| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
60 women randomised, 57 analysed
Withdrawals, 1 pregnancy, 2 failed to attend follow‐up
Method of assessing adverse effects: self reported prospectively on form |
| Participants |
Inclusion: women with primary dysmenorrhoea; no history or evidence of pelvic pathology as judged by clinical and gynaecological examinations
Exclusion: pelvic pathology; IUD; history of peptic ulcer or dyspepsia; asthma; breastfeeding
Age: 16 to 44, mean (SD) 29.3 (9.3)
Parity: 37 nulliparous, 20 parous
Contraception: 17 used OCP, the rest barrier or none
Location: Sweden |
| Interventions |
Flurbiprofen (100 mg twice daily as needed)
Naproxen sodium (500 mg twice daily)
Treatment for a total of 5 days
Duration: 4 cycles, 2 per treatment |
| Outcomes |
Pain relief: 5‐point scale
Reported mean scores for each individual
Interference with everyday life
Days off work
Additional analgesics
No serious side effects reported |
| Notes |
Pain scores etc compared between groups at baseline and at each phase |
| 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, code not broken until data processing, women and investigators blind. "The capsules supplied were identical to all outward appearance" |
| Selective reporting (reporting bias) |
Low risk |
Adverse effects data collected prospectively by patient and reported in detail |
| Complete follow‐up? |
Low risk |
57/60 analysed (95%) |
| Potential bias related to study funding |
Unclear risk |
Not stated |
