Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement

Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors' objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Standards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.     

Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items

Background/Purpose

In this study, we conducted a limited survey of reports of surgical randomized controlled trials, using the consolidated standards of reporting trials (CONSORT) statement and additional check items to clarify problems in the evaluation of surgical reports.

Methods

A total of 13 randomized trials were selected from two latest review articles on biliary surgery. Each randomized trial was evaluated according to 28 quality measures that comprised items from the CONSORT statement plus additional items. Analysis focused on relationships between the quality of each study and the estimated effect gap (“pooled estimate in meta-analysis” — “estimated effect of each study”).

Results

No definite relationships were found between individual study quality and the estimated effect gap. The following items could have been described but were not provided in almost all the surgical RCT reports: “clearly defined outcomes”; “details of randomization”; “participant flow charts”; “intention-to-treat analysis”; “ancillary analyses”; and “financial conflicts of interest”. The item, “participation of a trial methodologist in the study” was not found in any of the reports.

Conclusions

Although the quality of reporting trials is not always related to a biased estimation of treatment effect, the items used for quality measures must be described to enable readers to evaluate the quality and applicability of the reporting. Further development of an assessment tool is needed for items specific to surgical randomized controlled trials.

     

L’hormone antimüllérienne sérique n’est pas prédictive de la qualité ovocytaire en fécondation in vitro

Objectives

The assessment of the ovarian reserve is mandatory in women undergoing assisted reproduction. Anti-Müllerian hormone (AMH), produced by granulosa cells from pre-antral and early antral follicles, is a promising indicator of ovarian reserve. However, few studies have evaluated the predictive value of AMH on oocyte quality.

Patients and methods

A retrospective study was undertaken at the Bretonneau University Hospital of Tours. A total of 559 women undergoing in vitro fertilization treatment between January and December 2007 were included in the study. Serum AMH levels were determined by using an ultrasensitive Elisa test. Total number of oocytes, rate of mature oocytes, fertilization rate, embryo quality and clinical pregnancy rate were recorded.

Results

Serum AMH was significantly lower in groups of patients with few oocytes collected. However, serum AMH was not predictive of nuclear maturity of oocytes, fertilization rate and quality of early embryos. Additionally, low levels of AMH do not preclude clinical pregnancy in in vitro fertilization.

Conclusion

At the moment, serum AMH is a relatively predictive indicator of the ovarian reserve, in terms of quantity but not in terms of quality. Moreover, it is still not possible to determine serum AMH cut-off value to predict clinical pregnancy in IVF programmes.     

Effect of pharmacist intervention on glycemic control in diabetes

Aim

To conduct a meta-analysis evaluating the effect of pharmacist intervention on glycemic control.

Methods

A systematic search of Medline and CENTRAL was conducted from the earliest possible date through June 2010. Trials were included if they were randomized controlled trials in a diabetic population, evaluated any form of pharmacist intervention and reported data on hemoglobin A1C (A1C). A random-effects model was used to calculate weighted mean differences (WMDs) and 95% confidence intervals.

Results

Fourteen trials (n = 2073) evaluating the effect of pharmacist intervention on glycemic control were identified. Pharmacist intervention significantly lowered A1C (n = 14 trials, WMD −0.76%, 95%CI −1.06 to −0.47) and fasting blood glucose (FBG) (n = 4 trials, WMD −29.32 mg/dL, 95%CI −39.54 to −19.10). A moderate to high degree of statistical heterogeneity was observed in these analyses (I² ≥ 44.1% for both).

Conclusions

Our findings demonstrate statistically and clinically significant associations between pharmacist intervention and improvement in glycemic control.     

Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis

Background

Disease-management programs may enhance the quality of care provided to patients with chronic diseases, such as chronic obstructive pulmonary disease (COPD). The aim of this systematic review was to assess the effectiveness of COPD disease-management programs.

Methods

We conducted a computerized search of MEDLINE, EMBASE, CINAHL, PsychINFO, and the Cochrane Library (CENTRAL) for studies evaluating interventions meeting our operational definition of disease management: patient education, 2 or more different intervention components, 2 or more health care professionals actively involved in patients' care, and intervention lasting 12 months or more. Programs conducted in hospital only and those targeting patients receiving palliative care were excluded. Two reviewers evaluated 12,749 titles and fully reviewed 139 articles; among these, data from 13 studies were included and extracted. Clinical outcomes considered were all-cause mortality, lung function, exercise capacity (walking distance), health-related quality of life, symptoms, COPD exacerbations, and health care use. A meta-analysis of exercise capacity and all-cause mortality was performed using random-effects models.

