Effects of red clover (Trifolium pratense) isoflavones on the lipid profile of perimenopausal and postmenopausal women-A systematic review and meta-analysis.

AIM: The aim of this systematic review and meta-analysis was to clarify the effect of a specific standardised extract of red clover (Trifolium pratense) on the lipid profile of perimenopausal and postmenopausal women. METHODS: Medline (PubMed), EMBASE, and Cochrane Library electronic databases were searched for papers in English reporting randomized controlled trials published up to 2017. Reference lists from those papers were checked for further relevant publications. Studies were identified and reviewed for their eligibility for inclusion in this review. The changes from baseline in the levels of individual components of the lipid profiles were used to assess differences between the active treatment and placebo groups. Weighted mean differences and 95 % confidence intervals were calculated for continuous data using a random-effects model. RESULTS: Ten eligible studies (twelve comparisons) with 910 peri- and postmenopausal women were selected for systematic review. The meta-analysis showed changes in serum levels: total cholesterol, -0.29 (95 % CI: -0.53 to -0.06) mmol/L [-11.21 (95 % CI: -20.49 to -13.92) mg/dL], p = 0.0136; LDL-cholesterol, -0.13 (95 % CI: -0.35 to 0.09) mmol/L [-5.02 (95 % CI: -13.53 to 3.48) mg/dL], p = 0.2418; triglycerides, -0.15 (95 % CI: -0.32 to 0.01) mmol/L [-13.28 (95 % CI: -28.34 to 0.88) mg/dL], p = 0.0592; and HDL-cholesterol, 0.14 (95 % CI: -0.08 to 0.36) mmol/L [5.41 (95 % CI: -3.09-13.92) mg/dL], p = 0.2103. TheI2 statistic ranged from 87.95%-98.30 %, indicating significant heterogeneity. CONCLUSIONS: The results suggest that a red clover extract is efficacious in reducing the concentrations of total cholesterol; however, changes in HDL-C, LDL-C and triglycerides are not as pronounced. Potentially, this means that women takingTrifolium pratense for menopausal symptoms can derive additional benefits from the plant's specific effect that corrects abnormal cholesterol levels. Additional studies are needed to assess its effects on post-menopausal women.

Effectiveness of Chinese herbal medicine granules and traditional Chinese medicine-based psychotherapy for perimenopausal depression in Chinese women: a randomized controlled trial.

OBJECTIVE: The aim of the study was to assess the effectiveness of Chinese herbal medicine combined with traditional Chinese medicine (TCM)-based psychotherapy (TBP) on perimenopausal depression (PMD). METHODS: This multicenter, randomized, placebo-controlled clinical trial was conducted in nine hospitals in China between August 2015 and June 2017. The study included 307 women with PMD who were divided randomly into two treatment groups: the Bushen Tiaogan formula (BSTG) plus TBP (n = 156) and placebo plus TBP (n = 151). All participants underwent treatment for 8 weeks and were followed up for 4 weeks. The primary outcome measures included scores of the Greene Climacteric Scale (GCS), Self-Rating Depression Scale (SDS), and Self-Rating Anxiety Scale (SAS). Secondary outcomes included serum levels of sex hormones and lipids, as well as adverse events. RESULTS: The average GCS, SDS, and SAS scores after treatment were significantly lower in the BSTG-plus-TBP group than those in the placebo-plus-TBP group, and the differences were greatest at the end of the 12th week: the average GCS scores were 10.8 in the BSTG-plus-TBP group versus 18.5 in the placebo-plus-TBP group (P < 0.001); the average SDS scores were 30.7 in the BSTG-plus-TBP group versus 45.4 in the placebo-plus-TBP group (P < 0.001); the SAS scores were 28.6 in the BSTG-plus-TBP group versus 42.6 in the placebo-plus-TBP group (P < 0.001). In addition, treatments with BSTG plus TBP significantly reduced the levels of basal follicle-stimulating hormone (P = 0.045) and triglycerides (P = 0.039) and increased the level of high-density lipoprotein cholesterol (P < 0.001) compared to placebo treatments with TBP. No serious adverse events occurred, and the safety indices of complete blood counts, renal function, and liver function were within normal ranges, before and after treatments. CONCLUSIONS: Treatment with BSTG formula plus TBP was more effective than TBP alone for improving PMD symptoms, sexual hormone levels, and blood lipid conditions in women with mild PMD.

