Clinical efficacy of gamma-oryzanol combined with Femoston for perimenopausal syndrome

BACKGROUND Perimenopausal syndrome(PMS)is a chronic disease associated with estrogen deficiency.Because of the unsatisfactory outcomes of current conventional treatments for this condition,its treatment must be continuously explored and optimized.AIM To assess the clinical effectiveness ofγ-oryzanol in combination with Femoston for PMS.METHODS A total of 119 patients with PMS were selected from June 2023 to December 2023,which included 59 and 60 patients in the control and observation group,respectively.The control and observation groups were treated with Femoston andγ-oryzanol+Femoston,respectively.Comparative analyses were performed in terms of clinical effectiveness,safety(dizziness and headache,nausea and vomiting,and breast tenderness),sex hormones[estradiol(E2),luteinizing hormone(LH),and follicle-stimulating hormone(FSH)],lumbar spine(L1-4)and bilateral femoral bone mineral density(BMD),and sleep quality(sleeping time and frequency of awakenings from sleep).RESULTS Compared with the control group,the observation group had statistically higher total effective rates of treatment;lower overall incidence of adverse events;higher post-treatment E2 levels and L1-4 and bilateral femoral BMD;and lower LH and FSH levels,sleeping time,and frequency of awakenings from sleep after treatment.CONCLUSION Therefore,for the treatment of PMS,γ-oryzanol combined with Femoston is significantly better than Femoston alone in terms of clinical effectiveness,exhibiting more pronounced clinical advantages in improving safety,sex hormone levels,BMD,and sleep quality.

Study on the Molecular Mechanism of Danggui Buxue Decoction in Intervention of Perimenopausal Syndrome Based on Network Pharmacology and Molecular Docking

[Objectives]This study was conducted to explore the intervention mechanism of Danggui Buxue Decoction in perimenopausal syndrome based on network pharmacology and molecular docking.[Methods]The chemical components and targets of Danggui Buxue Decoction were acquired through the TCMSP database,and the main targets of perimenopausal syndrome were obtained through the GeneCards database.The component targets and disease targets were intersected,and combining with active components and Chinese herbs in the decoction,a traditional Chinese medicine-component-target network was constructed using Cytoscape 3.7.1 software.The STRING platform was employed for protein-protein interaction analysis.The DAVID analysis platform was used to conduct target GO and KEGG enrichment analysis,so as to predict the action mechanism Danggui Buxue Decoction.Finally,an active component-disease target-signal pathway network diagram was constructed.[Results]Twenty two components in Danggui Buxue Decoction related to perimenopausal syndrome and 120 corresponding targets were obtained,including active components such as 1,7-dihydroxy-3,9-dimquercetin and kaempferol,and key targets such as TNF,ESR1 and PPARG.The results of GO analysis and KEEG analysis indicated that Danggui Buxue Decoction might regulate the transcription of RNA polymerase II promoter,DNA templating,gene expression,signal transduction,hypoxia response and other biological processes by regulating multiple signal pathways such as chemical carcinogenesis-receptor activation,cancer pathways,lipid and atherosclerosis,tryptophan metabolism,malaria,steroid hormone biosynthesis and chemical carcinogenesis-DNA adduct.[Conclusions]Danggui Buxue Decoction intervenes in perimenopausal syndrome through multiple components,targets and pathways,providing a basis for elucidating the intervention mechanism of Danggui Buxue Decoction and expanding its clinical application.

A study on the clinical prediction model of the yin deficiency type of perimenopausal syndrome

