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A Clinical Study on the Effect of Red Ginseng for Postmenopausal Hot Flushes
Abstract
Purpose: The purpose of this study is to identify the clinical effect of Red Ginseng in the treatment of postmenopausal hot flushes. Methods: We studied 49 women from 45 to 55 years old who complained hot flushes. We randomly divided women into two groups, We treated one group with red ginseng capsule, and treated another group with placebo for 2 months. patients recorded the frequency of the hot flush on an everyday basis. And we measured temperature of patient's face by DITI. Results: Red ginseng and Placebo treated group significantly decreased the frequency of the hot flush. After treatment, the temperature on the cheekbones who treated by red ginseng get lower than before treatment. But there is no statistically difference between red ginseng and placebo. Conclusion: This study shows that both red ginseng and placebo have remarkable effects on patients, but red ginseng is not better than placebo.
... Of the 527 eligible studies, 17 RCTs were eligible [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28], and 2 duplicate reports [19,25] among the final 15 included were removed ( Fig. 1 and Table 1). There were 2 ongoing trials ( Table 2). ...
... There were 2 ongoing trials ( Table 2). Eleven of the included studies were conducted in Korea [12,15,16,18,[20][21][22][23][24]26,27], one study was from Sweden [13], one study was from the USA [28], and two studies were from Iran [14,17]. Ten studies used Korean red ginseng (KRG) [12,15,16,18,[20][21][22][23]26,27], one study used fermented KRG [24], two studies used American ginseng (Ginsena and another commercial supplement) [13,28], and the other two studies used Panax ginseng [14,17]. ...
... Eleven of the included studies were conducted in Korea [12,15,16,18,[20][21][22][23][24]26,27], one study was from Sweden [13], one study was from the USA [28], and two studies were from Iran [14,17]. Ten studies used Korean red ginseng (KRG) [12,15,16,18,[20][21][22][23]26,27], one study used fermented KRG [24], two studies used American ginseng (Ginsena and another commercial supplement) [13,28], and the other two studies used Panax ginseng [14,17]. Thirteen RCTs used a parallel group design [12-14,16-18,20-24, 27,28], and two used a crossover design [15,26]. ...
Purpose
This systematic review aimed to update the evidence of ginseng on menopausal women's health care.
Methods
We searched seven databases (PubMed, AMED, EMBASE, the Cochrane Library, RISS, and KoreaMed) from their inception to April 2022 and included all placebo-controlled RCTs comparing any type of ginseng in menopausal women. The methodological quality of all studies was assessed using the Cochrane Risk of Bias Tool 2.0.
Results
We included 15 RCTs with our inclusion criteria. The majority of studies considered bias a concern. Ginseng reduced menopausal symptoms in three studies (n = 515; standardized mean difference (SMD): −0.40, 95% confidence interval (CI): −0.73 to −0.07, P = 0.02) and lowed hot flashes (n = 515; SMD: −0.34, 95% CI: −0.66 to −0.01, P = 0.04). The meta-analysis of three other studies failed to show that ginseng was beneficial for sexual function (n = 491; SMD: 0.31, 95% CI: −0.30 to 0.92, P = 0.32). Three RCTs showed positive effects of ginseng on the quality of life score (n = 515, SMD: −0.31, 95% CI: −0.61 to −0.01, P = 0.05). In two studies, ginseng failed to produce significant effects on the vaginal maturation index and vaginal pH. Another three RCTs failed to demonstrate a beneficial effect of Korean red ginseng (KRG) on endometrial thickness.
Conclusion
This study demonstrated that ginseng can significantly reduce hot flashes, menopausal symptoms, and quality of life in menopausal women. In contrast, neither KRG nor ginseng appeared to have any direct effect on sexual dysfunction, hormones or biomarkers, or endometrial thickness. More rigorous RCTs are needed to overcome the current limitations.
