| Methods |
Randomisation/allocation method unclear
Cross‐over, double‐blind trial
46 women randomised, 44 analysed
2 excluded from analysis, 1 due to not completing 3 cycles, 1 only took 3 capsules of medication
Method of assessing adverse effects: unclear ‐ authors state that "adverse reactions recorded" at follow‐up visit |
| Participants |
Inclusion: primary spasmodic dysmenorrhoea, pain in recurrent cyclic fashion as diagnosed using Menstrual Distress Questionnaire, regular menstrual cycles, good physical health, emotionally stable, physical and pelvic exam performed
Exclusion: IUD or OCP use, congestive dysmenorrhoea, organic pelvic disease, intolerance to fenamates
Location: USA |
| Interventions |
Mefenamic acid (250 mg, 4 times daily at onset of menses, max. 3 days, dose could be reduced if needed)
Placebo
Duration: 3 cycles per treatment phase/6 cycles in total
Additional analgesia: 32.4 mg codeine allowed if necessary, no aspirin or paracetamol‐based products, or over the counter analgesia allowed during study |
| Outcomes |
Proportion with decrease in pain, weakness/dizziness/nausea and diarrhoea
Adverse effects |
| Notes |
Groups compared at baseline and trial also reported mean differences in pain from entry score for end of first phase. No numerical data reported for adverse effects |
| 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‐appearing placebo capsules" |
| Selective reporting (reporting bias) |
Unclear risk |
Data on adverse reactions not solicited prospectively |
| Complete follow‐up? |
High risk |
37/46 analysed (80%) |
| Potential bias related to study funding |
Unclear risk |
Drug supplied by Parke Davis |
