Joan Nashelsky, MLS

EVIDENCE SUMMARY

A 2007 Cochrane review on scabies treatment identified 11 trials that evaluated permethrin for treating scabies.¹ In 2 trials, 140 patients were randomized to receive either 200 mcg/kg of oral ivermectin or overnight application of 5% topical permethrin. Topical permethrin was superior to oral ivermectin with failure rates at 2 weeks of 8% and 39%, respectively (number needed to treat [NNT]=4; risk ratio [RR]=4.61; 95% confidence interval [CI], 2.07-10.26).

Two trials compared 5% topical permethrin with 10% topical crotamiton in 194 patients with follow-up at 28 days. Permethrin was superior to crotamiton with failure rates of 6% and 26%, respectively (NNT=6; RR=0.24; 95% CI, 0.10-0.55).

Five trials with 753 patients compared topical permethrin, 2.5% to 3.5%, with topical 1% lindane, but heterogeneity precluded pooling all the studies. In the 3 studies (554 patients) that were comparable, topical 3.5% permethrin was superior to lindane after a single application of each with failure rates of 9% and 15%, respectively (NNT=17; RR=0.59; 95% CI, 0.37-0.95).

Two trials that compared permethrin with topical benzyl benzoate (53 patients) and natural synergized pyrethrins (40 patients) showed no difference in treatment failures, but the trials were small and lacked sufficient statistical power.

Four additional studies included in the review compared crotamiton with lindane (100 patients), lindane with sulfur (68 patients), benzyl benzoate with sulfur (158 patients), and benzyl benzoate with natural synergized pyrethrins (240 patients). None demonstrated superiority, but all were small studies.¹ A single small trial of 55 patients that compared oral ivermectin 200 mcg/kg with placebo showed failure rates at one week of 21% and 85%, respectively (NNT=2; RR=0.24; 95% CI, 0.12-0.51).¹

Topical permethrin vs oral ivermectin

A 2014 systematic review of 5 studies included 2 new studies done after the 2007 Cochrane review.² The new RCTs compared a single application of 5% topical permethrin with a single dose or 2 doses of oral ivermectin given 2 weeks apart. No statistically significant differences were found in these studies.² Both underpowered studies favored topical permethrin, however.

The CDC and the European Guideline for the Management of Scabies both recommend topical permethrin as first-line therapy for classical scabies.

The P value was .42 in one study of 242 adults and children, and this trial showed a clinical cure rate at 2 weeks of 93% using topical permethrin vs 86% using oral ivermectin.²

The other study of 120 adults and children didn’t report a P value or identify statistically significant differences between topical permethrin and oral ivermectin.² This study reported a clinical cure rate of 87% with topical permethrin, 78% with a single dose of oral ivermectin, and 67% with 2 doses of oral ivermectin 2 weeks apart.²

Ivermectin may control endemic scabies better than permethrin

A 2015 randomized controlled trial with 2051 patients compared mass treatments in a scabies-endemic population in Fiji.³ The trial had 3 arms: a standard-care group treated with 5% topical permethrin if symptoms were present and retreated at 2 weeks if symptoms persisted; a permethrin group in which all participants, whether infected or not, received 5% permethrin followed by a second dose at 7 to 14 days if symptoms persisted; and an oral ivermectin group in which participants were treated with 200 mcg/kg, repeated in 7 to 14 days for those with baseline scabies.

At 12 months, the relative risk reductions were 94% (95% CI, 83%-100%) for the ivermectin group, 62% (95% CI, 49%-75%) for the permethrin group, and 49% (95% CI, 37%-60%) for the standard-care group.³ The study had multiple limitations, and all groups were permitted to receive standard care at any time during the 12-month follow-up period. Nevertheless, the findings suggest that endemic scabies control with ivermectin may be superior to topical permethrin.

RECOMMENDATIONS

The Centers for Disease Control and Prevention (CDC)⁴ and the European Guideline for the Management of Scabies⁵ both recommend topical permethrin as first-line therapy for classical scabies and note that oral ivermectin may be safe and effective but isn’t licensed for scabies treatment in most countries. Ivermectin isn’t approved by the United States Food and Drug Administration for treating scabies.

The CDC recommendations note that the safety of ivermectin in children weighing less than 15 kg and pregnant women hasn’t been established.⁴

EVIDENCE SUMMARY

A 2007 Cochrane review on scabies treatment identified 11 trials that evaluated permethrin for treating scabies.¹ In 2 trials, 140 patients were randomized to receive either 200 mcg/kg of oral ivermectin or overnight application of 5% topical permethrin. Topical permethrin was superior to oral ivermectin with failure rates at 2 weeks of 8% and 39%, respectively (number needed to treat [NNT]=4; risk ratio [RR]=4.61; 95% confidence interval [CI], 2.07-10.26).

Two trials compared 5% topical permethrin with 10% topical crotamiton in 194 patients with follow-up at 28 days. Permethrin was superior to crotamiton with failure rates of 6% and 26%, respectively (NNT=6; RR=0.24; 95% CI, 0.10-0.55).

Five trials with 753 patients compared topical permethrin, 2.5% to 3.5%, with topical 1% lindane, but heterogeneity precluded pooling all the studies. In the 3 studies (554 patients) that were comparable, topical 3.5% permethrin was superior to lindane after a single application of each with failure rates of 9% and 15%, respectively (NNT=17; RR=0.59; 95% CI, 0.37-0.95).

Two trials that compared permethrin with topical benzyl benzoate (53 patients) and natural synergized pyrethrins (40 patients) showed no difference in treatment failures, but the trials were small and lacked sufficient statistical power.

Four additional studies included in the review compared crotamiton with lindane (100 patients), lindane with sulfur (68 patients), benzyl benzoate with sulfur (158 patients), and benzyl benzoate with natural synergized pyrethrins (240 patients). None demonstrated superiority, but all were small studies.¹ A single small trial of 55 patients that compared oral ivermectin 200 mcg/kg with placebo showed failure rates at one week of 21% and 85%, respectively (NNT=2; RR=0.24; 95% CI, 0.12-0.51).¹

Topical permethrin vs oral ivermectin

A 2014 systematic review of 5 studies included 2 new studies done after the 2007 Cochrane review.² The new RCTs compared a single application of 5% topical permethrin with a single dose or 2 doses of oral ivermectin given 2 weeks apart. No statistically significant differences were found in these studies.² Both underpowered studies favored topical permethrin, however.

The CDC and the European Guideline for the Management of Scabies both recommend topical permethrin as first-line therapy for classical scabies.

The P value was .42 in one study of 242 adults and children, and this trial showed a clinical cure rate at 2 weeks of 93% using topical permethrin vs 86% using oral ivermectin.²

The other study of 120 adults and children didn’t report a P value or identify statistically significant differences between topical permethrin and oral ivermectin.² This study reported a clinical cure rate of 87% with topical permethrin, 78% with a single dose of oral ivermectin, and 67% with 2 doses of oral ivermectin 2 weeks apart.²

Ivermectin may control endemic scabies better than permethrin

A 2015 randomized controlled trial with 2051 patients compared mass treatments in a scabies-endemic population in Fiji.³ The trial had 3 arms: a standard-care group treated with 5% topical permethrin if symptoms were present and retreated at 2 weeks if symptoms persisted; a permethrin group in which all participants, whether infected or not, received 5% permethrin followed by a second dose at 7 to 14 days if symptoms persisted; and an oral ivermectin group in which participants were treated with 200 mcg/kg, repeated in 7 to 14 days for those with baseline scabies.

At 12 months, the relative risk reductions were 94% (95% CI, 83%-100%) for the ivermectin group, 62% (95% CI, 49%-75%) for the permethrin group, and 49% (95% CI, 37%-60%) for the standard-care group.³ The study had multiple limitations, and all groups were permitted to receive standard care at any time during the 12-month follow-up period. Nevertheless, the findings suggest that endemic scabies control with ivermectin may be superior to topical permethrin.

RECOMMENDATIONS

The Centers for Disease Control and Prevention (CDC)⁴ and the European Guideline for the Management of Scabies⁵ both recommend topical permethrin as first-line therapy for classical scabies and note that oral ivermectin may be safe and effective but isn’t licensed for scabies treatment in most countries. Ivermectin isn’t approved by the United States Food and Drug Administration for treating scabies.

The CDC recommendations note that the safety of ivermectin in children weighing less than 15 kg and pregnant women hasn’t been established.⁴

EVIDENCE SUMMARY

A 2007 Cochrane review on scabies treatment identified 11 trials that evaluated permethrin for treating scabies.¹ In 2 trials, 140 patients were randomized to receive either 200 mcg/kg of oral ivermectin or overnight application of 5% topical permethrin. Topical permethrin was superior to oral ivermectin with failure rates at 2 weeks of 8% and 39%, respectively (number needed to treat [NNT]=4; risk ratio [RR]=4.61; 95% confidence interval [CI], 2.07-10.26).

Two trials compared 5% topical permethrin with 10% topical crotamiton in 194 patients with follow-up at 28 days. Permethrin was superior to crotamiton with failure rates of 6% and 26%, respectively (NNT=6; RR=0.24; 95% CI, 0.10-0.55).

Five trials with 753 patients compared topical permethrin, 2.5% to 3.5%, with topical 1% lindane, but heterogeneity precluded pooling all the studies. In the 3 studies (554 patients) that were comparable, topical 3.5% permethrin was superior to lindane after a single application of each with failure rates of 9% and 15%, respectively (NNT=17; RR=0.59; 95% CI, 0.37-0.95).

Two trials that compared permethrin with topical benzyl benzoate (53 patients) and natural synergized pyrethrins (40 patients) showed no difference in treatment failures, but the trials were small and lacked sufficient statistical power.

