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1.
A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair.
Ablon, G, Kogan, S
Journal of drugs in dermatology : JDD. 2021;(1):55-61
Abstract
Hair loss is a complex and multi-factorial problem that is associated with significant psychological morbidity in women. Menopausal women represent a significant percentage of those affected, since the menopausal hormonal transition can be a contributing factor. A novel nutraceutical supplement has been specifically formulated with phytoactives to improve hair growth and quality in menopausal women (Nutrafol® Women’s Balance Capsules). The objective of this 6-month, randomized, double-blind, placebo-controlled study was to assess the safety and efficacy of this oral supplement to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning. Subjects were randomized to the study supplement (n=40) or placebo (n=30). The primary endpoint was a statistically significant increase in the number of terminal and vellus hairs based on phototrichogram analysis. Daily intake of the nutraceutical supplement resulted in progressive and significant increase in terminal and total hair counts on days 90 (P<0.01) and 180 (P<0.01) compared to placebo. The vellus hair counts significantly increased for the active treatment group (P<0.05) by day 180 while significantly decreasing for the placebo group subjects. Hair shedding progressively and significantly decreased for the active group compared to placebo, culminating in a reduction of 32.41% by day 180 (P<0.01). The study supplement was well-tolerated. ClinicalTrials.gov Identifier: NCT04048031 J Drugs Dermatol. 2021;20(1):55-61. doi:10.36849/JDD.5701 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.
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2.
The effects of Elaeagnus angustifolia L. whole fruit on the sex hormone profile in menopausal women: A double-blind, randomized, placebo-controlled study.
Emaminia, F, Rezaei, A, Badehnoosh, B, Ramezani, R, Shabani, M
Journal of ethnopharmacology. 2020;:112229
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Menopause is a product of interrupted ovarian activity and decrease in its estradiol production. Herbal medicines as an alternative to hormone therapy are increasingly used by menopausal women. Elaeagnus angustifolia L. (Senjed in Persian) is a well-known herbal remedy with various therapeutic effects according to Iranian traditional medicine which is recommended to relieve the menopausal side effects. The aim of present study was to evaluate the effects of oral intake of whole fruit powder of E. angustifolia on the sex hormones profile in menopausal women. MATERIALS AND METHODS In present double-blind randomized placebo-controlled trial, 58 eligible women who were referred to Kamali Women Hospital (Karaj, Iran, 2017) were randomly assigned into herbal medicine (15 g E. angustifolia) and placebo (7.5 g cornstarch +7.5 g isomalt) groups. Initially and after 10 weeks of the treatment, serum levels of estradiol, progesterone, testosterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH) hormones were measured. RESULTS According to between-group analyses, the changes in the studied parameters were not significant between herbal medicine and placebo groups, except for joint pain that improved significantly in herbal medicine group. However, by within-group analysis the levels of FSH and FSH to testosterone showed a significant increase, whereas the level of progesterone decreased significantly after 10 weeks of E. angustifolia consumption. CONCLUSIONS The improvement of the sex hormone profile was not in a full accordance with Iranian folklore after E. angustifolia consumption in the present menopausal participants. However, considering a strong belief on the beneficial effects of E. angustifolia in Iranian folklore, a long-term studies of larger group participants are needed to evaluate the efficacy.
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3.
Evaluation of the effect of Silybum marianum extract on menopausal symptoms: A randomized, double-blind placebo-controlled trial.
Saberi, Z, Gorji, N, Memariani, Z, Moeini, R, Shirafkan, H, Amiri, M
Phytotherapy research : PTR. 2020;(12):3359-3366
Abstract
The tendency to use herbs to manage menopausal symptoms has increased in recent years. The purpose of this study was to evaluate the effect of Silybum marianum (L.) compared with placebo in women with hot flashes. Eighty women were randomly allocated into two equal groups (S. marianum extract [400 mg/d] or placebo capsules). Hot flashes frequency and severity were evaluated in 12 weeks with the Greene Climacteric Scale (GCS) and the Hot Flash Related Daily Interference Scale (HFRDIS). The data were analyzed in SPSS software using t-test, Mann-Whitney, chi-square test and repeated measure analysis. Hot flashes frequency and severity decreased from 4.32 ± 0.20/day to 1.31 ± 0.15/day and from 5.25 ± 0.22 to 1.62 ± 0.08, respectively, during the study in test group (p < .001) which were significantly better than effects of placebo in all steps of study (p < .001). Significant decreases in GCS and HFRDIS scores were also detected in S. marianum group compared with placebo after 4, 8 and 12 weeks (p < .001). The results showed that S. marianum can decrease frequency and severity of hot flashes significantly. Considering the safety and high consumption of this herbal medicine worldwide, its use in women with menopausal symptoms can be helpful.
