| Methods |
Design: three group parallel trial
Purpose: examine the effect of dexfenfluramine on weight loss and thermogenesis in obese individuals |
| Participants |
Patients: out‐patients with body mass index > 25 kilograms per square meter
Baseline comparability: yes |
| Interventions |
Placebo: capsules for three months
Untreated: no capsules
Experimental: capsules with dexfenfluramine
(Co‐intervention: 8 week behavioural weight loss program) |
| Outcomes |
Weight loss
Other weight outcomes (waist/hip ratio, biceps fold, subscapular fold, arm circumference, etc)
Daily activity and changes in behaviour
Side effects |
| Notes |
13 of 32 patients in the no treatment group dropped out. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Patients in group I were randomly stratified into 2 subgroups... in a double‐blind, placebo‐controlled manner' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
High risk |
N = 37 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