... Key data from the remaining 10 RCTs are summarized in Table 1. [8][9][10][11][12][13][14][15][16][17] Eight of the included studies were performed in Korea, [8,9,[11][12][13][14][15][16] 1 trial was from Sweden, [10] and 1 study was from USA. [17] Six trials included the postmenopausal women who had not menstruated naturally from 6 to 12 months, [8][9][10][11]14,16] while the other 4 did not report in details. [12,13,15,17] Seven trials used Korean red ginseng (KRG), [8,9,11,[13][14][15][16] 1 study employed fermented KRG, [12] and the other 2 used American ginseng (Ginsena and another commercial supplement). Eight RCTs adopted a 2-arm parallel group design, [8][9][10]12,[14][15][16][17] and 2 used a cross-over design. ...
... Key data from the remaining 10 RCTs are summarized in Table 1. [8][9][10][11][12][13][14][15][16][17] Eight of the included studies were performed in Korea, [8,9,[11][12][13][14][15][16] 1 trial was from Sweden, [10] and 1 study was from USA. [17] Six trials included the postmenopausal women who had not menstruated naturally from 6 to 12 months, [8][9][10][11]14,16] while the other 4 did not report in details. [12,13,15,17] Seven trials used Korean red ginseng (KRG), [8,9,11,[13][14][15][16] 1 study employed fermented KRG, [12] and the other 2 used American ginseng (Ginsena and another commercial supplement). Eight RCTs adopted a 2-arm parallel group design, [8][9][10]12,[14][15][16][17] and 2 used a cross-over design. ...
... Key data from the remaining 10 RCTs are summarized in Table 1. [8][9][10][11][12][13][14][15][16][17] Eight of the included studies were performed in Korea, [8,9,[11][12][13][14][15][16] 1 trial was from Sweden, [10] and 1 study was from USA. [17] Six trials included the postmenopausal women who had not menstruated naturally from 6 to 12 months, [8][9][10][11]14,16] while the other 4 did not report in details. [12,13,15,17] Seven trials used Korean red ginseng (KRG), [8,9,11,[13][14][15][16] 1 study employed fermented KRG, [12] and the other 2 used American ginseng (Ginsena and another commercial supplement). Eight RCTs adopted a 2-arm parallel group design, [8][9][10]12,[14][15][16][17] and 2 used a cross-over design. ...
Background:
The aim of this systematic review was to update, complete, and critically evaluate the evidence from placebo-controlled randomized clinical trials (RCTs) of ginseng for managing menopausal women's health.
Methods:
We searched the literature using 13 databases (MEDLINE, AMED, EMBASE, the Cochrane Library, 6 Korean Medical, and 3 Chinese Databases) from their inception to July 2016 and included all double-blind RCTs that compared any type of ginseng with a placebo control in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool.
Results:
Ten RCTs met our inclusion criteria. Most RCTs had unclear risk of bias. One RCT did not show a significant difference in hot flash frequency between Korean red ginseng (KRG) and placebo. The second RCT reported positive effects of KRG on menopausal symptoms. The third RCT found beneficial effects of ginseng (Ginsena) on depression, well-being, and general health. Four RCTs failed to show significant differences in various hormones between KRG and placebo controls except dehydroepiandrosterone. Two other RCTs failed to show effects of KRG on endometrial thickness in menopausal women. The other RCT also failed to show the effects of American ginseng on oxidative stress markers and other antioxidant enzymes.
Conclusion:
Our systematic review provided positive evidence of ginseng for sexual function and KRG for sexual arousal and total hot flashes score in menopausal women. However, the results of KRG or ginseng failed to show specific effects on hot flash frequency, hormones, biomarkers, or endometrial thickness. The level of evidence for these findings was low because of unclear risk of bias.
... A total of 87 articles were located, and 83 were excluded for the reasons given in Fig. 1. The remaining 4 RCTs were included, and their key data are summarized in Table 1 [11][12][13][14]. Three of the included studies were conducted in Korea, and one trial was from Sweden. ...
... Three of the included studies were conducted in Korea, and one trial was from Sweden. Three trials used Korean red ginseng (KRG) [11][12][13], and the other employed ginseng (Ginsana) [14]. Three RCTs adopted a two-arms parallel group design [12][13][14], and one used a cross-over design [11]. ...
