de Mello 2004.
Methods | Allocation concealment: unclear Method of randomisation: unclear Double‐blinded parallel design 337 patients randomised and 337 analysed |
|
Participants | Included: women with primary dysmenorrhoea for previous 3 cycles, aged 18 to 10 Excluded: use of oral contraceptives or intrauterine contraception within previous 3 months, secondary dysmenorrhoea, concomitant use of analgesics, other medical conditions (listed in study) Age: mean 28 (range 17 to 40) years Location: Mexico and Brazil |
|
Interventions | Meloxicam 7.5 or 15 mg Mefenamic acid 500 mg Medicate 3 times daily over 3 to 5 days 3 cycles |
|
Outcomes | Ratings for pain and tolerability | |
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 | Low risk | Double‐blinded, "matching" placebo |
Selective reporting (reporting bias) | High risk | Adverse effects data not solicited prospectively, "no primary endpoints with regard to safety were defined" |
Complete follow‐up? | Low risk | 337/337 in safety analyses |
Potential bias related to study funding | Unclear risk | Boehringer‐Ingelheim sponsored and conducted |