| Methods |
Randomisation/allocation method unclear. 12 women randomised and analysed
Double‐blind, cross‐over study |
| Participants |
Inclusion: primary dysmenorrhoea; medical and gynaecological exams to confirm lack of pathology
Exclusion: secondary dysmenorrhoea; pregnancy; gastric or duodenal ulcers, ulcerative colitis, liver or kidney disease, asthma, rhinitis or allergy to NSAIDs; OCP in month prior to study
Age: means 28 to 30, ranges 18 to 38
Source: outpatients
Location: Italy |
| Interventions |
Piroxicam beta‐cyclodextrin 20 mg versus placebo
Taken as sachets |
| Outcomes |
Pain intensity
Adverse effects
Use of additional medication |
| Notes |
Day 1 data in graphical form only. No numerical data reported for adverse effects in placebo group |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Unclear, not stated |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, placebo described but does not state that it was identical |
| Selective reporting (reporting bias) |
High risk |
Only GI adverse effects recorded as such (other adverse effects classified as dysmenorrhoea symptoms) |
| Complete follow‐up? |
Low risk |
No losses to follow‐up |
| Potential bias related to study funding |
Unclear risk |
Not stated |
