| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
12 women randomised and analysed
Method of assessing adverse effects: no mention of adverse effects |
| Participants |
Inclusion: history of primary dysmenorrhoea within 1 year of menarche; pelvic and physical examinations
Exclusion: use of OCP or IUD; history of allergies or gastrointestinal disorders
Age: 16 to 35
Location: USA |
| Interventions |
Naproxen sodium (275 mg)
Placebo
2 tablets administered as a loading dose at start of pain then 1 tablet taken 4 x daily for 3 days
Duration: 3 cycles, 1 control then randomised to a treatment for the 2nd cycle, and crossed over to the alternate treatment for the 3rd cycle |
| Outcomes |
Relief of dysmenorrhoea |
| 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 not prospectively solicited |
| Complete follow‐up? |
Low risk |
No dropouts |
| Potential bias related to study funding |
Unclear risk |
Grant in aid from Syntex |
