Improvement In Menopausal Symptoms Research Articles

Effects of sports therapy on improvement of menopausal symptoms, psychological status, and body morphology in perimenopausal women.

The aim of this study was to increase the treatment rate of perimenopausal women by providing evidence-based nonpharmaceutical treatments through developing scientific evidence-based sports therapy and verifying its effectiveness. In a cross-over design, a total of 33 women were assigned to two different sequences of intervention: sports therapy and telephone intervention (n = 17) or telephone intervention and sports therapy (n = 16). A self-reported clinical symptom survey was conducted before and after the experimental and control periods using the following measures: the Menopause Rating Scale, Patient Health Questionnaire 9, and Patient Health Questionnaire 15. There were significant differences in the changes in the scores for Menopause Rating Scale total (exercise phase, 17.8 ± 5.5 at baseline [B] and 13.5 ± 4.2 at follow-up [F]; control phase, 15.9 ± 6.0 [B] and 15.4 ± 5.3 [F]; P < 0.01), somatic symptoms (exercise phase, 9.5 ± 2.6 [B] and 6.6 ± 2.0 [F]; control phase, 8.5 ± 2.8 [B] and 8.0 ± 1.3 [F], P < 0.01), and urogenital symptoms (exercise phase, 4.9 ± 1.7 [B] and 4.1 ± 1.4 [F]; control phase, 4.3 ± 1.6 [B] and 4.4 ± 1.5 [F]; P < 0.01) between the exercise and control phases. There were also significant differences in the changes in the scores for PHQ-9 (exercise phase, 4.6 ± 4.4 [B] and 3.6 ± 3.3 [F]; control phase, 4.5 ± 3.8 [B] and 5.5 ± 4.6 [F]; P = 0.008) and PHQ-15 (exercise phase, 7.2 ± 4.4 [B] and 5.5 ± 3.5 [F]; control phase, 6.8 ± 4.4 [B] and 7.2 ± 4.9 [F]; P = 0.009) between the two phases. Sports therapy would improve menopause symptoms, especially somatic and urogenital symptoms. In addition, sports therapy would improve depressive moods in perimenopausal women.

Cimicifuga racemosa isopropanolic extract for menopausal symptoms: an observational prospective case–control study

Objective We aimed to investigate the effectiveness of isopropanolic extract of Cimicifuga Racemosa (iCR) on reducing menopausal symptoms. Materials and Methods A single-center observational prospective case–control study was performed to assess the improvement of menopausal symptoms in menopausal women undergone iCR administration (cases) or no treatment (controls). Menopausal symptoms were assessed through a modified version of the Menopause Rating Scale questionnaire (mMRS) at T0 (baseline), T1 (1-month follow-up), and T2 (3 months follow-up). Univariate comparisons between cases and controls were performed by using the unpaired T test for two-tailed P value with α = 0.05 significance level. Results A total of 163 women (83 cases and 80 controls) were enrolled in the study. The difference in menopausal symptoms between cases and controls from T0 to T2, and from T0 to T1, was found significant for all analyses. In particular, the difference in all menopausal symptoms was 20.56 ± 0.90 points (95%CI: 18.77–22.33, p < .001) from T0 to T2, and 10.69 ± 0.6 (95%CI: 9.49–11.88, p < .001) from T0 to T1. Conclusion iCR may be effective in reducing menopausal symptoms, both after 1 month and after 3 months of treatment. The improvement was higher in vasomotor symptoms, sleep problems, and irritability.

Lactobacillus intestinalis YT2 restores the gut microbiota and improves menopausal symptoms in ovariectomized rats.

