Methods |
Study design: Cross‐over study comparing phenmetrazine hydrochloride with phenmetrazine hydrochloride plus phenbutrazate hydrochloride Randomization procedure: NR
Allocation concealment: Unclear
Follow‐up: 8w |
Participants |
Country: UKSetting: Hospital diabetes clinicNumber: 22Age: 58 from table 1Sex: 80%FMedications: NRBL wt: 78BL BMI: NRBL GHb: NR |
Interventions |
Drug: PhenmetrazineDosage: 25mg tidDuration: 8w (until first cross‐over)Diet: 1000 kcal/d Comparison: Filon® [phenmetrazine theoclate 30mg and phenbutrazate hydrochloride 20mg] tid with 1000 kcal/d diet |
Outcomes |
Weight: YesBMI:>5% loss (%):FBS:GHb:Cholesterol:LDL:HDL:TG:SBP:DBP:Side effects: Yes; dizziness (20%), abdominal discomfort and nausea (15%, and dry mouth 5%) |
Notes |
Funding: NRAbstract/full text: FTLOCF: NRITT: Yes, with attritionAttrition: 9%Blinding: Double‐blindBlinding assessor: UnclearBL comparable: NRJadad score: 1,1,0,BRisk of bias: B |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |