Berman 2004.
Study characteristics | ||
Methods | RCT with parallel design | |
Participants | 32 participants with end‐stage heart failure awaiting heart transplantation were randomly allocated to receive 60 mg U/day of ultrasome coenzyme Q10 or placebo for 3 months Adults (> 18 years) All participants continued their regular medication regimen | |
Interventions | Intervention: oral coenzyme Q10 60 mg daily Control: placebo |
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Outcomes | Symptoms improvement (NYHA classification) Symptoms improvement measured on the Minnesota Living with Heart Failure Questionnaire Quality of life on 6‐minute walk test Blood tests for atrial natriuretic peptide and tumor necrosis factor Echocardiography |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no details about random sequence generation |
Allocation concealment (selection bias) | Low risk | Group allocation was done by a third (external) party. Participants were given a personal addressed, sealed envelope containing the words "code A" or "code B" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants failed to complete the study because of death, need for heart transplantation, drug‐induced intestinal upset, inconvenient travel connections and lack of compliance (1 participant each). Study also did not report the number of participants in the treatment and placebo groups |
Selective reporting (reporting bias) | Unclear risk | No study protocol was available. |
Other bias | Low risk | No other bias could be found |