| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
69 women randomised, 62 analysed
3 dropouts before end of first cycle, 1 receiving niflumic acid had amenorrhoea, 2 for personal reasons
4 additional women left prior to completing the 2nd treatment, 1 for personal reasons, 1 hospitalised for depression, 1 pregnancy, 1 lost to follow‐up. In addition a woman initially randomised to group 1 (niflumic/placebo) was transferred to the other group and evaluated accordingly
Method of assessing adverse effects: self reported prospectively |
| Participants |
Inclusion: primary or essential dysmenorrhoea for more than 6 months; pain with a equal or greater severity than 50 mm on a 100 mm VAS; regular cycles
Exclusion: organic origin of dysmenorrhoea; OCP use; IUD use; pregnant; contraindication to NSAIDs; concomitant illness; chronic alcoholism or drug addition
Age: group 1: mean 30.6 (8.0), group 2 mean 29.1 (6.4)
Source: outpatients
Location: France |
| Interventions |
Niflumic acid 750 mg per day in 3 divided doses
Placebo
Taken for 3 days
Duration: 2 cycles, 1 per treatment |
| Outcomes |
Pain relief (efficacy on 4‐point scale)
Treatment efficacy evaluated by investigator and participant
Pain severity
Effect on daily activities
Adverse effects |
| Notes |
Groups compared at baseline. French with an English abstract, translated by Richmal Oates‐Whitehead |
| 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) |
Unclear risk |
Unclear whether adverse events data prospectively solicited |
| Complete follow‐up? |
Unclear risk |
62/69 analysed (90%) |
| Potential bias related to study funding |
Unclear risk |
Author affiliations with Laboratories UPSA |
