Study: Bockshorn clover standardized extract for menopausal symptoms

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This article is part of the special edition of women's health 2017. Read the full edition or download here. Relation Shamshad BS, Jayalakshmi HK, Vidyavathi HG, et al. A new -like extract made of bockshorn clover bowls (Fenusmart) relieves postmenopausal symptoms and helps to establish the hormonal balance: a randomized, double -blind, placebo -controlled study. Phytother res. 2016; 30 (11): 1775-1784. Study goal Evaluation of the security and effectiveness of a proprietary standardized extract from Trigonella Foenum-Graecum Husk (Fenusmart) In the treatment of menopause symptoms draft, double-blind, placebo-controlled study participants were women in menopause at the age of 45 to 58, but not in the last 12 months ...
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This article is part of the special edition of women's health 2017. Read the full edition or download here.

reference

Shamshad BS, Jayalakshmi HK, Vidyavathi HG, et al. A new -like extract made of bockshorn clover bowls (Fenusmart) relieves postmenopausal symptoms and helps to establish the hormonal balance: a randomized, double -blind, placebo -controlled study. Phytother-Res . 2016; 30 (11): 1775-1784.

Study goal

Assessment of the security and effectiveness of a proprietary standardized extract from trigonella foenum-graecum husk (fenusmart) in the treatment of menopause complaints

draft

randomized, double blind, placebo -controlled study

participant

The participants were women at the age of 45 to 58, who have had menstruation in the past 3 years, but not in the past 12 months. In order to be recorded, the participants had to have moderate to severe menopause complaints-determined by a green climacteric scale (GCS) average of ≥ 25-and at least 3 hot flashes per day during the previous 3 to 5 weeks. Potential participants have been excluded if they provide an earlier application of hormone therapy, a family history of breast cancer, a personal history of cancer, a hospital stay within the past 3 months, the prevalence of cardial risk factors or the current use of medication or food supplements. Of 130 women who have been checked for suitability, 88 women were randomized into treatment and control groups.

Intervention

The study intervention was a protected extract from trigonella foenum-graecum bowl with the components of protodioscin, trigonelline and 4-hydroxyisoleucine in an active ingredient extract ratio of 18: 1 (f/f). Each capsule contained 250 mg bockshorn clover shell extract; The dosage was 500 mg twice a day after meals for 90 days. The placebo was microcrystalline cellulose in hard -gelatin capsules (identical to extract capsules).

study parameters evaluated

The parameters assessed at the beginning of the course and after 90 days included questionnaires on the severity of the menopause complaints (GCS) and the quality of life [36-item short form (SF-36) Health Survey] anthropometric measurements (body mass index, center arm circumference, waist circumference, relationship of waist to hip), blood pressure and blood pressure and blood pressure Blood tests (serum estradiol, serum calcium, hemoglobin and lipid panel).

primary result measurements

The primary endpoints measured by this study were changes to the GCS and SF-36 questionnaires and the serum tradiol after 90 days in comparison to the Baseline and the control group.

important knowledge

The mean GCS total value dropped in the treatment group from 34.83 at 19.64 after 90 days (-15.19; 95 %confidence interval: -17.81 to -12.57, p <0.001). The values ​​were significantly reduced in sub -sections of the GCS, including anxiety (58.9 %), depression (47.7 %), vasomotor symptoms (47.7 %), mood fluctuations (68.2 %), insomnia (53.9 %) and vaginal dryness (56.3 %). The middle SF-36 score improved in 73 % of the participants who received the intervention compared to 32.5 % of the participants who received placebo. In particular, general well -being increased by 11.9 % ( p <0.05) and an increase in mental health by 9 % ( p <0.05) compared to the initial value.

The participants in this study went back from an average of 3 to 5 hot flashes to 1 to 2 per day, and the severity of the menopausal atmosphere and physical symptoms was reduced by about half.

The serum radio level rose in the treatment group in the course of the study by 120 % from 131.22 pmol/l at the beginning of the study to 288.46 pmol/l after 90 days ( p <0.01). The serum calcium increased by 2 % in the treatment group, compared to a decline of 8 % in the placebo group ( p <0.05).

In the course of the study, no unwanted events were observed or reported.

practice implications

Bockshorn clover seeds have a long history of medical use. In traditional Chinese medicine, Bockshorn clover seed acts as a warming kidney yang tonic. In Ayurveda, the sharply sharp herb Kapha and Vata Doshas compensate for. In western herbal medicine, the herb is used because of its carminative and galaktagogenic effects.

Research has identified the advantages of Bockshorn clover seeds on metabolic measures, including blood sugar and lipid. Dysmenorrhea. 10 The present study provides evidence that Bockshorn clovershell extract improves a number of subjective symptoms of menopause and increases serum estradiol. It is assumed that these effects are due to the effect of steroid saponins, alkaloids and non-proteinogenic amino acid on estrogen receptors, which convey estrogen and androgenicity. Based on the data provided, Bockshorn clover extract seems to be a moderately effective intervention for a wide range of menopause complaints. The participants in this study went back from an average of 3 to 5 hot flashes to 1 to 2 per day, and the severity of the menopausal atmosphere and physical symptoms was reduced by about half. In women who are in menopause, what is appropriate treatment is individualized, and therefore the reduction observed in this study, but not the elimination of symptoms for a certain patient can be acceptable.

The potential for synergistic advantages of bockshorn clovershell extract on lipids and glucose makes it a fascinating option for women with menopausal symptoms as well as hypercholesterolemia and/or type 2 diabetes mellitus. The researchers presented some evidence that this special extract contributed to reducing the overall cholesterol, low-density lipoprotein (LDL) cholesterol and the triglycerides for participants with hypercholesterolemia, but this information was not sufficiently specified for a review. Glukose was not a result of the result in this study, but hypothetically the observed increase in serum radiation could contribute to improved insulin sensitivity. 13.14 In this patient scenario, think of fingell horn clovershell extract, with the reservation that further research in glucose and lipid management is required are.

The increase in serum tradiol shown in this study and the alleged effects of Bockshorn clover on estrogen receptors are a puzzle for practitioners who treat women with a personal history of estrogen receptor-positive cancer. We do not know which types of estrogen receptors promote the components of Bockshorn clover, and even if we knew it, it is not clear whether Bockshorn clovershell extract would be useful, harmful or neutral with regard to the secondary prevention of cancer. There is a strong interest in finding effective nutritional remedies for menopausal symptoms in women with estrogen-receptor-positive cancer history, but based on the data presented in this study and the lack of specific information about the effect mechanism, it is advisable to proceed.

This study is limited by its small scope (n = 88), its short duration (90 days) and the conflict of interest in relation to its sources of financing.

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