Woman's Health Menopause Update

Woman's Corner

Estrogen Revisited

Bio-identical Hormones

Black Cohosh

Soy

Flax Seed

Menopause Update 2006 ⁺

The Women's Health Initiative (WHI), a large, federally funded study commissioned in 1991 to investigate a multiplicity of health issues in post-menopausal women, has been fraught with controversy. Research evolving from the WHI has been criticized for poor study design, resulting in controversial and confusing data on a variety of health issues involving post-menopausal women. In 2002 results from the WHI, which investigated the risks and benfits of hormone replacement therapy (HRT), overturned prevailing medical opinion (see Woman's Corner Archives). As a result millions of women abruptly went off hormone therapy.

Estrogen Revisited

The data was re-analyzed and, as many suspected, the pendulum swung back. Estrogen was exonerated to some extent, albeit cautiously. Progestin (synthetic progesterone) emerged as the hormone to avoid. The following is a summary of recent research:

Estrogen, by itself, does not seem to increase the risk of breast cancer in woman who take it for 5 years or less.¹
Progestin appears to be the culprit in breast cancer risk.
Estrogen does not increase the risk of heart disease in women 50 to 59 years old and may be of benefit.²
Women in the 50 to 59 years age group had a statistically significant 45% reduction in coronary bypass and angioplasty procedures.²
Estrogen, when started in younger, recently menopausal woman , may lower the risk of heart disease.³
Elderly woman, over 70 years old, seem to have a higher risk of heart attack if on estrogen, although this data was not statistically significant.²

Pharmaceutical companies are now promoting lower doses of estrogen and doctors are moving toward lowering exposure to progestin in woman who have an intact uterus.

Bio-identical Hormones

Compounding pharmacies are promoting the benefits of bio-identical hormone replacement therapy (BHRT). Some pharmacies claim bio-identical hormnes are safer than hormones produced by pharmaceutical companies. They incorporate a weaker estrogen called estriol into formulas and claim it is safer. Saliva testing is promoted by compounding pharmacies to determine the need for a given hormone and monitor therapy.

The pharmaceutical company, Wyeth has asked the FDA to crackdown on compounding pharmacies. A major controversy has erupted. Women seeking help for menopause symptoms are, again, stuck in the middle. As a pharmacist I would like to weigh in on this controversy, in order to help those who may be confused. While I support pharmacy's right to compound, I think information should presented to women should be balanced.

Here are some facts, plus my opinions:

There is no evidence that the three estrogens commonly used by compounding pharmacies - estrone (E1), estradiol (E2), and estriol (E3) - are safer than hormones made by drug companies. According to the North American Menopause Society, BHRT poses the same risks as convential HRT.
It may very well be that bio-identical is better than synthetic, we need more studies to know for sure.
Compounding pharmacies offer a great deal more flexibility in dosing and dosage form, allowing the use of smaller dosages.
Estriol, because it is a weaker estrogen, has to be used in a higher dose to combat hot flashes.
When compounded creams are used as the delivery system for hormones, there may be erratic blood levels. You may have break-through bleeding and flashing and may not be getting adequate bone protection.
Some insurance companies do not cover compounded hormone replacement therapy.
Saliva testing is expensive, generally not covered by insurers and, according to a recent study, does not correlate with a woman's symptoms. According to the study, saliva testing is not a reliable way to determine hormone requirements.⁴Many doctors, including those who practice complimentary medicine, use a combination of tests in conjuction with symptoms to evaluate hormine needs.
In my opinion, bio-identical (natural) progesterone may not be as safe as many compounding pharmacies proclaim. Progesterone is not heart healthy and may be over-used and over-dosed. Some individuals may experience a significant rise in blood pressure and it may produce insulin resistance. Be careful.
Quality is an issue with compounding pharmacies - you need to do your homework and make sure it is a reputable company.

Keep in mind that drug companies make "bio-identical" hormones also. Estradiol (E2) has long been used by pharmaceutical companies for HRT and comes in tablets, patches and vaginal products.

Herbal Products

Among all the herbal therapies for menopausal symptoms, Black Cohosh and Soy have the best evidence and are worth a try.

