Keogh 2003.
Study characteristics | ||
Methods | RCT with parallel design | |
Participants | 39 adult participants with NYHA class II or III heart failure were randomised in a double‐blind, placebo‐controlled study to 150 mg/day of oral coenzyme Q10 or placebo for 3 months 19 participants in the coenzyme Q10 group and 20 in the placebo group Adults (> 18 years) | |
Interventions | Intervention: oral coenzyme Q10 150 mg/day Control: placebo |
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Outcomes | Symptom class by NYHA and specific activities scale Exercise tolerance by a 6‐minute walk test Walk test and treadmill exercise test (modified Naughton stress test) assessment for clinical outcomes of heart failure Plasma levels of coenzyme Q10 Assessment for the clinical outcomes of heart failure including readmission, transplantation or death, serum creatinine, sodium and potassium |
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Notes | Study was partially funded by pharmaceutical companies that manufacture and distribute coenzyme Q10 supplements. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised, no details about random sequence generation mentioned |
Allocation concealment (selection bias) | Unclear risk | No information given |
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 | In the placebo group, 2 participants withdrew: 1 because of a rash and nausea and the other for epigastric burning with a history of peptic ulceration In the active group, 1 participant withdrew after 56 days due to increased lethargy and 1 withdrew in order to start carvedilol (prohibited medication) |
Selective reporting (reporting bias) | Unclear risk | No study protocol was available. |
Other bias | Low risk | No other bias could be found. |