| ABSTRACT Objective:To evaluate the efficacy of Transforming Phlegm and Disperse Conglomeration Method in treating adenomyosis with phlegm-dampness stagnated syndrome(PDSS) by comparing the clinical symptoms and signs, uterine volume and serum CA125. To explore its mechanisms. To provide an alternative treatment for those who failed surgical or pharmaceutical treatments, especially for patients who wish to maintain fertility.Methods:Totally 40 adenomyosis patients were accepted from August 2013 to January 2015 in Dongfang Hospital, the Second Affiliated Hospital of Beijing University of Chinese Medicine. The 10 patients in control group took Sanjie Zhentong Capsule,1.6g each time and 3 times a day after meals, while the 30 patients in trail group took Chuanxia Ningkun Granules, one dose per time, twice a day after breakfast and dinner starting from Day 3 after the end of menstruation to the next beginning. The PDSS scores, Numerical rating scale(NRS) scores, COX scores, serum CA125 level and (examine 2 or 3 days after their menstruation finished by type-B ultrasound) were compared after 3 menstrual periods. SPSS 17.0 software were used to record and analyze the statistics.Results:There was no statistical significance on the difference of the age, disease history, menstrual cycle, menstrual period, PDSS scores, NRS scores, COX scores, serum CA125 level or uterus volume between the two groups at the beginning.1.The clinical efficacy in the trail group was better than that in the control group (P= 0.033). In the control group,the clinical total efficacy was 50.0%.The recovery cases was 1(10.0%),the marked cases were 1(10.0%), the effective cases were 3(30.0%) and the ineffective cases were 5(50.0%). In the trail group, the clinical total efficacy was 83.33%.The recovery cases were 7(23.33%), the marked cases were 10(33.33%), the effective cases were 8(26.67%) and the ineffective cases were 5 (16.67%).2.Compared with the same group, PDSS scales were improved in both groups(the control group’P=0.002, the trail group’P< 0.001). The PDSS score of the controlled group was 14.60 ±3.06 at the beginning and 8.10+4.58 at the end. In the trail group it was 15.87± 4.95 at the beginning and 8.27±6.27 at the end. There was no statistically difference between the two groups(P=0.150). It may be more effective for the trail method to relieve some PDSSs like menorrhagia, fatigue,feeling dizzy and heart palpitating and leukorrhagia.3. Both treatments could relieve dysmenorrhea, and the trail group had better efficacy(P=0.040). NRS score was descended in the control group from 6.50±1.96 to 4.50± 2.07(P=0.041), while in the trail group it was descended from 6.03±2.01(M=5.50, QL=4.0, Qu=7.0)to 2.63±2.31(M=2.5, QL=0.75 Qu=5.0, P=0.015).4. After treatments, the frequency and severity score of COX descended in both groups. In the control group the frequency score descended from 20.40±9.87 to 12.80±9.20(P=0.002), while the severity score descended from 15.30±8.64 to 10.40±9.01(P=0.023). In the trail group the frequency score descended from 24.40±11.33 to 11.30±11.64(P<0.001), while the severity score descended from 18.80±10.15 to 8.83±8.89(P<0.001).5.Both treatments had no impact on the uterus volume.6.Both treatments could reduce serum CA125 level(the trail group from 40.44±15.84 to 27.51±19.83, P=0.015. the control group from 62.33±57.54 to 46.90±48.05,P=0.024).7.There were no obviously adverse reactions during the treatments.Conclusion:The Transforming phlegm and Disperse conglomeration method in treating Adenomyosis with accumulation of phlegm-dampness syndrome could relieve dysmenorrhea, menorrhagia and reduce serum CA125 level. It may be superior to the control drug on relieving dysmenorrhea and some PDSSs like pale color of face, fatigue,feeling dizzy and heart palpitating and leukorrhagia. The trail method has affirmatively clinical efficacy that deserves more attention and further researches. |
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