Kahan 1985b.
Methods | Double‐blind randomized placebo‐controlled prospective study Cross‐over design | |
Participants | N = 16 patients ‐ 14 women and 2 men Mean age 41.5 years, range 18 to 57 7 with systemic sclerosis, 2 rheumatoid arthritis, 1 systemic lupus erythematosus, 6 idiopathic Raynaud's phenomenon Mean disease duration 12.8 years No dropouts | |
Interventions | Each participant given placebo in a single‐blind fashion for 1 week Participants randomized to receive placebo or diltiazem in a double‐blind fashion for 2 weeks, then crossed over for the last 2 weeks Total study duration 5 weeks | |
Outcomes | Participant diary used to record frequency, severity, and number of attacks Participants asked about overall effectiveness of treatments Side effects recorded | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized double cross‐over protocol" 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 cross‐over study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Patients kept a record to attacks...severity, and effectiveness." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None detected |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Unclear risk | No mention of a washout period between cross‐over phases |