Support Sexual Health

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Introducing

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HerSynergy™ Female libido support

[/vc_column_text][vc_empty_space height=”32px”][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][vc_column_text]Low romantic desire affects about 27% of women in premenopause and 52% after menopause.† A woman’s libido is influenced by a complex combination of physical and psychological factors, including stress, tension, fatigue, mood, hormones, and health status. In addition to helping your patients with healthy lifestyle choices, stress management, and proper medical care, now you can offer targeted, advanced nutritional support with HerSynergy.

HerSynergy is formulated to support libido in women with a special, concentrated extract of fenugreek†† that may support female sexual health.†††
This formula also supplies targeted vitamins and minerals for the maintenance of good health.

• Features fenugreek, a safe and effective botanical to help libido in women
• Supplies a unique blend of vitamins and minerals to help address overall health

† West SL, et al. Arch Intern Med. 2008;168(13):1441-7449.
†† As Libifem®. Libifem® is a registered trademark of Gencor.
††† Rao A, et al. Menopause. 2014;21(12):1360-1361. Presented at the 25th Annual Meeting of the North American Menopause Society October 15-18, 2014, Washington, DC.

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HerSynergy™ by Metagenics is Now Available at Firstline Nutrition

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Fenugreek Seed Extract for
Support of Women’s Libido

Research Review

[/vc_column_text][vc_row_inner][vc_column_inner width=”1/1″][vc_column_text]BACKGROUND: LOW SEXUAL DESIRE

The commonest sexual complaint in adult women is low sexual desire, which can significantly affect a woman’s well-being.¹ The Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM) has previously classified this condition as Hypoactive Sexual Desire Disorder (HSDD)—a persistent or recurrent lack/absence of sexual fantasies and desire for sexual activity that causes marked distress or difficulty in interpersonal relationships and is not caused exclusively by another psychiatric disease, affectation, or substance (e.g., medications).2

According to a recent large-scale epidemiological study of the female population in the U.S.—the Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE STUDY)—the unadjusted prevalence of low desire was 38.7%, and the age-adjusted prevalence of a decrease in desire associated with distress (HSDD) was 9.5%.³ In May 2013, the fifth edition of the DSM (DSM-5) merged HSDD with Female Sexual Arousal Disorder (FSAD) into the diagnosis of Female Sexual Interest/Arousal Disorder (FSIAD).¹

There are a number of physiological, sociocultural, and psychological/interpersonal factors that affect sexual desire in women (Figure 1).⁴ Stress, relationship difficulties, age, menopausal status, medical comorbidities, and medications are some of the many underlying causes.⁴[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]

Figure 1. Factors Modulating Female Sexual Desire

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(Chart adopted from Maclaran and Panay.⁴)

[/vc_column_text][vc_empty_space height=”32px”][/vc_column_inner][/vc_row_inner][vc_column_text]Sex Hormones. Both estrogens and androgens are essential in female sexual function. Estrogens have a crucial role in the maintenance of healthy genital tissue. Postmenopausal estrogen deficiency causes vaginal atrophy and leads to significant impact on sexual health including sexual desire, and its systemic effects, such as hot flashes and mood disturbance, also impair sexual responses in these women.⁵ Androgens, particularly testosterone, clearly have an important role in sexual desire and arousal in women, although their exact mechanisms remain poorly understood.⁶ In addition, these sex hormones interact with neurotransmitters in the central nervous system, in which the equilibrium between excitatory factors (e.g., dopamine) and inhibitory factors (e.g., serotonin) modulate sexual desire.7[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]Limited Pharmacological Options. Because the etiology of HSDD/FSIAD is complex, the therapeutic direction depends on the possible causes and should incorporate basic counseling, individual psychotherapy or couples therapy. In cases in which a hormone deficiency is observed, the administration of androgens (or androgens plus estrogens) is recommended.⁸ However, androgen therapy for the treatment of female HSDD remains controversial. For example, the 2006 Endocrine Society Clinical Practice Guidelines on Androgen Therapy recommended against the use of androgen therapy citing multiple concerns.⁹ Shortly after, a research group published an article criticizing that the 2006 Guidelines were neither accurate nor complete, and were not based on the preponderance of scientific evidence, and did not necessarily represent the opinion held by the many healthcare professionals and clinicians who were specialized in the evaluation, diagnosis, and treatment of women’s health in androgen insufficiency states.¹⁰[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]Both oral and transdermal testosterone have been prescribed to treat low sexual desire. A recent review article performed an analysis of 20 randomized placebo-controlled trials and concluded that androgen therapy produced a positive effect on sexual responses in women, such as increases in sexual desire, the frequency of sexual activity, and sexual satisfaction.¹¹ However, several potential or known side effects of androgen therapy have caused significant concerns, such as increased frequency of cardiac events, increased risk of atherogenesis and thrombosis, hirsutism, deep voice, enlarged clitoris, and (most commonly) acne and increased oiliness of the skin and hair.¹¹[/vc_column_text][vc_empty_space height=”32px”][vc_column_text][In June 2010, the US FDA Advisory Panel voted unanimously against recommending approval of non-hormonal flibanserin (a 5-hydroxytryptamine_1A agonist and 5-hydroxytryptamine₂ antagonist that acts selectively on the neurotransmitter (Chart adopted from Maclaran and Panay.4) pathways involved in sexual desire) for the treatment of HSDD because its benefits did not outweigh the side effects.^12,13][/vc_column_text][vc_empty_space height=”32px”][vc_column_text]Limited Dietary Supplement Options. Dehydroepiandrosterone (DHEA) is a prohormone produced by the adrenal gland. It is metabolized in peripheral tissues into different steroids including estrogen and testosterone. DHEA is available as a dietary supplement in the U.S. However, recent studies of oral DHEA have not demonstrated improvements in sexual desire.⁴[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]FENUGREEK

