Abstract:Objective: To observe the clinical efficacy of Bushen Huoxue Tongluo decoction in treatment of glucocorticoid-induced osteoporosis (GIOP), and investigate its mechanism of action. Method: The 120 cases of GIOP patients were randomly divided into observation group and control group, 60 cases in each group. Patients in observation group took prednisone hormone and Bushen Huoxue decoction, and patients in control group received glucocorticoid, calcitriol capsules and calcium carbonate D3 tablets for 6 months. Before and after treatment, the two groups were evaluated by traditional Chinese medicine (TCM) syndrome scores, curative effects, levels of blood calcium, blood phosphorus, urinary calcium, urinary phosphorus, serum alkaline phosphatase (ALP), serum bone gla protein (BGP) and blood parathyroid hormone (PTH), bone mineral density (BMD) value and adverse reactions. Result: The markedly effective rate was 53.3% in observation group, higher than 30.0% in control group (P<0.05), and there was no difference in total effective rate between two groups. As compared with before treatment, total TCM syndrome scores were decreased in two groups; levels of blood calcium and phosphorus were increased, and BMD values were increased, with significant difference (P<0.05). As compared with control group, soreness and weakness of waist and knees, low back pain symptoms, leg pain, walking hardship symptom and total scores were decreased significantly after treatment in observation group (P<0.05), levels of serum PTH were decreased and BMD values were increased (P<0.05). The incidence of adverse effects was 0 in observation group, and 10% in control group (P<0.05). Conclusion: Bushen Huoxue Tongluo decoction has satisfactory efficacy for GIOP, which can reduce the levels of hormones, side effects and the incidence of fractures, with high safety.