Randomized double blind comparative study on efficacy and safety of oral oxaceprol 200 mg versus oral diclofenac 50 mg in patients with moderate osteoarthritis

P. G. M. Adamrafi, Usha Kiran Prayaga, B. S. S. Venkateswarlu


Background: Osteoarthritis of knee is the most common form of arthritis globally, approximately 250 million people are suffering from osteoarthritis of the knee alone throughout the world. It is a chronic joint disease leading to cause cartilage degradation that involves synovial Inflammation, Subchondral bone remodelling, and Formation of osteophyte pathologically, which leads to cause pain, joint destruction and difficulty in walking. Aim of the current study was to compare the safety and efficacy of oxaceprol 200 mg versus diclofenac 50 mg in patients with moderate osteoarthritis and to determine cost-effectiveness between these two drugs

Methods: this is a randomized controlled study, in our study total of 94 patients were screened, of which 85 patients met inclusion & exclusion criteria. In this, 78 members gave written informed consent, they were randomly assigned by double-blind fashion into two treatment groups (oxaceprol and diclofenac). Results were analyzed by applying paired and unpaired student t-test by using SPSS software

Results: In our study, both oxaceprol and diclofenac were extremely significant in reducing joint pain and joint stiffness and improving physical activity, but when comparing with one another oxaceprol group showed better results in improving physical activity

Conclusions: From our study, it is concluded that oxaceprol is equally efficacious as diclofenac in reducing knee pain, joint stiffness but more efficacious than diclofenac in improving physical activity of patients by enhancing bone remodelling.


Oxaceprol, Diclofenac, Osteo Arthritis, Randomized controlled trial

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Vos T, Flaxman AD, Naghavi M. Years lived with disability (YLDs) for1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012; 380(9859):2163-96.

Sellam J, Berenbaum F. The role of synovitis in pathophysiology and clinical symptoms of osteoarthritis. Nat Rev Rheumatol. 2010;6:625-35.

Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012;64:1697-707.

Kapoor M, Martel-Pelletier J, Lajeunesse D, Pelletier JP, Fahmi H. Role of proinflammatory cytokines in the pathophysiology of osteoarthritis. Nat Rev Rheumatol. 2011;7:33-42.

Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis:an update with relevance for clinical practice. Lancet. 2011;377:2115-26.

Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of osteoarthritis in Asia. Int J Rheum Dis. 2011;14:113-21.

Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of Osteoarthritis in Asia. Int J Rheum Dis. 2011;14:113-21.

Sharma R. Epidemiology of musculoskeletal conditions in India. New Delhi. Int J Occup Environ Health. 2018;24(1-2):27-37.

Mukhopadhyay K, Ghosh P, Ghorai P, Hazra A, Das AK. Oxaceprol versus tramadol for knee osteoarthritis: A randomized controlled trial. Indian J Pharmacol. 2018;50(5):266-72.

Herrmann G, Steeger D, Klasser M, Wirbitzky J, F├╝rst M, Venbrocks R, Rohde H, Jungmichel D, Hildebrandt HD, Parnham MJ, Gimbel W, Dirschedl H. Oxaceprol is a well-tolerated therapy for osteoarthritis with efficacy equivalent to diclofenac. Clin Rheumatol. 2000;19(2):99-104.

Bauer HW, Klasser M, von Hanstein KL, Rolinger H, Schladitz G, Henke HD, Gimbel W, Steinbach K. Oxaceprol is as effective as diclofenac in the therapy of osteoarthritis of the knee and hip. Clin Rheumatol. 1999;18(1):4-9.

Joshi VL, Chopra A. Is there an urban-rural divide? Population surveys of rheumatic musculoskeletal disorders in the Pune region of India using the COPCORD Bhigwan model. J Rheumatol. 2009; 36(3):614-22.

Parnham MJ. Antirheumatic agents and leukocyte recruitment. New light on the mechanism of action of Oxaceprol. Biochem Pharmacol. 1999;58:209-15.

Veihelmann A, Hofbauer A, Refior HJ, Messmer K. Oxaceprol, an atypical inhibitor of Inflammation, reduces leukocyte adherence in mouse antigen-induced arthritis. Acta Orthop Scand. 2001;72:293-8.

Riera H, Barbara A, Aprile F, Maheu E, Mitrovic D. Effect of oxaceprol on the synthesis and degradation in vitro of proteoglycans and proteins by calf articular cartilage explants. Rev Rhum Mal Osteoartic. 1990; 57:579-83.

Kalbhen DA, Kalkert B. Autoradiography studies of the effect of Oxaceprol on the metabolism of joint cartilage in vitro and in vivo. Z Rheumatol. 1987; 46:136-42.