| Objectives To study the therapeutic effect and safty of Chongcao Bushen Capsule for type 2 diabetes mellitus combined with osteoporosis(syndrome of yin deficiency of liver and kidney).Methods A total of 70 cases diagnosed with type 2 diabetes mellitus combined with osteoporosis(syndrome of yin deficiency of liver and kidney),according to the doctor order sorting,were divided into two groups: odd as the treatment group(35 cases),even as the control group(35 cases).Both groups were given reasonable diet,moderate exercise,adequate lighting,insulin.Additionally,the treatment group was given Chongcao Bushen Capsule,while the control group was given Reneed Calcium Carbonate and Vitamin D3 Tablets,with six months.The improvement of clinical symptoms,changes of bone density and Ca and P in the two groups were observed.Furthermore,changes in HbA1 c and liver and renal functions before and after taking medicine as well as any adverse reaction during treatment were recorded.The data collected were analyzed by SPSS17.0 statistics software.The measurement data were expressed in mean differences ± standard deviation(sx ±)and the data accorded with normal distribution were compared by t-test.The significance of differences between two groups was determined by independent-sample t-test,and intra group comparison used paired t-test.The data of non-normal distribution used rank-sum test.The numeration data were used frequency said.The numeration data between the two groups were compared with chi-squaretest,and the grade data was compared with ranksum test.Results A total of 70 cases were included into the study.3 cases did not finish the treatment.67 cases finished the treatment,including 33 cases in the treatment group and 34 cases in control group.1.The two groups had no differences in prior treatment,gender,age and course of disease(P>0.05).2.Comparison of TCM symptom score and curative effect: The TCM syndrome score of both groups were decreased after treatment,and that of the treatment group was significantly lower than that of the control group(P<0.05).The therapeutic effect in the treatment group was obviously improved than that in control group(P<0.05).3.Comparison of bone mineral density(BMD): After therapy,the improvement of BMD in the two groups were effectively improved(P<0.05),and the improvement of BMD in the treatment group was better than the control group,showing a statistically significance difference(P<0.05).4.Comparison of Ca,P,ALP: There were no significantly different in Ca,P,ALP between before treatment and after therapy(P>0.05),and there were no significantly different in the two groups after treatment(P>0.05).5.Comparison of HbA1c: The HbA1 c of treatment groups were obviously lower after treatment(P<0.05),and the decreases of the two levels in the treatment group were more obvious than the control group(P<0.05).The curative effect of the treatment group was much better.6.Comparison of liver and kidney functions: There were no significantly different in liver and kidney functions between the two groups(P>0.05).Conclusions Chongcao Bushen Capsule has an obvious curative effect for type 2 diabetes mellitus combined with osteoporosis(syndrome of yin deficiency of liver and kidney).It can relieve TCM clinical symptoms,improve bone mineral density,but it has no significant effect on calcium(Ca),phosphorus(P),Alkaline phosphatase(ALP). |