ArticleLiterature Review

Maca (Lepidium meyenii) for treatment of menopausal symptoms: A systematic review

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Abstract

Maca (Lepidium meyenii), an Andean plant of the brassica (mustard) family has been used for centuries in the Andes as an adaptogenic plant to manage anemia, infertility and female hormone balance. The aim of this review was to assess the evidence for and against the effectiveness of the maca plant as a treatment for menopausal symptoms. We searched 17 databases from their inception up to June 2011 and included all randomized clinical trials (RCTs) that compared any type of maca-based intervention to a placebo for the treatment of menopausal symptoms. All studies were assessed for methodological quality using the Cochrane 'risk of bias' assessment tool. Four RCTs met all inclusion criteria. These RCTs tested the effects of maca on menopausal symptoms in healthy perimenopausal, early postmenopausal, and late postmenopausal women. Using the Kupperman Menopausal Index and the Greene Climacteric Score, all RCTs demonstrated favorable effects of maca. There have been very few rigorous trials of maca for menopausal symptoms. The results of our systematic review provide limited evidence for the effectiveness of maca as a treatment for menopausal symptoms. However, the total number of trials, the total sample size, and the average methodological quality of the primary studies, were too limited to draw firm conclusions. Furthermore, the safety has not been proved yet. Therefore, the efficacy and safety should be tested in larger studies.

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... Brooks et al. 40 and Lee et al. 59 have suggested that Maca may have favorable effects on menopausal symptoms in postmenopausal women. Lee et al. 59 mention that the possible mechanisms that may be involved in Maca for menopausal symptoms are hypothetical; one possible mechanism may be the estrogenic activities previously associated with female fertility 60,61 . ...
... Brooks et al. 40 and Lee et al. 59 have suggested that Maca may have favorable effects on menopausal symptoms in postmenopausal women. Lee et al. 59 mention that the possible mechanisms that may be involved in Maca for menopausal symptoms are hypothetical; one possible mechanism may be the estrogenic activities previously associated with female fertility 60,61 . Meissner et al. 37 have proposed that Maca may stimulate the production of estrogens that optimize ovarian function and suppress FSH, while the other studies failed to show it 40,62 . ...
... Estradiol levels did not reach levels of 40 pg/mL or more, which are considered normal and eliminate climacteric symptoms. Therefore, further investigations are needed to clarify these results 59 . Another possible mechanism is the stimulation of hormonal reserves through fortification of the body's ability to regain and maintain hormonal homeostasis in the face of stressors 63 . ...
Article
The Lepidium meyenii plant also known as Peruvian Maca originates from high altitudes in the Andes, and it has a high nutritional content and is extensively used as an herbal supplement for conditions such as sexual dysfunction, semen quality, and menopausal symptoms. This narrative review was conducted to assess the effects of Maca on a variety of conditions but doing emphasis on menopausal symptoms. Studies published in the English and Spanish languages were included in the review. Following the PRISMA guidelines, we identified published studies through an electronic review of the literature searches of PubMed, Medline, ISI, DOAJ, Springer, and Embase. Web of Knowledge, DOAJ, and Google Scholar for original articles written in the English language, and Scielo, Lantidex, Imbiomed-L, Redalyc, and Google Scholar for original articles written in the Spanish language. After reviewing the literature, the information available does not provide enough evidence about the effectiveness of Maca in improving menopausal symptoms.
... As a result of these properties, preclinical (animal) and clinical studies combined, maca has become known for its therapeutic effect in myriad conditions, including fertility and reproductive health in men and women [17,31,59], prostate health [44,45,51], sexual performance [17,143] and sexual desire [50], cognitive impairment and memory loss [39,144], menopause [145,146], low chronic mountain sickness scores [97], skin health [147], anemia [145], cancer [17,95,140,148], vitality [17], gastrointestinal motility [149], and osteoporosis [17,28] (Table 1). Although not confirmed, it has been suggested that the effects on mood and cognition may be due to the possibility of maca metabolites crossing the blood-brain barrier [39]. ...
... As a result of these properties, preclinical (animal) and clinical studies combined, maca has become known for its therapeutic effect in myriad conditions, including fertility and reproductive health in men and women [17,31,59], prostate health [44,45,51], sexual performance [17,143] and sexual desire [50], cognitive impairment and memory loss [39,144], menopause [145,146], low chronic mountain sickness scores [97], skin health [147], anemia [145], cancer [17,95,140,148], vitality [17], gastrointestinal motility [149], and osteoporosis [17,28] (Table 1). Although not confirmed, it has been suggested that the effects on mood and cognition may be due to the possibility of maca metabolites crossing the blood-brain barrier [39]. ...
... In botanical medicine, maca is classified as an adaptogen [3,145]. Adaptogenic herbs are unique from other substances in their ability to modulate hormones and the immune system, assisting with maintaining optimal homeostasis. ...
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Maca (Lepidium meyenii, Lepidium peruvianum) is part of the Brassicaceae family and grows at high altitudes in the Peruvian Andes mountain range (3500–5000 m). Historically, it has been used as a nutrient-dense food and for its medicinal properties, primarily in enhancing energy and fertility. Scientific research has validated these traditional uses and other clinical applications by elucidating maca’s mechanisms of action, nutrition, and phytochemical content. However, research over the last twenty years has identified up to seventeen different colors (phenotypes) of maca. The color, hypocotyl size, growing location, cultivation, and post-harvest processing methods can have a significant effect on the nutrition content, phytochemical profile, and clinical application. Yet, research differentiating the colors of maca and clinical applications remains limited. In this review, research on the nutrition, phytochemicals, and various colors of maca, including black, red, yellow (predominant colors), purple, gray (lesser-known colors), and any combination of colors, including proprietary formulations, will be discussed based on available preclinical and clinical trials. The gaps, deficiencies, and conflicts in the studies will be detailed, along with quality, safety, and efficacy criteria, highlighting the need for future research to specify all these factors of the maca used in publications.
... One of the alternatives to HT is Lepidium Meyenii (Maca), which is an Andean plant of the brassica (mustard) family, widely spread in several South American countries. For centuries, Maca has been used successfully by native people of Peru for hormonal imbalances, menstrual irregularities and infertility [4]. Some reports suggest that Maca can be helpful in reducing discomfort caused by menopausal symptoms, including hot flashes, vaginal dryness, loss of energy, reduced libido and depression [4]. ...
... For centuries, Maca has been used successfully by native people of Peru for hormonal imbalances, menstrual irregularities and infertility [4]. Some reports suggest that Maca can be helpful in reducing discomfort caused by menopausal symptoms, including hot flashes, vaginal dryness, loss of energy, reduced libido and depression [4]. The other supplement used in this study is Pfaffia paniculata, a common root in South America, especially in Brazil, popularly known as Brazilian ginseng, with reported estrogen-like effects [5]. ...
... A border line difference was evidenced for fatigue, confirming a very recent study, in which 2 fractions of polysaccarhide extracted from Lepidium Meyenii presented dose-dependently positive effects on the fatigue related parameters [8]. A systematic review that included four RCTs tested the effects of Maca on menopausal symptoms in healthy perimenopausal, early postmenopausal, and late postmenopausal women [4]. The review showed favorable effects of Maca on menopausal symptoms using the KI and the Green Climacteric Score; despite some limitations of methodological quality. ...
... The PRISMA flow diagram is presented in Fig. 10.1. Key data from all three SRs are listed in Table 10.1 (Lee et al., 2011(Lee et al., , 2016Shin et al., 2010). The first authors originated from the same group in Korea for all the included SRs. ...
... The SRs investigated reproduction-related or women's related conditions, including menopausal symptoms (Lee et al., 2011), sexual function (Shin et al., 2010), and semen quality (Lee et al., 2016). The AMSTAR scores showed the high quality of the SRs in all of studies (Table 10.2). ...
... For menopausal symptoms, four randomized clinical trials (RCTs) were included and reported positive conclusions (Lee et al., 2011). Two SRs are related with sexual function (Shin et al., 2010) and semen quality (Lee et al., 2016). ...
... Maca (Lepidium meyenii) is a Peruvian plant that has been used as a food supplement and as medicine for humans and animals [9][10][11]. One of the medicinal usages for maca is to improve sexual function and menopausal symptoms [12,13]. Several in vivo studies showed that maca has spermatogenic and fertility-enhancing activities, improving sperm parameters, sexual behavior and enhancing androgen-like effects [9,11,[14][15][16][17][18][19]. ...
... Several in vivo studies showed that maca has spermatogenic and fertility-enhancing activities, improving sperm parameters, sexual behavior and enhancing androgen-like effects [9,11,[14][15][16][17][18][19]. Clinical trials and one systematic review have reported that maca may increase sperm count and mobility and improve sexual function in humans [12,13]. The mechanisms of action of maca for improving sperm parameters are not yet clear, however. ...
... Maca (Lepidium meyenii) is a Peruvian plant that has been used as a food supplement and as medicine for humans and animals [9][10][11]. One of the medicinal usages for maca is to improve sexual function and menopausal symptoms [12,13]. Several in vivo studies showed that maca has spermatogenic and fertility-enhancing activities, improving sperm parameters, sexual behavior and enhancing androgen-like effects [9,11,[14][15][16][17][18][19]. ...
... Several in vivo studies showed that maca has spermatogenic and fertility-enhancing activities, improving sperm parameters, sexual behavior and enhancing androgen-like effects [9,11,[14][15][16][17][18][19]. Clinical trials and one systematic review have reported that maca may increase sperm count and mobility and improve sexual function in humans [12,13]. The mechanisms of action of maca for improving sperm parameters are not yet clear, however. ...
Article
The aim of this review was to assess the evidence for the effectiveness of maca (Lepidium meyenii) in improving semen quality. We searched 11 databases from their inception to March 2016 and included all clinical trials on the improvement of semen quality parameters in infertile and healthy men, regardless of the study design or the type of maca. The risk of bias for each study was assessed using the Cochrane criteria. The selection of studies, data extraction, and validation were performed independently by the first two authors. Discrepancies were resolved through discussion by the same two authors. Five studies − 3 randomized clinical trials (RCTs) and 2 uncontrolled observational studies (UOSs) − met all of the inclusion criteria. One RCT found favorable effects of maca on sperm mobility in infertile men. The two other RCTs showed positive effects of maca on several semen quality parameters in healthy men. The two UOSs also suggested favorable effects of maca on semen quality. The results of our systematic review provide suggestive evidence for the effectiveness of maca in improving semen quality. However, the total number of trials, the total sample size, and the risk of bias of the included studies prevent the drawing firm conclusions. More rigorous studies are warranted.
... The nutritional value of Maca plant, Lepidium meyenii (L.M.) [4] consists of carbohydrates (55-60%), protein (10-14%), dietary fiber (8.5%), and fat (1.2%). It is rich in minerals such as calcium, potassium, iron, manganese, copper, zinc and sodium, in addition to fatty acids and secondary metabolites of medicinal and nutritional importance such as maca, macamides, macaridin and alkaloids that are found only in this plant [5]. ...
Article
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Due to the widespread use of the Oxymetholone and its widespread health problems, it was necessary to search for an alternative medicine treatment that reduces the harm of the Oxymetholone. Objectives from this study is determine the protective effect of the nano-extract of the Lepidium meyenii on the damage caused by the Oxymetholone in male rats. the experimental animals (28) were randomly divided into four groups, with 7 animals for each group The duration of the experiment was 55 days. The animal dosed daily, as follows: control group (G1): The animals were dosed with normal saline,Positive control group (G2): animals dosed orally with Oxymetholone (5 mg/kg B.w.),Group three (G3): Animals were dosed orally with the nano-extract of Lepidium meyenii ( 100 mg/kg B.w.),Group four (G4): It included animals dosed orally with the nano-extract of Lepidium meyenii (100 mg/kg B.w.) four hours before oral dosing with the Oxymetholone ( 5 mg/kg B.w.). The level of (GSH, SOD and number of sperm in epididymal tail) decreased in the Oxymetholone group and rose and was within the normal level in G3, G4.The histological sections of the epididymal in G2 It was noted that there were interstitial spaces between the epididymal tubules, and few sperm in the tubule cavities. With a lack of smooth muscle surrounding the tubules.Also showed in G3 and G4 the normal structure of the epididymis appears with regular epididymal tubules, an increase in the number of sperm in the lumen of the epididymis and the presence of connective tissue between the tubules. Maca root nano-extract has been shown to be effective in inhibiting oxymetholone-induced damage to oxidative stress and epididymal tissue in male rats.
