Challenor 1987.
Methods | Randomized placebo‐controlled double‐blind trial 3‐Way cross‐over design |
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Participants | 36 participants with primary Raynaud's (32 female, 4 male) Mean age 47 years (range 19 to 67) Mean Raynaud's phenomenon duration 26.2 years (range 2 to 60 years) Vasoactive drugs discontinued before entry and other concomitant drug discontinued in 19 patients |
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Interventions | Nisoldipine 5 mg, 10 mg daily or matching placebo before food 3‐Way cross‐over each with duration of 4 weeks Total study length 3 months |
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Outcomes | Daily Raynaud's phenomenon attacks Severity Number of times outdoors Subjective response to treatment on 1 to 5 scale (1 = much better, 2 = better, 3 = same, 4 = worse, 5 = much worse) and 10‐cm visual analogue scale (from 0 = much better to 10 = much worse) |
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Notes | Length of washover not clear Mean ambient temperature similar during all treatment periods |
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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 diary used to record number of attacks, severity, subjective improvement |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 4/36 dropouts |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Unclear risk | Length of washover not clear |