| ObjectiveTo systematically evaluate the clinical efficacy and safety of acupuncture or acupuncture combined with Traditional Chinese medicine in the treatment of uterine fibroids,in order to provide evidence-based medicine evidence for the clinical treatment of this disease by acupuncture or acupuncture combined with Traditional Chinese medicine.A randomized controlled single-blind study was conducted to explore the clinical efficacy and safety of Tongyuan acupuncture combined with Guizhi Fuling Capsule in the treatment of uterine fibroids,so as to provide a new idea and optimal treatment strategy for acupuncture combined with Traditional Chinese medicine in the treatment of this disease.MethodsPart Ⅰ;Systematic evalution and meta-analysis of the efficacy of acupuncture or acupuncture combined with Traditional Chinese medicine in the treatment uterine fibroids:Randomized Clinical Trials of acupuncture or acupuncture combined with Traditional Chiese medicine in the treatment of uterine fibroids were collected by searching English databases:Pubemd,Embase,Cochrane Library and Chinese databases:China Biomedical Abstracts Database(CBM),China Journal Full Text Database(CNKI),VIP and WanFang Data RCT,and retrieved the references included in the study.After the quality evaluation of the included studies was rigorously evaluated by evaluators and treatment extraction,RevMan5.3 software was used for systematic evaluation and meta-analysis.Part Ⅱ:Clinical study of Tongyuan acupuncture combined with Guizhi Puling Capsule in the treatment of uterine fibroids:150 cases of uterine fibroids patients who met the diagnostic criteria and inclusion criteria were randomized,controlled and single-blind,according to 1:1:1.The ratio of 1 was allocated to Guizhi Fuling Capsule group(control group),Tongyuan acupuncture group(treatment group A),Tongyuan acupuncture combined Guizhi Fuling Capsule group(treatment group B),and the clinical efficacy was observed according to the treatment plan of the corresponding groups.Control group took Guizhi Fuling Capsule.Treatment group A was treated with Tongyuan acupuncture method by Professor Lai Xinsheng.Main points:A:Baihui(DU 20),Zhongwan(Ren 12),Tianshu,Qihai(Ren 6),Zhongji(Ren 3).Guilai(,Xuehai(SP 10),Zusanli(St 36),Sanyinjiao(SP 6),Hegu(LI 4),Taichong(Liv 3).B:Geshu(BI 17),Ganshu(BI 18),Ciliao(BI 32),Zhongliao(BI 33).The two groups of main points were selected alternately.Add and subtract:Qi stagnation blood stasis type with Ligou(Liv 5),Zigongxue(EM 18),Diji(SP 8);qi deficiency blood stasis type with Guanyuan(Ren 4),Shenshu(BI 23),Yaoyangguan(Du 3).Treatment group B was treated with Tongyuan acupuncture combined with Guizhi Fuling Capsule.Treatment group A and treatment group B were treated with Lai Shi flying needle into the needle technique.Apart from that Guanyuan(Ren 4),Shenshu(BI 23)and Yaoyangguan(Du 3)use acupuncture reinforcement manipulation,and the rest of the acupoints were treated with the technique of smoothing and reinforcing and reducing until the patient got qi,afterwords in Zhongwan-Zhongji,Tianshu-Guilai,Ganshu-Geshu,Ciliao-Zhongliao,switch on the electroacupuncture instrument,continuous wave,electroacupuncture frequency of 3Hz,intensity of 2mA.the rest of the acupoints every 10min needle.The needle was left for 30min and then released.The patients were treated 2-3 times a week with an interval of 2-3 days,8 times as a course of treatment,a total of 3 courses(the same as the control group for 3 months),i.e.,24 times.Needles are forbidden during menstruation.Uterine fibroid volume and uterine volume were detected by B-ultrasound before and after treatment.Through the examination of sex hormone six(including generated follicle-stimulating hormone,luteinizing hormone,estradiol,prolactin,testosterone,progesterone),red blood cell count,hemoglobin,platelet count,body mass index(BMI),renal function the binomial(including creatinine,urea),liver meritorious service is three(alanine transaminase,aspartic transaminase,r-pancreatic acyltransferase)as objective indicators were observed to clarify the improvement of objective indicators of patients after treatment by Tongyuan acupuncture combined with Guizhi Fuling Capsule,Tongyuan acupuncture and Guizhi Fuling Capsule,and the safety evaluation of the three intervention methods.The Uterine Fibroid Symptom and Health-Related Quality of life(UFS-QOL)and TCM symptom scale were used to observe and evaluate the changes of four dimensions of uterine fibroid symptom score,energy/mood,physical activity limitation,sexual function and various TCM clinical symptoms after treatment.The original data was input into Excel and a database was established.SPSS 25.0 software was used for statistical analysis.The measurement data were in line with normal distribution and uniform