Clinical Research Of Using Ziyinliangxue Capsules In Treating Advanced Menstruation Of The Deficiency-heat Syndrome

ObjectiveThe study observes the therapeutic effect of using ziyinliangxue capsules in treating advanced menstruation of the deficiency-heat syndrome.MethodA total of 60 patients chosen during the period of March 2009 to January 2010 from the DeAn TCM Clinic in Taiwan participated in the study. They were all diagnosed with advanced menstruation due to ovulatory dysfunctional uterine bleeding (DUB) with luteal insufficiency and deficiency-heat syndrome in terms of TCM diagnosis. The 60 patients were randomly divided into 2 groups: the treatment group used ziyinliangxue capsules, and the control group used zhibodihuang capsules. After 2 courses of treatment, the curative effect of the ziyinliangxue capsules was analyzed, as well as observation of the degree of pathogenic heat in the blood in the patients by monitoring the change in the dryness in the mouth, pathogenic heat in the palms and feet, yellow urine color, and dry stool, in addition to the change in menstrual cycle, volume, color and nature of menses. The safety aspect of the experiment was monitored by taking blood, urine, and stool tests, electrocardiogram, and blood tests for liver and kidney functions.The treatment group was prescribed 4 capsules of ziyinliangxue (equivalent to 2g),3 times a day; the control group was prescribed 4 capsules of zhibodihuang3 times daily. Both types of capsules were made to look identical for the experiment. During treatment, the patients should not undergo other forms of therapies or take any other medication for the condition. One course of treatment was 14 days, and the patients underwent 2 courses of treatment in total. The patients were to begin their prescription post-menstruation, approximately 2 days after menstruation, and continue the prescription for 14 days as one course. After taking 2 courses, the patients were monitored for effectiveness for the following 3 months.Results1. Effectiveness in treating advanced menstruation:the treatment group (N=30) had a curative rate of 46.7%, effective rate of 63.3%, and total effective rate of 86.7%; the control group (N=30) had a curative rate of 20.0%, effective rate of 50.0% and total effective rate of 66.7%. The group difference was found to be statistically significant (p<0.05), which showed that the use of ziyinliangxue capsules was more effective in treating advanced menstruation of the deficiency-heat syndrome.2. Effectiveness in terms of TCM syndrome:the treatment group (N-30) had a curative rate of 60.0%, effective rate of 73.3%, and total effective rate of 93.3%; the control group (N=30) had a curative rate of 50.0%, effective rate of 66.7%, and total effective rate 83.3%. The group difference was found to be statistically significant (p<0.05), which showed that the use of ziyinliangxue capsules was more effective in treating advanced menstruation of the deficiency-heat syndrome in terms of the clinical symptoms.3. In both groups, the change in TCM symptoms observed before and after treatment was significant, which demonstrated that both therapies were effective in improving TCM symptoms. The effectiveness of the two groups was similar.4. The TCM symptoms significantly improved after treatment in both groups, for instance, less advancement in menstruation, decreased menstrual volume, improved color and nature of the menses, as well as improvements in dryness of the mouth, pathogenic heat in the palms and feet, constipation and dry stool, yellowish color of the urine. It showed that both therapies were effective in improving these symptoms; however, the ziyinliangxue capsules were more effective.5. The rate of improvement after one course of treatment for the treatment group (66.7%) was better than that for the control group (56.7%). The group difference was found to be statistically significant; the use of ziyinliangxue capsules was more effective in the treatment.6. Safety:The lab results for all 60 patients did not result in any abnormal readings, which showed that both therapies were safe to use in common practice. ConclusionThe following conclusion can be drawn from the clinical experiment and literature analysis:The ziyinliangxue capsules is an effective prescription for treating advanced menstruation, and works by removing the pathogenic heat in the blood, tonifying the kidney yin, regulating menstruation and menstrual volume. The treatment significantly improved clinical symptoms, such as advanced menses, menstrual volume, color and nature of menses, dryness in the mouth, pathogenic heat in the palms and feet, constipation and dry stool, yellowish urine color. The capsules are both safe and effective for common practice.