Four additional studies included in the review compared crotamiton with lindane (100 patients), lindane with sulfur (68 patients), benzyl benzoate with sulfur (158 patients), and benzyl benzoate with natural synergized pyrethrins (240 patients). None demonstrated superiority, but all were small studies.¹ A single small trial of 55 patients that compared oral ivermectin 200 mcg/kg with placebo showed failure rates at one week of 21% and 85%, respectively (NNT=2; RR=0.24; 95% CI, 0.12-0.51).¹

Topical permethrin vs oral ivermectin

A 2014 systematic review of 5 studies included 2 new studies done after the 2007 Cochrane review.² The new RCTs compared a single application of 5% topical permethrin with a single dose or 2 doses of oral ivermectin given 2 weeks apart. No statistically significant differences were found in these studies.² Both underpowered studies favored topical permethrin, however.

The CDC and the European Guideline for the Management of Scabies both recommend topical permethrin as first-line therapy for classical scabies.

The P value was .42 in one study of 242 adults and children, and this trial showed a clinical cure rate at 2 weeks of 93% using topical permethrin vs 86% using oral ivermectin.²

The other study of 120 adults and children didn’t report a P value or identify statistically significant differences between topical permethrin and oral ivermectin.² This study reported a clinical cure rate of 87% with topical permethrin, 78% with a single dose of oral ivermectin, and 67% with 2 doses of oral ivermectin 2 weeks apart.²

Ivermectin may control endemic scabies better than permethrin

A 2015 randomized controlled trial with 2051 patients compared mass treatments in a scabies-endemic population in Fiji.³ The trial had 3 arms: a standard-care group treated with 5% topical permethrin if symptoms were present and retreated at 2 weeks if symptoms persisted; a permethrin group in which all participants, whether infected or not, received 5% permethrin followed by a second dose at 7 to 14 days if symptoms persisted; and an oral ivermectin group in which participants were treated with 200 mcg/kg, repeated in 7 to 14 days for those with baseline scabies.

At 12 months, the relative risk reductions were 94% (95% CI, 83%-100%) for the ivermectin group, 62% (95% CI, 49%-75%) for the permethrin group, and 49% (95% CI, 37%-60%) for the standard-care group.³ The study had multiple limitations, and all groups were permitted to receive standard care at any time during the 12-month follow-up period. Nevertheless, the findings suggest that endemic scabies control with ivermectin may be superior to topical permethrin.

RECOMMENDATIONS

The Centers for Disease Control and Prevention (CDC)⁴ and the European Guideline for the Management of Scabies⁵ both recommend topical permethrin as first-line therapy for classical scabies and note that oral ivermectin may be safe and effective but isn’t licensed for scabies treatment in most countries. Ivermectin isn’t approved by the United States Food and Drug Administration for treating scabies.

The CDC recommendations note that the safety of ivermectin in children weighing less than 15 kg and pregnant women hasn’t been established.⁴

EVIDENCE SUMMARY

A 2011 meta-analysis of 5 RCTs (total 2975 patients) that compared ACE inhibitor therapy with placebo in diabetic patients without hypertension and albuminuria found that ACE inhibitors reduced the risk of new-onset microalbuminuria or macroalbuminuria by 18% (relative risk [RR]=0.82; 95% confidence interval [CI], 0.73-0.92).¹ Normal albuminuria was defined in all included studies as an albumin excretion rate of <30 mg/d on a timed specimen confirmed with 3 serial measurements.

The RCTs included patients treated with lisinopril, enalapril, and perindopril. All but one examined patients with type 1 diabetes (2781 patients). The study that evaluated type 2 diabetes (194 patients) assessed patients with hypertension who used other antihypertensives to achieve normal blood pressure targets before ACE inhibitor initiation, a potential limitation.

Compared with placebo or no treatment, ACE inhibitor therapy reduced the risk of death from any cause (6 studies; 11,350 patients; RR=0.84; 95% CI, 0.73-0.97).¹ Patient populations across pooled RCTs were heterogeneous, including subjects with type 1 and type 2 diabetes, with or without hypertension, and with or without albuminuria.

ACE inhibitors increase risk of cough

Patients taking an ACE inhibitor have an increased risk of cough (6 studies; 11,791 patients; RR=1.84; 95% CI, 1.24-2.72).¹ ACE inhibitor therapy doesn’t increase the risk of headache or hyperkalemia.

ARBs don’t help prevent diabetic kidney disease in normotensive patients

The 2011 meta-analysis also included 5 RCTs (4604 patients, approximately 3000 with type 2 diabetes and more than 1000 with type 1 diabetes) that compared ARBs with placebo in patients without hypertension.¹ Unlike ACE inhibitor therapy, ARB treatment didn’t significantly affect new-onset microalbuminuria or macroalbuminuria (RR=1.06; 95% CI, 0.67-1.69).

The trials evaluated losartan, candesartan, olmesartan, and valsartan. One study used other antihypertensives to achieve target blood pressure, and another included patients of any albuminuria status.

Compared with placebo or no treatment, ARBs didn’t reduce the risk of death (5 studies; 7653 patients; RR=1.12; 95% CI, 0.88-1.41).¹ All 5 RCTs assessed normoalbuminuric patients. Three of the 5 studies examined normotensive patients; one evaluated only hypertensive patients, and another assessed mostly hypertensive patients.

ARBs usually don’t produce significant adverse effects

Within the meta-analysis, ARBs didn’t increase risk of cough, headache, or hyperkalemia.¹

EVIDENCE SUMMARY

A 2011 meta-analysis of 5 RCTs (total 2975 patients) that compared ACE inhibitor therapy with placebo in diabetic patients without hypertension and albuminuria found that ACE inhibitors reduced the risk of new-onset microalbuminuria or macroalbuminuria by 18% (relative risk [RR]=0.82; 95% confidence interval [CI], 0.73-0.92).¹ Normal albuminuria was defined in all included studies as an albumin excretion rate of <30 mg/d on a timed specimen confirmed with 3 serial measurements.

The RCTs included patients treated with lisinopril, enalapril, and perindopril. All but one examined patients with type 1 diabetes (2781 patients). The study that evaluated type 2 diabetes (194 patients) assessed patients with hypertension who used other antihypertensives to achieve normal blood pressure targets before ACE inhibitor initiation, a potential limitation.

Compared with placebo or no treatment, ACE inhibitor therapy reduced the risk of death from any cause (6 studies; 11,350 patients; RR=0.84; 95% CI, 0.73-0.97).¹ Patient populations across pooled RCTs were heterogeneous, including subjects with type 1 and type 2 diabetes, with or without hypertension, and with or without albuminuria.

ACE inhibitors increase risk of cough

Patients taking an ACE inhibitor have an increased risk of cough (6 studies; 11,791 patients; RR=1.84; 95% CI, 1.24-2.72).¹ ACE inhibitor therapy doesn’t increase the risk of headache or hyperkalemia.

ARBs don’t help prevent diabetic kidney disease in normotensive patients

The 2011 meta-analysis also included 5 RCTs (4604 patients, approximately 3000 with type 2 diabetes and more than 1000 with type 1 diabetes) that compared ARBs with placebo in patients without hypertension.¹ Unlike ACE inhibitor therapy, ARB treatment didn’t significantly affect new-onset microalbuminuria or macroalbuminuria (RR=1.06; 95% CI, 0.67-1.69).

The trials evaluated losartan, candesartan, olmesartan, and valsartan. One study used other antihypertensives to achieve target blood pressure, and another included patients of any albuminuria status.

Compared with placebo or no treatment, ARBs didn’t reduce the risk of death (5 studies; 7653 patients; RR=1.12; 95% CI, 0.88-1.41).¹ All 5 RCTs assessed normoalbuminuric patients. Three of the 5 studies examined normotensive patients; one evaluated only hypertensive patients, and another assessed mostly hypertensive patients.

ARBs usually don’t produce significant adverse effects

Within the meta-analysis, ARBs didn’t increase risk of cough, headache, or hyperkalemia.¹

EVIDENCE SUMMARY

A 2011 meta-analysis of 5 RCTs (total 2975 patients) that compared ACE inhibitor therapy with placebo in diabetic patients without hypertension and albuminuria found that ACE inhibitors reduced the risk of new-onset microalbuminuria or macroalbuminuria by 18% (relative risk [RR]=0.82; 95% confidence interval [CI], 0.73-0.92).¹ Normal albuminuria was defined in all included studies as an albumin excretion rate of <30 mg/d on a timed specimen confirmed with 3 serial measurements.

The RCTs included patients treated with lisinopril, enalapril, and perindopril. All but one examined patients with type 1 diabetes (2781 patients). The study that evaluated type 2 diabetes (194 patients) assessed patients with hypertension who used other antihypertensives to achieve normal blood pressure targets before ACE inhibitor initiation, a potential limitation.

Compared with placebo or no treatment, ACE inhibitor therapy reduced the risk of death from any cause (6 studies; 11,350 patients; RR=0.84; 95% CI, 0.73-0.97).¹ Patient populations across pooled RCTs were heterogeneous, including subjects with type 1 and type 2 diabetes, with or without hypertension, and with or without albuminuria.

ACE inhibitors increase risk of cough

Patients taking an ACE inhibitor have an increased risk of cough (6 studies; 11,791 patients; RR=1.84; 95% CI, 1.24-2.72).¹ ACE inhibitor therapy doesn’t increase the risk of headache or hyperkalemia.

ARBs don’t help prevent diabetic kidney disease in normotensive patients

The 2011 meta-analysis also included 5 RCTs (4604 patients, approximately 3000 with type 2 diabetes and more than 1000 with type 1 diabetes) that compared ARBs with placebo in patients without hypertension.¹ Unlike ACE inhibitor therapy, ARB treatment didn’t significantly affect new-onset microalbuminuria or macroalbuminuria (RR=1.06; 95% CI, 0.67-1.69).

The trials evaluated losartan, candesartan, olmesartan, and valsartan. One study used other antihypertensives to achieve target blood pressure, and another included patients of any albuminuria status.