variance.One-way anOVA was used to represent the data with mean± standard deviation.When the measurement data did not conform to the homogeneity of normal distribution and variance,the rank sum test in nonparametric analysis was used to represent it by M(P25.P75).Chi-square test was used for counting data,denoted by n(%),and P<0.05 indicated statistically significant differences.ResultsThe first part is the systematic review and the meta-analysis:43 randomized controlled trials were included,involving 3621 patients.Meta-analysis results showed that:The total effective rate of acupuncture combined with Traditional Chinese medicine for uterine fibroids[OR=5.53;95%CI=(4.17,7.33)],uterine fibroid volume after treatment[SMD=-1.37;95%CI=(-1.9,-0.82)],uterine volume after treatment[MD=-14.08;95%CI=(17.70,10.46)],the lesions disappeared time[MD=2.85;95%CI=(3.39,2.31)],blood plasma viscosity[MD=0.67;95%CI=(0.79,0.56)],lumbosacral acid bilges disappear time[MD=2.22;95%CI=(3.23,1.21)],after menstruation often time[MD=4.22;95%CI=(4.86,3.58)],progesterone levels after treatment[SMD=1.57;95%CI=(2.52,0.62)],adverse reactions occurred(OR=0.15;95%CI=(0.08,0.27)]were statistically significant compared with the control group(P<0.05).Estradiol level after treatment[SMD=-0.95;95%CI=(-2.50,0.61)],luteinizing hormone level after treatment[SMD=-0.39;95%CI=(-1.52,0.75)],follicle stimulating hormone level after treatment[SMD=-1.18;95%CI=(-2.54,0.09)]and hemoglobin level after treatment[MD=5.58;95%CI=(-7.19.18.34)],there was no statistical significance between the two groups(P>0.05).The total effective rate of acupuncture treatment for uterine fibroids[OR=5.06;95%CI=(2.79,9.18)]was statistically significant compared with the control group(P<0.05),which was superior to the control group.The second part is the clinical study results of treating uterine leiomyoma with Tongyuan" acupuncture combined with Guizhi Fuling Capsule:a total of 150 cases were collected in this study,and 2 cases fell off during the study,including 48 cases in control group(Guizhi Fuling Capsule group),50 cases in treatment group A(Tongyuan acupuncture)and 50 cases in treatment group B(Tongyuan acupuncture combined Guizhi Fuling Capsule group).Statistically,there were no significant differences in gender,age,course of disease,tongue texture,tongue coating and pulse(P>0.05),with comparability.1.In terms of uterine fibroid volume and uterine volume:after treatment,compared with control group and treatment group A,there were statistical differences in treatment group B(P<0.05),fibroid volume and uterine volume in treatment group B were lower than those in the other two groups;There was no statistical difference between treatment group A and control group(P>0.05),but had a decreasing trend compared with the control group.There were statistically significant differences between each group and its own group before treatment(P<0.05),and the fibroid volume and uterine volume in the three groups after treatment were lower than before treatment.2.In six aspects of sex hormones:after treatment,FSH,LH,E2 and Prog in treatment group B were statistically different from those in control group and treatment group A(P<0.05),and there was statistical difference between treatment group A and control group(P<0.05),the therapeutic effect of FSH,LH,E2 and Prog in group B was the best,and the therapeutic effect of group A was better than the control group.There were statistical differences between each group and its own group before treatment(P<0.05).There was no significant difference in PRL and T among three groups after treatment(P>0.05),and there was no statistical difference between each group and its own group before treatment(P>0.05).3.In terms of improving blood loss:after treatment,RBC and Hb of treated group B were statistically different from those of the other two groups(P<0.05),there was statistical difference between treatment group A and control group(P<0.05),treatment group B was superior to treatment group A,treatment group A was superior to control group;There were statistical differences between each group and its own group before treatment(P<0.05).There was no significant difference in PLT among three groups after treatment(P>0.05),and no statistical difference between each group and its own group before treatment(P>0.05).4.In terms of improving body mass index(BMI):after treatment,treated group B were statistical different from control group and group A,and there were statistical differences between group A and control group(P<0.05),treatment group B was lower than treatment group A,and treatment group A was lower than control group.Except for the control group,there were statistical differences between treatment group A and treatment group B and their own groups before treatment(P<0.05).This