Objective: To conduct a meta-analysis to systematically evaluate the clinical efficacy of Taohong Siwu Decoction in treating knee osteoarthritis (KOA) and to provide data for the clinical application of Taohong Siwu Decoction in the treatment of KOA. Methods: The five major databases of HowNet (CKNI), Wanfang, VIP, PubMed, and Chinese Biomedical Database (CBM) were used to search for relevant papers, the search time was from the establishment of the database to April 15, 2023. The relevant data were extracted from randomized controlled trials (RCT) of the treatment of KOA with modified Taohong Siwu Decoction that met the inclusion and exclusion criteria. The risk of bias was assessed using the Cochrane tool, and the data were imported into RevMan5.3 software for statistical analysis. Results: The search included 11 RCT literature involving 951 cases. Among them, there were 487 cases in the observation group (modified Taohong Siwu Decoction or modified Taohong Siwu Decoction + control group) and 464 cases in the control group (traditional Chinese medicine or conventional Western medicine). According to meta-analysis: (1) The effective rates of modified Taohong Siwu Decoction (P = 0.03) and modified Taohong Siwu Decoction + control group (P < 0.0001) in the treatment of KOA were significantly higher than that of the control group. (2) The VAS score of the observation group was significantly lower than the control group (P < 0.00001). (3) The Lysholm knee function score of the observation group was significantly higher than the control group (P < 0.00001). Conclusion: Compared with conventional Western medicine or simple traditional Chinese medicine, modified Taohong Siwu Decoction or its combination with conventional Western medicine or traditional Chinese medicine in treating KOA can improve the treatment effective rate and Lysholm knee function score, and reduce VAS score.
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