Results

The studies included were 9 randomized controlled trials, 1 controlled trial, and 3 uncontrolled before-after trials. Results indicate that the disease-management programs studied significantly improved exercise capacity (32.2 m, 95% confidence interval [CI], 4.1-60.3), decreased risk of hospitalization, and moderately improved health-related quality of life. All-cause mortality did not differ between groups (pooled odds ratio 0.84, 95% CI, 0.54-1.40).

Conclusion

COPD disease-management programs modestly improved exercise capacity, health-related quality of life, and hospital admissions, but not all-cause mortality. Future studies should explore the specific elements or characteristics of these programs that bring the greatest benefit.     

Key elements for successful intensive insulin pump therapy in individuals with type 1 diabetes

Objective

Clinical trials have demonstrated that in individuals with type 1 diabetes the use of CSII pump resulted in better glucose control. Advantages of pumps therapy include many features such as the bolus calculators (wizard). These features are optional and therefore it is important to determine whether their use is associated with better glucose control. Thus, the aim of this analysis was to assess which features and parameters of insulin pump use are associated with better glucose control.

Methods

Data regarding consecutive patients with type 1 diabetes treated with an insulin pump and attending a tertiary referral for intensive glucose control was included in this analysis. The relationship between glycemic indices and treatment parameters (number of insulin units, number of glucose readings, bolus calculator use etc.) was assessed.

Results

A statistically significant relationship was found between glycemic indices and wizard use. Thus, individuals that used the wizard function in 50% of their boluses had an A1C, mean blood glucose values that were 0.6% (p = 0.008) and 25 mg/dL (p = 0.000) lower respectively.

Conclusion

The use of the bolus calculator feature was associated with better glucose control. Larger prospective clinical trials are needed in order to further validate this finding.     

Asthma in US Seniors: Part 2. Treatment. Seeing Through the Glass Darkly

Background

We sought to identify the best evidence for treatment of asthmatic patients aged 65 years or more.

Methods

We used computer-assisted searches to identify randomized, controlled trials for asthma in the elderly that were published in English between 1950 and 2008.

Results

Small trials of an inhaled corticosteroid versus a leukotriene antagonist and an oral beta₂-agonist versus placebo compose the controlled trial data on asthma therapy in seniors. Epidemiologic evidence suggests that the side effects of corticosteroids and beta-agonists may be more common in the elderly than in younger populations.

Conclusion

Seniors with asthma or comorbid conditions that are common in the elderly have been systematically excluded from asthma treatment trials. There is no compelling evidence to demonstrate the superiority of any pharmacologic therapy in these asthmatic patients. Evaluation of response to asthma treatment in clinical trials remains primarily symptom-based when symptoms have been shown to underestimate the severity of disease in seniors.     

Prevention of central venous catheter-associated thrombosis: a meta-analysis

Purpose

Anticoagulant prophylaxis in patients with central venous catheters is controversial. We performed a meta-analysis of randomized controlled trials of anticoagulant prophylaxis in patients with central venous catheters.

Methods

MEDLINE and EMBASE were searched up to May 2006, supplemented by manual searches of conference proceedings and bibliographies.

Results

Fifteen trials were included. Unfractionated heparin infusion, oral fixed low-dose vitamin K antagonist, and subcutaneous low-molecular-weight heparin were evaluated. For all catheter-associated deep vein thrombosis (symptomatic and asymptomatic combined), the summary relative risks ranged from 0.31 to 0.73 (all achieved statistical significance). For symptomatic deep vein thrombosis, the summary relative risks ranged from 0.28 to 0.72, but did not achieve statistical significance for any individual regimen.

Conclusion

Anticoagulant prophylaxis is effective for preventing all catheter-associated deep vein thrombosis in patients with central venous catheters. The effectiveness for preventing symptomatic venous thromboembolism, including pulmonary embolism, remains uncertain.     

Cilostazol, clopidogrel or ticlopidine to prevent sub-acute stent thrombosis: a meta-analysis of randomized trials

Background

Sub-acute thrombosis is a serious complication of coronary artery stenting. Clopidogrel plus aspirin is the accepted prophylactic regimen, but has yet to be proven superior to ticlopidine plus aspirin, and a new regimen combining cilostazol and aspirin has been introduced.