Black Cohosh (Cimicifuga Racemosa)

Black Cohosh modestly reduces hot flashes and anxiety associated with menopause.⁵ Based upon recent research, it is no longer considered a phytoestrogen.⁶ Consequently some physicians combine it with HRT in order to reduce exposure to hormones. Product quality is important. Remifemin is a high quality brand by Enzymatic Therapy. Remifemin, the most studied Black Cohosh, is the most often recommended by OBGYNs. A study compared Remifemin to a low dose prescription estrogen patch called Estraderm. Remifemin performed favorably in reducing menopausal symptoms.⁷ Black Cohosh may protect bone.

There have been a few reports of liver disease with black cohosh, so let your doctor know if you are taking it. Signs would be fatigue, yellowing of the skin, itching. In reported cases patients were taking other herbs or were taking a product that may have been contaminated with a toxic herb. Quality is important, so choose a brand such as Remifemin that is produced by a company that complies with Good Manufacturing Practices. PhytoPharmica, which owns Enzymatic Therapy, is such a company.

Soy (Glycine Max)

Soy protein and soy extracts decrease hot flashes in some woman. Effective amounts of soy protein are in the range of 20 to 60 grams per day, delivering 30 to 80 mg of isoflavones.⁸ When shopping for soy extracts, look for the dose of soy isoflavones on the label. Ranges of 30 to 100 mg. are effective.⁹ Avoid high doses of soy if you have had breast cancer. A recent study of soy in post-menopausal woman concluded that 60 mg of isoflavones a day improved mood and cognitive performance.¹⁰

Flax Seed

Flax seed contains substances are transformed in the gut to lignans. Lignans have weak estrogenic and anti-estrogenic activity. Post-menopausal woman who took 40 grams per day of flax seed experienced mild improvement in hot flashes.¹¹Flax seed derived lignans appear to compete for binding sites with estrogen in some tissues, such as the breast.¹² This competition may provide some protection against breast cancer. Women who do not have breast cancer have higher amounts of these lignans in their urine than woman with breast cancer.^13,14A lignan precursor from flax seed, called secoisolariciresinol diglycoside (SDG), is the primary ingredient in a supplement called BRxevail. Some woman have found this product helpful for menopausal symptoms, and have chosen it to protect breast health.

1) Stefnaik ML et al Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006 Apr 12;295(14):1647-57.

2) Hsia J et al Conjugated equine estrogens and coronary heart disease: the Women's Health Initiative. Arch Intern Med. 2006 Feb 13;166(3):357-65.

3) Manson JM, Grodstein, F, et al Hormone Therapy and Coronary Heart Disease: The Role of Time Since Menopause and Age at Hormone Initiation Journal of Woman's Health January/February 2006 issue (Vol. 15, No. 1)

4) Boothby, LA, Bioidentical hormone therapy: a review. Menopause. 2004 May-Jun;11(3):356-67. Review.

5) Wuttke W, Seidlova-Wuttke D, Gorkow C. The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers. Maturitas 2003;44:S67-77

6) Liske E, Hanggi W, Henneicke-von Zepelin HH, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med 2002;11:163-74.

7) Nappi RE, Malavasi B, Brundu B, Facchinetti F. Efficacy of Cimicifuga racemosa on climacteric complaints: a randomized study versus low-dose transdermal estradiol. Gynecol Endocrinol 2005;20:30-5.

8) Washburn S, Burke GL, Morgan T, et al. Effect of soy protein supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in perimenopausal women. Menopause 1999;6:7-13.

9) Scambia G, Mango D, Signorile PG, et al. Clinical effects of a standardized soy extract in postmenopausal women: a pilot study. Menopause 2000;7:105-11

10) Casini ML, Marelli G, et.al. Psychological assessment of the effects of treatment with phytoestrogens on postmenopausal women: a randomized, double-blind, crossover, placebo-controlled study. Erspamer, University La Sapienza, Rome, Italy. Fertil Steril. 2006 Apr;85(4):972-8

11) Lemay A, Dodin S, Kadri N, et al. Flaxseed dietary supplement versus hormone replacement therapy in hypercholesterolemic menopausal women. Obstet Gynecol 2002;100:495-504.

