| Objective To observe the clinical efficacy of Bushen Huoxue decoction in treating osteoporosis (OP) and evaluate its safety. Methods Recruit 60 patients with osteoporosis who were treated at Guangdong Provincial Hospital of Traditional Chinese Medicine from September 2021 to September 2023. The patients voluntarily chose whether to take traditional Chinese medicine, with the control group receiving OP basic treatment and Western medicine anti OP treatment plan. The experimental group received a combination of BuShen HuoXue decoction treatment on the basis of the control group, with a treatment course of 6 months for both groups. Before and after treatment, bone density, bone metabolism, and extracellular vesicles were measured. FRAX tool was used to assess the probability of brittle fractures in patients, and traditional Chinese medicine syndrome scores and safety evaluations were conducted. Results After treatment, both groups of patients showed significant improvement in bone density (P<0.05), but the experimental group was not superior to the control group (P>0.05); Two groups of patients showed a significant decrease in bone metabolism indicators compared to before treatment (P<0.05), but the experimental group was not superior to the control group (P>0.05); The serum levels of 25(OH)2VitD3 in both groups of patients increased significantly compared to before treatment (P<0.05), and the experimental group was higher than the control group (P<0.05); After treatment, both groups showed a decrease in FRAX scores (P<0.05), and the experimental group was better than the control group (P<0.05); After treatment, the total effective rate of the experimental group (92.3%) was significantly higher than that of the control group (76.9%) (P<0.05); As the treatment time progressed, the TCM syndrome scores of both groups of patients showed a downward trend, with the experimental group showing a more significant decrease (P<0.05); During the treatment period, neither group experienced serious adverse drug reactions, and there were no significant changes in the patients' liver and kidney function. Conclusion: Bushen Huoxue decoction can effectively reduce the bone metabolism level of OP patients, promote the secretion of serum exosomes, and improve traditional Chinese medicine syndromes. However, it is expected to expand the sample size and implement strict clinical randomized controlled trials to further verify its clinical effects. |