Background:The yin deficiency type of perimenopausal syndrome(PMS)as a common category of PMS based on the theory of traditional Chinese medicine(TCM)has a high prevalence with severe symptoms and long course of disease.Therefore,it is necessary to construct a prediction model to assist in diagnosis.Objective:This study aimed to investigate the independent predictors of the yin deficiency type of PMS and to develop a clinical prediction model of this disease.Methods:PMS patients who attended the Third Affiliated Hospital of Zhejiang Chinese Medical University between February 2020 and August 2023 were selected and divided chronologically into training and validation groups.Logistic regression analysis was applied in the training group to clarify the independent predictors of the yin deficiency type of PMS,and a nomogram was plotted.Internal and external validations were performed in the training and validation groups to evaluate the model’s accuracy,goodness of fit,and clinical adaptability.Results:Hot flashes and sweating(≥10 episodes/day),palpitations,emotional fluctuations,and abnormal sexual activity were independent predictors of the yin deficiency type of PMS(P>0.05).Based on the clinical prediction model constructed,the area under the receiver operating characteristic curve(AUR OC)in the training group was 0.989(95%CI 0.980–0.998),and the AUR OC in the validation group was 0.971(95%CI 0.940–0.999).This demonstrates that the model has superior prediction performance.The Hosmer-Lemeshow test was used to evaluate the model’s goodness of fit with P=0.596 for the training group and P=0.883 for the validation group,indicating a good fit.The decision curve analysis(DCA)curve and clinical impact curve(CIC)indicated good clinical adaptability.Conclusion:The model can accurately predict the occurrence of the yin deficiency type of PMS,which may help clinicians identify such patients at an early stage.

Clinical Observation on Acupuncture for Perimenopausal Syndrome

Objective: To observe the clinical efficacy of acupuncture for perimenopausal syndrome. Methods: A total of 40 perimenopausal syndrome cases who met the inclusion criteria were randomized into an observation group and a control group, 20 in each group. Acupuncture combining with ginger-partitioned moxibustion was used in the observation group, whereas acupuncture was used in the control group. Modified Kupperman Index (KI) was evaluated respectively before and after treatment. In addition, the clinical efficacies in the two groups were compared. Results: The total effective rate in the observation group was higher than that in the control group (P<0.05). After treatment, KI in both groups were significantly reduced (P<0.01) and there was a statistical difference between the two groups (P<0.01). Conclusion: Acupuncture combining with ginger-partitioned moxibustion could obtain a higher total effective rate for perimenopausal syndrome than acupuncture alone. Furthermore, it was also superior to acupuncture alone in improving hot flushes, insomnia, melancholia and arthralgia or myalgia.

Scraping therapy for treating the perimenopausal syndrome

Objective:To evaluate the clinical effect of scraping therapy in the treatment of perimenopausal syndrome(PMS).Methods:Thirty recruited PMS subjects were treated with scraping therapy in the Outpatient Department,Acupuncture-Moxibustion Hospital,China Academy of Chinese Medical Sciences,at the areas including Shéntíng(神庭GV24)-Běihuì(百会GV20),Qìhǎi(气海CV6)-Guānyuán(关元CV4),Zǐgōng(子宫EXCA1),Zúsānlǐ(足三里ST36)-Xiàjùxū(下巨虚ST39),Dìjī(地机SP8)-Sányīnjiāo(三阴交SP6),Tàichōng(太冲LR3)-Xíngjiān(行间LR2),Gānshū(肝俞BL18)-Dǎnshū(胆俞BL19),Píshū(脾俞BL20)-Wèishū(胃俞BL21),and Sānjiāoshū(三焦俞BL 22)-Shènshū(肾俞BL 23),with an even reinforcing-reducing method.Before and after treatment,the serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),and estradiol(E_(2)) were tested.And before treatment and at the 4 th week,8 th week,and 12 th week of treatment,the Kupperman index(KI) and menopause-specific quality of life questionnaire(MENQOL) symptom scores were recorded for evaluating the clinical efficacy.Results:Comparing with before treatment,the modified Kupperman symptom scores were all decreased after treatment,the difference was statistically significant(P<0.05);all symptoms were relieved significantly after treatment,the difference was statistically significant(all P<0.05).There was no significant difference in serum E_(2),FSH,and LH levels after treatment(all P>0.05);the total effective rate was 85.71%after the 4 weeks’ treatment,96.42% after the 8 weeks’ treatment,and 96.42% after the 12 weeks’ treatment.Conclusion:Scraping therapy can relieve the PMS symptoms to some extent.It can improve the life quality of PMS subjects.Its influence on the estrogen levels of PMS subjects was not obvious.

