| Methods |
Randomisation using sealed, opaque, sequentially numbered envelopes
Double‐blind, cross‐over study
14 women randomised and analysed (55 cycles)
Power calculation was performed by the pharmaceutical company Helsinn SA
Method of assessing adverse effects: reported retrospectively at follow‐up |
| Participants |
Inclusion: history of dysmenorrhoea for several cycles, regular cycles, general good health; physical and pelvic exams
Exclusion: OCP, IUD use, contraindications or hypersensitivity to NSAIDs, organic causes of dysmenorrhoea, irregular cycles
Age: 17 to 28, median 22
Location: Finland |
| Interventions |
Nimesulide (100 mg bid at onset of pain, as needed)
Placebo
Duration: 4 cycles, 2 cycles nimesulide, 2 cycles placebo or vice versa |
| Outcomes |
Pain
Adverse effects |
| Notes |
Groups comparable at baseline
Extra information supplied by authors. No numerical data reported for adverse effects |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation using sealed, opaque, sequentially numbered envelopes |
| Allocation concealment (selection bias) |
Low risk |
Sealed, opaque, sequentially numbered envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, placebo not described |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse effects data not systematically reported |
| Complete follow‐up? |
Low risk |
14 women randomised and analysed (55 cycles) |
| Potential bias related to study funding |
Unclear risk |
Power calculation was performed by the pharmaceutical company Helsinn SA |
