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Women's Health Update: Botanicals for Women with Infertility and PCOS--Current Evidence.

Polycystic ovary syndrome (PCOS) is a common endocrine syndrome that affects women of reproductive age. It is characterized by ovulatory dysfunction, biochemical and/or physical signs of androgen excess (e.g., acne, hirsutism, male-pattern hair loss), and in some women, polycystic ovaries. Concomitant morbidities can include infertility, increased risk for type 2 diabetes, mood disorders, and cardiovascular disease risk factors such as obesity, dyslipidemia, and metabolic syndrome.

For women trying to get pregnant, the complex metabolic and reproductive hormone dysfunction makes it challenging to conceive. Ovulation is infrequent and follicular development abnormal, often resulting in a higher percentage of atretic, or degenerating follicles. (1) Women are generally dissatisfied with pharmaceutical standard of care treatment options. In one study, 648 of 657, or 99% of women stated that they would like an alternative to standard birth control pills and ovulation-induction fertility medication. (2) Evidence suggests that treatment with certain botanicals may have a positive impact on PCOS comorbidities including infertility.

A recently published study in Phytotherapy Research (July 2017) examined the effectiveness and safety of an herbal plus lifestyle intervention against lifestyle alone in overweight women aged 18-44 with PCOS. (3) The primary outcome measured was menstrual length. Secondary outcomes measured included serum concentration of reproductive hormones; glucose and insulin sensitivity; anthropometric characteristics; health-related quality of life (HRQoL) for depression, anxiety, and stress; pregnancy and birth outcomes; blood pressure; as well as any adverse events.

One hundred and twenty-two women met the inclusion criteria and were randomized to either intervention (n=60) or control group (n=62). The herbal intervention consisted of two tablets. Tablet 1 contained equal parts of extract equivalent to 750 mg of each of the following dry herbs per tablet: Cinnamomum verum (stem bark), Glycyrrhiza glabra (root), Hypericum perforatum (flowering herb), and Paeonia lactiflora (root). G. glabra and P. lactiflora were chosen to target androgen reduction, C. verum to improve menstrual regularity, and H. perforatum to reduce depression, which is more common in women with PCOS. (4) Tablet 2 contained Tribulus terrestris (aerialparts) standardized to furostanol saponins 110 mg. T. terrestris was chosen as a possible potentiator of follicle stimulating hormone (FSH). Tablet 1 was administered as three tablets daily for three months, and Tablet 2 as three tablets daily for 10 consecutive days during the follicular phase (starting on Day 5 of cycle) for three months. Women were instructed to stop taking the herbal intervention if pregnancy occurred due to concerns over safety. Lifestyle recommendations included dietary instruction aimed at increased nutrient density, blood sugar optimization, and weight loss, and a structured aerobic plus progressive resistance exercise plan.

At three months, statistically significant results included the following:

* Primary Outcome

** Menstrual length was 43 days shorter than lifestyle alone (p< 0.001).

* Secondary Outcomes

** Lower BMI (p < 0.01).

** Decreased insulin (p = 0.02).

** Decreased luteinizing hormone (p = 0.04).

** Lowering of blood pressure (p = 0.01).

** Improved quality of life (p < 0.01).

** Improved depression, anxiety, and stress (p < 0.01).

** Increased clinical pregnancy rate (p <0.01).

The live birth rate was no different in the intervention group after accounting for sample size (p = 0.06).

While lack of a placebo group limits this study, it presents a novel and promising herbal combination treatment approach to the preconception window for overweight women with PCOS who are interested in conceiving.

Vitex agnus-castus (vitex) and Cimicifuga racemosa (black cohosh) have also been studied for their impact on fertility in women with PCOS. There is more evidence to support vitex's use in lowering prolactin and improving menstrual regularity than in its treatment of those with infertility. (5) In one study, vitex was administered through a proprietary combination blend consisting of 32.4 mg per day for three months. (6) In a subgroup analysis of those with amenorrhea or luteal insufficiency, the intervention group had more than doubled pregnancy rates over that of the placebo group. However, the study lacked an effect size large enough to show any power. The proprietary blend also contained homeopathic preparations of Caulophyllum thalictroides, Lilium majus, Cyclamen, Ignatia, and Iris, which may have confounded results.

Cimicifuga racemosa has promising evidence for its treatment of women with PCOS and infertility, in combination with clomiphene citrate therapy. In one study, 194 women <35 years old were randomized to take either clomiphene citrate 150 mg from days 3-7 alone, or in conjunction with C. racemosa 120 mg from Day 1 until pregnancy testing. (7) Statistically significant results included the following:

* Higher pregnancies per cycle (p = 0.01);

* Higher clinical pregnancies per cycle (p = 0.01).

There was no difference between groups in number of biochemical pregnancies, miscarriages, or multiple pregnancies per cycle.

It cannot be assumed that botanical treatments that may be effective for general PCOS may also be effective for patients with PCOS who are trying to get pregnant.

For example, a recent study examining toxicological effects of Trigonella foenum graecum, shows it has anti-fertility, anti-implantation, and abortifacient activity related to saponin compounds contained within the herb. (8) It is also important to advise your patients to stop taking any botanical treatments mentioned in this article once pregnancy occurs, as there is a lack of safety data.

We have a long way to go in examining the effects of botanical medicine on the treatment of PCOS and infertility. However, the treatments discussed above have interesting potential, and are worth exploring in patients opting for a more natural approach.

References

(1.) Webber LJ, et al. Formation and early development of follicles in the polycystic ovary. The Lancet. 2003;362. (9389): 1017-1021.

(2.) Sills ES, et al. Diagnostic and treatment characteristics of polycystic ovary syndrome: descriptive measurements of patient perception and awareness from 657 confidential self-reports. BMC Women's Health. 2001;1(1): 3.

(3.) Arentz S. Combined lifestyle and herbal medicine in overweight women with polycystic ovary syndrome (PCOS): a randomized controlled trial. Phytotherapy Research. 2017;31(9): 1330-1340.

(4.) Gaster B, Holroyd J. St John's wort for depression: a systematic review. Archives of Internal Medicine. 2000;160(2): 152-156.

(5.) Arentz S, et al. (2014). Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings. BMC Complementary and Alternative Medicine. 2014;14: 511.

(6.) Gerhard I, et al. Mastodynon[R] for Female Infertility. Randomized placebo controlled, clinical double-blind study. Forschende Komplementarmedizin/Res Compl Med. 1998; 5(6):272-278.

(7.) Shahin AY, Mohammed SA. Adding the phytoestrogen Cimicifugae Racemosae to clomiphene induction cycles with timed intercourse in polycystic ovary syndrome improves cycle outcomes and pregnancy rates-a randomized trial. Gynecol Endocrinol. 2014;30(7):505-510.

(8.) Ouzir M, et al. (2016). Toxicological properties of fenugreek (Trigonella foenum graecum). Food and Chemical Toxicology. 2016;96:145-154.

by Corina Dunlap, ND, MS, Guest Author

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Date:Jan 1, 2018
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