Rybo 1981.
Methods | Randomisation method not given Double‐blind placebo‐controlled trial with cross‐over design No loss to follow‐up |
|
Participants | Sweden 18 women with a complaint of menorrhagia, ovulatory cycles and a normal coagulation test (data reported for subgroup of 4 women with primary menorrhagia, the remaining 12 had IUD‐induced menorrhagia) Exclusion criteria: organic cause of menorrhagia |
|
Interventions | Group 1: naproxen 500 mg morning, 250 mg afternoon days 1 and 2, then 250 mg twice daily for up to 7 days, n = 4 Group 2: placebo same dosage regimen, n = 4 Duration: 2 + 2 cycles |
|
Outcomes | MBL (alkaline haematin method) | |
Notes | Not ITT analysis Data not available at end of first cross‐over period and so not suitable for pooling Very large standard deviation for mean MBL in Rx group |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Unclear risk |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double bind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported |
Other bias | Unclear risk | Nothing detected |