... For centuries, the Andes have used Maca as an adaptogenic plant to treat anaemia, and for balancing of female hormones. More recently, Maca has been introduced to Japan, Europe, and the US, and it is now being used more frequently throughout the world [26]. ...
Article
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Monosodium glutamate (MSG), a sodium salt derived from glutamic acid, is widely used in commercial food products to improve taste, quality, and preservation. However, its consumption may have detrimental effects on male reproductive function. Nevertheless, plant extracts, such as Lepidium meyenii (Maca), Trigonella foenum-graecum (Fenugreek), Spirulina platensis (Spirulina), and Tribulus arabica (Tribulus), may ameliorate these adverse effects. To this effect, the phytochemical properties of Lepidium meyenii, Trigonella foenum-graecum, Spirulina platensis, and Tribulus arabica were assessed, and their potential impact on MSG-induced impairment of reproductive parameters was examined. The phytochemical composition (steroids, terpenes, phenols, flavonoids) of the plants was profiled through spectrophotometry and the antioxidant activity was assessed using the 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging assay. Thirty-six male Wistar rats were divided into six groups at random: a control group receiving distilled water, and five experimental groups (MSG, Maca, Fenugreek, Spirulina, and Tribulus) receiving 900 mg/kg/day of MSG dissolved in water for 45 days. Subsequently, the animals in the experimental groups were administered 500 mg/kg/day of the respective plant extract via oral gavage for an additional 35 days, while the MSG group continued to receive water only. Following the treatment period, the animals were sacrificed, and their reproductive tract organs were collected, weighed, and subjected to further analysis. Phytochemical analysis revealed the presence of diverse bioactive elements in the plant extracts, including phenolic and flavonoid compounds. Exposure to MSG negatively impacted total and progressive sperm motility, which was ameliorated by Lepidium meyenii treatment. Sperm morphology showed no significant differences among groups. Treatment of the phytochemical agents diminished histomorphometric alternations of the testicular length, germinal epithelium height, and number of cells in seminiferous tubules, which were caused by the initial administration of MSG. Testosterone and LH levels were reduced in the MSG group but improved in extract-treated groups. The study suggests Lepidium meyenii as a potential remedy for reproductive dysfunction. However, further investigation into its mechanisms and human safety and efficacy is warranted.
... Despite a number of communications on the beneficial action of maca on menopausal symptoms, most were based on anecdotal evidence or small-scale samples. The meta-analysis by Lee et al. 8 did not identify a significant amelioration of menopausal symptoms. Afterward, although the same authors in their 2016 meta-analysis found a number of studies reporting that treatment with maca was beneficial to sperm parameters in men, only 5 of these efforts were included, of which one was an abstract, 2 were uncontrolled observational studies and 1 was an unpublished RCT. ...
... Lepidium meyenii, known as Peruvian maca, is used to regulate sexual dysfunction and for a memory enhancement and antidepressant; it also has neuroprotective, antioxidant, anti-cancer, and anti-inflammatory effects (Peres et al., 2020). According to another study, maca is used to manage anemia, infertility, and female hormone balance (Lee, Shin, Yang, Lim, & Ernst, 2011). Due to the Lepidium species potential for medical use, determining its morphological and anatomical characteristics and elucidating upon its distinguishing characteristics are important. ...
... 15,16 Citrus flavonoids attenuated bone and muscle loss and reduced glucose and cholesterol levels in animal models. 17,18 Moreover, it improved bone calcium retention among postmenopausal women 17 and improved lipid profile and cardiovascular parameters in adults. 19 In addition, these three compounds have antioxidant properties, thus potentially reducing the risk of cancer. ...
Article
Objective This study aimed to evaluate the short-term efficacy and safety of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids for menopausal symptoms in comparison with estrogen plus progestogen therapy (EPT) among postmenopausal women. Methods This was a pilot single-blinded, three-armed phase II randomized clinical trial, controlled with EPT. Sixty participants were randomly assigned to receive treatment for 3 months: (1) an oral herbal supplement of 1,500 mg/d (G1, n = 20), (2) an oral herbal supplement of 3,000 mg/d (G2, n = 20), or (3) conjugated equine estrogens 0.625 mg/d plus medroxyprogesterone acetate of 5 mg/d (EPT group, n = 20). The primary endpoint was the intensity of menopausal symptoms as measured using the Menopause-Specific Quality of Life Questionnaire (global and domain scores). The Menopause-Specific Quality of Life Questionnaire uses a 7-point scale to rate the symptom intensity, with higher scores indicating severity. The secondary endpoints were hormonal, lipid, and safety profiles. Results Fifty-four participants (n = 54) completed the study. The mean, model-estimated, and global menopausal symptom scores at 3 months were 85.8 in the EPT group, 61.3 in G1, and 62.5 in G2. Participants treated with the herbal compound had lower global (13.7 [6.9-20.4], P < 0.001) and physical symptom scores (6.6 [1.6-11.5], P = 0.002) on the second month and lower psychosocial symptom scores (3.8 [1.3 to 6.3], P < 0.001) on the third month of follow-up, compared with EPT. Conversely, participants receiving EPT showed better outcomes on vasomotor symptoms since the first month of treatment (−6.1 [−8.3 to −4.0], P < 0.001). The EPT group exhibited higher values of estradiol and lower follicle-stimulating hormone and luteinizing hormone since the first month of follow-up. Also, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were significantly higher in this group than in G2. Conclusions In this small single-blind exploratory trial, the oral herbal supplement was more efficacious in reducing global, physical, and psychosocial menopausal symptoms in the short term than EPT. However, further studies are needed to adequately assess the efficacy and safety of this herbal supplement in the treatment of menopausal symptoms.
... A systematic review of the efficacy of Eleutherococcus senticosus revealed its beneficial effect on cognitive functions and on physical and mental endurance (Gerontakos et al., 2021). A systematic review on the efficacy of Panax ginseng on semen quality , a systematic review on the efficacy of Lepidium peruvianum on menopausal symptoms (Lee et al., 2011), and a systematic review and meta-analysis on the efficacy of Withania somnifera on male infertility (Durg et al., 2018) concluded with limited evidence. A systematic review and meta-analysis on the efficacy of Withania somnifera on sleep quality revealed positive results; however, the investigators pointed out the lack of evidence regarding safety (Cheah et al., 2021). ...
... One such popular herbal medicine that is used to improve semen quality and treat infertility in general is the maca plant, and most of the experimental data in the literature mainly report the effects of the red, yellow and black hypocotyl types (Gonzales et al., 2004;Gonzales et al., 2006a). Notably, this plant from Peru has long been utilized to enhance sexual functions (Shin et al., 2010;Lee et al., 2011). According to numerous in vivo studies, maca is replete with spermatogenic features, which, in turn, positively affect sexual behavior and sperm parameters (Gonzales et al., 2001;Gonzales et al., 2004;Chung et al., 2005;Bogani et al., 2006;Lentz et al., 2006;Rubio et al., 2006;Clément et al., 2010;Clement et al., 2012). ...
Article
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Background: This study aimed to examine the evidence for the effect of Lepidium meyenii Walp. [Brassicaceae] (L. meyenii W.), known as maca, on improving semen quality. Methods: Nine databases were searched for randomized controlled trials (RCTs) that examined the parameters for improvements in semen quality, regardless of the type of L. meyenii W. The risk of bias (ROB) among the studies was evaluated according to the Cochrane ROB tool. Results: Five RCTs met all of the inclusion criteria. Three RCTs showed mixed efficacy of maca in improving semen quality parameters, including sperm concentration and sperm motility, in men experiencing infertility. The meta-analysis also failed to show the efficacy of maca in increasing the sperm concentration compared to the placebo (weighted mean difference, 2.22, 95% confidence interval −2.94 to 7.37, p = 0.4). Two other RCTs also showed mixed effects of maca on several semen quality parameters in healthy men. Conclusion: The evidence from the included studies suggests unclear effects of maca on semen quality parameters in both men experiencing infertility and healthy men. However, the total number of RCTs and the total sample size were too small to draw firm conclusions.
... Lepidium meyenii Walp (maca) grows at altitudes of 2800-5000 m above sea level and was probably domesticated between the years 4000-1200 BCE in Peru [6]. In human studies, it is already known that maca improves menopausal symptoms [7]. In other adult human subjects, maca improves mood, energy, and health status and reduces the chronic mountain sickness score (CMS), a kind of pathology that is observed in only people living at high altitudes [8]. ...
Article
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With aging, sarcopenia and the associated locomotor disorders, have become serious problems. The roots of maca contain active ingredients (triterpenes) that have a preventive effect on sarcopenia. However, the effect of maca on muscle hypertrophy has not yet been investigated. The aim of this study was to examine the effects and mechanism of maca on muscle hypertrophy by adding different concentrations of yellow maca (0.1 mg/mL and 0.2 mg/mL) to C2C12 skeletal muscle cell culture. Two days after differentiation, maca was added for two days of incubation. The muscle diameter, area, differentiation index, and multinucleation, were assessed by immunostaining, and the expression levels of the proteins related to muscle protein synthesis/degradation were examined by Western blotting. Compared with the control group, the muscle diameter and area of the myotubes in the maca groups were significantly increased, and the cell differentiation index and multinucleation were significantly higher in the maca groups. Phosphorylation of Akt and mTOR was elevated in the maca groups. Maca also promoted the phosphorylation of AMPK. These results suggest that maca may promote muscle hypertrophy, differentiation, and maturation, potentially via the muscle hypertrophic signaling pathways such as Akt and mTOR, while exploring other pathways are needed.
... It belongs to Brassicaceae family. It has been utilized as an adaptogen to treat infertility, anemia, rheumatism, respiratory disorders and female hormone balance for centuries [18,19]. There has been an increase in attention to maca-based products since the 1990s [20] due to its health benefits. ...
Article
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Adaptogens are non-toxic plant-based substances which help balance, restore, protect the body from the harmful stress effects. They are used to calm, energize, counteract stress and improve mood, mental clarity, keep fit or decrease disorders based on aging such as lack of attention. They can also show antioxidant, immunomodulator, hypoglycemic, nootropic, neuroprotective, antifatigue anxiolytic properties. Interest in adaptogens on the rise in foods and beverages because they are safe, economical and efficacious. It is anticipated that this increase will continue as consumers will seek food products improving mood and boosting brain health in the future. Adaptogens have the potential to serve for these purposes. Hence, this mini review addresses three of the most common adaptogens, namely Ashwaganda (Withania somnifera), Rhodiola rosea and Maca (Lepidium meyenii), which can be used in functional products improving the quality of life as proactive wellness and healthcare actions.
... Maca v testech na zvířatech i v klinických testech na dobrovolnících vykázala dílčí pozitivní účinky, ale pro stanovení účinnosti, bezpečnosti a zejména objasnění mechanismu účinku musí být provedeno více přísnějších, pečlivě definovaných studií, ideálně randomizovaných, dvojitě zaslepených a kontrolovaných placebem (34,35 ...
... Polysaccharides extracted from the Maca demonstrated high antioxidant activity and have bioactive efficacy against the ROS injury (Zha et al. 2014). Maca tubers can be found in more than 10 colours from white to black, and are used in traditional therapy as dried and powdered for natural remedies in various diseases (Lee et al. 2011, Gonzales 2012. Many groups of bioactive components, including macaenes/macamides, glucosinolates, alkaloids, and thiohydantoins identified from the edible parts of Maca (Huang et al. 2018). ...
