de Luis 2003.
Methods | Randomised controlled trial. Duration 3 months. | |
Participants | Adults (n = 70, dietary advice + supplement group 71.4% men, mean age (SD) 37.5 years (11), dietary advice group 82.8 % men, mean age (SD) 39.9 years (9 years)) with HIV infection and 5% or more weight loss in previous 6 months. | |
Interventions | Dietary advice to increase energy and protein intake and 3 x 250 ml supplement (Ensure) (n = 33) versus dietary advice to increase energy and protein intake (n = 33). | |
Outcomes | Survival*, weight*, BMI*, TSF*, MUAC*, energy intake*, immune function, cardiac function. | |
Notes | Additional data and information on quality obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Information from the author indicated that a random number series was used to generate a sequence. |
Allocation concealment (selection bias) | Low risk | Information from the author indicated that sealed envelopes were used to conceal allocation. |
Blinding (performance bias and detection bias) Clinical outcomes | High risk | Information from the author indicated that outcome assessment was not blinded. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Information from the author indicated that outcome assessment was not blinded. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Information from the author indicated that outcome assessment was not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 participants withdrew between randomisation and baseline: Intervention group: 4 deaths, 1 loss to follow‐up; Control group: 1 loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported but not all in a format usable for meta‐analysis. Change in weight, TSF, MAMC and energy intake are reported as mean (SD) at baseline and end of intervention. Mean change (SD) obtained from authors. |
Other bias | Low risk | Baseline variables stated, groups similar at baseline. |