Kinney 1982.
Methods | Double‐blind randomized placebo‐controlled trial Cross‐over design | |
Participants | 16 patients ‐ 10 progressive systemic sclerosis, 2 mixed connective tissue disease, 2 with systemic lupus erythematosus, 2 with Raynaud's disease 2 dropouts | |
Interventions | No vasoactive drug other than the one being tested (verapamil) All study participants non‐smokers except for 1 participant who continued to smoke 4 cigarettes a day throughout the duration of the experiment Concomitant medications not changed during this study Verapamil administered orally for 3 weeks followed by increased dosage for 3 weeks Last 6 weeks of study ‐ treatment groups crossed over Total study duration 12 weeks |
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Outcomes | Participants interviewed and examined at start of the study and every 3 weeks thereafter Diary analysis to ascertain whether participants had at least 1 episode of Raynaud's phenomenon on a given day Pulse volume, total blood flow in the tip of the finger, skin temperature, and cold pressor testing measured |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated randomization schedule" |
Allocation concealment (selection bias) | Low risk | Likely occurred on the basis of computer generation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The study was double‐blinded." "Placebo‐treated patients received equivalent numbers of capsules." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant diary used to record subjective assessments and to check compliance |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2/16 participants with completed diary excluded from analysis |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Unclear risk | Evidence insufficient for judgement of risk |