... Three trials used Korean red ginseng (KRG) [11][12][13], and the other employed ginseng (Ginsana) [14]. Three RCTs adopted a two-arms parallel group design [12][13][14], and one used a cross-over design [11]. ...
The aim of this review was to assess the effectiveness of ginseng as a treatment option for managing menopause symptoms. We searched the literature using 11 databases from their inception to 26 September 2012 and included all randomized clinical trials (RCTs) that compared any type of ginseng to a placebo controls in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool. Four RCTs met our inclusion criteria. Most RCTs had high risk of bias. One RCT showed that Korean red ginseng (KRG) significantly improved sexual arousal and global health compared with placebo. Another RCT reported the superiority of KRG over placebo for treating menopause symptoms on Kupperman's index and menopausal rating score. The third RCT failed to show a significant effect of KRG on hot flash frequency compared to placebo. The fourth RCT found beneficial effects of ginseng compared to placebo on depression and well-being. In conclusion, the evidence on ginseng as an effective treatment for managing menopause symptoms is limited. Most of the RCTs are burdened with a high risk of bias. Thus firm conclusions cannot be drawn. Rigorous studies seem warranted.
... While the total cholesterol and LDLcholesterol decreased significantly, the estrogen content was not affected (Seo et al., 2014). In menopausal women administered with either 0.9 g/day (8 weeks) or 6 g/day (30 days) of red ginseng, the frequency of the occurrence of hot flashes, which constitute a menopausal symptom, decreased (Kim et al., 2009). In women with menopausal symptoms who had taken red ginseng, the stress hormone ratio (cortisol/DHES-A) became similar to that of women without menopausal symptoms, and red ginseng mitigated menopausal stress and decreased tissue-type plasminogen activator inhibitor type 1, thus improving blood circulation (Kikuchi et al., 2003). ...
Ginseng has been traditionally utilized for several millennia in Asian countries, including Korea, China, and Japan, not only as a nourishing and tonifying agent but also as a therapeutic agent for a variety of diseases. In recent years, the different impacts of panax ginseng including immunity improvement, blood circulation improvement, antioxidation and anticancer an effect have been reported in clinical as well as basic research. Around the world, there is a trend of the rising utilization of health functional foods on the level of disease prevention along with increased interest in maintaining health because of population aging and the awareness of lifestyle diseases and chronic diseases. But till now, international ginseng monographs including those of the World Health Organization have been based on data on white ginseng and have mentioned red ginseng only partly. Another botanical species, although commonly called Siberian ginseng (Eleutherococcus senticosus), is not a true ginseng. The present monograph will contribute to providing accurate information on panax ginseng to agencies, businesses, and consumers both in Iraq and abroad.
... While the total cholesterol and LDL-cholesterol decreased significantly, the estrogen content was not affected [77]. In menopausal women administered with either 0.9 g/day (8 weeks) or 6 g/day (30 days) of red ginseng, the frequency of the occurrence of hot flashes, which constitute a menopausal symptom, decreased [78,79]. In women with menopausal symptoms who had taken red ginseng, the stress hormone ratio (cortisol/DHES-A) became similar to that of women without menopausal symptoms, and red ginseng mitigated menopausal stress and decreased tissue-type plasminogen activator inhibitor type 1, thus improving blood circulation [80,81]. ...
Ginseng has been traditionally used for several millennia in Asian countries, including Korea, China, and Japan, not only as a nourishing and tonifying agent but also as a therapeutic agent for a variety of diseases. In recent years, the various effects of red ginseng including immunity improvement, fatigue relief, memory improvement, blood circulation improvement, antioxidation, mitigation of menopausal women's symptoms, and anticancer an effect have been reported in clinical as well as basic research. Around the world, there is a trend of the rising consumption of health functional foods on the level of disease prevention along with increased interest in maintaining health because of population aging and the awareness of lifestyle diseases and chronic diseases. Red ginseng occupies an important position as a health functional food. But till now, international ginseng monographs including those of the World Health Organization have been based on data on white ginseng and have mentioned red ginseng only partly. Therefore, the red ginseng monograph is needed for component of red ginseng, functionality certified as a health functional food in the Korea Food and Drug Administration, major efficacy, action mechanism, and safety. The present red ginseng monograph will contribute to providing accurate information on red ginseng to agencies, businesses, and consumers both in South Korea and abroad.
