to limit children’s exposure to second-hand smoke.

Evidence summary

Parent education reduces clinic visits for asthmatic children

A 2001 trial randomized 81 families with a smoking parent and an asthmatic child between 3 and 12 years of age to 3 sessions of behavioral and educational counseling or usual care at an outpatient asthma clinic.¹ Parental education included information on second-hand smoke, basic asthma education, and feedback about urine cotinine levels (a marker of nicotine absorption). Behavioral counseling focused on reducing second-hand smoke exposure by caregivers.

The education group had a significantly reduced risk of 2 or more asthma-related clinic visits in the following 12 months compared with usual care (odds ratio=0.32; P=.03; number needed to treat=5). No significant decrease was noted in mean urine cotinine levels between groups (adjusted mean difference=-0.38 ng/mg favoring education; P=.26).

A similar trial that measured changes in urine cotinine randomized 91 families with a smoking parent and an asthmatic child into 3 groups:²

• A control group received usual care (regular office visits at an asthma clinic and medication management)
• A monitoring group used a parental smoking diary and a children’s asthma symptom diary
• A counseling group received 5 counseling sessions and also kept diaries. An environmental monitor in the home was used to assess exposure to secondhand smoke.

In the counseling group, 21.4% of patients (6 of 28) maintained 0% exposure throughout the 30-month trial period compared with 3.6% and 3.8% in the monitoring and control groups, respectively (P<.05 for comparison of counseling group to monitoring and control).

Banning indoor smoking sharply cuts nicotine exposure

No data are available on education about second-hand smoke in families with nonasthmatic children. However, strong evidence suggests that smoking outside the house reduces exposure generally.

A 2003 cross-sectional survey of 164 households in the United Kingdom with at least 1 smoking parent and 1 bottle-fed infant looked for a correlation between strategies to reduce second-hand smoke and urine cotinine-to-creatinine ratios in the infants.³ Parents were classified into 3 groups according to whether they maintained a strict ban on smoking in the home, a less strict ban (smoking at home but not near the infant), or no ban.

The mean infant urinary cotinine-to-creatinine ratio was 2.43 in the no-ban group and 2.61 in the less-strict ban group (difference not significant). The combined mean for these 2 groups—2.58—was significantly higher than the mean of 1.26 in the strictest group (P<.001).

A later study recruited a convenience sample of 49 interested families with a smoking mother and a nonbreastfeeding infant between 2 and 12 months of age.⁴ Families were classified by smoking history into one of 3 groups: nonsmoking households, smoking households where efforts were made to limit smoke exposure, and smoking households where no efforts were made to limit exposure. Urine samples were obtained 3 times over 1 week. Urine cotinine levels in infants averaged 0.33 ng/mL in nonsmoking households, 2.47 ng/mL in smoking households with limited exposure, and 15.47 ng/mL in smoking households with unlimited exposure (P<.001 for all comparisons).

A case-control study that recruited families with asthmatic and nonasthmatic children assessed the effectiveness of parental behaviors to reduce second-hand smoke in 182 households with 1 smoking parent and a child between 6 and 12 years of age.⁵ Researchers measured room air nicotine and salivary cotinine concentrations.

The nicotine levels on children’s belts and in their bedrooms and the family room were approximately 3 log units lower in houses with strict smoking bans compared with households with any degree of indoor smoking (P<.0001). Similarly, salivary cotinine levels were approximately 4 log units lower in children of households with indoor smoking bans (P<.0001).

Recommendations

The United States Preventive Services Task Force (USPSTF) strongly recommends that physicians help all smoking adults to quit.⁶ The American Academy of Family Physicians endorses the USPSTF position and further advises that smoking parents be counseled about the health effects of environmental tobacco smoke on their children.⁷

The American Academy of Pediatrics⁸ and the Veterans Administration⁹ recommend urging parents to stop smoking to prevent serious health implications for their children; they further encourage pediatric clinicians to offer parents advice on quitting in order to limit children’s exposure to second-hand smoke.

Evidence summary

Drug-seeking behaviors—known as aberrant behaviors in chronic pain literature—may suggest a substance abuse disorder (TABLE).² At least 4 validated screening tools are available for predicting or monitoring aberrant behaviors in patients with chronic, nonmalignant pain disorders who are being considered for, or receiving, opioid therapy:

The Screener and Opioid Assessment for Patients with Pain (SOAPP-R) is a 24-item, self-administered questionnaire that stratifies patients being considered for opioid therapy into lower or higher risk for future opioid-related aberrant behaviors.² Each item queries frequency of behaviors and emotions consistent with opioid misuse and can be scored as 0 (never) to 4 (very often). The items on the SOAPP-R were developed by a consensus panel of pain and addiction experts.

In a multidisciplinary pain center study, the SOAPP-R was administered to 283 chronic pain patients who were followed for 5 months. At a cutoff score of ≥18, the test had a positive likelihood ratio (LR+) of 3.80 and a negative likelihood ratio (LR–) of 0.29 for detecting opioid misuse. At this cutoff, the SOAPP-R was 81% sensitive and 68% specific for predicting patients at high risk for aberrant behavior.

The Opioid Risk Tool (ORT) is a self-administered, 5-item questionnaire used to predict and monitor aberrant behavior.³ Potential scores range from 0 to 26. When administered to 185 consecutive new patients at a chronic pain clinic, a score of <4 had an LR– of 0.08 and a score of ≥8 had an LR+ of 14 for manifesting opioid-related aberrant behaviors. Some ORT scoring criteria have not shown consistent results in other studies.⁴

The Current Opioid Misuse Measure (COMM) is used to monitor aberrant behaviors in patients on opioid therapy.⁵ Scoring for the 17-item, self-administered test is similar to the SOAPP-R. In a study of 86 patients at a multidisciplinary pain center, a score of ≥9 detected opioid misuse with an LR– of 0.08 and an LR+ of 3.48, at a sensitivity of 77% and specificity of 66%.

The Addiction Behaviors Checklist (ABC) is a 20-item Yes or No questionnaire administered by staff.⁶ At a cutoff score of 3 positive items, it had a sensitivity of 88% and specificity of 86% for detecting opioid misuse in 136 consecutive patients at a multidisciplinary pain center.

TABLE
Red flags for a substance abuse disorder

Limitations of the studies

These studies have several limitations. The investigators who validated or evaluated the SOAPP-R and ORT included only patients at chronic pain clinics, so the instruments may not be applicable to patients in primary care settings^2-4; the ORT study lacked standard measures of addiction³; and the ABC was tested in a population that was predominantly male.⁶

Recommendations

A 2006 guideline of the American Society of Interventional Pain Physicians describes behaviors that suggest abuse or misuse of opioid medication.⁷ These behaviors, which are similar to those listed in the TABLE, include failure to experience pain relief from high-dose opioids, lying to obtain opioids, obtaining drugs from multiple prescribers, functional deterioration or lack of functional improvement, exaggerating pain, and forgery. The guideline recommends monitoring patients for such behaviors.

Evidence summary

Drug-seeking behaviors—known as aberrant behaviors in chronic pain literature—may suggest a substance abuse disorder (TABLE).² At least 4 validated screening tools are available for predicting or monitoring aberrant behaviors in patients with chronic, nonmalignant pain disorders who are being considered for, or receiving, opioid therapy:

The Screener and Opioid Assessment for Patients with Pain (SOAPP-R) is a 24-item, self-administered questionnaire that stratifies patients being considered for opioid therapy into lower or higher risk for future opioid-related aberrant behaviors.² Each item queries frequency of behaviors and emotions consistent with opioid misuse and can be scored as 0 (never) to 4 (very often). The items on the SOAPP-R were developed by a consensus panel of pain and addiction experts.

In a multidisciplinary pain center study, the SOAPP-R was administered to 283 chronic pain patients who were followed for 5 months. At a cutoff score of ≥18, the test had a positive likelihood ratio (LR+) of 3.80 and a negative likelihood ratio (LR–) of 0.29 for detecting opioid misuse. At this cutoff, the SOAPP-R was 81% sensitive and 68% specific for predicting patients at high risk for aberrant behavior.

The Opioid Risk Tool (ORT) is a self-administered, 5-item questionnaire used to predict and monitor aberrant behavior.³ Potential scores range from 0 to 26. When administered to 185 consecutive new patients at a chronic pain clinic, a score of <4 had an LR– of 0.08 and a score of ≥8 had an LR+ of 14 for manifesting opioid-related aberrant behaviors. Some ORT scoring criteria have not shown consistent results in other studies.⁴

The Current Opioid Misuse Measure (COMM) is used to monitor aberrant behaviors in patients on opioid therapy.⁵ Scoring for the 17-item, self-administered test is similar to the SOAPP-R. In a study of 86 patients at a multidisciplinary pain center, a score of ≥9 detected opioid misuse with an LR– of 0.08 and an LR+ of 3.48, at a sensitivity of 77% and specificity of 66%.

