The Randomized Controlled Clinical Research On Thetreatment Of Primary Dysmenorrhea(Qi Stagnation And Blood Stasis)by Pre-medication Method

Objective:To evaluate the efficacy and security of the professor Yang Jialin’s treatment on primary dysmenorrhea(qi stagnation and blood stasis)by pre-medication method.In order to systematic research the special traditional Chinese medicine treatment which come from famous TCM doctors of primary dysmenorrhea.To provide scientific basis for inheriting and carrying forward traditional Chinese medicine characteristics of famous TCM doctors and for being widely applied in clinic.Methods:The research was a randomized, single-blind, controlled group trial.Patients with primary dysmenorrhea qi stagnation and blood stasis syndrome were selected as clinical research object.Gynecology clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from July 2013 to November 2014,150 patients met the inclusion criteria and exclusion criteria were randomly divided into three groups,premenstrual medication group, menstrual medication group and vacuity contrast group,each group had 50 cases.The treatment medicine were intelligent Chinese medicine granules(Jinling sini siwu shixiao decoction).The premenstrual medication group began from 3 days before menstruation to take medicine. The menstrual medication group began from the first day of menstruation to take the medicine,total for 6 days and three consecutive menstrual cycles. The blank control group was not treated with any other treatments related with the therapeutic effect of this disease for three consecutive menstrual cycles.The symptoms disappeared among the three groups of subjects were followed up for 3 months after the observation.Observe the changes of symptoms and the index of curative effect and security indicators among the three groups before and after treatment.Results:(1)Comparison of VAS score,duration of abdominal pain, CMSS scale and TCM syndrome score of the three groups.Compared within group before and after treatment of the three groups,the differences of the premenstrual medication group and the menstrual medication group had statistical significance(p< 0.05).There were no significant differences in the blank control group(p> 0.05).The comparison of the difference(pre-treatment score minus after-treatment score) before and after treatment between groups of the three groups were significant differences(P<0.01).(2)Comparison of the single TCM syndrome score:Compared the scores of single TCM syndrome within group before and after treatment of the three groups.the premenstrual medication group and the menstrual medication group showed statistical significance(p< 0.05) on the TCM syndrome of the degree of abdominal pain、 duration of pain、absence of menses、menstrual qualitative and colo、breast tenderness and chest discomfort.The blank control group had no significant difference above the individual symptoms(p>0.05). Compared between groups of the difference(pre-treatment score minus after-treatment score) before and after treatment. Compared with the blank control group, the differences of the premenstrual medication group were statistically significant in all the single TCM syndromes(p< 0.05),so as the comparison between menstrual medication group and blank control group(p< 0.05).The differences were statistically significant between premenstrual medication group and menstrual medication group on the TCM syndrome of the degree of abdominal pain and duration of pain(p<0.05),but no statistically significant on the syndrome of absence of menses、menstrual qualitative and color、breast tenderness and chest discomfort(p>0.05).(3)The totality curative effect comparison:①The comparison of the curative effect about TCM syndrome:The total effective rate of premenstrual medication group was 96.00%,menstrual medication group was 83.67%, blank control group was 12.77%.The differences about TCM syndromes of three groups were statistically significant(P<0.05). The difference that compared with each other in the three groups were statistically significant(P<0.05).②The disease comprehensive curative effect comparison:The total effective rate of premenstrual medication group was 98.00%,menstrual medication group was 85.71%, blank control group was 12.77%.The differences were statistically significant of the three groups about disease comprehensive curative effect (P<0.05). The differences that compared with each other in the three groups were statistically significant(P<0.05).(4)Safety comparison:Three groups of subjects found no adverse events and adverse reactions, and there were no clinical significance of study drug-related indicators of physical and chemical examination.The clinical application is safe.ConcLusion:(1)The pre-medication method is used to therapy PD(qi stagnation and blood stasis) by Jinling sini siwu shixiao decoction can significantly improve the degree of abdominal pain,the average severity of symptoms and TCM symptoms, shorten the duration of abdominal pain and dysmenorrhea symptom continual period.(2)For single TCM symptoms,the curative effect of premenstrual medication group is superior than menstrual medication group on the TCM syndrome of the degree of abdominal pain and duration of pain.The premenstrual medication group and menstrual medication group showed similar efficacy in the other four TCM syndromes.(3)The clinical curative effect of the pre-medication in treating primary dysmenorrhea (qi stagnation and blood stasis syndrome) is better than menstrual medication, and the clinical application is safe and effective,with no adverse reactions.The pre-medication is worthy of being widely applied in clinic.