Article
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Maca root extract on insulin, insulin receptor substrate-1 (IRS1), leptin, and NAD-dependent deacetylase sirtuin-1 (SIRT1), as well as body weight changes evaluated in this study for a 60 days model of normal and high-fat diet (HFD) fed rats. 28 male rats allocated to four groups: (i) Control, (ii) Maca (40 mg/kg/day), (iii) HFD, and (iv) HFD + Maca. After the 60 days of study, fat tissue and liver insulin levels decreased in the HFD and HFD + Maca groups in comparison to Control and Maca groups (p < .001). Maca group showed a significant IRS1 increase in the fat tissue (p < .0001). Leptin levels were the highest in the Maca group and the lowest in the HFD group in the fat tissue (p < .01). SIRT1 levels were found the highest in the Maca groups (p < .01). These results show the protective and regulatory effectiveness of Maca when fed with a normal or HFD diet.
... Its anti-postmenopausal osteoporosis effect is related to the presence of phytosterols and other secondary metabolites (Fahey et al., 2001). Maca is used locally for the enhancement of fertility and sexual behavior in men and women, and has been generally acknowledged as a traditional remedy for menopausal symptoms (Shin et al., 2010;Lee et al., 2011). More recently, its nutritional properties and effects on sexual performance and semen quality in rats and humans have been extensively reported (Poveda et al., 2013;Uchiyama et al., 2014;Melnikovova et al., 2015). ...
Article
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Macamides and Macaenes are the bioactive marker compounds in maca (Lepidium meyenii Walp., Brassicaceae) tuber. To simultaneously quantify these two types of compound, HPLC method was studied. To distinguish and group the growing regions of different maca samples, Hierarchical cluster analysis, a chemometric method, was applied to analyze the HPLC data. The calibration curves obtained using the HPLC method showed satisfactory linearity with determination coefficients >0.9998. The precision and repeatability relative standard deviation values were
... To date, some reviews have been published addressing the chemical composition, ethnobotanical and ethnopharmacological uses, and nutritional value of mainly Lepidium meyenii extracts ( Canales et al., 2000;Gonzales, 2012;Henauer, 2014;Kasprzak, Jodlowska-Jedrych, Borowska, & Wojtowicz, 2018;Lee, Lee, You, & Ha, 2016;Lee, Shin, Yang, Lim, & Ernst, 2011;Wang & Zhu, 2019b). To the best of our knowledge, this is the first review focusing on the structural diversity, biosynthetic aspects, and LC-MS data compilation of Lepidium meyenii compounds for the identification of bioactive compounds. ...
... 1,12 Maca (Lepidium meyenii Walp.) is a cruciferous plant that has been used as a functional food for centuries because of its high nutritional value and health benets. [13][14][15] Maca and its extracts exert various physiological activities such as anti-oxidative, 16 anti-fatigue, 17 and anti-osteoporotic effects, 18 promote spermatogenesis, 19 treat menopausal symptoms, 20 and especially improve depression symptoms, 21-23 improve cognitive function, 24 and prevent memory impairment. [25][26][27] Maca lipophilic extract containing macamides has shown neuroprotective effects against middle cerebral artery occlusion in vivo and H 2 O 2 injury in vitro. ...
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Maca has attracted considerable attention owing to its neuroprotective effects in vitro and vivo. Macamides, a series of nonpolar and long-chain fatty acid N-benzylamides, are considered unique constituents in maca. This study investigated the protective effects of ethanol extracts of maca (EEM) and macamides on corticosterone-induced (CORT) neurotoxicity in rat pheochromocytoma (PC12) cells. CORT reduced cell viability and increased LDH release, intracellular ROS levels, and MMP decline rate, and induced mitochondrial apoptosis. However, pretreatment with EEM and macamides ameliorated CORT-induced neurotoxicity. EEM increased the cell viability and reduced the LDH release. M 18:1, M 18:2, and M 18:3 increased cell viability and reduced LDH release and intracellular ROS generation. M 18:2 and M 18:3 inhibited MMP reduction and reduced the Bax/Bcl-2 ratios. M 18:1 reduced the intracellular ROS without affecting other factors. Moreover, M 18:3 prevented CORT-induced mitochondrial apoptosis, restrained the expression levels of pro-apoptotic proteins, namely, Bax, cytochrome C, cleaved-caspase-3, and cleaved-PARP, and increased the expression levels of Bcl-2. In addition, M 18:3 increased Akt phosphorylation and the ability of M 18:3 to protect against CORT-induced cytotoxicity was remarkably reduced by LY294002, a PI3K phosphorylation inhibitor. M 18:3 also elevated the phosphorylation of CREB and activated the BDNF protein levels in CORT-induced PC12 cells. In conclusion, macamides, especially M 18:3, exert protective effects on CORT-induced PC12 cells. The cellular mechanism of M 18:3 against CORT-induced cytotoxicity may involve inhibition of mitochondrial apoptosis, and activation of Akt and CREB phosphorylation. Overall, macamides may potentially treat neuronal damage induced by CORT.
... Studies on animal models have demonstrated an increased sexual behaviour in rats treated with Maca extracts (13,14). The efficacy and safety of Maca on humans is however still debated (15,16)1R,3S)-1-methyl-1,2,3,4-tetrahydro-?-carboline-3-carboxylic acid (MTCA) has been demonstrated to be present in the extracts of Maca. This compound is an inhibitor of the monoamine oxidase (MAO) enzyme, and a co-mutagenic or a precursor to mutagenic compounds (17)). ...
Chapter
Substance misuse has a strict relationship with sexual dysfunctions. Psychoactive substances differently affect sexual performances in both sexes, and specific drugs and natural products are often chosen by males and females to enhance their experience and feelings before/during sexual encounters. Moreover, long-term drug users may suffer low libido, erectile dysfunction, and other sexual debilities due to the chronic effects of psychoactives on their body. A further theme of interest for mental health service workers is the intentional practice of sex under the influence of psychoactive substances, known as “chemsex,” and acted mainly among homosexual males. All these issues will be discussed in this chapter.
... So researchers have similarly given priority to these issues. However, studies on antioxidant status of human are limited [54]. Stress and inflammation affect human health score in the worst way, and interleukin-6 as a marker of inflammation increases in serum. ...
Chapter
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Maca plant belongs to Brassicaceae such as broccoli, cabbage and radish, and has a tuber-ous root. With the declaration of The Food and Agriculture Organization (FAO) that maca is a forgotten and disappearing plant, the fresh, dried, powder and organic forms of it take part in nutrition as a food supplement worldwide. Studies have focused on antioxidant effects depending on its bioactive components such as phenols, glucosino-lates, alkamides and polysaccharides. Antioxidant enzymes and their ability of inhibition the free radicals in blood and tissues were measured to determine the antioxidant effects. The research results have suggested that these compounds present the antioxidant effect by increasing enzyme activity and scavenging free radicals. Yet further experiments are needed to understand this relation between antioxidant activity and maca's antioxidants. The objective of this chapter is to carry out the possible antioxidant activity of maca in human and animal nutrition related to its active compounds such as: phenols, glucosino-lates, alkamides and polysaccharides.
... There is no evidence for an androgen-mediated action of maca, and its site of action (central or peripheral) has not yet been identified [69]. Maca preparations have been clinically evaluated for improving the quality of semen [70] and for the treatment of menopausal symptoms [71]. ...
Article
Purpose: Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships. Objective: Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED. Materials and methods: We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool. Results: In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I2 = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies. Conclusions: Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the use of herbal products in ED can be recommended.
... Analysis of randomized clinical trials (RCT) that tested the effects of maca on menopausal symptoms in healthy perimenopausal ( Meissner et al., 2006d), early postmenopausal ( Meissner et al., 2005Meissner et al., , 2006b,c), and late postmenopausal women showed favorable effects. However, a systematic review considers that data are still limited to obtain convincing conclusions ( Lee et al., 2011). Then, although maca is recognized in the scientific literature to reduce vasomotor symptoms (Depypere and Comhaire, 2014), further evidences are still needed. ...
Chapter
The hypocotyls of Maca (Lepidium meyenii), a Peruvian cruciferous vegetable growing more than 4000 m and cultivated for more than 2000 years, have high nutritional value with 14% protein, 60% carbohydrates, 2.2% lipids, and its extracts exert a variety of therapeutic effects, such as an increase in sperm count and motility, improve embryo quality, reverse testosterone-induced prostate hyperplasia, and ovariectomy-induced osteoporosis. Maca improves learning and memory, delays fatigue and increases interferon gamma in different animal models and reduces glycemia through an improvement in insulin resistance and an increase in glucose consumption at different concentrations in streptozotocin-induced diabetes in HepG2 cells. In humans, maca increases health-related quality of life score, associated with a reduction in serum interleukin 6 levels. There are to date three known varieties of maca distinguishable by external color with different properties attributed to each variety. Lepidium meyenii is a prodigious crop and its potential as a nutraceutical is discussed in this chapter.
... Se han identificado dos RS 242,245 que analizan la eficacia de otros tratamientos de fitoterapia para mejorar la sintomatología asociada a la menopausia: Hypericum perforatum (entre otros tratamientos) 242 , y Lepidium meyenii 245 . Ninguna de las dos realizó metanálisis de los resultados. ...
... Lepidium meyenii (Maca) is a Peruvian plant in the family Brassicaceae (Toledo et al., 1998). It has been used as a folk medicine for centuries and it is currently used to treat a host of pathological conditions including menopausal symptoms (Lee et al., 2011), sexual and menstrual disorders Shin et al., 2010), memory loss (Liu et al., 2011;Rubio et al., 2007), cancer (Gonzales et al., 2005) and depression . Since it has these reported health benefits, Maca is used as a food supplement (Gonzales, 2007). ...
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Macamides are a distinct class of secondary metabolites, benzylamides of long chain fatty acids, which were isolated from the Peruvian plant Lepidium meyenii (Maca). As structural analogues of the endocannabinoid anandamide (AEA), they have demonstrated neuroprotective effects in vitro and in vivo. The purpose of this study was to demonstrate the neuroprotective activity of the macamides: N-(3-methoxybenzyl)oleamide (MAC 18:1), N-(3-methoxybenzyl)linoleamide (MAC 18:2) and N-(3-methoxybenzyl)linolenamide (MAC 18:3) in a neurotoxic environment caused by exposure of U-87 MG glioblastoma cells to manganese chloride (MnCl2). The neuroprotective effects of these macamides were reversed by the CB1 antagonist AM251. The mechanism by which manganese (Mn) induces cell damage was investigated by studying its effects on mitochondria. Reactive oxygen species (ROS) increase intracellular calcium and enhance the opening of mitochondrial permeability transition pores (MPTP), which leads to decreased mitochondrial membrane potential (MMP), to disruption of mitochondria and to neuron death in neurodegenerative disorders. In this study, MnCl2 at 50μM was responsible for mitochondrial disruption, which was attenuated by all three of the macamides tested. Human peroxisome proliferator-activated receptor gamma (PPARγ) has been proposed to be a cannabinoid target, and PPARγ has also been demonstrated to mediate some of the longer-term vascular effects of the plant cannabinoid, ∆9-tetrahydrocannabinol. PPARγ activation was observed in response to exposures of cells to MAC 18:2 and MAC 18:3. These findings suggest that macamides achieve their neuroprotective effects by binding to CB1 receptors to protect against Mn-induced toxicity in U-87 MG glioblastoma cells. Additionally these macamides, in a manner similar to the analogous endocannabinoid AEA, interact with other targets such as PPARγ to regulate metabolism and energy homeostasis, cell differentiation and inflammation.
... A systematic review of clinical trials concluded that evidence of the effectiveness of maca for the relief of menopausal symptoms was limited. However, because of the sample size, the number of trials and the quality of the trials, it is not pertinent to establish definite conclusions about the efficacy and safety [61]. ...
