| Methods |
Randomisation/allocation method unclear
Double‐blind, parallel trial
69 women randomised, 64 analysed (experimental n = 29, control n = 35)
Withdrawals: 4 lost to follow‐up, 1 adverse effects
Method of assessing adverse effects: not stated |
| Participants |
Inclusion: women with primary dysmenorrhoea, complete physical and pelvic exams
Exclusion: organic causes for dysmenorrhoea, cyclical irregularities
Age: 17 to 38, experimental group mean 24.2, control group mean 23.3
Source: referrals to outpatient clinic
Location: USA |
| Interventions |
Naproxen sodium (550 mg initially, then 275 mg every 6 hours as needed, max. 5 days)
Placebo
Taken at first sign of menstrual distress
Duration: 3 cycles
If the test medication did not provide pain relief women could taken additional analgesics or their next treatment dose sooner |
| Outcomes |
Pain relief: 6‐point scale (reported in graph form as each woman's score, and also numbers with moderate relief etc)
Interference with daily activities: 6‐point scale
Requirement for additional analgesia
Adverse effects |
| Notes |
The 2 treatment groups were comparable at baseline. No numerical data reported for adverse effects in placebo group |
| 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) |
High risk |
Adverse effects not reported for both groups |
| Complete follow‐up? |
Unclear risk |
64/69 analysed (93%) |
| Potential bias related to study funding |
High risk |
Syntex supported study and were part of authorship group |