There are many studies focusing on the alleviation of menopausal symptoms; however, little is known about the role of gut microorganisms in menopausal symptoms. Ovariectomized (OVX) rats were administered a novel strain (YT2) of Lactobacillus intestinalis (a species with significantly reduced abundance in OVX rats) and the potential probiotic effect on the improvement of menopausal symptoms was evaluated. Of note, the gut microbial composition completely shifted after ovariectomy in rats. Treatment with L. intestinalis YT2 significantly alleviated menopausal symptoms, such as increased fat mass, decreased bone mineral density, increased pain sensitivity, depression-like behaviour, and cognitive impairment. Additionally, the administration of L. intestinalis YT2 restored the intestinal microbial composition, including an increased Firmicutes/Bacteroides ratio. L. intestinalis YT2 also promoted gut barrier integrity by increasing the mRNA levels of tight junction-related markers. In conclusion, L. intestinalis YT2 treatment alleviated menopausal symptoms via the modulation of the gut microbiota. Importantly, these results suggest that L. intestinalis YT2 should be considered as a therapeutic probiotic agent for menopausal women.

Effects of herbal medicine (Danggwijagyaksan) for treating climacteric syndrome with a blood-deficiency-dominant pattern: A randomized, double-blind, placebo-controlled pilot trial

BackgroundDanggwijagyaksan (DJS) has been one of the most widely used herbal medicines for gynecological disorders in traditional East Asian medicine. Several clinical studies about DJS have shown improvement in menopausal symptoms. This pilot study aimed to evaluate the efficacy, safety and feasibility of DJS for treating climacteric syndrome with a blood-deficiency-dominant pattern. MethodsThis was a randomized, double-blind, placebo-controlled pilot trial. A group of 45-to 60-year-old women with climacteric syndrome were registered for the trial. The participants received treatment over a 4-week period and were then followed for 4 weeks. The primary outcome measure was the mean change in the Menopause Rating Scale (MRS). Secondary outcome measures included the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Blood-Deficiency Scoring System (BDSS), lean body mass, and serum hormone levels, including follicle-stimulating hormone (FSH) and estradiol (E2) levels. ResultsThe MRS and BDSS scores decreased significantly in both groups, but the differences between two groups were not significant. The WHOQOL-BREF scores increased in the control group. No statistically meaningful differences in serum hormone levels or lean body mass were observed in both groups. There were no serious adverse events, and the laboratory tests were within the normal range. The recruitment rate, completion rate and medication adherence rate were over 90% in both groups, indicating high feasibility. ConclusionsDJS showed clinical effectiveness in the treatment of climacteric syndrome with a blood-deficiency-dominant pattern. Additionally, DJS was shown to be safe and feasible for a large-scale study to confirm the efficacy of the treatment. Trial registration: Clinical Research Information Service (CRIS, https://cris.nih.go.kr): KCT0002387.

The Diverse Efficacy of Food-Derived Proanthocyanidins for Middle-Aged and Elderly Women.

Middle-aged and elderly women are affected by various symptoms and diseases induced by estrogen deficiency. Proanthocyanidins, widely present in many kinds of fruits and berries, have many beneficial effects, such as antioxidative, anti-inflammatory, and antimicrobial activities. We researched the effects of proanthocyanidins for middle-aged and elderly women, finding that it has been revealed in many clinical trials and cohort studies that proanthocyanidins contribute to the prevention of cardiovascular disease, hypertension, obesity, cancer, osteoporosis, and urinary tract infection, as well as the improvement of menopausal symptoms, renal function, and skin damage. Thus, proanthocyanidins can be considered one of the potent representatives of complementary alternative therapy.

Effects of Chlorogenic Acids on Menopausal Symptoms in Healthy Women: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial.

A reduction in estrogen levels in the perimenopausal and postmenopausal periods causes various symptoms in women, such as hot flushes, sweats, depression, anxiety, and insomnia. Chlorogenic acids (CGAs), which are phenolic compounds widely present in plants such as coffee beans, have various physiological functions. However, the effects of CGAs on menopausal symptoms are unknown. To examine the effects of CGAs on menopausal symptoms, especially hot flushes, a randomized, placebo-controlled, double-blind, parallel-group trial was conducted in healthy women. Eighty-two subjects were randomized and assigned to receive CGAs (270 mg) tablets or the placebo for 4 weeks. After 4 weeks of intake, the number of hot flushes, the severity of hot flushes during sleep, and the severity of daytime sweats decreased significantly in the CGA group compared to the placebo group. The modified Kupperman index for menopausal symptoms decreased significantly after 2 weeks in the CGA group compared to the placebo group. Adverse effects caused by CGAs were not observed. The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.

