Louthrenoo 2007.
Methods | Randomised controlled trial Multi‐centre (five medical schools in Thailand) Double‐blind Piroxicam‐controlled Parallel‐group |
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Participants | Participants with tibiofemoral X‐ray confirmed Kellgren‐Lawrence grade II or III OA according to ACR criteria between 40 and 65 years of age, with knee pain of at least 40 mm on at least two items of the WOMAC A, on a 0 to 100‐mm VAS scale, for at least 15 days | |
Interventions | Diacerein 100 mg/ d (N = 86) versus piroxicam 20 mg/d (N = 85). 16 weeks | |
Outcomes | WOMAC A, B, C SF‐36 Paracetamol consumption |
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Notes | Supported by a grant from TRB Chemedica International | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Each participant was randomly assigned to a treatment group using a randomisation table generated by a validated computer software |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) Clinical outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) Radiographic outcomes | Low risk | Not applicable |
Incomplete outcome data (attrition bias) All outcomes | High risk | A good description of withdrawals and the reasons for them were provided. 171 were randomly assigned (diacerein 86 and control 85); however, ITT analysis was performed in only 161 (82 diacerein, 79 control). 10 participants (four diacerein, six control) were excluded from ITT because they did not take any dose of medication. 150 participants completed the study |
Selective reporting (reporting bias) | Low risk | All data were properly reported |