Gjorup 1986a.
Methods | Double‐blind placebo‐controlled randomized trial Cross‐over design | |
Participants | N = 19 patients ‐ 15 female, 4 male Median age 40 years, range 22 to 60 All with typical Raynaud's phenomenon Selected from files of general practitioners in hospital area Study completed by all patients |
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Interventions | 3‐Week periods of active and placebo treatment Participants assigned to receive nisoldipine or placebo during first period Study conducted during March and April Total study duration 6 weeks |
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Outcomes | Participant diary used to record daily number of attacks, grade of the most severe attack (on a scale from 1 to 10), whether the day had been better or worse than expected, and overall evaluation of preferred treatment Side effects also recorded |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Evidence insufficient for judgement of risk |
Allocation concealment (selection bias) | Unclear risk | Evidence insufficient for judgement of risk |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blind cross‐over study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Patients recorded number of attacks, severity, and efficacy." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Unclear risk | No mention of a washout period between cross‐over phases |