... (RCTs), which were included in the review, tested the efficacy of KRG compared with placebo, and their results showed superior effects of KRG on sexual arousal and global health [72][73][74]. The other remaining one trial reported favorable effects of ginseng supplements on well-being and depression as compared with placebo [75]. ...
Ginseng has been used in China for at least two millennia and is now popular in over 35 countries. It is one of the world’s popular herbs for complementary and alternative medicine and has been shown to have helpful effects on cognition and blood circulation, as well as anti-aging, anti-cancer, and anti-diabetic effects, among many others. The pharmacological activities of ginseng are dependent mainly on ginsenosides. Ginsenosides have a cholesterol-like four trans-ring steroid skeleton with a variety of sugar moieties. Nuclear receptors are one of the most important molecular targets of ginseng, and reports have shown that members of the nuclear receptor superfamily are regulated by a variety of ginsenosides. Here, we review the published literature on the effects of ginseng and its constituents on two main sex steroid hormone receptors: estrogen and androgen receptors. Furthermore, we discuss applications for sex steroid hormone receptor modulation and their therapeutic efficacy.
... Kim and colleagues measured hot flash frequency with Korean red ginseng versus placebo and found no statistically significant difference between groups. 83 A second study from the same team 84 found that ginseng improved both Kupperman Index (P ¼ 0.032) and Menopause Rating Scale scores (P ¼ 0.035) but failed to specifically affect hot flash scores within either scale (P ¼ 0.046 and P ¼ 0.121, respectively). These findings were later summarized in a review by Kim and colleagues. ...
Objective: To update and expand The North American Menopause Society's evidence-based position on nonhormonal management of menopause-Associated vasomotor symptoms (VMS), previously a portion of the position statement on the management of VMS. Methods: NAMS enlisted clinical and research experts in the field and a reference librarian to identify and review available evidence. Five different electronic search engines were used to cull relevant literature. Using the literature, experts created a document for final approval by the NAMS Board of Trustees. Results: Nonhormonal management of VMS is an important consideration when hormone therapy is not an option, either because of medical contraindications or a woman's personal choice. Nonhormonal therapies include lifestyle changes, mind-body techniques, dietary management and supplements, prescription therapies, and others. The costs, time, and effort involved as well as adverse effects, lack of long-Term studies, and potential interactions with medications all need to be carefully weighed against potential effectiveness during decision making. Conclusions: Clinicians need to be well informed about the level of evidence available for the wide array of nonhormonal management options currently available to midlife women to help prevent underuse of effective therapies or use of inappropriate or ineffective therapies. Recommended: Cognitive-behavioral therapy and, to a lesser extent, clinical hypnosis have been shown to be effective in reducing VMS. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management ofVMS, although other selective serotonin reuptake/norepinephrine reuptake inhibitors, gabapentinoids, and clonidine show evidence of efficacy. Recommend with caution: Some therapies that may be beneficial for alleviating VMS are weight loss, mindfulness-based stress reduction, the S-equol derivatives of soy isoflavones, and stellate ganglion block, but additional studies of these therapies are warranted. Do not recommend at this time: There are negative, insufficient, or inconclusive data suggesting the following should not be recommended as proven therapies for managing VMS: cooling techniques, avoidance of triggers, exercise, yoga, paced respiration, relaxation, over-The-counter supplements and herbal therapies, acupuncture, calibration of neural oscillations, and chiropractic interventions. Incorporating the available evidence into clinical practice will help ensure that women receive evidence-based recommendations along with appropriate cautions for appropriate and timely management of VMS.