Mediterranean diet as tool to manage obesity in menopause: A narrative review.

Menopause is a physiological event in a woman's life characterized by the cessation of spontaneous menstrual cycles caused by a reduction in the sex hormones estrogen and progesterone and a consequent increase of gonadotropins, which occurs when the stocks of ovarian follicles end. Weight gain is a common phenomenon in menopause and age of onset is influenced by several factors. Among modifiable risk factors are sedentary lifestyle and unhealthy nutritional patterns, which often result in obesity that in turn contributes to an increase in cardiovascular risk in menopause, mostly through low-grade inflammation. The Mediterranean diet (MedD) is a healthy dietary pattern characterized by an adequate consumption of vegetables, fruits, whole grains, and legumes with a reduction of saturated animal fats in favor of unsaturated vegetable fats and a high intake of bioactive compounds including polyphenols and ω-3 fatty acids with anti-inflammatory and antioxidant potency. Because of its palatability and long-term sustainability, the MedD, especially if hypocaloric, combined with physical activity, has shown promising results in terms of weight loss in individuals with obesity, as well as similar beneficial effects in menopause-related obesity. It has been observed that greater adherence to the MedD in menopause is associated with reduced risk for becoming overweight/obese, better cardiometabolic profile, and an improvement in menopausal symptoms. Although it is necessary to confirm these data with future large intervention trials, the MedD can be considered a safe and healthy approach in the management of menopause-related obesity and its cardiometabolic complications.

Effect of the mixed herbal medicines extracts on menopausal symptoms: A randomized clinical trial study

Background:Menopause cause many symptoms, which may impair quality of life the women. The study aims to determine the effectiveness of mixed herbal medicinal extracts on menopausal symptoms.Method:A randomized, triple-blind, placebo-controlled clinical trial was conducted on 120 peri-menopausal women for 12 weeks. All participants took herbal extracts drops orally daily. They were randomly allocated into four groups: placebo (C), A (250 mg chamomile, 30 mg fennel, 15 mg saffron), B (1000 mg chamomile, 120 mg fennel, 60 mg saffron), and D (500 mg chamomile, 60 mg fennel, 30 mg saffron).They completed a demographic and MRS questionnaire at week 0, 6.12.Result:108 participants successfully completed the assessment. No significant differences in demographic variables were seen between the four groups. The median MRS score was significantly reduced in group B from 27.5±3 to 7.5±5. In group D, it was significantly reduced from 29±12 to 22±9.25The effect size in this study was 0.92.Conclusion:Study showed significant improvement in menopausal symptoms especially in group B.

Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms

Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms

Prospective observational study to evaluate the efficacy and safety of the pollen extract Sérélys® in the management of women with menopausal symptoms

Safety concerns or contraindications to the use of hormones have resulted in a rise of the use of herbal medicinal products for the management of menopausal symptoms. The pollen extract Sérélys® represents, due to its ingredients and mode of action, a new and innovative alternative for the management of these symptoms. The aim of the present study was to demonstrate the efficacy and safety of Sérélys®. A prospective, open, observational, and multicentre study was performed on 104 menopausal women. The patients received over 3 months the pollen extract Sérélys® containing the extracts PI82 and GC Fem in a dosage of twice 160 mg extract and 5 mg vitamin E. Using a validated menopausal rating score, the improvement of menopausal symptoms was recorded. A significant decrease of different menopausal symptoms was observed between the starting point of the study and after 12 weeks (p < .0001). Hot flashes were reduced by 48.5%, sleep disturbance by 50.1%, depressive mood by 51.2%, irritability by 47.9%, fatigue by 47.8%, vaginal dryness by 39.63% and muscles and joint pain by 27.4%. The pollen extract Sérélys® reduced significant menopausal symptoms showing a very low side effect profile.