Methods

We conducted a meta-analysis of all trials that compared ≥2 oral anti-thrombotic strategies in patients undergoing coronary stent placement to determine which treatment optimally prevents adverse cardiac events in the 30 days following stent insertion. We used meta-regression to compare all strategies to a shared control strategy: ticlopidine plus aspirin. We also compared randomized trials to historically controlled and other non-randomized trials. We conducted sensitivity analysis and subgroup analysis to assess for possible heterogeneity.

Results

In comparison to ticlopidine plus aspirin the odds-ratios for cardiac events, with 95% confidence intervals were: aspirin alone, 4.29 (3.09-5.97), coumadin plus aspirin, 2.65 (2.18-3.21), clopidogrel plus aspirin, 1.06 (0.86-1.31), cilostazol plus aspirin, 0.73 (0.47-1.14). Among trials that compared clopidogrel plus aspirin to ticlopidine plus aspirin, historically controlled trials were statistically distinct from randomized trials. The analysis of cilostazol was sensitive to the small size of the included studies.

Conclusions

Neither clopidogrel plus aspirin nor cilostazol plus aspirin can be statistically distinguished from ticlopidine plus aspirin for the prevention of adverse cardiac events in the 30 days after stenting. A randomized trial including cilostazol is warranted.     

Comparing COPD treatment: nebulizer, metered dose inhaler, and concomitant therapy

Purpose

Patients using albuterol and ipratropium for treating chronic obstructive pulmonary disease (COPD) can use either nebulizers or metered dose inhalers. This study compared the 2 methods of delivering medication and the concomitant use of both nebulizer and inhaler, with respect to health-related quality of life, patient symptoms, and efficacy.

Subjects and Methods

Patients over 50 years old with COPD were randomized into 3 groups: nebulizer, inhaler, or concomitant treatment. Quality of life was assessed using the St. George’s Respiratory Questionnaire at baseline, and at 6 and 12 weeks. Other efficacy measurements at these time-points included pre- and post-dose forced expired volume in 1 second (FEV₁). Symptom scores and peak flow measurements were recorded in patient diaries.

Results

Of 140 patients enrolled, 126 completed at least one post-baseline assessment. At week 6, both groups using a nebulizer achieved statistically significant improvements from baseline in questionnaire symptoms, and the concomitant treatment group had clinically and statistically significant improvement in total questionnaire score. At week 12, the concomitant group still maintained significant improvement in symptom sub-scores. The 3 groups showed little change over time in peak flow or FEV₁, with no significant difference among groups. Both groups using a nebulizer had significant improvement over time in diary symptom scores, although differences between groups were not significant.

Conclusions

Patients using combined nebulizer therapy morning and night with mid-day inhaler use had the most statistically significant improvements in quality of life indices. This concomitant regimen provides the additional symptom relief offered by a nebulizer with the convenience of an inhaler when patients are away from home.     

Efficacy of short-course antibiotic regimens for community-acquired pneumonia: a meta-analysis

Purpose

There is little consensus on the most appropriate duration of antibiotic treatment for community-acquired pneumonia. The goal of this study is to systematically review randomized controlled trials comparing short-course and extended-course antibiotic regimens for community-acquired pneumonia.

Methods

We searched MEDLINE, Embase, and CENTRAL, and reviewed reference lists from 1980 through June 2006. Studies were included if they were randomized controlled trials that compared short-course (7 days or less) versus extended-course (>7 days) antibiotic monotherapy for community-acquired pneumonia in adults. The primary outcome measure was failure to achieve clinical improvement.

Results

We found 15 randomized controlled trials matching our inclusion and exclusion criteria comprising 2796 total subjects. Short-course regimens primarily studied the use of azithromycin (n = 10), but trials examining beta-lactams (n = 2), fluoroquinolones (n = 2), and ketolides (n = 1) were found as well. Of the extended-course regimens, 3 studies utilized the same antibiotic, whereas 9 involved an antibiotic of the same class. Overall, there was no difference in the risk of clinical failure between the short-course and extended-course regimens (0.89, 95% confidence interval [CI], 0.78-1.02). In addition, there were no differences in the risk of mortality (0.81, 95% CI, 0.46-1.43) or bacteriologic eradication (1.11, 95% CI, 0.76-1.62). In subgroup analyses, there was a trend toward favorable clinical efficacy for the short-course regimens in all antibiotic classes (range of relative risk, 0.88-0.94).