A Double-Blind Placebo-Controlled Randomized Trial Evaluating the Effect of Polyphenol-Rich Herbal Congee on Bone Turnover Markers of the Perimenopausal and Menopausal Women.

Based on the benefit of polyphenolic compounds on osteoporosis, we hypothesized that the polyphenol-rich herbal congee containing the combined extract of Morus alba and Polygonum odoratum leaves should improve bone turnover markers in menopausal women. To test this hypothesis, a randomized double-blind placebo-controlled study was performed. A total of 45 menopausal participants were recruited in this study. They were randomly divided into placebo, D1, and D2 groups, respectively. The subjects in D1 and D2 groups must consume the congee containing the combined extract of M. alba and P. odoratum leaves at doses of 50 and 1500 mg/day, respectively. At the end of an 8-week consumption period, all subjects were determined serum bone markers including calcium, alkaline phosphatase, osteocalcin, and beta CTX. In addition, the hematological and blood clinical chemistry changes, and total phenolic content in the serum were also determined. The results showed that the menopausal women in D2 group increased serum alkaline phosphatase, osteocalcin, and total phenolic compounds content but decreased CTX level. Clinical safety assessment failed to show toxicity and adverse effects. Therefore, herbal congee containing the combined extract of M. alba and P. odoratum leaves is the potential functional food that can decrease the risk of osteoporosis.

Effects of red clover on perimenopausal and postmenopausal women's blood lipid profile: A meta-analysis.

The study aimed to perform a systematic review with meta-analysis of randomized controlled trials (RCTs) to access the effects of red clover isoflavones on the blood lipid profile of both perimenopausal and postmenopausal women. PubMed, Web of Science, Scopus, SciELO, and Cochrane Library were searched for the terms 'red clover', 'Trifolium pratense', and 'randomized controlled trial' during November 2017. Summary measures were reported as weighted mean differences (WMD) with 95% confidence interval (CI). Fixed or random effects models were used for meta-analyses, according to heterogeneity. Risk of bias was measured with the Cochrane tool. Twelve RCTs (totalizing 1284 perimenopausal and postmenopausal women receiving red clover isoflavones for 4 weeks-18 months) resulted in a significant decrease in total cholesterol (WMD = -12.34 mg/dl; 95% CI: -18.21, -6.48), low-density lipoprotein cholesterol (WMD = -10.61 mg/dl; 95% CI: -15.51, -5.72), and triglycerides (WMD = -10.18 mg/dl; 95% CI: -16.23, -4.13) together with a significant increase in high-density lipoprotein cholesterol (WMD = 1.60 mg/dl; 95% CI: 0.17, 3.03). In conclusion, the results demonstrate that the ingestion of red clover may have a beneficial effect on the lipid profile of perimenopausal and postmenopausal women.

Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure will be the mean change in the Menopause Rating Scale from baseline to week 5. Secondary outcome measures will include the World Health Organization Quality of Life-BREF (WHOQOL-BREF) score, the Blood Deficiency Scoring System score, lean body mass, and blood tests, including serum follicle-stimulating hormone and estradiol concentration. To assess the safety of DJS, a laboratory test will be conducted before and after treatment and the participants will be asked about any occurrence of adverse events every visit. The recruitment rate, completion rate, and medication adherence will also be calculated, to assess feasibility. DISCUSSION: The findings of this study will provide the basis for a full-scale randomized controlled trial to confirm the safety and efficacy of DJS for the treatment of climacteric syndrome in peri- and postmenopausal women. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002387 . Registered on 25 July 2017.

[Comparison between manual acupuncture and electroacupuncture for hot flashes and sex hormone of perimenopausal syndrome].

