Daniels 2008.
Methods | Allocation concealment unclear, computer‐generated randomisation sequences, double‐blind, cross‐over design 124/144 analysed |
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Participants | Included: women with primary dysmenorrhoea, healthy, non‐lactating, pregnancy test negative, using birth control Excluded: women with secondary dysmenorrhoea, hypersensitivity to NSAIDs, bowel disease or ulcers |
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Interventions | Naproxen 500 mg Placebo Medicate twice daily |
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Outcomes | Change in pain intensity (SPID score) Adverse effects |
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Notes | Study also included lumiracoxib (since withdrawn) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐blinded, placebo not described |
Selective reporting (reporting bias) | Unclear risk | "Adverse events were recorded throughout the study" |
Complete follow‐up? | High risk | 124/144 analysed (86%) |
Potential bias related to study funding | High risk | Novartis sponsored |