Conclusions

The available studies suggest that adults with mild to moderate community-acquired pneumonia can be safely and effectively treated with an antibiotic regimen of 7 days or less. Reduction in patient exposure to antibiotics may limit the increasing rates of antimicrobial drug resistance, decrease cost, and improve patient adherence and tolerability.     

The Impact of Revascularization on Mortality in Patients with Nonacute Coronary Artery Disease

Background

Although early revascularization improves outcomes for patients with acute coronary syndromes, the role of revascularization for patients with nonacute coronary artery disease is controversial. The objective of this meta-analysis was to compare surgical or percutaneous revascularization with medical therapy alone to determine the impact of revascularization on death and nonfatal myocardial infarction in patients with coronary artery disease.

Methods

The Medline and Cochrane Central Register of Controlled Trials databases were searched to identify randomized trials of coronary revascularization (either surgical or percutaneous) versus medical therapy alone in patients with nonacute coronary disease reporting the individual outcomes of death or nonfatal myocardial infarction reported at a minimum follow-up of 1 year. A random effects model was used to calculate odds ratios (OR) for the 2 prespecified outcomes.

Results

Twenty-eight studies published from 1977 to 2007 were identified for inclusion in the analysis; the revascularization modality was percutaneous coronary intervention in 17 studies, coronary bypass grafting in 6 studies, and either strategy in 5 studies. Follow-up ranged from 1 to 10 years with a median of 3 years. The 28 trials enrolled 13,121 patients, of whom 6476 were randomized to revascularization and 6645 were randomized to medical therapy alone. The OR for revascularization versus medical therapy for mortality was 0.74 (95% confidence interval [CI], 0.63-0.88). A stratified analysis according to revascularization mode revealed both bypass grafting (OR 0.62; 95% CI, 0.50-0.77) and percutaneous intervention (OR 0.82; 95% CI, 0.68-0.99) to be superior to medical therapy with respect to mortality. Revascularization was not associated with a significant reduction in nonfatal myocardial infarction compared with medical therapy (OR 0.91; 95% CI, 0.72-1.15).

Conclusion

Revascularization by coronary bypass surgery or percutaneous intervention in conjunction with medical therapy in patients with nonacute coronary artery disease is associated with significantly improved survival compared with medical therapy alone.     

Side Effects of Phytoestrogens: A Meta-analysis of Randomized Trials

Background

Phytoestrogens are widely used by postmenopausal women for the treatment of the climacteric syndrome. The risk of adverse effects of this treatment, however, is unknown.

Methods

Using a fixed-effects model, we performed a meta-analysis of side effects comparing phytoestrogen treatment with placebo or no treatment in randomized controlled trials.

Results

We identified 174 randomized controlled trials. Side effects were reported in 92/174 randomized controlled trials with 9629 participants. The overall incidence of side effects in the phytoestrogen and control groups was 2019/5502 (36.7%) and 1824/4806 (38.0%), respectively (P = .2; incidence rate ratio [IRR] 1.01; 95% confidence interval [CI], 0.95-1.08). Comparing various side effect categories, we found significantly higher rates of gastrointestinal side effects among phytoestrogen users (P = .003; IRR 1.28; 95% CI, 1.08-1.50). Gynecological (IRR 0.94; 95% CI, 0.74-1.20), musculoskeletal (IRR 1.20; 95% CI, 0.94-1.53), neurological (IRR 0.91; 95% CI, 0.70-1.19), and unspecific side effects (IRR 0.95; 95% CI, 0.88-1.03) were not significantly different between groups. Within side effect categories, we found no significantly higher rates of side effects in women using phytoestrogens. Specifically, the rates of hormone-related side effects such as endometrial hyperplasia, endometrial cancer, and breast cancer were not significantly different between groups.

Conclusions

Based on the available evidence, phytoestrogen supplements have a safe side-effect profile with moderately elevated rates of gastrointestinal side effects. Rates of vaginal bleeding, endometrial hyperplasia, endometrial cancer, and breast cancer were not significantly increased among phytoestrogen users in the investigated studies.     

High-dose N-acetylcysteine for the Prevention of Contrast-induced Nephropathy

Background

Whether N-acetylcysteine is beneficial for the prevention of contrast-induced nephropathy is uncertain.

