AIM: The present study should elucidate the efficacy, patient acceptability, and side effect profiles of Oxaprozin and Diclofenac retard when given to patients with active primary osteoarthrosis. METHODS: 80 outpatients with active primary osteoarthrosis with a radiological grade of II or III in the hip or knee joint (mean duration 4 years) were distributed randomly and equally to each treatment group. Patients age ranged from 40-66 years (mean age 51 years). After a washout period, they received one of the preparations for 6 weeks. Efficiency assessments consisted of pain, disturbance of sleep, individual and general functional impairment scales, laboratory determinations, and patients global evaluation. For statistical analyses Mann-Whitney-U-, Wilcoxon-, and chi 2-tests were applied. RESULTS: 74 Patients completed the study successfully, whereas 3 patients of each group withdrew due to adverse events. Significant differences favoring Oxaprozin were found for the individual and functional impairment scale and the patients' global evaluation of treatment at the final visit (6 weeks). Improvement compared to baseline visit was significant for both treatment groups. CONCLUSIONS: The results suggest that Oxaprozin is more effective than Diclofenac retard, a recognized standard therapy, when given for 6 weeks to patients with active osteoarthrosis.
RCT Entities:
AIM: The present study should elucidate the efficacy, patient acceptability, and side effect profiles of Oxaprozin and Diclofenac retard when given to patients with active primary osteoarthrosis. METHODS: 80 outpatients with active primary osteoarthrosis with a radiological grade of II or III in the hip or knee joint (mean duration 4 years) were distributed randomly and equally to each treatment group. Patients age ranged from 40-66 years (mean age 51 years). After a washout period, they received one of the preparations for 6 weeks. Efficiency assessments consisted of pain, disturbance of sleep, individual and general functional impairment scales, laboratory determinations, and patients global evaluation. For statistical analyses Mann-Whitney-U-, Wilcoxon-, and chi 2-tests were applied. RESULTS: 74 Patients completed the study successfully, whereas 3 patients of each group withdrew due to adverse events. Significant differences favoring Oxaprozin were found for the individual and functional impairment scale and the patients' global evaluation of treatment at the final visit (6 weeks). Improvement compared to baseline visit was significant for both treatment groups. CONCLUSIONS: The results suggest that Oxaprozin is more effective than Diclofenac retard, a recognized standard therapy, when given for 6 weeks to patients with active osteoarthrosis.