| BackgroundAdenomyosis is a common gynecological difficult disease in clinical.Recently,it has increased the incidence and tends to be younger woman,especially around 30-50 years old menstrual parturient.It mainly manifested with progressive aggravation of dystenorrhea,menstrual disorders,infertility.Among them,secondary dysmenorrhea accounts for about 70%of the patients,which is an urgent problem in clinic.Western treatment mainly includes drug intervention and surgical treatment.However,many for hormonal drugs with huge side effects and high recurrence rate.Traditional Chinese medicine treatment can significantly improve the symptoms of dysmenorrhea without affecting the fertility requirements,but the problem is the long medication cycle and the bad control of dysmenorrhea onset.Certain curative effect has been verified with acupuncture treatment for primary dysmenorrhea which includes immediate and the near-term analgesic effect as well as the prevention effect of next menstrual cramps attack.Acupuncture has potential advantages in the treatment of secondary dysmenorrhea of adenomyosis,this study intends to carry out exploratory research on acupuncture for adenomyosis.Purpose1.Meta analysis was used to evaluate the clinical efficacy of acupuncture in the treatment of adenomyosis to understand the current status of acupuncture in the treatment of adenomyosis and to analyze the role and efficacy characteristics of acupuncture in the treatment of adenomyosis which aimed at providing references for future clinical studies on adenomyosis.2.Through randomized controlled clinical trials,this study aims at comparing the acupuncture stage treatment with western dysmenorrhea clinical first-line drugs to observe the analgesic effect of secondary dysmenorrhea caused by uterine adenomyosis,and the influence of dysmenorrhea symptoms,quality of life and the the menstrual quantity,which explores the comprhensive effect of combined treatment of acupuncture scheme.Furhtermore,the stage acupuncture treatment in this study is an innovative exploratory program intending to provide effective reference,standard for clinical acupuncture treatment of this disease.Methods1.Literature research:Systematic evaluation and meta-analysis of acupuncture in the treatment of adenomyosisAccording to the international evidence-based medical center handbook standard,randomized or half-randomized controlled trials of acupuncture and moxibustion for adenomyosis were searched from China National Knowledge Infrastructure(CNKI),WanFang Database,Chinese Scientific and Technological Journals(VIP),Pubmed,the Cochrane Library and EMBASE Database from establishment time of databases to February,2020.Then we selected suitable literatures in accordance with the Cochrane Review Handhook5.0 quality evaluation criterion for quality evaluation into the literature.Review Manager 5.3 software to apply meta analysis in order to evaluate the effectiveness of acupuncture in relieving pain,reducing menstrual volume and improving quality of life in patients with adenomyosis.2.Clinical research:A randomized controlled clinical study on acupuncture treatment of secondary dysmenorrhea in adenomyosisA randomized controlled clinical study on acupuncture treatment of secondary dysmenorrhea in adenomyosis.The patients with secondary dysmenorrhea of adenomyosis who met the inclusion criteria were divided into the acupuncture group and the drug group according to the central random system.2.1 Treatment prescriptions2.1.1 Acupuncture group(1)acupoint selection and operation methodIt depends on the menstrual period or not.Menstrual period:SP8,SP6,BL32,EX-B8.Operation:Patients stayed in the prone position.All acupoints were routinely disinfected with 75%alcohol.SP8 dirBL32ectly inserted 1.2-1.5 inches,SP6 directly inserted 0.8-1.0 inches,BL32 obliquely inserted 1.8-3.0 inches inward and downward and penetrated into the posterior sacral hole,and EX-B8directly inserted 0.5-1 inches.All acupoints were treated with a even reinforcing and reducing method described as after the injection into the needle to get"deqi",a uniform lifting and twisting technique was applied.The amplitude and twist angle of each lifting and inserting were basically same with moderate frequency,moderate rhythm,moderate needle sensation and moderate penetration.We defined "deqi" as the sore and swollen feeling or needle conduction degree around the acupoints.The needles were retained for 30min.During the retention period,the needles were inserted once every 10min,and each time for 30s.Non-menstrual period:main acupoints includes CV4,EX-CA1,SP6 and ST36,SP8 and LR4 for the excess syndrome,SP10 and KI3 for deficiency syndrome.Operation:Patient stayed supine.All acupoints were routinely sterilized with 75%alcohol.guan yuan acupoint directly inserted 0.5-1.0 inches,uterus acupoint directly inserted 0.8-1.2 inches,sanyinjiao acupoint directly inserted 0.8-1.0 inches,zusanli acupoint directly inserted 1.2-1.5 inches,taixi acupoint and taichong acupoint directly inserted 0.5-0.8 inches.For the excess syndrome,we used the reducing method by lifting-thrusting and twisting-rotating method and reinforcing method for the deficiency syndrome with similar manipulations which all got "deqi".The needles were retained for 30min.During the retention period,the needles were inserted once every 10min,4 times in total,and each time the needles were inserted for 30s.