Survey on Clinical and Basic Study on Perimenopausal Syndrome Treated by Moxibustion

Objective： To review the general study situation of perimenopausal syndrome treated with moxibustion, and to summarize the therapeutic rules of moxibustion for perimenopausal syndrome. Methods： The literature about clinical and experimental study on moxibustion treatment for perimenopausal syndrome since 1996 was sorted out and analyzed by computer search. Results and Conclusion： Twenty-nine articles were collected upon the criteria of recruitment. Mostly used methods were salt-partitioned and warming needle moxibustion, and the most frequently used meridians were Conception Vessel, Governor Vessel, Spleen Meridian, and Kidney Meridian. In acupoints, Shenque （CV 8）, Guanyuan （CV 4）, Mingmen （GV 4） and Yinbai （SP 1） were used in high freauecy.

Research on the Effects of the Extract of Polygala fallax Hemsl on Sex Hormones andβ-EP in Perimenopausal Rat Models

Objective:To study the effects of the ethnic medicine Polygala fallax Hemsl with Guangxi characteristics on the sex hormones andβ-EP in research objective perimenopausal rat models.Methods:40 female SPF rats were randomly divided into 4 groups,including the normal,model,high-dose and lowdose groups.Rats of three groups except for the normal one were treated with perimenopausal modelling through the method of subcutaneous injection of compound 4-VCD for 15 consecutive days.Rats of the normal and model group were normally fed without any treatment.Rats of the high-dose and low-dose groups were administered by high-and low-dose intragastric administration of the extract of Polygala fallax Hemsl.According to the menstrual cycle of the vaginal smear of the rat,each menstrual cycle is a course of treatment and 6 consecutive courses of treatment would be given.The indexes of serum sex hormones(E2,FSH,LH)andβ-EP of rats in each group were observed after treatment.Results:After the treatment of 6 cycles,for the levels ofβ-EP and E2,the model group was lowest(P<0.05),the normal group was highest(P<0.05);and the high-dose group was higher than the low-dose group;For the levels of FSH and LH,the normal group was lowest(P<0.05),the model group was highest(P<0.05),and the high-dose group was lower than the low-dose group.Conclusion:Guangxi characteristic national medicine Polygala fallax Hemsl can effectively improve the levels of serum sex hormones andβ-EP in perimenopausal rat models and relieve the related symptoms with a certain dose-effect relationship.

A Multi-center,Randomized,Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

Objective： To evaluate the efficacy and safety of Heyan Kuntai Capsule（和颜坤泰胶囊, HYKT） and hormone therapy（HT） on perimenopausal syndromes（PMSs）. Methods： From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol（E2） below 30 ng/L, and follicle stimulating hormone（FSH） above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index（KMI） scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life（MENQOL） scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results： After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline（P〈0.01） and there was no significant difference between groups（P〉0.05）, except that KMI of HYKT group was higher after 3-month treatment（P〈0.05）. After treatment, hot flush and insomnia scores were both improved significantly in two groups（P〈0.01）; and HT had a better performance than HYKT in improving hot flush（P〈0.05）. MENQOL were significantly improved in both groups after treatment（P〈0.01）; but there was no significant difference between two groups（P〉0.05）. The incidence of adverse event in the HYKT group was much lower than that in the HT group（P〈0.01）. Conclusions： HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.

Clinical Study on Electroacupuncture for Perimenopausal Insomnia

Objective： To observe the clinical efficacy of electroacupuncture in treating perimenopausal insomnia. Methods： Seventy eligible subjects were randomized into two groups, 38 subjects in the treatment group were intervened by electroacupuncture, 30 min each session; 32 subjects in the control group were intervened by Alprazolam, 0.4 mg each time before sleep. Athens insomnia scale （AIS） was adopted to evaluate sleep quality. Results： The therapeutic efficacy in the treatment group was significantly better than that in the control group （P〈0.05）. Conclusion： Electroacupuncture efficacy in treating perimenopausal can produce a content therapeutic nsomnia.