12) Serraino M, Thompson LU. The effect of flaxseed supplementation on early risk markers for mammary carcinogenesis. Cancer Lett 1991;60:135-42

13) Adlercreutz H, Heikkinen R, Woods M, et al. Excretion of the lignans enterolactone and enterodiol and of equol in omnivorous and vegetarian postmenopausal women and in women with breast cancer. Lancet 1982;2:1295-9.

14) Adlercreutz H, Fotsis T, Bannwart C, et al. Determination of urinary lignans and phytoestrogen metabolites, potential antiestrogens and anticarcinogens, in urine of women on various habitual diets. J Steroid Biochem 1986;25:791-7.

Hormone Replacement HRT Soy Remifemin Black Cohosh Bio-identical Hormones Bioidentical Hormones Estriol Climacteric Menopause glycine max Cimicifuga racemosa Soy extracts isoflavones flax lignans Brevail BRxevail

+ These statements have not been approved by the Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any disease.

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Woman's Corner Estrogen Revisited Bio-identical Hormones Black Cohosh Soy Flax Seed Menopause Update 2006 ⁺ The Women's Health Initiative (WHI), a large, federally funded study commissioned in 1991 to investigate a multiplicity of health issues in post-menopausal women, has been fraught with controversy. Research evolving from the WHI has been criticized for poor study design, resulting in controversial and confusing data on a variety of health issues involving post-menopausal women. In 2002 results from the WHI, which investigated the risks and benfits of hormone replacement therapy (HRT), overturned prevailing medical opinion (see Woman's Corner Archives). As a result millions of women abruptly went off hormone therapy. Estrogen Revisited The data was re-analyzed and, as many suspected, the pendulum swung back. Estrogen was exonerated to some extent, albeit cautiously. Progestin (synthetic progesterone) emerged as the hormone to avoid. The following is a summary of recent research: Estrogen, by itself, does not seem to increase the risk of breast cancer in woman who take it for 5 years or less.¹ Progestin appears to be the culprit in breast cancer risk. Estrogen does not increase the risk of heart disease in women 50 to 59 years old and may be of benefit.² Women in the 50 to 59 years age group had a statistically significant 45% reduction in coronary bypass and angioplasty procedures.² Estrogen, when started in younger, recently menopausal woman , may lower the risk of heart disease.³ Elderly woman, over 70 years old, seem to have a higher risk of heart attack if on estrogen, although this data was not statistically significant.² Pharmaceutical companies are now promoting lower doses of estrogen and doctors are moving toward lowering exposure to progestin in woman who have an intact uterus. Bio-identical Hormones Compounding pharmacies are promoting the benefits of bio-identical hormone replacement therapy (BHRT). Some pharmacies claim bio-identical hormnes are safer than hormones produced by pharmaceutical companies. They incorporate a weaker estrogen called estriol into formulas and claim it is safer. Saliva testing is promoted by compounding pharmacies to determine the need for a given hormone and monitor therapy. The pharmaceutical company, Wyeth has asked the FDA to crackdown on compounding pharmacies. A major controversy has erupted. Women seeking help for menopause symptoms are, again, stuck in the middle. As a pharmacist I would like to weigh in on this controversy, in order to help those who may be confused. While I support pharmacy's right to compound, I think information should presented to women should be balanced. Here are some facts, plus my opinions: There is no evidence that the three estrogens commonly used by compounding pharmacies - estrone (E1), estradiol (E2), and estriol (E3) - are safer than hormones made by drug companies. According to the North American Menopause Society, BHRT poses the same risks as convential HRT. It may very well be that bio-identical is better than synthetic, we need more studies to know for sure. Compounding pharmacies offer a great deal more flexibility in dosing and dosage form, allowing the use of smaller dosages. Estriol, because it is a weaker estrogen, has to be used in a higher dose to combat hot flashes. When compounded creams are used as the delivery system for hormones, there may be erratic blood levels. You may have break-through bleeding and flashing and may not be getting adequate bone protection. Some insurance companies do not cover compounded hormone replacement therapy. Saliva testing is expensive, generally not covered by insurers and, according to a recent study, does not correlate with a woman's symptoms. According to the study, saliva testing is not a reliable way to determine hormone requirements.