OBJECTIVE: To compare the effect and differences sex the influence of hormone levels of perimenopau-sal syndrome patients between manual acupuncture and electroacupuncture (EA). METHODS: A total of 50 cases with perimenopausal syndrome were randomly assigned into an manual acupuncture group (27 cases) and an EA group (23 cases), and 1 case dropped in the EA group. The acupoints in the two groups were Guanyuan (CV 4), Zigong (EX-CA 1), Tianshu (ST 25), and Sanyinjiao (SP 6). Acupuncture with 3-time small and even manipulation of lifting, thrusting and twirling was used in the acupuncture group, once 10 min. EA with sparse-dense wave and 10 Hz/50 Hz was applied in the EA group for 30 min. The treatments in the two groups were for continuous 8 weeks (24 times in total), once the other day, 3 times a week. The scores of 24-hour hot flashes even, menopausal rating scale (MRS) and menopause-specific quality of life questionnaire (MENQOL) were recorded before treatment and after 4-week and 8-week treatment, as well as 12 and 24 weeks after treatment. Serum sex hormone levels were tested before and after 8-week treatment as well as 12 weeks after treatment, including serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estracliol (E2). RESULTS: Compared with those before treatment, the 24-hour hot flashes even score, MRS and MENQOL scores were significantly lower after 4-week and 8-week treatments, 12 and 24 weeks after treatment (all P<0.05). All the above scores after 8-week treatment were lower than those after 4-week treatment (all P<0.05); and the scores 12 and 24 weeks after treatment were lower than those after 4-week and 8-week treatments (all P<0.05); all the scores after treatment were not significantly different at any time between the two groups (all P>0.05). Compared with those before treatment, serum FSH and E2 apparently improved in the two groups after 8-week treatment and 12 weeks after treatment (all P<0.05). LH levels did not significantly change in the two groups (all P>0.05). All the serum sex hormone levels showed no significant difference between the two groups (all P>0.05). CONCLUSIONS: Both acupuncture and EA can improve perimenopausal symptoms and serum sex hormone. The effects are similar.

[Effects of moxibustion at Shenshu (BL 23) on level of sex hormones and AMH in sub-health peri-menopausal women].

OBJECTIVE: To compare the effects between moxibustion at Shenshu (BL 23) and oral administration of Vitamin E on quality of life and mechanism in sub-health perimenopausal women, aiming to provide clinical evidence of moxibustion for health care of sub-health female. METHODS: Sixty participants were randomly divided into a moxibustion group and a medication group, 30 cases in each one. The volunteers in the moxibustion group were treated with mild moxibustion at bilateral Shenshu (BL 23) for 15 min, once a day; five treatments were considered as a course of treatment, and totally 4 courses were given with an interval of 2 days between courses. The volunteers in the medication group were treated with oral administration of soft capsule of Vitamin E, once a day, continuously for 28 days. The scores of quality of life and serum levels of sex hormones, anti-Mullerian hormone (AMH) and inhibin B (INHB) were measured before and after treatment in the two groups. RESULTS: ① Compared before treatment, the scores of quality of life in the two groups were both significantly increased after treatment (both P<0.01), which was more superior in the moxibustion group (P<0.05). ② Compared before treatment, the serum levels of estradiol (E2) and progesterone in the moxibustion group were significantly increased after treatment, especially for premenopausal volunteers (both P<0.01). ③ After moxibustion, the serum level of AMH was significantly improved (P<0.01), however, the effect on INHB had no statistical difference (P>0.05). CONCLUSIONS: Moxibustion could effectively improve the quality of life in sub-health perimenopausal women, regulate the levels of sex hormones and AMH, improve ovarian reserve function, and delay ovarian aging.

Effect of acupuncture and its influence on cerebral activity in perimenopausal insomniacs: study protocol for a randomized controlled trial.

