Sauza 1984.
Methods | Parallel double‐blind randomized controlled trial | |
Participants | 25 patients entering the trial, 18 completing the 10‐week study 17/18 completing the trial female Mean age 41 years, range 24 to 71 Only 1 with primary Raynaud's, 17 with secondary Raynaud's, 10 with recurrent digital pitting scars, none given vasodilators for at least 2 weeks before start of the study |
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Interventions | 10 given nifedipine (30 mg to 60 mg/d) 8 given matching placebo |
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Outcomes | Number of Raynaud's attacks during previous 2 weeks Intensity of attacks Side effects Improvements |
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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 study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant subjective assessments |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 18/25 completing the 10‐week trial (7 exclusions due to compliance issues, failure to attend follow‐up appointments, or modifications in treatment programs) |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Low risk | Two groups with similar baseline characteristics |