Methods

We conducted a meta-analysis to evaluate the efficacy of high-dose N-acetylcysteine for the prevention of contrast-induced nephropathy. Our prespecified inclusion criteria were as follows: adult subjects; English language literature; administration of high-dose N-acetylcysteine a priori defined as a daily dose greater than 1200 mg or a single periprocedural dose (within 4 hours of contrast exposure) greater than 600 mg; prospective trials of individuals randomized to N-acetylcysteine, administered orally or intravenously, versus a control group; and trials that included the end point of the incidence of contrast-induced nephropathy. Trials that compared N-acetylcysteine with another active treatment were excluded.

Results

Sixteen comparisons of patients randomized to high-dose N-acetylcysteine versus controls met our prespecified inclusion criteria with a total sample size of 1677 subjects (842 assigned to high-dose N-acetylcysteine and 835 assigned to the control arm). The average population age was 68 years, 38.7% were diabetic, and the majority was male (67.8% of reported instances). The weighted mean baseline creatinine of the overall population was 1.58 mg/dL. No significant heterogeneity was detected (P = .09; I² = 34%). The overall effect size assuming a common odds ratio revealed an odds ratio of 0.46 (95% confidence interval [CI], 0.33-0.63) for the occurrence of contrast-induced nephropathy with the use of high-dose N-acetylcysteine. The results of the more conservative random effects approach were similar (odds ratio = 0.52; 95% CI, 0.34-0.78). There was no evidence of publication bias (P = .34).

Conclusion

Our results suggest that high-dose N-acetylcysteine decreases the incidence of contrast-induced nephropathy.     

Effect of aggressive versus moderate lipid-lowering therapy on myocardial ischemia: the rationale, design, and baseline characteristics of the Study Assessing Goals in the Elderly (SAGE)

Background

Patients with stable CHD who experience episodes of ischemia during routine daily activities are at increased risk of coronary events. Older patients are at a particularly high risk. Few trials have specifically investigated the effects of lipid-lowering therapy with statins in older patients.

Methods

The SAGE trial is a prospective, randomized, double-blind, parallel-arm study enrolling men and women with stable CHD at 192 centers worldwide. Qualifying participants (aged 65-85 years; low-density lipoprotein cholesterol 100-250 mg/dL) have had at least 1 episode of myocardial ischemia with total ischemia duration ≥3 minutes on 48-hour ambulatory electrocardiographic (AECG) monitoring performed during routine daily activities. Participants have been randomized to either atorvastatin 80 mg/day (aggressive lipid lowering) or pravastatin 40 mg/day (moderate lipid lowering). The primary efficacy measure is the absolute change in the total duration of myocardial ischemic events on 48-hour AECG monitoring from baseline to month 12.

Results

SAGE is fully enrolled and 893 patients have been randomized. The majority of the study participants are white (97%) men (69%). The mean age of the participants is 72 years. Most participants (94%) have a history of angina. Other high-risk patient groups included in the study are patients with hypertension (65%), patients with diabetes (23%), and patients with peripheral vascular disease (12%).

Conclusions

SAGE will evaluate the effect of aggressive versus moderate lipid lowering on the total duration of myocardial ischemia in older ambulatory patients with CHD. It is likely to provide valuable data on the benefits of statins in this patient population.     

Lipid lowering on progression of mild to moderate aortic stenosis: meta-analysis of the randomized placebo-controlled clinical trials on 2344 patients

Background

Aortic stenosis (AS) is believed to develop through an inflammatory similar to the atherosclerosis process. Based on findings from animal studies and uncontrolled clinical studies, lipid-lowering therapy with a statin is postulated to slow this process. Randomized trials, however, reported neutral results. This meta-analysis of randomized lipid trials on patients with AS examined the effects of treatment on AS progression and clinical outcomes.

Methods

Echocardiographic measures of AS (aortic valve jet velocity, peak and mean valve gradients, and aortic valve area) were pooled and clinical outcomes were evaluated in 4 randomized placebo controlled trials (N = 2344).

Results

Although active treatment with statin therapy was associated with highly significant 50% reduction in low-density lipoprotein cholesterol levels, there were no statistical differences between active and placebo groups in any of the echocardiographic indicators of AS severity: annual increase in AS velocity was 0.16 ± 0.28 m/sec, and mean gradient was 2.8 ± 3.0 mm Hg. Each trial reported no differences in clinical outcomes between the 2 treatment groups. Substantial events rates (6.6% aortic valve surgery and 1.2% cardiovascular deaths per year in SEAS with follow-up of 4.4 years and 5.8% aortic valve surgery and 0.7% cardiovascular deaths per year in ASTRONOMER over 3.5 years) were observed in these patients despite the relatively mild disease.

