| Methods |
Study design: RCTRandomization procedure: UnclearAllocation concealment: UnclearFollow‐up: 52w |
| Participants |
Country: Multicenter: England, Canada, France, BelgiumSetting: NRNumber: 195Age: 49Sex: 56%FMedications: MetforminBL wt: 103.3BL BMI: 36.3BL GHb: 9.6 |
| Interventions |
Drug: SibutramineDosage: 15 or 20 mg qdDuration: 52wDiet: Standard dietary adviceComparison: Dietary advice + placebo |
| Outcomes |
Weight: YesBMI: Yes>5% loss (%):FBS: YesGHb: YesCholesterol: YesLDL: YesHDL: YesTG: YesSBP: YesDBP: YesSide effects: Yes |
| Notes |
Funding: Abbott Laboratories Abstract/full text: FTLOCF: NRITT: NRAttrition: 26%Blinding: Double‐blind Blinding assessor: UnclearBL comparable: YesJadad score : 1,1,0,BRisk of bias: C |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
