| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
25 women randomised, 23 analysed (1 dropped out for personal reasons, 1 due to pulmonary disease, and 1 had a history of gastric upset and was only included in some analyses)
Method of assessing adverse effects: recorded at follow‐up visit if volunteered by participant |
| Participants |
Inclusion: regular severe dysmenorrhoea; regular cycles; general physical and gynaecological exams to show no organic cause of dysmenorrhoea; negative pregnancy test
Exclusion: organic disease; IUD use; irregular cycles; history of peptic ulcer or dyspepsia following NSAID use
Location: UK |
| Interventions |
Piroxicam (20 mg)
Placebo
Administered as 2 x 10 mg tablets taken each morning at start of dysmenorrhoea until the end of menstruation
Duration: 4 cycles, 1 per treatment |
| Outcomes |
Pain relief
Overall relief
Adverse effects
Paracetamol consumption |
| Notes |
Data in graphical form |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, placebo not described |
| Selective reporting (reporting bias) |
Low risk |
Data on adverse events prospectively solicited |
| Complete follow‐up? |
High risk |
22/25 analysed (88%) |
| Potential bias related to study funding |
Unclear risk |
Pfizer sponsorship |
