OBJECTIVE： To systematically review the efficacy and safety of reinforcing kidney and invigorating spleen principle in the treatment of primary osteoporosis （POP） in middle and elderly aged patients， and provide evidence-based reference for clinic. METHODS： Retrieved from VIP， Wanfang Database， CJFD， Medline， PubMed， Elsevier， Springer， Web of Science and Ovid， randomized control trials （RCT） about reinforcing kidney and invigorating spleen principle （test group） versus other methods （no reinforcing kidney and invigorating spleen principle， control group） in the treatment of POP were collected. Meta-analysis was performed by using Rev Man 5.3 software provided by Cochrane after data extraction and quality evaluation modified by Jadad scale. RESULTS： Totally 28 RCTs were enrolled， involving 2 849 patients. Results of Meta-analysis showed， the total effective rate [OR＝3.80，95％CI（2.76，5.23），P＜0.001]， BGP level [MD＝2.23，95％CI（1.80，2.66），P＜0.001]， BMD level of femoral neck [MD＝0.04，95％CI（0.00，0.08），P＝0.05] and BMD level of lumbar spine [MD＝0.07，95％CI（0.03，0.11），P＝0.001] in test group were significantly higher than control group， ALP level [MD＝－5.59，95％CI（－10.51，－0.66），P＝0.03] and VAS score [MD＝－1.38，95％CI（－1.87，－0.89），P＜0.001] were significantly lower than control group， with statistical significance. There were no significant differences in U-Ca/Cr [MD＝－0.07，95％CI（－0.17，0.02），P＝0.12] and serum Ca2+ level [MD＝0.16，95％CI（－0.07， 0.39），P＝0.17] in 2 groups. CONCLUSIONS： Reinforcing kidney and invigorating spleen principle can improve patients’ osteogenesis during bone metabolism， reduce the activity of the osteoclastic process and relief patients’ pain in the treatment of POP.