| ObjectiveThis randomized controlled clinical trial intends to discuss the clinical effect and safety of Modified Gentianae Decoction for Purging Liver Fire to treat leukorrhea disease due to dampness invasion of the lower energizer. MethodsResearch subjects are 60 patients treated in Chinese Medicine clinic in Tainan, Taiwan from March to November.2010. They are randomly classified into the Treatment Group and the Control Group with 30 subjects in each group.The Treatment Group subjects take the Modified Gentianae Decoction for Purging Liver Fire. The Control Group subjects with vulvovaginal candida mycoderma take fluconazol 150mg once daily; subjects with bacterial vaginal disease take metronidazole 400mg twice a day. The treatment lasts for two weeks. Two groups'subjects during treatment discontinue other medications for leukorrhea disease and other medicine that may affect the observation results. Spouses should simultaneously take the corresponding treatment during treatment.ResultsThe subjects of the Treatment Group are 19-49 years old and the average age is 35.7±7.55; the TCM Syndrome Scores before treatment are 4 points-22 points and the average score is 11.94±4.09 points; the pathogenetic condition degree is mild; bacterial vaginal disease:19 cases; vulvovaginal candidiasis (VVC):11 cases. The Control Group subjects are aged 24-50 years old and the average age is 36.81±7.47 years old; the TCM Syndrome Scores before treatment are 5 points-21 points, and the average is 12.81±3.87 points; the pathogenetic condition degree is mild; bacterial vaginal disease:17 cases; vulvovaginal candidiasis (VVC):13 cases. There's basic equilibrium in two groups' age and illness constituent ratio. The statistical analysis shows there's no significant difference (P>0.05) and there's comparability. Among 30 cases in the Treatment Group,11 cases are cured,14 are of excellence, 3 of utility and 2 of inefficacy with the recovery rate of 36.67% and the total effective rate 93.33%; among the 30 cases in the Control Group,8 cases are cured,9 cases of excellence,9 cases of utility and 4 cases of inefficacy with the recovery rate of 26.67% and the total effective rate 86.67%. The rank sum test demonstrates the difference in two groups' syndrome curative effect is not statistically significant (P>0.05). The t test demonstrates there's no significant difference (P> 0.05) in comparing the two groups' Syndrome Scores before and after treatment and their D-values which explains that the Modified Gentianae Decoction for Purging Liver Fire and western medicine both have significant curative effect in improving the TCM syndromes of leukorrhea diseases due to dampness invasion of lower energizer.After treatment, the two groups' symptoms (including cardinal symptoms and minor symptoms of the type of dampness invasion of lower energizer) are both improved at different degrees. The rank sum test shows the Treatment Group and the Control Group have no significant difference (P>0.05) in improving the cardinal symptoms. The chi-square test shows there's significant difference (P< 0.05) in the disappearance rate of bitter mouth and greasy fur. There's no significant difference (P>0.05) in the disappearance rate of other TCM minor symptom indexes. These demonstrate the Modified Gentianae Decoction for Purging Liver Fire and western medicine can both effectively improve the symptoms of leukorrhea disease of the type of dampness invasion of lower energizer, and the former is superior to the latter in improving the symptom of bitter mouth and greasy fur.After treatment, the two groups' local signs (gynecological check-up) were improved. By statistical analysis, it is found there's no significant difference (P> 0.05) between the two groups. It explains that the Modified Gentianae Decoction for Purging Liver Fire and the western medicine both have significant curative effect in improving the local signs of leukorrhea disease of the type of dampness invasion of lower energizer.No adverse reactions and toxicity are found during the clinical trial in the Treatment Group and the Control Group. No abnormal changes related to medical treatment occur in blood, urine, elctrocardiogram, liver and kidney function before and after treatment. ConclusionThe Modified Gentianae Decoction for Purging Liver Fire has confirmed curative effect in treating leukorrhea disease of the type of dampness invasion of lower energizer. It can improve patients'clinical symptoms and the life quality. Radix gentianae, scutellaria, gardenia, alisma rhizoma, bupleurum, angelica, plantain seed and other Chinese Herbal Medicine have a long history of clinical application. They have a variety of sources and don't have toxic or side effects and therefore are worthy of popularization.
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