| Purpose:1 : Using Meta-analysis system to evaluate the randomized clinical research literatures on acupuncture treatment of perimenopausal syndrome in the past 10 years,and to find modern evidence-based basis for acupuncture treatment of perimenopausal syndrome.2:According to the theory of “Kidney-Tiangui-Chongren-Uterus”Axis,women with perimenopausal syndrome are taken as the research object.Compare the small stimuli scalp acupuncture and body acupuncture,body acupuncture and Chinese patent medicine Zuogui Wan in the treatment of perimenopausal syndrome with kidney-yin deficiency syndrome,discusses the methods suitable for the treatment of this disease,acupuncture points,manipulations and stimulus,to provide a reference for the clinical guidance of the “KidneyTiangui-Chongren-Uterus”Axis to evaluate the comprehensive treatment of perimenopausal acupuncture significant effectiveness and safety.Method:1.Literature research(1)Literature search strategy:Computer search of Chinese and English databases for the past 10 years(2009 ～ 2019):China CNKI,Weipu Database,Wanfang Digital Journal Network,China Biomedical Literature Database;foreign databases include Pub Med,Science Direct,EMbase and Cochrane Library.All searches are from January 1,2009 to December 31,2019.(2)Screening and evaluation:Read and screen the collected literatures according to the inclusion and exclusion criteria and input the information content of the literatures that have been excluded and finally meet the inclusion criteria into Microsoft Excel and establish a database.For the unclear expressions in the text or the missing information,ask the researcher by telephone or email,and exclude the experimental research that is incorrectly stated or cannot be contacted.According to the literature quality evaluation method recommended by the Cochrane Handbook.(3)Statistical analysis:The statistical analysis software of Review Manager version 5.3 provided by Cochrane was used for statistical analysis.According to the literatures collected by the retrieval strategy,there were 278 preliminary inspection literatures,272 were in Chinese and 6 were in English.After detailed reading,screening,and return visits,29 were finally included,19 were in clinical journals and 10 were degree-graduate theses,28 are in Chinese and 1 in English.A total of 2238 patients were reported.(4)Characteristics of the included studies :(i)Study subjects :perimenopausal women,aged 45-55.(ii)Intervention measures:Acupuncture was used as the treatment method.For the included literatures,25 studies were acupuncture and 4 studies were electro-acupuncture.The control group was mainly oral drugs and psychological intervention.(iii)Metrics:For the 29 literatures included,4 studied perimenopausal syndrome,12 studied the depression symptoms of perimenopausal syndrome,and 12 studied insomnia symptoms of perimenopausal syndrome.13 studies use the Kupperman scale as the main measurement index,4 studies use the Hamilton Anxiety Scale(HAMA),13 studies use the Hamilton Depression Scale(HAMD),and 11 studies choose the Pittsburgh Sleep Quality Index(PSQI).In addition,Serum Estradiol(E2),Follicle Stimulating Hormone(FSH),and Luteinizing Hormone(LH)were used as outcome indicators.Guiding principles for clinical research of new Chinese medicines,standard of efficacy of traditional Chinese medicine symptoms,and one article uses the autonomic balance index.2.Clinical research(1)Recruitment and grouping:(1)Recruitment and grouping:The patients in this study came from the Hongpaak Traditional Chinese Medicine Medical Center and passed the center’s ethical review(reference number:2019FT01).This experiment is a randomized controlled experiment,using the envelope method for random grouping.The recruitment period is from May 2019 to May2020.Using a simple randomization method,using SPSS24.0 statistical software,put the numbers of 96 cases into the test random number and grouping results,finally divided into 3 groups:the first group is the Chinese patent medicine group;the second group is the body acupuncture group;The third group is small stimuli scalp acupuncture combined with body acupuncture group,a total of 96 people,33 people in each group.(2)Intervention method:(i)The small stimuli scalp acupuncture with body acupuncture group:acupoints:The scalp acupoints included:Baihui,Sishencong and the 3rd frontal line next to the forehead combined with the body acupoints:Sanyinjiao,Taixi,Xuehai,Zusanli,Neiguan,Guanyuan,Taichong,Operation:use 0.25 mm × 25 mm needle(Yashishitang International Medical Equipment Co.,Ltd.),for the scalp acupuncture quickly enter the depth of the needle to under the cap-shaped aponeurosis,slightly scratch the needle handle,does not make the patient feel pain or slight pain.For the body acupuncture twisting the needle until “deqi” and remain the needle for25mins;(ii)Body acupuncture group:acupoints:Sanyinjiao,Taixi,Xuehai,Zusanli,Neiguan,Guanyuan,Taichong,operation :0.25 mm × 25 mm needle(Yashitang International Medical Equipment Co.,Ltd.)twisting the needle until “deqi”,keeping the needle for 25mins;(iii)Chinese patent medicine group:Oral Chinese patent medicine Zuogui Wan,5g/time,2 times/d.