Research status of peri-menopausal insomnia based on bibliometrics

Objective:To reflect the current situation and development level of the treatment of peri-menopausal insomnia,to provide ideas and basis for the treatment of peri-menopausal insomnia,and to lay a scientific foundation.Methods:The relevant literatures about peri-menopausal insomnia in the past 20 years from January 1,2000 to September 30,2020 were searched in full-text database,and the publication time distribution,periodical distribution and research types were statistically analyzed with the help of NoteExpress 4.2.0,Excel 2010 and UCINET 6.2 software.Bibliometrics and social network analysis were used to grasp the research status and research hotspots.Results:979 articles about insomnia in peri-menopausal period were included.The number of literatures showed an upward trend and decreased from 2018 to 2020.The top three journals are Inner Mongolia traditional Chinese Medicine,Guangming traditional Chinese Medicine and Sichuan traditional Chinese Medicine,with 30,25 and 22 articles respectively.A total of 1,846 authors participated in the publication.The top three authors were Hong Li(14,0.63%),Jun-Shan Huang(9,0.40%)and Ying Chen(9,0.40%).The social network map shows that“insomnia”,“peri-menopausal period”,“perimenopausal insomnia”,“peri-menopausal syndrome”,“traditional Chinese medicine therapy”and“acupuncture”are the research hotspots and have the strongest correlation.Conclusion:The number of articles about peri-menopausal insomnia shows a downward trend in recent years,and the“core author group”has not been formed.The clinical research in this field is relatively perfect,but a more complete theoretical system has not been formed yet.Most of the treatment of insomnia in peri-menopausal period is based on traditional Chinese medicine,which shows that traditional Chinese medicine is more effective in clinical use,and the curative effect of syndrome differentiation of traditional Chinese medicine has been affirmed.However,there are relative deficiencies,such as the lack of strict experimental research and evaluation standards,the lack of unilateral prescription research,and so on.Future researchers should pay more attention to the experimental research of traditional Chinese medicine in the treatment of peri-menopausal insomnia and unilateral empirical prescription research.

Assessment of the Clinical Effect of Chinese Medicine Therapy Combined with Psychological Intervention for Treatment of Patients of Peri-menopausal Syndrome Complicated with Hyperlipidemia

Objective：To observe the effect of Chinese medicine therapy combined with psychological intervention（combined therapy） on the clinical symptoms and levels of blood lipids and sex hormones of patients of peri-menopausal syndrome complicated with hyperlipidemia.Methods：With the use of a randomizing digital table method,185 patients that fit the registration standard were randomly assigned to three groups.The 59 cases in Group A were treated with two Chinese patents,Kunbao Pill（坤宝丸） and Modified Xiaoyao Pill（加味逍遥丸）;the 63 in Group B received psychological intervention alone;and the 63 in Group C were treated with both（the combined therapy）,with the treatment course for all six months.The items of observation included： （1） scoring by SCL-90 on eight factors and seven symptoms;（2） scoring on Chinese medicine symptoms by Kupermann scale,including anxiety and bad temper,scorching sense ation with sweating,dizziness,tinnitus, soreness and weakness of the loin and knees,palpitation,insomnia,lassitude,weakness,and hyposexuality; （3） blood contents of total cholesterol（TC）,triglyceride（TG）,high-density lipoprotein cholesterol（HDL-C）, low-density lipoprotein cholesterol（LDL-C）,apoprotein Al（ApoAl） and B（ApoB）;（4） levels of sex hormones, including estradiol（E_2）,progesterone（P）,pituitary prolactin（PRL）,follicular stimulating hormone（FSH）,and luteinzing hormone（LH） in some randomly selected patients;（5） adverse reaction;and（6） one-year follow-up study on long-term effect.Results：A total of 21 patients（6,8,and 7 cases in Groups A,B,and C,respectively） dropped out;the drop-out rate was insignificant among groups.（1） The markedly effective rates in Group A, B,and C were 26.42%（14/53）,18.18%（10/55）,and 53.57%（30/56）,respectively,and the total effective rates in them were 64.15%（34/53）,50.91%（28/55）,and 87.50%（49/56）,respectively,suggesting the therapeutic efficacy in Group C was significantly better than that in Groups A and B（P〈0.01）.（2） SCL-90 scoring showed that the total scores decreased significantly after treatment in Group C（P〈0.01）,but remained unchanged in Groups A and B（P〉0.05）.（3） Scoring on Chinese medicine symptoms showed the same results as shown by SCL-90 scoring in terms of total scores and individual symptoms,except that menstrual disorder and amenorrhea were unchanged in all three groups（P〉0.05）.（4） Levels of HDL-C,ApoAl,and E_2 increased and those of TG,TC,LDL-C,ApoB,FSH,and LH decreased after treatment in Group C,reaching near normal levels;similar trends of blood lipids were shown in Group A,but the level of sex hormones was unchanged.In Group B all the above-mentioned indices were unchanged（P〉0.05）.（5） A one-year follow-up study showed the markedly effective rate and the total effective rate in Group C were higher than those in the other two groups respectively（P〈0.01）.（6） No adverse reaction was found.Conclusion：Chinese medicine therapy combined with psychological intervention could not only improve the nervous symptoms,but also regulate the blood levels of lipids and sex hormones in patients of peri-menopausal syndrome complicated with hyperlipidemia.

Clinical Efficacy Analysis on Treatment of Peri-menopausal Syndrome with Electroacpuncture

Objective and Methods： Thirty-three patients with perkmenopausal syndrome were treated by dectroacupuncture of points Guanyuan （CV 4） and Sanyinjiao （SP 6） according to the principle of regulating and tonifying the Thoroughfare and Conception vessels, and the curative effects were analyzed.Results and Conclusion： The results showed that there was a significant difference in the clinical symptoms of the patients with peri-menopausal syndrome between pre and post-electroacupuncture of points Guanyuan （CV 4） and Sanyinjiao （CV 6） and the clinical effective rate reached 93.9%. The measurement of sexual hormones showed E2, FSH and LH levels were better after treatment than before treatment in the patients with peri-menopausal syndrome, The analyses indicated that electroacupuncture of points Guanyuan （CV 4） and Sanyinjiao （CV 6） could rdieve the clinical symptoms in the patients with peri-menopausal syndrome and improve the patient＇s life quality.

Comparison of the effect and safety of Kuntai capsule and hormone replacement therapy in patients with perimenopausal syndrome:a systematic review and Meta-analysis

OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.

Efficacy and Safety Investigation of Kuntai Capsule for the Add-back Therapy of Gonadotropin Releasing Hormone Agonist Administration to Endometriosis Patients： A Randomized,Double-blind, Blank-and Tibolone-controlled Study

Background：As a Chinese Traditional Medicine product,Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women.But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist （GnRH-a） treatment.The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule,on peri-menopausal symptoms in endometriosis （EMS） patients,with postoperative GnRH-a treatment.Methods：Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study,and were randomly divided into Kuntai group,Tibolone group,or blank Control group.The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first GnRH-a injection,while Tibolone 2.5 mg qd,po for 12 weeks in Tibolone group.There was no drug addition in Control group.Climacteric complaints were evaluated by Kupperman menopausal index （KMI） and hot flash/sweating score.Liver and renal functions,lipid profile,serum sex hormone levels and endometrial thickness were measured,and the frequency of adverse events in Kuntai and Tibolone groups was recorded.Results：（l） Before GnRH-a therapy,the baseline parameter results were comparable in the three groups （P ＞ 0.05）.（2） After GnRH-a therapy,KMI and hot flash/sweating scores in all the three groups increased significantly （P ＜ 0.05）.At the 4th week after GnRH-a therapy,KMI and hot flash/sweating score results were as follows：Control group ＞ Kuntai group ＞ Tibolone group （P ＜ 0.05）; at the 8th and 12th week after GnRH-a therapy,KMI and hot flash/sweating score in Control group were significantly higher than the other two groups （P ＜ 0.05）,and no significant difference was identified between Kuntai and Tibolone group （P ＞ 0.05）.（3） No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment （P ＞ 0.05）.（4） The posttherapeutic serum follicle-stimulating hormone （FSH）,luteinizing hormone （LH） and estradiol （E2） level and endometrial thickness decreased significantly in all the three groups （P ＜ 0.05）.After therapy,serum E2 level in Tibolone group was obviously higher than the other two groups （P ＜ 0.05）,while FSH and LH levels were obviously lower （P ＜ 0.05）.（5） The incidence of vaginal bleeding,breast distending pain in Tibolne group was obviously higher than Kuntai group （P ＜ 0.05）.Conclusions：Kuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients,although its clinical effect might be a few weeks later than Tibolone.Kuntai capsule might be a little safer than Tibolone tablet.