Methods |
Study design: RCT; some Pre‐versus‐post without comparison group
Randomization procedure: NR
Allocation concealment: Unclear
Follow‐up: 32w
Note: This study did not fit inclusion criteria as did not present weight outcomes, however it presented adverse event data among persons with diabetes, and is therefore presented here. |
Participants |
Country: UKSetting: Multicenter; details unclearNumber: 210Age: 54Sex: 59Medications: None (diet only)BL wt: NRBL BMI: NRBL GHb: NR |
Interventions |
Drug: Sibutramine dosage: 15‐20mg qdDuration: 32wDiet: NRComparison: Placebo |
Outcomes |
Weight:BMI:>5% loss (%):FBS:GHb:Cholesterol:LDL:HDL:TG:SBP:DBP:Side effects: Yes |
Notes |
Funding: Knoll Pharmaceutical Co.,US and UKAbstract/full text: FTLOCF: NRITT: Yes, with attritionAttrition: 11%Blinding: Double‐blindBlinding assessor: UnclearBL comparable: YesJadad score: 1,1,1,BRisk of bias: B |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |