The Clinical Study of Using Cang Fu Dao Tan Wan in the Treatment of PCOS of the Phlegm Stagnation Syndrome
|School||Guangzhou University of Traditional Chinese Medicine|
|Keywords||Polycystic ovary syndrome Phlegm block Cang Fu Dao Tan Tang|
The purpose of this clinical study using randomized controlled methods, assessment Cang Fu Dao Tan Tang phlegm block in patients with polycystic ovary syndrome, efficacy and safety. Methods from March 2008 to March 2009 to benevolence Tang TCM Clinic for treatment of patients to comply with the the Western medicine polycystic ovary syndrome diagnostic criteria and TCM phlegm block Differentiation Standard 60 patients. Randomized controlled trials, eligible subjects assigned in a 1:1 ratio to the experimental group and the placebo group, 30 cases in each group. Were outpatients. Cang Fu Dao Tan oral medicine soup (Ingredients: Poria 20 grams, France Pinellia 12 grams, 6 grams of dried tangerine peel, 10 grams Atractylodes, Cyperus rotundus 12 grams, 15 grams of Citrus aurantium, 15 g of the Divine Comedy, the system test group Southern Star 9 g Codonopsis 20 g, 15 g psoralen Epimedium 10 grams, 15 grams of Angelica) combined with auricular pressure (endocrine, uterus, spleen) treatment. Placebo placebo particles (starch excipient) combined treatment of auricular pressure (endocrine, uterus, spleen). Cang Fu Dao Tan Tang made in accordance with a daily dose of GMP herbal preparations copies 9g December 10 Capsules 0 capsules morning and at night 5. Placebo starch excipients, the number of the way of taking the same test group, consistent with Cang Fu Dao Tan Tang drugs shape, color, packaging, Dosage requirements. Each group of medication in March. Auricular acupressure: Use King leaving no line of seed paste ear pressure, selecting the right auricular, 75% alcohol conventional disinfection auricular skin, then with 0.5cm × 0.5cm the tape to Vaccaria seed fixed in Auricular make a slight tenderness Zhu Huanzhe press five times a day, every 2-3min ears alternately affixed pressure treatment once every three days. Methods of operation: both groups from pre-menstrual three days starting medication, taking 10 consecutive days, and even served three menstrual cycles. Three months for a course of treatment, observation of the three courses to be made after the end of treatment, the therapeutic efficacy. With the establishment of a database EPIDATA3.1 software SPSS17.0 software for statistical analysis. Measurement data are expressed as mean ± standard deviation ((?) ± S), count data with constituent ratio (%). Measurement data groups were compared using t-test (unequal variances with t 'test or rank sum test), their own before and after using the paired t test or Wilcoxon paired rank sum test. Χ2 test was used to compare the segment information group level data groups were compared using the Wilcoxon rank sum test. Statistical graphics produced using software Graph Pad Prism 4.03 completed. The results of this study, a total of 60 cases of eligible subjects. Test group of 30 patients in the placebo group, 30 cases were outpatients. Western diagnosis of polycystic ovary syndrome, TCM is a phlegm block license. Before treatment, pre-treatment age, BMI, duration, severity of disease, menstruation, clinical symptoms, basal body temperature comparison, the difference was not statistically significant (P <0.05). The main factors that have prompted two groups affect the prognosis balanced and comparability. The results are as follows:. Comprehensive efficacy of the test group and the placebo group of diseases: the experimental group cure rate was 23.3%, the effective rate is 53.3%, the effective rate was 10.0%, with a total effective rate of 86.67%; placebo cure rate was 0.0 %, effective rate of 13.3%, the effective rate was 60.0%, with a total effective rate of 73.33%. Efficacy comparison of the two groups of diseases, the difference was statistically significant (z = 4.26, P = 0.00). The test group, the total efficiency (86.7%) than in the placebo group (73.3%). Test and placebo groups TCM designate the total effect: the experimental group cure rate was 36.6%, the effective rate is 43.3%, the effective rate was 13.3%, the total effective rate was 93.4%; cure rate was 20.0% in the placebo group, The effective rate is 36.67%, the effective rate was 20.0%, with a total effective rate of 86.7%. The two sets of TCM syndromes total effect, the difference was statistically significant (z = 2.09, P = 0.03). The test group TCM syndromes total efficiency (93.4%) than in the placebo group (86.7%). 3. Clinical symptoms of the test group and the placebo group to improve the situation: after treatment, the test group menstrual abnormalities, chest and abdominal fullness, Shenpi drowsiness, face and impractical disappearance rate were 86.7%, 90.5%, 82.6%, 75.0%, comfort The agent group disappearance rate less than 50%, two groups, the difference was statistically significant (P <0.05). The treatment group hairy six cases, four cases disappear after treatment, disappearance rate was 66.7%; placebo in the hairy four cases before, after treatment disappeared, but the two groups disappears rate comparison, the difference was not statistically significant (P> 0.05 ). Test group before treatment acne eight cases, five cases disappear after treatment, the disappearance rate of 62.5%; six cases in the placebo before treatment, after treatment disappear one cases, the disappearance rate of 16.7%, and the two groups, the difference was not statistically significant (P> 0.05). It is suggested that Cang Fu Dao Tan soup can effectively alleviate clinical symptoms of phlegm polycystic ovary syndrome. Especially in improving the menstrual cycle, reduce the TCM clinical symptoms, hairy, acne also have a certain effect. After treatment, the test group blood FSH, LH, E2, P, PRL, T and LH / FSH than before treatment, after treatment than before treatment, before and after treatment group differences were statistically significant (P <0.05). Cang Fu Dao Tan soup can regulate hormone secretion in patients. The test group after treatment in patients with ovarian smaller. Description Cang Fu Dao Tan Tang can be reduced ovarian volume, to improve polycystic ovarian changes state. During the entire experiment found no abnormal changes in any laboratory parameters, also did not find any adverse reactions. Conclusion Cang Fu Dao Tan Tang treatment of phlegm block polycystic ovary syndrome have a significant effect, and relatively the control group can significantly reduce the patient's clinical symptoms, the effective regulation of the patient's hormone levels, reduced ovarian volume, improve ovarian polycystic change status. The mechanism may be by acting on the hypothalamus - pituitary - ovarian axis, the axis adjustment disorders returned to normal, the patient returned to normal ovulation. And less worthy of widespread toxicity.