Chapter
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Menopause transition is recognized as a vulnerable period in women life to develop or aggravate symptoms of psychiatric disorders. Several treatments including antidepressants and hormonal restitution with estrogens have been suggested to ameliorate the symptoms. Also, in this period of life is frequent the use of other drugs to treat is also frequent the use of other drugs to treat comorbid pathologies that might even increase the risk of drug-drug interactions. Literature reports that some phytochemicals with estrogenic activity have beneficial effects during menopausal transition without collateral events. This chapter shows evidence about the use of phytoestrogens as an alternative therapy for the treatment of some psychiatric symptoms associated with the menopausal transition. Data derived from preclinical research related to the use of classical phytoestrogens (isoflavones), considering the beneficial effects, as well as adverse events, are discussed. Also, the use of polyphenols and organosulfurate compounds as an alternative for the treatment of anxiety-and depres-sive-like behavior as well as fibromyalgia is included. A narrative review was conducted using bibliography reporting the use of isoflavones (genistein, daidzein, equol), coumes-tans or lignans for the reduction of depressive-like or anxiety-like behavior. Furthermore, it is described if the use of this compounds impact in other signs of menopause, i.e. vasomotor and osteoporosis. In addition, due to the high frequency of comorbid pathologies as diabetes mellitus, dyslipidemia or metabolic syndrome with psychiatric disorders, the use of these phytochemicals is discussed.
... Scientific evidence of the medicinal properties of maca is still lacking. A few clinical trials were analyzed in only one review, in which maca is promoted as a dietary supplement for several womens health issues including menopause symptoms (Lee et al., 2011 ). However , the clinical evidence and significance of these studies seems to be questionable. ...
Article
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Malnutrition, poor health, hunger, and even starvation are still the world's greatest challenges. Malnutrition is defined as deficiency of nutrition due to not ingesting the proper amounts of nutrients by simply not eating enough food and/or by consuming nutrient-poor food in respect to the daily nutritional requirements. Moreover, malnutrition and disease are closely associated and incidences of such diet-related diseases increase particularly in low- and middle-income states. While foods of animal origin are often unaffordable to low-income families, various neglected crops can offer an alternative source of micronutrients, vitamins, as well as health-promoting secondary plant metabolites. Therefore, agricultural and horticultural research should develop strategies not only to produce more food, but also to improve access to more nutritious food. In this context, one promising approach is to promote biodiversity in the dietary pattern of low-income people by getting access to nutritional as well as affordable food and providing recommendations for food selection and preparation. Worldwide, a multitude of various plant species are assigned to be consumed as grains, vegetables, and fruits, but only a limited number of these species are used as commercial cash crops. Consequently, numerous neglected and underutilized species offer the potential to diversify not only the human diet, but also increase food production levels, and, thus, enable more sustainable and resilient agro- and horti-food systems. To exploit the potential of neglected plant (NP) species, coordinated approaches on the local, regional, and international level have to be integrated that consequently demand the involvement of numerous multi-stakeholders. Thus, the objective of the present review is to evaluate whether NP species are important as “Future Food” for improving the nutritional status of humans as well as increasing resilience of agro- and horti-food systems.
... However, there are other HM studies that failed to demonstrate a significant improvement in hot flushes symptoms [30,31]. There are other HMs used in many countries that have potential effectiveness in decreasing hot flushes or menopausal symptoms, such as hop (Humulus lupulus) [32], linseed or flaxseed [33], maritime pine bark extract [34], maca (Lepidium meyenii) [35], and Hypericum perforatum L. (St. John's Wort) [36]. ...
Article
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Objective. This systematic review was conducted to evaluate the clinical effectiveness and safety of herbal medicine (HM) as an alternative management for hot flushes induced by endocrine therapy in breast cancer patients. Methods. Key English and Chinese language databases were searched from inception to July 2015. Randomized Controlled Trials (RCTs) evaluating the effects of HM on hot flushes induced by endocrine therapy in women with breast cancer were retrieved. We conducted data collection and analysis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Statistical analysis was performed with the software (Review Manager 5.3). Results. 19 articles were selected from the articles retrieved, and 5 articles met the inclusion criteria for analysis. Some included individual studies showed that HM can relieve hot flushes as well as other menopausal symptoms induced by endocrine therapy among women with breast cancer and improve the quality of life. There are minor side effects related to HM which are well tolerated. Conclusion. Given the small number of included studies and relatively poor methodological quality, there is insufficient evidence to draw positive conclusions regarding the objective benefit of HM. Additional high quality studies are needed with more rigorous methodological approach to answer this question.
... This is in line with observation made by Yabar et al. (40), who linked reduction in Glucosinolates level during the process of drying to myrosinase activity in the cells of fresh Maca hypocotyls affected by the process of drying. Reduction in Total Glucosinolates after drying fresh hypocotyls as reported in this paper is consistent with observations by Jing Li et al. (41), who reported some 57% decrease in Glucosinolate content after raw Maca was dried for 24 hr. ...
Article
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Peruvian Maca crops (Lepidium peruvianum), grown in two geographically-distant cultivation sites located at similar altitudes in the highlands of the Peruvian Andes (Junin at 4,200 m a.s.l. and Ancash 4,150 m a.s.l.), were used in the study. Four prime Maca phenotypes, distinguished by hypocotyl colours labelled as "Yellow", "Purple", "Red" and "Black" were selected to determine distribution in levels and corresponding ratios between individual Glucosinolates (Glucotropaeolin and m-methylglucotropaeolin) in an attempt to identify four Peruvian Maca phenotypes from analyses of powdered hypocotyls. There were highly significant differences (P<0.01) in hypocotyl weight/size of four Maca phenotypes harvested in two locations. The Junin crop represented a mostly "large" class (13.3 g) with "small" size hypocotyls (7.2 g), while a "small" class was predominant in Ancash (3.5 g). Powdered Yellow Maca showed significantly higher (P<0.001) microbial contamination than the other three, with Black Maca being the least infected. Only minor, statistically-confirmed differences were detected in nutritive characteristics between the four Maca phenotypes grown in Junin, however highly significant differences (P<0.01) in Glucosinolates existed between the Red and Black Maca grown in Junin and Ancash. Irrespective of the cultivation location, Red phenotypes showed the highest content of Total Glucosinolates, followed by Black and Purple, with the Yellow phenotype showing consistently lower levels. Highly significant P<0.01) differences determined in ratios of individual Glucosinolates between four Maca phenotypes grown in two locations, confirms an earlier assumption that sums of individual Glucosinolates, their ratios and profiles, may be feasible to explore in analytically identifying individual Maca phenotypes in pulverised marketed Maca products.
... All showed improvements in Greene Climacteric Scale or Kupperman Index scores, but all were poor quality with poor trial design, very small sample sizes, or limited reporting of study data. 88 Thus, these studies are not strong enough to support the use of maca for VMS. Level II evidence Omega-3 fatty acids. ...
Article
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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.
Article
BACKGROUND The Lepidium meyenii plant also known as Peruvian Maca, originates from high altitudes in the Andes, it has a high nutritional content and is extensively used as an herbal supplement for conditions such as sexual dysfunction, semen quality and menopausal symptoms. OBJECTIVE This systematic review was conducted to assess the effects of Maca on variety of conditions and not limited to sexual dysfunction, semen quality and menopausal symptoms. METHODS An extensive systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2015. Three databases (PubMed, Science Direct and Google Scholar) in addition to patents were searched up to March 2021. The key criteria for inclusion were; (1) in vivo study (2) randomized controlled clinical trial; (3) subjects were given Maca regardless of the type, preparation and/or administration route; and (4) measurable clinical data on a physiological and/or psychological aspect were reported. Studies were categorised into human and animal model studies and were further grouped by the type and preparation of Maca, dose, duration and condition assessed. The studies were also assessed for risk of bias according to the Cochrane Collaborations tool. Studies were compared to ascertain whether a meta-analysis was feasible. RESULTS A total of 57 studies, 14 clinical and 43 pre-clinical trials met the pre-defined criteria; although patent applications were searched none met the criteria. Nine different extraction methods of Maca were used with various coloured roots namely black, yellow and red roots or a mixture of all three. Different colour variations showed different effects thought to be due to the presence and/or concentration of secondary metabolites. Maca was reported to have an effect on conditions such as memory impairment, depression, bone structure, UV irradiations amongst others. Placebo and dose-dependent effects were observed in some studies. The overall quality of risk of bias was unclear due to insufficient information being published in addition to a high risk of reporting bias. Doses and durations varied, and an insufficient number of studies had further analysed whether these factors had an effect on the outcome made a meta-analysis unfeasible. Therefore, recommendations for future studies were discussed. CONCLUSION Evidence to date suggests that Maca root could be an effective treatment for a range of conditions with 55 out of 57 studies reporting an effect. Clinical trials with rigorous reporting and methods are warranted.
Article
Objectif: Proposer des stratégies pour améliorer les soins aux femmes ménopausées ou en périménopause d'après les plus récentes données probantes publiées. Population cible: Femmes ménopausées ou en périménopause. BéNéFICES, RISQUES ET COûTS: La population cible bénéficiera des plus récentes données scientifiques publiées que leur communiqueront les fournisseurs de soins de santé. Aucun coût ni préjudice ne sont associés à cette information, car les femmes seront libres de choisir parmi les différentes options thérapeutiques offertes pour la prise en charge des symptômes et morbidités associés à la ménopause, y compris l'abstention thérapeutique. DONNéES PROBANTES: Les auteurs ont interrogé les bases de données PubMed, Medline et Cochrane Library pour extraire des articles publiés entre 2002 et 2020 en utilisant des termes MeSH spécifiques à chacun des sujets abordés dans les 7 chapitres. MéTHODES DE VALIDATION: Les auteurs ont évalué la qualité des données probantes et la force des recommandations en utilisant le cadre méthodologique d'évaluation, de développement et d'évaluation (GRADE). Voir l'annexe A en ligne (tableau A1 pour les définitions et tableau A2 pour l'interprétation des recommandations fortes et faibles). PROFESSIONNELS CONCERNéS: médecins, y compris gynécologues, obstétriciens, médecins de famille, internistes, urgentologues; infirmières, y compris infirmières autorisées et infirmières praticiennes; pharmaciens; stagiaires, y compris étudiants en médecine, résidents, moniteurs cliniques; et autres fournisseurs de soins auprès de la population cible. DÉCLARATIONS SOMMAIRES: RECOMMANDATIONS.
Chapter
Maca (Lepidium myenii) root has been used by people of the Andes for more than 2000 years for nutrition, cognition, and fertility. Of the three main colors it comes in, red maca is the rarest and provides the most antioxidants. Black maca has been shown to significantly increase sperm count and sperm mobility in men and to reduce stress and fatigue, increase memory and learning ability, and work as a natural antidepressant, while yellow maca has shown a moderate effect on sperm count and sex drive. Maca root may be beneficial for menopause, menopausal sexual dysfunction, erectile dysfunction, male infertility, and general wellness at high altitudes. This chapter examines some of the scientific research conducted on maca, both alone and in combination formulas, for treating numerous health conditions. It summarizes results from several human studies of maca’s use in treating genitourinary disorders and disorders of vitality. Finally, the chapter presents a list of maca’s active constituents, different Commonly Used Preparations and Dosage, and a section on “Safety and Precaution” that examines side effects, toxicity, and disease and drug interactions.
Article
Lepidium meyenii (Maca) contains several active components, including alkaloids, glucosinolates, isothiocyanates, polysaccharides, polyphenols, and sterols, which make it have the traditional therapeutic uses. In this paper, we summarized the analytical progress of the active components associated with alkaloids, polysaccharides, glucosinolates, sterols, free fatty acids, flavonoids, and natural phenols in Maca by mass spectrometry (MS). Due to the effect of color and type on active components in Maca, we summarized the study of quality evaluation about Maca according to the type and the content of active components such as glucosinolates, essential oils, macamides, and macaenes by MS. Additionally, the research on the change of active components in Maca at different growth stages by MS will be beneficial to full utilization of active components in Maca and other natural resources. We reviewed the study in the visible distribution of amino acids, amide alkaloids, imidazolium alkaloids, and saccharides in Maca by imaging mass spectrometry (IMS). We also reviewed the pharmacology value associated with improvement of reproductive function, anti‐stress response, anti‐osteoporosis, antitumor activity, clinical research and toxicity of Maca, and so forth. Nevertheless, due to individual differences and limitations of the subjects, further high‐quality studies are needed to confirm the clinical efficacy of the plant.
