Van Mil 2007.

Methods	Parallel controlled clinical trial, randomisation ratio 1:1, superiority design
Participants	Inclusion criteria: aged 12 to 18 years, initially selected for BMI ≥ 97th percentile, and further selected for triceps skinfold thickness ≥ 97th percentile for age and sex with persisting obesity despite previous professionally supervised weight loss attempts (97.5th percentile is equivalent to 2 SD) Exclusion criteria: endocrine causes or other secondary causes of obesity significant physical or medical illness that could influence the results of the trial Diagnostic criteria: see above
Interventions	Intervention: sibutramine + energy‐restricted diet and exercise plan Comparator: placebo + energy‐restricted diet and exercise plan Number of trial centres: 1 Treatment before trial: no Titration period: 5 mg placebo or sibutramine, taken once daily in the morning. After 2 weeks, the dose was increased to 10 mg/day
Outcomes	Outcomes reported in abstract of publication: BMI‐SDS, BMI, % fat mass, BMRadj, total energy expenditure
Study details	Run‐in period: no 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 objective of this trial was to examine the effect of treatment with sibutramine (10 mg) on body composition and energy expenditure in obese adolescents"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomisation was performed by Knoll Pharmaceuticals. Boxes with medication for each visit were numbered for each subject. Subjects received their number and the boxes with medication that belonged to that number. The numbers/medication was handed out in order of inclusion in the study" Comment: author clarified randomisation process; however, it was unclear if the process would have introduced selection bias
Allocation concealment (selection bias)	Low risk	Quote: "Knoll Pharmaceuticals BV [currently Abbott Laboratories (Hoofddorp, The Netherlands)], manufactured and provided code‐numbered placebo and sibutramine capsules. Subjects received their trial and medication code according to order of entrance into the study, without stratification" Comment: allocation was concealed
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Comment: author confirmed participants and personnel were blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Comment: author confirmed participants and personnel were blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Comment: author confirmed outcome assessment was blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Comment: author confirmed outcome assessment was blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: an imputation method was used; however, results only shown for completers. Dropout rates fairly low
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: an imputation method was used; however, results only shown for completers. Dropout rates fairly low
Selective reporting (reporting bias)	Unclear risk	Comment: unclear whether all outcomes were reported due to no previously published protocol
Other bias	Unclear risk	Quote: "E.G.A.H.V.M. was previously employed by Maastricht University, partly on a research grant from Knoll, currently Abbott Pharmaceuticals, The Netherlands" Comment: potential influence of funding source