(3)Treatment course:Two acupuncture group is treated twice a week,and 8 weeks is a course of treatment.The treatment course of the Chinese patent medicine group was also 8 weeks.(4)Observation items and detection time point:Observation items and detection time point:The observation items include modified Kupperman scale score,TCM symptom observation table and MENQOL observation table.The Kupperman scale score and the TCM symptom observation table are filled out by the physician.The detection time points:the first time before treatment,the second time after the first week of treatment,the third time after the fifth week of treatment,and the fourth time after the treatment of the 8th week;the MENQOL observation form is filled out by the patient.The detection time point:the first time before treatment,the second time after the 8th week of treatment.(5)Efficacy evaluation standard:Refer to the domestic improved Kupperman scoring standard and add the symptom scores to obtain the Kupperman index.Record one index before and after the treatment and compare the indexes before and after treatment to determine the efficacy standard.Fill in the safety evaluation at the end of the course of treatment.(5)Efficacy evaluation criteria : Refer to the domestic modified Kupperman scoring criteria and add the scores of each symptom to obtain the Kupperman index.The index is recorded once before and after treatment,and the index before and after treatment is compared to determine the efficacy standard.In terms of TCM symptom scores,refer to the “Guiding Principles for Clinical Research of New Chinese Medicines” and formulate an improved calculation formula to compare the index before and after treatment,and fill in the safety evaluation at the end of the treatment.(6)Data statistical analysis uses Excel to establish a database,uses SPSS24.0 version statistical software for statistical analysis,the measurement data meets the normal distribution,and the mean plus or minus standard deviation is expressed as the F test when the variance is uniform,and when the data is normally distributed,One-way analysis of variance was used for comparison between the three groups;Mann-Whitney U test was used for non-parametric test.Ridit test is used to test the effective rate data,and P<0.05 is considered as significant difference,and P<0.01 is considered as extremely significant difference.Result1.Literature research:A total of 29 randomized controlled studies included in this systematic review treated a total of 2238 patients.According to the results of the meta-analysis:(1)acupuncture was compared with other treatment methods(oral western medicine and psychological education).The effectiveness of perimenopausal syndrome and improvement of insomnia and depression symptoms in perimenopausal syndrome are statistically significant(P<0.01).(2)Besides HAMA,acupuncture treatment of perimenopausal syndrome regardless of several index is used to observe(Kupperman Index,HAMD,PSQI,or endocrine hormone),its effectiveness is better than other treatment methods.(3)Acupuncture includes scalp acupuncture and body acupuncture have better efficiency than other treatment methods.The difference between treatment methods including scalp acupuncture combinate with body acupuncture is as high as P<0.00001.Pure body acupuncture(Excluding scalp acupuncture)is P=0.004.(4)Regarding the amount of acupuncture stimulation,the stimulation amount of body acupuncture generally adopts the stimulation amount of flat replenishment and reduction,but there is no uniformity to the amount of scalp acupuncture stimulation.(5)Sanyinjiao is the most commonly selected acupuncture point for treating perimenopausal syndrome,followed by Baihui,Neiguan,Shenmen,Taichong,,Shishencong,Yintang,Taixi,Zusanli,Guanyuan,etc.(6)Acupuncture is kinds of relatively safe treatment with less side effects compared with oral medications.2.Clinical research:The results of this clinical experiment,the overall effectiveness is equivalent to the results of the systematic review analysis,acupuncture treatment of perimenopausal syndrome is more effective.