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Objective: To systematically evaluate the efficacy and safety of Gushukang (GSK) capsules in the treatment of primary osteoporosis., Methods: Randomized controlled trials related to the treatment of primary osteoporosis were collected through online retrieval of the China National Knowledge Infrastructure (CNKI), Wanfang database, Chinese Biomedical Literature Database (Sino-Med), VIP, US National Library of Medicine (PubMed), Web of Science and Cochrane library. The literature was searched from January 1, 2000, to March 17, 2022. The risk bias and quality of the trials included in the meta-analysis were evaluated with the Cochrane Collaboration's risk assessment tool. The effect size was expressed as risk ratios (RRs) or mean differences (MDs) with 95% confidence intervals (CIs)., Results: A total of 24 randomized controlled clinical trials (RCTs) were incorporated into this systematic review. The 2363 patients were all primary osteoporosis patients, of whom 1197 were in the observation group and 1166 were in the control group. GSK capsule group was superior to conventional medication group in improving beta type I collagen carboxy-terminal peptide (β-CTX) (MD - 0.28, 95% CI [- 0.31, - 0.25]), while in improving prepeptide of type I procollagen (PINP), conventional medications group was superior to GSK capsule group (MD - 1.37, 95% CI [- 1.92, - 0.82]), and there were no significant differences between the two groups in overall efficacy (OE) (OR 1.62, 95% CI [0.89, 2.98]), increase of bone mineral density (BMD) (lumbar spine: MD - 0.02, 95% CI [- 0.08, 0.04]; femoral neck: MD - 0.01, 95% CI [- 0.07, 0.05]; hip: MD 0.01, 95% CI [- 0.02, 0.02]), enhancement of alkaline phosphatase (ALP) (MD - 1.37, 95% CI [- 13.29, 10.55]), serum calcium (S-Ca) (MD 0.02, 95% CI [- 0.13, 0.17]), bone glutamyl protein (BGP) (MD 3.75, 95% CI [- 12.26, 19.76]), safety (OR 0.37, 95% CI [0.07, 2.02]) and pain relief (MD 0.32, 95% CI [- 0.59, 1.22]). GSK capsule combined with conventional medications group was superior to conventional medications group in improvement of OE (OR 3.19, 95% CI [2.20, 4.63]), BMD (lumbar spine (MD 0.06, 95% CI [0.02, 0.10]), femoral neck (MD 0.08, 95% CI [0.03, 0.13]), hip (MD 0.14, 95% CI [0.08, 0.21]) and other parts (MD 0.04, 95% CI [0.03, 0.05]), ALP (MD - 5.56, 95% CI [- 10.08, - 1.04]), β-CTX (MD - 0.15, 95% CI [- 0.18, - 0.12]) and pain relief (MD - 1.25, 95% CI [- 1.83, - 0.68]), but there was no difference in S-Ca (MD 0.02, 95% CI [- 0.13, 0.17]), BGP (MD 1.30, 95% CI [- 0.29, 2.89]), PINP (MD 1.30, 95% CI [- 0.29, 2.89]), serum phosphorus (S-P) (MD 0.01, 95% CI [- 0.09, 0.12]) and safety (OR 0.71, 95% CI [0.38, 1.35])., Conclusion: GSK capsules can effectively treat primary osteoporosis, and when combined with conventional medications, the drug significantly increased bone mineral density, relieved pain and improved bone metabolism-related indicators in primary osteoporosis patients with better efficacy. However, due to the inclusion of Chinese literature and possible publication bias, the reliability of conclusions still requires more high-quality RCTs to enhance., (© 2023. The Author(s).)