(2)treatment time and course of treatmentTreatment frequency:treatment during menstrual period was from the first day of menstruation,once a day until the ending of it.Treatment in the non-menstrual period was 2 times per week,2-3 days between the interval between the treatment.Course of treatment:the first week(non-menstrual period)after the first menstrual period was determined as the beginning of the course of treatment,followed by 3 consecutive menstrual cycles for 1 course of treatment.In this study,1 course of treatment was standardized.2.1.2 control groupIbuprofen sustained-release capsule(fenbo,0.3 g/pill),produced by Tianjin SK&F.,with the national drug approval word H10900089,was selected.Method of administration:starting from the 1st day of the 1st menstrual period after the confirmation of the group and only in the menstrual period,oral administration:1 pill for once and 2 times for a day(once in the morning and once in the evening,after meals),every 5 days for one course,3 menstrual cycles continuously.This is one course of clinical treatment in this study.2.2 Assessment2.2.1 The primary outcome and evaluation time pointsDegree of pain:VAS score at the most painful point of menstruation and the duration of painEvaluation time points:at the ending of each menstural cycle for four times in total,cycle 0 for baseline and menstrual cycle 1,2,3 for treatment.2.2.2 Secondary outcome and evaluation time pointDysmenorrhea symptom scale(CMSS),quality of life scale(EHP-5),menstrual volume score(PBAC).Evaluation time points:CMSS and EHP-5 at cycle 0(baseline)and cycle 3(treatment),evaluate at the end of the every menstrual cycle for twice in total.PBAC at cycle 0(baseline),cycle 1,2,and 3(treatment),with a total of 4 time points.Results1.Literature research1.1 Included studiesA total of 3575 relevant papers(3383 Chinese papers and 192 English papers)were eventually retrieved.After screening,21 papers were finally included and 2 of which were the same experiment,so finally 20 RCTS in total were included.All of them were domestic studies,however,the evaluation criteria for diagnosis and efficacy were not unified.The sample size was small and only one study was estimated.The included control design contained acupuncture compared with drug,acupuncture and drug combination compared with drug only.The results of bias risk assessment showed that the methodological quality and reporting quality of the included literature were generally low.1.2 Results for systematic evaluation and Meta-analysisMeta analysis results showed that compared with the control group,acupuncture treatment in AM had the advantage in the total efficiency,easing the extent of dysmenorrhea,reducing the menstrual quantity,improving TCM syndrome integral,the quality of life and pregnancy rate as well as reducing the serum CA125 level and the incidence of adverse reactions(P>0.05),but in terms of uterine volume with no difference between treatment and control group(P<0.05).Among them,the most literatures related to the efficacy indicators such as pain,uterine volume,and menstrual volume score were 17,8,and 4,respectively.Therefore,it may be considered that the prominent advantages of acupuncture in the treatment of AM are analgesia and reduction of menstrual volume.After subgroup analysis showed that:compared with oral hormone,acupuncture treatment alone can significantly relieve patients with AM dysmenorrhea symptoms,improve TCM symptoms integral,reduce the patients with menstrual quantity,improve patient quality of life,reduce the patients’ serum CA125 level(P>0.05),but in general curative effect,AM improved aspect of the distribution of the degree of dysmenorrhea patients with no obvious advantage(P<0.05).However,associated with traditional Chinese medicine medicinal broth,its overall curative effect and AM from heavy to light the distribution of patients have obvious advantages(P<0.05).Compared with non-steroidal anti-inflammatory drugs,acupuncture alone has no obvious advantages in relieving pain and relieving dysmenorrhea related symptoms(P>0.05),but it has obvious advantages in improving the distribution of dysmenorrhea degree from severe to mild in patients and the overall efficacy(P<0.05).Compared with intrauterine morena therapy