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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Berneis 2000.

Study characteristics
Methods RCT.
Parallel design with 2 arms.
Duration: 12 weeks.
Location: Basel, Switzerland.
Participants Inclusion criteria: adults with HIV infection and weight loss 5% or more in 6 months or BMI < 21 or CD4 cell count < 500/mm‐3 in a stable condition without acute infectious complications.
Exclusion criteria: not specified.
Number randomised: 18 adults but 3 not included because of non‐adherence and severe disease complications, so 15 participants.
Gender split: 14 males and 1 female.
Age: not reported.
Nutritional status: not reported
Interventions Intervention: participants (n = 8) received dietary advice and ONS in the form of dietary advice and nutritional supplements (target unspecified).
Control: participants (n = 7) received no dietary advice and no ONS in the form of no nutritional therapy.
Outcomes Weight*, lean and fat mass, macronutrient intake, energy intake*, immune function, QoL.
Publication details Language: English.
Funding: grant from the Swiss Federal Office of Health (Grant no 94–7189), Novartis Nutrition (Bern, Switzerland), and the Swiss National Science Foundation.
Publication status: peer‐reviewed journal.
Notes Additional data and information on quality requested from authors. Received a reply to say information no longer available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Information from author states that randomisation performed by pharmacy using a random number generator.
Allocation concealment (selection bias) Unclear risk The author could not supply details about allocation concealment.
Blinding (performance bias and detection bias)
Clinical outcomes Low risk Although not specifically mentioned, the trial must have been unblinded due to the nature of the intervention. However, this is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk The trial was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias)
Nutritional outcomes Unclear risk The trial was unblinded. Nutritional outcomes could have been influenced by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judged to be unclear because low risk for clinical outcomes and high risk for functional and nutritional outcomes.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Original group consisted of 18 participants, but 3 (17%) not included because of non‐adherence and severe disease complications. Author unable to provide details of which groups the drop‐outs were in.
Selective reporting (reporting bias) High risk No study protocol identified, thus unable to judge whether all planned outcomes were reported. Outcomes were reported, as mean change at baseline and end of follow‐up therefore change scores were calculated and SDs imputed.
Other bias Unclear risk Baseline variables not stated, don't know if groups similar at baseline.