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Efficacy and safety of combined Chinese and Western medicine in the treatment of knee osteoarthritis: a prospective, multicenter cohort study

Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Ye, Qian-Yun;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Lin, Qing;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Hu, Xue-Ling;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Yang, Yu-Mei;
Affiliation
Department of Nephropathy and Rheumatology ,Foshan Hospital of TCM ,Foshan ,China
Zheng, Bao-Lin;
Affiliation
Department of Nephropathy and Rheumatology ,Foshan Hospital of TCM ,Foshan ,China
Li, Ting;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Zhong, Wen-Qiang;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Wang, Hao-Yu;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Zhang, Zhi-Fen;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Luo, Bing-Jie;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Xiao, Ya-Wen;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Wu, Ai-Ling;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Li, Yan;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Zou, Zhuo-Ling;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Li, Ling-Yu;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Li, Xiao-Yun;
Affiliation
First Affiliated Hospital of Jinan University ,Guangzhou ,China
Wang, Pan-Pan;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Yang, Li;
Affiliation
College of Traditional Chinese Medicine ,Jinan University ,Guangzhou ,China
Zhu, Xiao-Feng;
Affiliation
First Affiliated Hospital of Jinan University ,Guangzhou ,China
Han, Li;
Affiliation
College of Pharmacy ,Jinan University ,Guangzhou ,China
Zhang, Rong-Hua

Purpose: To conduct a real-world evaluation of the efficacy and safety of combined Chinese and Western medicine in treating knee osteoarthritis (KOA). Methods: A multicenter, prospective cohort study design was employed, enrolling 450 KOA patients (Kellgren-Lawrence score of 3 or less). The patients were divided into a Western medicine treatment group (WM group) and a combined Western and traditional Chinese medicine treatment group (WM-CM group). A 6-week treatment plan was administered, and follow-up visits occurred at 2 weeks, 4 weeks, and 6 weeks after initiating treatment. The primary outcome indicator was the total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score after 6 weeks of treatment. Secondary outcome indicators included WOMAC subscales for pain, stiffness, and joint function, visual analogue scale (VAS) score, physical component summary (PCS), mental component summary (MCS), and clinical effectiveness. The incidence of drug-related adverse events was used as a safety evaluation indicator. Results: A total of 419 patients were included in the final analysis: 98 in the WM group and 321 in the WM-CM group. The baseline characteristics of the two groups were comparable, except for the incidence of stiffness symptoms and stiffness scores. After 6 weeks of treatment, the WM-CM group exhibited superior results to the WM group in improving the total WOMAC score (24.71 ± 1.38 vs. 16.36 ± 0.62, p < 0.001). The WM-CM group also outperformed the WM group in WOMAC pain and joint function scores, VAS score, PCS score, MCS score, and clinical effectiveness ( p < 0.05), which was consistent with the findings of the main evaluation index. Subgroup analysis indicated that the combined Chinese and Western medicine treatment showed more pronounced benefits in patients under 65 years of age and in those with a Kellgren-Lawrence (K-L) classification of 0-I. Throughout the study, no adverse effects were observed in either group. Conclusion: The combination of Chinese and Western medicine demonstrated superiority over Western medicine alone in relieving knee pain symptoms, improving knee function, and enhancing the quality of life for KOA patients with a K-L score of 3 or less. Moreover, the treatment exhibited a good safety profile. Clinical Trial Registration: ( https://www.chictr.org.cn/ ), identifier (ChiCTR1900027175).

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License Holder: Copyright © 2023 Ye, Lin, Hu, Yang, Zheng, Li, Zhong, Wang, Zhang, Luo, Xiao, Wu, Li, Zou, Li, Li, Wang, Yang, Zhu, Han and Zhang.

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