The Addiction Behaviors Checklist (ABC) is a 20-item Yes or No questionnaire administered by staff.⁶ At a cutoff score of 3 positive items, it had a sensitivity of 88% and specificity of 86% for detecting opioid misuse in 136 consecutive patients at a multidisciplinary pain center.

TABLE
Red flags for a substance abuse disorder

Limitations of the studies

These studies have several limitations. The investigators who validated or evaluated the SOAPP-R and ORT included only patients at chronic pain clinics, so the instruments may not be applicable to patients in primary care settings^2-4; the ORT study lacked standard measures of addiction³; and the ABC was tested in a population that was predominantly male.⁶

Recommendations

A 2006 guideline of the American Society of Interventional Pain Physicians describes behaviors that suggest abuse or misuse of opioid medication.⁷ These behaviors, which are similar to those listed in the TABLE, include failure to experience pain relief from high-dose opioids, lying to obtain opioids, obtaining drugs from multiple prescribers, functional deterioration or lack of functional improvement, exaggerating pain, and forgery. The guideline recommends monitoring patients for such behaviors.

Evidence summary

Drug-seeking behaviors—known as aberrant behaviors in chronic pain literature—may suggest a substance abuse disorder (TABLE).² At least 4 validated screening tools are available for predicting or monitoring aberrant behaviors in patients with chronic, nonmalignant pain disorders who are being considered for, or receiving, opioid therapy:

The Screener and Opioid Assessment for Patients with Pain (SOAPP-R) is a 24-item, self-administered questionnaire that stratifies patients being considered for opioid therapy into lower or higher risk for future opioid-related aberrant behaviors.² Each item queries frequency of behaviors and emotions consistent with opioid misuse and can be scored as 0 (never) to 4 (very often). The items on the SOAPP-R were developed by a consensus panel of pain and addiction experts.

In a multidisciplinary pain center study, the SOAPP-R was administered to 283 chronic pain patients who were followed for 5 months. At a cutoff score of ≥18, the test had a positive likelihood ratio (LR+) of 3.80 and a negative likelihood ratio (LR–) of 0.29 for detecting opioid misuse. At this cutoff, the SOAPP-R was 81% sensitive and 68% specific for predicting patients at high risk for aberrant behavior.

The Opioid Risk Tool (ORT) is a self-administered, 5-item questionnaire used to predict and monitor aberrant behavior.³ Potential scores range from 0 to 26. When administered to 185 consecutive new patients at a chronic pain clinic, a score of <4 had an LR– of 0.08 and a score of ≥8 had an LR+ of 14 for manifesting opioid-related aberrant behaviors. Some ORT scoring criteria have not shown consistent results in other studies.⁴

The Current Opioid Misuse Measure (COMM) is used to monitor aberrant behaviors in patients on opioid therapy.⁵ Scoring for the 17-item, self-administered test is similar to the SOAPP-R. In a study of 86 patients at a multidisciplinary pain center, a score of ≥9 detected opioid misuse with an LR– of 0.08 and an LR+ of 3.48, at a sensitivity of 77% and specificity of 66%.

The Addiction Behaviors Checklist (ABC) is a 20-item Yes or No questionnaire administered by staff.⁶ At a cutoff score of 3 positive items, it had a sensitivity of 88% and specificity of 86% for detecting opioid misuse in 136 consecutive patients at a multidisciplinary pain center.

TABLE
Red flags for a substance abuse disorder

Limitations of the studies

These studies have several limitations. The investigators who validated or evaluated the SOAPP-R and ORT included only patients at chronic pain clinics, so the instruments may not be applicable to patients in primary care settings^2-4; the ORT study lacked standard measures of addiction³; and the ABC was tested in a population that was predominantly male.⁶

Recommendations

A 2006 guideline of the American Society of Interventional Pain Physicians describes behaviors that suggest abuse or misuse of opioid medication.⁷ These behaviors, which are similar to those listed in the TABLE, include failure to experience pain relief from high-dose opioids, lying to obtain opioids, obtaining drugs from multiple prescribers, functional deterioration or lack of functional improvement, exaggerating pain, and forgery. The guideline recommends monitoring patients for such behaviors.

Evidence summary

Breast stimulation works

A systematic review of 6 trials with a total of 719 participants compared unilateral breast stimulation with no intervention to induce labor in women at term.¹ In 2 trials, the 300 participants stimulated 1 breast for 1 hour a day for 3 days; in the other 4 trials, 419 women stimulated either breast alternately for 3 hours a day.

Breast stimulation significantly reduced the number of women who hadn’t gone into labor at 72 hours compared with nonintervention (62.7% vs 93.6%; relative risk [RR]=0.67; 95% confidence interval [CI], 0.60-0.74; number needed to treat [NNT]=3.2). This result remained significant when primiparous and multiparous women were analyzed separately, but not in the 1 trial (37 participants) that reported on women with an unfavorable cervix.¹ Breast stimulation also reduced postpartum hemorrhage (0.7% vs 6%; RR=0.16; 95% CI, 0.03-0.87; NNT=18.8).

None of the trials documented uterine hyperstimulation or meconium-stained fluid, and they didn’t find significant differences in the rates of cesarean section (9% vs 10%; RR=0.90; 95% CI, 0.38-2.12). One trial reported 4 perinatal deaths in a high-risk population—3 in the breast stimulation group and 1 in the control group—but this finding was not replicated in any other trials.¹

Acupuncture may also help

A Cochrane systematic review evaluating acupuncture for inducing labor identified 1 randomized trial with methodologic flaws (allowing no conclusion), 3 case series, and 2 nonrandomized trials. The first case series used electroacupuncture at 38 to 42 weeks to successfully induce labor in 21 of 31 women. The second series, using acupuncture with and without electrical stimulation, induced labor in 10 of 12 women at 19 to 43 weeks. The third study induced labor with electroacupuncture in 78% of 41 women—34 term and postterm patients and 7 with a fetal demise.

In the first nonrandomized trial, 20 of 27 women at term who received electroacupuncture gave birth between 39 weeks 3 days and 40 weeks, compared with 47 of 102 women in the control group. In the second study, 31 of 35 women who received electroacupuncture reported increased intensity of contractions compared with none of the 35 women in the control group.²

Sexual intercourse induces pregnancy, not labor

A Cochrane systematic review found 1 observational study of the effect of sexual intercourse on cervical ripening and induction of labor among 28 women at term. The study evaluated cervical Bishop scores after sexual intercourse with intravaginal semen deposition for 3 consecutive nights compared with no intercourse. The difference in Bishop score was not significant (1.0 with coitus vs 0.5 controls; P>.05) and no difference in the number of women who delivered within 3 days was noted in the 2 groups (RR=0.99; 95% CI, 0.45-2.20).³

Castor oil made women nauseous

A Cochrane systematic review included 1 study of women at term with intact membranes who received 1 dose of castor oil to induce labor (n=52) compared with no treatment (n=48). All women who received castor oil felt nauseous, but no other differences were noted between the castor oil group and controls in rates of cesarean section, meconium-stained fluid, or Apgar scores less than 7 at 5 minutes.⁴

Herbal preparations raise many questions—and some concerns

A prospective controlled trial that randomized 192 women to receive either red raspberry leaf tablets (1.2 g twice daily beginning at 32 weeks) or placebo found no significant differences in duration of the first stage of labor or birth outcomes. Symptom surveys of 108 women revealed no adverse effects.⁵

A retrospective cohort study compared pregnancy outcomes in 54 women who took evening primrose oil (500 mg 3 times a day beginning at 37 weeks) with a matched group of 54 women who did not take it. The study found no significant differences between the groups in maternal age, Apgar scores, or days of gestation. However, the women taking evening primrose oil tended to have protracted active phase of labor, prolonged rupture of membranes, arrest of descent, and oxytocin augmentation (none of which were statistically significant).⁶

A systematic review of the literature on black cohosh in pregnancy found no trials that evaluated its efficacy for inducing labor.⁷ A review of herbal preparations used by midwives reported a case of an infant with low Apgar scores after black cohosh use.⁸ Both articles described black cohosh as potentially unsafe because of the lack of trials demonstrating safety and possible deleterious estrogenic effects.

A systematic review of the literature on blue cohosh found only in vitro studies of efficacy (increased estradiol-induced transcription in estrogen-responsive cells and increased tone in excised guinea pig uteri) and 3 case reports of maternal adverse events after ingestion (perinatal stroke, congestive heart failure with shock, and multiorgan hypoxic injury).⁹ In vitro evidence presented in the review suggests that blue cohosh may have teratogenic, embryotoxic, and oxytocic effects.

