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B Saletu - One of the best experts on this subject based on the ideXlab platform.

  • double blind placebo controlled psychometric studies on the effects of a combined estrogen progestin regimen versus estrogen alone on performance mood and personality of Menopausal Syndrome patients
    Drug Research, 2011
    Co-Authors: L Linzmayer, B Saletu, M Metka, H V Semlitsch, J C Huber, Doris M Gruber, G Saletuzyhlarz, Gerda Bock, Ali Zoghlami, Michael Oettel
    Abstract:

    The influence of a combined estrogen progestin regimen (Climodien®) on noo psyche, thymopsyche, personality and psychophysiological measures of meno pausal Syndrome patients was investi gated in a double blind, placebo con trolled, comparative, randomized 3 arm trial phase (Climodien 2/3 = estradiol val erate (CAS 979-32-8) 2 mg + the proges tin dienogest (CAS 65928-58-7) 3 mg = re gimen A, estradiol valerate 2 mg = regi men EV, and placebo = regimen P) fol lowed by an open label phase in which all patients received Climodien 2/2 (estra diol valerate 2 mg + dienogest 2 mg) = re gimen A*. 49 women (16, 17, 16 valid patients per arm) aged between 46 and 67 years (mean 58, 58, 56 years, respec tively) with the diagnoses of insomnia (G 47.0) related to postMenopausal syn drome (N 95.1) were included in the anal ysis of the double blind phase. Both the double blind and the open label phase lasted 2 months. Noopsychic investigations demon strated an improvement in associative verbal memory after 2 months of regi men A, which was significant as com pared with both baseline and placebo. Re garding visual memory, regimen A* in duced an improvement, which was signif icantly different from the decline in correct reproductions in the Benton Test observed under estradiol. Errors in the Benton Test decreased significantly after regimen A* as compared with regimen EV. These findings suggest that hormone replacement therapy with estradiol, and even more in combination with dieno-gest, improves verbal and visual memory, which is in line with the improvement in information processing speed and capacity objectified by event-related potentials (ERP). Thymopsychic investigations demonstrated a significant improvement in somatic complaints and trait anxiety after both regimen A and regimen EV as compared with baseline. State anxiety decreased significantly under regimen A* as compared with EV. The Freiburger Personality Inventory showed an improvement in aggressivity after regimen A* as compared with the preceding placebo as well as an improvement in striving after dominancy after both regimen A and regimen EV as compared with pre-treatment, but also after regimen A* as compared with regimen EV. Extraversion increased after 2 months of regimen A as compared to regimen P. Psychophysiological findings including pupillary and skin conductance variables were not significant.

  • hormone replacement therapy and vigilance double blind placebo controlled eeg mapping studies with an estrogen progestogen combination climodien lafamme versus estrogen alone in Menopausal Syndrome patients
    Maturitas, 2002
    Co-Authors: B Saletu, M Metka, P Anderer, J C Huber, Doris M Gruber, G Saletuzyhlarz
    Abstract:

    Abstract The aim of the double-blind, placebo-controlled study was to investigate the effects of a continuous combined estrogen–progestogen treatment (Climodien®, Lafamme®) as compared with estrogen alone on vigilance in insomniac postMenopausal Syndrome patients, objectified by EEG mapping. Methods: In a 3-arm, 2-month parallel group design phase, patients received a combination of estradiol valerate 2 mg and the novel progestogen dienogest 3 mg (Climodien 2/3) or estradiol valerate 2 mg alone or placebo. In a subsequent open-label phase, all patients received estradiol valerate 2 mg+dienogest 2 mg (Climodien 2/2). EEG mapping was carried out before and after the 2-month double-blind phase as well as after the 2-month open-label treatment. Results: As compared with placebo, Climodien 2/3 induced a marked and highly significant increase in absolute power in all frequency bands, specifically in alpha-2 activity. Moreover, a significant increase in relative alpha-2 power, a decrease in relative delta and beta power as well as an acceleration of the dominant frequency and of the delta and alpha centroids suggested a marked improvement in vigilance. In contrast, under estradiol valerate 2 mg alone, only a slight augmentation of alpha and attenuation of relative delta and beta power occurred, suggesting only a slight vigilance improvement as compared with placebo. Thus, dienogest 2 mg increased the estrogen effect, which was also confirmed by a statistical evaluation of the differences between Climodien 2/3 and estradiol valerate alone (augmentation of alpha-2, attenuation of relative beta, acceleration of the dominant frequency). Moreover, Climodien 2/2 also markedly increased alpha-2 power, decreased relative beta-2 power and accelerated the alpha centroid. Finally, comparing Climodien 2/3 with Climodien 2/2, there was even a dose–efficacy relation. Conclusions: Estradiol valerate 2 mg improves vigilance slightly, thereby confirming previous findings. The additional administration of dienogest does not minimize the effect of estrogen, but on the contrary increases it, which makes the combination superior to both placebo and estradiol valerate alone. Vigilance improvement may be of great therapeutic benefit to Menopausal Syndrome patients at a time when increased adaptability is needed to adjust to increasing sexual, marital, occupational and social difficulties known to occur specifically in this period of life.

  • hormonal syndromal and eeg mapping studies in Menopausal Syndrome patients with and without depression as compared with controls
    Maturitas, 1996
    Co-Authors: B Saletu, N Brandstatter, M Metka, M Stamenkovic, P Anderer, H V Semlitsch, G Heytmanek, J C Huber, J Grunberger, L Linzmayer
    Abstract:

    The aim of the study was to investigate brain function in Menopausal depression by EEG mapping, as compared with Menopausal Syndrome patients without depression and normal controls, and to correlate neurophysiological with clinical and hormonal findings in order to elucidate the pathogenesis of depression in the menopause. Methods: One hundred and twenty-nine Menopausal women, aged 45–60 years, with no previous hormonal replacement therapy were investigated in regard to hormones (estradiol [E2], follicle stimulating hormone [FSH], clinical symptomatology (Kupperman Index [KI], Hamilton depression score [HAMD]) and brain function (EEG mapping). Based on KI and DSM-III-R research criteria for major depression, 3 groups were available for statistics (after removal of protocol violators): group A had a KI of <15 and no depression (n = 29); group B had a KI of ≥ 15 and no depression (n = 29) and group C had a KI of ≥ 15 and fulfilled the criteria for major depression (n = 60). Results: EEG maps of depressed patients demonstrated less total power and absolute power in the delta, theta and beta band, more relative delta and less alpha power as well as a slower delta/theta and faster alpha and beta centroid than controls, suggesting a vigilance decrement. Group B did not differ from group A. Correlation maps showed significant relationships between estradiol levels and EEG measures (the lower the E2, the worse the vigilance) and between the EEG measures and the Hamilton depression (HAMD) score (the worse the vigilance, the higher the depression score). There were no correlations between the hormones E2 and FSH and the Syndromes KI and HAMD. In the target variable, the asymmetry index, depressed patients showed less alpha power over the right than left frontal lobe, whereas normal controls exhibited the opposite. Group B did not differ from group A. The frontal asymmetry index was significantly correlated with the Hamilton depression score and suggests right frontal hyper- and left frontal hypoactivation in depression. Conclusion: Although hormonal findings are not directly linked to psychic changes, low estradiol levels do contribute to a decreased vigilance at the neurophysiological level, which is in turn correlated with higher depressive and Menopausal symptomatology at the behavioural level. Depression is furthermore correlated to a right frontal hyper- and left frontal hypoactivation.

Tzi Bun Ng - One of the best experts on this subject based on the ideXlab platform.