Improvement of menopausal symptoms and the impact on work ability: A retrospective cohort pilot study

ObjectiveIn this study we aimed to pilot test the hypothesis that in women who are severely bothered by their menopausal complaints, improvement of menopausal symptoms is associated with an improvement in self-perceived work ability. Study designThis retrospective cohort study assessed the work ability of first-time attendees (n = 31) of a menopause clinic at baseline (T0) and 3–9 months follow-up (T1). All patients received care as usual according to local protocol, no interventions were applied by the researchers. Self-reported questionnaire data assessing work ability (Work Ability Index; WAI) and menopausal symptoms (Greene Climacteric Scale; GCS) were used. Main outcome measuresMultiple linear regression was used in an exploratory analysis to examine the relationship between change in WAI score (ΔWAI) and change in menopausal symptoms (ΔGCS), after adjustment for potential confounders. Additional exploratory univariate linear regression analyses were performed to assess the associations of change in WAI score with change in the different GCS domains and with type of treatment. ResultsTwenty-seven out of 31 women reported improvement in work ability at follow-up (T1) (M = 30.73, SD = 6.42 respectively, M = 34.86, SD = 5.98). All women reported to be less bothered by their menopausal symptoms at T1 (M = 26.57, SD = 8.69 respectively, M = 14.73, SD = 6.36). Multivariate linear regression demonstrated a significant association between the WAI and GCS change scores after correction for confounders (beta ΔGCS = 0.283, p = 0.014). After additional adjustment for WAI at baseline, this association was no longer significant (beta ΔGCS = 0.172, p = 0.164). Change in GCS depression domain (ΔGCS depression) was significantly associated with ΔWAI, although after correction for WAI at baseline the effect of ΔGCS depression was no longer significant (beta = 0.855, p = 0.113). The WAI and GCS change scores were highly correlated, as a result their coefficients were not statistically significant separately. ConclusionsTreatment aimed at alleviating menopausal symptoms in symptomatic women could lead to improvement of menopausal symptoms along with improvement in work ability. Improvement of depressive symptoms seem particularly important for this outcome.

Results of a phase Ib study of Q-122 treatment of vasomotor symptoms in breast cancer patients.

99 Background: Breast cancer patients taking tamoxifen (TAM) or an aromatase inhibitor (AI) often develop severe vasomotor symptoms (VMS) yet the only FDA approved non-hormonal treatment for VMS, 7.5 mg paroxetine, has a warning against concomitant use with TAM. Q-122, an orally-available small molecule, is being developed to address this unmet medical need. Results from the Phase 1b study, Q-1001, are presented. Methods: Q-1001 was a Phase 1 open-label, two-dose, dose-escalation study of the safety and preliminary effectiveness of Q-122 in females with breast cancer currently taking TAM or an AI and experiencing an average of at least 7-8 moderate to severe hot flashes per day. Key exclusion criteria included significant renal or hepatic disease, untreated hyperthyroidism and clinically significant abnormal laboratory findings. The study period included a 2 week drug-free screening phase, 28 day treatment phase, and 2 week drug-free follow-up period. Subjects were initially enrolled into Group 1 (100 mg Q-122) followed by Group 2 (200 mg Q-122). Safety was assessed by review of adverse events (AEs), physical findings and laboratory values. The primary efficacy endpoints were mean changes in frequency and severity (hot flash severity score, HFSS) of moderate and severe hot flashes from baseline to Week 4. Menopausal symptoms were assessed using the Greene Climacteric Scale (GCS). Results: 10 and 11 subjects received 100 and 200 mg Q-122 respectively; 8 subjects in each group completed the study. At the end of treatment for groups 1 and 2 respectively, the daily average frequency of hot flashes was reduced from 9.9 to 4.1 and from 8.6 to 3.2, and the mean HFSS was reduced by 62% and 68% from baseline values. Menopausal symptoms assessed using the GCS were significantly reduced from baseline (psychological: -82%; somatic: -65%; vasomotor: -65%). All AEs (n = 29) were either mild (79%) or moderate (21%) in severity and only 3 (all in one subject) were considered possibly related to study drug. Conclusions: Treatment with Q-122 resulted in significant reduction in the frequency and severity of VMS and improvement in menopausal symptoms as assessed by the GCS. No safety issues associated with the use of Q-122 were identified in this study.

