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Objective   This study aimed to appraise the efficacy and safety of the tonifying-Shen (kidney) principle (TS (TK) principle) for primary osteoporosis (POP).Methods   Randomized controlled clinical trials (RCTs) using the TS (TK) principle for POP were searched from eight electronic databases to search for relevant literature that was published from the initiation to September 2019. Two reviewers performed study selection, data extraction, data synthesis, and quality assessment independently. Review Manager 5.3 software was used to assess the risk of bias and conduct the data synthesis. We assessed the quality of evidence for outcomes by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.Results   Thirty-six studies with 3617 participants were included. Meta-analysis showed a consistently superior effect of the TS (TK) principle combined with conventional Western medicine (CWM) in terms of total effectiveness rates (RR = 1.28; 95% CI (1.23, 1.33);  P  < 0.00001), BMD of the lumbar spine (SMD = 0.71; 95% CI (0.47, 0.95);  P  < 0.00001) and proximal femur (SMD = 0.94; 95% CI (0.49, 1.38);  P  < 0.00001), TCM symptom integral (SMD = −1.23; 95% CI (−1.43, −1.02);  P  < 0.00001), and VAS scores (SMD = −3.88; 95% CI (−5.29, −2.46);  P  < 0.00001), when compared to using CWM alone and with significant differences. Besides, in respect of adverse effects, it showed no significant statistical difference between the experimental and control groups, RR = 0.99 and 95% CI (0.65, 1.51),  P =0.97.Conclusion   Our meta-analysis provides promising evidence to suggest that using the TS (TK) principle combined with CWM for POP is more effective than using CWM alone. Also, both of them are safe and reliable for POP.

evidence-based complementary and alternative medicine

The Efficacy and Safety of Traditional Chinese Medicine Tonifying-Shen (Kidney) Principle for Primary Osteoporosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials