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. 2014 Feb 10;2014(2):CD005117. doi: 10.1002/14651858.CD005117.pub3

Pham 2004.

Methods Randomised controlled trial
 Double‐blind
Three arms
Multi‐centre (46 centres)
Participants Outpatients with knee OA
 Country: France and UK
 N = 301
Mean age, years: 65
 Female 70%;
male 30%
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
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)
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