Double-blind, placebo-controlled study of a nutritional supplement (FB) for improving fertility in women.

Westphal LM, Polan ML, Trant AS. Department of Gynecology/Obstetrics, Stanford University School of Medicine, Stanford, CA 94305, USA. Clin Exp Obstet Gynecol. 2006;33(4):205-8.

Purpose: To determine the impact of nutritional supplementation on female fertility.

Methods: A double blind, placebo-controlled study of the effects of FB for Women, a nutritional supplement containing vitex agnus-castus, green tea, L-arginine, vitamins (including folate) and minerals, on progesterone level, basal body temperature, menstrual cycle length, pregnancy rate and side-effects.

Results: Ninety-three (93) women, aged 24-42 years, who had tried unsuccessfully to conceive for six to 36 months, completed the study. After three months, the FB group (N = 53) demonstrated a trend toward increased mean mid-luteal progesterone (P(ml)), but among women with basal pretreatment P(ml) < 9 ng/ml, the increase in progesterone was highly significant. The average number of days with luteal-phase basal temperatures over 98 degrees F increased significantly in the FB group. Both short and long cycles (< 27 days or > 32 days pretreatment) were normalized in the FB group. The placebo group (N = 40) did not show any significant changes in these parameters. After three months, 14 of the 53 women in the FB group were pregnant (26%) compared to four of the 40 women in the placebo group (10%; p = 0.01). Three additional women conceived after six months on FB (32%). No significant side-effects were noted.

Conclusion: Nutritional supplements could provide an alternative or adjunct to conventional fertility therapies.

Epigallocatechin-3-gallate (EGCG) inhibits estrogen-induced activation of endometrial cells in vitro and causes regression of endometriotic lesions in vivo.

Laschke MW, Schwender C, Scheuer C, Vollmar B, Menger MD. Institute for Clinical and Experimental Surgery, University of Saarland, Homburg, Saar, Germany. matthias.laschke@uniklinik-saarland.de Hum Reprod. 2008 Oct;23(10):2308-18. Epub 2008 Jul 4.

Background: Epigallocatechin-3-gallate (EGCG), the major component of green tea, is a pleiotropic substance, which may inhibit tumor growth via multiple intracellular signaling pathways. Herein, we studied whether EGCG may also be effective in the treatment of endometriosis.

Methods: We investigated the effect of EGCG on activation by estradiol (E(2)), proliferation and vascular endothelial growth factor (VEGF) expression of isolated hamster endometrial stromal cells and glandular cells in vitro using the water-soluble tetrazolium (WST)-1 colorimetric assay and western blot analysis. In the dorsal skinfold chamber model of Syrian golden hamsters, which were treated for 14 days with EGCG or vehicle, we further analyzed angiogenesis, blood perfusion and tissue integrity of both endometriotic lesions and ovarian follicles by intravital fluorescence microscopy and histology.

Results: We found that EGCG suppresses E(2)-stimulated activation, proliferation and VEGF expression of endometrial cells in vitro (all P < 0.05). Furthermore, EGCG selectively inhibited angiogenesis and blood perfusion (P < 0.05) of endometriotic lesions in vivo without affecting blood vessel development in ovarian follicles. Histology confirmed that EGCG-treatment induces regression of the endometriotic lesions.

Conclusions: Our data indicate that EGCG might be a promising therapeutic agent in the treatment of endometriosis, preventing the establishment of new endometriotic lesions.