Fenugreek (Trigonella foenum-graecum L.) is an annual plant of the legume family (the Fabaceae). It is one of the oldest medicinal plants recognized in recorded history, and its leaves and seeds have been used as food, spice, and traditional medicine.^14,15 The seeds of fenugreek are a rich source of steroidal saponins, predominantly as furostanol saponins.¹⁶ The main saponin is disgenin and its isomers yamogenin, gitogenin and tigogenin. Other constituents include mucilaginous fiber, proteins high in tryptophan and lysine, pyridine-type alkaloids, such as trigonelline, flavonoids, free amino acids, vitamins, minerals, and volatile oils.¹⁷

Due to its traditional use as medicinal plant, fenugreek has been studied for various health applications. Studies have found that fenugreek has antimicrobial, cholesterol-lowering, anti-inflammatory, hypoglycemic/antidiabetic, and antitumor potential (reviewed in Snehleta and Payal).¹⁷

Recently, fenugreek seed extract was found to exhibit estrogenic activities including binding to estrogen receptors and inducing the expression of estrogen responsive gene.¹⁸ A 2010 clinical study found that an herbal formulation containing standardized fenugreek extract had a positive effect on physiological aspects of libido in men.¹⁹ Other unpublished, preliminary data suggested that fenugreek extract had a positive effect on anabolic activity and increased free testosterone and creatinine. These new insights led to a clinical trial conducted by Australian investigators from University of Queensland School of Medicine, Princess Alexandra Hospital Department of Diabetes and Endocrinology, University of Southern Queensland, Integrated Health Group, and Medlab.²⁰[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]CLINICAL STUDY

A double-blind, randomized, placebo-controlled study (Rao et al.) was conducted to evaluate the effect of fenugreek seed extract on sex hormones and sexual function in 80 healthy menstruating women (ages 20-49) who reported low sexual drive, but were in a stable sexual relationship with a partner with normal sexual function.²⁰

Participants were randomized to receive either a standardized fenugreek seed extract (dry concentrate 33:1; 300 mg/capsule twice daily) or placebo over 2 menstrual cycles.Participants completed the blood test in a fasting state and completed the Female Sexual Function Index (FSFI) questionnaire and the Derogatis Interview for Sexual Functioning–Self-Report (DISFSR) questionnaire at baseline and at the end of month 2. Both FSFI and DISF-SR have been validated and are designed to measure quality of sexual functioning with multidimensional outcome measures.^21,22

Sex hormones were analyzed for the whole cohort and separately for those not using oral contraceptive pills (non- OCP users). At baseline, the active treatment and placebo groups were well matched for age and body mass index, and the hormone levels or measures of sexual functioning were not statistically different between groups.

At the end of month 2, body weight and liver function did not change for either group. Serum levels of total cholesterol, triglycerides, DHEA sulfate, androstenedione, and prolactin were similar between groups. Result highlights:²⁰

• Significant increase in serum estradiol. Among non- OCP users, serum estradiol was significantly increased in participants receiving the standardized fenugreek seed extract, but not in participants receiving placebo (p=0.013)(Figure 2).
• Significant increase in free testosterone. Among non- OCP users, calculated free testosterone was significantly increased in participants receiving the standardized fenugreek seed extract but not in participants receiving placebo (p=0.043)(Figure 3).

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• Significant increase in FSFI sexual arousal score. There was a significant inter-group difference in change from baseline to month 2 between fenugreek seed and placebo in the mean scores of the domain of Sexual Arousal of the FSFI (p=0.026). Other domains did not differ between groups.
• Significant increase in DISF-SR total score. The DISFSR total score increased from 57.80 at baseline to 72.98 at month 2 in the fenugreek seed group, but remained similar in the placebo group. The change in score from baseline to month 2 was statistically significant between groups (p=0.001)(Figure 4).
• Significant increases in all DISF-SR individual domains. When assessing each of the 5 individual domains of the DISF-SR questionnaire, the findings were consistent; there was a significant inter-group difference in each domain of the DISF-SR, favoring the fenugreek seed group (Figures 5-9).

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• Significant increase in sexual activity. In the fenugreek seed arm, the frequency of sexual activity increased from 1-2 times per month to an average of 1 time per week. In the placebo arm, the frequency remained the same at 1-2 times per month throughout the study duration. The change in sexual frequency from baseline to month 2 was statistically significant between groups (p=0.001).
• Well tolerated. No major adverse reactions occurred during the study. Minor reactions include migraines (2 cases) and indigestion (2 cases) in the active treatment group.

