Hawkins 1985.
Methods | Randomized controlled trial Double‐blinding not explicitly stated but given benefit of the doubt |
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Participants | 71 entering the study and 57 completing the study ‐ 49 female, 8 male At least 2 attacks during last 2 weeks before enrollment Mean age 49 years, range 17 to 78 Mean duration of Raynaud's 14.7 years, range 1 to 52 20 with idiopathic Raynaud's 25 with systemic sclerosis 4 with seropositive rheumatoid arthritis 3 with mixed connective tissue disease 3 with systemic lupus erythematosus 1 with Sjogren's syndrome and seropositive polyarthritis |
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Interventions | Following 2‐week run‐in period without therapy Randomized to either 10 mg nifedipine 4×/d or placebo Underwent 4 consecutive periods of treatment with alternating nifedipine and placebo |
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Outcomes | Number of attacks per week Severity on a 10‐cm visual analogue scale and on a 5‐point scale (none, mild, moderate, severe, and very severe) BP, presence of digital ulcers Thermal stress test |
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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 | Does not explicitly state double‐blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Subjective participant assessments of number and severity of attacks |
Incomplete outcome data (attrition bias) All outcomes | High risk | 14/71 dropouts ‐ 6 due to intercurrent illness, 8 due to drug side effects (7 from nifedipine and 1 from placebo) |
Selective reporting (reporting bias) | Unclear risk | Severity of attacks not reported on a 5‐point Likert scale as proposed |
Other bias | Unclear risk | No mention of washout period between cross‐over phases |