Pham 2004.
Methods | Randomised controlled trial
Double‐blind Three arms Multi‐centre (46 centres) |
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Participants | Outpatients with knee OA
Country: France and UK
N = 301 Mean age, years: 65 Female 70%; male 30% |
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Interventions | Diacerein 50 mg BID + 3 × 3 intra‐articular injections of saline solution versus 3 × 3 HA intra‐articular injections (NRD101) and placebo capsules versus 3 × 3 intra‐articular injections of saline solution and daily placebo capsules Duration: one year |
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Outcomes | Pain (0 to 100‐mm VAS)
Lequesne Impairment Index
Participants' global assessment (0 to 100 VAS)
Percentage of painful days (0 to 100 VAS)
Assessment of treatment efficacy by participant and investigator (0 to 5 scale) at the end of the study Radiography after one year (JWS measurement) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomised allocation schedule was centralised (Cassene Laboratories) |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinding of participants and personnel |
Blinding of outcome assessment (detection bias) Clinical outcomes | Unclear risk | No reference about assessors' blinding to evaluate clinical outcomes |
Blinding of outcome assessment (detection bias) Radiographic outcomes | Low risk | Two observers who were unaware of participants' identity, study group, signal knee and sequence of radiographs |
Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analysis was done for efficacy outcomes. Structural evaluation was analysed only in participants with X‐rays in the baseline table. Nine participants were excluded from the analysis |
Selective reporting (reporting bias) | Low risk | All data were properly reported |