Abstract
Objective: This double-blind randomised study was designed to compare paracetamol 500mg/codeine 30mg (PC) [3 times daily] plus diclofenac 50mg once a day with diclofenac 50mg twice a day (DI) over 7 days in two parallel groups of 30 patients with residual persisting pain despite adjusted basic therapy for rheumatoid arthritis (RA).
Patients and Methods: Ten men and 50 women (aged 21 to 73 years, mean 57 years) with RA were included. The two groups were comparable before treatment. Efficacy was assessed by the patient every evening by: (a) pain scores rated on a 100mm visual analogue scale [VAS]; (b) discomfort scores defining the activity level reduction [none, mild, moderate, severe]; (c) duration of morning stiffness; and (d) number of awakenings caused by the pain during the previous night. At the end of the study overall efficacy was assessed by the patient on a 5-point verbal scale and by the desire to continue the treatment (yes, no). Pain scores on VAS and on a 5-point verbal scale and Ritchie Index were assessed before [day 0 (D0)] and after (D7) treatment. Any adverse effects were recorded continuously during the study and overall tolerability was assessed at the end of the study.
Results: Analgesic efficacy was not significantly different between the two groups on all criteria: global efficacy (good or very good: PC = 47%, DI = 44%), desire to continue the treatment (PC = 57%, DI = 47%), evolution of daily VAS pain score, difference from D0 to D7 on VAS (PC = −31.5mm, DI = −23.4mm) and the Ritchie index (PC = −2.2, DI = −2.2), duration of morning stiffness, number of awakenings. The number of patients presenting adverse effects (PC = 8, DI = 9), the number of withdrawals as a result of adverse effects causing cessation of treatment (PC = 3, DI = 1), and the overall tolerability assessment were not significantly different (good or very good: PC = 82%, DI = 87%).
Conclusion: In RA, an inflammatory disease, the analgesic combination of paracetamol 500mg and codeine 30mg allowed a decrease in the NSAID dose for comparable relief of a residual persisting pain.
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Glowinski, J., Boccard, E. Placebo-Controlled Study of the Analgesic Efficacy of a Paracetamol 500mg /Codeine 30mg Combination Together with Low-Dose vs High-Dose Diclofenac in Rheumatoid Arthritis. Clin. Drug Investig. 18, 189–197 (1999). https://doi.org/10.2165/00044011-199918030-00003
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DOI: https://doi.org/10.2165/00044011-199918030-00003