| Methods |
Random allocation, pharmacy‐coded drugs
Cross‐over, double‐blind trial
40 women randomised and analysed
Method of assessing adverse effects: reported daily on a questionnaire at trial office (which they visited daily) |
| Participants |
Inclusion: primary dysmenorrhoea; diagnosed by results of questionnaire for self assessment, physical and gynaecological exams; regular cycles 24 to 31 days
Exclusion: clinical pathology of genital tract; lactating or contemplating pregnancy; allergies to NSAIDs; use of OCP or other long‐term drug therapy
Age: 18 to 40, mean 24
Source: volunteers
Location: Iraq |
| Interventions |
Indomethacin suppositories (100 mg, 1 to 3 times daily, at onset of symptoms, max. 5 days)
Placebo suppositories
Duration: 2 cycles per treatment/4 cycles in total
No additional medication allowed during study |
| Outcomes |
Pain relief 0 to 18 scale
Dysmenorrhoeic symptoms
Side effects ‐ only counted if not experienced in previous menses |
| Notes |
Women visited clinic every day to ensure compliance
Baseline assessment performed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not described |
| Allocation concealment (selection bias) |
Low risk |
Adequate, "coded by pharmacy" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinded, codes broken at end of study. "All the patients were provided with identical suppositories" |
| Selective reporting (reporting bias) |
Low risk |
Adverse effects quantified |
| Complete follow‐up? |
Low risk |
All women completed the study |
| Potential bias related to study funding |
Unclear risk |
Not stated |