Recommendations

We found no recommendations from professional organizations regarding folk methods to stimulate labor. The authors of a survey of herbal preparations used by midwives do not advocate their use in pregnancy because of unknown risks to the fetus, although “raspberry leaf tea does not seem to have any significant pharmacologic activity and is probably safe.”⁸

Evidence summary

Breast stimulation works

A systematic review of 6 trials with a total of 719 participants compared unilateral breast stimulation with no intervention to induce labor in women at term.¹ In 2 trials, the 300 participants stimulated 1 breast for 1 hour a day for 3 days; in the other 4 trials, 419 women stimulated either breast alternately for 3 hours a day.

Breast stimulation significantly reduced the number of women who hadn’t gone into labor at 72 hours compared with nonintervention (62.7% vs 93.6%; relative risk [RR]=0.67; 95% confidence interval [CI], 0.60-0.74; number needed to treat [NNT]=3.2). This result remained significant when primiparous and multiparous women were analyzed separately, but not in the 1 trial (37 participants) that reported on women with an unfavorable cervix.¹ Breast stimulation also reduced postpartum hemorrhage (0.7% vs 6%; RR=0.16; 95% CI, 0.03-0.87; NNT=18.8).

None of the trials documented uterine hyperstimulation or meconium-stained fluid, and they didn’t find significant differences in the rates of cesarean section (9% vs 10%; RR=0.90; 95% CI, 0.38-2.12). One trial reported 4 perinatal deaths in a high-risk population—3 in the breast stimulation group and 1 in the control group—but this finding was not replicated in any other trials.¹

Acupuncture may also help

A Cochrane systematic review evaluating acupuncture for inducing labor identified 1 randomized trial with methodologic flaws (allowing no conclusion), 3 case series, and 2 nonrandomized trials. The first case series used electroacupuncture at 38 to 42 weeks to successfully induce labor in 21 of 31 women. The second series, using acupuncture with and without electrical stimulation, induced labor in 10 of 12 women at 19 to 43 weeks. The third study induced labor with electroacupuncture in 78% of 41 women—34 term and postterm patients and 7 with a fetal demise.

In the first nonrandomized trial, 20 of 27 women at term who received electroacupuncture gave birth between 39 weeks 3 days and 40 weeks, compared with 47 of 102 women in the control group. In the second study, 31 of 35 women who received electroacupuncture reported increased intensity of contractions compared with none of the 35 women in the control group.²

Sexual intercourse induces pregnancy, not labor

A Cochrane systematic review found 1 observational study of the effect of sexual intercourse on cervical ripening and induction of labor among 28 women at term. The study evaluated cervical Bishop scores after sexual intercourse with intravaginal semen deposition for 3 consecutive nights compared with no intercourse. The difference in Bishop score was not significant (1.0 with coitus vs 0.5 controls; P>.05) and no difference in the number of women who delivered within 3 days was noted in the 2 groups (RR=0.99; 95% CI, 0.45-2.20).³

Castor oil made women nauseous

A Cochrane systematic review included 1 study of women at term with intact membranes who received 1 dose of castor oil to induce labor (n=52) compared with no treatment (n=48). All women who received castor oil felt nauseous, but no other differences were noted between the castor oil group and controls in rates of cesarean section, meconium-stained fluid, or Apgar scores less than 7 at 5 minutes.⁴

Herbal preparations raise many questions—and some concerns

A prospective controlled trial that randomized 192 women to receive either red raspberry leaf tablets (1.2 g twice daily beginning at 32 weeks) or placebo found no significant differences in duration of the first stage of labor or birth outcomes. Symptom surveys of 108 women revealed no adverse effects.⁵

A retrospective cohort study compared pregnancy outcomes in 54 women who took evening primrose oil (500 mg 3 times a day beginning at 37 weeks) with a matched group of 54 women who did not take it. The study found no significant differences between the groups in maternal age, Apgar scores, or days of gestation. However, the women taking evening primrose oil tended to have protracted active phase of labor, prolonged rupture of membranes, arrest of descent, and oxytocin augmentation (none of which were statistically significant).⁶

A systematic review of the literature on black cohosh in pregnancy found no trials that evaluated its efficacy for inducing labor.⁷ A review of herbal preparations used by midwives reported a case of an infant with low Apgar scores after black cohosh use.⁸ Both articles described black cohosh as potentially unsafe because of the lack of trials demonstrating safety and possible deleterious estrogenic effects.

A systematic review of the literature on blue cohosh found only in vitro studies of efficacy (increased estradiol-induced transcription in estrogen-responsive cells and increased tone in excised guinea pig uteri) and 3 case reports of maternal adverse events after ingestion (perinatal stroke, congestive heart failure with shock, and multiorgan hypoxic injury).⁹ In vitro evidence presented in the review suggests that blue cohosh may have teratogenic, embryotoxic, and oxytocic effects.

Recommendations

We found no recommendations from professional organizations regarding folk methods to stimulate labor. The authors of a survey of herbal preparations used by midwives do not advocate their use in pregnancy because of unknown risks to the fetus, although “raspberry leaf tea does not seem to have any significant pharmacologic activity and is probably safe.”⁸

Evidence summary

Breast stimulation works

A systematic review of 6 trials with a total of 719 participants compared unilateral breast stimulation with no intervention to induce labor in women at term.¹ In 2 trials, the 300 participants stimulated 1 breast for 1 hour a day for 3 days; in the other 4 trials, 419 women stimulated either breast alternately for 3 hours a day.

Breast stimulation significantly reduced the number of women who hadn’t gone into labor at 72 hours compared with nonintervention (62.7% vs 93.6%; relative risk [RR]=0.67; 95% confidence interval [CI], 0.60-0.74; number needed to treat [NNT]=3.2). This result remained significant when primiparous and multiparous women were analyzed separately, but not in the 1 trial (37 participants) that reported on women with an unfavorable cervix.¹ Breast stimulation also reduced postpartum hemorrhage (0.7% vs 6%; RR=0.16; 95% CI, 0.03-0.87; NNT=18.8).

None of the trials documented uterine hyperstimulation or meconium-stained fluid, and they didn’t find significant differences in the rates of cesarean section (9% vs 10%; RR=0.90; 95% CI, 0.38-2.12). One trial reported 4 perinatal deaths in a high-risk population—3 in the breast stimulation group and 1 in the control group—but this finding was not replicated in any other trials.¹

Acupuncture may also help

A Cochrane systematic review evaluating acupuncture for inducing labor identified 1 randomized trial with methodologic flaws (allowing no conclusion), 3 case series, and 2 nonrandomized trials. The first case series used electroacupuncture at 38 to 42 weeks to successfully induce labor in 21 of 31 women. The second series, using acupuncture with and without electrical stimulation, induced labor in 10 of 12 women at 19 to 43 weeks. The third study induced labor with electroacupuncture in 78% of 41 women—34 term and postterm patients and 7 with a fetal demise.

In the first nonrandomized trial, 20 of 27 women at term who received electroacupuncture gave birth between 39 weeks 3 days and 40 weeks, compared with 47 of 102 women in the control group. In the second study, 31 of 35 women who received electroacupuncture reported increased intensity of contractions compared with none of the 35 women in the control group.²

Sexual intercourse induces pregnancy, not labor

A Cochrane systematic review found 1 observational study of the effect of sexual intercourse on cervical ripening and induction of labor among 28 women at term. The study evaluated cervical Bishop scores after sexual intercourse with intravaginal semen deposition for 3 consecutive nights compared with no intercourse. The difference in Bishop score was not significant (1.0 with coitus vs 0.5 controls; P>.05) and no difference in the number of women who delivered within 3 days was noted in the 2 groups (RR=0.99; 95% CI, 0.45-2.20).³

Castor oil made women nauseous

A Cochrane systematic review included 1 study of women at term with intact membranes who received 1 dose of castor oil to induce labor (n=52) compared with no treatment (n=48). All women who received castor oil felt nauseous, but no other differences were noted between the castor oil group and controls in rates of cesarean section, meconium-stained fluid, or Apgar scores less than 7 at 5 minutes.⁴

Herbal preparations raise many questions—and some concerns

A prospective controlled trial that randomized 192 women to receive either red raspberry leaf tablets (1.2 g twice daily beginning at 32 weeks) or placebo found no significant differences in duration of the first stage of labor or birth outcomes. Symptom surveys of 108 women revealed no adverse effects.⁵

A retrospective cohort study compared pregnancy outcomes in 54 women who took evening primrose oil (500 mg 3 times a day beginning at 37 weeks) with a matched group of 54 women who did not take it. The study found no significant differences between the groups in maternal age, Apgar scores, or days of gestation. However, the women taking evening primrose oil tended to have protracted active phase of labor, prolonged rupture of membranes, arrest of descent, and oxytocin augmentation (none of which were statistically significant).⁶

A systematic review of the literature on black cohosh in pregnancy found no trials that evaluated its efficacy for inducing labor.⁷ A review of herbal preparations used by midwives reported a case of an infant with low Apgar scores after black cohosh use.⁸ Both articles described black cohosh as potentially unsafe because of the lack of trials demonstrating safety and possible deleterious estrogenic effects.