  • a novel stable estradiol stimulating osteogenic yam protein with potential for the treatment of Menopausal Syndrome
    Scientific Reports, 2015
    Co-Authors: Kam Lok Wong, Yanbo Zhang, Tzi Bun Ng, Ka Wan Li, H P Cheung, Ricky N S Wong, Pangchui Shaw, John Wong, Zhangjin Zhang
    Abstract:

    A novel protein, designated as DOI, isolated from the Chinese yam (Dioscorea opposita Thunb.) could be the first protein drug for the treatment of Menopausal Syndrome and an alternative to hormone replacement therapy (HRT), which is known to have undesirable side effects. DOI is an acid- and thermo-stable protein with a distinctive N-terminal sequence Gly-Ile-Gly-Lys-Ile-Thr-Thr-Tyr-Trp-Gly-Gln-Tyr-Ser-Asp-Glu-Pro-Ser-Leu-Thr-Glu. DOI was found to stimulate estradiol biosynthesis in rat ovarian granulosa cells; induce estradiol and progesterone secretion in 16- to 18-month-old female Sprague Dawley rats by upregulating expressions of follicle-stimulating hormone receptor and ovarian aromatase; counteract the progression of osteoporosis and augment bone mineral density; and improve cognitive functioning by upregulating protein expressions of brain-derived neurotrophic factor and TrkB receptors in the prefrontal cortex. Furthermore, DOI did not stimulate the proliferation of breast cancer and ovarian cancer cells, which suggest it could be a more efficacious and safer alternative to HRT.

  • a novel mechanism erxian decoction a chinese medicine formula for relieving Menopausal Syndrome
    Journal of Ethnopharmacology, 2009
    Co-Authors: Yao Tong, Yanbo Zhang, Zhangjin Zhang, Henry K Wong, K W Tsang, Tzi Bun Ng
    Abstract:

    Abstract Ethnopharmacological relevance Many clinical and experimental reports demonstrated that Erxian Decoction (EXD) was effective in relieving Menopausal Syndrome. Aim of the study The mechanisms of action of EXD were explored on the endocrine and antioxidant regimen. Materials and methods Menopause causes a decline in both endocrine function and activities of antioxidant enzymes. In this study, 12-month-old female Sprague–Dawley-rats (SD-rats) with a low serum estradiol level were employed. Their endocrine functions after treatment with EXD were assessed by the determination of their serum estradiol level and ovarian mRNA levels of aromatase, which is a key enzyme for biosynthesis of estradiol. Meanwhile, superoxide dismutase-1 (SOD), catalase (CAT) and glutathione peroxidase (GPx-1) in the liver were also determined to assess the effect of EXD on the antioxidant regimen. Results Results revealed a significant elevation in serum estradiol level and the mRNA level of ovarian aromatase and liver CAT in the EXD-treated Menopausal rat model. Conclusions The results obtained from mRNA and estradiol level of the present investigation revealed that the EXD relieves the Menopausal Syndrome involved an increase of endocrine and antioxidant function through, at least, the activation of aromatase and CAT detoxifying pathways.

Guoqing Zheng - One of the best experts on this subject based on the ideXlab platform.

  • erxian decoction a chinese herbal formula for Menopausal Syndrome an updated systematic review
    Journal of Ethnopharmacology, 2019
    Co-Authors: Yong Wang, Qiang Tong, Guoqing Zheng
    Abstract:

    Abstract Ethnopharmacological relevance Erxian decoction (EXD), a famous Chinese herbal prescription, consists of Rhizoma Curculiginis, Herba Epimedii, Radix Morindae Officinalis, Radix Angelicae Sinensis, Cortex Phellodendri, Rhizoma Anemarrhenae, all of which are recorded in the Chinese Pharmacopoeia. Objective To conduct an updated systematic and meta-analysis investigating efficacy and safety of EXD for Menopausal Syndrome. Methods An electronic search was conducted in eight databases from inception until July 2018. Randomized controlled trials with risk-of-bias score ≥ 7 according to the Cochrane Back Review Group were included for analyses. All participants with a diagnosis of Menopausal Syndrome met the established criteria. The treatment group was EXD monotherapy or adjunct therapy. Comparators were placebo, hormone replace therapy, hormone plus nonhormonal agents, nonhormonal agents and no treatment. The primary outcome measurements were the Kupperman index, total hot flush scores, total menopause rating scale (MRS) scores and total menopause-specific quality of life (MENQOL) scores. The secondary outcomes were total clinical effective rate, traditional Chinese medicine (TCM) Syndrome scores, Hamilton depression (HAMD) scale scores, self-rating depression scale (SDS) scores, self-Rating Anxiety Scale (SAS) scores, athens insomnia scale (AIS) scores, serological indicators, blood pressure, and adverse events. RevMan 5.3 Software was used for data analyses. GRADE system was used to assess the level of evidence. Results Sixteen eligible studies with 1594 subjects were identified. Five studies showed EXD was contradictory results according to Kupperman index of Menopausal Syndrome compared with hormone. One study showed EXD significantly improved total hot flush scores, total MRS scores and total MENQOL scores compared with placebo (P  Conclusions The present findings do not allow an assessment of the evidence because the low-quality studies included cannot be reproduced. However, we identified an area, which is worthy of further research. Rigorous RCTs are still needed in the future.