Compared with placebo or no treatment, ARBs didn’t reduce the risk of death (5 studies; 7653 patients; RR=1.12; 95% CI, 0.88-1.41).¹ All 5 RCTs assessed normoalbuminuric patients. Three of the 5 studies examined normotensive patients; one evaluated only hypertensive patients, and another assessed mostly hypertensive patients.

ARBs usually don’t produce significant adverse effects

Within the meta-analysis, ARBs didn’t increase risk of cough, headache, or hyperkalemia.¹

EVIDENCE SUMMARY

A systematic review and meta-analysis of 84 moderate- to high-quality RCTs with 24,010 patients evaluated the use of “eHealth” interventions in preventing and treating overweight and obesity in adults 35 to 65 years of age (75% female).¹ The studies included 183 active intervention arms with durations as long as 24 months (64% <6 months, 46% >6 months). The term eHealth included all forms of information technology used to deliver health care, but predominantly the Internet (Web site/Web-based), e-mail, and text messaging. Sixty percent (84) of eHealth interventional arms used one modality and 34% (47) used 2. Some intervention arms included non-eHealth modalities, such as paper-based measures and counseling.

The eHealth interventions were associated with significantly greater weight loss than minimal or no intervention (TABLE).¹ Comparing eHealth interventions with no intervention showed significant differences by eHealth type (P=.05). The greatest weight loss accompanied interventions that combined Web-based measures with a non-eHealth intervention, (mean difference [MD]= −3.7 kg; 95% confidence interval [CI], −4.46 to −2.94), followed by mobile interventions alone (MD= −2.4 kg; 95% CI, −4.09 to −0.71) and Web-based interventions alone (MD= −2.2 kg; 95% CI, −2.98 to −1.44).

Similarly, comparing combined interventions (eHealth + eHealth or eHealth + non-eHealth) with a minimal intervention control showed a trend for difference by eHealth type (P=.005). Only a combination of eHealth with non-eHealth interventions resulted in significantly greater weight loss (Web site + non-eHealth: MD= −2.7 kg; 95% CI, −3.76 to −1.54; text + non-eHealth: MD= −1.8 kg; 95% CI, −2.49 to −1.12; computer + non-eHealth: MD=1.1 kg; 95% CI, −1.36 to −0.89).

Personal coaching plus smartphone monitoring beats interactive app

A 3-arm RCT of 385 overweight and obese participants (mean body mass index [BMI], 35 kg/m²) 18 to 35 years of age compared the effectiveness of weight loss interventions delivered by interactive smartphone application (CP [cell phone]), personal coaching enhanced by smartphone self-monitoring (PC), and usual care (control).² The PC arm attended 6 weekly group sessions and received monthly phone calls. The usual care arm received 3 handouts on healthy eating and physical activity.

The CP arm showed the least amount of weight loss (−0.9 kg, −1.5 kg, and −1.0 kg at 6, 12, and 24 months, respectively) and no significant difference compared with controls at all measurement points. The PC arm had significantly greater weight loss than controls at 6 months (−1.9 kg; 95% CI, −3.17 to −0.67) and significantly greater weight loss than CP at 6 months (−2.2 kg; 95% CI, −3.42 to −0.97) and 12 months (−2.1 kg; 95% CI, −3.94 to −0.27). After 24 months, however, there was no significant difference in mean weight loss among treatment arms.

Automated behavioral program reduced weight and waist circumference

An RCT of 339 prediabetic, overweight, and obese patients 30 to 69 years old (mean BMI, 31 kg/m²) compared the effectiveness of Alive-PD, a fully automated, tailored, behavioral program, to usual care (control) for diabetes prevention.³ In addition to behavioral support, the program included weekly emails, Web-based tracking, a mobile phone app, and automated phone calls.

At 6 months, the intervention group had significantly greater mean weight loss (−3.4 kg vs −1.3 kg; P<.001), mean BMI (−1.1 kg/m² vs −0.4 kg/m²; P<.001), and mean waist circumference (−4.6 cm vs 2.2 cm; P<.001).

Web-based program improves weight loss at 3 months, but not 12 months

An RCT of 65 overweight and obese participants (mean BMI, 32 kg/m²) with at least one cardiovascular risk factor compared the effect of a Web-based program with usual care on weight change at 3, 6, and 12 months.⁴ Participants in the intervention group were provided with Bluetooth-enabled scales and accelerometer activity bands to allow daily uploads. The Web-based program also provided weekly feedback based on the participant’s performance and a food diary.

The Web-based group had significantly greater weight loss at 3 months (mean= −3.4 kg [95% CI, −4.70 to −2.13] vs −0.5 kg [95% CI, −1.55 to 0.52]; P<.001) and 6 months (mean= −3.4 kg [95% CI, −4.95 to −1.98] vs −0.8 kg [95% CI, −2.23 to 0.61]; P=.02). At 12 months, however, the groups showed no significant difference (mean= −2.4 kg [95% CI, −3.48 to −0.97] vs −1.8 kg [95% CI, −3.15 to −0.44]; P=.77).

RECOMMENDATIONS

Guidelines from the American College of Cardiology, American Heart Association, and Obesity Society state that electronically delivered weight-loss programs may be prescribed, but may result in smaller weight loss than face-to-face interventions (SOR: B, moderate evidence from RCTs with some limitations or non-randomized trials).⁵

EVIDENCE SUMMARY

A systematic review and meta-analysis of 84 moderate- to high-quality RCTs with 24,010 patients evaluated the use of “eHealth” interventions in preventing and treating overweight and obesity in adults 35 to 65 years of age (75% female).¹ The studies included 183 active intervention arms with durations as long as 24 months (64% <6 months, 46% >6 months). The term eHealth included all forms of information technology used to deliver health care, but predominantly the Internet (Web site/Web-based), e-mail, and text messaging. Sixty percent (84) of eHealth interventional arms used one modality and 34% (47) used 2. Some intervention arms included non-eHealth modalities, such as paper-based measures and counseling.

The eHealth interventions were associated with significantly greater weight loss than minimal or no intervention (TABLE).¹ Comparing eHealth interventions with no intervention showed significant differences by eHealth type (P=.05). The greatest weight loss accompanied interventions that combined Web-based measures with a non-eHealth intervention, (mean difference [MD]= −3.7 kg; 95% confidence interval [CI], −4.46 to −2.94), followed by mobile interventions alone (MD= −2.4 kg; 95% CI, −4.09 to −0.71) and Web-based interventions alone (MD= −2.2 kg; 95% CI, −2.98 to −1.44).

Similarly, comparing combined interventions (eHealth + eHealth or eHealth + non-eHealth) with a minimal intervention control showed a trend for difference by eHealth type (P=.005). Only a combination of eHealth with non-eHealth interventions resulted in significantly greater weight loss (Web site + non-eHealth: MD= −2.7 kg; 95% CI, −3.76 to −1.54; text + non-eHealth: MD= −1.8 kg; 95% CI, −2.49 to −1.12; computer + non-eHealth: MD=1.1 kg; 95% CI, −1.36 to −0.89).

Personal coaching plus smartphone monitoring beats interactive app

A 3-arm RCT of 385 overweight and obese participants (mean body mass index [BMI], 35 kg/m²) 18 to 35 years of age compared the effectiveness of weight loss interventions delivered by interactive smartphone application (CP [cell phone]), personal coaching enhanced by smartphone self-monitoring (PC), and usual care (control).² The PC arm attended 6 weekly group sessions and received monthly phone calls. The usual care arm received 3 handouts on healthy eating and physical activity.

The CP arm showed the least amount of weight loss (−0.9 kg, −1.5 kg, and −1.0 kg at 6, 12, and 24 months, respectively) and no significant difference compared with controls at all measurement points. The PC arm had significantly greater weight loss than controls at 6 months (−1.9 kg; 95% CI, −3.17 to −0.67) and significantly greater weight loss than CP at 6 months (−2.2 kg; 95% CI, −3.42 to −0.97) and 12 months (−2.1 kg; 95% CI, −3.94 to −0.27). After 24 months, however, there was no significant difference in mean weight loss among treatment arms.

Automated behavioral program reduced weight and waist circumference

An RCT of 339 prediabetic, overweight, and obese patients 30 to 69 years old (mean BMI, 31 kg/m²) compared the effectiveness of Alive-PD, a fully automated, tailored, behavioral program, to usual care (control) for diabetes prevention.³ In addition to behavioral support, the program included weekly emails, Web-based tracking, a mobile phone app, and automated phone calls.

At 6 months, the intervention group had significantly greater mean weight loss (−3.4 kg vs −1.3 kg; P<.001), mean BMI (−1.1 kg/m² vs −0.4 kg/m²; P<.001), and mean waist circumference (−4.6 cm vs 2.2 cm; P<.001).

Web-based program improves weight loss at 3 months, but not 12 months

An RCT of 65 overweight and obese participants (mean BMI, 32 kg/m²) with at least one cardiovascular risk factor compared the effect of a Web-based program with usual care on weight change at 3, 6, and 12 months.⁴ Participants in the intervention group were provided with Bluetooth-enabled scales and accelerometer activity bands to allow daily uploads. The Web-based program also provided weekly feedback based on the participant’s performance and a food diary.

The Web-based group had significantly greater weight loss at 3 months (mean= −3.4 kg [95% CI, −4.70 to −2.13] vs −0.5 kg [95% CI, −1.55 to 0.52]; P<.001) and 6 months (mean= −3.4 kg [95% CI, −4.95 to −1.98] vs −0.8 kg [95% CI, −2.23 to 0.61]; P=.02). At 12 months, however, the groups showed no significant difference (mean= −2.4 kg [95% CI, −3.48 to −0.97] vs −1.8 kg [95% CI, −3.15 to −0.44]; P=.77).

