| ObjectiveThis randomized controlled clinical trial intends to discuss the clinical efficacy and safety on the treatment of hysteromyoma with Ramulus Cinnamomi and Poria Cocos Pills together with seaweed and liquorice (18 antagonisms) and leeches.MethodsAccording to the Western Medicine diagnosis criteria of hysteromyoma and the TCM syndrome differentiation standards,60 cases of age between 20 and 50 years old are collected in Gaotang TCM Joint Clinics in Tainan City, Taiwan. They are randomly divided into two groups with each group 30 cases. The Treatment Group adopts the Chinese Medicine compounds including ramulus cinnamomi, poria cocos,18 antagonisms and insect drugs. The Control Group takes the Ramulus Cinnamomi and Poria Cocos Capsules. The administration starts from the non-menstruation period with 3 doses daily for three months which consist one period of treatment. Adopt the quantitative scoring of Chinese Medicine syndromes and conduct the clinical observation on the hysteromyoma treatment with two therapies, with the index examination results taken into consideration.The Treatment Group:30 cases were treated with the Chinese Medicine compounds including ramulus cinnamomi, poria cocos, seaweed, liquorice and leeches, etc. from the non-menstruation period. Take 3 times a day after meal with warm water (Science Chinese Medicine products from Chuang Songzong Pharmaceutical Co., Ltd.,3 months/1 person, unit:grams. Ramulus Cinnamomi and Poria Cocos Pill 15×30×2×3= 2700, rhizoma sparganii:1×30×3 = 90, Chinese Clematis Root:1×30×3= 90, zedoaria:1×30×3=90, paper mulberry fruit:1×30×3= 90, leeches:1×30×3= 90, seaweed:1×30×3= 90, liquorice:1×30×3= 90).The Control Group:30 cases were treated with Ramulus Cinnamomi and Poria Cocos Capsules (Chuang Songzong Pharmaceutical Co., Ltd.) from the non-menstruation period. Orally intake for 3 times a day after meals in the morning, noon and evening with warm water. ResultsAfter treatment, the TCM syndrome total effective rates of the Treatment Group and Control Group are respectively 90.0% and 83.33% whose interclass grade distributional difference has statistical significance (P< 0.05). Comparing the TCM syndrome curative effect, the author finds the difference has significance and the curative effect of the Treatment Group is superior to that of the Control Group.After treatment, comparing the TCM syndrome scores, the author finds the Treatment Group is superior to the Control Group. The Treatment Group is superior to the Control Group in D-value comparison.No statistically significant difference (P> 0.05) is found in the improvement degree comparison of uterine, menstrual volume and abdominal pain conditions, which indicate two groups'treatment methods have equivalent effect for the syndromes mentioned.The Treatment Group and Control Group's serum FSH levels decrease from 6.53±2.43 and 5.39±2.20 before treatment to 2.13±0.85 and 3.55±0.71 after treatment respectively. The interclass difference after treatment and the in-class AP difference have statistical significance (P< 0.05).The Treatment Group and Control Group's serum LH levels respectively decrease from 44.58±11.57 and 50.78±13.24 before treatment to 23.23±7.48 and 33.37±9.33 after treatment. The interclass difference and in-class AP differences after treatment have statistical significance (P< 0.05). The interclass AP D-value comparison has statistical significance (P> 0.05).The Treatment Group and Control Group's serum E2 levels respectively rise from 161.2±20.85 and 152.4±22.11 before treatment to 297.5±59.3 and 271.4±60.2 after treatment. The interclass difference and in-class D-value differences after treatment have no statistical significance (P> 0.05). The in-class AP comparison has statistical significance (P< 0.05).The Treatment Group and Control Group's serum PRL levels decrease respectively from 13.54±4.79 and 14.77±5.27 before treatment to 9.01±4.26 and 12.88±5.57 after treatment. The interclass difference after treatment and in-class AP differences have statistical significance (P< 0.05).The Treatment Group and Control Group's t values decrease respectively from 6.09±3.54 and 6.69±2.68 before treatment to 3.21±1.08 and 3.54±0.56 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).The Treatment Group and Control Group's p values decrease respectively from 16.5±9.3 and 15.3±10.3 before treatment to 13.6±11.3 and 12.1±7.1 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).The disappearance rates of body signs and symptoms like dizziness have significant difference (P< 0.05). The disappearance rates of body signs and symptoms like feverish palms and soles, deficient breath, fatigue and debility, decreased food appetite, etc. have no statistically significant difference (P> 0.05).Safety test indicates those with normal blood, urine, stool, kidney function and electrocardiogram examination results before treatment have no abnormal changes which indicate that the drug can be clinically applied safely.Conclusion1. Ramulus Cinnamomi and Poria Cocos together with seaweed, liquorice and leeches, etc. (18 antagonisms combined with insect-drugs) have better curative effect than Ramulus Cinnamomi and Poria Cocos Capsules to treat hysteromyoma in improving the TCM syndromes. No adverse effect is found till now. It indicates that seaweed combined with liquorice is safe.2.18 antagonisms combined with insect-drugs can reduce the serum FSH, LH and PRL levels of hysteromyoma patients more effectively than Ramulus Cinnamomi and Poria Cocos Capsules.
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