The Clinical Study Of Jiawei Danggui-Shaoyao-San And Ear Acupoint Pressing Beans In The Treatment Of Dysmenorrhea Caused By Endometriosis And Adenomyosis

ObjectiveThis study followed the principle of syndrome differentiation and treatment in traditional Chinese medicine,through prospective clinical studies,studied the clinical efficacy and safety of Jiawei Danggui Shaoyao San combined with auricular point sticking in the treatment of dysmenorrhea caused by endometriosis and adenomyosis.MethodsThis study is a prospective,randomized,control led,clinical trial.We will select patients who experienced dysmenorrhea caused by endometriosis and adenomyosis between January 2018 and December 2019 at Guangdong Provincial Hospital of Chinese Medicine.Patients will be randomly assigned to the following groups:(1)Danggui Shaoyao San(DSS)group;(2)Danggui Shaoyao San(DSS)and auricular point therapy(APT)group and(3)Marvel on(DET)group.We will then evaluate the effectiveness and safety of Danggui Shaoyao San(DSS),and ear acupoint pressing beans,for patients by comparing a range of indices between different groups,including Visual Analog Scale(VAS)for pain,Short-Form McGill Pain Questionnaire(SF-MPQ),Dysmenorrhea symptom timepoints,TCM correlative symptom timepoints and so on.Safety assessments including routine blood tests,liver and kidney function tests,and an electrocardiogram will be performed both before and after treatment.Results1.The baseline before treatment:There were no statistically significant differences(P>0.05)in age,menstrual status,dysmenorrhea VAS score before treatment,dysmenorrhea symptom score before treatment,TCM syndrome score before treatment and other baseline conditions between the three groups before treatment,and the three groups were comparable.2.Dysmenorrhea VAS score and dysmenorrhea symptom score:(1)Dysmenorrhea VAS score:①After one month treatment,DSS+APT group pain VAS was 5.34±2.57,DSS group was 5.00±2.19,and DET group was 6.09±2.37.It turns out that DSS+APT group and DET group were lower than before treatment within group,the difference was statistically significant(P<0.05),except DSS group(P>0.05).②After a 3-month treatment,DSS+APT group pain VAS was 4.06±2.49,DSS group was 3.31±2.20,DET group was 4.21±2.25,three group could relieve of patients with endometriosis/adenomyosis dysmenorrhea before and after treatment within group.The reduction of VAS score before and after treatment in the three groups was not statistically significant by the rank-sum test of various comparisons(P>0.05).(2)Dysmenorrhea symptom score;①After one month treatment,DSS+APT group pain VAS was 8.39±2.91,DSS group was 8.33±2.73,and DET group was 9.41±2.68.It turns out that DSS group and DET group were lower than before treatment within each group,the difference was statistically significant(P<0.05),except DSS+APT group(P>0.05).②After a 3-month treatment,all group could relieve of the dysmenorrhea symptom self before and after treatment,the difference was statistically significant(P<0.05).The reduction of dysmenorrhea symptom score before and after treatment in the three groups was not statistically significant(P>0.05),indicating that the three group have no difference in relieve dysmenorrhea symptom.3.In terms of TCM syndrome score:(1)Comparison was made between each group,in terms of the difference value of the decrease of TCM syndrome score between each group after 1 month of treatment an d 3 months of treatment,the data of the three groups were statistically significant(P<0.05).It shows that all groups have an obvious effect in improving TCM symptoms.(2)The reduction of TCM syndrome score before and after treatment in the three groups was not statistically significant(P>0.05).(3)A 3-month follow-up after treatment,self before and after,DSS+APT group and DSS group were lower than just after treatment,the difference was statistically significant(P<0.05),except DET group(P>0.05),indicating that Danggui-Shaoyao San with/without ear acupoint pressing beans has better curative effect than that of Marvelon in improving the TCM symptoms.4.VAS curative effect:DSS+APT group total effective rate 77.4%,DSS group total effective rate 76.9%,DET group total effective rate 78.8%.After multiple independent sample rank sum tests,the difference was not statistically significant(P>0.05).5.TCM syndrome score:DSS+APT group total effective rate 83.9%,DSS group total effective rate 80.8%,DET group total effective rate 81.2%.After multiple independent sample rank sum tests,the difference was not statistically significant(P>0.05).ConclusionJiaWei Danggui-Shaoyao-San with/without Ear Acupoint Pressing Beans and Marvelon have the same effect in improving women with dysmenorrhea due to endometriosis and/or adenomyosis,and the overall symptoms of patients with dysmenorrhea score and dysmenorrhea symptoms related to disharmony between liver and spleen,blood deficiency and blood stasis.During the study,JiaWei Danggui-Shaoyao-San with Ear Acupoint Pressing Beans group has no obvious side effects,TCM combined treatment can effectively improve the comprehensive symptoms of patients with liver and spleen disorders,blood deficiency and blood stasis caused by adenomyosis/endometriosis.The curative effect is clear and safe,which is worthy of further clinical exploration and extensive application.