RECOMMENDATIONS

Guidelines from the American College of Cardiology, American Heart Association, and Obesity Society state that electronically delivered weight-loss programs may be prescribed, but may result in smaller weight loss than face-to-face interventions (SOR: B, moderate evidence from RCTs with some limitations or non-randomized trials).⁵

EVIDENCE SUMMARY

A systematic review and meta-analysis of 84 moderate- to high-quality RCTs with 24,010 patients evaluated the use of “eHealth” interventions in preventing and treating overweight and obesity in adults 35 to 65 years of age (75% female).¹ The studies included 183 active intervention arms with durations as long as 24 months (64% <6 months, 46% >6 months). The term eHealth included all forms of information technology used to deliver health care, but predominantly the Internet (Web site/Web-based), e-mail, and text messaging. Sixty percent (84) of eHealth interventional arms used one modality and 34% (47) used 2. Some intervention arms included non-eHealth modalities, such as paper-based measures and counseling.

The eHealth interventions were associated with significantly greater weight loss than minimal or no intervention (TABLE).¹ Comparing eHealth interventions with no intervention showed significant differences by eHealth type (P=.05). The greatest weight loss accompanied interventions that combined Web-based measures with a non-eHealth intervention, (mean difference [MD]= −3.7 kg; 95% confidence interval [CI], −4.46 to −2.94), followed by mobile interventions alone (MD= −2.4 kg; 95% CI, −4.09 to −0.71) and Web-based interventions alone (MD= −2.2 kg; 95% CI, −2.98 to −1.44).

Similarly, comparing combined interventions (eHealth + eHealth or eHealth + non-eHealth) with a minimal intervention control showed a trend for difference by eHealth type (P=.005). Only a combination of eHealth with non-eHealth interventions resulted in significantly greater weight loss (Web site + non-eHealth: MD= −2.7 kg; 95% CI, −3.76 to −1.54; text + non-eHealth: MD= −1.8 kg; 95% CI, −2.49 to −1.12; computer + non-eHealth: MD=1.1 kg; 95% CI, −1.36 to −0.89).

Personal coaching plus smartphone monitoring beats interactive app

A 3-arm RCT of 385 overweight and obese participants (mean body mass index [BMI], 35 kg/m²) 18 to 35 years of age compared the effectiveness of weight loss interventions delivered by interactive smartphone application (CP [cell phone]), personal coaching enhanced by smartphone self-monitoring (PC), and usual care (control).² The PC arm attended 6 weekly group sessions and received monthly phone calls. The usual care arm received 3 handouts on healthy eating and physical activity.

The CP arm showed the least amount of weight loss (−0.9 kg, −1.5 kg, and −1.0 kg at 6, 12, and 24 months, respectively) and no significant difference compared with controls at all measurement points. The PC arm had significantly greater weight loss than controls at 6 months (−1.9 kg; 95% CI, −3.17 to −0.67) and significantly greater weight loss than CP at 6 months (−2.2 kg; 95% CI, −3.42 to −0.97) and 12 months (−2.1 kg; 95% CI, −3.94 to −0.27). After 24 months, however, there was no significant difference in mean weight loss among treatment arms.

Automated behavioral program reduced weight and waist circumference

An RCT of 339 prediabetic, overweight, and obese patients 30 to 69 years old (mean BMI, 31 kg/m²) compared the effectiveness of Alive-PD, a fully automated, tailored, behavioral program, to usual care (control) for diabetes prevention.³ In addition to behavioral support, the program included weekly emails, Web-based tracking, a mobile phone app, and automated phone calls.

At 6 months, the intervention group had significantly greater mean weight loss (−3.4 kg vs −1.3 kg; P<.001), mean BMI (−1.1 kg/m² vs −0.4 kg/m²; P<.001), and mean waist circumference (−4.6 cm vs 2.2 cm; P<.001).

Web-based program improves weight loss at 3 months, but not 12 months

An RCT of 65 overweight and obese participants (mean BMI, 32 kg/m²) with at least one cardiovascular risk factor compared the effect of a Web-based program with usual care on weight change at 3, 6, and 12 months.⁴ Participants in the intervention group were provided with Bluetooth-enabled scales and accelerometer activity bands to allow daily uploads. The Web-based program also provided weekly feedback based on the participant’s performance and a food diary.

The Web-based group had significantly greater weight loss at 3 months (mean= −3.4 kg [95% CI, −4.70 to −2.13] vs −0.5 kg [95% CI, −1.55 to 0.52]; P<.001) and 6 months (mean= −3.4 kg [95% CI, −4.95 to −1.98] vs −0.8 kg [95% CI, −2.23 to 0.61]; P=.02). At 12 months, however, the groups showed no significant difference (mean= −2.4 kg [95% CI, −3.48 to −0.97] vs −1.8 kg [95% CI, −3.15 to −0.44]; P=.77).

RECOMMENDATIONS

Guidelines from the American College of Cardiology, American Heart Association, and Obesity Society state that electronically delivered weight-loss programs may be prescribed, but may result in smaller weight loss than face-to-face interventions (SOR: B, moderate evidence from RCTs with some limitations or non-randomized trials).⁵

EVIDENCE SUMMARY

A 2014 meta-analysis of 15 trials (quasi-random and RCT) with a total of 28,271 patients that compared the effect of vitamin D on fracture risk with placebo or no treatment, found no benefit for vitamin D supplementation (TABLE).¹ Patients lived in community and nursing home settings and ranged in age from 50 to 85 years; 24% to 100% were female.

Only 3 trials required patients to have had a previous fracture. Exclusions included: diseases affecting bone metabolism, cognitive impairment, drugs affecting bone metabolism (bisphosphonates, selective estrogen receptor modulators, and corticosteroids), renal failure, hypercalcemia, nephrolithiasis, and decreased mobility (recent stroke recovery and Parkinson’s disease).

Formulations of vitamin D included cholecalciferol (D₃) 400 to 2000 IU/d for 4 months to 5 years or 100,000 to 500,000 IU every 3 to 12 months for 1 to 5 years; calcifediol (25(OH)D₃) 600 IU/d for 4 years; and ergocalciferol (D₂) 400 IU/d for 2 years or 3000 to 300,000 IU every 3 to 12 months for 10 months to 3 years.

Vitamin D analogs generally have no benefit either

The same meta-analysis compared vitamin D analogs to placebo or no treatment (8 trials, quasi-random and RCT, 1743 patients) on the risk of fracture, again finding no benefit in all but one case. Included patients were mostly by referral to tertiary or university hospitals and outpatient community settings.

Most of the studies included only a small number of patients (about 200), with the largest study having 740 patients. The age range was 50 to 77 years, and 50% to 100% were female. Most of the trials required patients to have osteoporosis or vitamin D deficiency with a previous vertebral deformity on imaging. Study exclusions included osteomalacia, malabsorption, hyperparathyroidism, active kidney stones, history of hypercalciuria, cancer, incurable disease, dementia, severe chronic illness (renal or liver failure), recent stroke or fracture, and drugs that affect bone metabolism.

Vitamin D analogs were given as alfacalcidol (1-alphahydroxyvitamin D₃) 0.5 mcg twice daily or 1 mcg/d for 36 weeks to 2 years or calcitriol (1,25-dihydroxyvitamin D₃) 0.25 to 1 mcg once or twice daily for one to 3 years. Researchers found a significant reduction in vertebral (but not nonvertebral or hip) fractures with alfacalcidol, but the finding occurred in a single trial that was assessed by the authors of the meta-analysis as subject to bias.

Supplementation doesn’t affect mortality, but does have some side effects

Patients taking vitamin D or an analog with or without calcium showed no difference in risk of death compared with patients taking placebo (29 trials, 71,032 patients; relative risk [RR]=0.97; 95% confidence interval [CI], 0.93-1.01).

Patients taking vitamin D or an analog were more likely than controls to have mild hypercalcemia, with an average increase of 2.7 mmol/L (21 trials, 17,124 patients; RR=2.28; 95% CI, 1.57-3.31). Patients taking calcitriol had the highest risk (4 trials, 988 patients; RR=4.41; 95% CI, 2.14-9.09).

Gastrointestinal adverse effects (4% increase) and renal calculi or mild renal insufficiency (16% increase) were more common with vitamin D and analogs than placebo (GI adverse effects: 15 trials, 47,761 patients; RR=1.04; 95% CI, 1.00-1.08; renal calculi or mild renal insufficiency: 11 trials, 46,548 patients; RR=1.16; 95% CI, 1.02-1.33).

RECOMMENDATIONS

There are no guidelines recommending vitamin D supplementation without calcium to prevent fracture.

EVIDENCE SUMMARY

A 2014 meta-analysis of 15 trials (quasi-random and RCT) with a total of 28,271 patients that compared the effect of vitamin D on fracture risk with placebo or no treatment, found no benefit for vitamin D supplementation (TABLE).¹ Patients lived in community and nursing home settings and ranged in age from 50 to 85 years; 24% to 100% were female.

Only 3 trials required patients to have had a previous fracture. Exclusions included: diseases affecting bone metabolism, cognitive impairment, drugs affecting bone metabolism (bisphosphonates, selective estrogen receptor modulators, and corticosteroids), renal failure, hypercalcemia, nephrolithiasis, and decreased mobility (recent stroke recovery and Parkinson’s disease).

Formulations of vitamin D included cholecalciferol (D₃) 400 to 2000 IU/d for 4 months to 5 years or 100,000 to 500,000 IU every 3 to 12 months for 1 to 5 years; calcifediol (25(OH)D₃) 600 IU/d for 4 years; and ergocalciferol (D₂) 400 IU/d for 2 years or 3000 to 300,000 IU every 3 to 12 months for 10 months to 3 years.

Vitamin D analogs generally have no benefit either

The same meta-analysis compared vitamin D analogs to placebo or no treatment (8 trials, quasi-random and RCT, 1743 patients) on the risk of fracture, again finding no benefit in all but one case. Included patients were mostly by referral to tertiary or university hospitals and outpatient community settings.

