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. 2013 Mar 28;2013(3):CD004310. doi: 10.1002/14651858.CD004310.pub3

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
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.
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