indicates that treatment group A and B have a significantly better effect on BMI than the control group,and treatment group B has a better effect than treatment group A.5.In terms of sub-domain scores of the UFS-QOL:In the field of uterine fibroid symptoms,after treatment,there were statistical differences in treatment group B compared with control group and treatment group A(P<0.05),the therapeutic effect of group B was better than the other two groups;There was no statistical difference between treatment group A and control group(P>0.05);There were statistical differences between each group and its own group before treatment(P<0.05).In the field of energy/mood,after treatment,compared with the control group and the treatment group A,there were statistical differences(P<0.05),there was statistical difference between treatment group A and control group(P<0.05),the therapeutic effect of group A was better than that of group B,and the therapeutic effect of group B was better than that of control group.There were statistical differences between each group and its own group before treatment(P<0.05).In the area of limited physical activity,after treatment,treatment group B compared with the control group,treatment group A were statistically different(P<0.05);There was statistical difference between treatment group A and control group(P<0.05),the therapeutic effect of group A was better than that of group B,and the therapeutic effect of group B was better than that of control group.There were statistical differences between each group and its own group before treatment(P<0.05).In the field of sexual function,after treatment,treatment group B compared with the control group,treatment group A were statistically different(P<0.05);There was statistical difference between treatment group A and control group(P<0.05),the therapeutic effect of group B was better than that of group A,and the therapeutic effect of group A was better than that of control group.There were statistical differences between each group and its own group before treatment(P<0.05).6.In terms of the total score of TCM symptom scale:after treatment,there was statistical difference between the treatment group B and the control group and the treatment group A(P<0.05),there was statistical difference between treatment group A and control group(P<0.05),treatment group B was significantly better than treatment group A and control group,and treatment group A was better than control group.There were statistical differences between each group and its own group before treatment(P<0.05).7.In terms of safety and adverse reactions:after treatment,there were no significant differences in CR,BUN,ALT,AST and GGT in the three groups,and no statistical differences between each group and its own group before treatment(P>0.05).In terms of adverse reactions,no adverse reactions were found in treatment group A and treatment group B,while there were 5 cases of gastrointestinal reactions in control group.8.Clinical efficacy evaluation:after treatment,11 cases of group B showed significant effect,30 cases improved,9 cases were ineffective,and the total effective rate of group B was 82%;The total effective rate of group A was 62%.In the control group,there were 2 cases of marked effect,26 cases of improvement and 20 cases of ineffectiveness.The total effective rate in the control group was 58.33%.The total effective rate was significantly different among the three groups(P<0.05),and the total effective rate of treatment group B was the highest compared with treatment group A and control group,and there was no significant difference between treatment group A and control group(P>0.05),but has a good upward trend.Conclusions1.Acupuncture or acupuncture combined with Traditional Chinese medicine can effectively treat uterine fibroids,significantly reduce the fibroid volume,high safety.The conclusions are of certain reference value and provide evidence-based medical basis for this clinical study,but more rigorous randomized controlled trials are needed to verify them in the future.2.This clinical study result shows that the Tongyuan acupuncture combined with Guizhi Fuling Capsule more significantly reduce uterus volume and fibroid volume,improve sex hormone disorder due to the influence of uterine fibroids,chronic blood loss,improve the clinical symptoms of patients with uterine fibroids,sexual function,TCM symptoms,reduce the body mass index(BMI)of patients with uterine fibroids,Moreover,Tongyuan acupuncture can significantly improve the energy state,mood state and restricted physical activity of patients with uterine fibroids,and Tongyuan acupuncture has the effect of alleviating the adverse drug reaction of Guizhi Fuling Capulse with high safety. |
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