| Summary: | Introduction: This study aimed to evaluate the clinical effectiveness and safety of tonifying kidney, lung, and spleen (TKLS) combined with Western medicine for stable chronic obstructive pulmonary disease (COPD). Materials and Methods: Randomized controlled trials (RCTs) of TKLS for stable COPD were searched from four databases including PubMed, the Cochrane Library, China Biology Medicine, and China National Knowledge Infrastructure from inception to December 2017. Two reviewers independently screened the literature, extracted the data, and assessed the risk of bias in the included studies. RevMan5.3 software was used for meta-analysis. Results: Fourteen RCTs involving 1339 patients with stable COPD were included. Five of the included articles described the specific method of randomization, 1 of them was double-blind method research, and 1 of them was single-blind method research. Compared with the conventional Western medicine (CWM) group, the use of TKLS, if combined with CWM demonstrated significantly improved effective rate (relative risk = 1.25, 95% confidence interval [CI]: 1.18–1.33, P < 0.00001), decreased traditional Chinese medicine syndrome score (mean difference [MD] −5.72, 95% CI: −8.31 to −3.14, P < 0.0001), Decreased St George's Respiratory Questionnaire total score (MD −7.39, 95% CI: −10.46 to −4.31, P < 0.00001), increased 6-min walk distance in meters (MD 78.46, 95% CI: 60.18–96.73, P < 0.00001), increased forced expiratory volume 1% (MD 6.49, 95% CI: 3.64–9.33, P < 0.00001), increased CD4 (MD 9.84, 95% CI: 6.73–12.94, P < 0.00001), CD8 (MD −1.84, 95% CI: −3.62 to −0.06, P = 0.04) and CD4/CD8 (MD 0.26, 95% CI: 0.20–0.32, P < 0.0001), and increased immunoglobulin M (MD 0.15, 95% CI: 0.10–0.20 P < 0.00001).. Conclusions: For stable COPD, TKLS combined with CWM is superior to CWM alone with regard to clinical effectiveness, symptoms, and quality of life. The above conclusion needs to be validated by further well-designed, multicentric, large-scale, double-blinded RCTs.
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