Objective:To observe the changes of clinic indices before and after treatment on primary dysmenorrhea patients with syndrome of cold congelation and blood stasis,evaluate the clinical efficacy and safety of Shao-fu-Zhu-yu Decoction combined with Heat-sensitive moxibustion,in order to provide other new ideas for the study of clinical treatment of primary dysmenorrhea.Methods:A randomized,controlled study was conducted.Ninety patients who met the inclusion criteria were selected and divided into three groups,named the traditional Chinese medicine group(30 cases),the heat-sensitive moxibustion group(30 cases)and the traditional Chinese medicine combined with heat-sensitive moxibustion group(30 cases)according to the principle of random allocation in clinical experimental study.In this study,the first group was treated with the Chinese medicine named Shao-fu-zhu-yu Decoction,and the second group was treated with the heat-sensitive moxibustion.And the third group was given the Heat-sensitive moxibustion on the basis of the first group.During the observation,none of cases were excluded and dropped out.The course of treatment took three months in all groups.The changes of clinic indices(the level of pain,dysmenorrhea accompanied symptoms,TCM symptom score,clinical efficacy,safety,etc.)which were observed before and after treatment.Result:1.There was no significant difference in age,course of disease,severity of dysmenorrhea in the three groups before treatment(P>0.05).The baseline of general data of the three groups before treatment were consistent and comparable.2.Severity of dysmenorrhea: The difference among the three groups before and after treatment was statistically significant(P<0.01).3.Comparison of dysmenorrhea symptoms scores in the three groups: the scores of each groups in the third cycle and the the sixth cycle were significantly lower than before treatment(P<0.05).During the observation,the traditional Chinese medicine combined with heat-sensitive moxibustion group has the lowest score among the three groups(P<0.05).4.Comparison of TCM syndrome scores in the three groups:The improvement of TCM syndrome scores in traditional Chinese medicine combined with heat-sensitive moxibustion treatment group was the best among three groups in the third cycle and the the sixth cycle(P<0.05).5.Comparison of curative effects of TCM syndromes: In the third cycle,the total effective rate of the traditional Chinese medicine group was 83.33%,the total effective rate of the heat-sensitive moxibustion group was 73.33%.The total effective rate of the traditional Chinese medicine combined with heat-sensitive moxibustion treatment group was 96.67%.Compared with the traditional Chinese medicine group and the heat-sensitive moxibustion group,the third group had higher effective rate(P<0.01).In the sixth cycle,the total effective rate of the first group was 66.67%,the total effective rate of the second group was 73.33%.The total effective rate of the third group was 96.67%.The traditional Chinese medicine combined with heat-sensitive moxibustion treatment group was significantly better than the other groups in curative effect of TCM syndromes(P<0.01).And there were no significantdifferences between the traditional Chinese medicine group and the heat-sensitive moxibustion group(P>0.05).6.Comparison of Clinical Disease curative effect: In the third cycle,the total effective rate of the traditional Chinese medicine group was 83.33%,the cure rate and marked improvement rate was 33.33%.The total effective rate of the heat-sensitive moxibustion group was 86.67%,the cure rate and marked improvement rate was 26.67%.The total effective rate of the traditional Chinese medicine combined with heat-sensitive moxibustion treatment group was 96.67%,the cure rate and marked improvement rate was 66.67%.Statistical analysis showed that there were significant difference among the three groups(P<0.05).In the sixth cycle,the total effective rate of the first group was 83.33%,the cure rate and marked improvement rate was 40.00%.The total effective rate of the second group was96.67%,the cure rate and marked improvement rate was 26.67%.The total effective rate of the third group was 96.67%,the cure rate and marked improvement rate was 66.67%.The traditional Chinese medicine combined with heat-sensitive moxibustion treatment group was significantly better than the other groups in clinical disease curative effect(P<0.05).There were no significant differences between the traditional Chinese medicine group and the heat-sensitive moxibustion group(P>0.05).Conclusion:Shao-fu-zhu-yu Decoction combined with Heat-sensitive moxibustion therapy has good clinical efficacy and safety in treating primary dysmenorrhea patients with syndrome of cold congelation and blood stasis.During the observation,it can effectively improve the clinical indices such as reduce the level of pain,symptom score of dysmenorrhea,TCM symptom score,etc.And the curative effect was better than that of Shao-fu-zhu-yu Decoction only.It has high clinical application value. |