Clinical Study Of The Effect Of Jingu Formula In OPG Level Of Senile Osteoporosis Patient

Objective:To explore the mechanism of anti-osteoporosis of "Jingu Formula" at the molecular level, via evaluating the effect of Compound Recipe "Jingu Formula" in OPG level of Senile osteoporosis patients (insufficiency of liver and kidney syndrome), which as one part of the project for researching and developing hospital-made prescription "Jingu Capsule". And the deeper evaluation provides theoretical foundation for further large-scale and multi-center clinical trials.Method:46 qualified cases from out-patient and in-patient department were enrolled in study, which were randomly classified into treatment group and control group,23 cases for each. The treatment group was treated with "Jingu Formula" (granules), Sig:Qd. And the control group was treated with Gusongbao Capsule, Sig:3# Tid. The serum OPG level would be measured before taking medicine, and 1 month,2 months,3 months after taking medicine. And the bone mineral density and the improvement of TCM symptoms would be recorded.Results:1,Significant effects were achieved in both groups. The effective percentage was 91.3% in treatment group, and 82.6% in control group. After chi-square test, there was no statistic significance(P>0.05) between two groups total efficiency and neither the rate of clinical remarkable improvement.In treatment group, the improvement of Chinese medicinal symptom scores after the first and second months are both significantly better than that in control group, with statistic significance(P<0.05),but there is no statistic significance after the third month.2,After the one-month treatment, there was improvement in the symptom relief of backache, soreness and fatigue in both groups, and the improvement efficiency in the treatment group was significantly better than that in the control group (P<0.05). But there was no significance in the improvement of dizzeness, cramp in lower limbs, and tinnitus between two groups (P>0.05). After the two-month treatment, the treatment group was still better than the control group in relieving backache, soreness and fatigue, which indicated statistic significance by comparison(P<0.05). But the control group was significantly better in the improvement of cramp in lower limbs,,while no significance in the improvement of dizzeness and tinnitus (P>0.05). There was no significant difference of TCM symptoms improvement between two groups after three months (P >0.05).3,No significant difference existed although the bone mineral density measurement of calcaneus quantitative ultrasound was improved after treatment (P>0.05), and neither before and after treatment in each group(P >0.05).4,There was a significant difference in the OPG level before and after treatment in each group by comparing at different time points(P<0.05).The OPG level in the treatment group was higher than that in the control group after treatment, and the same in the comparison at different time points, although there was not significant difference (P>0.05). Conclusion:1,Jingu Formula can relieve effectively the clinical symptoms of Senile osteoporosis, and improve the TCM syndrome, also increase bone density to some extent. It indicates Jingu Formula can inhibit the further loss of bone mass at a certain degree, and regulate the bone metabolism. The relief of TCM syndromes especially backache in Jingu Formula is better than that in control group in early stage, and that may because its fuction to dissolve stasis and reunion bone, besides tonify kidney, strengthen tendon, nourish Yin and marrow. The further research and development worth be applied in this study.2,Both Jingu Formula and Gusongbao Capsule can increase the serum OPG level in the Senile osteoporosis patients, and both of them have similar efficiency. Jingu Formula has some prevention and treatment of Senile osteoporosis,for the probable mechanism is by increasing the OPG level to reduce the osteoclasts RANK and RANKL protein binding rate, and thereby inhibit the activation and mature of osteoclasts, and decrease the bone resorption, finally correct the imbalance of bone metabolism and inhibit or reverse the bone loss. Then it improves clinical symptoms in Senile osteoporosis patients, and increases the bone density.