MenoHarmony
CLINICAL STUDIES ON THE FOLLOWING INGREDIENTS:
Passionflower (Passiflora Incarnata Linnaeus)
Role Identification of Passiflora Incarnata Linnaeus: A Mini Review*
Abstract
Some species of traditional herbal medicine has a history of use, most traditional natural herbs have been used for various diseases such as diabetes, hypertension, and obesity. Among them, Passiflora incarnata L. is a traditional natural medicine, flowers as well as berries, roots, and leaves have been used as a medicine. It has been used as a natural medicine for the treatment of insomnia and anxiety for a longtime in Europe, and it has been used primarily for sedation tea in North America. Moreover, Passiflora incarnata L. is widely used anti-asthmatic, analgesic and sedation in Brazil. In other words, Passiflora incarnata L. has been used to treat a sedative, dysmenorrhea, insomnia, cancer, etc. in many countries. Present review of the plants showed a wide range of pharmacological activity in anxiolytic relax the clinical disease, such as anti-inflammatory, anxiety and antioxidant. In addition, Passiflora incarnata L. affects menopause symptoms such as vasomotor symptoms, insomnia, and depression. This review aims to provide the latest information on specific functional components of Passiflora incarnata L. especially the results of clinical trials will provide new insights into opportunities for the future development of natural medicines and doors will be used for purposes of analysis.
Source; Mijin Kim, Hee-Sook Lim, Hae-Hyeog Lee, and Tae-Hee Kim. “Role Identification of Passiflora Incarnata Linnaeus: A Mini Review” Journal of Menopausal Medicine (2017): 23(3): 156–159.
Hops (Humulus lupulus)
Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial*
Abstract
Objectives: Soy and hop extracts have been investigated as alternatives for hormone replacement therapy. However, their combined efficacy is not known. We investigated the efficacy and safety of a combined soy and hop extract on postmenopausal symptoms.
Design: Double-blinded, randomized controlled trial.Settings/Location: Gynecological outpatient clinic of tertiary hospital.
Subjects: Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20.
Interventions: They received either a combined soy and hop extract (n = 38) or placebo (n = 40).
Outcome measures: Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores at baseline and after 6 and 12 weeks. We assessed serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety.
Results: After 12 weeks of the treatment, treatment group scores decreased by 20.61 points compared with 14.80 points in the placebo group (p < 0.05). Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks (p < 0.05). Urine N-telopeptide in participants ≥50 years in the treatment group showed a reduced increase. Endometrial thickness and hormonal profiles did not show significant changes in either group. No serious adverse events were reported.
Conclusion: The results suggest that 190 mg of combined soy and hop extract is safe and effective for improvement of menopausal symptoms. CRIS No.: KCT0006019.
Source: Hye In Kim, Min Kyoung Kim, Inha Lee, Jisun Yun, Eui Hyeok Kim, and Seok Kyo Seo. “Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial” Journal of Alternative and Complementary Medicine (New York, NY) (2021): 27(11):959-967.
Red Clover (Trifolium pratense)
Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study*
Abstract
Objective: To determine the efficacy and safety of the herbal formula Phyto-Female Complex (SupHerb, Netanya, Israel; ingredients: standardized extracts of black cohosh, dong quai, milk thistle, red clover, American ginseng, chaste-tree berry) for the relief of menopausal symptoms.
Methods: A randomized, double-blind, placebo-controlled trial in 50 healthy pre and postmenopausal women, aged 44-65 years, to whom oral Phyto-Female Complex or matched placebo was prescribed twice daily for 3 months. A structured questionnaire on the frequency and intensity of menopausal symptoms was administered weekly from one week before throughout the 3-month treatment period, followed by biochemical tests, breast check, and transvaginal ultrasonography.
Results: The women receiving Phyto-Female Complex reported a significantly superior mean reduction in menopausal symptoms than the placebo group. The effect of treatment improvements in menopausal symptoms increased over time; by 3 months there was a 73% decrease in hot flushes and a 69% reduction of night sweats, accompanied by a decrease in their intensity and a significant benefit in terms of sleep quality. Hot flushes ceased completely in 47% of women in the study group compared with only 19% in the placebo group. There were no changes in findings on vaginal ultrasonography or levels of relevant hormones (estradiol, follicle-stimulating hormone), liver enzymes or thyroid-stimulating hormone in either group.
Conclusion: Phyto-Female Complex is safe and effective for the relief of hot flushes and sleep disturbances in pre- and postmenopausal women, at least for 3 months' use.
Source: Carmela Rotem and Boris Kaplan.“Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study” Gynecological Endocrinology (2007): 23(2):117-22.
Sage (Salvia officinalis)
The effect of Salvia officinalis extract on symptoms of flushing, night sweat, sleep disorders, and score of forgetfulness in postmenopausal women*
Abstract
Background: Complications of hormone therapy (as replacement) during menopause prompted us to research on alternative therapies including herbal therapy in this regard.
Objectives: The effect of Salvia officinalis extract on symptoms of flushing, night sweat, sleep disorders, and score of forgetfulness in postmenopausal women on Namazi Hospital Bone Density Center in Shiraz 2015.
Methods: In a double-blind randomized controlled clinical trial, 66 postmenopausal women complaining of menopausal symptoms were divided into two groups of intervention and control, respectively. The intervention group received S. officinalis tablets (containing 100 mg S. officinalis extract), with a dose of three tablets a day for 3 months, while the control group received placebo tablets with the same prescription order. MRS (Menopause Rating Scale) and PSQI (Pittsburgh Sleep Quality Index) questionnaires were completed at the beginning and end of the study. The checklists of hot flushing and night sweating were completed a week before the intervention and at weeks 2, 4, 6, 8, 10, 12 during the intervention. Finally, the data were analyzed through SPSS18 software, using paired t-test, ANOVA. A significant level of 5% was considered.
Results: According to the paired t-test, the mean score of flushing, palpitation, sleeping disorders, muscle and joint aches, depression, nervousness, anxiety, and sexual desire and satisfaction significantly decreased by 1.6, 0.4, 1.6, 2.1, 1.4, 1.2, 1.6, and 0.8 units, respectively, in the intervention group compared to the control group (P < 0.001). Therefore, the mean score of PSQI significantly decreased by 3.8 units in the intervention group after the intervention (9.4 ± 3.7 vs 5.6 ± 1.9 (P < 0.05).
Conclusions: Salvia extract improved menopausal symptoms such as flushing, night sweat, heart palpitations, muscle and joint pain, depression, anxiety, sleep disorders, and sexual desire.
Source: Afsaneh Zeidabadi, Zahra Yazdanpanahi, Mohammad Hossain Dabbaghmanesh, Mohammad Resa Sasani, Masoumeh Emamghoreishi, and Marzieh Akbarzadeh. “The effect of Salvia officinalis extract on symptoms of flushing, night sweat, sleep disorders, and score of forgetfulness in postmenopausal women” Journal of Family Medicine and Primary Care (2020): 9(2): 1086–1092.
Angelica gigas
Decursin, an active compound isolated from Angelica gigas, inhibits fat accumulation, reduces adipocytokine secretion and improves glucose tolerance in mice fed a high-fat diet*
Abstract
Decursin (De), an active component of Angelica gigas, is known to exert anticancer and neuroprotective effects. However, its antiobesity and antidiabetic potential has not yet been investigated. This study evaluated the antiobesity effect of decursin, particularly focusing on its ability to inhibit adipocyte differentiation in 3T3-L1 cells. Decursin treatment resulted in the inhibition of adipocyte differentiation and the expression of fatty acid synthase. The study further investigated these antiobesity effects using mice fed a normal diet (ND), a high-fat diet (HFD) and a HFD plus decursin 200 mg/kg diet (HFD + De) for 7 weeks. Mice administered HFD plus decursin showed a drastic decrease in weight gain, triglyceride content, total cholesterol content and fat size compared with those that received the HFD alone; this was observed despite similar quantities of total food intake. Furthermore, decursin improved glucose tolerance in mice fed a HFD. Finally, administration of decursin along with the HFD significantly reduced the secretion of HFD-induced adipocytokines such as leptin, resistin, IL-6 and MCP-1. These results suggest that decursin might be useful for the treatment of obesity and diabetes.
Source: Jin-Taek Hwang, Sung Hee Kim, Haeng Jeon Hur, Hyun Jin Kim, Jae Ho Park, Mi Jeong Sung, Hye Jeong Yang, Shi Yong Ryu, Young Sup Kim, Mi Ran Cha, Myung Sunny Kim, and Dae Young Kwon. “Decursin, an active compound isolated from Angelica gigas, inhibits fat accumulation, reduces adipocytokine secretion and improves glucose tolerance in mice fed a high-fat diet” Physiotherapy Research (2012): 26(5):633-8.
