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Scientifically formulated and clinically tested nutritional supplements

Natural alternatives for Hormone Replacement Therapy (HRT)

Extensive research has suggested that HRT may decrease the risk of heart disease, stroke osteoporosis and colorectal cancer. However since at least 1996 it has been known that for heart disease and stroke, that this may not be the case. More recent studies have concluded that HRT does not reduce the risk of heart disease and in fact there is evidence of increased risk of heart disease early on in therapy. In addition to heart disease there is an increased incidence of stroke, cancer of the breast, endometrium ( lining layer of uterus) ovaries and increased incidence of gall bladder problems. HRT helps in certain symptoms of menopause such as hot flashes, vaginal dryness, osteoporosis and mood changes.

Hot flashes are the most common symptom associated with estrogen deficiency in perimenopausal and menopausal women. Hot flashes appear several years before other symptoms of menopause occur. Studies have shown that HRT is an effective treatment for relieving the hot flashes.

Estrogen loss during menopause causes physical changes in the vagina and urinary tract. Low levels of estrogen make the vaginal tissue drier, thinner and less elastic, which can make sexual intercourse painful. HRT reverses most of these changes of the vaginal mucosa.

Before menopause, estrogen helps maintain calcium and other minerals in bones, keeping them dense, healthy and strong. During menopause, because of low levels of estrogen, the bone loses it's calcium and other minerals and becomes brittle. About 50% of women over age 50 have, are at risk for osteoporotic bone weakness and fractures as their estrogen levels decrease. HRT is an effective method of preventing osteoporosis, reducing the risk of osteoporosis-related fractures.

For reasons not well understood, declining levels of estrogen in menopause, can cause emotional highs and lows. Some women may also notice that their interest in sexual relations becomes reduced. HRT has a role in alleviating some of the mood swings and reduced sexual desire that are common in menopause.

Additionally, studies have demonstrated that HRT has an inverse relation with colon cancer, Alzheimer's disease and other cognitive disorders (JAMA 2002).

With the above concerns related to a possible increased risk of heart disease, stroke and some cancers, symptomatic women, may have to think twice before considering HRT.

What can you do safely about the hot flashes, the dryness of vaginal mucosal surfaces short of HRT etc? Certainly you can live with the symptoms as some women choose to do, however this is not very palatable.

A significant amount of research is ongoing to investigate alternative treatments for symptoms of menopause and premenstrual syndrome particularly with herbs and natural alternatives to estrogen and progesterone. Herbs that have been used in the study for menopausal symptoms include Black cohosh (Actaea racemosa), Chaste tree berry (vitex agnus-castus), Soy protein, Dong quai, licorice and alfalfa.

Black cohosh: Black cohosh has become a popular treatment for hot flashes and other menopausal symptoms. Black cohosh is a perennial woodlands plant, native to North America. Neither the identity of the plant's active constituents nor its precise mode of action is yet known. Most of the clinical studies have used the standardized product Remifemin. A randomized, doubleblind, placebo-controlled trial in 80 menopausal women compared 4mg Remifemin bid to placebo or 0.625mg/d conjugated estrogens. At 12 weeks, Kupperman index (Index of menopausal symptoms used to evaluate the effectiveness of different therapies for reducing menopausal symptoms)and Hamilton anxiety scale (scale to quantify the severity of anxiety symptoms) scores were significantly lower in both treated groups compared to the placebo group. This is one of the few studies that assessed vaginal epithelium, and also one of the few that assessed hot flashes separately from other symptoms. Vaginal epithelium was significantly improved in the Remifemin group. Daily hot flashes decreased from 4.9 to 0.7 in the Remifemin group; from 5.2 to 3.2 in the estrogen group; and from 5.1 to 3.1 in the placebo group. The studies have also proven that black cohosh does not effect two specific hormones, lutenizing hormone (LH) and Follicular stimulating hormone. Black cohosh has been used by midwives; it may be combined with the unrelated blue cohosh (caulophyllum thalictroides) to prepare for labor or strengthen or restart contractions. Some adverse events have been reported with this combination and it is due to the vasoconstrictive component of blue cohosh and is not related to the black cohosh.

Side effects: Side effects of Black cohosh include gastrointestinal discomfort or a frontal headache; nausea, dizziness, and bradycardia (reduced heart rate) also have been attributed to Black cohosh.

Black cohosh traditionally has not been used for long periods of time, and no published studies have followed women for more than six months. Long term use has not been carefully studied and further investigation is appropriate and on-going. There is some suggestion that women with breast cancer should avoid black cohosh until its effects on breast tissue have been better established. However, there is no proof that there are harmful effects.

