| ObjectiveIn the first part of this study,through the meta analysis of the related literature on the treatment of primary dysmenorrhea with Xuefu Zhuyu Decoction,the clinical efficacy and safety of Xuefu Zhuyu Decoction in the treatment of primary dysmenorrhea were systematically evaluated;In the second part,we observe the clinical effect of Danhong Huayu oral liquid in the treatment of primary dysmenorrhea of qi stagnation and blood stasis type,so as to provide methodological reference for the research of new TCM drugs of qi stagnation and blood stasis type.Methods1.Meta analysis:The randomized controlled trials of Xuefu Zhuyu Decoction in the treatment of primary dysmenorrhea in CNKI,VIP,wangfang,Pub Med,web of science and MEDLINE were searched by computer from the establishment of the database to February 2020.According to the inclusion exclusion criteria,two researchers independently selected literature,extracted data,and assessed the bias risk of the included literature.And then used Revman 5.3 software for meta analysis.2.Clinical observation:In this study,31 patients with primary dysmenorrhea of qi stagnation and blood stasis type who met the inclusion criteria were selected from the gynecological clinic of Affiliated Hospital of Chengdu University of traditional Chinese medicine from October 2017 to November 2018,or recruited through the subject advertisement published by QQ group and wechat group of Chengdu University of traditional Chinese medicine.Using double-blind design,31 subjects were divided into experimental group and control group by using central random system.The experimental group took Danhog Huayu oral liquid,starting 5 days before menstruation,taking 7 days,10 ml per time,3 times a day,treatment of 3 consecutive menstrual cycles;The control group took Danhong Huayu oral liquid simulation,starting 5 days before menstruation,taking 7 days,10 ml per time,3 times a day,treatment of 3 consecutive menstrual cycles.Before and after treatment,the curative effect of TCM syndrome,the change of TCM syndrome integral,the change of VAS score and the change of CMSS scale integral were observed,and the safety was evaluated.Results1.Meta analysis: A total of 11 articles were included,including 1247 cases of primary dysmenorrhea.The results of meta analysis showed that the therapeutic effect of Xuefu Zhuyu decoction or Xuefu Zhuyu Decoction Combined with western medicine on primary dysmenorrhea was better than that of single western medicine alone or multiple western medline(P<0.05).The therapeutic effect of Xuefu Zhuyu Decoction in the treatment of primary dysmenorrhea was better than that of single western medicine alone in the improvement of TCM symptoms(premenstrual or menstrual abdominal pain,breast pain)and the degree of pain(P<0.05).2.Clinical observation:(1)VAS score: After one course,two courses and three courses of treatment,there was no significant difference in VAS score between the two groups(P>0.05).The VAS scores of the second and third course of treatment in the experimental group and the control group were significantly lower than those before treatment(P<0.05).The results of FAS analysis and PPS analysis are consistent.(2)CMSS scale pain time: After one course,two courses and three courses of treatment,there was no significant difference in the pain time between the two groups(P>0.05).There was significant difference in the pain time of the second and third course of treatment between the experimental group and the control group(P<0.05).The results of FAS analysis and PPS analysis are consistent.(3)Severity of CMSS: After the first course,the second course and the third course of treatment,there was no significant difference between the two groups(P>0.05).The severity of CMSS in the first,second and third course of treatment in the experimental group and the third course of treatment in the control group was significantly lower than that before treatment(P<0.05).The results of FAS analysis and PPS analysis are consistent.(4)TCM syndrome efficacy:FAS ananlysis: The total effective rate of the experimental group was 68.75%,the recovery rate was 0%,the apparent efficiency was 25%,the effective rate was 43.75%,and the ineffective rate was 31.25%.The total effective rate of the control group was 46.66%,the apparent efficiency was13.33%,the effective rate was 33.33%,and the ineffective rate was 53.34%.There was no significant difference between the two groups(P>0.05).PPS analysis: the total effective rate of the experimental group was 73.33%,the recovery rate was0%,the apparent efficiency was 26.67%,the effective rate was 46.66%,and the ineffective rate was 26.67%.The total effective rate of the control group was58.33%,the apparent efficiency was 16.66%,the effective rate was 41.67%,and the ineffective rate was 41.67%.There was no significant difference between the two groups(P>0.05).After the first course,the second course and the third course of treatment,there was no significant difference between the two groups(P>0.05).The first,second and third courses of TCM syndrome integral in the experimental group and the second and third courses in the control group were significantlylower than those before treatment(P<0.05).The results of FAS analysis and PPS analysis are consistent.(5)Safety evaluation: During this trial,no adverse reactions and clinically significant physical and chemical examination indicators related to the trial drug were found,so the clinical application is relatively safe.Conclusion1.Meta analysis: Xuefu Zhuyu Decoction alone or Xuefu Zhuyu Decoction in combination with western medicine is superior to western medicine alone or in combination in improving the pain degree of primary dysmenorrhea and TCM symptoms(premenstrual or menstrual abdominal pain,breast pain).However,due to the small number and low quality of the included documents,the results may be biased.Large sample,high quality,multicenter randomized controlled clinical trials are needed to further verify the results.2.Clinical observation:(1)There was no significant difference in clinical effect between Danhong Huayu oral liquid and Danhong Huayu oral liquid simulant,which may be related to the insufficient number of study cases and other factors affecting dysmenorrhea.(2)There was no statistical significance in the integral results of CMSS and TCM Syndromes of Danhong Huayu oral liquid and Danhong Huayu oral liquid simulant;(3)There was no significant difference between Danhong Huayu oral liquid and Danhong Huayu liquid simulant in improving the pain of dysmenorrhea.(4)This topic is a part of the clinical research which study on the effectiveness and safety of Chinese patent medicines treating qi stagnation and blood stasis syndrome with multi-center,multi-disciplinary cooperation and useTCM syndromes as its main index.It is also the initial stage of clinical research on the treatment of primary dysmenorrhea with Danhong Huayu oral liquid.The lack of positive results in this study was mainly related to the insufficient sample size. |
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