| Methods |
Double‐blind randomized placebo‐controlled trial
Cross‐over design |
| Participants |
N = 30 patients ‐ 26 female and 4 male
Mean age 42.9 years
All with Raynaud's phenomenon ‐ 10 associated with progressive systemic sclerosis, 5 systemic lupus erythematosus, 3 rheumatoid arthritis, 12 idiopathic Raynaud's phenomenon
No dropouts |
| Interventions |
For 2 consecutive weeks, participants given 20 mg nifedipine and placebo 3× daily in random order |
| Outcomes |
Participant diary used to record weekly frequency of attacks and side effects |
| 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 |
Number of attacks reported by participants |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No losses to follow‐up reported |
| Selective reporting (reporting bias) |
Unclear risk |
None detected |
| Other bias |
Unclear risk |
No mention of a washout period between cross‐over phases |
