| Objectives This paper is aimed to observe the clinical effect of Cordyceps sinensis Capsule,one of the Chinese patent medicines,in the treatment of postmenopausal osteoporosis with deficiency of liver-yin and kidney-yin symptoms.And to explore its functional mechanisms by observing the changes in various indexes,such as sex hormone levels,TCM symptom scores,clinical effect,bone mineral density(BMD),serum calcium,and adverse reactions,expanding the clinical application of Cordyceps sinensis Capsule.Methods The subjects of this study are 60 patients who met diagnostic criteria of postmenopausal osteoporosis in the outpatient of Shijiazhuang Hospital of Traditional Chinese Medicine.They were randomly numbered and randomly classified into two groups,which are control group and treatment group,each with 30 patients.Patients in the control group were treated by 2 Caltrate D()tablets once a day,while patients in the treatment group were treated by 6 Cordyceps sinensis Capsule tablets three times a day,The observation was lasted for 2 courses and 3 months per course.After that,the changing in the clinical effect,bone mineral density,estradiol,testosterone,serum calcium and symptom scores were observed and recorded.The complete data were statistically analyzed by the spss17.0 statistics software.Results 60 patients were included in the study.The general data of the two groups' patients were statistically analyzed before the treatment.Comparisons on the baseline data such as age,disease duration,and age of menopause was conducted,showing that the baseline data had no significant difference(P>0.05)and comparable.Clinical experimental observation on 60 patients of postmenopausal osteoporosis was conducted in this study.After 2 courses of treatment,the results obtained were as follows: 1 Overall Response Rate: there were 11 marked-effect cases,15 effective cases and 4 ineffective cases among the 30 cases in the control group,the Overall Response Rate was 86.6%.Likewise,there were 5 marked-effect cases,16 effective cases and 9 ineffective cases among the 30 cases in the treatment group,the Overall Response Rate was 70%.There was difference of statistical meaning between them(p<0.05),leading to the conclusion that the Overall Response Rate of treatment group was better than the control group.2 Comparison of symptom scores: The TCM symptom scores of the two groups were compared and the results showed the same decline trend after treatment(P<0.05),and the TCM symptom scores of the treatment group were significantly lower(4.37±1.95)than that of the control group(6.33±2.77)(P<0.05).There was difference of statistical meaning between them,leading to the conclusion that both of the treatment could improve the clinical symptoms and the Cordyceps sinensis Capsule showed better effect.3 Comparison of serum calcium: After treatment,serum calcium in the treatment group was higher than before(p<0.05),with statistical significance,and serum calcium in the control group did not change significantly(p>0.05).The difference was not statistically significant.4 Increase in Bone Mineral Density: There are increase on the Bone Mineral Density of lumbar vertebra and hip joint after treatment,and the increase in the treatment group was more significant than that in the control group(P<0.05),statistically significant.5 Sex hormone levels: In the comparison within the treatment group,the results showed that the level of estrogen was higher than before(P<0.05),and the level of testosterone was lower than before,leading to the conclusion that Cordyceps sinensis Capsule could regulate hormones.As for the control group,there was no significant change in estrogen and testosterone levels.6 Safety indexes:There was no significant difference in liver function and renal function between the two groups before and after treatment(P>0.05),and no other adverse reactions,either.Conclusions According to the results of preliminary clinical studies,Cordyceps sinensis Capsule could effectively treat postmenopausal osteoporosis with deficiency of liver-yin and kidney-yin symptoms and improve the TCM clinical symptoms of PMOP patients.From the perspective of improvement in the indexes of western medicine,Cordyceps sinensis Capsule could increase the bone mineral density and regulate the sex hormone levels,causing no adverse reactions in liver and kidney function and prevent further development of postmenopausal osteoporosis.We can conclude that Cordyceps sinensis Capsule could treat postmenopausal osteoporosis safely and effectively,and is worth studying and developing further.Due to the dis advantages caused by limited cases in this study,it is hoped that further studies will be conducted in the future. |
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