Chaste tree berry (Vitex agnus-castus) The chaste tree berry gets its name from the belief that the plant would inspire chastity. To help with chastity, monks would eat the berries or seeds as a spice to decrease sexual desire. Vitex is effective in the treatment of the premenstrual syndrome based on a study conducted on 178 women with a mean age of 36 years and the following parameters: irritability, mood alteration, anger, headache, breast fullness, and other menstrual symptoms including bloating. More than half the women had a 50% or greater improvement in their symptoms without change in their libido.

Soy and hot flashes: High dietary soy intake in Japan and other Asian countries has been suggested to be the major reason for the apparently lower prevalence of menopausal symptoms in Asia. In post menopausal women the estrogen levels are low and most of the post menopausal symptoms are due to low estrogen levels. Plant based estrogens are called Phytoestrogens and they are isoflavone, lignans, dadzein, genistein and coumestans. There are many others as well, but these are the primary ones. Isoflavone precursors are found in soybeans, other beans, clover and alfalfa. Lignan precursors are found in whole grains, seeds fruits and vegetables especially flaxseed, rye, millet and legumes. Intestinal bacteria convert Isoflavone precursors into their activated unconjugated isoflavones, genestein, daidzein and equol. Eleven randomized controlled trials have examined soy or isoflavone supplementation for hot flashes. Four found a positive effect, five found a negative effect, and two found mixed effects. Only three of eight studies with treatment phases that lasted longer than six weeks showed significant improvement in hot flashes at the end of the study. Nonetheless, many have reported a benefit of being of being on soy products which have been shown to reduce the risk of osteoporosis and heart disease.

Safety: Soy foods have been a staple in Asian cuisine for thousands of years and are presumed safe. Supplementing the diet with beans or bean products should not cause any problems. Since soy is composed of phytoestrogens (plant based estrogen) there has been some concern in the use of soy in patients who have proven estrogen receptor positive breast cancer. Thus at this time if you have a known diagnosis of breast cancer, you should avoid consumption of high amounts of soy products if you are estrogen receptor positve. There has also been a concern about ingesting the genetically modified or altered soy products. So until it is proven safe it is probably best to consume soy products/supplements that have not been genetically altered.

Dong Quai: Dong quai is used orally for gynecological ailments including menstrual cramps, irregularity, retarded flow, weakness during menstrual period and symptoms of menopause. It is also used orally to manage hypertension, rheumatism, ulcers, anemia and constipation; and in the prevention and treatment of allergic attacks. Dong quai is also used orally for the treatment of skin depigmentation and psoriasis. Dong quai acts on estrogen receptors present in estrogen responsive cells by competitively inhibiting estrogen, thereby increasing their cell division. Dong quai increases uterine weight, decreases Lutenizing hormone levels and favors the growth of estrogen dependent breast cancer cell. Dong quai has several coumarin constituents which act as vasodialators, anticoagulent and antispasmodics. Dong quai is safe when used orally and appropriately. It is possibly unsafe when used in large amounts as it contains several carcinogens and some of the constituents can cause photosensitization and photodermatitis. Dong quai is unsafe in pregnancy as it has an uterine stimulant and relaxant effects. Dong quai is ineffective for treating menopausal symptoms according to one well designed study had found that dong quai had no effect on endometrial wall thickness or menopausal symptoms (Hirata JD, et al., Fertil Steril, 1997) Concomitant use of any medications that have coumarin constituents or affect platelet aggregation could theoretically increase the risk of bleeding in some people. Dong quai can be taken upto 3 to 4 gms per day in divided doses. In the doses that are provided by most herbalists, Dong quai is considered safe and effective.

