Wollersheim 1991.
| Methods | Randomized double‐blind placebo‐controlled cross‐over trial Washout period of 2 weeks separating cross‐over phases |
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| Participants | 25 patients ‐ 10 male and 15 female Mean age 41.2 ± 10.7 years 16 with primary and 9 with secondary Raynaud's phenomenon Mean duration of disease 6.5 ± 6.1 years 10 smokers Mean attack rate in the winter 7.2 ± 2.9/d, range 2 to 14 attacks/d 8 with skin lesions, 3 who had undergone sympathectomy |
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| Interventions | Nicardipine 30 mg 3× per day or matching placebo capsules for 3 weeks, then cross‐over to opposite treatment after 2‐week washout period for another 3 weeks Trial preceded by 3‐week baseline period without medication |
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| Outcomes | Frequency, duration, and severity of attacks Treatment preference Drug effectiveness (rated on a 5‐point scale: much worse, worse, no difference, better, or much better) Ischemic attack changes Side effects Objective measurements: weight, systolic blood pressure, temperature, diastolic blood pressure, heart rate |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information insufficient for judgement of risk |
| Allocation concealment (selection bias) | Low risk | "A sheet detailing the assignment of all periods for all medication sets was provided in sealed envelopes to be opened only in the event of a serious adverse event." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind; matching treatment and placebo capsules given |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant diary used for subjective assessments; participants unaware of allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 3 dropouts; no data provided (2 from treatment group and 1 from placebo group) |
| Selective reporting (reporting bias) | Unclear risk | All prespecified outcomes reported |
| Other bias | Unclear risk | Washout period of 2 weeks separating cross‐over phases |
ANF: XXX.
AVD: atrioventricular dissociation.
BP: blood pressure.
CREST: calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia.
FSP: XXX.
IA: intracranial aneurysm.
NSAIDs: non‐steroidal anti‐inflammatory drugs.
RA: rheumatoid arthritis.
VAS: visual analogue scale.