Methods |
Study design: Two study groups; pre‐versus‐postRandomization procedure: NAAllocation concealment: NAFollow‐up: 20‐240d |
Participants |
Country: ItalySetting: NRNumber: 50Age: 54Sex: 65%FMedications: 17% insulin; 67% oral agentsBL wt: I 97 , C 92 BL BMI: NRBL GHb: NR |
Interventions |
Drug: DiethylpropionDosage: 2‐3qd (dosage not specified)Duration: 20‐240dDiet: 1000‐1800kcal/dComparison: Both groups got same diet and dosage diethylpropion; group A was on hypoglycemic agents, group B was diet controlled |
Outcomes |
Weight: YesBMI:>5% loss (%):FBS: YesGHb:Cholesterol:LDL:HDL:TG:SBP:DBP:Side effects: Yes; per Pina: 4/50 quit for SE, including general malaise, epigastric disturbance, and dermatitis. No untoward effects in person with HT and CVD; normal LFT and renal function |
Notes |
Funding: NRAbstract/full text: FTLOCF: NRITT: Yes, with attritionAttrition: 8%Blinding assessor: NRBL comparable: NRJadad score: NARisk of bias: NA |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
D ‐ Not used |