... Korean red ginseng powder improved menopausal symptoms such as hot flushes and decreased blood cholesterol and LDL-cholesterol levels in menopausal females [36,37]. ...
Background:Panax ginseng C.A. Meyer is one of the most frequently used herbs in the world. The roots of Panax ginseng have been used as a traditional tonic and medicine for thousands of years in Korea and China. Today, ginseng root is used as a dietary supplement and complementary medicine and for adjuvant therapeutics worldwide. The efficacy of ginseng has been studied in a wide range of basic research and clinical studies. However, it has been reported that the results from clinical studies are conflicting, and they depend on the parameters of the protocol design including the conditions of the participants and the types of ginseng used such as red ginseng, white ginseng, fermented ginseng and cultured ginseng. [...].
Women face a significant change in their reproductive health as menopause sets in. It is marred with numerous physiological changes that negatively impact their quality of life. This universal, transition phase is associated with menopausal and postmenopausal syndrome, which may spread over 2–10 years. This creates a depletion of female hormones causing physical, mental, sexual and social problems and may, later on, manifest as postmenopausal osteoporosis leading to weak bones, causing fractures and ultimately morbidity and mortality. Menopausal hormone therapy generally encompasses the correction of hormone balance through various pharmacological agents, but the associated side effects often lead to cessation of therapy with poor clinical outcomes. However, it has been noticed that phytotherapeutics is trusted by women for the amelioration of symptoms related to menopause and for improving bone health. This could primarily be due to their reduced side effects and lesser costs. This review attempts to bring forth the suitability of phytotherapeutics/herbals for the management of menopausal, postmenopausal syndrome, and menopausal osteoporosis through several published research. It tries to enlist the available botanicals with their key constituents and mechanism of action for mitigating symptoms associated with menopause as well as osteoporosis. It also includes a list of a few herbal commercial products available for these complications. The article also intends to collate the findings of various clinical trials and patents available in this field and provide a window for newer research avenues in this highly important yet ignored health segment.
Appendix 1: 11 electronic databases and 16 manually searched Korean journals for literature search.
Appendix 2: Search terms for used electronic databases for literature search.
Appendix 3: PRISMA flow diagram of the whole literature search process.
Appendix 4: The number of complementary and traditional medicine randomised clinical trials in the Korean literature published by journal, respectively.
Appendix 5: Total list of complementary and traditional medicine RCTs included in bibliometric analysis and quality assessment.
Objective: To describe the prevalence and treatment of hot flushes in premenopausal and postmenopausal women from the 1960s to the 1990s. Design: This prospective study, based on a random sample or the total female population of 430,000 in Gothenburg, Sweden, was started in 1968, with follow-ups in 1974, 1980, and 1992. The participants were 1,462 women born ill 1930, 1922, 1918, 1914, and 1908 (participation rate 90.1%) who were representative of women of the same age in the general population. For the purpose of analyzing secular trends, we included 122 participants who were 38 years old and 47 who were 50 years old in 1980-1981. Results: The prevalence of hot flushes increased from similar to11% at 38 years to a maximal prevalence, of similar to60% at 52 to 54 years of age, then declined successively from similar to30% at 60 years of age to similar to15% at 66 years of age, and then to similar to9% at 72 years of age. The predominant type of medication being prescribed changed during the observation period from sedatives/anticholinergic drugs in the 1960s to hormone replacement therapy in the 1980s. Hormone replacement therapy was considered to be an effective form of treatment for hot flushes by 70% to 87% of the women. Conclusions: Hot flushes were a common symptom, with a maximal prevalence of 64% at 54 years of age. Medical consultation and treatment did not increase in 50-year-old women from 1968-1969 to 1980-1981. Treatment changed and became more effective during the observation period.
