IMPROVEMENT IN PAIN RELIEF USING A DMSO BASED DICLOFENAC IN COMPARISON TO CONVENTIONAL DICLOFENAC GELS IN OSTEOARTHRITIS –A RANDOMIZED CONTROLLED TRIAL

Background: Topical NSAIDs are the first line choice of drug for management Osteoarthritis elderly patients, which produce less systemic exposure compared with oral NSAIDs. Now a day’s several topical formulations are available. This study provides a comparison between two various topical diclofenac formulations. Methods: 12 weeks, randomized controlled trial to evaluate dimethyl sulfoxide (DMSO) based diclofenac solution and Linseed oil based diclofenac gel safety and efficacy profile. 43 men and women, age 40-65 years, with radiologically confirmed primary OA of the knee were included in this study. The included participants treated with DMSO based diclofenac solution; 40 drops 3 times daily directly to the painful knee without a massage (test group) and Linseed oil based diclofenac gel; 1 gram 3 times daily to the painful knee(control group). The primary outcome measure included the continuous variable pain relief and improved physical function measured by the Western Ontario McMaster Universities (WOMAC) Likert 3.1OA Index. Secondary efficacy measure was reduced stiffness. Safety assessment included adverse events and application site reactions. Results: DMSO based diclofenac solution group had a significantly greater mean change in score (final minus baseline) compared to the linseed oil based diclofenac gel group for pain (-9.8 vs. -6.9, p=0.032), stiffness (-3.7 vs. -2.4, p=0.048) and function, daily living (-26.4 vs. -15.9, p=0,019). Overall, each drug’s application was well tolerated, and no adverse event was reported. Conclusion: This DMSO based diclofenac solution group showed statistically significant improvement in pain, stiffness and physical function compared to the conventional diclofenac gels.