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4.
Effects of Chlorogenic Acids on Menopausal Symptoms in Healthy Women: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial.
Enokuchi, Y, Suzuki, A, Yamaguchi, T, Ochiai, R, Terauchi, M, Kataoka, K
Nutrients. 2020;(12)
Abstract
A reduction in estrogen levels in the perimenopausal and postmenopausal periods causes various symptoms in women, such as hot flushes, sweats, depression, anxiety, and insomnia. Chlorogenic acids (CGAs), which are phenolic compounds widely present in plants such as coffee beans, have various physiological functions. However, the effects of CGAs on menopausal symptoms are unknown. To examine the effects of CGAs on menopausal symptoms, especially hot flushes, a randomized, placebo-controlled, double-blind, parallel-group trial was conducted in healthy women. Eighty-two subjects were randomized and assigned to receive CGAs (270 mg) tablets or the placebo for 4 weeks. After 4 weeks of intake, the number of hot flushes, the severity of hot flushes during sleep, and the severity of daytime sweats decreased significantly in the CGA group compared to the placebo group. The modified Kupperman index for menopausal symptoms decreased significantly after 2 weeks in the CGA group compared to the placebo group. Adverse effects caused by CGAs were not observed. The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.
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Acupuncture or phy(F)itoestrogens vs. (E)strogen plus progestin on menopausal symptoms. A randomized study.
Palma, F, Fontanesi, F, Facchinetti, F, Cagnacci, A
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(11):995-998
Abstract
The effect of acupuncture and phytoestrogens on climacteric symptoms was compared to the effect of hormone therapy (HT) with estrogen plus progestin. A total of 75 postmenopausal women with hot flushes were randomized to receive for 3 months conjugated estrogens/medroxyprogesterone acetate (0.30 mg/1.5 mg/d), acupuncture weekly or soy isoflavones (75 mg/2/d). Evaluations were performed prior to, at the end, and 3 months after treatments. Main outcomes were modification of the Greene's climacteric scale and menopause quality of life (MenQoL). The Greene's score significantly declined (p < .05) during HT (-5.6 ± 3.1), acupuncture (-6.9 ± 4.5) and phytostrogens (-3.4 ± 4.3) (p < .05 vs. HT). Mean Greene's vasomotor sub-score declined less during phytoestrogens than HT (-0.8 ± 2.0 vs. -2.0 ± 1.9; p < .05) and a ≥ 80% reduction was observed in 17.4% of women on phytoestrogens (p < .05 vs. HT), 44% of women on HT, and 41.7% of women on acupuncture. MenQoL score improved similarly (p < .05) during HT (-1.4 ± 1.3), acupuncture (-1.7 ± 1.0) and phytoestrogens (-1.0 ± 1.3). Three months after treatment end, benefits on MenQoL were conserved more following acupuncture than HT (p < .006). The present data indicate that acupuncture, and in lesser extent phytoestrogens, can be effective therapies for climacteric symptoms. Trial registration: EudraCT Number 2008-006053-4.
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Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis.
Molaie, M, Darvishi, B, Jafari Azar, Z, Shirazi, M, Amin, G, Afshar, S
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2019;(1):58-61
Abstract
The goal of the current study was to evaluate the efficiency of a phytotherapeutic intervention consisting of a combination of Nigella sativa and Vitex agnus-castus with citalopram in the control of hot flashes in healthy menopausal women. An 8 week, double-blind, randomized, placebo-controlled study was performed among 46 women aged between 40 and 60 years experiencing an average of more than four hot flashes per day recruited during July 2016 to June 2017. Data on severity of vasomotor symptoms were collected at the end of the eighth week. Herbal medication or placebo capsules were administered once daily in morning. At the end of the 8-week treatment period, analyses of covariance demonstrated the superiority of herbal combination with citalopram over placebo and citalopram for three MENQOL domain scores including vasomotor (p < .001), physical (p = .036), psychosocial (p = .001) but no significant differences were observed in terms of sexual function (p = .231). Based on the results, the addition of a combination of N. sativa and V. agnus-castus to the citalopram may be a potential clinical application for improving therapeutic outcomes. Larger randomized, controlled trials are also warranted for further investigations of these symptoms.