Objective: To investigate the effect of soy protein supplementation with known levels of phyto-estrogens on cardiovascular disease risk factors and menopausal symptoms in perimenopausal women. Methods: A randomized, double- blind crossover trial was conducted in 51 women consuming isocaloric supplements containing 20 g of complex carbohydrates (comparison diet), 20 g of soy protein containing 34 mg of phytoestrogens given in a single dose, and 20 g of soy protein containing 34 mg of phytoestrogens split into two doses. Women were randomly assigned to one of the three diets for 6-week periods and subsequently were randomized to the remaining two interventions to determine whether differences existed between the treatment diets for cardiovascular disease risk factors, menopausal symptoms, adherence, and potential adverse effects. Results: Significant declines in total cholesterol (6% lower) and low density lipoprotein cholesterol (7% lower) were observed in both soy diets compared with the carbohydrate placebo diet. A significant decline in diastolic blood pressure (5 mm Hg lower) was noted in the twice-daily soy diet, compared with the placebo diet. Although nonsignificant effects were noted for a number of measures of quality of life, a significant improvement was observed for the severity of vasomotor symptoms and for hypoestrogenic symptoms in the twice-daily group compared with the placebo group. No significant effects were noted for triglycerides, high density lipoprotein cholesterol or frequency of menopausal symptoms. Adherence was excellent in all groups. Conclusions: Soy supplementation in the diet of nonhypercholesterolemic, nonhypertensive, perimenopausal women resulted in significant improvements in lipid and lipoprotein levels, blood pressure, and perceived severity of vasomotor symptoms. These data corroborate the potential importance of soy supplementation in reducing chronic disease risk in Western populations.
A survey based on a postal questionnaire sent to all women born in 1936 living in four Copenhagen suburbs (n = 597, response rate = 88%) revealed an overall prevalence of hormone replacement therapy (HRT) use of 22% and a cumulative incidence of 37%. This paper describes the use of HRT in this population and the patterns of exposure to treatment. Our results indicate that the use of HRT, particularly combined oestrogen-progestogen therapy, is increasing and is being initiated during the pre-menopause. Climacteric complaints were the main reason for starting treatment; only a minority of the respondents were motivated by prophylactic considerations. Forty percent discontinued treatment, the majority stating that they had done so because of unpleasant adverse reactions or lack of effect.
Results of a postal questionnaire survey of 638 women aged 45 to 54, living in the London area in 1964-65, indicate (consistently with other recent surveys) that hot flushes and night sweats are clearly associated with the onset of a natural menopause and that they occur in the majority of women. Hot flushes were reported to occur more frequently (usually daily) and over more of the body by women whose menstrual flow showed evidence of change or cessation, and for 25% of those women whose menses had ceased for at least one year, hot flushes persisted for five years or more. The other six symptoms specified, namely, headaches, dizzy spells, palpitations, sleeplessness, depression, and weight increase, showed no direct relationship to the menopause but tended to occur together, each being reported by approximately 30 to 50% of the respondents with little variation according to menopausal status. None of the six sociodemographic variables investigated, i.e., employment status, school leaving age, social class, domestic workload, marital status, and parity, had any marked association with the reported frequency of symptoms. The majority of respondents did not anticipate or experience any difficulties and only about 10% expressed regret at the cessation of menses. Despite embarrassment and/or discomfort from hot flushes, reported by nearly three-quarters of those experiencing this symptom, only one-fifth had apparently sought medical treatment.
A survey was designed to determine why menopausal women do not take hormone replacement therapy (HRT).
A sample of 3,600 women > 50 years old were randomly selected from six zip codes in northwest suburban Chicago. They received a maximum of three survey mailings. Those who did not respond were called and asked to respond over the phone. The data that were obtained included knowledge of, physician discussion about, use of, and reason for not currently taking HRT, menopausal status, last physician visit, and age grouping.
A total of 1,966 (65%) women responded. Of these, 1,448 (74%) knew about HRT, 1,193 (61%) had discussed HRT with their physicians, and 815 (41%) had been treated with HRT in the past. A total of 552 women (28%) were currently being treated with HRT, of whom 419 (76%) had been treated for > 2 years. A total of 1,356 respondents were not being treated with HRT. Of these, 1,114 (82%) were menopausal, of whom 742 (67%) knew about HRT, 551 (50%) had discussed HRT with their physicians, 837 (75%) had seen their physician in the past year, and 236 (21%) had been treated with HRT in the past. Reasons for not taking HRT included the following: 49% no longer had menopausal symptoms, 45% did not want to take HRT, 33% were not offered it by their doctors, 28% were afraid to use it, and 27% were not menopausal.
