Clinical Study On Berberine In The Treatment Of Insulin Resistance In Women With Polycystic Ovary Syndrome

ObjectiveThe aim of our clinical study is to discuss the clinical efficacy and safety of Berberine through the comparision of Berberine and Metformin in the treatment of insulin resistance in women with polycystic ovary syndrome, which is looking forward to become one of the scientific evidence in the treatment of PCOS-IR and provide a new treatment program for the clinical.MethodsThis study was a randomized and parallel controlled trial,60PCOS-IR patients were randomly divided into2groups:treated group and control group. The treated group was treated with Berberine and the control one was treated with Metformin. In this study, we measured some clinical symptoms and biochemical indexes, such as fasting glucose and insulin,2-hour postprandial glucose and insulin, reproductive hormones (including FSH, T, LH and LH/FSH), blood fat, BMI, WHR, TCM four diagnostic and so on.Microsoft Office Excel was used to establish the database. All these data were analyzed with PASW Statistics18.0statistical analysis system:the measured data were analyzed with χ2test, the enumeration data were expressed x±s and analyzed with paired-samples T test or independent-samples T test. When the normality or homogeneity of variance assumptions were not met the data were analyzed with the nonparametric rank sum test.Results1. Total effective rate in the treated group and the control group was91.30%and85.71%respectively. There was no significant difference between the two groups in this part(P>0.05).2. Body weight, body mass indes(BMI), waist circumstance, hip girth and waist-hip ratio (WHR) of the patients in the two groups have been reduced. Both of the two groups could significantly decrease the body weight, BMI, waist circumstance, hip girth and WHR of the patients than it before treatment(P <0.05). Independent-samples T test/the nonparametric rank sum test showed that there is no significant difference between the two groups (P>0.05).3. Insulin and HOMA-IR of the patients in the two groups have been reduced. Paired-samples T test and nonparametric rank sum test showed that there are statistical differences in fasting glucose of the control group and fasting insulin of the treated group before and after treating (P<0.05). In reducing HOMA-IR, both of two groups had distinct statistical differences (P<0.05). Nonparametric rank sum test showed that there is no statistical significance between the two groups (P>0.05).4. Blood-fat levels of the patients in the two groups have been reduced. TC, TG, LDL-C had distinct statistical differences after treatment both in the two groups(P<0.0), but HDL-C had no statistical significance after treatment in both of them(P>0.05). In decreasing TC, TG and LDL-C, there was no distinct statistical difference between the two groups(P>0.05).5. Reproductive hormones of the patients in the treated group were reduced. Nonparametric rank sum test showed that the levels of LH and T are significantly decreased in the treated group(P<0.05), differences were statistical significance. But LH, T of the control group and FSH, LH/FSH in both of the two groups had no statistical significance after treatment(P>0.05). Nonparametric rank sum test showed that there were significant differences in LH and LH/FSH between the two groups after treating(P<0.05).6. Points of Chinese medicine syndromes graded tables of the patients in two groups were reduced. Paired-samples T test showed that there are statistical difference in the points of Chinese medicine syndromes graded tables of the two groups (P<0.05). It was confirmed that there was no significant difference between the treated group and the control group by independent-samples T test(P>0.05).ConelusionThis clinical study prove that Berberine has significant efficacy in treating insulin resistance in women with polycystic ovary syndrome, there was no significant difference in the total effective rate between Berberine and Metformin. Berberine can significantly reduce the levels of T and LH, there are significant differences in LH and LH/FSH between the two groups after treating. And in the part of reducing body weight, BMI, waist circumstance, hip girth and WHR, there is no significant difference between the two medicines. Metformin decreases fasting glucose and Berberine decreases fasting insulin, both of them can significantly reduce HOMA-IR. In reducing TC, TG and LDL-C, there is no significant difference between the two groups. Both Berberine and Metformin can effectively reduce the points of Chinese medicine syndromes graded tables.