Effect of Chaihushugan San on expression of the Raf/mitogen-activated protein kinase/extracellular signal-regulated kinase pathway in the hippocampi of perimenopausal rats induced by immobilization stress

OBJECTIVE: We wished to study the impact of Chaihushugan San(CSS) on the behavior of perimenopausal rats with liver-Qi stagnation(LQS) and to investigate the effect of CSS on signal transduction of the Raf/mitogen-activated protein kinase(MEK)/extracellular signal-regulated kinase(ERK) cascade in the hippocampi of rats induced by immobilization.METHODS: Twenty 52-week-old female rats were divided into two groups by the random number table method: model control group(MCG) and CSS group(CSSG), with 10 rats in each group.Ten-week-old female rats were used as the normal control group(NCG). CSS effects were assessed using rats exposed to immobilization stress by measuring body weight and sucrose consumption, serum hormone levels, and observing performance in the open field test(OFT). Molecular mechanisms were examined by measuring the effect of CSS on expression of Raf1, MEK1/2 and ERK1/2 m RNA in hippocampi using quantitative real-time polymerase chain reaction and by measuring levels of these proteins and related phospho-proteins using Western blotting.RESULTS: Perimenopausal rats with LQS had decreased locomotor activity; reduced sucrose consumption; and increased serum levels of corticotropin releasing hormone(CRH) and corticosterone(CORT). Activation of hippocampal Raf/MEK/ERK cascade was suppressed significantly in the MCG,and activation was increased after 21 days of CSS treatment.CONCLUSION: CSS has significant effects upon relief of the symptoms of LQS in immobilization-induced rats. The mechanism underlying this action might(at least in part) be mediated by reversal of disruption of the Raf/MEK/ERK pathway.

Clinical Study on Electroacupuncture for Perimenopause Syndrome

Objective： To observe the clinical effect of electroacupuncture in treating perimenopause syndrome （PMS） and explore its possible action mechanism. Methods： All of 110 cases with PMS were randomized into group A [Guanyuan （CV 4） and Sanyinjiao （SP 6）] and group B [Neiguan （PC 6） and Zusanli （ST 36）], 55 cases in each. After 4-week treatments, the Kupperman Menopausal Index （KMI） was adopted to evaluate the therapeutic effect. Estradiol （E2）, follicle-stimulating hormone （FSH） and luteinizing hormone （LH） were assayed respectively before and after treatments. Results： The KMI decreased by 52.6% in group A, versus 47.4% in group B. The total effective rate was 93.6% in group A, versus 85.7% in group B, and the difference was not significant （P〈0.05）. The content of E2 both increased in the two groups after 4-week treatments （P〈0.05）; the contents of FSH and LH dropped but without statistical difference （P〈0.05）. Conclusion： Both of the two acupoints groups can significantly lower KMI, and effectively increase the contents of E2 in patients with PMS

Discussion on the Best Intervention Time for Electroacupuncture in Treating Rats with Perimenopause Syndrome

Objective： To explore the best opportunity for electroacupuncture therapy to treat perimenopause syndrome. Methods： The rats were duplicated as ovariectomized model and took the electroacupuncture therapy at 5 different periods. The heat-resistance ability, physical strength and sleeping ability of the rats at different intervention time were recorded. Results： For the rats with perimenopause syndrome at all periods, the electroacupuncture could promote the beat-resistance and the physical strength, shorten the sleep latency and prolong the sleeping time. The results of the rats in the 7 d pre-modeling group, 1 d post-modeling group and 8 d post-modeling group were the best, followed by the results of 15 d post-modeling group and 22 d post-modeling group. Conclusion： The prevention and early intervention of electroacupuncture on the rats with perimenopanse syndrome were satisfied and the effect declined with a later intervention time, indicating the importance of prevention and early intervention.

Ear Acupuncture for Perimenopause Syndrome:A Multi-centered Randomized Controlled Trial

Objective： To observe and evaluate the clinical effect of ear acupuncture in treating perimenopause syndrome. Methods： A multi-centered randomized controlled trial was conducted and the enrolled participants were divided into an ear acupuncture group and a control group. The ear acupuncture group was treated by electroacupuncture at auricular points, and the control one was prescribed for Geng Nian An （Menopause Helper） tablets. The therapeutic effects were evaluated after 10-day treatments. Results： For pre-menopausal patients, the total effective rate was 96.8% in the ear acupuncture group, versus 56.3% in the control. For post-menopausal patients, the total effective rate was 85.7% in the ear acupuncture group, versus 53.0% in the control. Conclusion： Both ear acupuncture and Geng Nian An （Menopause Helper） tablets were effective in ameliorating symptoms of perimenopause syndrome, with satisfactory compliance and safety. The clinical effect of ear acupuncture is better than that of Geng Nian An （Menopause Helper） tablets.