Most of the studies included only a small number of patients (about 200), with the largest study having 740 patients. The age range was 50 to 77 years, and 50% to 100% were female. Most of the trials required patients to have osteoporosis or vitamin D deficiency with a previous vertebral deformity on imaging. Study exclusions included osteomalacia, malabsorption, hyperparathyroidism, active kidney stones, history of hypercalciuria, cancer, incurable disease, dementia, severe chronic illness (renal or liver failure), recent stroke or fracture, and drugs that affect bone metabolism.

Vitamin D analogs were given as alfacalcidol (1-alphahydroxyvitamin D₃) 0.5 mcg twice daily or 1 mcg/d for 36 weeks to 2 years or calcitriol (1,25-dihydroxyvitamin D₃) 0.25 to 1 mcg once or twice daily for one to 3 years. Researchers found a significant reduction in vertebral (but not nonvertebral or hip) fractures with alfacalcidol, but the finding occurred in a single trial that was assessed by the authors of the meta-analysis as subject to bias.

Supplementation doesn’t affect mortality, but does have some side effects

Patients taking vitamin D or an analog with or without calcium showed no difference in risk of death compared with patients taking placebo (29 trials, 71,032 patients; relative risk [RR]=0.97; 95% confidence interval [CI], 0.93-1.01).

Patients taking vitamin D or an analog were more likely than controls to have mild hypercalcemia, with an average increase of 2.7 mmol/L (21 trials, 17,124 patients; RR=2.28; 95% CI, 1.57-3.31). Patients taking calcitriol had the highest risk (4 trials, 988 patients; RR=4.41; 95% CI, 2.14-9.09).

Gastrointestinal adverse effects (4% increase) and renal calculi or mild renal insufficiency (16% increase) were more common with vitamin D and analogs than placebo (GI adverse effects: 15 trials, 47,761 patients; RR=1.04; 95% CI, 1.00-1.08; renal calculi or mild renal insufficiency: 11 trials, 46,548 patients; RR=1.16; 95% CI, 1.02-1.33).

RECOMMENDATIONS

There are no guidelines recommending vitamin D supplementation without calcium to prevent fracture.

EVIDENCE SUMMARY

A 2014 meta-analysis of 15 trials (quasi-random and RCT) with a total of 28,271 patients that compared the effect of vitamin D on fracture risk with placebo or no treatment, found no benefit for vitamin D supplementation (TABLE).¹ Patients lived in community and nursing home settings and ranged in age from 50 to 85 years; 24% to 100% were female.

Only 3 trials required patients to have had a previous fracture. Exclusions included: diseases affecting bone metabolism, cognitive impairment, drugs affecting bone metabolism (bisphosphonates, selective estrogen receptor modulators, and corticosteroids), renal failure, hypercalcemia, nephrolithiasis, and decreased mobility (recent stroke recovery and Parkinson’s disease).

Formulations of vitamin D included cholecalciferol (D₃) 400 to 2000 IU/d for 4 months to 5 years or 100,000 to 500,000 IU every 3 to 12 months for 1 to 5 years; calcifediol (25(OH)D₃) 600 IU/d for 4 years; and ergocalciferol (D₂) 400 IU/d for 2 years or 3000 to 300,000 IU every 3 to 12 months for 10 months to 3 years.

Vitamin D analogs generally have no benefit either

The same meta-analysis compared vitamin D analogs to placebo or no treatment (8 trials, quasi-random and RCT, 1743 patients) on the risk of fracture, again finding no benefit in all but one case. Included patients were mostly by referral to tertiary or university hospitals and outpatient community settings.

Most of the studies included only a small number of patients (about 200), with the largest study having 740 patients. The age range was 50 to 77 years, and 50% to 100% were female. Most of the trials required patients to have osteoporosis or vitamin D deficiency with a previous vertebral deformity on imaging. Study exclusions included osteomalacia, malabsorption, hyperparathyroidism, active kidney stones, history of hypercalciuria, cancer, incurable disease, dementia, severe chronic illness (renal or liver failure), recent stroke or fracture, and drugs that affect bone metabolism.

Vitamin D analogs were given as alfacalcidol (1-alphahydroxyvitamin D₃) 0.5 mcg twice daily or 1 mcg/d for 36 weeks to 2 years or calcitriol (1,25-dihydroxyvitamin D₃) 0.25 to 1 mcg once or twice daily for one to 3 years. Researchers found a significant reduction in vertebral (but not nonvertebral or hip) fractures with alfacalcidol, but the finding occurred in a single trial that was assessed by the authors of the meta-analysis as subject to bias.

Supplementation doesn’t affect mortality, but does have some side effects

Patients taking vitamin D or an analog with or without calcium showed no difference in risk of death compared with patients taking placebo (29 trials, 71,032 patients; relative risk [RR]=0.97; 95% confidence interval [CI], 0.93-1.01).

Patients taking vitamin D or an analog were more likely than controls to have mild hypercalcemia, with an average increase of 2.7 mmol/L (21 trials, 17,124 patients; RR=2.28; 95% CI, 1.57-3.31). Patients taking calcitriol had the highest risk (4 trials, 988 patients; RR=4.41; 95% CI, 2.14-9.09).

Gastrointestinal adverse effects (4% increase) and renal calculi or mild renal insufficiency (16% increase) were more common with vitamin D and analogs than placebo (GI adverse effects: 15 trials, 47,761 patients; RR=1.04; 95% CI, 1.00-1.08; renal calculi or mild renal insufficiency: 11 trials, 46,548 patients; RR=1.16; 95% CI, 1.02-1.33).

RECOMMENDATIONS

There are no guidelines recommending vitamin D supplementation without calcium to prevent fracture.

EVIDENCE SUMMARY

In 2015, the American College of Rheumatology (ACR) redefined the clinical criteria for diagnosis of gout based on a 3-step system¹ that can be found at: http://goutclassificationcalculator.auckland.ac.nz. The ACR rule was derived from a cross-sectional study of 983 patients in 25 rheumatology centers in 16 countries who presented with a swollen joint.² Of the 983 patients, 509 had gout; the prevalence was 52%. Data from 653 of these patients were used to develop the rule and then validated in the remaining 330 patients.

Compared with the gold standard of monosodium urate crystals in synovial fluid, the ACR rule has a sensitivity of 92% and a specificity of 89%. The rule, designed for the research setting, involves using synovial fluid analysis, ultrasound imaging, and radiography, which makes it less useful in a primary care setting.

The Netherlands rule for primary care

A prospective diagnostic study in 328 family medicine patients (74% male; mean age 57) with monoarthritis tested the ability of multiple clinical variables to diagnose gout using monosodium urate crystals in synovial fluid as the gold standard.³ The prevalence of gout in this population was 57%.

The best diagnostic rule (Netherlands rule) comprised the following predefined variables: male sex, previous patient-reported arthritis attack, onset within one day, joint redness, first metatarsophalangeal joint (MTP1) involvement, hypertension or cardiovascular disease (angina pectoris, myocardial infarction, heart failure, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease), and serum uric acid level above 5.88 mg/dL. The rule gives one point for each item. A score >8 had a positive likelihood ratio for diagnosing gout of 3.48 (TABLE¹) and a higher positive predictive value (PPV) than family physicians’ clinical impressions (83% vs 64%).

The prevalence of gout in patients with scores of <4, 4 to 8, and >8 were 2.8%, 27%, and 80%, respectively. For scores of 4 to 8, the probability of gout is indeterminate, and synovial fluid analysis is recommended.

The Netherlands rule, validated in a secondary care practice of 390 patients with monoarthritis, found that a score >8 had a PPV of 87% and a score <4 had a negative predictive value of 95%.⁴ The probability of gout based on this rule can be calculated at http://www.umcn.nl/goutcalc.

Clinical prediction rules effectively diagnose gout without joint fluid analysis.In the study used to develop the Netherlands rule, no patients with a high probability of gout had septic arthritis. The ability of the rule to differentiate between gout and septic arthritis was tested retrospectively in 33 patients with acute gout (podagra excluded) diagnosed by the presence of monosodium urate joint crystals and 27 patients with septic arthritis diagnosed by positive bacterial culture.⁵ Patients with gout had significantly higher scores than patients with septic arthritis (7.8 ± 1.59 vs 3.4 ± 2.3; P<.001).

A study of 82 Veterans Administration patients compared the American Rheumatology Association (ARA), New York, and Rome prediction rules with regard to their ability to diagnose gout with synovial urate crystals.⁶ The ARA criteria for gout diagnosis require either tophi or monosodium urate crystals in synovial fluid, or 6 out of a list of 12 other criteria.⁷

The New York prediction rule requires that patients meet 2 or more of the following criteria: at least 2 attacks of painful joint swelling with complete resolution within 2 weeks, podagra, tophi, and rapid response to colchicine treatment, defined as a major reduction in the objective signs of inflammation within 48 hours.

The Rome prediction rule requires meeting 2 of 3 criteria: serum uric acid >7 mg/dL in men and >6 mg/dL in women, presence of tophi, and history of attacks of painful joint swelling with abrupt onset and resolution within 2 weeks.

The New York prediction rule had the highest positive likelihood ratio of 4.4 compared with the ARA (1.8) and Rome (4.3) rules.⁶ The utility of the New York and Rome rules, although they have fewer criteria than ARA, is limited by the fact that they include a previous episode of joint swelling and tophi. These criteria increase their specificity but make them less useful in diagnosing a first episode of gout, when tophi are unlikely to have developed.

Prediction rules are more sensitive in established gout

The new ACR prediction rule was compared with the ARA, Rome, and New York clinical prediction rules using urate crystals as the gold standard in early (less than 2 years) and established disease (longer than 2 years).⁸ All clinical prediction rules were more sensitive in established disease than early disease (95.3% vs 84.1%; P<.001) and more specific in early disease than established disease (79.9% vs 52.5%; P<.001).

