Efficacy and Safety of Traditional Transdermal Patch (Ya-Pok- Dud-Pid) in Primary Knee Osteoarthritis Patients: A Randomized Controlled Trial

Abstract

Background: Patients with Knee Osteoarthritis (KOA) have a progressive decline in their social and physical abilities, which affects their quality of life. The Thai Traditional Transdermal Patch (Ya-Pok-Dud- Pid; YP) has been widely used for the treatment of KOA. Objective: To determine the clinical efficacy and safety of YP in comparison with diclofenac gel (DG) for the treatment of KOA. Methods: 74 primary KOA Patients were enrolled and randomly assigned to YP groups or DG groups. The outcomes were assessed the Visual Analog Scale (VAS), Time Up and Go (TUG), Active Knee Flexion (AKF) and Passive Knee Flexion, chair sit and reach, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results: YP and DG significantly improved VAS, TUG, AKF, PKF, chair sit and reach, and WOMAC (p < 0.05). Remarkably, YP experienced the same immediate pain relief after day 1 treatment as DG. The VAS scores of the YP group exhibited a significant reduction from 60±11.06 to 38.92±17.76, while DG decreased VAS score from 61.24±17.84 to 39.19±20.05 (p <0.001). However, there was no significant difference between the two treatment groups. For adverse event, skin reaction (rash, itchy, and dry skin) was noted in the YP group because of the participant receiving YP for an extended period. Altogether, YP has a similar effect to diclofenac gel on pain severity and physical function in patients with knee osteoarthritis. Conclusion: YP is recommended as a natural therapeutic agent with efficacy and safety treatment for knee osteoarthritis. Keywords: Traditional, Transdermal Patch, Diclofenac, Osteoarthritis of knee