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. 2017 Dec 13;2017(12):CD000467. doi: 10.1002/14651858.CD000467.pub2

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
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