A systematic review of the literature on blue cohosh found only in vitro studies of efficacy (increased estradiol-induced transcription in estrogen-responsive cells and increased tone in excised guinea pig uteri) and 3 case reports of maternal adverse events after ingestion (perinatal stroke, congestive heart failure with shock, and multiorgan hypoxic injury).⁹ In vitro evidence presented in the review suggests that blue cohosh may have teratogenic, embryotoxic, and oxytocic effects.

Recommendations

We found no recommendations from professional organizations regarding folk methods to stimulate labor. The authors of a survey of herbal preparations used by midwives do not advocate their use in pregnancy because of unknown risks to the fetus, although “raspberry leaf tea does not seem to have any significant pharmacologic activity and is probably safe.”⁸

Evidence summary

A systematic review evaluating whether antepartum perineal massage reduced perineal trauma included 3 RCTs with a total of 1941 primagravidas and 493 multigravidas.¹ Women were randomized to receive either instruction in perineal massage or no instruction.

Beginning at 34 weeks, women or their partners performed perineal massage for 4 minutes, 3 to 4 times a week,² or once a day for 10 minutes.^3,4 Massage was performed by inserting 1 or 2 fingers 3 to 5 cm into the vagina and sweeping downward and from side to side, using almond oil for lubrication.

Birth attendants were blinded to patients’ assignments. All studies evaluated immediate postpartum outcomes; 1 study included a 3-month follow-up questionnaire.³

Massage reduces trauma, but less is more

Massage reduced perineal trauma requiring suturing by 10% among primigravid patients, compared with controls (relative risk [RR]=0.90; 95% confidence interval [CI], 0.84-0.96; number needed to treat [NNT]=14). Subgroup analysis revealed an inverse relationship between reduced trauma and frequency of massage: Primagravidas who massaged fewer than 1.5 times a week showed a 17% reduction (RR=0.83; 95% CI, 0.75-0.92; NNT=9), compared with an 8% reduction for women who massaged 1.5 to 3.4 times a week (RR=0.92; 95% CI, 0.85-1.00; NNT=22) and a statistically insignificant 7% reduction for the group that massaged more than 3.5 times a week (RR=0.93; 95% CI, 0.86-1.02).

Perineal massage reduced the incidence of episiotomy by 15% among primigravidas compared with controls (RR=0.85; 95% CI, 0.74-0.97; NNT=20); the largest reduction occurred in primagravidas who massaged as often as 1.5 times per week (RR=0.72; 95% CI, 0.57-0.91). This effect was not seen in primagravidas who massaged more often. Multigravid patients didn’t experience a statistically significant reduction in episiotomy.

Perineal massage didn’t affect the overall incidence of first- and second-degree perineal lacerations (first-degree laceration: RR=0.95; 95% CI, 0.78-1.16; second-degree laceration: RR=0.98; 95% CI, 0.84-1.15), nor the incidence of third- or fourth-degree lacerations (RR=0.81; 95% CI, 0.56-1.15). No difference was noted in the incidence of instrument delivery (RR=0.94; 95% CI, 0.81-1.08).

Massage means less pain for multigravidas

Massage reduced postpartum perineal pain in multigravidas, according to a questionnaire administered at 3 months in 1 study, to which 376 of 493 women (76%) responded (RR=0.45; 95% CI, 0.02-0.87; NNT=13).³ A subgroup of women who massaged more often than 3.5 times a week had a larger reduction in pain (RR=0.51; 95% CI, 0.33-0.79; NNT=11). At 3 months, massage produced no difference in rates of dyspareunia, sexual satisfaction, or incontinence of urine or feces when compared with standard care.

Recommendations

We found no expert or advocacy group guidelines on this topic.

Evidence summary

A systematic review evaluating whether antepartum perineal massage reduced perineal trauma included 3 RCTs with a total of 1941 primagravidas and 493 multigravidas.¹ Women were randomized to receive either instruction in perineal massage or no instruction.

Beginning at 34 weeks, women or their partners performed perineal massage for 4 minutes, 3 to 4 times a week,² or once a day for 10 minutes.^3,4 Massage was performed by inserting 1 or 2 fingers 3 to 5 cm into the vagina and sweeping downward and from side to side, using almond oil for lubrication.

Birth attendants were blinded to patients’ assignments. All studies evaluated immediate postpartum outcomes; 1 study included a 3-month follow-up questionnaire.³

Massage reduces trauma, but less is more

Massage reduced perineal trauma requiring suturing by 10% among primigravid patients, compared with controls (relative risk [RR]=0.90; 95% confidence interval [CI], 0.84-0.96; number needed to treat [NNT]=14). Subgroup analysis revealed an inverse relationship between reduced trauma and frequency of massage: Primagravidas who massaged fewer than 1.5 times a week showed a 17% reduction (RR=0.83; 95% CI, 0.75-0.92; NNT=9), compared with an 8% reduction for women who massaged 1.5 to 3.4 times a week (RR=0.92; 95% CI, 0.85-1.00; NNT=22) and a statistically insignificant 7% reduction for the group that massaged more than 3.5 times a week (RR=0.93; 95% CI, 0.86-1.02).

Perineal massage reduced the incidence of episiotomy by 15% among primigravidas compared with controls (RR=0.85; 95% CI, 0.74-0.97; NNT=20); the largest reduction occurred in primagravidas who massaged as often as 1.5 times per week (RR=0.72; 95% CI, 0.57-0.91). This effect was not seen in primagravidas who massaged more often. Multigravid patients didn’t experience a statistically significant reduction in episiotomy.

Perineal massage didn’t affect the overall incidence of first- and second-degree perineal lacerations (first-degree laceration: RR=0.95; 95% CI, 0.78-1.16; second-degree laceration: RR=0.98; 95% CI, 0.84-1.15), nor the incidence of third- or fourth-degree lacerations (RR=0.81; 95% CI, 0.56-1.15). No difference was noted in the incidence of instrument delivery (RR=0.94; 95% CI, 0.81-1.08).

Massage means less pain for multigravidas

Massage reduced postpartum perineal pain in multigravidas, according to a questionnaire administered at 3 months in 1 study, to which 376 of 493 women (76%) responded (RR=0.45; 95% CI, 0.02-0.87; NNT=13).³ A subgroup of women who massaged more often than 3.5 times a week had a larger reduction in pain (RR=0.51; 95% CI, 0.33-0.79; NNT=11). At 3 months, massage produced no difference in rates of dyspareunia, sexual satisfaction, or incontinence of urine or feces when compared with standard care.

Recommendations

We found no expert or advocacy group guidelines on this topic.

Evidence summary

A systematic review evaluating whether antepartum perineal massage reduced perineal trauma included 3 RCTs with a total of 1941 primagravidas and 493 multigravidas.¹ Women were randomized to receive either instruction in perineal massage or no instruction.

Beginning at 34 weeks, women or their partners performed perineal massage for 4 minutes, 3 to 4 times a week,² or once a day for 10 minutes.^3,4 Massage was performed by inserting 1 or 2 fingers 3 to 5 cm into the vagina and sweeping downward and from side to side, using almond oil for lubrication.

Birth attendants were blinded to patients’ assignments. All studies evaluated immediate postpartum outcomes; 1 study included a 3-month follow-up questionnaire.³

Massage reduces trauma, but less is more

Massage reduced perineal trauma requiring suturing by 10% among primigravid patients, compared with controls (relative risk [RR]=0.90; 95% confidence interval [CI], 0.84-0.96; number needed to treat [NNT]=14). Subgroup analysis revealed an inverse relationship between reduced trauma and frequency of massage: Primagravidas who massaged fewer than 1.5 times a week showed a 17% reduction (RR=0.83; 95% CI, 0.75-0.92; NNT=9), compared with an 8% reduction for women who massaged 1.5 to 3.4 times a week (RR=0.92; 95% CI, 0.85-1.00; NNT=22) and a statistically insignificant 7% reduction for the group that massaged more than 3.5 times a week (RR=0.93; 95% CI, 0.86-1.02).

Perineal massage reduced the incidence of episiotomy by 15% among primigravidas compared with controls (RR=0.85; 95% CI, 0.74-0.97; NNT=20); the largest reduction occurred in primagravidas who massaged as often as 1.5 times per week (RR=0.72; 95% CI, 0.57-0.91). This effect was not seen in primagravidas who massaged more often. Multigravid patients didn’t experience a statistically significant reduction in episiotomy.

Perineal massage didn’t affect the overall incidence of first- and second-degree perineal lacerations (first-degree laceration: RR=0.95; 95% CI, 0.78-1.16; second-degree laceration: RR=0.98; 95% CI, 0.84-1.15), nor the incidence of third- or fourth-degree lacerations (RR=0.81; 95% CI, 0.56-1.15). No difference was noted in the incidence of instrument delivery (RR=0.94; 95% CI, 0.81-1.08).

