| Methods |
Randomisation/allocation method unclear
Cross‐over, double‐blind trial
44 women randomised and analysed
Method of assessing adverse effects: not stated |
| Participants |
Inclusion: primary dysmenorrhoea, medical and gynaecological exam
Exclusion: pelvic abnormality, history of dyspepsia or peptic ulceration, use of OCP
Age: 15 to 42, mean 22.6
Location: UK |
| Interventions |
Flufenamic acid (200 mg 3 times daily while dysmenorrhoea persisted, encouraged to start medication a few hours prior to menses)
Placebo
Duration: 3 cycles per treatment/6 in total |
| Outcomes |
Pain relief (4‐point scale)
Adverse effects |
| Notes |
First‐phase data shown on graph as mean pain relief |
| 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 |
Data on adverse effects not systematically collected and/or reported |
| Complete follow‐up? |
Low risk |
40/40 women analysed |
| Potential bias related to study funding |
Unclear risk |
Parke‐Davis supplied drug and placebo |
