Melatonin Versus Duloxetine for Managing Symptoms of Osteoarthritis: A Randomized Controlled Trial Study

Background: Osteoarthritis (OA) is a degenerative joint disorder causing pain and disability. The present treatments are inadequate to improve the underlying pathogenesis of OA. Melatonin, because of its chondroprotective, anti-inflammatory, and antioxidant properties, may have a role in the management of OA. Duloxetine is presumed to modulate pain through serotonergic and noradrenergic pathways. In the present study, as a first study, melatonin has been compared with duloxetine for its efficacy in reducing OA-related knee pain. Methods: This randomized controlled trial (RCT) study involved 60 knee OA patients treated at Imam Hossein Hospital in Tehran, Iran. Participants were randomly assigned to receive either melatonin, 3-10 mg per day, or duloxetine, 60-120 mg per day. The primary outcome measure was the 3-month change in the Western Ontario and McMaster universities OA index (WOMAC) score. Results: Compared to the duloxetine group, a reduction in the total WOMAC score was noted in the melatonin group (P=0.001 and P=0.09, respectively). Changes in WOMAC pain score were significant in both groups (P=0.0001). Additionally, the need for naproxen for breakthrough pain was significantly lower in the melatonin group (318.33±16 mg vs 810±35 mg with a P 0.001). Conclusion: Melatonin is more potent than duloxetine in pain reduction and functional improvement in patients with knee OA. Considering the ability of melatonin to reduce the usage of nonsteroidal anti-inflammatory drugs, melatonin may be a safer agent for managing pain in OA.