Von Roenn 1994.
Methods | Double‐blind, randomised, controlled, multicentre | |
Participants | 271 patients with AIDS who had substantial weight loss and anorexia 270 M and 1 F a) 75 pts = 75 M Mean age 38 yrs b) 75 pts = 75 M Mean age 39 yrs c) 82 pts = 81 M + 1 F Mean age 39 yrs d) 38 pts = 38 M Mean age 38 yrs |
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Interventions | a) MA 800 mg/d, suspension b) MA 400 mg/d, suspension c) MA 100 mg/ d, suspension d) Placebo, suspension | |
Outcomes | Weight Appetite Mid‐arm circumference Triceps skinfold QoL by linear analogue self assessment questionnaire | |
Notes | 12 weeks of treatment
QS = 2 Clinically significant weight loss was defined as a decrease of 20% from usual body weight, or as 10% below ideal body weight for patients whose premorbid weight was greater than ideal body weight, or as a loss of 10% or more of usual body weight for those whose premorbid weight was below ideal body weight. Patients with stable weight or excessive weight gain could be removed from the study after completing the 12‐week trial period. Patients otherwise continued on their assigned treatment as long as they did not have additional weight loss of more than 10% of their baseline body weight. 75 were not evaluable for the efficacy analysis (27 patients did not meet the premorbid weight loss requirement, 46 patients had no follow‐up visits and 7 patients had only 1 follow‐up visit. Authors do not describe how many patients were in each arm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement of low risk or high risk |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of low risk or high risk |
Blinding (performance bias and detection bias) All outcomes | Low risk | See below |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The main outcome was weight. This is a blinded study and the main outcome is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The main outcome was weight. This is a blinded study and the main outcome is not likely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No data on balance of withdrawals in each arm |
Selective reporting (reporting bias) | Low risk | All the results were available |
Other bias | Unclear risk | Insufficient information to permit judgement of low risk or high risk |