Conclusion

The current data do not support the hypothesis that statin therapy reduces AS progression. Patients with mild to moderate AS may require closer follow-up because despite the less severe disease in these trials, event rates remain substantial.     

An assessment of the electrocardiogram as a screening test for large atrial septal defects in children

Background and Purpose

The electrocardiogram (ECG) is commonly used as a screening tool for diagnosis of the ostium secundum atrial septal defect (ASD). We sought to analyze the utility of conventional ECG criteria in detecting right ventricular enlargement (RVE) due to the presence of an ASD.

Methods

Patients who underwent transcatheter or surgical closure of an isolated ASD between 1997 and 2004 were included if an ECG was performed less than 9 months before ASD closure and had echocardiographic RVE.

Results

Of 99 children (aged 6.8 ± 4.7 years; range, 1-18 years) with RVE and ASD, 57% had an ECG that met 1 or more RVE criteria. The sensitivity of ECG increased to 70% in younger patients and to 80% for the largest defects.

Conclusions

Electrocardiographic criteria for RVE are present in just more than over half of young patients with large ASDs. Although ECG is more sensitive in younger patients, it is unreliable as a screen for this lesion.     

The expectation effect and cardiac pacing for refractory vasovagal syncope

Background

Clinical trials of pacing for vasovagal syncope have shown conflicting results. We performed a meta-analysis to determine whether permanent pacemaker therapy prevents refractory vasovagal syncope.

Methods

Randomized trials comparing pacemaker therapy with medical therapy, usual care, placebo, or different pacing algorithms in the prevention of recurrent vasovagal syncope were considered. The primary endpoint was first recurrence of syncope.

Results

Nine randomized trials (2 double blind, 7 open label or single blind) were included. There was significant heterogeneity when all 9 trials were pooled (P =.0009 and I² = 69.6%), reflecting methodological diversity in blinding and the nature of the control therapy. When pooled by trial methodology, heterogeneity was no longer apparent. Permanent pacing reduced the risk of recurrent syncope in unblinded studies (odds ratio [OR] 0.09, 95% confidence interval [CI], 0.04 to 0.22) and in studies comparing pacemaker algorithms (OR 0.04, 95% CI, 0.0 to 0.23). No effect was seen in double-blinded trials (OR 0.83, 95% CI, 0.41 to 1.70). Awareness that a permanent pacemaker was implanted and functional was associated with a significant ‘expectation’ effect, which itself reduced the risk of recurrent syncope (OR 0.16, 95% CI, 0.06 to 0.40, P =.0001). Results were similar when restricted to patients with a marked cardioinhibitory response on baseline tilt table testing.

Conclusion

The results of small, preliminary trials have overestimated the treatment effect of pacemakers due to a lack of blinding of physicians and patients. Blinded trials suggest that the apparent response is due to a strong expectation response to pacing.     

Quality of weight loss advice on internet forums

Background

Adults use the Internet for weight loss information, sometimes by participating in discussion forums. Our purpose was to analyze the quality of advice exchanged on these forums.

Methods

This was a retrospective analysis of messages posted to 18 Internet weight loss forums during 1 month in 2006. Advice was evaluated for congruence with clinical guidelines; potential for causing harm; and subsequent correction when it was contradictory to guidelines (erroneous) or potentially harmful. Message- and forum-specific characteristics were evaluated as predictors of advice quality and self-correction.

Results

Of 3368 initial messages, 266 (7.9%) were requests for advice. Of 654 provisions of advice, 56 (8.6%) were erroneous and 19 of these 56 (34%) were subsequently corrected. Forty-three (6.6%) provisions of advice were harmful, and 12 of these 43 (28%) were subsequently corrected. Messages from low-activity forums (fewer messages) were more likely than those from high-activity forums to be erroneous (10.6% vs 2.4%, P < .001) or harmful (8.4% vs 1.2%, P < .001). In high-activity forums, 2 of 4 (50%) erroneous provisions of advice and 2 of 2 (100%) potentially harmful provisions of advice were corrected by subsequent postings. Compared with general weight loss advice, medication-related advice was more likely to be erroneous (P = .02) or harmful (P = .01).

Conclusions

Most advice posted on highly active Internet weight loss forums is not erroneous or harmful. However, clinical and research strategies are needed to address the quality of medication-related advice.