[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]ADDITIONAL SAFETY DATA

In addition to the aforementioned clinical study, other clinical trials evaluating fenugreek seed extract for different populations and different indications also demonstrated its safety. For example, a meta-analysis of 10 clinical trials which evaluated fenugreek’s effect on glucose homeostasis only reported few mild side effects such as gastrointestinal symptoms, specific urine smell, and nausea.²³ A clinical study in unmarried women evaluating the effect of fenugreek on dysmenorrhea reported no side effects.²⁴ Another study evaluating the effect of fenugreek on male libido found no adverse events in adult men.¹⁹[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]SUMMARY

The clinical trial conducted by Rao and colleagues demonstrated that the standardized seed extract from fenugreek (Trigonella foenum-graecum L.) is a safe and effective treatment for increasing sexual desire, arousal, and frequency of sexual activity in healthy women who reported low sexual drive.[/vc_column_text][vc_empty_space height=”32px”][vc_column_text]

REFERENCES

1. Poels S, Bloemers J, van Rooij K, et al. Two novel combined drug treatments for women with hypoactive sexual desire disorder. Pharmacol Biochem Behav. 2014;121:71-79.

2. Diagnostic and Statistical Manual of Mental Disorders. 4th Edition, Text Revision ed. Washington, DC: American Psychiatric Association; 2000.

3. Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112:970-978.

4. Maclaran K, Panay N. Managing low sexual desire in women. Womens Health (Lond Engl). 2011;7:571-581; quiz 82-83.

5. Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause. 2008;15:661-666.

6. Shifren JL. The role of androgens in female sexual dysfunction. Mayo Clin Proc. 2004;79:S19-24.

7. Pfaus JG. Pathways of sexual desire. J Sex Med 2009;6:1506-33.

8. Palacios S. Hypoactive Sexual Desire Disorder and current pharmacotherapeutic options in women. Womens Health (Lond Engl). 2011;7:95-107.

9. Wierman ME, Basson R, Davis SR, et al. Androgen therapy in women: an Endocrine Society Clinical Practice guideline. J Clin Endocrinol Metab. 2006;91:3697-3710.

10. Traish A, Guay AT, Spark RF. Are the Endocrine Society's Clinical Practice Guidelines on Androgen Therapy in Women misguided? A commentary. J Sex Med. 2007;4:1223-1234; discussion 34-35.

11. Reis SL, Abdo CH. Benefits and risks of testosterone treatment for hypoactive sexual desire disorder in women: a critical review of studies published in the decades preceding and succeeding the advent of phosphodiesterase type 5 inhibitors. Clinics (Sao Paulo). 2014;69:294-303.

12. Stahl SM, Sommer B, Allers KA. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8:15-27.

13. Transcript for the June 18, 2010 Meeting of the Advisory Committee for Reproductive Health Drugs. US FDA; 2010. (Avaialble at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMat erials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM248753.pdf. Accessed July 25, 2014.)

14. Acharya SN, Thomas JE, Basu SK. Fenugreek, an alternative crop for semiarid regions of North America. Crop Sci. 2008;48:841-853.

15. Sauvaire Y, Baissac Y, Leconte O, Petit P, Ribes G. Steroid Saponins from Fenugreek and some of their Biological Properties. In: Waller G, Yamasaki K, eds. Saponins Used in Food and Agriculture: Springer US; 1996:37-46.

16. Pang X, Kang L, Yu H, et al. Rapid isolation of new furostanol saponins from fenugreek seeds based on ultra-performance liquid chromatography coupled with a hybrid quadrupole time-of-flight tandem mass spectrometry. J Sep Sci. 2012;35:1538-1550.

17. Snehlata HS, Payal DR. Fenugreek (Trigonella foenum-graecum L.): an overview. IJCPR. 2014;2:169-187.

18. Sreeja S, Anju VS, Sreeja S. In vitro estrogenic activities of fenugreek Trigonella foenum graecum seeds. Indian J Med Res. 2010;131:814-819.

19. Steels E, Rao A, Vitetta L. Physiological aspects of male libido enhanced by standardized Trigonella foenum-graecum extract and mineral formulation. Phytother Res. 2011.

20. Rao A, Steels E, Beccaria G, Inder W, Vitetta L. Influence of a specialized Trigonella foenum-graecum seed extract (Libifem) on testosterone, estradiol and sexual function in healthy menstruating women: a randomized placebo controlled study. (Under review for publication; accepted for oral presentation at NAMS 2014 meeting, Washington, DC.)

21. Derogatis LR. The Derogatis Interview for Sexual Functioning (DISF/DISFSR): an introductory report. J Sex Marital Ther. 1997;23:291-304.

22. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191-208.

23. Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a metaanalysis of clinical trials. Nutr J. 2014;13:7.

24. Younesy S, Amiraliakbari S, Esmaeili S, Alavimajd H, Nouraei S. Effects of fenugreek seed on the severity and systemic symptoms of dysmenorrhea. J Reprod Infertil. 2014;15:41-48.

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