Chapter
Sexual and reproductive health are important and valued aspects of a woman’s health and well-being and can be profoundly impacted by breast cancer diagnosis and treatments. For breast cancer survivors, sexual and reproductive health changes are associated with significant emotional distress and often negatively impact women’s emotional well-being, relationships, sense of self, and overall quality of life. In order to guide psychoeducation and normalization of sexual health problems, this chapter provides information regarding female sexual response and the impacts of breast cancer treatments on sexual function. Additionally, with the purpose of guiding proper evaluation, assessment, and treatment of sexual problems, latter sections include approaches for assessment and evaluation of sexual problems and strategies for managing sexual problems. Lastly, as many breast cancer treatments can adversely affect fertility, essential information regarding these effects and common methods for managing fertility concerns are provided.
Chapter
Hot flashes are common in breast cancer survivors because they can occur as a result of natural aging, surgery, or medications used in the treatment of cancer. Unfortunately, some survivors will have to cope with bothersome hot flashes for years even after completing cancer-directed therapies, and these symptoms can detrimentally impact life quality in multiple domains. Many drug and non-drug interventions have been studied in recent decades, and some are quite effective at reducing the frequency and severity of hot flashes. This chapter provides a succinct overview of supportive care strategies for dealing with hot flashes, the data behind each approach, and important information about toxicities that may occur as a result of therapies.
Article
Objective: To evaluate the safety and tolerability of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids (Warmi®, Lima Perú;) in otherwise healthy adult women. Methods: This was a phase-I, randomized parallel three arms, double-blinded, and a placebo-controlled clinical trial. A total of 55 participants aged 18-40 were randomly assigned to one of three groups to receive for three months: (1) an oral herbal supplement of 1650 mg/day; (2) an oral herbal supplement of 3300 mg/day; or (3) an oral placebo 3300 mg/day. The primary endpoints were oral safety and tolerability of the supplement. The secondary endpoint was its effect on vital functions, anthropometrics, and laboratory tests. We used an exploratory approach by covariance analysis (ANCOVA) adjusted for the variables' baseline value for the secondary outcomes. Results: All women completed three months of follow-up, reporting no side effects. Our exploratory analysis revealed that treatment with the herbal supplement of 1650 mg/day was associated with increased glucose and uric acid levels. In comparison, the herbal supplement 3300 mg/day was associated with reduced breathing rate, increased basal temperature, and systolic blood pressure, both compared to the placebo group. However, despite significant differences, none of these was clinically significant. Conclusion: The oral herbal supplement had a favorable safety and tolerability profile in studied women. There is a need to study its potential as an option to treat menopausal symptoms.
Article
Objective Provide strategies for improving the care of perimenopausal and postmenopausal women based on the most recent published evidence. Target Population Perimenopausal and postmenopausal women. Benefits, Harms, and Costs Target population will benefit from the most recent published scientific evidence provided via the information from their health care provider. No harms or costs are involved with this information since women will have the opportunity to choose among the different therapeutic options for the management of the symptoms and morbidities associated with menopause, including the option to choose no treatment. Evidence Databases consulted were PubMed, MEDLINE, and the Cochrane Library for the years 2002–2020, and MeSH search terms were specific for each topic developed through the 7 chapters. Validation Methods The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations). Intended Audience physicians, including gynaecologists, obstetricians, family physicians, internists, emergency medicine specialists; nurses, including registered nurses and nurse practitioners; pharmacists; medical trainees, including medical students, residents, fellows; and other providers of health care for the target population.
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Objective: To evaluate the effect of a herbal preparation containing glucosinolates, phytosterols and citrus flavonoids (supplement) on body weight and metabolic parameters usually impaired by menopause. Methods: A pre-clinical experimental study carried out in twenty-five Swiss strain mice (Mus musculus) randomly distributed (1:1:1:1:1 ratio) to five groups to receive for ten weeks: (1) oral gelatinized maca extract 0.5625 mg/kg/day + bilateral ovariectomy (Maca + OVX); (2) oral supplement 0.5625 mg/kg/day + bilateral ovariectomy (S1 + OVX); (3) oral supplement 1.6875 mg/kg/day + bilateral ovariectomy (S2 + OVX); (4) oral saline 100 µl/kg/day + bilateral ovariectomy (OVX); and (5) oral saline 100 µl/kg/day + sham surgery (sham). The primary endpoint was change in body weight gain from baseline to final. Secondary endpoints were uterine weight and cholesterol, triglyceride, glucose, and glucose/triglycerides index values at the end of the study. A modified intention-to-treat analysis was performed through linear regression models and using the Bonferroni method to penalized p-values by multiple comparisons. Results: Twenty-three animals completed the study. There was a significant average difference in weight gain, with a greater reduction in the S2 + OVX group compared to the OVX group (difference= -3.5; 95% CI (-5.27; -1.74); p < .001). S2 + OVX group also displayed a significant average reduction of total blood cholesterol (difference: -16.94; 95% CI (-33.73; -0.15); p = .037). No significant effects of the supplement were found on other secondary endpoints. Conclusion: In this murine menopausal model, triple oral supplement dose resulted in an average reduction of weight gain and total cholesterol levels, suggesting that the compound could have a potential effect at regulating menopausal altered metabolism.
Article
Maca (Lepidium meyenii) is a herbaceous plant grown at over 4,000 m in Peru. It has been studied worldwide for its properties on fertility. Previous studies have assessed maca effects on semen quality, but there is need of randomised, double‐blind trials in order to make clinical decisions. The objective of this study was to assess the effect of maca on seminal parameters in infertile adult men. This is a double‐blind, randomised, placebo‐controlled pilot trial in which sixty‐nine patients diagnosed with mild asthenozoospermia and/or mild oligozoospermia were supplied by maca (n = 35) or placebo (n = 34) (2 g/day) for a period of 12 weeks. When compared patients treated with maca and patients treated with placebo, there were no significant differences in semen volume (2.95 ± 0.52 vs. 2.90 ± 0.52; p = .392), sperm motility (22.34 ± 2.22 vs. 23.05 ± 2.22; p = .462) and normal sperm morphology (7.89 ± 1.89 vs. 7.04 ± 2.28; p = .801), but there was a significant difference in sperm concentration (15.04 ± 5.61 vs. 10.16 ± 3.59, respectively; p = .011). In conclusion, patients treated with 2 g of maca for a period of 12 weeks showed a significant improvement in seminal concentration compared with patients treated with placebo. There were no significant differences in semen volume, sperm mobility and morphology when compared both groups.
Article
Scope Maca (Lepidium meyenii), a well‐known plant from the Andean highlands of Peru, has been used widely as a nutritional supplement to increase sexual function and fecundity. However, the identity of its active ingredients and how they function remain unknown. Methods and results Chemical substances in maca were identified by UPLC‐Q‐TOF, and the active ingredients were screened through HotMap coupled with an artificial neural network (ANN). Lepidiline A (LA), an imidazole alkaloid, was identified as the key active compound. LA affected the balance of endogenous sex hormones in mice and improved fecundity in Drosophila. Using a molecular LA probe, HSD17B1 was revealed to be the potential target of LA using a fishing‐rod strategy. We demonstrated with experimental data that LA targets HSD17B1 to enhance the enzyme's activity and increase its bioconversion efficiency of actively formed sex hormones including estrogen to 17β‐estradiol and 4‐androsten‐3,7‐dione to testosterone which ultimately improved reproductive activity. Conclusion LA improved the balance of endogenous sex hormones and increased fecundity by targeting HSD17B1. This underlying mechanism of action provides a useful insight into the application of maca in the regulation of dietary nutrition and healthy fertility. This article is protected by copyright. All rights reserved
Article
Objectives: To systematically review Clinical Practice Guidelines (CPGs) for the management of menopause-related vasomotor symptoms (VMS) to 1) identify those that include Natural Health Products (NHPs); 2) identify which NHPs were included and the evidence supporting the recommendation for the place in therapy; and 3) compare methodological quality of the CPGs. Methods: PubMed, EMBASE, Web of Science, BMJ Best Practice, DynaMed Plus and websites of gynecological and menopausal societies were searched (Jan 2000-Nov 2018). Records were screened to identify CPGs that were published in English, since 2000 and were for use in North America. CPGs were reviewed for inclusion of NHPs. Data regarding NHPs (evidence, recommendation) were extracted and analyzed. CPGs were critically appraised using the AGREE II tool. Results: Five of six CPGs that met general inclusion criteria included NHPs. Black cohosh, isoflavones, soy food/extracts and phytoestrogens were included in all five CPGs. Comparative analysis of recommendations and level of supporting evidence revealed differences. All CPGs included recommendations regarding the use of NHPs in general, although recommendations differed. Four of five CPGs made recommendations for unique NHPs, however, recommendations differed. Using the AGREE II tool, CPGs scored well on domains for purpose and clarity. Lack of detailed description of methodology and author expertise affected scores in other domains. Conclusion: Five CPGs included general recommendations for the role of NHPs in treating VMS, with recommendations ranging from use with caution to not recommended. There were inconsistencies among CPGs regarding NHPs included and what evidence was used in making recommendations.
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In this study, we examined the phytochemical properties and antioxidant activities of the methanol extracts of maca (Lepidium meyenii Walp.) leaves and roots. A total of 25 chemical compounds were identified by LC-Q-TOF and classified as saponins, phenols, flavonoids, steroids, alkybenzenes, and amines. Among all the chemical compounds identified, three saponins (tanshinone I, panaxytriol, and rotundifolioside), one phenol (gingerol), and one steroid (ergosterol peroxide) were found in the both leaf and root extracts. Levels of saponins, phenols, and flavonoids in the methanol extract from maca leaves were significantly higher than in the extract of roots. Antioxidant activities (1,1-diphenyl-2-picrylhydrazyl radical scavenging activity and ferric reducing ability of plasma) of the methanol extracts of maca leaves were higher than those of the roots. Antioxidant activities were highly correlated with total phenol content in the methanol extracts of maca leaves. Therefore, the methanol extract from maca leaves exhibited higher antioxidant activities than those of roots, and could be used as a nutritional material with potential health benefits.
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Menopause is associated with problematic symptoms, including hot flashes, sleep problems, mood disorders, sexual dysfunction, weight gain, and declines in cognitive functioning. Many women seek complementary and alternative medicine (CAM) for symptom management. This article critically reviews the existing literature on CAM treatments most commonly used for menopausal symptoms. Electronic searches were conducted to identify relevant, English-language literature published through March 2017. Results indicate that mind and body practices may be of benefit in reducing stress and bothersomeness of some menopausal symptoms. In particular, hypnosis is a mind-body intervention that has consistently shown to have a clinically significant effect on reducing hot flashes. Evidence is mixed in regard to the efficacy of natural products and there are some safety concerns. Health care providers should consider the evidence on CAM in providing an integrative health approach to menopausal symptom management.