Massage means less pain for multigravidas

Massage reduced postpartum perineal pain in multigravidas, according to a questionnaire administered at 3 months in 1 study, to which 376 of 493 women (76%) responded (RR=0.45; 95% CI, 0.02-0.87; NNT=13).³ A subgroup of women who massaged more often than 3.5 times a week had a larger reduction in pain (RR=0.51; 95% CI, 0.33-0.79; NNT=11). At 3 months, massage produced no difference in rates of dyspareunia, sexual satisfaction, or incontinence of urine or feces when compared with standard care.

Recommendations

We found no expert or advocacy group guidelines on this topic.

Evidence summary

Effects of self-examination on patients with melanoma

Two studies of a group of Connecticut residents examined the relationship between skin self-examination (SSE) and melanoma. The first, a case-control study compared SSE among 650 Caucasian patients newly diagnosed with melanoma and 549 age- and sex-matched controls.¹ Fifteen percent of all patients practiced SSE. Investigators monitored a statewide registry system for 5.4 years to identify 110 participants with melanoma who had major adverse outcomes (distant metastases or death).

Patients with a history of melanoma who practiced SSE had lower mortality (odds ratio [OR]=0.42; 95% confidence interval [CI], 0.21-0.85) than those who didn’t. One potential weakness of the study was possible lead-time bias, which could overestimate the risk reduction from SSE. Another was the 5.4-year follow-up, because malignant melanoma can recur as long as 10 years later.

In the second study, involving a cohort of 255 patients from the first study who discovered their own melanomas, researchers questioned patients about their knowledge of melanoma signs and symptoms, awareness of the appearance of their own skin, and whether they delayed seeking medical attention for >3 months after detecting the initial lesion.²

More knowledgeable patients were less likely to have a thick (≥0.75 mm) tumor and a delayed diagnosis (OR=0.34; 95% CI, 0.13-0.88). Similarly, patients with greater awareness of their skin were less likely to have a thick tumor and a delayed diagnosis (OR=0.50; 95% CI, 0.28-0.89 and OR=0.30; 95% CI, 0.12-0.71, respectively). Investigators found no significant difference in mortality based on knowledge or skin awareness.

Which patients are more likely to detect melanoma?

A retrospective series of 816 consecutive cases of newly diagnosed melanoma investigated the frequency of self-detection in a Mediterranean population at intermediate risk.³ Subjects were statistically more likely to find melanoma themselves if they had a lesion on the lower limbs, were of younger age (49.8 vs 52.9 years of age), had fewer atypical nevi, had >8 years education, were knowledgeable about the characteristic features of melanoma, and performed regular SSE (P<.01 for all comparisons).

Recommendations

The US Preventive Services Task Force finds insufficient evidence to recommend for or against routine counseling by primary care clinicians to prevent skin cancer.⁴

The Cancer Care Ontario Program in Evidence-based Care, on the other hand, advises health care providers to perform annual total-body skin examinations of high-risk patients and teach the patients to examine themselves.⁵

The American Cancer Society (ACS) and the American Academy of Dermatology (AAD) both provide information about recognizing melanoma on their Web sites and recommend that people at high risk perform monthly self-examinations. They further advise such people to periodically see a health care professional qualified to diagnose skin cancer (ACS), or a dermatologist (AAD), for a complete skin examination.^6,7

Evidence summary

Effects of self-examination on patients with melanoma

Two studies of a group of Connecticut residents examined the relationship between skin self-examination (SSE) and melanoma. The first, a case-control study compared SSE among 650 Caucasian patients newly diagnosed with melanoma and 549 age- and sex-matched controls.¹ Fifteen percent of all patients practiced SSE. Investigators monitored a statewide registry system for 5.4 years to identify 110 participants with melanoma who had major adverse outcomes (distant metastases or death).

Patients with a history of melanoma who practiced SSE had lower mortality (odds ratio [OR]=0.42; 95% confidence interval [CI], 0.21-0.85) than those who didn’t. One potential weakness of the study was possible lead-time bias, which could overestimate the risk reduction from SSE. Another was the 5.4-year follow-up, because malignant melanoma can recur as long as 10 years later.

In the second study, involving a cohort of 255 patients from the first study who discovered their own melanomas, researchers questioned patients about their knowledge of melanoma signs and symptoms, awareness of the appearance of their own skin, and whether they delayed seeking medical attention for >3 months after detecting the initial lesion.²

More knowledgeable patients were less likely to have a thick (≥0.75 mm) tumor and a delayed diagnosis (OR=0.34; 95% CI, 0.13-0.88). Similarly, patients with greater awareness of their skin were less likely to have a thick tumor and a delayed diagnosis (OR=0.50; 95% CI, 0.28-0.89 and OR=0.30; 95% CI, 0.12-0.71, respectively). Investigators found no significant difference in mortality based on knowledge or skin awareness.

Which patients are more likely to detect melanoma?

A retrospective series of 816 consecutive cases of newly diagnosed melanoma investigated the frequency of self-detection in a Mediterranean population at intermediate risk.³ Subjects were statistically more likely to find melanoma themselves if they had a lesion on the lower limbs, were of younger age (49.8 vs 52.9 years of age), had fewer atypical nevi, had >8 years education, were knowledgeable about the characteristic features of melanoma, and performed regular SSE (P<.01 for all comparisons).

Recommendations

The US Preventive Services Task Force finds insufficient evidence to recommend for or against routine counseling by primary care clinicians to prevent skin cancer.⁴

The Cancer Care Ontario Program in Evidence-based Care, on the other hand, advises health care providers to perform annual total-body skin examinations of high-risk patients and teach the patients to examine themselves.⁵

The American Cancer Society (ACS) and the American Academy of Dermatology (AAD) both provide information about recognizing melanoma on their Web sites and recommend that people at high risk perform monthly self-examinations. They further advise such people to periodically see a health care professional qualified to diagnose skin cancer (ACS), or a dermatologist (AAD), for a complete skin examination.^6,7

Evidence summary

Effects of self-examination on patients with melanoma

Two studies of a group of Connecticut residents examined the relationship between skin self-examination (SSE) and melanoma. The first, a case-control study compared SSE among 650 Caucasian patients newly diagnosed with melanoma and 549 age- and sex-matched controls.¹ Fifteen percent of all patients practiced SSE. Investigators monitored a statewide registry system for 5.4 years to identify 110 participants with melanoma who had major adverse outcomes (distant metastases or death).

Patients with a history of melanoma who practiced SSE had lower mortality (odds ratio [OR]=0.42; 95% confidence interval [CI], 0.21-0.85) than those who didn’t. One potential weakness of the study was possible lead-time bias, which could overestimate the risk reduction from SSE. Another was the 5.4-year follow-up, because malignant melanoma can recur as long as 10 years later.

In the second study, involving a cohort of 255 patients from the first study who discovered their own melanomas, researchers questioned patients about their knowledge of melanoma signs and symptoms, awareness of the appearance of their own skin, and whether they delayed seeking medical attention for >3 months after detecting the initial lesion.²

More knowledgeable patients were less likely to have a thick (≥0.75 mm) tumor and a delayed diagnosis (OR=0.34; 95% CI, 0.13-0.88). Similarly, patients with greater awareness of their skin were less likely to have a thick tumor and a delayed diagnosis (OR=0.50; 95% CI, 0.28-0.89 and OR=0.30; 95% CI, 0.12-0.71, respectively). Investigators found no significant difference in mortality based on knowledge or skin awareness.

Which patients are more likely to detect melanoma?

A retrospective series of 816 consecutive cases of newly diagnosed melanoma investigated the frequency of self-detection in a Mediterranean population at intermediate risk.³ Subjects were statistically more likely to find melanoma themselves if they had a lesion on the lower limbs, were of younger age (49.8 vs 52.9 years of age), had fewer atypical nevi, had >8 years education, were knowledgeable about the characteristic features of melanoma, and performed regular SSE (P<.01 for all comparisons).

Recommendations

The US Preventive Services Task Force finds insufficient evidence to recommend for or against routine counseling by primary care clinicians to prevent skin cancer.⁴

The Cancer Care Ontario Program in Evidence-based Care, on the other hand, advises health care providers to perform annual total-body skin examinations of high-risk patients and teach the patients to examine themselves.⁵

The American Cancer Society (ACS) and the American Academy of Dermatology (AAD) both provide information about recognizing melanoma on their Web sites and recommend that people at high risk perform monthly self-examinations. They further advise such people to periodically see a health care professional qualified to diagnose skin cancer (ACS), or a dermatologist (AAD), for a complete skin examination.^6,7

Evidence summary

For cervicogenic headaches: Spinal manipulative therapy reduces pain

Three studies¹ evaluated SMT for treatment of recurrent cervicogenic headaches). A multicenter trial² randomized 200 patients with cervicogenic headaches to either SMT (8–12 sessions over 6 weeks) or placebo. The SMT group had significantly reduced pain (at 1 week, effect size [ES]=0.7; 95% confidence interval [CI], 0.3–1.2; and at 12 months, ES=0.4; 95% CI, 0.0–0.8) and fewer headaches (ES=0.7; 95% CI, 0.3–1.1 at both time points) than placebo.

