Rupp 1987.
Methods | Double‐blind randomized trial Cross‐over design | |
Participants | N = 30 patients ‐ 28 women and 2 men 28 participants at start of study Source: Outpatient Rheumatology Clinic at the University of Iowa Hospitals and Clinics Patients with systemic Raynaud's vasospasms, at least 3 attacks per week during the month preceding start of the study 2 patients excluded before the trial began; 1 dropout |
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Interventions | Complete history and examination for participants, who received placebo or nicardipine for 4 weeks followed by a cross‐over for the next 4 weeks Total study duration 8 weeks | |
Outcomes | Participant diary used to record vasospastic attacks and side effects. Severity rated on an ordinal scale from 0 to 4. Pain associated with vasospasm recorded on a 15‐cm visual analogue scale. Daily number of episodes recorded. Variables recorded on a diary sheet; after completion of each 4‐week trial, participants evaluated in the human physiology laboratory. At study end, participants asked to give subjective evaluation of treatment periods. Used 15‐cm horizontal visual analogue scale to rate degree of pain with cold challenge with immersion of the right hand in ice for 90 seconds | |
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 | Participant assessment of attacks, severity, and side effects |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/28 dropouts while taking placebo for side effects |
Selective reporting (reporting bias) | Unclear risk | None detected |
Other bias | Unclear risk | No mention of a washover period |