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Botanical dietary supplements are increasingly popular for women's health, particularly for older women. The specific botanicals women take vary as a function of age. Younger women will use botanicals for urinary tract infections, especially Vaccinium macrocarpon (cranberry), where there is evidence for efficacy. Botanical dietary supplements for premenstrual syndrome (PMS) are less commonly used, and rigorous clinical trials have not been done. Some examples include Vitex agnus-castus (chasteberry), Angelica sinensis (dong quai), Viburnum opulus/prunifolium (cramp bark and black haw), and Zingiber officinale (ginger). Pregnant women have also used ginger for relief from nausea. Natural galactagogues for lactating women include Trigonella foenum-graecum (fenugreek) and Silybum marianum (milk thistle); however, rigorous safety and efficacy studies are lacking. Older women suffering menopausal symptoms are increasingly likely to use botanicals, especially since the Women's Health Initiative showed an increased risk for breast cancer associated with traditional hormone therapy. Serotonergic mechanisms similar to antidepressants have been proposed for Actaea/Cimicifuga racemosa (black cohosh) and Valeriana officinalis (valerian). Plant extracts with estrogenic activities for menopausal symptom relief include Glycine max (soy), Trifolium pratense (red clover), Pueraria lobata (kudzu), Humulus lupulus (hops), Glycyrrhiza species (licorice), Rheum rhaponticum (rhubarb), Vitex agnus-castus (chasteberry), Linum usitatissimum (flaxseed), Epimedium species (herba Epimedii, horny goat weed), and Medicago sativa (alfalfa). Some of the estrogenic botanicals have also been shown to have protective effects against osteoporosis. Several of these botanicals could have additional breast cancer preventive effects linked to hormonal, chemical, inflammatory, and/or epigenetic pathways. Finally, although botanicals are perceived as natural safe remedies, it is important for women and their healthcare providers to realize that they have not been rigorously tested for potential toxic effects and/or drug/botanical interactions. Understanding the mechanism of action of these supplements used for women's health will ultimately lead to standardized botanical products with higher efficacy, safety, and chemopreventive properties.
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A polysaccharide (MP21) was extracted and purified from Lepidium meyenii Walp. using DEAE-52 and Sephacryl™ S-500 columns. Its physicochemical properties and macrophage immunomodulatory activity were investigated in vitro. The results indicated that MP21 had an average molecular weight of 3.68 × 105 Da and was mainly composed of rhamnose, arabinose and galactose in a molar ratio of 1: 4.84: 5.34. The conformation of MP21 was between a sphere and random coil, and different treatments could change its conformation and asymmetry. RAW264.7 murine macrophages treated with MP21 could significantly inhibit the proliferation of human hepatocellular carcinoma HepG-2. MP21 could enhance the phagocytic capacity and induce elevated NO, ROS, TNF-α, and IL-1β secretion in RAW264.7 in a dose-dependent manner. MP21 promoted the expression of both iNOS protein and mRNA. The expression of the NF-κB p65 protein was also up-regulated by MP21. These results suggest that MP21 could exert cytotoxicity towards HepG-2 by activating macrophages via the NF-κB signaling pathway.
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Maca dried plates were used as raw material. Based on the effects of different extraction methods, dry methods and drying auxiliary drying agents on the product yield and nutrition composition, ultrasonic extraction and malt dextrin as spray drying auxiliary drying agent were utilized to prepare instant soluble maca powder. The optimal conditions were obtained as follows: ultrasonic power 600 W, ratio of solid to liquid 1 g/25 mL, ultrasonic temperature 50°C, duty ratio 1:1 and ultrasonic time 40 min, under the conditions, the extraction rate of total soluble solid was 52.0%. Under the drying conditions of mass ratio of maca soluble solid to drying auxiliary drying agent 1:1, soluble solid content in the feed liquid 0.1 g/mL, hot air temperature 220°C, feed temperature 56°C, feed flux 17.46 mL/min, and hot air flux 5 m3/min, the yield of instant soluble maca powder was 58.7%, the granularity of powder 2.1 mm, and the solution time 2.4 s. Auxiliary drying agents could inhibit the hygroscopicity of maca powder.
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This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly. Results and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05) production of E2, suppressed (P<0.05) blood FSH, Thyroid (T3) and Adrenocorticotropic hormones, Cortisol, and BMI, increased (P<0.05) low density lipoproteins, blood Iron and alleviated (P<0.001) menopausal symptoms. Maca-GO noticeably increased bone density markers. In conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes along the Hypothalamus-Pituitary-Ovarian axis, (ii) balanced hormone levels and (iii) relieved symptoms of menopausal discomfort, (hot flushes and night sweating in particular), thus, (iv) exhibited a distinctive function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence on hormone therapy programs (HRT).
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This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.
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Roots of cruciferous plant Lepidium peruvianum Chacon cultivated in high plateaus of Andes and known under its common name Maca, have been traditionally-used as an energizing vegetable with therapeutic properties for both men and women. Maca has been recognized by natives of Peru as herbal remedy helping to treat conditions affecting menopausal women. The effects of Pre-Gelatinized Organic Maca (Maca-GO) on quantitative physiological responses and alleviation of symptoms contributing to menopausal discomfort in perimenopausal women was examined. IN THIS, FOUR MONTHS, DOUBLE BLIND, CROSSOVER, RANDOMIZED PILOT TRIAL, MONTHLY MEASUREMENTS OF THE FOLLOWING BLOOD SERUM CONSTITUENTS WERE TAKEN: Estrogen (E2), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Progesterone (PGS), Cortisol (CT), Adrenocorticotropic Hormone (ACTH), Thyroid Hormones (TSH, T3, T4), minerals (Ca, K, Fe) and lipid profile (Triglicerides, Total Cholesterol, LDL, HDL). In monthly interviews conducted by gynecologist, body weight and blood pressure were registered and Menopausal Index according to Kupperman's was determined. Toxicity of Maca -GO determined on rats showed its safe use at the level of 7.5mg/kg body weight. A group of 20 women (aged 41-50 years), who fulfilled criteria of being in perimenopausal stage (E2 above 40pg/ml and FSH below 30IU/ml), were randomly allocated to two even groups, one receiving for two months Maca-GO and the other Placebo capsules followed by a crossover with treatment change for another two months period. All participants signed informed consent to participate. Two 500mg hard capsules with Maca-GO or Placebo were self-administered by participants twice daily with meals (total 2g/day). Two months administration of Maca-GO significantly alleviated symptoms of discomfort observed in majority of women involved in the study (74%-87%) as assessed by Kupperman's Menopausal index. This was associated with significant increase in E2 and FSH, Progesterone and ACTH levels, and reduction in blood pressure, body weight, Triglycerides and Cholesterol levels. There was a distinctive placebo effect observed at the beginning of the study. The results showed that in addition to reduction in body weight, blood pressure and increasing serum HDL and Iron, pre-gelatinized Maca-GO may be a valuable non-hormonal plant preparation for balancing levels of hormones (FSH, E2, PG and ACTH) and alleviating negative physiological and psychological symptoms (frequency of hot flushes, incidence in night sweating, interrupted sleep pattern, nervousness, depression and heart palpitations) experienced by women in perimenopausal stage. It appears that Maca-GO may act as a toner of hormonal processes, leading to alleviation of discomfort felt by perimenopausal women, hence, its potential use as non-hormonal alternative to HRT program.
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This double-blind, placebo-corrected clinical pilot study was aimed at assessing the use of hypocotyls of cruciferous Andean plant Maca (Lepidium peruvianum Chacon), in alleviating symptoms of menopausal discomfort experienced by women in early post menopause as measured by profiles of serum hormones: Luteinizing Hormone (LH), Follicle-stimulating Hormone (FSH), Estrogen (E2) and Progesterone (PG) and as assessed by Greene's Menopausal Index. Study was conducted on 20 Caucasian healthy early-postmenopausal women volunteers during the three months period (Trial I) and on eight women during nine months period (Trial II). Hormone levels were determined in blood with a simultaneous assessment of menopausal index at the start of study, after one month use of placebo, and after two and eight months administration of 2g gelatinized Maca root powder (Maca-GO) in the form of two 500mg hard gel capsules, twice daily. In comparison to placebo, after both, two and eight months administration of Maca-GO capsules to EPMW, level of FSH significantly (P<0.05) decreased with a simultaneous significant (P<0.05) increase in the LH level, resulting in significant (P<0.05) increase in both E2 and PG, after eight months of Maca-GO treatment only. There was a significant (P<0.05) placebo effect resulting in an elevated PG level after one month administration of placebo capsules. Changes in hormone levels was accompanied by substantially-reduced feeling of discomfort associated with menopause, although, there was a distinctive, positive placebo effect as judged by responses to Greene's questionnaire. It is reasonable to suggest that Maca-GO when used in EPMW, depending on the length of use, was acting as a toner of hormonal processes as reflected by decrease in FSH and increased LH secretion, which stimulated production of both ovarian hormones, E2 and PG and resulted in a substantial reduction of menopausal discomfort felt by women participating in the study, with a distinctive placebo effect, thus, fully justifying further, more complex study on effectiveness of Maca-GO as a reliable alternative to HRT program.
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Maca (Lepidium meyenii) is an Andean plant of the brassica (mustard) family. Preparations from maca root have been reported to improve sexual function. The aim of this review was to assess the clinical evidence for or against the effectiveness of the maca plant as a treatment for sexual dysfunction. We searched 17 databases from their inception to April 2010 and included all randomised clinical trials (RCTs) of any type of maca compared to a placebo for the treatment of healthy people or human patients with sexual dysfunction. The risk of bias for each study was assessed using Cochrane criteria, and statistical pooling of data was performed where possible. The selection of studies, data extraction, and validations were performed independently by two authors. Discrepancies were resolved through discussion by the two authors. Four RCTs met all the inclusion criteria. Two RCTs suggested a significant positive effect of maca on sexual dysfunction or sexual desire in healthy menopausal women or healthy adult men, respectively, while the other RCT failed to show any effects in healthy cyclists. The further RCT assessed the effects of maca in patients with erectile dysfunction using the International Index of Erectile Dysfunction-5 and showed significant effects. The results of our systematic review provide limited evidence for the effectiveness of maca in improving sexual function. However, the total number of trials, the total sample size, and the average methodological quality of the primary studies were too limited to draw firm conclusions. More rigorous studies are warranted.
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The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
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The present study was designed to determine the effect of a 4-month oral treatment with tablets of Lepidium meyenii (Maca) on seminal analysis in nine adult normal men aged 24-44 years old. Nine men received tablets of Maca (1500 or 3000 mg/day) for 4 months. Seminal analysis was performed according to guidelines of the World Health Organization (WHO). Serum luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin (PRL), testosterone (T) and estradiol (E2) were measured before and after treatment. Treatment with Maca resulted in increased seminal volume, sperm count per ejaculum, motile sperm count, and sperm motility. Serum hormone levels were not modified with Maca treatment. Increase of sperm count was not related to dose of Maca. Maca improved sperm production and sperm motility by mechanisms not related to LH, FSH, PRL, T and E2.
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Lepidium meyenii (Maca) is a Peruvian hypocotyl that grows exclusively between 4000 and 4500 m in the central Andes. Maca is traditionally employed in the Andean region for its supposed aphrodisiac and/or fertility-enhancing properties. This study was a 12-week double-blind, placebo-controlled, randomized, parallel trial in which active treatment with different doses of Maca Gelatinizada was compared with a placebo. The study aimed to test the hypothesis that Maca has no effect on serum reproductive hormone levels in apparently healthy men when administered in doses used for aphrodisiac and/or fertility-enhancing properties. Men aged between 21 and 56 Years received 1500 mg or 3000 mg Maca. Serum levels of luteinizing hormone, follicle-stimulating hormone, prolactin, 17-alpha hydroxyprogesterone, testosterone and 17-beta estradiol were measured before and at 2, 4, 8 and 12 weeks of treatment with placebo or Maca (1.5 g or 3.0 g per day). Data showed that compared with placebo Maca had no effect on any of the hormones studied nor did the hormones show any changes over time. Multiple regression analysis showed that serum testosterone levels were not affected by treatment with Maca at any of the times studied (P, not significant). In conclusion, treatment with Maca does not affect serum reproductive hormone levels.