Therapeutic Evaluation on Needling Method of Regulating the Conception Vessel and Calming the Mind for Perimenopausal Sleep Disorder

Objective: To observe the clinical efficacy of needling method of regulating the Conception Vessel and calming the mind in treating sleep disorder in perimenopausal women, and to provide clinical evidence for future treatment of the disease. Methods: Sixty eligible subjects with perimenopausal sleep disorder were enrolled and randomized into an observation group and a control group, 30 cases in each group. The observation group was intervened by needling method of regulating the Conception Vessel and calming the mind, and the control group was treated by taking Yi Kun Yin orally. Two-week treatment was considered as a treatment course. Major symptoms of traditional Chinese medicine and Pittsburgh Sleep Quality Index (PSQI) were observed, and clinical efficacies were compared. Results: After treatment, the difference in total effective rate between the two groups was statistically significant (P<0.05); except for flaccidity of lumbar and knees, both groups achieved significant improvements in the other 5 symptoms of traditional Chinese medicine (P<0.05 or P<0.01); PSQI global score and component scores dropped in both groups, and the improvements in the observation group were markedly superior to that in the control group (P<0.05 or P<0.01). Conclusion: The needling method of regulating the Conception Vessel and calming the mind is better than Yi Kun Yin in improving traditional Chinese medicine symptoms and sleep quality in patients with perimenopausal sleep disorders.

Combined Acupuncture-moxibustion and Psychotherapy for Perimenopause Syndrome

Objective： To observe the effect of combined acupuncture-moxibustion with psychotherapy in treating perimenopause syndrome. Methods： Eighty patients with perimenopause syndrome were randomized into two groups. Forty-two patients in the treatment group were intervened by acupuncture-moxibustion and psychotherapy, and the other 38 in the control group were treated by acupuncture-moxibustion only. The treatment was given once a day, 15 times constitute a treatment course. The therapeutic effects were evaluated after 3 treatment courses. Results： The total effective rate and the effective rate of the emotional state were both 97.6% in the treatment group, versus 89.5% and 73.7% in the control. The comparison of the total effective rate and the effective rate of the emotional state between the two groups both showed significant difference （P〈0.05）. Conclusion： Acupuncture-moxibusiton has better effect in treating perimenopause syndrome when combined with psychotherapy.

Clinical Study on Acupuncture in Treating Perimenopausal Insomnia

Objective:To observe the clinical efficacy of acupuncture for insomnia in perimenopausal women.Methods:According to simple randomized controlled principle,sixty female patients with perimenopausal insomnia were randomized into two groups:30 in the treatment group were intervened by acupuncture and the other 30 in the control group were intervened by taking sleeping pills.Therapeutic efficacies were compared between the two groups at the end of treatment.Results:The total effective rate was 100.0%in the treatment group versus 83.3%in the control group,and the difference was statistically significant(P<0.05).Conclusion:Acupuncture has better therapeutic efficacy than taking sleeping pills in treating perimenopausal insomnia.

Clinical Observation on Acupuncture Therapy for Depression at Perimenopause

Objective:To observe the effect of acupuncture therapy on depression at perimenopause.Methods:Sixty patients who had depression at perimenopause were divided into a treatment group and a control group,thirty patients in each group.Patients in the treatment group were treated with Bo’s abdominal acupuncture,while patients in the control group were treated with Prozac.Hamilton depression scale(HAMD)and Beck depression inventory(BDI)were observed before and after treatment to evaluate the clinical effect.Results:Depression levels decreased after treatments in both groups(P<0.05).There were no statistical differences between the two groups in the total effective rate and BDI.Conclusion:Abdominal acupuncture has similar effect in treating depression at perimenopause with Prozac..