BACKGROUND: Perimenopausal insomnia is one of the core symptoms of the menopausal transition. Acupuncture is considered to exert a positive effect on restoring the normal sleep-wake cycle. However, there is little intuitive evidence besides evaluation using clinical effectiveness scales. We therefore designed this study, aiming to use more intuitive and reliable detection techniques such as functional magnetic resonance imaging before and after applying acupuncture to provide neuroimaging evidence, as well as to verify the effectiveness with other curative effect indicators. METHODS/DESIGN: This study is a randomized, assessor-statistician-blinded, positive medicine controlled trial involving 40 participants. A total of 40 eligible patients with perimenopausal insomnia will be randomly assigned to two groups in a 1:1 ratio as an intervention group using acupuncture and a control group taking estazolam. Participants in the intervention group will receive six acupuncture treatment sessions per week for 4 consecutive weeks, for a total of 24 sessions during the study. Meanwhile, the medicine control group will be prescribed estazolam 1-2 mg/day to be taken 30 minutes before sleep for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index. Secondary outcomes are the micro-movement sensitive mattress-type sleep monitoring system, the Hamilton Depression Scale, and the Hamilton Anxiety Scale. All outcomes will be evaluated before and after treatment. The safety of interventions will be assessed at every visit. DISCUSSION: The results of this trial, which will be available in 2018, will investigate the impact of acupuncture treating perimenopausal insomnia from assessment of the sleep architecture, hormone level, and emotional-circuit neurological function, and will uncover the effective mechanism of acupuncture regulating the emotional center integrated effect. TRIAL REGISTRATION: Chinese Clinical Trials Register, ChCTR-IPC-16007832 . Registered on 26 January 2016.

Survey on the levels of 25-hydroxy vitamin D and bone metabolic markers and evaluation of their correlations with osteoporosis in perimenopausal woman in Xi'an region.

It has been accepted that vitamin D (VD) plays an important role in bone metabolism. However, the levels of VD in people of different regions are quite different and there is still no final conclusion on the significant correlation between VD and osteoporosis. 245 cases of peri-menopausal women were collected to study the relationship between VD and osteoporosis in western China. The mean value of 25-hydroxyvitamin D for the participants was 14.39 ng/mL. The average values of parathyroid hormone (PTH), calcium (Ca) and phosphorus (P) were 47.62 pg/mL, 2.26 mmol/L and 1.18 mmol/L, respectively. The average value of bone mineral density (BMD) in lumbar vertebrae was -1.20 SD and that in femoral neck was -0.04 SD. Compared with normal group, PTH of VD deficiency group was significantly increased (P < 0.05), Ca was remarkably decreased (P < 0.01) while the BMD between these two groups showed no significant difference (P > 0.05). VD was in positive correlation with the age (P < 0.01) and Ca (< 0.01) of the participants, negative correlation with PTH (P < 0.01) while no significant correlation with the BMD of lumbar vertebrae and femoral neck (P > 0.05). The risk factors resulting in the occurrence of osteoporosis in the lumbar vertebrae of the participants covered Ca increase (OR = 66.247, P<0.05), age growth (OR = 1.194, P<0.01) and menopause (OR = 2.285, P<0.05). This study has found that the status of VD deficiency showed no significant correlation with the level of BMD, which hinted that independent measurement of the bone metabolic markers, including Ca, P, VD and PTH, was difficult to accurately reflect the status of BMD in peri-menopausal women of this region. It's necessary to combine multi-site bone scanning to diagnose the patients' status of osteoporosis so as to provide reasonable guidance for early clinical prevention and treatment.

Forty to fifty-five-year-old women and iron deficiency: clinical considerations and quality of life.

Between the age of 40 and 55 years, women experience important changes in their lives. This period, which corresponds to the perimenopause for most women, is associated with the risk of iron deficiency anemia (IDA). The clinical presentation of anemia can be misleading, and the underlying cause, particularly bleeding, is frequently treated without concomitant iron prescription. Iron deficiency (ID) remains a social and economic burden in European countries. Underdiagnosed and undertreated, this problem has a strong negative impact on women's quality of life. The risk factors for ID are well known. The physician's role is essential in recognizing the symptoms, identifying the risk factors, detecting IDA by testing hemoglobin, and evaluating the degree of ID by measuring serum ferritin (SF). Iron therapy treats the anemia and restores iron stores, thus decreasing symptoms such as fatigue and restoring quality of life. Among the available forms of iron, evidence is in favor of ferrous sulfate in a slow release formulation, which is well-tolerated and results in good adherence, a key factor for efficacious supplementation.

