Malamet 1984.
Methods | Double‐blind cross‐over randomized placebo‐controlled trial Placebo, nifedipine (2 10‐mg capsules 3× daily), and dazoxiben (100 mg 4× daily) 10‐Week study with 6 treatment periods 2‐Week single‐blind placebo run‐in period 3 2‐week double‐blind cross‐over treatment periods (separated by 1‐week single‐blind washout periods) |
|
Participants | 13 patients ‐ 7 female and 2 male Mean age 34.6 ± 4.0 years, range 21 to 55 Duration of Raynaud's 11.4 ± 2.6 years, range 1 to 22 8 patients with secondary Raynaud's (associated with connective tissue disease), 1 with primary Raynaud's |
|
Interventions | Placebo Nifedipine (2 10‐mg capsules 3× daily) Daxoziben (100 mg 4× daily) |
|
Outcomes | Number of Raynaud's attacks Severity of attacks (3‐point scale) Pain intensity (VAS scale) Duration of episodes (minutes) |
|
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 | Participant diary used to record subjective assessments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Low risk | 1‐Week single‐blind washout period between cross‐over phases |