Another RCT³ with 105 patients compared SMT (3 times a week for 3 weeks) with placebo. The SMT group reported significantly less pain after 3 weeks (ES=2.2; 95% CI, 1.7–2.7).

A third trial⁴ randomized 30 patients to either SMT, mobilization (small oscillatory movements to a joint within its normal range), or wait-list placement. At the end of treatment, there was a nonsignificant trend toward greater pain reduction in patients receiving SMT than either those receiving mobilization (ES=0.4; 95% CI, –0.5 to 1.4) or those on the wait list (ES=0.6; 95% CI, –0.4 to 1.5).

For tension-type headaches: Results are mixed

Two trials⁵ investigated the efficacy of SMT on tension-type headaches. The first, an RCT with 150 patients with recurrent headaches, compared SMT (2 sessions per week) with amitriptyline (10 mg daily week 1, 20 mg daily week 2, then 30 mg daily) for 6 weeks. At the end of 6 weeks, the SMT group reported a nonsignificant trend toward more headache pain (ES for SMT vs amitriptyline= –0.4; 95% CI, –0.8 to 0.0), but fewer side effects. They had similar headache frequency and medication use.

Another study⁶ of 22 patients compared SMT with 2 different controls (palpation and rest) for acute tension-type headache. The SMT group was significantly more likely to experience immediate improvement (ES=1.8; 95% CI, 0.4–3.2).

For migraine: Spinal manipulative therapy is similar to amitriptyline

In 1 trial⁷ of migraine prophylaxis, 218 patients were randomized to either 14 sessions of SMT for 2 months or oral amitriptyline (titrated up weekly during the first month and continued at 100 mg daily over the second month). The headache index (a measure of daily pain intensity) was equivalent in both groups in the last 4 weeks of treatment (ES for SMT vs amitriptyline= –0.1; 95% CI, –0.5 to 0.3).

A month after both therapies were stopped, there was a nonsignificant trend toward a lower headache index in the group that had received SMT than the group that had received amitriptyline (ES=0.4; 95% CI, 0.0–0.8). Ten percent of the medication group withdrew from this study due to side effects; no side effects were reported from SMT.⁷

Another RCT⁸ of migraine prophylaxis with 88 patients compared SMT twice weekly for 8 weeks with mobilization techniques. At 8 weeks post-treatment, there was a nonsignificant trend favoring SMT over mobilization in decreasing pain (ES=0.4; 95% CI, –0.2 to 1.0).

Recommendations from others

The National Headache Foundation⁹ states that “the value and cost-effectiveness of chiropractic, osteopathic medicine, and physical therapy in migraine have not been proven in clinical trials. Conflicting results and poor clinical trial design limit the ability to judge the effectiveness of manipulative treatments. Physical therapy, although limited in its study, has proven more effective than manipulative treatment in selective cases.”

Evidence summary

For cervicogenic headaches: Spinal manipulative therapy reduces pain

Three studies¹ evaluated SMT for treatment of recurrent cervicogenic headaches). A multicenter trial² randomized 200 patients with cervicogenic headaches to either SMT (8–12 sessions over 6 weeks) or placebo. The SMT group had significantly reduced pain (at 1 week, effect size [ES]=0.7; 95% confidence interval [CI], 0.3–1.2; and at 12 months, ES=0.4; 95% CI, 0.0–0.8) and fewer headaches (ES=0.7; 95% CI, 0.3–1.1 at both time points) than placebo.

Another RCT³ with 105 patients compared SMT (3 times a week for 3 weeks) with placebo. The SMT group reported significantly less pain after 3 weeks (ES=2.2; 95% CI, 1.7–2.7).

A third trial⁴ randomized 30 patients to either SMT, mobilization (small oscillatory movements to a joint within its normal range), or wait-list placement. At the end of treatment, there was a nonsignificant trend toward greater pain reduction in patients receiving SMT than either those receiving mobilization (ES=0.4; 95% CI, –0.5 to 1.4) or those on the wait list (ES=0.6; 95% CI, –0.4 to 1.5).

For tension-type headaches: Results are mixed

Two trials⁵ investigated the efficacy of SMT on tension-type headaches. The first, an RCT with 150 patients with recurrent headaches, compared SMT (2 sessions per week) with amitriptyline (10 mg daily week 1, 20 mg daily week 2, then 30 mg daily) for 6 weeks. At the end of 6 weeks, the SMT group reported a nonsignificant trend toward more headache pain (ES for SMT vs amitriptyline= –0.4; 95% CI, –0.8 to 0.0), but fewer side effects. They had similar headache frequency and medication use.

Another study⁶ of 22 patients compared SMT with 2 different controls (palpation and rest) for acute tension-type headache. The SMT group was significantly more likely to experience immediate improvement (ES=1.8; 95% CI, 0.4–3.2).

For migraine: Spinal manipulative therapy is similar to amitriptyline

In 1 trial⁷ of migraine prophylaxis, 218 patients were randomized to either 14 sessions of SMT for 2 months or oral amitriptyline (titrated up weekly during the first month and continued at 100 mg daily over the second month). The headache index (a measure of daily pain intensity) was equivalent in both groups in the last 4 weeks of treatment (ES for SMT vs amitriptyline= –0.1; 95% CI, –0.5 to 0.3).

A month after both therapies were stopped, there was a nonsignificant trend toward a lower headache index in the group that had received SMT than the group that had received amitriptyline (ES=0.4; 95% CI, 0.0–0.8). Ten percent of the medication group withdrew from this study due to side effects; no side effects were reported from SMT.⁷

Another RCT⁸ of migraine prophylaxis with 88 patients compared SMT twice weekly for 8 weeks with mobilization techniques. At 8 weeks post-treatment, there was a nonsignificant trend favoring SMT over mobilization in decreasing pain (ES=0.4; 95% CI, –0.2 to 1.0).

Recommendations from others

The National Headache Foundation⁹ states that “the value and cost-effectiveness of chiropractic, osteopathic medicine, and physical therapy in migraine have not been proven in clinical trials. Conflicting results and poor clinical trial design limit the ability to judge the effectiveness of manipulative treatments. Physical therapy, although limited in its study, has proven more effective than manipulative treatment in selective cases.”

Evidence summary

For cervicogenic headaches: Spinal manipulative therapy reduces pain

Three studies¹ evaluated SMT for treatment of recurrent cervicogenic headaches). A multicenter trial² randomized 200 patients with cervicogenic headaches to either SMT (8–12 sessions over 6 weeks) or placebo. The SMT group had significantly reduced pain (at 1 week, effect size [ES]=0.7; 95% confidence interval [CI], 0.3–1.2; and at 12 months, ES=0.4; 95% CI, 0.0–0.8) and fewer headaches (ES=0.7; 95% CI, 0.3–1.1 at both time points) than placebo.

Another RCT³ with 105 patients compared SMT (3 times a week for 3 weeks) with placebo. The SMT group reported significantly less pain after 3 weeks (ES=2.2; 95% CI, 1.7–2.7).

A third trial⁴ randomized 30 patients to either SMT, mobilization (small oscillatory movements to a joint within its normal range), or wait-list placement. At the end of treatment, there was a nonsignificant trend toward greater pain reduction in patients receiving SMT than either those receiving mobilization (ES=0.4; 95% CI, –0.5 to 1.4) or those on the wait list (ES=0.6; 95% CI, –0.4 to 1.5).

For tension-type headaches: Results are mixed

Two trials⁵ investigated the efficacy of SMT on tension-type headaches. The first, an RCT with 150 patients with recurrent headaches, compared SMT (2 sessions per week) with amitriptyline (10 mg daily week 1, 20 mg daily week 2, then 30 mg daily) for 6 weeks. At the end of 6 weeks, the SMT group reported a nonsignificant trend toward more headache pain (ES for SMT vs amitriptyline= –0.4; 95% CI, –0.8 to 0.0), but fewer side effects. They had similar headache frequency and medication use.

Another study⁶ of 22 patients compared SMT with 2 different controls (palpation and rest) for acute tension-type headache. The SMT group was significantly more likely to experience immediate improvement (ES=1.8; 95% CI, 0.4–3.2).

For migraine: Spinal manipulative therapy is similar to amitriptyline

In 1 trial⁷ of migraine prophylaxis, 218 patients were randomized to either 14 sessions of SMT for 2 months or oral amitriptyline (titrated up weekly during the first month and continued at 100 mg daily over the second month). The headache index (a measure of daily pain intensity) was equivalent in both groups in the last 4 weeks of treatment (ES for SMT vs amitriptyline= –0.1; 95% CI, –0.5 to 0.3).

