Shamshad BS, Jayalakshmi HK, Vidyavathi HG, et al. A novel extract of fenugreek husk (FenuSMART) alleviates postmenopausal symptoms and helps to establish the hormonal balance: a randomized, double-blind, placebo-controlled study. Phytother Res. 2016;30(11):1775-1784.
To assess the safety and efficacy of a proprietary standardized extract of Trigonella foenum-graecum husk (FenuSMART) in the management of menopausal complaints
Randomized, double-blind, placebo-controlled study
Participants were menopausal women aged 45 to 58 who had a menstrual period within the past 3 years but not within the previous 12 months. To be included, participants had to have moderate-to-severe menopausal symptom severity—determined by a Greene Climacteric Scale (GCS) mean score of ≥25—and a minimum of 3 hot flashes per day during the preceding 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 supplements. Of 130 women who were screened for eligibility, 88 women were randomized into treatment and control groups.
The study intervention was a proprietary extract of Trigonella foenum-graecum husk containing the constituents protodioscin, trigonellin, and 4-hydroxyisoleucine at a drug extract ratio of 18:1 (w/w). Each capsule contained 250 mg of fenugreek husk extract; dosage was 500 mg twice a day after meals for 90 days. The placebo was food-grade microcrystalline cellulose in hard-shell gelatin capsules (identical to extract capsules).
Study Parameters Assessed
Parameters assessed at baseline and 90 days included questionnaires related to menopausal symptom severity (GCS) and quality of life [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 outcomes measured by this study were changes in GCS and SF-36 questionnaire scores and serum estradiol at 90 days compared both to baseline and control group.
Mean GCS total score decreased in the treatment group 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%), headaches (53.9%), and vaginal dryness (56.3%). Mean SF-36 score improved in 73% of participants who received the intervention, compared with 32.5% of those who received placebo. In particular, there was an 11.9% increase in general well-being (P<0.05) and a 9% increase in mental health (P<0.05) compared to baseline.
The participants in this study went from an average of 3 to 5 hot flashes daily down to 1 to 2 per day, and severity of menopause-related mood and physical symptoms reduced by about half.
Serum estradiol levels increased 120% in the treatment group over the course of the study, from 131.22 pmol/L at baseline to 288.46 pmol/L at 90 days (P<0.01). Serum calcium increased 2% in the treatment group, compared to an 8% decrease in the placebo group (P<0.05).
No adverse events were observed or reported over the course of the study.
Fenugreek seed has a long history of medicinal use. In traditional Chinese medicine, fenugreek seed acts as a warming kidney yang tonic. In Ayurveda, the hot pungent herb balances kapha and vata doshas. In Western herbal medicine, the herb is used for its carminative and galactagogue effects.
Research has identified benefits of fenugreek seed on metabolic measures, including blood glucose and lipids.1-7 More recently, studies have evaluated its effects on hormone-mediated conditions, such as low libido (male and female)8,9 and dysmenorrhea.10 The present study provides evidence that fenugreek husk extract improves a range of subjective symptoms of menopause and increases serum estradiol. These effects are surmised to be due to the action of steroidal saponins, alkaloids, and a nonproteinogenic amino acid on estrogen receptors that mediates estrogen and androgen activity.9,11,12
Based on the data presented, fenugreek extract appears to be a moderately effective intervention for a broad spectrum of menopausal symptoms. The participants in this study went from an average of 3 to 5 hot flashes daily to 1 to 2 per day, and severity of menopause-related mood and physical symptoms reduced by about half. In women undergoing the menopause transition, what represents adequate management is individualized, and so the reduction but not elimination of symptoms observed in this study may or may not be acceptable for a given patient.
The potential for synergistic benefits of fenugreek husk extract on lipids and glucose make it an intriguing option for women with menopause symptoms as well as hypercholesterolemia and/or type 2 diabetes mellitus. The researchers presented some evidence that this particular extract helped reduce total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides in participants with hypercholesterolemia, but this information was not fleshed out adequately for scrutiny. Glucose was not an outcome measure in this study, but hypothetically the increase in serum estradiol observed could contribute to improved insulin sensitivity.13,14 Keep fenugreek husk extract in mind for this patient scenario, with the caveat that further research is needed with regards to its usefulness in glucose and lipid management.
The increase in serum estradiol presented in this study and the purported effects of fenugreek on estrogen receptors pose a conundrum for practitioners treating women with a personal history of estrogen receptor–positive cancer. We do not know which types of estrogen receptors the constituents in fenugreek favor, and even if we did know, it is not clear whether fenugreek husk extract would be beneficial, deleterious, or neutral with regards to secondary prevention of cancer. There is strong interest in finding effective nutraceutical 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 specifics about mechanism of action, it is advisable to proceed cautiously.
This study is limited by its small size (N=88), short duration (90 days), and the conflict of interest with respect to its funding sources.