EVIDENCE SUMMARY

In 2015, the American College of Rheumatology (ACR) redefined the clinical criteria for diagnosis of gout based on a 3-step system¹ that can be found at: http://goutclassificationcalculator.auckland.ac.nz. The ACR rule was derived from a cross-sectional study of 983 patients in 25 rheumatology centers in 16 countries who presented with a swollen joint.² Of the 983 patients, 509 had gout; the prevalence was 52%. Data from 653 of these patients were used to develop the rule and then validated in the remaining 330 patients.

Compared with the gold standard of monosodium urate crystals in synovial fluid, the ACR rule has a sensitivity of 92% and a specificity of 89%. The rule, designed for the research setting, involves using synovial fluid analysis, ultrasound imaging, and radiography, which makes it less useful in a primary care setting.

The Netherlands rule for primary care

A prospective diagnostic study in 328 family medicine patients (74% male; mean age 57) with monoarthritis tested the ability of multiple clinical variables to diagnose gout using monosodium urate crystals in synovial fluid as the gold standard.³ The prevalence of gout in this population was 57%.

The best diagnostic rule (Netherlands rule) comprised the following predefined variables: male sex, previous patient-reported arthritis attack, onset within one day, joint redness, first metatarsophalangeal joint (MTP1) involvement, hypertension or cardiovascular disease (angina pectoris, myocardial infarction, heart failure, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease), and serum uric acid level above 5.88 mg/dL. The rule gives one point for each item. A score >8 had a positive likelihood ratio for diagnosing gout of 3.48 (TABLE¹) and a higher positive predictive value (PPV) than family physicians’ clinical impressions (83% vs 64%).

The prevalence of gout in patients with scores of <4, 4 to 8, and >8 were 2.8%, 27%, and 80%, respectively. For scores of 4 to 8, the probability of gout is indeterminate, and synovial fluid analysis is recommended.

The Netherlands rule, validated in a secondary care practice of 390 patients with monoarthritis, found that a score >8 had a PPV of 87% and a score <4 had a negative predictive value of 95%.⁴ The probability of gout based on this rule can be calculated at http://www.umcn.nl/goutcalc.

Clinical prediction rules effectively diagnose gout without joint fluid analysis.In the study used to develop the Netherlands rule, no patients with a high probability of gout had septic arthritis. The ability of the rule to differentiate between gout and septic arthritis was tested retrospectively in 33 patients with acute gout (podagra excluded) diagnosed by the presence of monosodium urate joint crystals and 27 patients with septic arthritis diagnosed by positive bacterial culture.⁵ Patients with gout had significantly higher scores than patients with septic arthritis (7.8 ± 1.59 vs 3.4 ± 2.3; P<.001).

A study of 82 Veterans Administration patients compared the American Rheumatology Association (ARA), New York, and Rome prediction rules with regard to their ability to diagnose gout with synovial urate crystals.⁶ The ARA criteria for gout diagnosis require either tophi or monosodium urate crystals in synovial fluid, or 6 out of a list of 12 other criteria.⁷

The New York prediction rule requires that patients meet 2 or more of the following criteria: at least 2 attacks of painful joint swelling with complete resolution within 2 weeks, podagra, tophi, and rapid response to colchicine treatment, defined as a major reduction in the objective signs of inflammation within 48 hours.

The Rome prediction rule requires meeting 2 of 3 criteria: serum uric acid >7 mg/dL in men and >6 mg/dL in women, presence of tophi, and history of attacks of painful joint swelling with abrupt onset and resolution within 2 weeks.

The New York prediction rule had the highest positive likelihood ratio of 4.4 compared with the ARA (1.8) and Rome (4.3) rules.⁶ The utility of the New York and Rome rules, although they have fewer criteria than ARA, is limited by the fact that they include a previous episode of joint swelling and tophi. These criteria increase their specificity but make them less useful in diagnosing a first episode of gout, when tophi are unlikely to have developed.

Prediction rules are more sensitive in established gout

The new ACR prediction rule was compared with the ARA, Rome, and New York clinical prediction rules using urate crystals as the gold standard in early (less than 2 years) and established disease (longer than 2 years).⁸ All clinical prediction rules were more sensitive in established disease than early disease (95.3% vs 84.1%; P<.001) and more specific in early disease than established disease (79.9% vs 52.5%; P<.001).

EVIDENCE SUMMARY

In 2015, the American College of Rheumatology (ACR) redefined the clinical criteria for diagnosis of gout based on a 3-step system¹ that can be found at: http://goutclassificationcalculator.auckland.ac.nz. The ACR rule was derived from a cross-sectional study of 983 patients in 25 rheumatology centers in 16 countries who presented with a swollen joint.² Of the 983 patients, 509 had gout; the prevalence was 52%. Data from 653 of these patients were used to develop the rule and then validated in the remaining 330 patients.

Compared with the gold standard of monosodium urate crystals in synovial fluid, the ACR rule has a sensitivity of 92% and a specificity of 89%. The rule, designed for the research setting, involves using synovial fluid analysis, ultrasound imaging, and radiography, which makes it less useful in a primary care setting.

The Netherlands rule for primary care

A prospective diagnostic study in 328 family medicine patients (74% male; mean age 57) with monoarthritis tested the ability of multiple clinical variables to diagnose gout using monosodium urate crystals in synovial fluid as the gold standard.³ The prevalence of gout in this population was 57%.

The best diagnostic rule (Netherlands rule) comprised the following predefined variables: male sex, previous patient-reported arthritis attack, onset within one day, joint redness, first metatarsophalangeal joint (MTP1) involvement, hypertension or cardiovascular disease (angina pectoris, myocardial infarction, heart failure, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease), and serum uric acid level above 5.88 mg/dL. The rule gives one point for each item. A score >8 had a positive likelihood ratio for diagnosing gout of 3.48 (TABLE¹) and a higher positive predictive value (PPV) than family physicians’ clinical impressions (83% vs 64%).

The prevalence of gout in patients with scores of <4, 4 to 8, and >8 were 2.8%, 27%, and 80%, respectively. For scores of 4 to 8, the probability of gout is indeterminate, and synovial fluid analysis is recommended.

The Netherlands rule, validated in a secondary care practice of 390 patients with monoarthritis, found that a score >8 had a PPV of 87% and a score <4 had a negative predictive value of 95%.⁴ The probability of gout based on this rule can be calculated at http://www.umcn.nl/goutcalc.

Clinical prediction rules effectively diagnose gout without joint fluid analysis.In the study used to develop the Netherlands rule, no patients with a high probability of gout had septic arthritis. The ability of the rule to differentiate between gout and septic arthritis was tested retrospectively in 33 patients with acute gout (podagra excluded) diagnosed by the presence of monosodium urate joint crystals and 27 patients with septic arthritis diagnosed by positive bacterial culture.⁵ Patients with gout had significantly higher scores than patients with septic arthritis (7.8 ± 1.59 vs 3.4 ± 2.3; P<.001).

A study of 82 Veterans Administration patients compared the American Rheumatology Association (ARA), New York, and Rome prediction rules with regard to their ability to diagnose gout with synovial urate crystals.⁶ The ARA criteria for gout diagnosis require either tophi or monosodium urate crystals in synovial fluid, or 6 out of a list of 12 other criteria.⁷

The New York prediction rule requires that patients meet 2 or more of the following criteria: at least 2 attacks of painful joint swelling with complete resolution within 2 weeks, podagra, tophi, and rapid response to colchicine treatment, defined as a major reduction in the objective signs of inflammation within 48 hours.

The Rome prediction rule requires meeting 2 of 3 criteria: serum uric acid >7 mg/dL in men and >6 mg/dL in women, presence of tophi, and history of attacks of painful joint swelling with abrupt onset and resolution within 2 weeks.

The New York prediction rule had the highest positive likelihood ratio of 4.4 compared with the ARA (1.8) and Rome (4.3) rules.⁶ The utility of the New York and Rome rules, although they have fewer criteria than ARA, is limited by the fact that they include a previous episode of joint swelling and tophi. These criteria increase their specificity but make them less useful in diagnosing a first episode of gout, when tophi are unlikely to have developed.

Prediction rules are more sensitive in established gout

The new ACR prediction rule was compared with the ARA, Rome, and New York clinical prediction rules using urate crystals as the gold standard in early (less than 2 years) and established disease (longer than 2 years).⁸ All clinical prediction rules were more sensitive in established disease than early disease (95.3% vs 84.1%; P<.001) and more specific in early disease than established disease (79.9% vs 52.5%; P<.001).

EVIDENCE SUMMARY

A 2007 Cochrane review of 12 RCTs with 671 patients compared the efficacy of corticosteroid injections for CTS with placebo injections or other nonsurgical interventions.¹ Patients who received corticosteroid injections showed clinical improvement at one month or less compared with placebo (2 trials, 141 patients; 73% corticosteroids vs 28% placebo; relative risk [RR]=2.58; 95% confidence interval [CI], 1.72-3.87; number needed to treat [NNT]=2).

Compared with systemic corticosteroids, corticosteroid injections didn’t improve symptoms on a Global Symptom Score (scale of 0-50, with 50 indicating the most severe symptoms) at 2 weeks (one trial, 60 patients; mean difference [MD]= −4.2; 95% CI, −8.7 to 0.26), but did improve symptoms at 8 weeks (MD= −7.16; 95% CI, −11.5 to −2.86) and 12 weeks (MD= −7.1; 95% CI, −11.7 to −2.52).

Patients showed no difference in scores between corticosteroid injection and oral anti-inflammatory medication with neutral angle wrist splints on the Symptom Severity Scale (1 to 5, with 5 indicating the most severe symptoms) at 2 weeks (1 trial, 23 patients [37 wrists]; MD=0.0; 95% CI, −0.64 to 0.64) or 8 weeks (MD=0.1; 95% CI, −0.33 to 0.53).