A month after both therapies were stopped, there was a nonsignificant trend toward a lower headache index in the group that had received SMT than the group that had received amitriptyline (ES=0.4; 95% CI, 0.0–0.8). Ten percent of the medication group withdrew from this study due to side effects; no side effects were reported from SMT.⁷

Another RCT⁸ of migraine prophylaxis with 88 patients compared SMT twice weekly for 8 weeks with mobilization techniques. At 8 weeks post-treatment, there was a nonsignificant trend favoring SMT over mobilization in decreasing pain (ES=0.4; 95% CI, –0.2 to 1.0).

Recommendations from others

The National Headache Foundation⁹ states that “the value and cost-effectiveness of chiropractic, osteopathic medicine, and physical therapy in migraine have not been proven in clinical trials. Conflicting results and poor clinical trial design limit the ability to judge the effectiveness of manipulative treatments. Physical therapy, although limited in its study, has proven more effective than manipulative treatment in selective cases.”

Evidence summary

The law of informed consent defines the right to informed refusal. Thus, each case must establish:

1. that the patient or decision maker is competent,
2. that the decision is voluntary, and
3. that the physician disclosed the risks of the choice to the patient, including a discussion of risks and alternatives to treatment, and potential consequences of treatment refusal, including jeopardy to health or life.¹

The general standard of disclosure has evolved to what an ordinary, reasonable patient would wish to know.² To understand the patient’s perspective,³ reasons for the refusal should be explored⁴ and documented.⁵

Medical records that clearly reflect the decision-making process can be pivotal in the success or failure of legal claims.⁶ In addition to the discussion with the patient, the medical record should describe any involvement of family or other third parties. If imminently or potentially serious consequences are likely to result from patient refusal, health care providers might consider having the refusal signed and witnessed.⁷

Not all AMA forms afford protection. There are samples of refusal of consent forms,⁸ but a study of annotated case law revealed that the “discharge against medical advice” forms used by some hospitals might provide little legal protection.⁹ Documenting what specific advice was given to the patient is most important.

Recommendations from others

The American College of Obstetricians and Gynecologists addresses this issue explicitly in a committee opinion on Informed Refusal.² They advocate documenting the explanation of the need for the proposed treatment, the patient’s refusal to consent, the patient’s reasons, and the possible consequences of refusal.

Guidelines on vaccination refusal from the Advisory Committee on Immunization Practices and the American Academy of Family Physicians encourage physicians to enter into a thorough discussion of the risks and benefits of immunization, and document such discussions clearly in the medical record.¹⁰

The American Academy of Pediatrics has published a “Refusal to Vaccinate” form,¹¹ though they warn that it does not substitute for good communication.¹²

The Renal Physicians Association and the American Society of Nephrology guideline on dialysis promotes the concepts of patient autonomy, informed consent or refusal, and the necessity of documenting physician-patient discussions.¹³

Likewise, the American Academy of Pediatrics addresses similar issues in its guidelines on forgoing life-sustaining medical treatment.¹⁴

Evidence summary

The law of informed consent defines the right to informed refusal. Thus, each case must establish:

1. that the patient or decision maker is competent,
2. that the decision is voluntary, and
3. that the physician disclosed the risks of the choice to the patient, including a discussion of risks and alternatives to treatment, and potential consequences of treatment refusal, including jeopardy to health or life.¹

The general standard of disclosure has evolved to what an ordinary, reasonable patient would wish to know.² To understand the patient’s perspective,³ reasons for the refusal should be explored⁴ and documented.⁵

Medical records that clearly reflect the decision-making process can be pivotal in the success or failure of legal claims.⁶ In addition to the discussion with the patient, the medical record should describe any involvement of family or other third parties. If imminently or potentially serious consequences are likely to result from patient refusal, health care providers might consider having the refusal signed and witnessed.⁷

Not all AMA forms afford protection. There are samples of refusal of consent forms,⁸ but a study of annotated case law revealed that the “discharge against medical advice” forms used by some hospitals might provide little legal protection.⁹ Documenting what specific advice was given to the patient is most important.

Recommendations from others

The American College of Obstetricians and Gynecologists addresses this issue explicitly in a committee opinion on Informed Refusal.² They advocate documenting the explanation of the need for the proposed treatment, the patient’s refusal to consent, the patient’s reasons, and the possible consequences of refusal.

Guidelines on vaccination refusal from the Advisory Committee on Immunization Practices and the American Academy of Family Physicians encourage physicians to enter into a thorough discussion of the risks and benefits of immunization, and document such discussions clearly in the medical record.¹⁰

The American Academy of Pediatrics has published a “Refusal to Vaccinate” form,¹¹ though they warn that it does not substitute for good communication.¹²

The Renal Physicians Association and the American Society of Nephrology guideline on dialysis promotes the concepts of patient autonomy, informed consent or refusal, and the necessity of documenting physician-patient discussions.¹³

Likewise, the American Academy of Pediatrics addresses similar issues in its guidelines on forgoing life-sustaining medical treatment.¹⁴

Evidence summary

The law of informed consent defines the right to informed refusal. Thus, each case must establish:

1. that the patient or decision maker is competent,
2. that the decision is voluntary, and
3. that the physician disclosed the risks of the choice to the patient, including a discussion of risks and alternatives to treatment, and potential consequences of treatment refusal, including jeopardy to health or life.¹

The general standard of disclosure has evolved to what an ordinary, reasonable patient would wish to know.² To understand the patient’s perspective,³ reasons for the refusal should be explored⁴ and documented.⁵

Medical records that clearly reflect the decision-making process can be pivotal in the success or failure of legal claims.⁶ In addition to the discussion with the patient, the medical record should describe any involvement of family or other third parties. If imminently or potentially serious consequences are likely to result from patient refusal, health care providers might consider having the refusal signed and witnessed.⁷

Not all AMA forms afford protection. There are samples of refusal of consent forms,⁸ but a study of annotated case law revealed that the “discharge against medical advice” forms used by some hospitals might provide little legal protection.⁹ Documenting what specific advice was given to the patient is most important.

Recommendations from others

The American College of Obstetricians and Gynecologists addresses this issue explicitly in a committee opinion on Informed Refusal.² They advocate documenting the explanation of the need for the proposed treatment, the patient’s refusal to consent, the patient’s reasons, and the possible consequences of refusal.

Guidelines on vaccination refusal from the Advisory Committee on Immunization Practices and the American Academy of Family Physicians encourage physicians to enter into a thorough discussion of the risks and benefits of immunization, and document such discussions clearly in the medical record.¹⁰

The American Academy of Pediatrics has published a “Refusal to Vaccinate” form,¹¹ though they warn that it does not substitute for good communication.¹²

The Renal Physicians Association and the American Society of Nephrology guideline on dialysis promotes the concepts of patient autonomy, informed consent or refusal, and the necessity of documenting physician-patient discussions.¹³

Likewise, the American Academy of Pediatrics addresses similar issues in its guidelines on forgoing life-sustaining medical treatment.¹⁴

Evidence summary

A recent Cochrane review identified 11 randomized controlled trials (RCTs) (with a total of 917 patients) addressing antibiotic therapy for COPD exacerbations characterized by 1 or more of the following: an increase in sputum purulence or volume, dyspnea, wheezing, chest tightness, or fluid retention.¹ Eight trials were conducted on hospital wards, 1 was in a medical intensive care unit, and 2 trials were in the outpatient setting. Antibiotics were given orally in 9 of the 11 studies.

Overall, antibiotics reduced risk of short-term mortality by 77% (relative risk [RR]=0.23; 95% confidence interval [CI],0.10–0.52; number needed to treat [NNT]=8), treatment failure by 53% (RR=0.47; 95% CI, 0.36–0.62; NNT=3), and sputum purulence by 44% (RR=0.56; 95% CI, 0.41–0.77; NNT=8). A subgroup analysis that excluded the outpatient and intensive-care unit studies did not change the result. Another subgroup analysis of the 2 outpatient studies failed to find a significant effect, although the studies had very different designs.

These findings are more robust than those of an earlier, lower-quality meta-analysis of 9 randomized controlled trials (RCTs) with 1101 patients with presumed COPD, which also compared antibiotic therapy with placebo for acute exacerbations.² Specific diagnostic criteria were not stated for the diagnosis of either COPD or an acute exacerbation. No single outcome measure was common to all studies. The authors found a summary beneficial effect size of antibiotic therapy of 0.22 (95% CI, 0.10–0.34), which is generally interpreted as small. One clinical parameter, peak expiratory flow rate (PEFR), was reported in 6 of the studies. Antibiotic therapy resulted in an average 10.75 L/min improvement in PEFR compared with placebo (95% CI, 4.96–16.54 L/min).