Efficacy of porcine placental extract on climacteric symptoms in peri- and postmenopausal women.

OBJECTIVES: Injections of human placental extract have long been used to treat menopausal symptoms. Recently, porcine placental extract (PPE), an oral supplement, has been developed for this purpose. The aim of this study was to assess whether PPE has an impact on climacteric symptoms in perimenopausal and postmenopausal women. METHODS: Seventy-six women with climacteric symptoms were enrolled into this open-label, randomized, controlled study. The control group (n = 38) underwent 24 weeks of open treatment with Toki-shakuyaku-san (TJ23), an oral herbal remedy used to alleviate climacteric symptoms. The PPE group (n = 38) received three capsules of PPE/day orally for the initial 12 weeks and six capsules/day for the next 12 weeks. Climacteric symptoms were evaluated in both groups using the Simplified Menopausal Index (SMI) score, Zung's Self-Rating Depression Scale (ZSDS) and the Spielberger State-Trait Anxiety Inventory (STAI) before commencing treatment, after 12 weeks of treatment and on completion of treatment. RESULTS: Treatment with PPE was significantly (p < 0.01) more effective in reducing the SMI, ZSDS and STAI measures at 12 and 24 weeks than TJ23 treatment alone. Treatment with PPE was also significantly effective (p < 0.01) in reducing the subscale scores of the SMI for items such as hot flushes, insomnia, irritability, depression, fatigue and joint pain. PPE treatment had no significant adverse effects. CONCLUSION: Oral PPE treatment is another possible option for treating perimenopausal and postmenopausal women with climacteric symptoms.

Menopause and age-driven changes in blood level of fat- and water-soluble vitamins.

OBJECTIVE: The purpose of this cross-sectional study was to assess the association of the menopausal transition with changes in vitamins. METHODS: The study group comprised women aged 17-85 years from the Third National Health and Nutrition Examination Survey (NHANES), which was conducted between 1988 and 1994, and from the NHANES surveys conducted between 1999 and 2006. Menopausal status was defined using the time since the last period, < 2, 2-12, and > 12 months, for the pre-, peri-, and postmenopause, respectively. The data-cleaning technique employing serum follicle stimulating hormone activity resulted in pre-, peri- and postmenopausal samples encompassing the following age brackets: 17-50, 42-51, and 46-85 years. Statistical inferences were analyzed using non-parametric techniques. RESULTS: Significant increases in vitamin A and vitamin E concentrations across all phases of the menopausal transition were observed. There was a gradual decrease in the vitamin C concentration across all stages of the menopause but a fairly stable concentration of vitamin B12. There was a statistically significant increase in vitamin D between the pre- and postmenopause. Body mass index correlated negatively with serum vitamin concentration in the pre- and postmenopause. CONCLUSIONS: Vitamin A should be supplemented in postmenopausal women to decrease the risk of bone fracture. The daily diet should be supplemented with vitamin B12, to avoid possible neurological symptoms due to vitamin B12 deficiency, and with vitamin D to decrease the risk of developing secondary hyperparathyroidism. Due to an adverse influence on serum vitamin concentration, body mass index should be monitored in pre- and postmenopausal women.

Effect of low-dose calcium supplements on bone loss in perimenopausal and postmenopausal Asian women: a randomized controlled trial.

