| Methods |
Randomisation/allocation method unclear
Double‐blind (participant and assessor), cross‐over trial
60 women randomised and analysed
Method of assessing adverse effects: unclear ‐ authors state only "women complained of..." |
| Participants |
Inclusion: primary dysmenorrhoea
Exclusion: menstrual irregularities; history peptic ulcer, renal or blood disorders; pregnant; use of other medicines for condition
Age: 17 to 33, mean 18.4
Parity: 46 nulliparous (8 with previous pregnancy), 14 parous
Source: volunteer student nurses/midwives and women from local gynaecological clinic
Location: Nigeria |
| Interventions |
Piroxicam (20 mg), placebo
2 tablets per day for 2 days, then 1 tablet per day until symptoms or menses subsided
Duration: 4 cycles per participant, 240 cycles in total |
| Outcomes |
Pain ‐ abdominal cramps yes/no
Pain scale (very severe, severe, moderate, slight)
Adverse effects |
| Notes |
No mention of baseline or cross‐over analysis |
| 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) |
High risk |
Adverse effects data collected prospectively but not reported in detail |
| Complete follow‐up? |
Low risk |
60/60 analysed |
| Potential bias related to study funding |
Unclear risk |
Pharma |