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Epidemiological studies have found that consumption of cruciferous vegetables is associated with a reduced risk of prostate cancer. This effect seems to be due to aromatic glucosinolate content. Glucosinolates are known for have both antiproliferative and proapoptotic actions. Maca is a cruciferous cultivated in the highlands of Peru. The absolute content of glucosinolates in Maca hypocotyls is relatively higher than that reported in other cruciferous crops. Therefore, Maca may have proapoptotic and anti-proliferative effects in the prostate. Male rats treated with or without aqueous extracts of three ecotypes of Maca (Yellow, Black and Red) were analyzed to determine the effect on ventral prostate weight, epithelial height and duct luminal area. Effects on serum testosterone (T) and estradiol (E2) levels were also assessed. Besides, the effect of Red Maca on prostate was analyzed in rats treated with testosterone enanthate (TE). Red Maca but neither Yellow nor Black Maca reduced significantly ventral prostate size in rats. Serum T or E2 levels were not affected by any of the ecotypes of Maca assessed. Red Maca also prevented the prostate weight increase induced by TE treatment. Red Maca administered for 42 days reduced ventral prostatic epithelial height. TE increased ventral prostatic epithelial height and duct luminal area. These increases by TE were reduced after treatment with Red Maca for 42 days. Histology pictures in rats treated with Red Maca plus TE were similar to controls. Phytochemical screening showed that aqueous extract of Red Maca has alkaloids, steroids, tannins, saponins, and cardiotonic glycosides. The IR spectra of the three ecotypes of Maca in 3800-650 cm (-1) region had 7 peaks representing 7 functional chemical groups. Highest peak values were observed for Red Maca, intermediate values for Yellow Maca and low values for Black Maca. These functional groups correspond among others to benzyl glucosinolate. Red Maca, a cruciferous plant from the highland of Peru, reduced ventral prostate size in normal and TE treated rats.
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The biological activity of methanolic and aqueous extracts from dehydrated hypocotyls of Lepidium meyenii (Brassicaceae, vernacular name "maca"), was studied on rat hepatocytes and human breast cancer MCF-7 cells. The extracts did not exhibit cytotoxicity in hepatocyte primary cultures up to 10 mg/ml as measured by the MTT viability test, and lactate dehydrogenase (LDH) and aspartate aminotransferase (AST) leakage. Moreover, after 72 h, extracts inhibited LDH and AST leakage from the hepatocytes. When hepatocytes were intoxicated by t-butyl hydroperoxide, neither extract prevented oxidative damage. Both extracts showed weak antioxidant activity in the DPPH radical scavenging test with IC(50) values of 3.46 +/- 0.16 and 0.71 +/- 0.10 mg/ml, for aqueous and methanolic extracts, respectively. Thus, the observed effect on spontaneous enzyme leakage is probably mediated through mechanisms other than antioxidant activity. Both methanolic and aqueous extracts have shown estrogenic activity comparable with that of silymarin in MCF-7 cell line. Maca estrogenicity was exhibited in the range from 100 to 200 mug of extract per ml. The findings in the present study show that maca does not display in vitro hepatotoxicity. In contrast, a slight cytoprotective effect, probably not mediated by antioxidant capacity, was noted. Maca extracts exhibited estrogenic activity comparably to the effect of silymarin in MCF-7 cells.
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The systematic review "movement" that has transformed medical journal reports of clinical trials and reviews of clinical trials has taken hold in public health, with the most recent milestone, the publication of the first edition of The Guide to Community Health Services in 2005. In this paper we define and distinguish current terms, point out important resources for systematic reviews, describe the impact of systematic review on the quality of primary studies and summaries of the evidence, and provide perspectives on the promise of systematic reviews for shaping the agenda for public health research. Several pitfalls are discussed, including a false sense of rigor implied by the terms "systematic review" and "meta-analysis" and substantial variation in the validity of claims that a particular intervention is "evidence based," and the difficulty of translating conclusions from systematic reviews into public health advocacy and practice.
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Systematic reviews are considered the most reliable tool to summarize existing evidence. To determine whether reviews that address the same questions can produce different answers we examined systematic reviews of herbal medicine, homeopathy, and acupuncture taken from a previously established database. Information on literature searching, inclusion criteria, selection process, quality assessment, data extraction, methods to summarize primary studies, number of included studies, results and conclusions was compared qualitatively. Seventeen topics (eight on acupuncture, six on herbal medicines, three on homeopathy) had been addressed by 2–5 systematic reviews each. The number of primary studies in the reviews varied greatly within most topics. The most obvious reason for discrepancies between the samples was different inclusion criteria (in thirteen topics). Methods of literature searching may have contributed with some topics but the equivalence of the searches was difficult to assess. Differences were frequently observed in other methodological aspects, in results and in conclusions. This analysis shows that, at least in the three areas examined, systematic reviews often differ considerably. Readers should be aware that apparently minor decisions in the review process can have major impact.
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The maca species Lepidium meyenii grows all over several South American countries, but, to date, only maca from Peru has been significantly researched and shown to have therapeutic benefit. This has resulted in many botanists referring to maca that grows in Peru as Lepidium peruvianum in order to specify the exact origin. Some botanists, in fact, believe L. peruvianum to be a different species than L meyenii. While there will continue to be dissension on maca's correct botanical nomenclature, the most important point to clarify is that the origin of the maca referred to in this article is Peru and, due to this fact, will be referred to as L peruvianum. Maca's high nutritional value makes it a Peruvian dietary staple. Traditionally, the herb is best known as an adaptogenic plant, ie, a plant that modulates the body's response by supporting it in dealing with physiological, biochemical, and psychological stressors. Traditional healing methods include using the herb to benefit the endocrine and reproductive systems by addressing such disorders as chronic fatigue, anemia, and infertility and to aid in enhanced stamina and hormonal balance. Maca research shows benefit in the production of sex hormones, enhanced sex drive, stimulation of body metabolism, control of body weight, and increased energy, stress reduction, antidepressant activity, and memory improvement. It has been suggested that maca's therapeutic actions rely on plant sterols stimulating the hypothalamus, pituitary, adrenal, and ovarian glands and, therefore, also affecting the thyroid and pineal glands and, thus, improving sleep, mood, fertility, energy, and hot flashes. As such, this herb has been found clinically useful in perimenopausal and menopausal women.
Article
CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: 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. INTERVENTIONS: 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). MAIN OUTCOMES MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.
Article
Lepidium meyenii or "Maca is an herbal product from the highlands of Peru that is used for sexual dysfunction. The use of Maca in men is safe with no recognized adverse effects. Placebo-controlled trials in humans and animals have suggested that Maca leads to subjective and objective improvement in spermatogenesis, sexual desire, and sexual function without affecting anxiety, depression, or locomotion. However, most studies are significantly limited by methodological flaws, small patient numbers, and brief treatment intervals.
Article
Study Design. A systematic review of randomized controlled trials. Objectives. To evaluate the efficacy and effectiveness of acupuncture for the management of nonspecific low back pain. Summary of Background Data. Acupuncture is one of the oldest forms of therapy, but little is known about the effectiveness of acupuncture for low back pain. Methods. Randomized controlled trials were done to assess the effectiveness of all types of acupuncture treatment, which involves needling for subjects with nonspecific low back pain. Two reviewers blinded with respect to authors, institution, and journal independently assessed the methodologic quality of the studies. Because data were statistically and clinically too heterogeneous, a qualitative review was performed. The evidence was classified into four levels: strong, moderate, limited, or no evidence. Results. Eleven randomized controlled trials were included. Overall, the methodologic quality was low. Only two studies met the preset “high quality” level for this review. No study clearly evaluated acupuncture for acute low back pain. The results indicate that there was no evidence showing acupuncture to be more effective than no treatment. There was moderate evidence indicating that acupuncture is not more effective than trigger‐point injection or transcutaneous electrical nerve stimulation, and there was limited evidence that acupuncture is not more effective than placebo or sham acupuncture for the management of chronic low back pain. Conclusions. Because this systematic review did not clearly indicate that acupuncture is effective in the management of back pain, the authors would not recommend acupuncture as a regular treatment for patients with low back pain. There clearly is a need for more high‐quality randomized controlled trials.
Article
Maca (Lepidium meyenii walp.), a biennial herbaceous plant of the family Brassicae, which is cultivated mainly in the central Andes of Peru, has been used as both a food and a traditional medicine in the region for over 2000 years. The subterranean parts of the plant have long been used as a staple foodstuff by indigenous peoples in the Andean region, but the plant is also valued for its medicinal role. As is usual with many traditional “folk” medicines, many claims have been made regarding the efficacy of maca in treating a wide range of illnesses and medical conditions. However, in the 20th century most scientific attention has been focused in the areas where the pharmacological actions of maca seem most strongly attested, these include, enhancement of sexual drive in humans, increasing overall vigour and energy levels, and increasing sexual fertility in humans and domestic livestock. Since the early days of the 20th century numerous scientific studies have been carried out into the basis of its pharmacological action in these areas. In this review, the composition and pharmacological function of maca are systematically discussed. Additionally, the current discussion surrounding its mode of action in the areas listed above is also presented.
Book
The Cochrane Handbook for Systematic Reviews of Interventions (the Handbook) has undergone a substantial update, and Version 5 of the Handbook is now available online at www.cochrane-handbook.org and in RevMan 5. In addition, for the first time, the Handbook will soon be available as a printed volume, published by Wiley-Blackwell. We are anticipating release of this at the Colloquium in Freiburg. Version 5 of the Handbook describes the new methods available in RevMan 5, as well as containing extensive guidance on all aspects of Cochrane review methodology. It has a new structure, with 22 chapters divided into three parts. Part 1, relevant to all reviews, introduces Cochrane reviews, covering their planning and preparation, and their maintenance and updating, and ends with a guide to the contents of a Cochrane protocol and review. Part 2, relevant to all reviews, provides general methodological guidance on preparing reviews, covering question development, eligibility criteria, searching, collecting data, within-study bias (including completion of the Risk of Bias table), analysing data, reporting bias, presenting and interpreting results (including Summary of Findings tables). Part 3 addresses special topics that will be relevant to some, but not all, reviews, including particular considerations in addressing adverse effects, meta-analysis with non-standard study designs and using individual participant data. This part has new chapters on incorporating economic evaluations, non-randomized studies, qualitative research, patient-reported outcomes in reviews, prospective meta-analysis, reviews in health promotion and public health, and the new review type of overviews of reviews.
Article
Several products derived from processed maca hypocotyls (Lepidium peruvianum Chacón, previously known as L. meyenii Walp.) were surveyed for glucosinolate content and quantified by HPLC analysis. These included pills, capsules, flour, liquor, tonic and mayonnaise. Different plant organs such as fresh hypocotyls and leaves, seeds, dry hypocotyls, and sprouts were also included in the survey. The most abundant glucosinolates detected in fresh and dry hypocotyls and leaves were the aromatic glucosinolates, benzylglucosinolate (glucotropaeolin) and p-methoxybenzylglucosinolate. Maca seeds and sprouts differed in profile from hypocotyls and leaves due to the modification of benzylglucosinolate. No glucosinolates were detected in liquor and tonic, while mayonnaise had only trace amounts of those glucosinolates. It had instead allylglucosinolate (sinigrin), which is an aliphatic glucosinolate. The pills, capsules and flour had the same glucosinolates as those observed in hypocotyls, but in variable amounts. The richest sources of glucosinolates were seeds, fresh hypocotyls and sprouts, in that order.
