| Objective:To evaluate the rational use and curative effect of TCM external treatment in breast hyperplasia by summarizing the clinical medication rules and observing the therapeutic effect of TCM external treatment in breast hyperplasia.Methods:(1) Search terms such as disease (breast hyperplasia) and interventions (TCM external therapy) were searched in databases of Cochrane library, CNKI and Wanfang, while the searching period was before 31th December 2014. The medication usage laws of TCM external formula in treating breast hyperplasia were analyzed by TCM inheritance assistant system. Medication frequency, correlation of couplet medicines, and new formula evolution were analyzed. (2) 260 breast hyperplasia patients from 5 research centers were randomly divided into two groups-treatment group (N=130, given Sanjie Rupi Gao) and control group (N=130, given Sanjie Rupi Gao simulation agent) by random, double-blind, and placebo parallel control method. One piece of plaster was sticked on the most pain points of the bilateral breasts for seven hours a day. Each group was treated for 2 menstrual cycles except the menstruation period. Breast pain, lumps, general symptoms, and TCM syndromes were observed and evaluated.Results:(1) The most frequently used Chinese herbs were Frankincense (Ruxiang), m yrrh (Moyao), borneol (Bingpian).18 new formula were found, such as Radix Paeonia e Alba (Baishao)-borneol (Bingpian)-Trichosanthes kirilowii (Gualou)-liquorice (G ancao) and Fructus forsythia (Lianqiao)-Chinese gall (Wubeizi)-Notopterygium (Qia nghuo)-Akebia quinata (Mutong), etc.(2) After the treatment, results showed as follows:①TCM external therapy can effec tively relieve the pain and shorten the duration. ② TCM external therapy can improve the lumps caused by hyperplasia of mammary gland. ③General symptom scores:tre atment group was superior to control group in alleviating symptoms as hypochondriac pain, dysmenorrhea, soreness and weakness of waist and knees, there was significant d ifference with P<0.05～0.01, which indicated that TCM external therapy was prominent in alleviating the symptoms caused by liver qi stagnation by soothing the liver and p romoting qi.④ Curative effect:The total therapeutic effect of treatment group was 73. 2% while the control group was 31.8%.⑤ TCM external therapy had exact curative effect on breast hyperplasia with the total effective rate of TCM syndrome in treatmen t group and control group were separately 69.1% and 27.9%.Conclusion:The medication law of TCM external therapy can be used as clinical medication reference. TCM external therapy has prominent curative effect in treating breast hyperplasia.
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