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. 2023 Aug 28:14:1176980.
doi: 10.3389/fphar.2023.1176980. eCollection 2023.

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

Qian-Yun Ye  1   2 , Qing Lin  1 , Xue-Ling Hu  3 , Yu-Mei Yang  3 , Bao-Lin Zheng  4 , Ting Li  4 , Wen-Qiang Zhong  3 , Hao-Yu Wang  1 , Zhi-Fen Zhang  3 , Bing-Jie Luo  3 , Ya-Wen Xiao  1 , Ai-Ling Wu  1 , Yan Li  1 , Zhuo-Ling Zou  1 , Ling-Yu Li  3   5   6 , Xiao-Yun Li  3 , Pan-Pan Wang  2   5   6 , Li Yang  3 , Xiao-Feng Zhu  1   5 , Li Han  2 , Rong-Hua Zhang  3   5   6
Affiliations

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

Qian-Yun Ye et al. Front Pharmacol. .

Abstract

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).

Keywords: combined Chinese and Western medicine; efficacy; knee osteoarthritis; prospective cohort; real-world study.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flow chart of the study.
FIGURE 2
FIGURE 2
Overall trend of the WOMAC total scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 3
FIGURE 3
Overall trend of the WOMAC pain scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 4
FIGURE 4
Overall trend of the WOMAC stiffness scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 5
FIGURE 5
Overall trend of the WOMAC physical function scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 6
FIGURE 6
Overall trend of the VAS scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 7
FIGURE 7
Overall trend of the PCS scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 8
FIGURE 8
Overall trend of the MCS scores. Note: The values shown are least-squares mean calculated based on generalized linear mixed model, with 95% confidence intervals (indicated by error bars) in parentheses.
FIGURE 9
FIGURE 9
Forest plot for subgroup analysis. Note: The forest plot shows the differences in the changes in WOMAC total score between the two groups compared with baseline after 6 weeks of treatment stratifying by different subgroups. The difference between groups is calculated based on the least squares mean using GLMM, with a 95% confidence interval in parentheses. p values were Bonferroni corrected at a significance level of 0.05.
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