Xiaoyun Wang - One of the best experts on this subject based on the ideXlab platform.

  • effect of combining therapy with traditional chinese medicine based psychotherapy and herbal medicines in women with Menopausal Syndrome a randomized controlled clinical trial
    Evidence-based Complementary and Alternative Medicine, 2012
    Co-Authors: Hongyan Yang, Jing Yang, Xuchun Huang, Chunlin Zhang, Aiping Lu, Miao Jiang, Xiaoyun Wang
    Abstract:

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of Menopausal Syndrome. Altogether 424 eligible women diagnosed as Menopausal Syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating Menopausal Syndrome.

  • chinese medicine for Menopausal Syndrome current status problems and strategies
    Chinese Journal of Integrative Medicine, 2011
    Co-Authors: Xiaoyun Wang, Hongyan Yang, Lili Zong
    Abstract:

    The use of Chinese medicine (CM) for the management of: Menopausal Syndrome is considered effective both at home and abroad, and more and more clinical studies are confirming its efficacy. However, many problems still exit in current studies, such as the standard of CM Syndrome differentiation, the design methodology and criteria to assess the quality of clinical trials and the efficacy of interventions. In this paper, the authors present the CM research and treatment strategies for Menopausal Syndrome with concepts explaining the CM understanding of the mechanism of the disorder. It is concluded that CM is effective for Menopausal Syndrome, but improvement in both study methodology and treatment strategy is needed. In detail, it is firstly necessary to conduct clinical studies to evaluate the difference of various CM treatments for Menopausal Syndrome manifesting different symptoms, so as to establish a comprehensive treatment protocol of CM. Secondly, an acknowledged evaluation system needs to be founded, which embodies the characteristics of CM, and covers appropriate endpoint indices and parameters to objectively evaluate the effect and study quality of CM. Finally, an epidemiological survey with large sample size should be implemented with robust statistical design and CM expertise to collect data for establishing diagnostic criteria for menopause in different stages and with different symptoms.

G Saletuzyhlarz - One of the best experts on this subject based on the ideXlab platform.

  • double blind placebo controlled psychometric studies on the effects of a combined estrogen progestin regimen versus estrogen alone on performance mood and personality of Menopausal Syndrome patients
    Drug Research, 2011
    Co-Authors: L Linzmayer, B Saletu, M Metka, H V Semlitsch, J C Huber, Doris M Gruber, G Saletuzyhlarz, Gerda Bock, Ali Zoghlami, Michael Oettel
    Abstract:

