Nilsson 1987.
Methods | Randomized double‐blind placebo‐controlled trial | |
Participants | 28 patients ‐ 24 female and 4 male Average age 47.5 years Mean duration of symptoms 17.5 years |
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Interventions | Nifedipine 10 mg for 1 week and 20 mg (2 10‐mg capsules/d) for the next week or placebo 3×/d for 2 weeks during first treatment period, followed by 1‐week washover period Second period ‐ participants crossed over to opposite treatment |
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Outcomes | Changes in symptoms Side effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was made in blocks of 6." |
Allocation concealment (selection bias) | Low risk | Blind allocation based on blocking |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind cross‐over study; code broken only after conclusion of treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant assessment of changes in symptoms and side effects |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/28 (1 participant on nifedipine with dropout due to side effects) |
Selective reporting (reporting bias) | Unclear risk | None detected |
Other bias | Low risk | Cross‐over phases separated by 1‐week washout period |