Clinical Study On The Treatment Of Acupuncture And Moxibustion For Premenstrual Dysphoric Disorder

Objective:1.Via the systematic evaluation of clinical trials,to explore the evidence of acupuncture and moxibustion for premenstrual dysphoric disorder.2.To carry out randomized controlled trials to evaluate the effectiveness and safety of acupuncture treatment for premenstrual dysphoric disorder.Method:1.literature researchBase on the CBM,CNKI,VIP,Wan Fang database,Pubmed,Embase,Library Cochrane and other clinical trials,retrieval date till to April 2016.Assess bias risk according to Cochrane Handbook 5.2.0,and used the Review Managers 5.3 software for statistical analysis.2.clinical research(1)PatientsPatients were come from Haikou city or Hainan Provincial Hospital of TCM.From January 2015 to June 2016.(2)Study methods105 patients who met the inclusion criteria were divided into 3 treatment groups equally,treatment group,non acupoint superficial group and sham acupuncture group.Only the operator knowed patients came from which group,those who it was appointed to evaluate and statistical analysis didn' t know that.(3)InterventionTreatment groupAcupoints:DU20(Baihui),EX-HN03(Yintang),CV12(Zhongwan),CV10(Xiawan),CV7(Qihai),RN4(Guanyuan),EX-CA1(Zigong),SP6(Sanyinjiao),KI6(Zhaohai),LI4(Hegu),ST25(Tianshu)and LR3(Taichong).Tntradermal needing therapy was provided on BI15(Xinshu),BI23(Shenshu).Operation:We usde 1.5-inch needle for Zhongwan,Xiawan,Qihai,Guanyuan and Zigong,1—inch needle for the other acupoints,the trocar was clap vertically into skin,until picerced at the parietal peritoneum then removed the tubes.The trocar was clap at 30 degrees in Baihui and Yintang,they were stick by 0.5 inch.Sanyinjiao,Zhaohai,Taichong and Hegu were pierc by 0.5-0.8 inch,we appilied manual therathy 10 minents a time,all of them were stab for 30 minutes.Then,we performed tntradermal needing at Xinshu and Shenshu after extract needle,the needle body was pierced for 3-5mm,stay on the skin,and then use the medical plaster pasted,3 acupoints for every time,for 2-3 days.Non-acupoint superficial groupAcupoints:as the same as treatment grop,but beside them for 1 inch or lcm.The points for tntradermal needing as the same as treatment group.Location:Zhongwan,Xiawan,Qihai and Guanyuan were flat horizontal right side for 1 inch.Tianshu,Zigong and Taichong were flat horizontal outside for 1 inch.Hegu was radius horizontal side for lcm,Zhaohai was achillis tendon horizontal side for lcm.Sanyinjiao was tibia horizontal side for lcm,next to nexe to the acupoints 1cm.Yintang and Baihui were flat horizontal right side for lcm.Operation:As the same the treatment grop,but needling only puncture for 0.5cm,and no hand-manipulating.Operation of tntradermal needle as the same as the treatment group.Sham acupuncture groupAcupoints:the same like treatment group.Operation:We used indigitation needle for acupuncture.Hand-manipulating were performed;acctually we did not penetrate skin.The needle was stracted after 30 minutes,then tntradermal needle were carried out like the treatment grop,but needling only puncture for 0.5cm,and no hand-manipulating.The tntradermal needle were cut off the tip for 1mm,and the needle were not penetrating into the skin in fact,also use the medical plaster paste for 2-3 days.(4)Sessions and follow-upAcupuncture treatment was 3 weeks,two closed treatment interval was at lest 24 hours.Tntradermal needle treatment for 2 times a week,t two closed treatment interval at lest 72 hours.4 weeks is one course,we ordered patients to complete two courses,and the follow-up was 2 months.(5)OutcomesMain evaluation indexes:Hamilton Anxiety Scale(HAMA).Secondary evaluation indexes:WHO Quality of Life-BREF scale(WHOQOL-BREF),Daily record of severity of problems scale(DRSP).(6)Evaluation criteria:Reduction rate of HAMA score.(7)Evaluation time:There are 5 numbers of evaluation,they were before treatment,after 4 and 8 weeks of treatment,1 and 2 months after the end of treatment course respectively.(8)Statistical methods:We used SPSS22.0 software for statisticalanalysis.Comparison between groups used T-test or Fisher exact test,rank data used rank sum.Data with normal distribution are expressed as mean ± SD,comparison between groups used F test.IF there was significant difference existed between groups then we compared that by SNK test.According to data does not conform to the normal distribution,comparison between groups by Kruskal-Wallis test,if two groups had statistical significance,then used Wilcoxon test,Bonferroni method for adjusted inspection level,Repeated ANOVA Test for repeated measurement data.Result:1.Literature researchA total of 294 literatures were retrieved,including 11 Englishliteratures and 283 Chinese literatures.Finally,12 literatures and 859 patients were included.The effective rate of treatment group was higher than that of the control group.OR=4.51,95%CI(2.77,28.07),Z=4.72,P<0.00001.The effective rate of acupuncture is higher than that oftraditional Chinese medicine,OR=2.28,95%CI(0.99,5.27),Z=1.93,P=0.05.The effective rate of acupuncture is higher than that of hormone medication,OR=8.83,95%CI(2.77,28.07),Z=3.69,P=0.0002.The effective rate ofacupuncture is higher than that of drug combination therapy,OR=5.94,95%CI(2.84,12.46),Z=4.72,P<0.00001.Effective rate of acupuncture plusmedicine treatment is higher than drug only,OR=7.90,95%CI(2.52,27.34),Z=3.55,P=0.0004.According to comparison of HAMA score,HAMA score of acupuncture treatment group is higher than that of the medicine group,WMD=-3.10,95%CI(-5.17,-1.03),Z=2.94,P=0.003.2.Clinical researchWe included 105 patients,after 5 patients excluded,there are 34 in treatment group,33 in non-acupuncture shallow needling group,33 in sham acupuncture group,all of the 105 patients' data were carried out statistical analysis.