OSTEOARTHRITIS;
Objective: To assess the efficacy and safety of aceclofenac in the treatment ofosteoarthritis. Study design: Randomized double blind Phase IV trial. Place and Duration ofstudy: This study was conducted in the department of Orthopaedics & Spine Surgery, GhurkiTrust Teaching Hospital, Lahore. The duration was eight weeks. Methodology: A total of 90subjects, fulfilling the inclusion criteria and willing to give free informed consent were enrolled inthis trial. All these subjects were randomized into two treatment groups (A & B). Subjects eitherreceived Aceclofenac 100 mg twice daily or Diclofenac 75 mg twice daily for 08 weeks. During thescreening visit, information on their demographic characteristics, medical history and previousand current medications were collected. A thorough physical examination and necessarylaboratory investigations were carried out before drug administration and after the completion oftreatment (end of week 8). Clinical examination was done at baseline visit, randomization and 2, 4and 8 weeks. Gastrointestinal (GI) safety was assessed using adverse drug reaction (ADR)reports. WOMAC questionnaire was used to see improvement in activities of daily living and painwas assessed using visual analogue scale (VAS). All data was collected in the case report form(CRF). Statistical evaluation was performed at the end of the trial and results were analyzed usingSPSS. Results: 70 subjects completed the study while 20 were lost in follow-up. There were 28males and 34 females in the study with mean age of 56 years. There was a significant decrease inWOMAC and VAS scores in both groups. In group A (Diclofenac group) VAS decreased from7.107 to 2.538 (p= 0.000) and WOMAC decreased from 32.75 to 7.38 (p=0.000). In group B(Aceclofenac group), VAS decreased from 7.912 to 6.0 (p=0.001) while WOMAC decreased from37.29 to 21.50 (p=0.000) showing the efficacy of both drugs. There was also significant decreasein the disease severity in both groups at the end of treatment. But the safety profile of (Diclofenac)group A was not significant (p=0.767) as compared to (Aceclofenac) group B (p=0.022).Conclusions: Aceclofenac is efficacious and safe drug for the treatment of osteoarthritis in adultsas compared to Diclofenac.