Makarainen 1986.
Methods | Randomisation by manufacturer using tables for random numbers Double‐blind, placebo‐controlled using cross‐over design No loss to follow‐up No power calculation made |
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Participants | Finland 13 women, mean age 39 years with a complaint of menorrhagia (subgroup from a total number of 30 women: primary menorrhagia (n = 13), myoma‐associated menorrhagia (n = 10), factor VIII deficiency (n = 1) and normal blood loss (n = 6)) No exclusions specifically mentioned |
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Interventions | Group 1: ibuprofen 600 mg daily throughout menstrual cycle (maximum 10 days), n = 13 Group 2: ibuprofen 1200 mg daily throughout menstrual cycle (maximum 10 days), n = 13 Group 3: placebo same dosage regimen, n = 13 |
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Outcomes | MBL (alkaline haematin method) Adverse events (any vs none) Duration of bleeding (days) Menstrual pain |
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Notes | No ITT analysis Data not available at end of first treatment period and so not suitable for pooling Data not given by author for duration of bleeding or menstrual pain |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Tables of random numbers |
Allocation concealment (selection bias) | Unclear risk | Unclear risk |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported |
Other bias | Unclear risk | Nothing detected |