Effectiveness And Safety Evaluation Of Tiaojing Yangyan Capsule In The Treatment Of Primary Dysmenorrhea

Objective To evaluate the efficacy and safety of Tiaojing Yangyan Capsule in the treatment of primary dysmenorrhea(Qi and Blood Deficiency and Blood Stasis Syndrome),and to provide the basis for applying for the protection of traditional Chinese medicine.Methods 108 patients with primary dysmenorrhea were included in Yichun People's Hospital,the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine and the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine.The subjects were randomly divided into two groups: 72 cases in the experimental group and 36 cases in the control group.The experimental group began to take Tiaojing Yangyan Capsule 2 weeks before menstruation,4 capsules at a time,3 times a day;continued to take three menstrual cycles,drug withdrawal during menstruation,and took Fukang tablet simulator,5 tablets at a time,2 times a day.The control group took Fukang tablets,5 tablets at a time,twice a day,and Tiaojing Yangyan capsule simulator,4 tablets at a time,3 times a day,according to the same method and course of treatment.VAS(Visual Analogue Scale/Score)score was used to observe the changes of pain degree before and after taking medicine in the two groups;CMSS(Cox Menstrual Symptom Scale)score was used to observe the changes of total attack time and average severity of dysmenorrhea before and after taking medicine in the two groups;and the changes of patients before and after taking medicine were observed by evaluating the curative effect of TCM syndromes and the efficiency of individual TCM symptoms,and blood routine,urine routine,stool routine and electrocardiogram before and after taking medicine were also observed.Fig,B-mode ultrasonography,liver and kidney function,coagulation and urinary pregnancy were used to detect the safety indicators and record the combined use of drugs and adverse events.Results 108 cases were enrolled in the experiment plan,108 cases were actually enrolled in the experiment group,105 cases completed the experiment,3 cases quit.The reasons for quitting were "lost interview".Among them,1 case in the experiment group and 2 cases in the control group.(1)After drug treatment,the VAS score of the experimental group was significantly lower than that of the control group(? < 0.0001).There was no significant difference between the experimental group and the control group at follow-up.The efficacy of the experimental drug was not inferior to that of the positive control drug,and the experimental drug was effective.(2)The scores of CMSS scale of two groups after drug treatment showed that the scores of the experimental group before and after treatment were significantly lower than those of the control group(P<0.0001).There was no significant difference between the two groups after treatment,that is,the efficacy of the experimental drugs could reach the level of the control group,and the experimental drugs were effective.(3)The changes of TCM syndrome score and relative baseline of the two groups after taking medicine showed that the changes of self-control score were significant(P < 0.0001).Compared with the control group,the scores of TCM syndromes in the experimental group decreased significantly at visiting 6,follow-up 1 and follow-up 2(P = 0.0030,P = 0.0263,P = 0.0278).That is to say,the scores of TCM syndromes in the experimental group were better than those in the control group at the three time points.There was no difference in the scores of TCM syndromes between the experimental group and the control group at visiting 2,visiting 3,visiting 4 and follow-up 3.Significant,that is,the experimental group and the control group of TCM syndrome score showed similar efficacy.Relative baseline changes of the experimental group were significantly different from those of the control group at visiting 6(P= 0.0277).In the relative baseline changes,the curative effect of the experimental group was better than that of the control group at visiting 6.There was no significant difference in the relative baseline changes between the experimental group and the control group at other visiting and follow-up time points.Effectiveness.(4)The experimental group and the control group had a higher percentage of oligoabdominal pain and dark purple meridian after taking medicine,and the curative effect was outstanding;the percentage of the experimental group was slightly lower than that of the control group in the aspect of the single TCM syndrome score of pale complexion;the symptoms such as dark purple,dim complexion or dark spots,oligoabdominal pain,fatigue,dizziness and lazy speech were improved.The scores of good aspects were higher than those of the control group.(5)Comparing the cure rate,marked cure rate and total effective rate of the two groups before and after treatment,the results showed that the marked cure rate and total effective rate of the experimental group were 15.28% and 97.22%,respectively,which were significantly higher than those of the control group(2.78% and 72.22%).The experimental group had better therapeutic effect.(6)During the experiment,the incidence of adverse events was 1.39% in the experimental group and 2.78% in the control group,and the incidence of adverse reactions was 0.00% in both groups.(7)At 3 months of treatment,the changes of vital signs in both groups had no significant clinical significance.(8)Most of the laboratory tests before and after treatment in both groups were within the normal range.Conclusion Tiaojing Yangyan Capsule is relatively effective and safe in the treatment of primary dysmenorrhea.