Kirch 1987.
Methods | Single‐blind placebo‐controlled randomized trial Cross‐over design | |
Participants | N = 10 patients ‐ 5 male, 5 female Age 18 to 60 years Typical Raynaud's phenomenon and related connective tissue disorders No dropouts |
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Interventions | Participants given no drugs other than ketanserin, nifedipine, or placebo Initially received placebo orally during washout period of 4 weeks, then randomly assigned to receive either nifedipine or ketanserin orally for 4 weeks Then, a 2‐week lasting placebo phase interconnected with a cross‐over to the final 4‐week lasting therapy phase Total study duration 14 weeks | |
Outcomes | Participant diary used to record possible adverse effects and frequency, duration, and severity of attacks Severity assessed on a 3‐point scale Patient treatment rating on a 3‐point scale Laboratory parameters performed including blood cell count, erythrocyte sedimentation rate, and biochemical analysis of renal and hepatic function Skin temperature recordings and videomicroscopy performed, thereby monitoring flowmetry, a standard cold provocation test, and typical morphological changes in skin capillaries | |
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 | Unclear risk | Single‐blind study ‐ patients unaware of their treatment arm |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant diary used to record attack frequency and duration and adverse effects |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Low risk | Washout period of 2 weeks separating cross‐over periods |