Myburgh 1995.
Methods | open randomized crossover trial. After 4 weeks run‐in phase, patients received ramipril in the morning and at bedtime each for 4 weeks
Sample size calculation: not reported carryover effects: not reported no washout period between treatment arms |
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Participants | Country: South African Number randomised: 39 gender: 35 men, 4 women age range: 24‐73 years mean age: 49 years Ethnicity: not reported inclusion criteria: sitting DBP≥95 mm Hg and <114 mm Hg exclusion criteria: not stated | |
Interventions | 2.5 mg od ramipril taken at 8 AM to 11AM or at 8 PM to 11PM | |
Outcomes |
Mortality: not reported Morbidity: not reported Blood Pressure data:24h BP change by 24h ABPM, data was obtained from graph and text (fig 1 on page 1302 and fig 2 on page 1303) Adverse Events: withdrawals due to adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | not reported |
Allocation concealment (selection bias) | Unclear risk | not reported |
Blinding (performance bias and detection bias) All outcomes | High risk | open label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were reported. Three patients was excluded due to increase dose of ramipril to 5 mg, three patients withdrawn because of adverse events |
Selective reporting (reporting bias) | High risk | Morning SBP, DBP were not reported |
Other bias | Unclear risk | carryover effects were not reported |