Vitex and Fertility Research

A vitex preparation was used in a study of 3,162 women to assess the effectiveness of vitex for corpus luteum insufficiency. 77.4% had menstrual cycle disturbances of various types and the others suffered from a range of gynecological problems, which included symptoms of corpus luteum insufficiency. The average length of treatment was 5 months. Hormone cytology and symptoms were used to assess the treatment.*

The women reported the treatment as completely effective (33%), significant improvement (55%), and no change (7%). Their doctors reported very good results in 68% of cases, adequate in 22%, and no change in 7% (Loch, 1993).*

In another study, 20 women with secondary amenorrhea took a vitex extract for 6 months. Lab testing was done to measure progesterone, FSH, and LH, and pap smears were done at the beginning of the study, at 3 months, and at 6 months. At the end of the study, the researchers were able to evaluate 15 of the women. Ten out of the 15 women had a return of their menstrual cycles. Testing showed that values for progesterone and LH increased, and FSH values either did not change or decreased slightly (Loch et al, 1990).*

In a third study, 18 women with abnormally low progesterone levels were given vitex daily. After 3 months of treatment, 13 showed increases in progesterone and 2 became pregnant( Propping et al, 1987).*

Vitex and hyperprolactinemia

52 women with luteal phase defects due to latent hyperprolactinemia (high prolactin levels) were given either vitex or a placebo. Prolactin levels were normalized after 3 months in the treatment group and deficits in luteal progesterone production were eliminated. Two of the women became pregnant (Milewicz et al, 1993).*

In another study, 13 women with high prolactin levels and irregular cycles were given a vitex compound. Their prolactin levels fell, and a normal menstrual cycles returned to all of the women ( Roeder, 1994).*

Vitex and acne

A vitex preparation was used in women with menstrual cycle abnormalities. Acne was either eliminated or improved during treatment (Bleier, 1959).*

In another study, 117 women with four different types of acne were treated with a vitex preparation for 1-2 years. Improvement was seen after 6 weeks and by 3 months, about 70% were free of acne. Some treatment relapses were observed after 3-6 weeks (Giss et al, 1968).*

Vitex acts on the hypothalamus and pituitary glands by increasing luteinizing hormone (LH) production and mildly inhibiting the release of follicle stimulating hormone (FSH). The result is a shift in the ratio of estrogen to progesterone, in favor of progesterone. The ability of vitex to raise progesterone levels in the body is an indirect effect, so the herb itself is not a hormone.*

Lack of menstruation (amenorrhea) that is caused by a lack of ovulation, and therefore a lack of progesterone production, should result in menses when progesterone is taken. Progesterone-induced menses indicates an intact reproductive system that just isn't going through its cycle.*

It suggests that the body is producing enough FSH to stimulate the ovaries, and that the ovaries can develop follicles. It also indicates that follicular production of estrogen is sufficient to cause the lining of the uterus (endometrium) to grow and that the sloughed endometrium is able to pass through the cervical opening and the vagina. Therefore it's possible that the problem is a dysfunction in the hypothalamus or pituitary glands. The ability of vitex to modulate the hypothalamus or pituitary then makes this herb useful in the treatment of amenorrhea (infertility).*

High levels of the hormone prolactin are commonly found with corpus luteum insufficiency. Vitex is useful for reducing high prolactin levels. It inhibits prolactin release by the pituitary gland, especially when you are under stress.*

References

Bleier, VW, Therapie von zyklus-und blutungsstrorungen und weiteren endokrin bedingten erkrankungen der frau mit pflanzlichen wirkstoffen, Zbl Gynakologie, 1959, 18:701-9

Giss, G et al, Phytotherapeutische behandlung der akne, Haut-und Gesch, 1968, 43:645

Loch, E, et al, [Diagnosis and treatment of dyshormonal menstrual periods in the general practice], Gynakol Praxis, 1990, 14 (3):489-95

Loch, EG Gynaecology in practice - A sure choice of therapy, Tjherapiewoche, 1993, 43(48):2577-80

Milewicz A, et al, [Vitex agnus castus extract in the treatment of luteal phase defects due to latent hyperprolactinaemia. Results of a randomized placebo-controlled double-blind study], Arzniem-Forschung, 1993, 43(II-7):752-6

Propping, D et al, Treatment of corpus luteum insufficiency, Zeitscchrift Fur Allgemein, 1987, 63:932-3

Roeder, D, Therapy of cyclical disorders with vitex agnus castus, Zeiterschrift fur Phytotherapie, 1994, 15(3):157-63

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.