Digiesi 1990.
Methods | Randomized, placebo‐controlled, cross‐over trial. 2 week washout period, 10 week treatment period, 2 week treatment suspension, 10 week cross‐over treatment. |
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Participants | 18 patients (4 women, 14 men) with essential hypertension, WHO stages 1 and 2, average age 55.9 years (range 42 to 66 years). Patients older than 70 years, renal failure or body weight > 90 kg excluded. | |
Interventions | Intervention: Monotherapy with 100 mg oral coenzyme Q10 daily for 10 weeks Control: Placebo |
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Outcomes | Resting supine SBP and DBP at 10 weeks | |
Notes | Sources of funding not stated. Small study size. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote "...patients were randomly assigned... then each patient in group A crossed over to placebo treatment and each patient in group B crossed over to CoQ treatment..." Does not describe the sequence generation process. |
Allocation concealment (selection bias) | High risk | Insufficient information provided. Does not describe how allocation concealment was ensured. |
Blinding (performance bias and detection bias) Blood Pressure | High risk | No information provided as to whether blinding was achieved. |
Incomplete outcome data (attrition bias) Blood Pressure | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | High risk | BP reported was stated as end of treatment. BPs at other times were not reported. |
Other bias | High risk | No indication as to how patients were selected, "eighteen subjects were selected from among those presenting with essential arterial hypertension," so they could have been selected based on previous response to CoQ10. BP standard deviations are lower and not as variable as would be expected. |