The Investigation of Understanding and Comfort of Patients Taking Divigel&lt;sup&gt;®&lt;/sup&gt; 1 mg

Hormone replacement therapy (HRT) given by injection or administered orally or topically can improve the QOL of patients with menopausal symptoms. Because patient comfort is influenced largely by the dosage form, pharmacists should understand the properties of each dosage form and provide appropriate information to individual patients. In this study, we investigated the understanding of medicines and diseases of patients receiving HRT and discuss the approaches pharmacists can take to improve patients' adherence. Thirty-seven patients (mean age 51.7±3.6 years) taking estradiol gel (Divigel(®) 1 mg) completed a questionnaire asked by their pharmacist. Responses indicated 70% of patients failed to use the gel as prescribed, and they had poor knowledge of both the sites where the gel shouldn't be applied and appropriate measures to take if having forgotten to apply the gel (43% and 11% correct understanding, respectively). Since the duration of HRT treatment for menopausal symptom is 2-5 years, patients should be administered the minimum effective dose in the shortest amount of time. Hence it is important to maintain patients' adherence particularly in this limited administration period. HRT guidelines define HRT outcome as not only improvement of menopausal symptoms but also suppression of bone resorption, improvement of glucose and lipid metabolism, and reduced prevalence of Alzheimer's disease. Accordingly, pharmacists should facilitate proper adherence to HRT to improve and maintain women's QOL in the perimenopausal period, necessitating they actively provide pharmaceutical care such as preparing useful instructions patients can repeatedly use and periodically checking patients' understanding of their HRT medications.

Osteoporosis: Current review

Although hormone therapy using estrogens plus progestogens (EPT) is effective for the management of menopausal symptoms (e.g., vasomotor symptoms and vulvar/vaginal atrophy) and prevention/treatment of postmenopausal osteoporosis, EPT is associated with safety and tolerability concerns. A new alternative to EPT is the tissue selective estrogen complex (TSEC), which partners a selective estrogen receptor modulator (SERM) with one or more estrogens and is designed to treat menopausal symptoms and prevent postmenopausal osteoporosis without the tolerability concerns associated with EPT. The first TSEC to reach advanced clinical development is a combination of the SERM bazedoxifene (BZA) with conjugated estrogens (CE). BZA has been shown to inhibit the stimulatory activity of CE on uterine tissue and breast in vitro and in vivo. In clinical studies, BZA/CE treatment has been associated with significant improvements in menopausal symptoms including hot flushes and vulvar/vaginal atrophy and significant increases in bone mineral density, coupled with reductions in bone turnover marker levels and improvements in sleep and health-related quality of life. Additionally, BZA/CE has been shown to have a neutral effect on endometrial and breast tissue because BZA inhibits the stimulatory effects of estrogens in selective tissue fashion in these two organs. Taken together, results of these preclinical and clinical studies indicate that the benefits of estrogens for treating menopausal symptoms are maintained with BZA/CE without endometrial or breast stimulation, resulting in a safe and effective treatment for symptomatic postmenopausal women.

One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17β-estradiol in postmenopausal women

Objectives To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5 mg norethisterone acetate (NETA)/1.0 mg E2, in postmenopausal women.Methods A total of 662 postmenopausal women aged between 40 and 65 years with an indication for hormone therapy verified by the investigator were randomized to participate in this 1-year, double-blind, active comparator-controlled study. The primary efficacy variable was the proportion of women with an endometrial biopsy assessment of ‘hyperplasia or worse’ at any time during or after 13 cycles of treatment.Results No evaluable women in the DRSP/E2 or NETA/E2 groups had an endometrial biopsy result of ‘hyperplasia or worse’. The incidence of amenorrhea was higher in the DRSP/E2 group than the NETA/E2 group during months 1–3 (69.0% vs. 56.0%), with comparable amenorrhea rates of approximately 80% during months 10–12. Improvements in menopausal symptoms (exploratory efficacy variables) were similar in the two groups, while there were fewer women with treatment-related adverse events (18.4% vs. 25.6%) or adverse events leading to discontinuation of study drug (8.4% vs. 15.1%) in the DRSP/E2 group than the NETA/E2 group. There were no treatment-related thromboembolic or cardiovascular events in the DRSP/E2 group vs. two events in the NETA/E2 group.Conclusions The low-dose, 0.25 mg DRSP/0.5 mg E2 dose combination met the criteria for endometrial safety and demonstrated a favorable risk/benefit profile in this 1-year, double-blind, randomized study of postmenopausal women.

