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EXTENDED REPORT |
1 Cochin Hospital, AP-HP, René Descartes University, Paris, France
2 International Medical Organisation/Europe, Bristol-Myers Squibb-UPSA
3 Biostatistics and Data Management Unit, France, Bristol-Myers Squibb-UPSA
Correspondence to:
Correspondence to:
Professor M Dougados
Cochin Hospital, AP-HP, René Descartes University, Paris, France; maxime.dougados{at}cch.ap-hop-paris.fr
Background: Paracetamol is a recommended symptomatic treatment of osteoarthritis (OA), but in clinical trials sample sizes have been relatively small and variable daily doses of paracetamol have been used.
Objectives: To determine the therapeutic efficacy of paracetamol in OA of the knee and identify predictive factors of clinical response to treatment.
Methods: A double blind, parallel group, placebo controlled trial of analgesic efficacy and safety of paracetamol versus placebo including 779 patients with OA of the knee. Patients were randomly assigned to receive paracetamol 4 g/day (n = 405) or placebo (n = 374) for 6 weeks. Symptomatic OA of the knee was required at inclusion with global pain intensity of the knee during physical activities for the past 24 hours of 
30 mm on a 100 mm visual analogue scale. The primary end point was a 30% decrease of global pain intensity of the knee. Intention to treat analyses were performed.
Results: The percentage of responders did not differ significantly between groups: 52.6% and 51.9% in paracetamol and placebo groups, respectively (p = 0.840). In a subgroup of patients with chronic mechanical knee pain without signs of inflammation (n = 123), the mean change in pain intensity from baseline was 25.2 mm v 15.2 mm, in the paracetamol (n = 63) and placebo (n = 60) groups, respectively—mean difference 10.0 mm; 95% CI 1.0 to 19.0; p = 0.0294. No serious adverse events were attributable to treatment.
Conclusion: A statistically significant symptomatic effect of oral paracetamol 4 g/day over placebo was not found, suggesting that paracetamol use in symptomatic OA of the knee should be further explored. The tolerability and safety of paracetamol, at the recommended maximum dose of 4 g/day, was confirmed over 6 weeks.
Abbreviations: AEs, adverse events; ITT, intention to treat; NSAIDs, non-steroidal anti-inflammatory drugs; OA, osteoarthritis; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index
Keywords: osteoarthritis; knees; paracetamol; pain; WOMAC
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