Background: With the development of Traditional Chinese Medicine (TCM), comprehensive traditional Chinese therapy is often used to treat Granulomatous Lobular Mastitis (GLM), but the effectiveness and risk are still controversial. This study is aimed to evaluate the efficacy of comprehensive therapy of traditional Chinese medicine on GLM.Methods: Articles in both international databases (PubMed, EMBASE, Cochrane Library, Web of Science and Clinicaltrials.gov) and Chinese databases (Chinese National Knowledge Internet (CNKI), Chinese Biomedical Databases (CBM), VIP Chinese periodical service platform and Wan Fang Digital Journals)) were searched. Original studies which reported the effective rate and/or recurrence rate and/or maximum diameter of the mass of comprehensive traditional Chinese therapy were included. The 95% confidence interval (95% CI) for effective rate, recurrence rate and maximum diameter of the mass were calculated and analyzed by review manager 5.3.Results: Eight eligible trials with 309 cases and 265 controls were included, six in Chinese and two in English. Statistical analysis suggested a statistical difference in effective rate (RR = 0.86, 95% CI [0.74, 1.00], P = 0.047) between comprehensive traditional Chinese therapy group and control. Meanwhile, there was statistical difference found in recurrence rate between comprehensive traditional Chinese therapy and western medicine therapy (RR = 3.09, 95% CI [1.50, 6.40], P = 0.002). Besides, no statistical difference existed in maximum diameter of the mass between the two therapies (RR = -5.25, 95% CI [-125.42, 114.93], P = 0.93).Conclusion: Although there was no significant difference in the reduction of breast mass size between comprehensive traditional Chinese therapy and western medicine alone, comprehensive traditional Chinese therapy demonstrated the efficacy in improving the effective rate and reducing the recurrence rate. For GLM patients, comprehensive traditional Chinese therapy could be a potential option.
Objective: to systematically evaluate the clinical efficacy of external treatment of granulomatous mastitis (including clinical efficiency and the change of mass size). Methods: the computer was used to search CNKI, Wanfang database, VIP net, CBM, PubMed and Embase, and it was used to search and select the clinical randomized controlled trials of treating granulomatous mastitis by external treatment of traditional Chinese medicine, the retrieval time limit was from the establishment of the database to December 2020, and the key words were granulomatous mastitis, external treatment of traditional Chinese medicine. After selecting literatures, extracting datas and evaluating the risk of bias included in the study, the data included in the study were analyzed by RevMan5.3 software. Results: Seven clinical randomized controlled trials were included and 600 patients met the inclusion criteria. Seven of the trials were effective observations, and four of them were tumor size observations. There were 310 cases in the experimental group and 290 cases in the control group. All the included documents were Chinese literature. The results of the study showed that the effective rate of the experimental group (combined with the external treatment of traditional Chinese medicine) for granulomatous mastitis was 95.9%, which was significantly higher than that of the control group (without the external treatment of traditional Chinese medicine). The effective rate was 82.8% [95% CI (1.02, 1.22), Z=2.41, P=0.02<0.05]. The experimental group (combined with the external treatment of traditional Chinese medicine) had a significantly higher degree of the tumor size recovery than the control group (without the external treatment of traditional Chinese medicine) [95% CI (-2.05, -1.83), Z=34.91, P<0.00001]. Conclusion: the external treatment of granulomatous mastitis had a good clinical effect. It not only improved the clinical efficiency, but also effectively reduced the size of breast mass, which was worthy of clinical promotion. However, due to the low quality of clinical trials, further verification was needed.
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