Seeing a physician in the past year did not ensure that these women understood the symptom course of menopause. Confirming women's knowledge about menopausal health or assisting physician education about menopausal health may offer opportunities both to assist women's decision making about HRT and to improve women's health care.
To investigate the effect of soy protein supplementation with known levels of phytoestrogens on cardiovascular disease risk factors and menopausal symptoms in perimenopausal women.
A randomized, double-blind crossover trial was conducted in 51 women consuming isocaloric supplements containing 20 g of complex carbohydrates (comparison diet), 20 g of soy protein containing 34 mg of phytoestrogens given in a single dose, and 20 g of soy protein containing 34 mg of phytoestrogens split into two doses. Women were randomly assigned to one of the three diets for 6-week periods and subsequently were randomized to the remaining two interventions to determine whether differences existed between the treatment diets for cardiovascular disease risk factors, menopausal symptoms, adherence, and potential adverse effects.
Significant declines in total cholesterol (6% lower) and low density lipoprotein cholesterol (7% lower) were observed in both soy diets compared with the carbohydrate placebo diet. A significant decline in diastolic blood pressure (5 mm Hg lower) was noted in the twice-daily soy diet, compared with the placebo diet. Although nonsignificant effects were noted for a number of measures of quality of life, a significant improvement was observed for the severity of vasomotor symptoms and for hypoestrogenic symptoms in the twice-daily group compared with the placebo group. No significant effects were noted for triglycerides, high density lipoprotein cholesterol or frequency of menopausal symptoms. Adherence was excellent in all groups.
Soy supplementation in the diet of nonhypercholesterolemic, nonhypertensive, perimenopausal women resulted in significant improvements in lipid and lipoprotein levels, blood pressure, and perceived severity of vasomotor symptoms. These data corroborate the potential importance of soy supplementation in reducing chronic disease risk in Western populations.
Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis.
This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects.
Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks. There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed.
The soy product did not alleviate hot flashes in breast cancer survivors.
Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain.
To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States.
Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998.
Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102).
The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes.
On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years.
Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
To investigate the effect of an oral soy isoflavone extract (Phytosoya) on hot flushes in menopausal women.
The study was conducted on outpatients according to a multicenter, randomized, double-blind, placebo-controlled, parallel-group design. A total of 75 patients in natural or surgical menopause suffering from at least seven hot flushes per day were randomized to receive during 4 months either soy isoflavone extract (total of 70 mg genistin and daidzin per day) or placebo.
There is evidence to suggest that 16 weeks of treatment with soy extract can help reduce the mean number of hot flushes per 24 hours in menopausal women. Withdrawals during this trial made it difficult to obtain an unbiased estimate of the true treatment effect, but numerous sensitivity analyses lend support to the suggestion that taking soy extract can be beneficial in the treatment of hot flushes. In particular, women taking soy extract had a 38% reduction in the mean number of hot flushes by week 4 and a 51% reduction by week 8. By the end of week 16, patients taking soy extract had a 61% reduction in their daily hot flushes versus a 21% reduction obtained with the placebo. "Responders" (defined as patients whose hot flushes were reduced by at least 50% at the end of treatment period) were 65.8% in the soy extract group and 34.2% in the placebo group ( < 0.005).
Soy isoflavone extract may help to reduce the frequency of hot flushes in climacteric women and provides an attractive addition to the choices available for relief of hot flushes.
Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: a north central cancer treatment group trial
- Quella
- Quella
Menopausal Hormone Therapy Information
- Nih Homepage
Menopause & Hormones brochure
- Fda Homepage
- Jonathan S Berek
Jonathan S. Berek. Gynecology. NWW.
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The Women's Health Initiative Streering Committee : Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy-The Women's Health Initiative Randomized Controlled Trial
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