Current standard-dose calcium supplements (eg, 1000 mg/d) may increase the risk for cardiovascular events. Effectiveness of lower-dose supplements in preventing bone loss should thus be considered. This study aimed to assess whether calcium supplements of 500 or 250 mg/d effectively prevent bone loss in perimenopausal and postmenopausal Japanese women. We recruited 450 Japanese women between 50 and 75 years of age. They were randomly assigned to receive 500 mg of calcium (as calcium carbonate), 250 mg of calcium, or placebo daily. Medical examinations conducted three times over a 2-year follow-up period assessed bone mineral density (BMD) of the lumbar spine and femoral neck. One-factor repeated measures ANOVA was used for statistical tests. Subgroup analyses were also conducted. Average total daily calcium intake at baseline for the 418 subjects who underwent follow-up examinations was 493 mg/d. Intention-to-treat analysis showed less dramatic decreases in spinal BMD for the 500-mg/d calcium supplement group compared to the placebo group (1.2% difference over 2 years, p = 0.027). Per-protocol analysis (≥80% compliance) revealed that spinal BMD for the 500-mg/d and 250-mg/d calcium supplement groups decreased less than the placebo group (1.6%, p = 0.010 and 1.0%, p = 0.078, respectively), and that femoral neck BMD for the 500-mg/d calcium supplement group decreased less relative to the placebo group (1.0%, p = 0.077). A low-dose calcium supplement of 500 mg/d can effectively slow lumbar spine bone loss in perimenopausal and postmenopausal women with habitually low calcium intake, but its effect on the femoral neck is less certain. Calcium supplementation dosage should thus be reassessed. (Clinical Trials Registry number: UMIN000001176).

Brief telephone intervention increases soy intake in peri- and postmenopausal US women: the Herbal Alternatives Trial (HALT).

OBJECTIVE: Effective dietary intervention strategies that can be widely disseminated and have the potential for sustainable dietary modifications are needed. The purpose of this study was to describe and evaluate the effectiveness of a telephone-based soy intervention. DESIGN: A randomized controlled trial comparing self-reported intake and serum measures of soy during a 1-year dietary soy (Soy) to fruit and vegetable (Placebo) intervention conducted in two of five arms from the Herbal Alternatives Trial between May 2001 and September 2004. SUBJECTS/SETTING: One hundred sixty-three peri- and postmenopausal women (mean age=52 years) consuming self-selected diets in the Pacific Northwest, United States. INTERVENTION: Five telephone contacts with a registered dietitian during a 12-month intervention with the goal to increase soy food consumption to two servings daily. MAIN OUTCOME MEASURES: Change from baseline in self-reported soy servings and serum isoflavone (daidzein and genistein) concentrations were estimated using analysis of variance and generalized estimating equations. Proportions of participants achieving the intervention goal were compared using chi(2) tests. RESULTS: Ninety-four percent (n=74) of participants in the Soy arm and 89% (n=75) in the Placebo arm completed the trial, and slightly more than one third (n=27) received five phone contacts. Mean (+/-standard deviation) intakes of soy were similar for the Soy and Placebo arms at baseline (0.6+/-1.0 vs 0.4+/-0.8 servings/day; P>0.05). At 12-month follow-up visit, mean+/-standard deviation servings of soy per day were 1.6+/-1.4 for the Soy intervention compared to 0.5+/-0.9 within the Placebo arm (P<0.001). There were concomitant increases in serum isoflavones at 3 and 6 months from baseline in the Soy arm only, with approximately twofold increases in both daidzein (mean=66.4 nmol/L, 95% confidence interval [CI]: 39.0 to 93.9 [mean 16.9 ng/mL, 95% CI: 9.9 to 23.8]) and genistein (mean=100.4 nmol/L, 95% CI: 60.9 to 139.9 [mean 27.1 ng/mL, 95% CI: 16.5 to 37.8]) concentrations. Mean weight changed by <1 kg during the 12-month period in each group and physical activity remained stable, suggesting that participants incorporated soy foods into their diet by substituting for non soy foods rather than adding them to their diet. CONCLUSIONS: A brief telephone-based intervention with a focused message delivered by a registered dietitian is a feasible approach for encouraging targeted dietary changes, such as an increase in soy intake among peri- and postmenopausal women.

Chinese medicinal herbs in relieving perimenopausal depression: a randomized, controlled trial.

