| ObjectiveThis study intends to discuss the clinical effect and safety of Chinese Medicine compounds of Tumor-clearing Decoction (Hua Liu Tang) in the treatment of hysteromyoma by observing the changes of symptoms, signs, size of hysteromyoma before and after treatment and to explore the inner pathophysiological mechanism of hysteromyoma.Methods60 cases aged 25-50 years old who met the Western Medicine hysteromyoma diagnosis criteria and Chinese Medicine syndrome differentiation criteria were included from the Gynecology and Obstetrics Hospital in Zhanghua, Taiwan. The 60 cases were randomly divided into two groups with 30 cases in the Trial Group (Tumor-clearing Decoction) and the Control Group (mifepristone). The administration started from the non-menstrual period. The Tumor-clearing Decoction used by the Trial Group are the science Chinese Medicine produced by Chuang Songzong Pharmaceutical Co., Ltd. The dose includes salvia miltiorrhiza 3.5g, paeoniae radix 2g, peach seed 2g, rhizome sparganii 1.2g, rhizome curcumae 1.2g, nutgrass galingale rhizome 2g and eupatorium 2g, etc. Take a dose at 3 times each day with empty stomach. Three months make a treatment period and stop the administration in menstrual period. Stop taking other medications during treatment. Avoid cold and uncooked food and recheck regularly. The Control Group subjects started the oral taking of medicine since the second day of menstruation period with 12.5 mg each time and once daily. Three months make one period of treatment. Take the quantization scoring of TCM syndromes and conduct the clinical observation of hysteromyoma treated with two methods, considering the index check-up results.ResultsAfter treatment, the Trial Group:the clinical full recovery rate is 60.0%, the rate of excellence 20.0%; the Control Group:the clinical full recovery rate is 33.3% and the rate of excellence 20.0%. The total effective rates of TCM syndrome of the Test Group and the Control Group are 90.0% and 76.67% respectively. The difference of two groups'Chinese Medicine syndrome curative effect has significant difference and the Trial Group is superior to the Control Group.After treatment, two groups'Chinese Medicine syndrome scores show the Test Group is superior to the Control Group. The D-value comparison indicates the Test Group is superior to the Control Group.The comparison of two groups'improvement of uterus condition, the menstrual blood volume, the menstrual color and the menstrual quality after treatment shows no statistically significant difference (P>0.05). It indicates two groups have equivalent curative effect in treatment of syndromes mentioned above.The improvement degree comparison of bradymenorrhea shows significant difference (P<0.05). It indicates the Test Group is better than the Control Group in curative effect.The Trial Group and Control Group's blood serum E2 levels rise from 157.45±30.75 and 149.14±32.81 before treatment to 317.53±99.53 and 267.83±90.72 after treatment respectively. The two groups'interclass difference, the interclass D-value difference and the in-class AP difference after treatment have statistical significant differences (P<0.05).The Trial Group and Control Group's P assessment values decrease from 17.55±9.43 and 18.13±10.13 before treatment to 12.16±5.37 and 15.51±7.81 after treatment respectively. The two groups'interclass difference, the interclass D-value difference and the in-class AP difference after treatment have statistical significant differences (P<0.05).The Trial Group and Control Group's blood serum FSH levels decrease from 7.29±2.66 and 6.62±2.73 before treatment to 2.53±1.04 and 3.47±1.57 after treatment respectively. The two groups'interclass difference, the interclass D-value difference and the in-class AP difference have statistical significant differences (P<0.05).The Trial Group and Control Group's blood serum LH levels decrease from 49.75±21.47 and 51.14±22.04 before treatment to 23.58±12.08 and 25.47±11.61 after treatment respectively. The two groups'in-class AP difference has statistical significant differences (P<0.05). After treatment, the interclass difference and the interclass AP D-value difference have no statistical significance (P>0.05).The Trial Group and Control Group's T assessment values decrease from 6.34±3.04 and 6.88±2.46 before treatment to 4.01±1.88 and 3.75±1.46 after treatment respectively. The two groups'in-class AP difference has statistical significant differences (P<0.05). After treatment, the interclass difference and the interclass AP D-value difference have no statistical significance (P>0.05).The Trial Group and Control Group's PRL levels decrease from 14.24±6.84 and 15.11±7.23 before treatment to 9.84±2.71 and 10.78±4.07 after treatment respectively. The two groups'in-class AP difference has statistical significant differences (P<0.05). After treatment, the interclass difference and the interclass AP D-value difference have no statistical significance (P> 0.05).After treatment, the two groups'disappearance rates of symptoms and signs like breast tenderness have significant difference (P<0.05). There's no significant difference (P>0.05) in comparing the disappearance rates of symptoms and body signs including uterine bleeding, abdominal pain, anus fall etc.Safety test indicates no abnormal changes occurred to those with normal blood, stool, urine, liver and kidney function and electrocardiogram results. It confirms the drug has clinical safety.Conclusion1. In the treatment of hysteromyoma, Tumor-clearing Decoction has better curative effect than mifepristone.2. Tumor-clearing Decoction has better curative effect than mifepristone in lowering hysteromyoma patients'blood P and FSH levels and enhancing the E2 level.3. Tumor-clearing Decoction can effectively ameliorate patients' bradymenorrhea. |
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