| Methods |
Randomized double‐blind placebo‐controlled trial
Parallel design |
| Participants |
N = 24 patients with Raynaud's phenomenon ‐ 19 women and 5 men
Mean age 41 years, range 19 to 63
Mean disease duration 3 years
6 idiopathic Raynaud's phenomenon, 6 connective tissue disease, 1 AVD, 1 IA
7 dropouts |
| Interventions |
2 groups of 12 participants
1 group treated with nifedipine 20 mg for a month, the other group treated with matching placebo for a month |
| Outcomes |
Clinical and instrumental parameters evaluated at beginning and end of treatment
Entity and frequency of ischemic attacks
Skin trophism stage and degree of pain
Capillaroscopy |
| 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 investigation |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Low riskUnclear riskHigh risk |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
7/24 dropouts: 3 from treatment group (2 for side effects and 1 for incorrect application of treatment) and 4 from placebo group (for side effects) |
| Selective reporting (reporting bias) |
Low risk |
None detected |
| Other bias |
Unclear risk |
Evidence insufficient for judgement of risk |
