Objectives: GuiZhi-ShaoYao-ZhiMu decoction (GSZD), a traditional Chinese herbal medication for the management of rheumatoid arthritis (RA), has a long history of use and modern scientific research support for efficacy, but the studies have not been systematically evaluated. Therefore, this study systematically reviewed the efficacy of GSZD using the available human clinical trials and conducted a meta-analysis. Methods: The available databases were searched using proper languages of English, Korean, and Chinese. The key erms used for searching were GSZD, Cassia Twig, Guizhi, Paeonia lactiflora, Shaoyao, Anemarrhena Rhizome, Zhimu, rheumatoid arthritis, randomized, controlled trial, and clinical trial. Randomized clinical trials (RCTs) using GSZD were included in the review and meta-analysis. According to heterogeneity, odds ratio and confidence intervals in the pooled RCTs were assessed by a fixed or random model in meta-analysis. Risk of bias was evaluated for all included studies. Results: Thirteen RCTs met the inclusion criteria and were included in the meta-analysis. All studies evaluated the efficacy of GSZD for treating RA, but the herbal formulations varied since some studies added herbs to the basic GSZD formulation. However, all formulations contained the essential herbs: Guizhi, Shaoyao, and Zhimu. Each RCT included an experimental group (GSZD with or without Western-style medicine) and a control group (either standard Western-style medicines or placebo). When compared to placebo, the GSZD treatment was found to be three to six times more effective than standard Western drugs for some symptoms. Furthermore, only two studies reported any adverse events associated with the GSZD group, whereas several reported serious adverse events in the control groups. Conclusions: The Traditional Chinese Medicine, GSZD, may have equal or superior effectiveness and safety for treating RA compared to Western RA drugs. It should be considered a viable alternative to Western medicine. However, more long-term research is needed in larger patient groups to better establish its safety and efficacy.
