| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
42 women randomised, 39 analysed (3 withdrawals: 1 woman did not meet protocol criteria for the trial, 2 did not return after 1st interview)
Method of assessing adverse effects: authors state only "side effects were noted" |
| Participants |
Inclusion: regularly occurring menstrual pain requiring medication
Exclusion: lactation; history or sign of severe generalised allergic or gastrointestinal disease; use of analgesics
Age: range 17 to 45, median 26
Location: Sweden |
| Interventions |
Ketoprofen (100 mg)
Naproxen (500 mg)
Single dose
Duration: 2 cycles, 1 treatment per cycle |
| Outcomes |
Pain severity 100 mm VAS
Activity level permitted 1 to 7 scale
Pain reduction 1 to 7 scale
Adverse effects |
| Notes |
Differences in baseline pain levels were reported ‐ therefore calculations of outcomes were transformed to difference from base value. The ketoprofen group initially had higher pain levels
Data on adverse effects reports number of symptoms but not number of women affected |
| 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 broken at end of study |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether information on side effects actively solicited |
| Complete follow‐up? |
Unclear risk |
3/42 patients were not analysed (93% analysed) |
| Potential bias related to study funding |
Unclear risk |
Not stated |