Article
Objective: This double-blind, placebo-corrected clinical pilot study was aimed at assessing the use of hypocotyls of cruciferous Andean plant Maca (Lepidium peruvianum Chacon), in alleviating symptoms of menopausal discomfort experienced by women in early post menopause as measured by profiles of serum hormones: Luteinizing Hormone (LH), Follicle-stimulating Hormone (FSH), Estrogen (E2) and Progesterone (PG) and as assessed by Greene's Menopausal Index.Design: Study was conducted on 20 Caucasian healthy early-postmenopausal women volunteers during the three months period (Trial I) and on eight women during nine months period (Trial II). Hormone levels were determined in blood with a simultaneous assessment of menopausal index at the start of study, after one month use of placebo, and after two and eight months administration of 2g gelatinized Maca root powder (Maca-GO) in the form of two 500mg hard gel capsules, twice daily.Results: In comparison to placebo, after both, two and eight months administration of Maca-GO capsules to EPMW, level of FSH significantly (P<0.05) decreased with a simultaneous significant (P<0.05) increase in the LH level, resulting in significant (P<0.05) increase in both E2 and PG, after eight months of Maca-GO treatment only. There was a significant (<0.05) placebo effect resulting in an elevated PG level after one month administration of placebo capsules. Changes in hormone levels was accompanied by substantially-reduced feeling of discomfort associated with menopause, although, there was a distinctive, positive placebo effect as judged by responses to Greene's questionnaire. Conclusions: It is reasonable to suggest that Maca-GO when used in EPMW, depending on the length of use, was acting as a toner of hormonal processes as reflected by decrease in FSH and increased LH secretion, which stimulated production of both ovarian hormones, E2 and PG and resulted in a substantial reduction of menopausal discomfort felt by women participating in the study, with a distinctive placebo effect, thus, fully justifying further, more complex study on effectiveness of Maca-GO as a reliable alternative to HRT program.
Article
To examine the estrogenic and androgenic activity of Lepidium meyenii (Maca) and its effect on the hormonal profile and symptoms in postmenopausal women. Fourteen postmenopausal women completed a randomized, double-blind, placebo-controlled, crossover trial. They received 3.5 g/day of powered Maca for 6 weeks and matching placebo for 6 weeks, in either order, over a total of 12 weeks. At baseline and weeks 6 and 12 blood samples were collected for the measurement of estradiol, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin, and the women completed the Greene Climacteric Scale to assess the severity of menopausal symptoms. In addition, aqueous and methanolic Maca extracts were tested for androgenic and estrogenic activity using a yeast-based hormone-dependent reporter assay. No differences were seen in serum concentrations of estradiol, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin between baseline, Maca treatment, and placebo (P > 0.05). The Greene Climacteric Scale revealed a significant reduction in scores in the areas of psychological symptoms, including the subscales for anxiety and depression and sexual dysfunction after Maca consumption compared with both baseline and placebo (P < 0.05). These findings did not correlate with androgenic or alpha-estrogenic activity present in the Maca as no physiologically significant activity was observed in yeast-based assays employing up to 4 mg/mL Maca extract (equivalent to 200 mg/mL Maca). Preliminary findings show that Lepidium meyenii (Maca) (3.5 g/d) reduces psychological symptoms, including anxiety and depression, and lowers measures of sexual dysfunction in postmenopausal women independent of estrogenic and androgenic activity.
Article
Research review has long been one of the most important scholarly activities in all branches of science. While there is sometimes a single study so well-designed, well carried out, and difficult to replicate that its findings are accepted as conclusive, more often there are many studies on a given topic, no one of which clearly supersedes the others. These studies may be done by different investigators using different methods or different populations. They may arrive at different conclusions. When this is the case, there is a need for reviewers to carefully consider the evidence and to put forth conclusions or hypotheses about where the weight of the evidence lies.
Article
A systematic review of randomized controlled trials. To evaluate the efficacy and effectiveness of acupuncture for the management of nonspecific low back pain. Acupuncture is one of the oldest forms of therapy, but little is known about the effectiveness of acupuncture for low back pain. Randomized controlled trials were done to assess the effectiveness of all types of acupuncture treatment, which involves needling for subjects with nonspecific low back pain. Two reviewers blinded with respect to authors, institution, and journal independently assessed the methodologic quality of the studies. Because data were statistically and clinically too heterogeneous, a qualitative review was performed. The evidence was classified into four levels: strong, moderate, limited, or no evidence. Eleven randomized controlled trials were included. Overall, the methodologic quality was low. Only two studies met the preset "high quality" level for this review. No study clearly evaluated acupuncture for acute low back pain. The results indicate that there was no evidence showing acupuncture to be more effective than no treatment. There was moderate evidence indicating that acupuncture is not more effective than trigger-point injection or transcutaneous electrical nerve stimulation, and there was limited evidence that acupuncture is not more effective than placebo or sham acupuncture for the management of chronic low back pain. Because this systematic review did not clearly indicate that acupuncture is effective in the management of back pain, the authors would not recommend acupuncture as a regular treatment for patients with low back pain. There clearly is a need for more high-quality randomized controlled trials.
Article
In the course of conducting a series of prospective clinical trials devoted to defining new treatment opportunities for hot flashes in cancer survivors, considerable experience has been acquired with related methodologic issues. This article has been written in response to many queries regarding this methodology. A series of seven different clinical trials that involved 968 patients was used for this work. Reliable and valid definitions of hot flash intensity were developed from patient-reported descriptions. Concomitant validity and reliability assessment of patient-completed diaries was undertaken to compare hot flash data with toxicity and quality-of-life (QOL) end points and to examine consistency across patient groups using variability analysis and correlation procedures. Parametric data from this meta-analysis was used to examine relative power considerations for the design of phase II and phase III clinical trials. Daily diaries used in these studies exhibited consistency and reliability and had few missing data. Hot flash frequency and hot flash score (frequency multiplied by average severity) variables produced almost identical end point results. For phase III placebo-controlled studies, 50 patients per treatment arm seem appropriate to provide sufficient power specifications to detect a clinically meaningful change in hot flash activity. For phase II trials, 25 patients per trial seem to provide reasonable estimates of eventual hot flash efficacy to screen potential agents for more definitive testing. Given the data gained from these experiences, we can plan and carry out more efficient trials to identify efficacious agents for the reduction of hot flash activity.
Article
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.
Article
Systematic reviews are considered the most reliable tool to summarize existing evidence. To determine whether reviews that address the same questions can produce different answers we examined systematic reviews of herbal medicine, homeopathy, and acupuncture taken from a previously established database. Information on literature searching, inclusion criteria, selection process, quality assessment, data extraction, methods to summarize primary studies, number of included studies, results and conclusions was compared qualitatively. Seventeen topics (eight on acupuncture, six on herbal medicines, three on homeopathy) had been addressed by 2-5 systematic reviews each. The number of primary studies in the reviews varied greatly within most topics. The most obvious reason for discrepancies between the samples was different inclusion criteria (in thirteen topics). Methods of literature searching may have contributed with some topics but the equivalence of the searches was difficult to assess. Differences were frequently observed in other methodological aspects, in results and in conclusions. This analysis shows that, at least in the three areas examined, systematic reviews often differ considerably. Readers should be aware that apparently minor decisions in the review process can have major impact.
Article
Despite the increasing availability of effective conventional medical treatments, plant-derived and herbal remedies continue to provide a popular alternative for men and women seeking to improve their sex life. Nevertheless, the efficacy of most herbal agents in treating sexual problems remains uncertain. Therapists and consumers alike would benefit from an increased understanding of commonly used herbal agents on the market, their purported or supported effects, and their potential side effects. To this end, we cataloged the major prosexual herbal agents currently sold in several representative health food stores. We also specify the sexual problem purportedly ameliorated by each herbal agent. Finally, we evaluate eight herbal agents commonly promoted for the treatment of sexual problems. This evaluation includes a review of the research supporting the use, efficacy, dose, adverse effects, contraindications, and possible mechanism of action of each. We conclude by commenting on the quality of current research, pointing out gaps in our knowledge, and noting the need for rigorous research and product control to adequately address questions regarding the efficacy of these agents.
Article
Erectile dysfunction affects 50 percent of men ages 40-70 in the United States and is considered an important public health problem by the National Institutes of Health. Consumers are exposed to a plethora of natural products claiming to restore erection and sexual vitality. A review of the available empirical evidence reveals most naturally occurring compounds lack adequate clinical trials to support efficacy. However, arginine, yohimbine, Panax ginseng, Maca, and Ginkgo biloba all have some degree of evidence they may be helpful for erectile dysfunction. Improvements in penile endothelial L-arginine-nitric oxide activity appear to be a unifying explanation for the actions of these naturally occurring agents.
Article
Recent exceptional growth in human exposure to natural products known to originate from traditional medicine has lead to a resurgence of scientific interest in their biological effects. As a strategy for improvement of the assessment of their pharmacological and toxicological profile, scientific evidence-based approaches are being employed to appropriately evaluate composition, quality, potential medicinal activity and safety of these natural products. Using this approach, we comprehensively reviewed existing scientific evidence for known composition, medicinal uses (past and present), and documented biological effects with emphasis on clinical pharmacology and toxicology of two commonly used medicinal plants from South America with substantial human exposure from historical and current global use: Uncaria tomentosa (common name: cat’s claw, and Spanish: uña de gato), and Lepidium meyenii (common name: maca). Despite the geographic sourcing from remote regions of the tropical Amazon and high altitude Andean mountains, cat’s claw and maca are widely available commercially in industrialised countries. Analytical characterisations of their active constituents have identified a variety of classes of compounds of toxicological, pharmacological and even nutritional interest including oxindole and indole alkaloids, flavonoids, glucosinolates, sterols, polyunsaturated fatty acids, carbolines and other compounds. The oxindole alkaloids from the root bark of cat’s claw are thought to invoke its most widely sought-after medicinal effects as a herbal remedy against inflammation. We find the scientific evidence supporting this claim is not conclusive and although there exists a base of information addressing this medicinal use, it is limited in scope with some evidence accumulated from in vitro studies towards understanding possible mechanisms of action by specific oxindole alkaloids through inhibition of nuclear factor (NF)-κB activation. Although controlled clinical studies have demonstrated reduction in pain associated with cat’s claw intake in patients with various chronic inflammatory disorders, there is insufficient clinical data overall to draw a firm conclusion for its anti-inflammatory effects. An important observation was that experimental results were often dependent upon the nature of the preparation used. It appears that the presence of unknown substances has an important role in the overall effects of cat’s claw extracts is an important factor for consideration. The available animal toxicological studies did not indicate severe toxicity from oral intake of cat’s claw preparations but rather were suggestive of a low potential for acute and subacute oral toxicity, and a lack of evidence to demonstrate genotoxic potential and mutagenic activity. Maca is a clear example of a herb with substantial medicinal use in traditional herbal medicine by indigenous cultures in South America since the first recorded knowledge of it in the seventeenth century. The hypocotyls of maca are the edible part of the plant used for nutritional and proposed fertility-enhancing properties. Maca has been described to possess many other medicinal properties in traditional herbal medicine but only a few of them have been well studied scientifically. Published clinical studies of maca seem to be related to its property as a nutrient, for male fertility and for energy. There are inadequate data regarding the precise mechanism of action of maca. Some studies suggest that secondary metabolites found in maca extracts are important constituents responsible for its physiological effects. Maca has been reported in the scientific literature to have a low degree of acute oral toxicity in animals and low cellular toxicity in vitro. An important finding unveiled by this review is the importance of standardisation in quality and additional basic and clinical research to scientifically validate and understand composition, biological activity, safety and risk. Development of a comprehensive pharmacological and toxicological profile through critical evaluation of existing and future experimental data, especially carefully conducted clinical studies would facilitate the scientific evidence-based approach to understanding potential biological effects of these major traditionally based herbals in current global use.
Article
Maca (Lepidium meyenii Walp.) is a cruciferous plant from the Andes of Peru. The root of Maca is traditionally employed for its supposed properties in aphrodisiacs and improving fertility, it also has been widely used to help alleviate the symptoms of menopause. The purpose of this study was to evaluate the effect of ethanol extract of Maca on postmenopausal osteoporosis in ovariectomized rats. Female Sprague-Dawley rats were divided into four groups: Sham-operated and ovariectomized groups were fed with equivolume of distilled water, and the remaining ovariectomized groups were orally administrated with ethanol extract of Maca at 0.096 and 0.24 g/kg for 28 weeks. The findings derived from the basis of bone mineral density, biomechanical, biochemical and histopathological parameters indicated that higher dose of ethanol extract of Maca was effective in the prevention of estrogen deficient bone loss.