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7.
The effect of ginseng on sexual dysfunction in menopausal women: A double-blind, randomized, controlled trial.
Ghorbani, Z, Mirghafourvand, M, Charandabi, SM, Javadzadeh, Y
Complementary therapies in medicine. 2019;:57-64
Abstract
OBJECTIVES Sexual problems constitute a largely-overlooked problem for women during menopause. The present study was conducted to determine the effect of Ginseng on sexual function (primary outcome), quality of life and menopausal symptoms (secondary outcomes) in postmenopausal women with sexual dysfunction. DESIGN This randomized controlled trial was conducted on 62 women who were randomly assigned to the intervention/control groups using block randomization. INTERVENTION The intervention group received 500 mg of Panax Ginseng and the control group received placebo twice daily for four weeks. MAIN OUTCOME MEASURES Standard questionnaires including the Female Sexual Function Index (FSFI), the Menopause-Specific Quality of Life (MENQOL) and the Greene Menopausal Symptom Scale were completed before and four weeks after the intervention. RESULTS There were no statistically significant differences between the two groups in terms of demographic characteristics and the baseline scores of sexual function, quality of life and menopausal symptoms (P > 0.05). After the intervention, the mean total score of FSFI (Adjusted Mean Difference = 6.32, 95% CI = 3.48 to 9.16, P < 0.001) was significantly higher in the intervention group compared to the control group. The mean total score of quality of life (AMD=-20.79, 95% CI=-25.83 to -15.75, P < 0.001) and menopausal symptoms (AMD=-8.25, 95% CI=-10.55 to -5.95, P < 0.001) were significantly lower in the treatment group than the control group. CONCLUSION Ginseng has significant effects in improving sexual function and quality of life and mitigating menopausal symptoms. As a multipotent plant, Ginseng can be a suitable alternative for conventional therapies to promote the health of menopausal women.
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Urtica dioica in comparison with placebo and acupuncture: A new possibility for menopausal hot flashes: A randomized clinical trial.
Kargozar, R, Salari, R, Jarahi, L, Yousefi, M, Pourhoseini, SA, Sahebkar-Khorasani, M, Azizi, H
Complementary therapies in medicine. 2019;:166-173
Abstract
OBJECTIVES The purpose of this research was to investigate the effect of Urtica dioica in comparison with placebo, acupuncture and combined therapy on hot flashes and quality of life in postmenopausal women. METHODS In a double-blinded randomized controlled trial, patients were treated for 7 weeks then followed up 4 weeks. Seventy-two postmenopausal women who reported at least 20 hot flashes attacks per week were randomly allocated into one of the 4 groups of Urtica dioica 450 mg/day and acupuncture 11 sessions (A), acupuncture and placebo (B), sham acupuncture and Urtica dioica (C), and sham acupuncture and placebo (D). The primary outcomes were the change in hot flashes score from baseline to the end of treatment and follow up; and the change in the quality of life (MENQOL) from baseline to the end of treatment. Secondary outcomes included changes in FSH, LH, and ESTRADIOL levels from baseline to the end of treatment. The trial was conducted from October 2017 to July 2018 in Acupuncture clinic of a teaching hospital in Iran. RESULTS A total of 72 women 45-60 years old were enrolled, and 68 were included in the analyses. The median (IQR) hot flashes score decreased in the A group by 20.2 (31.7) and 21.1 (25.1), B group by 19 (18) and 17.3 (27), C group by 14.6 (25.4) and 20.8 (13), and D group by 1.6 (11.6) and 1 (13.3) at the end of treatment and follow up (P < 0.0001, P < 0.0001); no significant difference between A, B and C groups. The mean (SD) of MENQOL score decreased in the A group by 42.6 (21.1), B group by 40.7 (29.8), C group by 37.8 (26.8) and D group by 9.8 (14.3) at the end of treatment (P = 0.001); no significant difference between A, B and C groups. CONCLUSIONS Urtica dioica can decrease menopausal hot flashes and increase the quality of life of postmenopausal women better than placebo-sham control but same as acupuncture. The combination of Urtica dioica and acupuncture did not add to the effects of those therapies.