Evening Primrose Oil: (Oenothera biennis) Primrose oil is used orally for premenstrual syndrome, cyclic and non-cyclic mastalgia (breast pain), endometriosis, and symptoms of menopause such as hot flashes and osteoporosis. It is also used orally for atopic eczema; psoriasis; acne; rheumatoid arthritis; hypercholesterolemia syndrome; coronary heart disease; Alzheimer's disease; and schizophrenia. Evening primrose oil has also been used orally in pregnancy for preventing preeclampsia, shortening the duration of labor, stimulating labor, and preventing post-date deliveries. Evening primrose oil is safe when used orally and appropriately. Several studies were done without reports of significant side effects. Evening primrose oil is obtained from the plant seed. It contains 2-16% gamma-linolenic acid (GLA), 65-80% linoleic acid and vitamin E (Kleijnen J, BMJ 1994 and Belch J, Hill A. Am J Clin Nutr 2000). The GLA constituent is responsible for the anti inflammatory, effects of evening primrose oil. There is also interest in using evening primrose oil for conditions that might result from metabolic deficiencies. Patients with premenstrual syndrome are thought to have lower levels of GLA, possibly due to a defect in the conversion of Linoleic acid to GLA (Hardy ML. J Am Pharm Assoc 2000),hence supplementing with primrose oil to these patients might relieve some of the symptoms of premenstrual syndrome. Evening primrose oil might help in lowering elevated plasma lipid and inhibit platelet aggregation (Guivernau M, Meza N, Barja P, Roman O, Prostaglandins, Leukot, Essent fatty acids,1994). Evening Primrose oil can cause indigestion, nausea, soft stools and headache in some people. Evening primrose oil might increase the risk for pregnancy complications, including premature rupture of membranes, oxytocin augmentation and arrest of descent (Dove D, Johnson P, J Nurse Midwifery, 1999). Since primrose oil has antiplatelet properties, concomitant use of herbs or medications that affect platelet aggregation could increase the risk of bleeding in some people. Seizures have been reported in people with schizophrenia treated concomitantly with phenothiazine drugs and evening primrose oil. For premenstrual syndrome 2-4gms per day of evening primrose oil can be safely given. For mastalgia (breast pain), it should be given in a dose of 3-4gms per day.

Wild Yam (Discorea Villosa)Wild yam is used orally as a natural alternative for estrogen replacement therapy, postmenopausal vaginal dryness, premenstrual syndrome, osteoporosis, increasing libido in men and women, and for breast enlargement.. Wild yam is also used orally for treating diverticulosis, gallbladder colic, painful mestruation, cramps and rheumatiod arthritis. Diosgenin, the constituent of wild yam is used as a precursor in the commercial preparation of human steroidal hormones. During pregnancy and lactation there is insufficient information available about usage of wild yam and hence in these circumstances, it should be avoided. The applicable part of wild yam is the root, which contains diosgenin, a steroid precursor. Wild yam extract enhances estradiol binding to estrogen receptors and induces transcription activity in estrogen responsive cells (Eagon PK, Elm MS, Hunter DS, et al., Breast Cancer Res Prog, Atlanta, 2000) and should be avoided in women with hormone sensitive conditions like uterine fibroids, endometriosis, breast, uterine, and ovarian cancers. Orally, ingestion of large amounts of wild yam tincture has caused emesis. Orally, ingestion of large amounts of wild yam tincture has caused emesis. Insufficient information is available regarding interactions with other herbs or medications.

Magnets for Hot flashes: A randomized, placebo-controlled, crossover pilot trial in 15 postmenopausal breast cancer survivors with hot flashes was conducted and this study does not support the use of magnets for treating hot flashes.

Complementary/Integrative Medicine (CIM) Use for menopause: A Telephone survey of 886 women (ages 45-65) in a health maintenance organization in Washington State was conducted. Women were asked about their use of eight CIM categories: herbal, homeopathic, or naturopathic therapies; visits to a homeopathic or naturopathic physician; visits to an herbalist; dietary soy products; acupuncture; massage therapy or other body work; chiropractic; or relaxation and stress management. Women were asked about past or present use of the therapy category; if they had ever used it for menopausal symptoms, and if so, how helpful the therapy was.

Results: For past and present use for any reason, relaxation or stress management was the most popular therapy reported, being utilized by 362 (43.1%) of respondents; herbal, homeopathic, or naturopathic therapies were used by 328 (37%); chiropractic by 280 (31.6%); bodywork by 261 (29.5%); dietary soy products by 203 (22.9%); acupuncture by 92 (10.4%); visits to a homeopathic or naturopathic physician 83 (9.4%) and visits to an herbalist 41 (1.2%). Women who were not on HRT were twice as likely to use alternative therapies than women on HRT. Of those who used CAM therapies, more than 80% in each category reported that the therapies were somewhat or very helpful for symptom relief.

References:

1. Hardy ML. Herbs of special interest to women. J Am Pharm Assoc (Wash). 2000 Mar-Apr 40(2): 234-42.

2. Herbal medicine. Black cohosh: the woman's herb? Harv Womens Health Watch. 2000 Apr 7(8): 6.

3. Lieberman S. A review of the effectiveness of cimicifuga racemosa (black cohosh) for the symptoms of menopause. J Womens Health. 1998 Jun 7(5): 525-9.

4. Wade C, Kronenberg F, Kelly A, Murphy PA. Hormone-modulating herbs: implications for women's health. J Am Med Women's Assoc. 1999 Fall 54(4): 181-3.

