| Methods |
Randomized double‐blind placebo‐controlled prospective study
Cross‐over design |
| Participants |
N = 15 patients ‐ 11 female, 4 male
Mean age 53, ranging from 15 to 74
Mean disease duration 8.3 years
3 patients with scleroderma, 1 with systemic lupus erythematosus, 1 with limited scleroderma (CREST), 8 with primary Raynaud's phenomenon
No dropouts |
| Interventions |
Study duration 7 weeks
For 1 week, all participants given placebo, followed by random assignment to placebo or nifedipine for 2 weeks
Then 2‐week washout period and final 2‐week cross‐over period |
| Outcomes |
Daily record kept by participant of number, duration, and severity of attacks, as well as side effects
During assessments, heart rate, finger blood flow, blood work, digital systolic pressure, and blood pressure recorded |
| 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 |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
"Patients kept a daily diary of number, duration and severity of attacks." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No loss to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
None detected |
| Other bias |
Low risk |
Washout period of 2 weeks included between cross‐overs |