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Evolution of Serum 25OHD in Response to Vitamin D3-Fortified Yogurts Consumed by Healthy Menopausal Women: A 6-Month Randomized Controlled Trial Assessing the Interactions between Doses, Baseline Vitamin D Status, and Seasonality.
Bonjour, JP, Dontot-Payen, F, Rouy, E, Walrand, S, Rousseau, B
Journal of the American College of Nutrition. 2018;(1):34-43
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Abstract
BACKGROUND Adequate vitamin D status contributes to bone fragility risk reduction and possibly other pathological conditions that occur with aging. In response to pharmaceutical vitamin D3 supplements, several studies have documented the influence of doses, baseline status, and seasonality on serum 25-hydroyvitamin D (s25OHD). OBJECTIVE Using fortified yogurt, we investigated in one randomized controlled trial how both baseline status, as assessed by measuring s25OHD prior the onset of the trial, and the season of enrollment quantitatively influenced the response to the supplemented (Suppl.) of vitamin D3 (VitD3) in healthy community-dwelling women. METHODS A 24-week controlled trial was conducted in menopausal women (mean age: 61.5). Participants were randomized into 3 groups (Gr): Gr.Suppl.0, time controls maintaining dietary habits; Gr.Suppl.5 and Gr.Suppl.10 consuming one and two 125-g servings of VitD3-fortified yogurts with 5- and 10-µg daily doses, respectively. The 16 intervention weeks lasted from early January to mid-August, the 8 follow-up weeks, without product, from late August to mid-October. Before enrollment, subjects were randomized into 2 s25OHD strata: low stratum (LoStr): 25-50 nmol/L; high stratum (HiStr): >50-75 nmol/L. RESULTS All enrolled participants adhered to the protocol throughout the 24-week study: Gr.Suppl.0 (n = 45), Gr.Suppl.5 (n = 44), and Gr.Suppl.10 (n = 44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than in Gr.Suppl.5. At the end of the intervention, the subject proportion with s25OHD ≥ 50 nmol/L was 37.8, 54.5, and 63.6% in Gr.Suppl.0, Gr.Suppl.5, and Gr.Suppl.10, respectively. The constant rate of s25OHD per supplemental VitD3 microgram was greater in LoStr than HiStr. The s25OHD increase was greater with late (mid-March) than early (mid-January) inclusion. CONCLUSION This randomized trial demonstrates (1) a dose-dependent s25OHD improvement related to fortified yogurt consumption; (2) an inversely baseline-dependent increase in s25OHD; and (3) a seasonal effect that highlights the importance of VitD3-fortified foods during winter, even at 5 µg/d, in healthy menopausal women.
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The effect of Valerian on the severity and frequency of hot flashes: A triple-blind randomized clinical trial.
Jenabi, E, Shobeiri, F, Hazavehei, SMM, Roshanaei, G
Women & health. 2018;(3):297-304
Abstract
Valerian is one of the most widely used herbal supplements and a phytoestrogenic herb. The aim of this study was to determine the effect of Valerian on the severity and frequency of hot flashes. This triple-blind, randomized, controlled clinical trial was conducted during a three-month period in Hamadan, Iran, in 60 postmenopausal women aged 45-55 years. Participants were randomly assigned to one of two groups- either placebo or Valerian. An oral Valerian 530 mg capsule was given twice per day for two months. An oral placebo 530 mg capsule (starch) was similarly administered. The severity and frequency of hot flashes were determined by the Kupperman index, before the intervention, one month after, and two months after initiation of the intervention. The severity of hot flashes in the Valerian group was significantly lower than that in the placebo group at one (p = .048) and two months (p = .020) after initiation of the intervention. Compared with the placebo group, the mean frequency of hot flashes was significantly reduced two months after initiating the use of Valerian (p = .033). Health-care providers should consider Valerian to be effective for menopausal women with hot flashes.