Wigley 1987.
Methods | Randomized double‐blind placebo‐controlled trial Cross‐over design | |
Participants | N = 25 patients ‐ 21 female, 4 male Mean age 39 ± 2.6 years, range 22 to 65 19 of Caucasian descent Average disease duration 4.75 ± 0.8 years 10 with primary Raynaud's phenomenon, 15 with Raynaud's phenomenon secondary to connective tissue disorder No dropouts during cross‐over phase, 2 dropouts during parallel phase |
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Interventions | Participants randomly assigned to receive nicardipine or placebo for first 2 weeks followed by a second 2‐week period with agent not taken Continuation of agent from the second treatment period for an additional 4 weeks in a parallel design Total study duration 4 weeks | |
Outcomes | Participant diary used to record frequency and severity Finger systolic pressure and venous sampling performed Beta‐thromboglobulin and platelet factor 4 measured | |
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 | "Subjects kept a daily diary of the frequency and severity of attacks." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts during cross‐over period of the study |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Unclear risk | Evidence insufficient for judgement of risk |