| Methods |
Randomisation/allocation method unclear
Cross‐over, double‐blind trial
47 women randomised, 269 cycles analysed, 90 indomethacin, 89 aspirin, 90 placebo
Method of assessing adverse effects: self reported prospectively on report cards |
| Participants |
Inclusion: primary dysmenorrhoea, nulliparous, unsatisfactory relief from analgesics
Exclusion: use of OCP, specific aetiology of dysmenorrhoea, or symptoms suggesting specific aetiology such as endometriosis
Age: 17 to 28, mean 22.8
Location: Finland |
| Interventions |
Indomethacin (25 mg, 3 times daily at first sign of distress for at least 2 days)
Aspirin (500 mg, taken as above)
Placebo
Duration: 2 cycles per treatment/6 cycles in total |
| Outcomes |
Degree of pain
Overall effect
Adverse effects |
| Notes |
Outcomes recorded per cycle rather than per participant |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not described |
| Allocation concealment (selection bias) |
Unclear risk |
Method not described |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, placebo not described |
| Selective reporting (reporting bias) |
Low risk |
Adverse effects data prospectively solicited |
| Complete follow‐up? |
Unclear risk |
Unclear: analysed as cycles |
| Potential bias related to study funding |
Unclear risk |
Dumex supplied drug |
