Invigorating Spleen And Kidney Prevents Aromatase Inhibitors -associated Bone Loss In Postmenopausal Women With Early Breast Cancer Receiving Als:a Clinical Study

ObjectiveThe clinical trials have demonstrated that adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors increases bone loss. At present, the methods for preventing AIBL have some defects. Theoretically, Invigorating spleen and kidney should prevent AIBL. So it is to explore whether invigorating spleen and kidney could prevent AIBL and its possible mechanism, also to observe the safety.MethodsUsing cohort study, the trial enrolls postmenopausal women of hormone receptor-positive breast cancer with aromatase inhibitors treatment, who have detected BMD at the baseline with results of upper-2.5. The patients from Guangdong Provincial Hospital of TCM are enrolled as the JPBS group, and receive JPBS decoction and calcium with basic intervene therapy. The patients from Guangdong Provincial People’s Hospital and Guangdong Provincial Maternity and Child Care Center are enrolled as the Western Medicine group and receive calcium with basic intervene therapy. Bone mineral density (BMD) at the lumbar vertebra and the proximal femur and bone turnover markers are assessed at baseline and after 12months treatment. The hepatic and renal function is detected at baseline and after 6 and 12months treatment. All patients receive physical examination every 6 months.ResultsOne hundred and fourteen patients are assessable. The reduction of BMD in JPBS group is less than that in Western Medicine group significantly. In the JPBS group, JPBS decoction results in a 3.9% increase and 1.8% decrease from baseline in BMD in the lumbar vertebra and proximal femur respectively, which is maintained at 12 months. In the Western Medicine group, the BMD in the lumbar vertebra and proximal femur significantly decline by 14.58%,22.45% from the baseline respectively.At the baseline, bone resorption marker β-CTx and bone formation marker PINP increase abnormally, which means that the bone metabolism is in the high transition state. In the JPBS group, bone resorption marker β-CTx significantly decrease by 21.67% at 12 month. PINP, one of the formation marker, decrease by 2% at 12 month, but there is no significant difference. N-MID,the other bone formation marker, increase by 9.27% significantly at 12 month.There are two patients with metastasis sites, one for the JPBS group, one for the Western Medicine group. The hepatic and renal function are normal clinically.Conclusioninvigorating spleen and kidney can prevent AIBL, and slow down the bone loss. Its possible mechanism could be that the herbal inhibit bone resorption and promote bone formation. It is safe to teat with herbal for some time.