| Methods |
Double‐blind randomized placebo‐controlled trial
Cross‐over design |
| Participants |
N = 17 patients, all female
Mean age 41 years, range 16 to 67
All with typical Raynaud's phenomenon with mean duration of 9.9 years
5 with idiopathic Raynaud's phenomenon, Raynaud's phenomenon secondary to systemic sclerosis, and RP secondary to systemic lupus erythematosus (in 1 patient) |
| Interventions |
After 2 weeks of baseline, participants randomized to receive placebo or nifedipine for 2 weeks followed by a cross‐over for 2 weeks
Total study duration 6 weeks |
| Outcomes |
Frequency, severity (10‐cm visual analogue scale), drug effectiveness (10‐cm visual analogue scale) recorded in a participant diary
Blood pressure, heart rate, side effects, and skin temperature recovery times measured during visits |
| 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 |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Participant diary used to record daily attacks, severity, side effects, and drug effectiveness |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
None |
| Selective reporting (reporting bias) |
Unclear risk |
None detected |
| Other bias |
Unclear risk |
No mention of a washover period |
