Comparative Efficacy and Safety of Benjakul vs. Naproxen in Primary Knee Osteoarthritis: A Multicenter RCT
Chitrada Kongkham¹, Piya Pinsornsak², Arunporn Itharat³,⁴, Puritat Kanokkangsadal³,⁴, Nichamon Mukkasombut³,⁴, Sunita Makchuchit⁴, Pranporn Kuropakornpong⁴, Neal M Davies⁵
Affiliation : ¹ PhD Student in Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand; ² Department of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand; ³ Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand; ⁴ Center of Excellence on Applied Thai Traditional Medicine Research (CEATMR), Faculty of Medicine, Thammasat University, Pathum Thani, Thailand; ⁵ Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB T6G 2P5, Canada
Objective: To compare the efficacy and safety of Benjakul (BJK) and Naproxen (NPX) for treating primary knee osteoarthritis (KOA) in a multicenter randomized trial.
Materials and Methods: Three hundred fifty participants were randomly assigned to receive either BJK or NPX for four weeks. The primary endpoint was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Similarly, secondary endpoints including the 40-meter fast-paced walk test (40mFPWT), Timed Up and Go test (TUG), WOMAC, Knee Injury and Osteoarthritis Outcome Score (KOOS), and the 12-item Short Form Survey (SF-12V2). Statistical analysis revealed comparable improvements across all measures (p≤0.05), confirming treatment equivalence. Safety evaluations were performed through laboratory tests.
Results: BJK showed notable improvements in pain reduction and functional outcomes compared to NPX, with significant improvements in VAS, TUG, total WOMAC score, and individual categories of the KOOS score at 14 and 28 days. The adverse event rate was dry lips and throat in 8.2% in the BJK group and 6.5% in the NPX group with abdominal discomfort, and constipation being the most common side effect.
Conclusion: BJK demonstrates comparable efficacy and safety to NPX in treating KOA, with no significant safety concerns identified in the clinical trial. This suggests that BJK can be recommended as a natural anti-inflammatory drug for patients suffering from knee osteoarthritis.
Received 12 November 2024 | Revised 25 January 2025 | Accepted 7 February 2025
DOI: 10.35755/jmedassocthai.2025.3.223-231-02178
Keywords : Thai Traditional Remedy; Knee Osteoarthritis; Clinical Efficacy and Safety; Randomized Controlled trial; Adverse events