Higher corticosteroid dose reduces surgery at one year

A 2013 high-quality RCT with 111 patients assessed pain relief and rates of surgery at one year with local corticosteroid injections for CTS.² This trial had 3 arms with 37 patients in each: 80-mg methylprednisolone injection, 40-mg methylprednisolone injection, or placebo injection.

Both corticosteroid groups showed greater improvement on the Symptom Severity Scale at 10 weeks compared with placebo (40-mg methylprednisolone group: MD= −0.88; 95% CI, −1.3 to −0.46; 80-mg methylprednisolone group: MD= −0.64; 95% CI, −1.06 to −0.21). There was no difference between the methylprednisolone groups.

The incidence of surgery at one year was lower in the 80-mg methylprednisolone group compared with placebo (73% vs 92%; RR=0.79; 95% CI, 0.64-0.99; NNT=5) but not in the 40-mg methylprednisolone group compared with placebo (81% vs 92%; RR=0.88; 95% CI, 0.73-1.06).

Corticosteroids improve symptoms and disability, but effects wear off

A randomized double-blind, placebo-controlled trial conducted in 2010 examined the effectiveness of corticosteroid injections given by general practitioners to 69 patients with CTS.³ Patients were randomized to receive 10 mg of either triamcinolone or saline. They were reassessed after one week, and patients in the saline injection group who had inadequate symptom relief received a triamcinolone injection as bail-out treatment. Follow-up by patient questionnaire was done at 1, 3, 6, and 12 months.

Investigators assessed symptoms and disability using the Symptom Severity Scale and Functional Disability Scale, which are part of the Boston Carpal Tunnel Questionnaire. Like the Symptom Severity Scale, the Functional Disability Scale is scored from 1 to 5, with higher scores indicating more severe disability.

One week after treatment, the corticosteroid group showed greater improvement in symptom severity and functional disability than the saline group (symptom severity decreased from 2.9 to 1.9 with triamcinolone vs 2.8 to 2.5 with saline; MD=0.64; 95% CI, 0.32-0.96; functional disability decreased from 2.5 to 1.9 with triamcinolone but remained at 2.4 with saline; MD=0.59; 95% CI, 0.23-0.94).

Long-term follow-up of 35 patients who responded to corticosteroid injections found that the effects wore off over 12 months when assessed using the Symptom Severity Scale (mean score 1.5 at 1 month, 2.0 at 12 months; P=.08).

Surgery rates at one and 5 years

A 2012 prospective cohort study examined the 5-year rate of surgical intervention after a 20-mg methylprednisolone injection in 824 patients diagnosed with CTS who had failed conservative treatment.⁴ A total of 500 patients had a relapse of symptoms, and 372 of them elected to have a second injection. A Kaplan-Meier survivorship analysis determined rates of surgical intervention to be 14.5% (95% CI, 11.9-17) at one year and 33.2% (95% CI, 28.7-37.8) at 5 years.

RECOMMENDATION

A 2010 American Academy of Orthopaedic Surgeons evidence-based practice guideline on the treatment of CTS  recommends corticosteroid injection before considering surgery (Grade B, Level 1 suggested recommendation with good evidence).⁵

EVIDENCE SUMMARY

A 2007 Cochrane review of 12 RCTs with 671 patients compared the efficacy of corticosteroid injections for CTS with placebo injections or other nonsurgical interventions.¹ Patients who received corticosteroid injections showed clinical improvement at one month or less compared with placebo (2 trials, 141 patients; 73% corticosteroids vs 28% placebo; relative risk [RR]=2.58; 95% confidence interval [CI], 1.72-3.87; number needed to treat [NNT]=2).

Compared with systemic corticosteroids, corticosteroid injections didn’t improve symptoms on a Global Symptom Score (scale of 0-50, with 50 indicating the most severe symptoms) at 2 weeks (one trial, 60 patients; mean difference [MD]= −4.2; 95% CI, −8.7 to 0.26), but did improve symptoms at 8 weeks (MD= −7.16; 95% CI, −11.5 to −2.86) and 12 weeks (MD= −7.1; 95% CI, −11.7 to −2.52).

Patients showed no difference in scores between corticosteroid injection and oral anti-inflammatory medication with neutral angle wrist splints on the Symptom Severity Scale (1 to 5, with 5 indicating the most severe symptoms) at 2 weeks (1 trial, 23 patients [37 wrists]; MD=0.0; 95% CI, −0.64 to 0.64) or 8 weeks (MD=0.1; 95% CI, −0.33 to 0.53).

Higher corticosteroid dose reduces surgery at one year

A 2013 high-quality RCT with 111 patients assessed pain relief and rates of surgery at one year with local corticosteroid injections for CTS.² This trial had 3 arms with 37 patients in each: 80-mg methylprednisolone injection, 40-mg methylprednisolone injection, or placebo injection.

Both corticosteroid groups showed greater improvement on the Symptom Severity Scale at 10 weeks compared with placebo (40-mg methylprednisolone group: MD= −0.88; 95% CI, −1.3 to −0.46; 80-mg methylprednisolone group: MD= −0.64; 95% CI, −1.06 to −0.21). There was no difference between the methylprednisolone groups.

The incidence of surgery at one year was lower in the 80-mg methylprednisolone group compared with placebo (73% vs 92%; RR=0.79; 95% CI, 0.64-0.99; NNT=5) but not in the 40-mg methylprednisolone group compared with placebo (81% vs 92%; RR=0.88; 95% CI, 0.73-1.06).

Corticosteroids improve symptoms and disability, but effects wear off

A randomized double-blind, placebo-controlled trial conducted in 2010 examined the effectiveness of corticosteroid injections given by general practitioners to 69 patients with CTS.³ Patients were randomized to receive 10 mg of either triamcinolone or saline. They were reassessed after one week, and patients in the saline injection group who had inadequate symptom relief received a triamcinolone injection as bail-out treatment. Follow-up by patient questionnaire was done at 1, 3, 6, and 12 months.

Investigators assessed symptoms and disability using the Symptom Severity Scale and Functional Disability Scale, which are part of the Boston Carpal Tunnel Questionnaire. Like the Symptom Severity Scale, the Functional Disability Scale is scored from 1 to 5, with higher scores indicating more severe disability.

One week after treatment, the corticosteroid group showed greater improvement in symptom severity and functional disability than the saline group (symptom severity decreased from 2.9 to 1.9 with triamcinolone vs 2.8 to 2.5 with saline; MD=0.64; 95% CI, 0.32-0.96; functional disability decreased from 2.5 to 1.9 with triamcinolone but remained at 2.4 with saline; MD=0.59; 95% CI, 0.23-0.94).

Long-term follow-up of 35 patients who responded to corticosteroid injections found that the effects wore off over 12 months when assessed using the Symptom Severity Scale (mean score 1.5 at 1 month, 2.0 at 12 months; P=.08).

Surgery rates at one and 5 years

A 2012 prospective cohort study examined the 5-year rate of surgical intervention after a 20-mg methylprednisolone injection in 824 patients diagnosed with CTS who had failed conservative treatment.⁴ A total of 500 patients had a relapse of symptoms, and 372 of them elected to have a second injection. A Kaplan-Meier survivorship analysis determined rates of surgical intervention to be 14.5% (95% CI, 11.9-17) at one year and 33.2% (95% CI, 28.7-37.8) at 5 years.

RECOMMENDATION

A 2010 American Academy of Orthopaedic Surgeons evidence-based practice guideline on the treatment of CTS  recommends corticosteroid injection before considering surgery (Grade B, Level 1 suggested recommendation with good evidence).⁵

EVIDENCE SUMMARY

A 2007 Cochrane review of 12 RCTs with 671 patients compared the efficacy of corticosteroid injections for CTS with placebo injections or other nonsurgical interventions.¹ Patients who received corticosteroid injections showed clinical improvement at one month or less compared with placebo (2 trials, 141 patients; 73% corticosteroids vs 28% placebo; relative risk [RR]=2.58; 95% confidence interval [CI], 1.72-3.87; number needed to treat [NNT]=2).

Compared with systemic corticosteroids, corticosteroid injections didn’t improve symptoms on a Global Symptom Score (scale of 0-50, with 50 indicating the most severe symptoms) at 2 weeks (one trial, 60 patients; mean difference [MD]= −4.2; 95% CI, −8.7 to 0.26), but did improve symptoms at 8 weeks (MD= −7.16; 95% CI, −11.5 to −2.86) and 12 weeks (MD= −7.1; 95% CI, −11.7 to −2.52).

Patients showed no difference in scores between corticosteroid injection and oral anti-inflammatory medication with neutral angle wrist splints on the Symptom Severity Scale (1 to 5, with 5 indicating the most severe symptoms) at 2 weeks (1 trial, 23 patients [37 wrists]; MD=0.0; 95% CI, −0.64 to 0.64) or 8 weeks (MD=0.1; 95% CI, −0.33 to 0.53).

Higher corticosteroid dose reduces surgery at one year

A 2013 high-quality RCT with 111 patients assessed pain relief and rates of surgery at one year with local corticosteroid injections for CTS.² This trial had 3 arms with 37 patients in each: 80-mg methylprednisolone injection, 40-mg methylprednisolone injection, or placebo injection.

Both corticosteroid groups showed greater improvement on the Symptom Severity Scale at 10 weeks compared with placebo (40-mg methylprednisolone group: MD= −0.88; 95% CI, −1.3 to −0.46; 80-mg methylprednisolone group: MD= −0.64; 95% CI, −1.06 to −0.21). There was no difference between the methylprednisolone groups.

The incidence of surgery at one year was lower in the 80-mg methylprednisolone group compared with placebo (73% vs 92%; RR=0.79; 95% CI, 0.64-0.99; NNT=5) but not in the 40-mg methylprednisolone group compared with placebo (81% vs 92%; RR=0.88; 95% CI, 0.73-1.06).

