| Methods |
Randomisation/allocation method unclear
Double‐blind
Cross‐over design
50 women randomised, 47 completed all 4 cycles/analysed, 1 left group A after cycle 1 and 2 left group B after cycles 2 and 3; 48 or 49 analysed in each group
Method of assessing adverse effects: not stated |
| Participants |
Inclusion: primary dysmenorrhoea; no organic cause on examination; older than 12 years; no history of peptic ulcer, hepatic, renal or haematological disease
Age: mean 18.6, range 16 to 24
Source: medical, midwifery and nursing students
Location: Nigeria |
| Interventions |
Piroxicam 20 mg
Placebo
2 capsules on day 1 and day 2, then 1 capsule daily until end of menses
Duration: 4 cycles; ABBA, or BAAB treatment design
Paracetamol was allowed as additional medication, all use was recorded |
| Outcomes |
Abdominal cramps
Pain‐related symptoms
Minor symptoms
Overall pain
Paracetamol consumption |
| Notes |
— |
| 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 all adverse effects data reported |
| Complete follow‐up? |
Low risk |
50 women randomised, 47 completed all 4 cycles, 1 left group A after cycle 1 and 2 left group B after cycles 2 and 3, 48 or 49 analysed in each group (98%) |
| Potential bias related to study funding |
Unclear risk |
Pfizer provided drugs and placebo |
