Study: Fenugreek standardized extract for menopausal symptoms

This article is part of the 2017 Women's Health special issue. Read the full issue or download it here.

Relation

Shamshad BS, Jayalakshmi HK, Vidyavathi HG, et al. A novel fenugreek husk extract (FenuSMART) relieves postmenopausal symptoms and helps restore hormonal balance: a randomized, double-blind, placebo-controlled study.Phytother Res. 2016;30(11):1775-1784.

Study objective

To evaluate the safety and effectiveness of a proprietary standardized extract ofTrigonella foenum-graecumhusk (FenuSMART) in the treatment of menopausal symptoms

Draft

Randomized, double-blind, placebo-controlled trial

Participant

Participants were menopausal women aged 45 to 58 years who had menstruated in the last 3 years but not in the last 12 months. To be included, participants had to have moderate to severe menopausal symptoms – as determined by a Greene Climacteric Scale (GCS) mean score of ≥ 25 – and at least 3 hot flashes per day for the previous 3 to 5 weeks. Potential participants were excluded if they reported prior use of hormone therapy, family history of breast cancer, personal history of cancer, hospitalization within the past 3 months, prevalence of cardiac risk factors, or current use of medications or dietary supplements. Of 130 women screened for eligibility, 88 women were randomized into treatment and control groups.

intervention

The study intervention was a protected extract fromTrigonella foenum-graecumBowl containing the components protodioscin, trigonelline and 4-hydroxyisoleucine in an active ingredient extract ratio of 18:1 (w/w). Each capsule contained 250 mg of fenugreek husk extract; The dosage was 500 mg twice daily after meals for 90 days. The placebo was food-grade microcrystalline cellulose in hard gelatin capsules (identical to extract capsules).

Study parameters assessed

Parameters assessed at baseline and 90 days included menopausal symptoms (GCS) severity and quality of life questionnaires [36-Item Short Form (SF-36) Health Survey], anthropometric measurements (body mass index, mid-arm circumference, waist circumference, hip circumference, waist-to-hip ratio), blood pressure and Blood tests (serum estradiol, serum calcium, hemoglobin and lipid panel).

Primary outcome measures

The primary endpoints measured by this study were changes in GCS and SF-36 questionnaire scores and serum estradiol at 90 days compared to both baseline and control group.

Key insights

The mean total GCS score in the treatment group decreased from 34.83 at baseline to 19.64 at 90 days (-15.19; 95% confidence interval: -17.81 to -12.57,P<0.001). Scores were significantly reduced in subsections of the GCS including anxiety (58.9%), depression (47.7%), vasomotor symptoms (47.7%), mood swings (68.2%), insomnia (75%), headache (53.9%), and vaginal dryness (56.3%). The mean SF-36 score improved in 73% of participants who received the intervention compared to 32.5% of participants who received placebo. In particular, general well-being increased by 11.9% (P<0.05) and a 9% increase in mental health (P<0.05) compared to the initial value.

Participants in this study went from having an average of 3 to 5 hot flashes per day to 1 to 2 per day, and the severity of menopause-related mood and physical symptoms was reduced by about half.

Serum estradiol levels in the treatment group increased by 120% over the course of the study from 131.22 pmol/L at baseline to 288.46 pmol/L after 90 days (P<0.01). Serum calcium increased by 2% in the treatment group compared to an 8% decrease in the placebo group (P<0.05).

No adverse events were observed or reported during the course of the study.

Practice implications

Fenugreek seeds have a long history of medicinal use. In traditional Chinese medicine, fenugreek seeds act as a warming kidney yang tonic. In Ayurveda, the pungent herb balances Kapha and Vata doshas. In Western herbal medicine, the herb is used for its carminative and galactagogenic effects.

Research has identified the benefits of fenugreek seeds on metabolic measures, including blood sugar and lipids.^1-7More recently, studies have examined its effects on hormone-mediated conditions such as low libido (male and female).^8.9and dysmenorrhea.¹⁰The present study provides evidence that fenugreek husk extract improves a range of subjective symptoms of menopause and increases serum estradiol. These effects are believed to be due to the action of steroid saponins, alkaloids, and a nonproteinogenic amino acid on estrogen receptors, which mediate estrogenic and androgen activity.^9,11,12

Based on the data presented, fenugreek extract appears to be a moderately effective intervention for a broad range of menopausal symptoms. Participants in this study went from having an average of 3 to 5 hot flashes per day to 1 to 2 per day, and the severity of menopause-related mood and physical symptoms was reduced by about half. In menopausal women, what constitutes appropriate treatment is individualized and therefore the reduction, but not elimination, of symptoms observed in this study may or may not be acceptable for a particular patient.

The potential for synergistic benefits of fenugreek husk extract on lipids and glucose makes it an intriguing option for women with menopausal symptoms as well as hypercholesterolemia and/or type 2 diabetes mellitus. Researchers presented some evidence that this particular extract helped lower total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides in participants with hypercholesterolemia, but this information was not fleshed out enough for review. Glucose was not an outcome measure in this study, but hypothetically the observed increase in serum estradiol could contribute to improved insulin sensitivity.^13,14Consider fenugreek husk extract in this patient scenario, with the caveat that further research is needed regarding its usefulness in glucose and lipid management.

The increase in serum estradiol shown in this study and the purported effects of fenugreek on estrogen receptors present a conundrum for practitioners treating women with a personal history of estrogen receptor-positive cancer. We don't know what types of estrogen receptors fenugreek's components benefit, and even if we did, it's not clear whether fenugreek husk extract would be useful, harmful, or neutral in terms of secondary prevention of cancer. There is strong interest in finding effective nutraceutical remedies for menopausal symptoms in women with estrogen receptor-positive cancer histories, but based on the data presented in this study and the lack of specific information on the mechanism of action, it is advisable to proceed with caution.

This study is limited by its small size (N = 88), short duration (90 days), and conflict of interest related to its funding sources.