    The influence of a combined estrogen progestin regimen (Climodien®) on noo psyche, thymopsyche, personality and psychophysiological measures of meno pausal Syndrome patients was investi gated in a double blind, placebo con trolled, comparative, randomized 3 arm trial phase (Climodien 2/3 = estradiol val erate (CAS 979-32-8) 2 mg + the proges tin dienogest (CAS 65928-58-7) 3 mg = re gimen A, estradiol valerate 2 mg = regi men EV, and placebo = regimen P) fol lowed by an open label phase in which all patients received Climodien 2/2 (estra diol valerate 2 mg + dienogest 2 mg) = re gimen A*. 49 women (16, 17, 16 valid patients per arm) aged between 46 and 67 years (mean 58, 58, 56 years, respec tively) with the diagnoses of insomnia (G 47.0) related to postMenopausal syn drome (N 95.1) were included in the anal ysis of the double blind phase. Both the double blind and the open label phase lasted 2 months. Noopsychic investigations demon strated an improvement in associative verbal memory after 2 months of regi men A, which was significant as com pared with both baseline and placebo. Re garding visual memory, regimen A* in duced an improvement, which was signif icantly different from the decline in correct reproductions in the Benton Test observed under estradiol. Errors in the Benton Test decreased significantly after regimen A* as compared with regimen EV. These findings suggest that hormone replacement therapy with estradiol, and even more in combination with dieno-gest, improves verbal and visual memory, which is in line with the improvement in information processing speed and capacity objectified by event-related potentials (ERP). Thymopsychic investigations demonstrated a significant improvement in somatic complaints and trait anxiety after both regimen A and regimen EV as compared with baseline. State anxiety decreased significantly under regimen A* as compared with EV. The Freiburger Personality Inventory showed an improvement in aggressivity after regimen A* as compared with the preceding placebo as well as an improvement in striving after dominancy after both regimen A and regimen EV as compared with pre-treatment, but also after regimen A* as compared with regimen EV. Extraversion increased after 2 months of regimen A as compared to regimen P. Psychophysiological findings including pupillary and skin conductance variables were not significant.

  • hormone replacement therapy and vigilance double blind placebo controlled eeg mapping studies with an estrogen progestogen combination climodien lafamme versus estrogen alone in Menopausal Syndrome patients
    Maturitas, 2002
    Co-Authors: B Saletu, M Metka, P Anderer, J C Huber, Doris M Gruber, G Saletuzyhlarz
    Abstract:

    Abstract The aim of the double-blind, placebo-controlled study was to investigate the effects of a continuous combined estrogen–progestogen treatment (Climodien®, Lafamme®) as compared with estrogen alone on vigilance in insomniac postMenopausal Syndrome patients, objectified by EEG mapping. Methods: In a 3-arm, 2-month parallel group design phase, patients received a combination of estradiol valerate 2 mg and the novel progestogen dienogest 3 mg (Climodien 2/3) or estradiol valerate 2 mg alone or placebo. In a subsequent open-label phase, all patients received estradiol valerate 2 mg+dienogest 2 mg (Climodien 2/2). EEG mapping was carried out before and after the 2-month double-blind phase as well as after the 2-month open-label treatment. Results: As compared with placebo, Climodien 2/3 induced a marked and highly significant increase in absolute power in all frequency bands, specifically in alpha-2 activity. Moreover, a significant increase in relative alpha-2 power, a decrease in relative delta and beta power as well as an acceleration of the dominant frequency and of the delta and alpha centroids suggested a marked improvement in vigilance. In contrast, under estradiol valerate 2 mg alone, only a slight augmentation of alpha and attenuation of relative delta and beta power occurred, suggesting only a slight vigilance improvement as compared with placebo. Thus, dienogest 2 mg increased the estrogen effect, which was also confirmed by a statistical evaluation of the differences between Climodien 2/3 and estradiol valerate alone (augmentation of alpha-2, attenuation of relative beta, acceleration of the dominant frequency). Moreover, Climodien 2/2 also markedly increased alpha-2 power, decreased relative beta-2 power and accelerated the alpha centroid. Finally, comparing Climodien 2/3 with Climodien 2/2, there was even a dose–efficacy relation. Conclusions: Estradiol valerate 2 mg improves vigilance slightly, thereby confirming previous findings. The additional administration of dienogest does not minimize the effect of estrogen, but on the contrary increases it, which makes the combination superior to both placebo and estradiol valerate alone. Vigilance improvement may be of great therapeutic benefit to Menopausal Syndrome patients at a time when increased adaptability is needed to adjust to increasing sexual, marital, occupational and social difficulties known to occur specifically in this period of life.