Schwenk 1999.
Methods | Randomised controlled trial (block randomisation). Duration 8 weeks. | |
Participants | HIV positive adults (n = 50, 47 men, 3 women; dietary counselling group mean (SD) age 39.5 years (10.2 years); supplement group mean (SD) age 39.4 years (9.2 years)) who had lost >5% of usual weight or who were actively losing weight, >3% in last month. 3 dropouts in dietary counselling group and 2 dropouts in supplement group. |
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Interventions | Dietary counselling to increase food intake by 600 kcal using household food items (n = 24) versus oral nutritional supplements (0.6 ‐ 1.5 kcal/ml) to increase energy intake by 600 kcal (n = 26). | |
Outcomes | Survival*, change in body cell mass and change in weight*, change in energy intake*, hospital admissions*. | |
Notes | Additional data and information obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Information from author, block randomisation derived using random numbers. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes prepared by a person not involved in the study. |
Blinding (performance bias and detection bias) Clinical outcomes | High risk | Information from author indicates that the study was not blinded. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Information from author indicates that the study was not blinded. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Information from author indicates that the study was not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 dropouts in dietary counselling group and 2 dropouts in supplement group. Reasons for drop out were opportunistic infections in 4 cases and change of residence in one. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported but data was not in a form usable for meta analysis. Data on weight change were reported as % change in area under the curve and data on energy intake was reported as mean calories per kg, therefore mean change (SD) obtained from authors. Data on number of hospital admissions confirmed with the author. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |