| ObjectiveThis randomized controlled clinical trial intends to discuss the clinical efficacy and safety of Polycystic Ovary Syndrome (Type of Phlegm Stagnation) treatment with Modified Erchen Decoction.MethodsResearch objects are patients who met the Western Medicine diagnosis criteria of Polycystic Ovary Syndrome and the Chinese Medicine differentiation criteria of Type of Phlegm Stagnation.Western Medicine diagnosis standard:Refer to ESHRE/ASRM diagnosis standard of May 2003. Being in accordance with any two of the following three results and excluding other etiological factors can be confirmed:ultrasound examination shows the existence of polycystic ovary, clinical or biochemical hyperandrogenism and anovular menstruation. The standards formulated are as follows:anovular menstruation, such as oligomenorrhea and even menostasia, etc.; Type-B Ultrasonic Examination indicates> 12 small egg chambers of diameter 2-8 mm around unilateral or bilateral ovaries; reinforced resonance in the intramural portion or the enlarged ovary volume; the hormone examination shows andrusol is above normal value, or LH/FSH>2.5. Those in accordance with any two of the three indexes mentioned above and excluded other etiological factors can be confirmed diagnosis of PCOS.Chinese Medicine syndrome diagnosis criteria:Conduct Chinese Medicine differentiation according to the criteria in "Clinical Research Guiding Principles about Menoxenia and Amenorrheria by Chinese Medicine New Drugs" listed in Clinical Research Guiding Principles of Chinese Medicine New Drugs (Clinical Research Guiding Principles about Menoxenia by Chinese Medicine New Drugs, First Version, May 2002; Clinical Research Guiding Principles about Amenorrheria by Chinese Medicine New Drugs, First Edition):Type of Phlegm Stagnation. Principal syndrome:delayed menorrhea, small quantity, amenorrhea. Minor syndrome:plumpness, hairiness, dizziness, chest distress, phlegm in throat, lassitude in four limbs and debilitation; much leucorrhea and infertility long after marriage; fat body of tongue, light color, thick and greasy fur, deep and slippery pulse. Having one of the principal syndromes and one or more than one minor syndromes can be confirmed diagnosis with tongue and pulse indications.Adopt the randomized control trial method and classify the qualified subjects at 1:1 into the Trial Group and the Control Group with 30 subjects in each group. The case grouping is randomized.The Trial Group:Modified Erchen Decoction:orange peel 10 g, pinelliae tuber 10 g, hoelen 15 g, liquorice 5 g, alismae rhizoma 12 g, bile arisaema 6 g, orange pease 12 g, rhubarb 10 g, Bulbus fritillariae cirrhosae 10 g, herba epimedii 15 g. Take one dose of decoction daily.The Control Group:take placebo (starch) tablets. Regiment:placebo tablets taking from three days before the menstruation for 10 days in each menstruation cycle. Take for 6 continuous menstruation cycles. Dosage:4 placebo tablets each time and twice a day.After the clinical research finishes, summarize the clinical material and input into the computer and establish a database. Use Epi Data software to make statistical analysis. Analyze and compare two groups'total curative effect, clinical symptoms and body sign efficacy and finally objectively evaluate its clinical efficacy and safety.Statistical methods:X2 test for classified material, Wilcoxon rank sum inspection (adjustment) for ranked material, t-test or Wilcoxon rank sum test for two samples'average comparison, pair t-test or Wilcoxon rank sum test for self AP comparison. Statistics is done used by SPSS17.0 statistical software.ResultsThis clinical study has 60 qualified subjects till the end of the trial. 30 are in the Trial Group and 30 in the Control Group. These outpatient clinic patients are diagnosed as polycystic ovarian syndrome and type of phlegm stagnation by TCM. There's no significant difference in two groups'age, disease duration, disease degree, menstruation, clinical symptoms, basal body temperature, tongue demonstration and pulse tracing, etc before treatment. It indicates the major factors of the prognosis of two groups have balance and comparability.The Trial Group:the recent clinical full recovery rate is 36.6%, the excellence rate 43.3%, the utility rate 13.3%, and the recent clinical full recovery and excellence rate 80%, the total effective rate 93.4%; the Control Group:the recent clinical full recovery rate is 0.0%, the excellence rate 3.3%, the utility rate 16.6%, and the recent clinical full recovery and excellence rate 3.3%, the total effective rate 20.0%. The ranking comparison of two groups'total curative effect has significant difference (z= 5.5, P= 0.00). The comparison of two groups'total effective rates shows significant difference (Pearson Chi-square value=32.8, P=0.00). These indicate the Trial Group has better curative effect than the Control Group in PCOS treatment.The Trial Group is superior to the Control Group in improving the menstrual cycle, the menstruation, the menstruation volume, etc. and the difference has statistical significance after treatment. There's statistical significance in comparing the disappearance rates of symptoms like large quantity of leucorrhea, short breath, chest full, loose stools, lassitude and palpitations, etc. which indicates the Trial Group can improve PCOS clinical symptoms better than the Control Group.Two groups'blood FSH levels decrease after treatment. There's statistically significant difference in the in-class AP comparison. Before treatment, no statistical significance is found in the interclass comparison. The D-value interclass comparison of two groups after treatment and the comparison before and after treatment have statistical significance. The two groups'blood FSH levels decrease after treatment and the in-class comparison has statistical significance before and after treatment. Before treatment, the interclass comparison has no statistical significance. There's statistical significance in comparing the interclass D-values before and after treatment and in comparing the two groups'D-values after treatment. Two groups'blood E2 levels decrease after treatment. There's statistical significance in the in-class difference before and after treatment in the Trial Group. There's no statistical significant difference in the interclass comparison before treatment. The comparison of D-values after treatment and the comparison of D-values before and after treatment have statistical significance. Two groups'P levels decrease after treatment and there's statistical significance in the in-class comparison before and after treatment. There's no statistical significance in the interclass comparison before treatment. There's statistical significance in comparing the interclass D-values after treatment and comparing the D-values before and after treatment. Two groups'PRL levels decrease after treatment. There's statistical significance in the in-class comparison before and after treatment in the Trial Group. There's no statistical significance in the interclass comparison before treatment. There's statistical significance in comparing the interclass D-values after treatment and comparing the D-values before and after treatment. Two groups'T levels decrease after treatment. There's statistical significance in the in-class comparison before and after treatment in the Trial Group. There's no statistical significance in the interclass comparison before treatment. There's statistical significance in comparing the interclass D-values after treatment and comparing the D-values before and after treatment. Two groups'LH/FSH levels decrease after treatment. There's statistical significance in the in-class comparison before and after treatment in the Trial Group. There's no statistical significance in the interclass comparison before treatment. There's statistical significance in comparing the interclass D-values after treatment and comparing the D-values before and after treatment.There are no abnormal changes in laboratory indexes and no adverse reaction found during the whole trial process.ConclusionErchen Decoction has safety and efficacy in the treatment of Polycystic Ovary Syndrome (Type of Phlegm Stagnation).
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