| OBJECTIVE:To explore the efficacy and safety of acupuncture combined with traditional Chinese medicine of promoting blood circulation and dispersing nodules in the treatment of uterine leiomyomas(ULs)of blood stasis type.METHODS:This study adopted a prospective cohort study method to collect ULs patients who met the inclusion criteria and did not meet the exclusion criteria from the gynecological clinic of Guang’anmen Hospital,Chinese Academy of Chinese Medical Sciences from July 2022 to February 2023.According to whether the patients had received acupuncture treatment,the included participants was divided into an observation group and a control group in a ratio of 2:3.The control group was treated with traditional Chinese medicine of promoting blood circulation and dispersing nodules for 3 months,while the observation group was treated with acupuncture on the basis of the control group for 3 months.Myoma volume,uterine volume,scores of pictorial blood loss assessment chart(PBAC),the frequency of menstrual cycle,the length of menstrual period,scores of traditional Chinese medical symptom,scores of symptom severity(SS)for ULs,scores of 7-tiem generalized anxiety disorder scale(GAD-7),scores of patients’ health questionnaire depression scale-9 item(PHQ-9)between the two groups before and after treatment,as well as liver function,renal function and incidence of adverse reactions during treatment was compared.SPSS26.0 was used to establish a database and conduct statistical analysis.RESULTS:1.A total of 75 participants were included in this study,including 30 in the observation group and 45 in the control group;There were 3 cases of shedding in the observation group and2 cases in the control group;A total of 70 cases with complete data were finally observed and included in the statistics,including 27 cases in the observation group and 43 cases in the control group.There was no statistically significant difference between the two groups in terms of age,body mass index(BMI),educational background,work intensity,monthly income,marital status,pregnancy and childbirth history,history of fibroid surgery,age at menarche,menstrual status,volume of myoma and uterine(P>0.05),indicating comparability.2.Compared with before treatment,myoma volume in the control group and observation group significantly decreased after treatment(P=0.007 and P<0.001);Compared between the two groups,myoma volume in the observation group decreased more significantly after treatment compared to the control group(P=0.020).The results of subgroup analysis on different sizes of fibroids showed that compared with before treatment,the large fibroid group in the control group significantly reduced the myoma volume after treatment(P<0.05),while there was no significant difference between the medium and small fibroid groups(P>0.05);After treatment,both the small and large myoma groups in the observation group showed significant reduction in myoma volume(P<0.05),while the medium myoma group showed no significant difference(P>0.05).3.Compared with before treatment,there was no significant difference in uterine volume between the control group and the observation group after treatment(P=0.498 and P=0.799);There was also no significant difference between the two groups after treatment(P>0.05).4.Compared with before treatment,the scores of PBAC of the control group and the observation group were significantly reduced after treatment(P=0.008 and P=0.001);There was no significant difference between the two groups after treatment(P>0.05).5.Compared with before treatment,there was no significant change in the frequency of menstrual cycles after treatment in both the control group and the observation group(P>0.05);There was also no significant difference between the two groups after treatment(P>0.05).6.Compared with before treatment,there was no significant change in the length of menstrual period after treatment in both the control group and the observation group(P>0.05);There was also no significant difference between the two groups after treatment(P>0.05).7.Compared with before treatment,the scores of traditional Chinese medicine symptoms in the control group and observation group after treatment were significantly reduced(P<0.05);There was no significant difference between the two groups after treatment(P>0.05).8.Compared with before treatment,the scores of SS for ULs in both the control group and the observation group were significantly reduced after treatment(P<0.05);After treatment,the observation group showed a more significant improvement in the scores of SS for ULs compared to the control group(P<0.05).9.Compared with before treatment,the scores of GAD-7 of the control group and the observation group after treatment was significantly reduced(P<0.05 and P<0.01);There was no significant difference between the two groups after treatment(P>0.05).10.Compared with before treatment,the observation group showed a significant decrease in the scores of PHQ-9 after treatment(P<0.01),while the control group showed no significant difference in the scores of PHQ-9 after treatment(P>0.05);After treatment,the observation group showed a more significant improvement in the scores of PHQ-9 compared to the control group(P<0.05).11.Compared with before treatment,there were no significant changes in alanine transferase(ALT),aspartate transaminase(AST),creatinine(Cr)and blood urea nitrogen(BUN)between the two groups after treatment(P>0.05).There was no significant difference in all indicators between the two groups after treatment(P>0.05).During the study,only 3 mild adverse events were reported in the observation group,and there was no significant difference in the proportion of adverse events between the two groups(P=0.053).There were no serious adverse events in both groups,and no subjects discontinued treatment or withdrew from the trial due to adverse events.CONCLUSION:1.Acupuncture combined with traditional Chinese medicine of promoting blood circulation and dispersing nodules can effectively reduce the myoma volume,reduce menstrual flow,improve symptoms,alleviate anxiety and depression,and do not affect the frequency and length of menstrual cycles;In terms of reducing the myoma volume,improving symptoms,and alleviating depression,it is better than using traditional Chinese medicine treatment alone.2.Acupuncture combined with traditional Chinese medicine of promoting blood circulation and dispersing nodules has a certain degree of safety in the treatment of ULs of blood stasis type. |
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