Godoy‐Matos 2005.

Methods	Parallel randomised controlled clinical trial, randomisation ratio 1:1, superiority design
Participants	Inclusion criteria: boys and girls, aged 14 to 17 years, with a BMI of 30 to 45 (BMI calculated as weight (kg) divided by height squared (m)). To avoid growth variation, all participants were required to have adult bone age, as determined by left hand radiography (Greulich‐ Pyle method) Exclusion criteria: diabetes mellitus endocrine diseases predisposing to obesity (e.g. Cushing's syndrome) severe hyperlipidaemia (total cholesterol 300 mg/dL or triglycerides 500 mg/dL) systemic or major psychiatric disorders history of bulimia or anorexia uncontrolled hypertension (DBP 110 mm Hg) or other cardiovascular diseases weight loss ≥ 3 kg within 2 months or use of weight loss or weight gain drugs within 3 months before recruitment drug or alcohol abuse recent tobacco cessation or intention to quit during trial period pregnancy or lactation Diagnostic criteria: see above
Interventions	Intervention: sibutramine + hypocaloric diet + exercise Comparator: placebo + hypocaloric diet + exercise Number of trial centres: 1 Treatment before trial: during the run‐in period all participants received dietary counselling to achieve an energy deficit of 500 kcal/day. They also all received placebo capsules Titration period: no
Outcomes	Outcomes reported in abstract of publication: weight loss, mean BMI reduction, adverse events
Study details	Run‐in period: a single‐blind, 4‐week, placebo run‐in period Trial terminated early: no
Publication details	Language of publication: English Commercial funding Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "The aim of this study was to determine the efficacy and safety of sibutramine in obese adolescents"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were allocated in a random block fashion to placebo or sibutramine" Comment: details of the randomisation process was provided by the author ‐ process seems adequate
Allocation concealment (selection bias)	Low risk	Quote: "By means of a sealed envelope with a coded number. A container with boxes for each patient displaying the code number were provided. Each box had blisters for each visit with 40 capsules (similar for placebo or active drug). Patients were supplied in each visit with a new box. Adherence was judged by counting used capsules" Comment: allocation was concealed as confirmed by the author
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Quote: "a randomised, double‐blind, placebo‐controlled trial" Comment: author confirmed all participants and personnel were blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: "a randomised, double‐blind, placebo‐controlled trial" Comment: author confirmed all participants and personnel were blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "a randomised, double‐blind, placebo‐controlled trial" Comment: author confirmed all participants and personnel were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "a randomised, double‐blind, placebo‐controlled trial" Comment: author confirmed all participants and personnel were blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: dropout fairly low; however, was higher in the placebo group. Only completers results shown
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: dropout fairly low; however, was higher in the placebo group. Only completers results shown
Selective reporting (reporting bias)	Unclear risk	Comment: a protocol was not published before the trial was completed, therefore it is unclear whether all outcomes were reported
Other bias	High risk	Quote: "this work was supported by a grant from Abbott Laboratories" Comment: the trial did not highlight how involved Abbott Laboratories were the trial design, analysis and interpretation of the results Quote: "Conclusions regarding treatment group differences are somewhat limited by the small sample size" Comment: the trial did not perform a power calculation. Likely the trial was underpowered