5. Zhu DP. Dong Quai. Am J Chin Med. 1987 15(3-4): 117-25.

6. Fugh-Berman A. Herb-drug interactions. Lancet. 2000 Jan 8 355(9198): 134-8.

7. Hirata JD, Swiersz LM, Zell B, Small R, Ettinger B. Does dong quai have estrogenic effects in postmenopausal women? A double-blind, placebo-controlled trial. Fertil Steril. 1997 Dec 68(6): 981-6.

8. Shaw CR. The perimenopausal hot flash: epidemiology, physiology, and treatment. Nurse Pract. 1997 Mar 22(3): 55-6.

9. Messina M. Modern applications for an ancient bean: soybeans and the prevention and treatment of chronic disease. J Nutr. 1995 Mar;125(3 Suppl):567S-569S.

10. Glencross RG, Festenstein GN, King HG. Separation and determination of isoflavones in the protein concentrate from red clover leaves. J Sci Food Agric. 1972 Mar 23 (3): 371-6.

11. Howes JB, Sullivan D, Lai N, Nestel P, Pomeroy S, West L, Eden JA, Howes LG. The effects of dietary supplementation with isoflavones from red clover on the lipoprotein profiles of post-menopausal women with mild to moderate hypercholesterolaemia. Atherosclerosis. 2000 Sep 152(1): 143-7.

12. Merz-Demlow BE, Duncan AM, Wangen KE, Xu X, Carr TP, Phipps WR, Kurzer MS. Soy isoflavones improve plasma lipids in normocholesterolemic, premenopausal women. Am J Clin Nutr. 2000 Jun 71(6): 1462-9.

13. Nestel PJ, Pomeroy S, Kay S, Komesaroff P, Behrsing J, Cameron JD, West L. Isoflavones from red clover improve systemic arterial compliance but not plasma lipids in menopausal women. J Clin Endocrinol Metab. 1999 Mar 84(3): 895-8.

14. Clarkson TB, Anthony MS. Phytoestrogens and coronary heart disease. Baillieres Clin Endocrinol Metab. 1998 Dec 12(4): 589-604.

15. Dwyer J. Overview: dietary approaches for reducing cardiovascular disease risks. J Nutr. 1995 Mar 125(3): 656S-665S.

16. Knight DC, Eden JA. A review of the clinical effects of phytoestrogens. Obstet Gynecol. 1996 May 87(5 Pt 2): 897-904.

17. Dollbaum CM. Lab analyses of salivary DHEA and progesterone following ingestion of yam-containing products. Townsend Letter for Doctors and Patients. Oct 1995:104.

18. Bordia A, Verma SK, Srivastava KC. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease. Prostaglandins Leukot Essent Fatty Acids. 1997 May 56(5): 379-84.

19. Ravikumar P, Anuradha CV. Effect of fenugreek seeds on blood lipid peroxidation and antioxidants in diabetic rats. Phytother Res. 1999 May 13(3):197-201.

20. Sauvaire Y, Ribes G, Baccou JC, Loubatieeres-Mariani MM. Implication of steroid saponins and sapogenins in the hypocholesterolemic effect of fenugreek. Lipids. 1991 Mar 26(3): 191-7.

21. Auterhoff H, Haufel HP. Contents of Damiana drugs. Arch Pharm Ber Dtsch Pharm Ges. 1968 Jul 301(7): 537-44.

22. Lowry TP. Damiana. J Psychoactive Drugs. 1984 Jul-Sep 16(3): 267-8.

23. Zava DT, Dollbaum CM, Blen M. Estrogen and progestin bioactivity of foods, herbs, and spices. Proc Soc Exp Biol Med. 1998 Mar 217(3): 369-78.

Side effects:

Black cohosh may cause gastrointestinal discomfort, nausea, dizziness and/or bradycardia (reduced heart rate). There is some suggestion that women with breast cancer should avoid black cohosh until its effects on breast tissue have been better established.

Dong quai may increase sensitivity to sunlight. Dong quai should not be used in conjunction with other blood-thinning medications or supplements. Because of dong quai's ability to increase bleeding time, use should be discontinued as soon as menstruation begins.

Wild yam should be avoided in women with hormone sensitive conditions like uterine fibroids, endometriosis, breast, uterine, and ovarian cancers.

Possible side effects of Vitex include headache, nausea, gastrointestinal and abdominal discomfort, and a skin rash.

Damiana may have a mild laxative and stool-softening effect, especially when used at high doses.

Body Language Vitamin Co reserves all rights to this proprietary information. Any use of this information without the express written consent of BLV Co or Michael D. Seidman, MD is considered a violation of copyright/trademark laws and persons knowingly or unknowingly found guilty of copying or using this information will be punished to the fullest extent of the law.

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