OBJECTIVE: To explore the effects of GengNianLe (GNL, also called perimenopausal depression relieving formula), a defined formula of Chinese medicinal herbs in relieving perimenopausal depression in Chinese women. METHODS: Between September 2004 and April 2008, 47 Chinese women were randomized into a GNL group (n = 21) and a control group which received tibolone (n = 26) using a randomization chart. Depression was rated with the 24-item Hamilton Depression Scale (HAMD). The serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E(2)) were detected before and after the treatment. RESULTS: After 12 weeks of treatment, HAMD scores in both groups decreased significantly (p < 0.05) with no significant difference between the groups (p > 0.05). The levels of FSH decreased significantly and the level of E(2) increased significantly in both groups, and they changed more in the control group. No side-effect of treatment was reported in either group during treatment. CONCLUSIONS: The Chinese medicinal formula GNL showed promise in relieving perimenopausal depression and merits further study.

[Clinical observation on combination of source point and Back-Shu Point for treatment of perimenopausal syndrome].

OBJECTIVE: To observe the clinical therapeutic effect of combination of Source Point and Back-Shu Point on perimenopausal syndrome, and provide a new thought of therapy for perimenopausal syndrome. METHODS: Eighty cases of perimenopausal syndrome were randomly divided into a combination of Source Point and Back-Shu Point group and a routine acupuncture group, 40 cases in each group. The combination of Source Point and Back-Shu Point group was treated with acupuncture at Taixi (KI 3), Taichong (LR 3), Taibai (SP 3), Sanyinjiao (SP 6), Shenshu (BL 23), Ganshu (BL 18), Pishu (BL 20), Guanyuan (CV 4); and the routine acupuncture group was treated with acupuncture at Baihui (GV 20), Guanyuan (CV 4), Shenshu (BL 23), Taixi (KI 3), San-yinjiao (SP 6). The Kupperman score and the changes of serum estradiol (E2), follicle stimulating hormone (FSH) and luteinizing hormone (LH) were observed before and after treatment in the two groups. RESULTS: The total effective rate of 92.5% in the combination of Source Point and Back-Shu Point group was superior to 80.0% in the routine acupuncture group, with a significant difference (P < 0. 05); the Kupperman score of 24. 85 +/- 8.35 in the combination of Source Point and Back-Shu Point group was significantly decreased as compared with 35.38 +/- 9.83 in the routine acupuncture group (P < 0.05) after treatment; the contents of E2, FSH and LH in the combination of Source Point and Back-Shu Point group were significantly improved after treatment, and with a significant difference compared to the routine acupuncture group (P < 0.01, P < 0.05). CONCLUSION: Combination of Source Point and Back-Shu Point has a benign regulation function for E2, FSH and LH, and can significantly improve the Kupperman score, is superior to routine acupuncture for perimenopausal syndrome.

[Multicentral randomized controlled clinical trials about treatment of perimenopausal syndrome with electroacupuncture of sanyinjiao (SP 6)].

OBJECTIVE: To evaluate the effect of electroacupuncture (EA) of Sanyinjiao (SP 6) on perimenopausal syndrome (PMS). METHODS: Multicentral randomized controlled trials and single blind test were adopted in the present study. A total of 157 PMS patients were randomly divided into EA group (n=81) and medication group (n=76) . EA (2/100 Hz, 8-10 mA) was applied to bilateral Sanyinjiao (SP 6), 3 times a week and for 3 months (mon). Patients of medication group were treated by oral administration of nylestriol, 2 mg/time, twice a mon for 3 mon. For PMS patients, medroxyprogesterone (6 mg/d, for 10 days) was added from the third mon on after the treatment. The therapeutic effect was evaluated by using "symptoms-signs score scale", and changes of serum estradiol (E2), follicle stimulating hormone (FSH) and luteotrophic hormone (LH) were detected by chemiluminescence immune assay. Kupperman index was determined before and after the treatment. RESULTS: In comparison with pre-treatment, Kupperman index of EA group decreased significantly (P < 0.01). After the treatment, contents of serum FSH and LH of EA group decreased significantly (P < 0.01), while serum E2 contents of EA and medication groups increased significantly (P < 0. 01). Serum LH and E2 levels of EA group were significantly lower than those of medication group (P < 0.05). No significant differences were found between two groups in Kupperman index, markedly-effective rates and total effective rates (P > 0.05). CONCLUSION: EA of Sanyinjiao (SP 6) is able to regulate serum E2, FSH and LH levels and effectively improve perimenopausal syndrome.