(1)BaselineThere is no significance difference in age,ill duration,education,marital status,comorbidities and treatment history.No significance difference exsisted in HAMA score,WHOQOL-BREF score,and DRSP score of 5 days in premenstruum.(2)Compared with the HAMA scores,three groups were able to reduce the HAMA score,and the difference was statistically significant between them.Differences were statistically significant in comparison between prior treatment and treatment or follow-up.The results of repeated measures ANOVA showed that the score of the three groups changed with time,and the difference was statistically significant.(3)According to WHOQOL-BREF score comparison,three groups during can increase the WHOQOL-BREF score,compared between prior treatment and after treatment,follow-up,the difference was statistically significant.The difference was statistically significant in comparing between prior treatment and after treatment in treatment group and the non-acupoint superficial needling group,while there was no significant difference in sham acupuncture group.Differences were statistically significant in three groups of comparison between follow-up and treatment.The results of repeated measures ANOVA showed that WHOQOL-BREF score of the three groups changed with time,besides the difference was statistically significant.(4)About DRSP total score of 5 days in premenstruum,three groups had a bility of reduceing the total score of DRSP.The differences were statistically significant when compareing between before treatment and any other time during treatment and follow-up.There are statistically significant in comparison of groups at any other time during treatment and follow-up.Repeated ANOVA measures showed that three groups can change of DRSP total score in 5 days of premenstruum,besides the difference was statistically significant.About treatment group and non-acupoint shallow needling group,the difference was statistically significant in compareing between prior treatment and any other time of treatment and follow-up in emotion change aspet.While in sham acupuncture group,statistically difference exsisted in the treatment period and one-month follow-up when compareing with prior treatment.There was no significant difference between prior treatment and two-months follow-up in such two group.Significant differences between groups at any time during the treatment and follow-up period.The results of repeated measures ANOVA showed that emotion change aspet of DRSP score changed with time,and the difference was statistically significant.Under aspet of symptoms and signs,there were significant differences between the three groups in the whole treatment and follow-up period when compareing with prior treatment.The difference in three groups was statistically significant.ANOVA of repeated measures indicated that three groups changed with time,and the difference was statistically significant.About the aspet of degree of impact in DRSP,differences were statistically significant in the compareing between any time of the treatment or follow-up period and prior treatment.The difference in three groups was statistically significant.ANOVA of repeated measures indicated that three groups changed with time,and the difference was statistically significant.(5)According to effective rate of HAMA score,effective rate of treatment group,non-acupuncture superficial needing group and sham acupuncture group were 63.6%,33.3%and 88.2%respectively.There was no significant difference between them,however,the difference was statistically significant between the treatment group and the sham acupuncture group.During two months of follow-up,the effective rates of the three groups were 85.3%,57.6%,21.2%respectively,the difference was statistically significant between each two groups.(6)About adverse even,3 in 100 patients with adverse reactions,the incidence of adverse was 7%,It mainly were hematoma,pain,skin redness or itching.There was no significant difference in the incidence of adverse between the three groups.Conclusion:1.Literature research shows that the effect of acupuncture may be higher than drugs,HAMA score change of acupuncture group is superior to traditional Chinese medicine.Bleeding rate of acupuncture and moxibustion was 13.64%,while the control group showed no adverse even,which indicated that the drug treatment may be more saftive,because literature inclued did not mention safety evaluation of medicine or the number of literature inclued was still small,we need future research to confirm safety of acupuncture and medicine on PMDD.2.Clinical research shows:three groups can relieve anxiety symptoms at different degree,the treatment group may be the best,non-acupuncture suferficial needling group next,sham acupuncture group is the lest.The treatment group and non-acupuncture superficial group were able to improve the quality of life,however the treatment group may be the best,sham acupuncture group improve the quality of life only duaring in treatment cause.