Leppert 1989.
Methods | Single‐blind dose response study Cross‐over design | |
Participants | 10 female patients Mean age 43 ± 7 years All with disabling primary Raynaud's phenomenon All with finger cytosolic pressure at 10°C below 50% of the value at 30°C All with severe Raynaud's phenomenon for a mean period of 12 ± 6 years 0 dropouts |
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Interventions | Total duration of treatment 9 weeks After an initial placebo run‐in period of 3 weeks, participants given isradipine capsules at a dose of 1.25 mg twice daily for 3 weeks, followed by 2.5 mg for a further 3 weeks No vasoactive compounds other than isradipine taken |
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Outcomes | Finger systolic pressure measured
At the end of each period, finger systolic blood pressure measured and participants questioned regarding side effects Participant assessment of effectiveness of therapy on a 0 to 100 mm visual analogue scale |
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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; participants unaware of their treatment arm |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Subjective participant assessment of outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Unclear risk | None detected |
Other bias | Unclear risk | Evidence insufficient for judgement of risk |