(1)According to the Kupperman score,the treatment method of acupuncture including small stimuli scalp acupuncture with body acupuncture group is higher than that of body acupuncture.The effective rate of small stimuli scalp acupuncture with body acupuncture group is 97%,and the effective rate of the body acupuncture group is 93.3%.The effective rate of the Chinese patent medicine group is 87%;according to the TCM symptom score,the effective rate of the small stimuli scalp acupuncture with body acupuncture group is 94%,the effective rate of the body acupuncture group is 76.6%,and the effective rate of the Chinese patent medicine group is67%.In the MENQOL score,the results of the vascular and socio-psychological dimensions are that the effect of the small stimuli scalp acupuncture with body acupuncture group is better than the Chinese patent medicine group or the body acupuncture group;the results of the physical dimensions are that small stimuli scalp acupuncture with body acupuncture group and the body acupuncture group have better effects than the Chinese patent medicine group,the small stimuli scalp acupuncture with body acupuncture group was better than the body acupuncture group;there was no statistical difference in the sex dimension results between the 3 groups.(2)To summarize this clinical observation,in terms of hot flashes,sweating symptoms,after 5 weeks of treatment,small stimuli scalp acupuncture with body acupuncture group was statistically significant compared with the Chinese patent medicine group,and after 8 weeks of treatment,compared with the traditional Chinese medicine group and the body acupuncture group,the small stimuli scalp acupuncture with body acupuncture group has statistical significance.In terms of symptoms of irritability and dizziness,after 5 weeks of treatment,the small stimuli scalp acupuncture with body acupuncture group has statistical significance compared with the Chinese patent medicine group and the body acupuncture group.Depressive symptoms,after 1,5 and 8 weeks of treatment,small stimuli scalp acupuncture with body acupuncture group has statistical significance compared with the Chinese patent medicine group and the body acupuncture group.For headache symptoms,starting from the first week,small stimuli scalp acupuncture with body acupuncture group has statistical significance compared with the Chinese patent medicine group and the body acupuncture group.After 5 and 8 weeks of treatment,the difference is still statistically significant.For palpitations and insomnia,after 8 weeks of treatment,there was a statistically significant difference between the small stimuli scalp acupuncture with body acupuncture group and the Chinese patent medicine group.The symptoms of bone and joint muscle pain,fatigue and muscle tics,after 5 and 8 weeks of treatment,there were statistically significant differences between the small stimuli scalp acupuncture with body acupuncture group and the body acupuncture group compared with the Chinese patent medicine group.(3)In terms of the course of the disease and the impact of the condition on the efficacy,after an 8-week course of treatment,the average score of patients with a course of less than or equal to 3 months is lower than that of patients with a course of 4-6 months and the course of more than 7 months Mean.And in terms of treatment efficiency,the treatment effect of patients with a course of less than or equal to 3 months is better than that of patients with a course of 4-6 and those with a course of more than or equal to 7 months.For patients with a course of less than or equal to 3 months,the effect will begin to appear after the first week of treatment,and patients with a course of 4-6 or more than or equal to 7 months need to be treated after the 5th week.The treatment effect meets the statistical difference.In addition,the treatment effect of patients with mild and moderate disease is higher than that of patients with severe disease.The curative effect of patients with mild and moderate illness began to appear after the first week of treatment.Although the curative effect of severe illness tends to be better,there is no statistically different treatment effect.The therapeutic effect of small stimuli scalp acupuncture with body acupuncture group is more significant in the mild and moderate disease groups.Conclusion:(1)According to the Meta system analysis,acupuncture is more effective than other treatment methods(oral drugs and psychological education)in the treatment of perimenopausal syndrome symptoms;acupuncture that includes scalp acupuncture and body acupuncture is more effective for pure body acupuncture.(2)Small stimuli scalp acupuncture with body acupuncture group,body acupuncture group and Chinese patent medicine group can all improve the symptoms of women with kidney-yin deficiency syndrome in perimenopausal syndrome,but the overall therapeutic effect of small stimuli scalp acupuncture with body acupuncture group is better than that of body acupuncture and Chinese patent medicine group.Small stimuli scalp acupuncture with body acupuncture group is especially effective for mental and analgesic symptoms,such as insomnia,mood disorders,headaches,and muscle and joint pain. |