Cynanchum wilfordii
Selective activation of the estrogen receptor-β by the polysaccharide from Cynanchum wilfordii alleviates menopausal syndrome in ovariectomized mice*
Abstract
The menopausal syndrome caused by rapid changes in hormone levels greatly influences the quality of life of women. Though hormone replacement therapy (HRT) is widely used to treat the menopausal syndrome, it exhibits many side effects, including the risk of thrombosis, cardiovascular diseases, and increased incidence of breast cancer; thus, diversifying the interest for phytotherapy-based materials as alternatives to HRT. Here, we isolated a crude polysaccharide fraction (CWPF) from Cynanchum wilfordii root that alleviated the ovariectomy-induced uterine atrophy and bone loss without changes in plasma estradiol concentration in mice. Increased plasma levels of follicle-stimulating hormone (FSH), alkaline phosphatase (ALP), osteocalcin (OC) in ovariectomized mice were also reduced to normal levels by CWPF administration. We found that the inhibitory effects of CWPF on menopausal symptoms were mediated by the estrogen receptor β (ER-β) specific activation, not ER-α. Moreover, CWPF treatment suppressed the phosphorylation of Akt, suggesting that CWPF alleviates post-menopausal symptoms by regulating ER-β related Akt signaling pathway. These results demonstrate that the polysaccharides corresponding to CWPF among the water-soluble extracts of CW could be used as a beneficial herbal alternative for the development of therapeutic agents to prevent menopausal syndrome in women.
Source: Eunjung Lee, Mi Jang, Tae-Gyu Lim, Taesoo Kim, Hyunil Ha, Jeong Hoon Lee, Hee-Do Hong, and Chang-Won Cho. “Selective activation of the estrogen receptor-β by the polysaccharide from Cynanchum wilfordii alleviates menopausal syndrome in ovariectomized mice” International Journal of Biological Macromolecules (2020): 165(Pt A):1029-1037.
Jerusalem Sage (Phlomis umbrosa) & Angelica gigas & Cynanchum wilfordii
Evaluation of Estrogenic Activity of Extract from the Herbal Mixture Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai*
Abstract
Hormone replacement therapy (HRT) consists of highly effective prescription medications for treating menopausal symptoms; however, these agents have exhibited side effects including the risk of estrogen-induced carcinogenesis. Therefore, interest in phytotherapy-based materials as a natural source of alternatives to estrogen therapy has increased. However, some of these herbal medicines have been reported to increase the risk of estrogen-induced cancer. Herbal formulations composed of a combination of Cynanchum wilfordii Hemsley (CW), Phlomis umbrosa Turczaninow (PU), and Angelica gigas Nakai (AG) extracts (CPAE) have been used for treating menopausal symptoms. Therefore, in this study, we aimed to examine the safety of CPAE by determining its potential adverse estrogenic activity using the Organization for Economic Cooperation and Development (OECD) test guideline 455 (TG455) in a stably transfected transcriptionally activated human estrogen receptor α (hERα)-HeLa9903 cell model. We found that CPAE did not how any estrogenic activity or stimulate promoters containing estrogen response elements in MCF-7 cells. In addition, CPAE showed no significant selective activity against hERα and hERβ, non-selective activity against the ER, or effects on ER target gene expression. Furthermore, CPAE did not significantly induce MCF-7 cell proliferation and uterine weight increase in ovariectomized rats. These results demonstrate that CPAE can be used as beneficial herbal drug for prevention and therapeutic intervention of estrogen carcinogenesis in menopausal women.
Source: Se Jong Kim, Sun Woo Jin, Gi-Ho Lee, Yong An Kim, and Hye Gwang Jeong. “Evaluation of Estrogenic Activity of Extract from the Herbal Mixture Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai” Toxicological Research (2017): 33(1): 71–77.
References:
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5770524/
- https://pubmed.ncbi.nlm.nih.gov/34399063/
- https://pubmed.ncbi.nlm.nih.gov/17454163/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7114003/
- https://pubmed.ncbi.nlm.nih.gov/21972114/
- https://pubmed.ncbi.nlm.nih.gov/32991896/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5266372/