| Methods |
Randomisation/allocation method unclear
Double‐blind, parallel trial
40 women randomised and analysed (plus additional 20 women on drug now withdrawn)
Method of assessing adverse effects: assessed retrospectively at follow‐up |
| Participants |
Inclusion: primary or incapacitating dysmenorrhoea for at least 6 months, clinically and generally healthy women, pain susceptible to pharmacological treatment
Exclusion: pelvic‐genital pathology, secondary dysmenorrhoea, IUD use, irregular menstrual cycles, OCP use, anticoagulants, gastric or peptic disease, hypersensitivity to anti‐inflammatories or steroids
Age: 18 to 36, mean 28.5 (4.7)
Location: Mexico |
| Interventions |
Nimesulide (100 mg every 12 hours)
Fentiazac (100 mg every 12 hours)
Mefenamic acid (500 mg every 8 hours)
Medication taken 3 times a day with placebo tablets added to ensure blinding was maintained, treatment for 5 days starting day prior to menses
Duration: 3 months
No use of analgesics or anti‐inflammatories during study period |
| Outcomes |
Pain intensity 0 to 10 scale |
| Notes |
Spanish ‐ translated by Monica C Davis. Outcomes recorded per cycle rather than per participant |
| 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 placebo |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether adverse effects data prospectively solicited. Data reported per cycle not per woman |
| Complete follow‐up? |
Unclear risk |
Unclear |
| Potential bias related to study funding |
Unclear risk |
Unclear |
