Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
83 women randomised, 69 analysed
Method of assessing adverse effects: self reported prospectively on questionnaire |
Participants |
Inclusion: clinical diagnosis of primary dysmenorrhoea for at least 6 months; gynaecological exam to exclude clinical pathology; over the age of 15
Exclusion: potential pregnancy; IUD or OCP use; contraindications to NSAIDs
Source: outpatients
Location: Sweden |
Interventions |
Naproxen sodium 1000 mg per day
Piroxicam 40 mg per day for day 1 and 2, then 20 mg for days 3 and 4 |
Outcomes |
Pain intensity
Additional treatment
Ability to work
Overall effect
Adverse effects |
Notes |
— |
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 |
Unclear risk |
Double‐blinded, drugs not described |
Selective reporting (reporting bias) |
Unclear risk |
Unclear whether adverse effects prospectively solicited |
Complete follow‐up? |
High risk |
69/83 analysed (83%) |
Potential bias related to study funding |
Unclear risk |
Pfizer |