| Methods |
Randomisation/allocation method unclear. Double‐blind, cross‐over study
39 women randomised and analysed
Method of assessing adverse effects: self reported prospectively "on specially printed cards" |
| Participants |
Inclusion: primary dysmenorrhoea, women on treatment with oral contraceptives but not receiving relief, full medical and gynaecological exam
Exclusion: women with organic causes of dysmenorrhoea, women with contraindications for taking prostaglandin synthetase inhibitors
Age: 16 to 40
Location: Sweden |
| Interventions |
Naproxen (500 mg at onset then 250 mg every 4 to 6 hours as needed, max. daily dose 1250 mg)
Placebo
Duration: 2 cycles each treatment, 4 cycles in total
If the test drug did not alleviate pain within 4 hours the women were allowed supplementary analgesics |
| Outcomes |
Pain relief (5‐point scale)
Adverse effects |
| Notes |
— |
| 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 |
Low risk |
Double‐blinded, "identical" placebo |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse effects data prospectively solicited but not reported for both groups |
| Complete follow‐up? |
Low risk |
No losses |
| Potential bias related to study funding |
Unclear risk |
Astra Syntex authors |
