The efficacy of topical sesame oil in patients with knee osteoarthritis: A randomized double-blinded active-controlled non-inferiority clinical trial

Objective: Sesame oil is an herbal product that has been used to treat the joints pain in several traditional medicines. In this study, we evaluated the efficacy of topical sesame oil versus diclofenac gel in patients with knee osteoarthritis (OA). Methods: One hundred and four patients were randomly enrolled in two arms of the trial, Patients were treated by topical sesame oil or diclofenac (three times a day) for 4 weeks. Outcome measures were knee pain via visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, knee joint's flexion angle, 8-meter walk test and number of used analgesics. Patients were evaluated at baseline, 2 and then 4 weeks after the intervention. Results: At the follow-up visits, sesame oil was not inferior to diclofenac regarding scores of WOMAC pain, 8-meter walk test, and knee flexion angle. Although, its non-inferiority was not proved regarding scores of VAS, WOMAC stiffness, and WOMAC total at the 4th week. Moreover, sesame oil was not inferior to diclofenac regarding consumed analgesics. Conclusion: It seems that the topical sesame oil was non-inferior to diclofenac gel on the reduction of the knee OA pain and improvement of some indicators of its function.