[Clinical observation on acupuncture at the five-zangshu for treatment of perimenopausal syndrome].

OBJECTIVE: To observe therapeutic effect and safety of acupuncture at the five-zangshu for treatment of perimenopausal syndrome (PMS). METHODS: Forty cases of PMS were randomly divided into a treatment group and a control group, 20 cases in each group. The treatment group were treated with acupuncture at the five-zangshu and the control group with oral administration of Premarin tablets. The therapeutic effects and changes of Kupperman scores, and serum estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH) levels before and after treatment were observed. RESULTS: The total effective rate was 90. 0% in the treatment group which was better than 65.0% in the control group (P<0. 05). After treatment, serum E2 level significantly increased (P<0.01), with a significant difference between the two groups (P<0.05), and with a significant difference between the two groups in Kupperman symptom score index (MI) after treatment (P<0.05). CONCLUSION: Therapeutic effect of acupuncture at the five-zangshu is better than that of Premarin for treatment of perimenopausal syndrome.

Genotypes of vitamin D and estrogen receptors in pre and perimenopausal women from Córdoba, Argentina.

The aim of this study was to determine the frequency of vitamin D receptor and estrogen receptor genotypes and their relationship with the lumbar spine or femoral neck bone mineral density in healthy pre and perimenopausal women from Córdoba (Argentina) and adjacent areas. Genotypes were assessed by restriction fragment length polymorphism-polymerase chain reaction technique. Bsm I and Fok I for vitamin D receptor gene and Xbal and Pvull for estrogen receptor gene were used as restrictases. Two hundred and ten healthy pre and perimenopausal women were recruited and analyzed by age. Calcemia and serum parathyroid hormone did not change, but serum P and beta-CrossLaps decreased with age. Femoral neck bone mineral density decreased significantly after 30 years old. Vitamin D receptor and estrogen receptor genotype frequencies were similar to those from other Caucasian women. No association between vitamin D receptor and estrogen receptor genotypes with the lumbar spine or femoral neck bone mineral density has been detected. Analysis of interaction between vitamin D receptor and estrogen receptor genes using covariates such as age, height and body mass index did not show any influence of the combination of those genotypes on bone mineral density. Lifestyle, smoking and alcohol intake had no effect on lumbar spine and femoral neck bone mineral density. To conclude, these data do not support the hypothesis that vitamin D receptor and estrogen receptor genotypes influence on lumbar spine and femoral neck bone mineral density in healthy pre and perimenopausal women from this area of Argentina.

Acupuncture for perimenopausal symptoms in women who underwent oophorectomy a comparative study.

OBJECTIVE: To explore the effects of acupuncture on perimenopausal symptoms in women who underwent oophorectomy. METHODS: 67 women who had undergone oophorectomy were divided into an acupuncture group (n = 36) and a comparison group (n = 31) according to their wishes. The first group was treated by acupuncture and the latter group by Livial. Clinical symptoms were assessed by the modified Kupperman index. The levels of venous blood serum beta-endorphin (beta-EP), follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and the maturation index (MI) of vaginal epithelial cells were assessed. RESULTS: There were no significant group differences for the MI of vaginal exfoliative cells nor for the levels of FSH, LH and E2 after treatment (p > 0.05), but Kupperman scoring and the levels of beta-EP differed significantly between the acupuncture and the Livial group (p < 0.05). No side-effects were reported in either group. CONCLUSION: Acupuncture results in a significant improvement in perimenopausal symptoms in women who have had an oophorectomy. Acupuncture performs as well or better than Livial. Yet, this result may have been influenced by a potential bias and the small sample size.