Two RCTs addressing antibiotic use in the outpatient setting were identified in the Cochrane review. One double-blind crossover trial performed in Canada compared antibiotic with placebo therapy for 173 outpatients with 362 exacerbations classified according to severity.³ The protocol used oral trimethoprim-sulfamethoxazole, amoxicillin, or doxycycline (according to the attending physician’s preference) or a look-alike placebo. Symptom resolution was seen by 21 days in 68% of antibiotic users vs 55% of those on placebo (P<.01, NNT=8). Ten percent of patients taking antibiotics deteriorated to the point where hospitalization or unblinding of the therapy was necessary, compared with 19% in the placebo group (P<.05, NNT=11).

For patients with all 3 cardinal COPD symptoms (increased dyspnea, sputum production, and sputum purulence) at enrollment, there was resolution at 21 days in 63% with antibiotics vs 43% for placebo (P value not given). Antibiotics did not benefit patients with 1 cardinal symptom (74% success with antibiotics vs 70% on placebo; P value not given).

The Cochrane review also identified a Danish RCT that studied 278 patients presenting to their general practitioners with subjective acute worsening of their COPD. Patients were randomized to 7 days of oral amoxicillin or placebo. There was no difference between the groups in terms of symptom resolution at 1 week (odds ratio=1.03, favoring placebo; 95% CI, 0.75–1.41) or in changes in PEFR (weighted mean difference=–0.89, favoring placebo; 95% CI, –29 to 27 L/min).

Recommendations from others

The Veterans Health Administration recommends antibiotics if a patient with COPD has changes in sputum volume or quality as well as increased dyspnea, cough, or fever; infiltrate on x-ray suggesting pneumonia should be treated as such.⁴

The American College of Chest Physicians recommends that with severe COPD exacerbations, narrow spectrum antibiotics are reasonable first-line agents.⁵ They also note that the superiority of newer, more broad-spectrum antibiotics has not been established.

Evidence summary

A recent Cochrane review identified 11 randomized controlled trials (RCTs) (with a total of 917 patients) addressing antibiotic therapy for COPD exacerbations characterized by 1 or more of the following: an increase in sputum purulence or volume, dyspnea, wheezing, chest tightness, or fluid retention.¹ Eight trials were conducted on hospital wards, 1 was in a medical intensive care unit, and 2 trials were in the outpatient setting. Antibiotics were given orally in 9 of the 11 studies.

Overall, antibiotics reduced risk of short-term mortality by 77% (relative risk [RR]=0.23; 95% confidence interval [CI],0.10–0.52; number needed to treat [NNT]=8), treatment failure by 53% (RR=0.47; 95% CI, 0.36–0.62; NNT=3), and sputum purulence by 44% (RR=0.56; 95% CI, 0.41–0.77; NNT=8). A subgroup analysis that excluded the outpatient and intensive-care unit studies did not change the result. Another subgroup analysis of the 2 outpatient studies failed to find a significant effect, although the studies had very different designs.

These findings are more robust than those of an earlier, lower-quality meta-analysis of 9 randomized controlled trials (RCTs) with 1101 patients with presumed COPD, which also compared antibiotic therapy with placebo for acute exacerbations.² Specific diagnostic criteria were not stated for the diagnosis of either COPD or an acute exacerbation. No single outcome measure was common to all studies. The authors found a summary beneficial effect size of antibiotic therapy of 0.22 (95% CI, 0.10–0.34), which is generally interpreted as small. One clinical parameter, peak expiratory flow rate (PEFR), was reported in 6 of the studies. Antibiotic therapy resulted in an average 10.75 L/min improvement in PEFR compared with placebo (95% CI, 4.96–16.54 L/min).

Two RCTs addressing antibiotic use in the outpatient setting were identified in the Cochrane review. One double-blind crossover trial performed in Canada compared antibiotic with placebo therapy for 173 outpatients with 362 exacerbations classified according to severity.³ The protocol used oral trimethoprim-sulfamethoxazole, amoxicillin, or doxycycline (according to the attending physician’s preference) or a look-alike placebo. Symptom resolution was seen by 21 days in 68% of antibiotic users vs 55% of those on placebo (P<.01, NNT=8). Ten percent of patients taking antibiotics deteriorated to the point where hospitalization or unblinding of the therapy was necessary, compared with 19% in the placebo group (P<.05, NNT=11).

For patients with all 3 cardinal COPD symptoms (increased dyspnea, sputum production, and sputum purulence) at enrollment, there was resolution at 21 days in 63% with antibiotics vs 43% for placebo (P value not given). Antibiotics did not benefit patients with 1 cardinal symptom (74% success with antibiotics vs 70% on placebo; P value not given).

The Cochrane review also identified a Danish RCT that studied 278 patients presenting to their general practitioners with subjective acute worsening of their COPD. Patients were randomized to 7 days of oral amoxicillin or placebo. There was no difference between the groups in terms of symptom resolution at 1 week (odds ratio=1.03, favoring placebo; 95% CI, 0.75–1.41) or in changes in PEFR (weighted mean difference=–0.89, favoring placebo; 95% CI, –29 to 27 L/min).

Recommendations from others

The Veterans Health Administration recommends antibiotics if a patient with COPD has changes in sputum volume or quality as well as increased dyspnea, cough, or fever; infiltrate on x-ray suggesting pneumonia should be treated as such.⁴

The American College of Chest Physicians recommends that with severe COPD exacerbations, narrow spectrum antibiotics are reasonable first-line agents.⁵ They also note that the superiority of newer, more broad-spectrum antibiotics has not been established.

Evidence summary

A recent Cochrane review identified 11 randomized controlled trials (RCTs) (with a total of 917 patients) addressing antibiotic therapy for COPD exacerbations characterized by 1 or more of the following: an increase in sputum purulence or volume, dyspnea, wheezing, chest tightness, or fluid retention.¹ Eight trials were conducted on hospital wards, 1 was in a medical intensive care unit, and 2 trials were in the outpatient setting. Antibiotics were given orally in 9 of the 11 studies.

Overall, antibiotics reduced risk of short-term mortality by 77% (relative risk [RR]=0.23; 95% confidence interval [CI],0.10–0.52; number needed to treat [NNT]=8), treatment failure by 53% (RR=0.47; 95% CI, 0.36–0.62; NNT=3), and sputum purulence by 44% (RR=0.56; 95% CI, 0.41–0.77; NNT=8). A subgroup analysis that excluded the outpatient and intensive-care unit studies did not change the result. Another subgroup analysis of the 2 outpatient studies failed to find a significant effect, although the studies had very different designs.

These findings are more robust than those of an earlier, lower-quality meta-analysis of 9 randomized controlled trials (RCTs) with 1101 patients with presumed COPD, which also compared antibiotic therapy with placebo for acute exacerbations.² Specific diagnostic criteria were not stated for the diagnosis of either COPD or an acute exacerbation. No single outcome measure was common to all studies. The authors found a summary beneficial effect size of antibiotic therapy of 0.22 (95% CI, 0.10–0.34), which is generally interpreted as small. One clinical parameter, peak expiratory flow rate (PEFR), was reported in 6 of the studies. Antibiotic therapy resulted in an average 10.75 L/min improvement in PEFR compared with placebo (95% CI, 4.96–16.54 L/min).

Two RCTs addressing antibiotic use in the outpatient setting were identified in the Cochrane review. One double-blind crossover trial performed in Canada compared antibiotic with placebo therapy for 173 outpatients with 362 exacerbations classified according to severity.³ The protocol used oral trimethoprim-sulfamethoxazole, amoxicillin, or doxycycline (according to the attending physician’s preference) or a look-alike placebo. Symptom resolution was seen by 21 days in 68% of antibiotic users vs 55% of those on placebo (P<.01, NNT=8). Ten percent of patients taking antibiotics deteriorated to the point where hospitalization or unblinding of the therapy was necessary, compared with 19% in the placebo group (P<.05, NNT=11).

For patients with all 3 cardinal COPD symptoms (increased dyspnea, sputum production, and sputum purulence) at enrollment, there was resolution at 21 days in 63% with antibiotics vs 43% for placebo (P value not given). Antibiotics did not benefit patients with 1 cardinal symptom (74% success with antibiotics vs 70% on placebo; P value not given).

The Cochrane review also identified a Danish RCT that studied 278 patients presenting to their general practitioners with subjective acute worsening of their COPD. Patients were randomized to 7 days of oral amoxicillin or placebo. There was no difference between the groups in terms of symptom resolution at 1 week (odds ratio=1.03, favoring placebo; 95% CI, 0.75–1.41) or in changes in PEFR (weighted mean difference=–0.89, favoring placebo; 95% CI, –29 to 27 L/min).

Recommendations from others

The Veterans Health Administration recommends antibiotics if a patient with COPD has changes in sputum volume or quality as well as increased dyspnea, cough, or fever; infiltrate on x-ray suggesting pneumonia should be treated as such.⁴

The American College of Chest Physicians recommends that with severe COPD exacerbations, narrow spectrum antibiotics are reasonable first-line agents.⁵ They also note that the superiority of newer, more broad-spectrum antibiotics has not been established.