| ObjectiveUsing a randomized controlled method, the study observes the safety and therapeutic effect of taking Luo's jiawei tianqi tongjing san in the treatment of endometriosis-related dysmenorrhea of the kidney deficient and blood stasis syndrome.MethodPatients in the study must qualify the Western medicine diagnosis of endometriosis-related dysmenorrhea and the TCM diagnosis of the kidney deficient and blood stasis syndrome. They were randomly divided into treatment and control group. The patients in the treatment group were prescribed Luo's tianqi tongjing san, while those in the control group were given shixiao san. The prescriptions were to be taken for 3 courses of treatment. The patients'menstrual cycle, volume, color, and change in menstruation, especially the level of menstrual pain and any accompanying symptoms were monitored.ResultsThe study had a total of 80 qualified patients from the out-patients department; each group contained 40 subjects. Before treatment, their age, course, severity, staging of disease, the site and volume of endometriosis, menstrual condition, basal body temperature, tongue and pulse diagnosis, and blood CA-125 level were assessed, and found that there was no significant group difference; thus, the groups were comparable.After 3 courses of treatment, the treatment group resulted in a curative rate of 62.5%, very effective rate of 17.5%, effective of 12.5%, the curative and very effective rate amount to 80.0%, and the total effective rate was 92.5%; for the control group, the curative rate was 40.0%, very effective rate of 20.0%, effective of 27.5%, the curative and very effective rate amount to 60.0%, and the total effective rate was 87.5%. The group difference was statistically significant. The rate of improvement after 3 courses of treatment for the treatment group was 65.0%, and that for the control group was 42.5%; their group difference was also statistically significant.The average diameter of the endometrial cyst for the treatment and control group was 4.32±1.26cm and 3.88±1.35, respectively before treatment, and they respectively shrunk to 2.79±1.03cm and 3.14±1.15cm after 3 courses of treatment. The group difference was statistically significant (p<0.05), and the difference within each group showed statistical significance as well (p<0.01). Both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial cyst, but the former was more effective than the latter.Before treatment, the average diameter of the endometrial lesions for the treatment and control group was 3.17±1.54cm and 2.96+1.30cm, respectively; after 3 courses of treatment however, the lesions decreased to 1.97±0.75cm and 2.23±0.88cm for the two groups. The change was not significantly different between the groups. However, the change within the groups showed significant difference (p<0.01), which demonstrates that both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial lesions.The serum CA-125 level for the treatment group was 56.26±8.71μg/L before treatment, and after one, two and three courses of treatment, the level dropped to 23.17±7.32μg/L,34.17±7.23μg/L and 40.53±6.46μg/L, respectively. As for the control group, it was 54.30±7.65μg/L before treatment, and after 1,2 and 3 courses, the level dropped to 18.81±6.88μg/L,28.84±7.06μg/L, 36.12±6.72μg/L, respectively. The group difference and the difference with each group showed statistical significance.The study did not encounter any abnormal lab readings or adverse reactions in patients. ConclusionLuo's jiawei tianqi tongjing san was effective in treating endometriosis-related dysmenorrhea. It improved clinical symptoms, reduced the dimension of both endometrial cyst and lesion. It was both safe and effective for common practice.
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