commonly used in clinical practice,morena combined with acupuncture has more advantages in analgesia(P<0.05).Compared with traditional Chinese medicine or proprietary Chinese medicine,traditional Chinese medicine decoction or proprietary Chinese medicine combined with acupuncture has no obvious advantage in the overall efficacy(P>0.05),but with obvious advantage in the improvement of dysmenorrhea related symptoms and the degree of dysmenorrhea from mild to severe in patients(P<0.05).2.Clinical research2.1 Maximum pain V AS score and duration of painComparison within groups:VAS score and duration of pain in the first,second and third cycles after treatment were significantly lower than that before treatment(P<0.01),and every cycle after treatment were lower than that before last cycle.(P<0.01).Comparison between groups:in the first cycle of treatment,the maximum pain VAS score and the change before and after treatment was with statistically significant difference(P<0.05),but in the second and third cycle,the maximum pain VAS score and the changes before and after during cycle were not with statistically significant difference(P>0.05).Meanwhile,the two groups in the third cycle compared with before treatment,the changse between them were not with statistically significant difference(P>0.05).There was no statistically significant difference between the two groups in the duration of pain at each time point of treatment period and the difference between the two groups and the previous period(P>0.05).Moreover,there was no statistically significant difference between the two groups in the third period and the period before treatment(P>0.05).2.2 CMS S scoreComparison within groups:the CMSS scores of the two groups after treatment were significantly lower than that before treatment(P<0.01).Comparison between groups:there was no statistically significant difference in CMCC score before and after treatment between the two groups(P>0.05)and there was no statistically significant difference in CMCC difference between the two groups before and after treatment(P>0.05).2.3 The EHP-5 scoreComparison within groups:EHP-5 score in both groups after treatment were significantly lower than that before treatment(P<0.01).Comparison between groups:there was no statistically significant difference in EHP-5 score between the two groups before and after treatment(P>0.05)and there was no statistically significant difference in EHP-5 score between the two groups before and after treatment(P>0.05).2.4 The PBAC scoreComparison within groups:PBAC score in the acupuncture group after treatment was significantly lower than that before treatment(P<0.01)and every cycle was lower than that in the last cycle(P<0.01).There was no statistically significant difference in PBAC score of western medicine group after treatment compared with that before treatment(P>0.05).Comparison between groups:the differences between the two groups at each cycle and the previous cycle were statistically significant(P<0.01)and the difference between the two groups after treatment of 3 menstrual cycles were statistically significant compared with that before treatment(P<0.01).The results indicated that the improvement of menstrual volume in the acupuncture group in the first,second and third cycle of treatment was better than that in the western medicine group,and the reduction of menstrual volume in the acupuncture group was significantly better than that in the western medicine group after the treatment of the third cycleConclusion1.The results of literature research suggested that acupuncture alone or acupuncture combined with herbal medicine was effective for adenomyosis and its advantages mainly manifested in analgesia,reduction of menstrual volume,improvement of patients’ quality of life,reduction of serum CA125 level,improvement of pregnancy rate and reduction of incidence of adverse reactions.Hence,acupuncture alone or acupuncture combined with herbal medicine had better effect compared with western medicine but no advantage in comparing with herbal medicine or Chinese patent herbal medicine.2.Clinical research showed that:acupuncture by stages and ibuprofen sustained-release capsule can relieve dysphoria and menstrual discomfort in patients with adenomyosis and improve the quality of life.However,acupuncture treatment was more effective than ibuprofen sustained-release capsule in analgesia,reducing the menstruation quantity.In addition,the satisfaction and acceptance of acupuncture treatment were also higher than the western medicine.3.Clinical studies were consistent with the results of literature studies,indicating that the advantages of acupuncture in the treatment of adenomyosis are analgesia,reduction of menstrual volume,and improvement of patients’ quality of life. |
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