ABSTRACT
Objective: To assess the efficacy and safety of aceclofenac in the treatment of osteoarthritis. Study design: Randomized double blind Phase IV trial. Place and Duration of study: This study was conducted in the department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital, Lahore. The duration was eight weeks
Methodology: A total of 90 subjects, fulfilling the inclusion criteria and willing to give free informed consent were enrolled in this trial. All these subjects were randomized into two treatment groups [A and B]. Subjects either received Aceclofenac 100 mg twice daily or Diclofenac 75 mg twice daily for 08 weeks. During the screening visit, information on their demographic characteristics, medical history and previous and current medications were collected. A thorough physical examination and necessary laboratory investigations were carried out before drug administration and after the completion of treatment [end of week 8]. Clinical examination was done at baseline visit, randomization and 2, 4 and 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 pain was 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 using SPSS
Results: 70 subjects completed the study while 20 were lost in follow-up. There were 28 males and 34 females in the study with mean age of 56 years. There was a significant decrease in WOMAC and VAS scores in both groups. In group A [Diclofenac group] VAS decreased from 7.107 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 from 37.29 to 21.50 [p=0.000] showing the efficacy of both drugs. There was also significant decrease in 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 adults as compared to Diclofenac