PrimaryOsteoporosisPrimary osteoporosis (POP) is a bone metabolic disorder characterized by reduced bone mass and destruction of bone tissue microstructure, leading to increased bone fragility and fracture risk. POP is generally divided into three categories: postmenopausal.Osteoporosis(Type I), age-related osteoporosis (Type II), and idiopathic osteoporosis. Type I and Type II are the most common types of primary osteoporosis. It is predicted that by 2050, the population aged 60 and above in China will account for 25% of the total population, and the number of POP patients will reach 212 million. Additionally, in the coming decades, the number of fractures associated with POP will also increase sharply.
In recent years, with traditional Chinese medicineGSK Capsules（GSK)Traditional Chinese medicines, represented by GSK, have attracted the interest of medical researchers due to their low cost and minimal side effects. GSK is composed of several traditional herbs, including Epimedium acuminatum, Atractylodes lancea, Astragalus membranaceus, andSupplementBoneLipidGSK contains naringin and icariin, which can effectively stimulateVitamin Dgeneration. A study found that GSK exerts a systemic bone-protective effect by inhibiting osteoclast formation and stimulating osteoblast formation, laying the foundation for the development of new drugs to treat POP. According to Traditional Chinese Medicine (TCM),Primary OsteoporosisIt is caused by deficiencies in the liver, spleen, and kidney, as well as stagnation of qi and blood. Therefore, the basis of treatment is to warm the kidney and liver, strengthen the spleen, and resolve stasis. Currently, most research findings on GSK are positive, but the quality of some trials is not sufficiently reliable, and there has been no systematic analysis of the drug. Thus, we aim to conduct a systematic review of the efficacy and safety of GSK in treating POP, with the goal of providing evidence-based support for the rational clinical use of this drug in preventing and treating POP.。
Method：Through online searches in CNKI (China National Knowledge Infrastructure), Wanfang Database, China Biology Medicine Database, VIP (Chongqing Weipu Information Co., Ltd.), PubMed (U.S. National Library of Medicine), Web of Science, and the Cochrane Library, randomized controlled trials related to the treatment of primary osteoporosis were collected. The literature search period was from January 1, 2000, to March 17, 2022. The risk of bias and quality of the trials included in the meta-analysis were assessed using the Cochrane Collaboration’s Risk of Bias Assessment Tool. Effect sizes are presented with 95% confidence intervals (CI) Risk Ratio (RR) or mean difference (MD) is indicated.
Figure 1. Flowchart of the study selection process
Results：This systematic review included a total of 24 randomized controlled trials (RCTs). All 2,363 patients had primary osteoporosis, with 1,197 in the observation group and 1,166 in the control group. The GSK capsule group was superior to the conventional drug group in improving β-C-terminal telopeptide of type I collagen (β-CTX) (MD = -0.28, 95% CI [-0.31, -0.25]), while the conventional drug group performed better than the GSK capsule group in improving procollagen type I N-terminal propeptide (PINP) (MD = -1.37, 95% CI [-1.92, -0.82]). There was no significant difference in overall efficacy (OE) between the two groups.StatisticsStatistical significance (OR = 1.62, 95% CI [0.89, 2.98]). Bone mineral density (BMD) increase (Lumbar spine: MD = 0.02, 95% CI [-0.08, 0.04]; Femoral neck: MD = 0.01, 95% CI [-0.07, 0.05]; Hip joint: MD = 0.01, 95% CI [−0.02, 0.02]), alkaline phosphatase (ALP) enhancement (MD - 1.37, 95% CI [−13.29, 10.55]), serum calcium (MD - 0.02, 95% CI [−0.13, 0.17]), bone gla 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]).
Summary of Bias Risk
Risk of Bias Graph
GSK CapsulesCombining conventional drug therapy group was superior to the conventional drug therapy group in improving 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])), high mountain (MD −5.56, 95% CI [−10.08, −1.04]), βctx (MD −0.15, 95% CI [−0.18, −0.12]) and pain relief (MD −1.25, 95% CI [−1.83, −0.68]). However, there were no differences 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 (MD 0.01, 95% CI [−0.09, 0.12]), and safety (OR 0.71, 95% CI [0.38, 1.35]).
OE Forest Plot
Forest Plot of Bone Density
BMD Funnel Chart
OE Funnel Chart
Conclusion:GSK capsules can effectively treat primary osteoporosis. Combined with conventional drugs, they can significantly increase bone density, alleviate pain, and improve bone metabolism-related indicators in patients with primary osteoporosis, showing better efficacy. However, due to the inclusion of Chinese literature and potential publication bias, the reliability of the conclusions still requires more high-quality studies.RCTTo improve.
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