Effects of tibolone on depressive and anxiety symptoms in symptomatic postmenopausal women / Semptomatik postmenopozal kadınlarda tibolonun aksiyete ve depresif belirtiler üzerindeki etkileri

Effects of tibolone on depressive and anxiety symptoms in symptomatic postmenopausal women Aims: We investigated the effect of tibolone therapy on menopausal symptoms, depression and anxiety scores in women with symptomatic natural menopause compared to control group using Kupperman’s Index, Hamilton Depression Rating Scale and Beck Anxiety Inventory. Methods: One hundred thirty patients with menopausal symptoms enrolled into the study, and 121 patients completed. Group I patients were treated with tibolone 2.5 mg/day. Group II patients received placebo (calcium forte tablet 1000 mg/day). The menopausal, depressive and anxiety symptoms were assessed using Kupperman’s Index, Hamilton Depression Rating Scale and Beck Anxiety Inventory before and at the end of the treatment. For statistical analysis, paired t, multivariate analyses tests were used. Results: At the end of 3 months of therapy, we observed significant improvement in menopausal symptoms, depression and anxiety scores in both groups. When we compared two groups’ Kupperman and Beck Anxiety Inventory (BDI) scores according to time before and after the treatment, Group I scored better than Group II. The superiority of tibolone comparing placebo on depressive symptoms could not be shown in this study. Conclusion: Tibolone’s effects in calming vasomotor symptoms and improving anxiety symptoms suggest it as an alternative when the possible side effects of estrogen and progesterone combination or estrogen

Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: A randomized, double‐blind, controlled trial

To define the effects of continuous sequential estrogen plus progestin therapy on menopausal symptoms in women with systemic lupus erythematosus (SLE). We performed a randomized, double-blind, 24-month clinical trial involving 106 women with SLE who were in the menopausal transition or early or late postmenopause. Patients received continuous sequential estrogen plus progestin (n = 52) or placebo (n = 54). Menopausal symptoms were assessed using the Greene Climacteric Scale at 0, 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 months. A new factor analysis of the scale reduced 21 items to 5 factors. The primary outcome was improvement of menopausal symptoms throughout the followup period. Results were analyzed by the intent-to-treat principle. At baseline, demographic and disease characteristics were similar in both groups. Fifteen of 21 menopausal symptoms had a prevalence of ≥50%, with a similar distribution between groups. Vasomotor factor scores decreased over time in both groups (P = 0.002), but in the estrogen plus progestin group the reduction was more pronounced than in the placebo group (1.5-2.0 versus 0.35-0.8 points on a scale of 0-6; P = 0.03). Maximum effects were observed among the most symptomatic women. Psychological, subjective-somatic, and organic-somatic factors scores also improved along time (P < 0.001), but the treatment and placebo arms improved to a similar degree. Thromboses occurred in 3 patients receiving estrogen plus progestin and in 1 patient receiving placebo. Menopausal symptoms are highly prevalent in peri- and postmenopausal lupus patients. Estrogen plus progestin improved vasomotor symptoms at a clinically significant level, but not other menopausal symptoms. Given the thrombotic risks of menopausal hormone therapy, this should be used only in women with significant vasomotor symptoms.

Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial

ABSTRACTObjective To evaluate the efficacy and safety of a complex remedy compared with placebo to treat menopausal symptoms.Methods A total of 102 peri- and postmenopausal women requiring treatment for menopausal symptoms were randomized to receive a complex anthroposophic remedy prepared in the homeopathic manner (Apis regina tota GL D4, Argentum metallicum D5, Ovaria bovis GL D4), 3 × 10 globuli daily (2 × 12 weeks) and placebo (12 weeks) in different orders of remedy (R) and placebo (P) (1: R/R/P, 2: P/R/R, 3: R/P/R). The primary endpoint was change in climacteric symptoms assessed by the Menopause Rating Scale II (MRS II) after 12 weeks. Secondary endpoints were changes of symptoms and safety throughout the study.Results Reduction of symptoms after 12 weeks did not differ between remedy and placebo (total score MRS II: –1.4, 95% confidence interval (CI) −2.8 to 0 vs. −2.3, 95% CI −4.4 to −0.3, p = 0.441) and had no clinical relevance (defined as reduction in MRS II ≥ −3.5). Comparison of secondary outcomes at 12 weeks between remedy and placebo or between groups after the 2nd or 3rd period compared to previous periods did not differ. Treatment with remedy for 24 consecutive weeks did not reach clinical relevance either. However, total reduction of symptoms after three periods in Group 1 (R/R/P) (−5.0, 95% CI −7.5 to −2.5) and Group 2 (P/R/R) (−5.9, 95% CI −8.7 to −3.1) reached clinical relevance whereas almost no decrease of symptoms after three periods was seen in Group 3 (R/P/R) (−0.5, 95% CI −2.9 to 1.9).Conclusions Treatment with the complex remedy for 12 or 24 weeks did not result in clinically significant improvement of menopausal symptoms.

Improvement of Menopausal Symptoms with Acupuncture Not Reflected in Changes to Heart Rate Variability

Hypothesis Studies indicate that menopausal symptoms are relieved by acupuncture. Additional studies have suggested that acupuncture may affect heart rate variability (HRV). This paper reports a pilot study that investigated whether menopausal symptoms responded to acupuncture, and if changes in the spectral analysis of HRV, either suppression of low frequency or augmentation of high frequency bands, corresponded with symptom report. Methods/interventions 12 healthy menopausal subjects were enrolled in this feasibility study. At baseline, subjects were experiencing moderately distressing menopausal symptoms, scoring at least 22 of a possible 44 points on the Menopausal Rating Scale. 10 traditional Chinese medicine-based, protocol acupuncture treatments were administered over a 4 week period, three times a week for 2 weeks, followed by twice a week for 2 weeks. Outcome measures Menopausal Rating Scale questionnaire, 11 menopausal symptoms were evaluated on a zero to four severity scale via self-administered daily checklist for 4 weeks. Dynamic measures of HRV (autoregressive model) were captured before, during and after acupuncture at each session. Spectral analysis of the heart rate was used to compute power in the low frequency and high frequency bands, and their ratio. All subjects complied fully with the protocol without any reported adverse events. While all 11 symptoms showed significant improvement, and one HRV measure changed, on average over the study period, there was essentially no support for a relationship between HRV, menopausal symptom report and acupuncture intervention.

Raloxifene: is it really effective on mood changes in postmenopausal osteopenic women?

Objective. To investigate the effect of raloxifene therapy on menopausal symptoms, depression and anxiety scores using Kupperman's Scale, Hamilton Depression Rating Scale (HDRS) and Beck Anxiety Rating Scale (BARS) in osteopenic postmenopausal women.Methods. This was a prospective, randomised, parallel and open labeled clinical study. One-hundred thirty-two postmenopausal osteopenic women with natural menopause enrolled into the study. One-hundred twenty-four of them completed the study. Group I patients were treated with oral raloxifene (60 mg/day), Group II patients were treated with oral calcium supplementation (1000 mg/day) for 3 months. The patient's menopausal, depressive and anxiety symptoms were assessed by using Kupperman's Scale, HDRS and BARS, before and at the end of treatment. For statistical analysis unpaired t, ANOVA, RM-ANOVA, MANCOVA, Pearson correlation tests were used. Statistical significance level was established at p < 0.05.Results. Baseline Kupperman's Scale, HDRS and BARS scores were not different among two groups. At the end of 3 months of therapy, there was improvement in menopausal symptoms, depression and anxiety scores within both groups. When we compared change of scores before and after the treatment; group I scores were better than group II scores.Conclusion. Our results suggest that raloxifene may have a positive effect on mood in osteopenic postmenopausal women.