Summerbell 1992.
Methods | Randomised controlled trial | |
Participants | 14 patients with HIV infection | |
Interventions | MA 40 mg daily which was increased by 40 mg daily on alternate weeks to a maximum of 160 mg daily if there was no response in weight, or cyproheptadine 12 mg daily for a period of 3 months | |
Outcomes | Weight, sexual thoughts, arousal and orgasms | |
Notes | The study was discontinued after 14 patients were enrolled Cachexia was defined as weight loss < 5 kg QS: 2 |
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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 not a blinded study but 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 not a blinded study but the main outcome is not likely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients were studied |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | High risk | The study was discontinued after 14 patients were enrolled, because recruitment was too slow and the majority of patients had diarrhoea or overt infections |