Franco 2014.

Methods	Cross‐over randomised controlled clinical trial, randomisation ratio 1:1, superiority design
Participants	Inclusion criteria: aged 10 to 18 years diagnosis of obesity (classification according to the World Health Organization) ability to understand the guidelines the adolescent's consent and the legal guardian for initial inclusion, the participant needed to have already carried out some conventional treatments (diet/behavioural) prior, for at least 6 months Exclusion criteria: cardiovascular problems and or arrhythmias history of anorexia, bulimia and or psychiatric disorders hypertension chronic diseases prior use of any other medication that interfered with the weight change, genetic syndromes, neuropsychomotor development delay, or a combination glaucoma use of illicit drugs, tobacco or alcohol pregnant girls or that they had sexual intercourse without contraceptives Diagnostic criteria: see above
Interventions	Intervention: sibutramine + dietary guidance Comparator: placebo + dietary guidance Number of trial centres: 1 Treatment before trial: all participants had to have under gone at least 6 months of lifestyle intervention prior to recruitment Titration period: none
Outcomes	Outcomes reported in abstract of publication: % of participants who lost 10% of initial weight, weight, BMI
Study details	Run‐in period: no Trial terminated early: no
Publication details	Language of publication: Portuguese Noncommercial funding Publication status: peer‐reviewed journal
Stated aim for study	Quote from publication: "The aim of this study was to evaluate the efficacy and safety of sibutramine in association with a multidisciplinary program for treatment of obesity and check its influence on metabolic laboratory changes"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	From author: "patients were distributed according to a table of random numbers" Comment: randomisation process assessed as low risk
Allocation concealment (selection bias)	Low risk	From author: "the study was double‐blind placebo‐controlled. Patients received placebo or sibutramine for 6 months, 1 month washout and in the next six months who received placebo began receiving sibutramine and vice verse. The researchers had no knowledge who was getting the drug and who was getting the placebo" Comment: allocation was concealed
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Quote: "This study was double blinded placebo controlled cross‐over type with duration of 13 months" Comment: author confirmed participants, trial personnel and outcome assessors were all blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Low risk	Quote: "This study was double blinded placebo controlled cross‐over type with duration of 13 months" Comment: author confirmed participants, trial personnel and outcome assessors were all blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: "This study was double blinded placebo controlled cross‐over type with duration of 13 months" Comment: author confirmed participants, trial personnel and outcome assessors were all blinded.
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote: "This study was double blinded placebo controlled cross‐over type with duration of 13 months" Comment: author confirmed participants, trial personnel and outcome assessors were all blinded
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Quote: "of the 63 patients who initiated the study only 23 patients completed the study" Comment: high attrition rate likely to affect objective outcomes
Incomplete outcome data (attrition bias) Subjective outcomes	High risk	Quote: "of the 63 patients who initiated the study only 23 patients completed the study" Comment: high attrition rate likely to affect subjective outcome (i.e. adverse effects)
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available so risk was unclear
Other bias	High risk	Comment: lacked appropriate methodological detail and the failed to present the results in a meaningful and balanced manner. The cross‐over nature of the trial added to the difficulty in deciphering the results with such a high attrition rate. No power calculation performed