Corticosteroids improve symptoms and disability, but effects wear off

A randomized double-blind, placebo-controlled trial conducted in 2010 examined the effectiveness of corticosteroid injections given by general practitioners to 69 patients with CTS.³ Patients were randomized to receive 10 mg of either triamcinolone or saline. They were reassessed after one week, and patients in the saline injection group who had inadequate symptom relief received a triamcinolone injection as bail-out treatment. Follow-up by patient questionnaire was done at 1, 3, 6, and 12 months.

Investigators assessed symptoms and disability using the Symptom Severity Scale and Functional Disability Scale, which are part of the Boston Carpal Tunnel Questionnaire. Like the Symptom Severity Scale, the Functional Disability Scale is scored from 1 to 5, with higher scores indicating more severe disability.

One week after treatment, the corticosteroid group showed greater improvement in symptom severity and functional disability than the saline group (symptom severity decreased from 2.9 to 1.9 with triamcinolone vs 2.8 to 2.5 with saline; MD=0.64; 95% CI, 0.32-0.96; functional disability decreased from 2.5 to 1.9 with triamcinolone but remained at 2.4 with saline; MD=0.59; 95% CI, 0.23-0.94).

Long-term follow-up of 35 patients who responded to corticosteroid injections found that the effects wore off over 12 months when assessed using the Symptom Severity Scale (mean score 1.5 at 1 month, 2.0 at 12 months; P=.08).

Surgery rates at one and 5 years

A 2012 prospective cohort study examined the 5-year rate of surgical intervention after a 20-mg methylprednisolone injection in 824 patients diagnosed with CTS who had failed conservative treatment.⁴ A total of 500 patients had a relapse of symptoms, and 372 of them elected to have a second injection. A Kaplan-Meier survivorship analysis determined rates of surgical intervention to be 14.5% (95% CI, 11.9-17) at one year and 33.2% (95% CI, 28.7-37.8) at 5 years.

RECOMMENDATION

A 2010 American Academy of Orthopaedic Surgeons evidence-based practice guideline on the treatment of CTS  recommends corticosteroid injection before considering surgery (Grade B, Level 1 suggested recommendation with good evidence).⁵

EVIDENCE SUMMARY

A 2012 Cochrane review of 52 studies (44 RCTs and 8 cluster-randomized trials; N=56,451) assessed the overall effectiveness of multiple supportive measures on decreasing cessation of “any” (partial and exclusive) and “exclusive” breastfeeding compared with usual care.¹ Participants were healthy breastfeeding mothers of healthy term babies. Support interventions were defined broadly but included individual and group interactions, as well as contact in person or over the phone by professionals or lay volunteers. Patients were approached proactively or reactively upon request, and the interventions occurred one or more times.

The interventions reduced discontinuation rates among both “exclusive” and “any” breastfeeding mothers (TABLE¹). The review found lay and professional support to be equally effective at promoting continuation of breastfeeding. Limitations include a moderate to high amount of heterogeneity, as well as the inherent difficulty of blinding subjects in the studies.

Lay support can make a significant difference in the short term

A 2008 systematic review of 38 RCTs (N=29,020) compared any counseling or behavioral intervention initiated from a clinician’s practice (office or hospital) with usual care.² The review excluded community and peer-initiated interventions. The reviewers defined breastfeeding duration as follows: initiation (up to 2 weeks), short-term (one to 3 months), intermediate-term (4 to 5 months), long-term (6 to 8 months), and prolonged (9 or more months). Investigators also analyzed breastfeeding rates by “exclusive” and “nonexclusive” (formula supplementation) regimens.

For nonexclusive breastfeeding, the review found interventions to promote breastfeeding improved rates only at initiation (18 RCTs, N=7688; relative risk [RR] for cessation of breastfeeding=1.04; 95% confidence interval [CI], 1.0-1.08; number needed to treat [NNT]=38) and in the short term (18 RCTs, N= 19,358; RR=1.10; 95% CI, 1.02-1.19; NNT=7). For exclusive breastfeeding, interventions improved rates only in the short term (17 RCTs, N=20,552; RR=1.72; 95% CI, 1.0-2.97; NNT=3).

The review found that lay support (defined as counseling or social support from peers) but not professional support was significantly associated with improving rates of both “nonexclusive” and “exclusive’ breastfeeding, but only over the short term (5 RCTs, N not provided; RR=1.22; 95% CI, 1.08-1.37; and 4 RCTs, N not provided; RR=1.65; 95% CI, 1.03-2.63; respectively). As with the Cochrane review, the results for all study groups demonstrated moderate to significant heterogeneity.

RECOMMENDATIONS

The Surgeon General, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists all recommend that women be educated about the benefits of breastfeeding and receive supportive interventions before and after delivery.^3-6

EVIDENCE SUMMARY

A 2012 Cochrane review of 52 studies (44 RCTs and 8 cluster-randomized trials; N=56,451) assessed the overall effectiveness of multiple supportive measures on decreasing cessation of “any” (partial and exclusive) and “exclusive” breastfeeding compared with usual care.¹ Participants were healthy breastfeeding mothers of healthy term babies. Support interventions were defined broadly but included individual and group interactions, as well as contact in person or over the phone by professionals or lay volunteers. Patients were approached proactively or reactively upon request, and the interventions occurred one or more times.

The interventions reduced discontinuation rates among both “exclusive” and “any” breastfeeding mothers (TABLE¹). The review found lay and professional support to be equally effective at promoting continuation of breastfeeding. Limitations include a moderate to high amount of heterogeneity, as well as the inherent difficulty of blinding subjects in the studies.

Lay support can make a significant difference in the short term

A 2008 systematic review of 38 RCTs (N=29,020) compared any counseling or behavioral intervention initiated from a clinician’s practice (office or hospital) with usual care.² The review excluded community and peer-initiated interventions. The reviewers defined breastfeeding duration as follows: initiation (up to 2 weeks), short-term (one to 3 months), intermediate-term (4 to 5 months), long-term (6 to 8 months), and prolonged (9 or more months). Investigators also analyzed breastfeeding rates by “exclusive” and “nonexclusive” (formula supplementation) regimens.

For nonexclusive breastfeeding, the review found interventions to promote breastfeeding improved rates only at initiation (18 RCTs, N=7688; relative risk [RR] for cessation of breastfeeding=1.04; 95% confidence interval [CI], 1.0-1.08; number needed to treat [NNT]=38) and in the short term (18 RCTs, N= 19,358; RR=1.10; 95% CI, 1.02-1.19; NNT=7). For exclusive breastfeeding, interventions improved rates only in the short term (17 RCTs, N=20,552; RR=1.72; 95% CI, 1.0-2.97; NNT=3).

The review found that lay support (defined as counseling or social support from peers) but not professional support was significantly associated with improving rates of both “nonexclusive” and “exclusive’ breastfeeding, but only over the short term (5 RCTs, N not provided; RR=1.22; 95% CI, 1.08-1.37; and 4 RCTs, N not provided; RR=1.65; 95% CI, 1.03-2.63; respectively). As with the Cochrane review, the results for all study groups demonstrated moderate to significant heterogeneity.

RECOMMENDATIONS

The Surgeon General, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists all recommend that women be educated about the benefits of breastfeeding and receive supportive interventions before and after delivery.^3-6

EVIDENCE SUMMARY

A 2012 Cochrane review of 52 studies (44 RCTs and 8 cluster-randomized trials; N=56,451) assessed the overall effectiveness of multiple supportive measures on decreasing cessation of “any” (partial and exclusive) and “exclusive” breastfeeding compared with usual care.¹ Participants were healthy breastfeeding mothers of healthy term babies. Support interventions were defined broadly but included individual and group interactions, as well as contact in person or over the phone by professionals or lay volunteers. Patients were approached proactively or reactively upon request, and the interventions occurred one or more times.

The interventions reduced discontinuation rates among both “exclusive” and “any” breastfeeding mothers (TABLE¹). The review found lay and professional support to be equally effective at promoting continuation of breastfeeding. Limitations include a moderate to high amount of heterogeneity, as well as the inherent difficulty of blinding subjects in the studies.

Lay support can make a significant difference in the short term

A 2008 systematic review of 38 RCTs (N=29,020) compared any counseling or behavioral intervention initiated from a clinician’s practice (office or hospital) with usual care.² The review excluded community and peer-initiated interventions. The reviewers defined breastfeeding duration as follows: initiation (up to 2 weeks), short-term (one to 3 months), intermediate-term (4 to 5 months), long-term (6 to 8 months), and prolonged (9 or more months). Investigators also analyzed breastfeeding rates by “exclusive” and “nonexclusive” (formula supplementation) regimens.

For nonexclusive breastfeeding, the review found interventions to promote breastfeeding improved rates only at initiation (18 RCTs, N=7688; relative risk [RR] for cessation of breastfeeding=1.04; 95% confidence interval [CI], 1.0-1.08; number needed to treat [NNT]=38) and in the short term (18 RCTs, N= 19,358; RR=1.10; 95% CI, 1.02-1.19; NNT=7). For exclusive breastfeeding, interventions improved rates only in the short term (17 RCTs, N=20,552; RR=1.72; 95% CI, 1.0-2.97; NNT=3).

The review found that lay support (defined as counseling or social support from peers) but not professional support was significantly associated with improving rates of both “nonexclusive” and “exclusive’ breastfeeding, but only over the short term (5 RCTs, N not provided; RR=1.22; 95% CI, 1.08-1.37; and 4 RCTs, N not provided; RR=1.65; 95% CI, 1.03-2.63; respectively). As with the Cochrane review, the results for all study groups demonstrated moderate to significant heterogeneity.

RECOMMENDATIONS

The Surgeon General, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists all recommend that women be educated about the benefits of breastfeeding and receive supportive interventions before and after delivery.^3-6