⁴Many doctors, including those who practice complimentary medicine, use a combination of tests in conjuction with symptoms to evaluate hormine needs. In my opinion, bio-identical (natural) progesterone may not be as safe as many compounding pharmacies proclaim. Progesterone is not heart healthy and may be over-used and over-dosed. Some individuals may experience a significant rise in blood pressure and it may produce insulin resistance. Be careful. Quality is an issue with compounding pharmacies - you need to do your homework and make sure it is a reputable company. Keep in mind that drug companies make "bio-identical" hormones also. Estradiol (E2) has long been used by pharmaceutical companies for HRT and comes in tablets, patches and vaginal products. Herbal Products Among all the herbal therapies for menopausal symptoms, Black Cohosh and Soy have the best evidence and are worth a try. Black Cohosh (Cimicifuga Racemosa) Black Cohosh modestly reduces hot flashes and anxiety associated with menopause.⁵ Based upon recent research, it is no longer considered a phytoestrogen.⁶ Consequently some physicians combine it with HRT in order to reduce exposure to hormones. Product quality is important. Remifemin is a high quality brand by Enzymatic Therapy. Remifemin, the most studied Black Cohosh, is the most often recommended by OBGYNs. A study compared Remifemin to a low dose prescription estrogen patch called Estraderm. Remifemin performed favorably in reducing menopausal symptoms.⁷ Black Cohosh may protect bone. There have been a few reports of liver disease with black cohosh, so let your doctor know if you are taking it. Signs would be fatigue, yellowing of the skin, itching. In reported cases patients were taking other herbs or were taking a product that may have been contaminated with a toxic herb. Quality is important, so choose a brand such as Remifemin that is produced by a company that complies with Good Manufacturing Practices. PhytoPharmica, which owns Enzymatic Therapy, is such a company. Soy (Glycine Max) Soy protein and soy extracts decrease hot flashes in some woman. Effective amounts of soy protein are in the range of 20 to 60 grams per day, delivering 30 to 80 mg of isoflavones.⁸ When shopping for soy extracts, look for the dose of soy isoflavones on the label. Ranges of 30 to 100 mg. are effective.⁹ Avoid high doses of soy if you have had breast cancer. A recent study of soy in post-menopausal woman concluded that 60 mg of isoflavones a day improved mood and cognitive performance.¹⁰ Flax Seed Flax seed contains substances are transformed in the gut to lignans. Lignans have weak estrogenic and anti-estrogenic activity. Post-menopausal woman who took 40 grams per day of flax seed experienced mild improvement in hot flashes.¹¹Flax seed derived lignans appear to compete for binding sites with estrogen in some tissues, such as the breast.¹² This competition may provide some protection against breast cancer. Women who do not have breast cancer have higher amounts of these lignans in their urine than woman with breast cancer.^13,14A lignan precursor from flax seed, called secoisolariciresinol diglycoside (SDG), is the primary ingredient in a supplement called BRxevail. Some woman have found this product helpful for menopausal symptoms, and have chosen it to protect breast health. 1) Stefnaik ML et al Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006 Apr 12;295(14):1647-57. 2) Hsia J et al Conjugated equine estrogens and coronary heart disease: the Women's Health Initiative. Arch Intern Med. 2006 Feb 13;166(3):357-65. 3) Manson JM, Grodstein, F, et al Hormone Therapy and Coronary Heart Disease: The Role of Time Since Menopause and Age at Hormone Initiation Journal of Woman's Health January/February 2006 issue (Vol. 15, No. 1) 4) Boothby, LA, Bioidentical hormone therapy: a review. Menopause. 2004 May-Jun;11(3):356-67. Review. 5) Wuttke W, Seidlova-Wuttke D, Gorkow C. The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers. Maturitas 2003;44:S67-77 6) Liske E, Hanggi W, Henneicke-von Zepelin HH, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med 2002;11:163-74. 7) Nappi RE, Malavasi B, Brundu B, Facchinetti F. Efficacy of Cimicifuga racemosa on climacteric complaints: a randomized study versus low-dose transdermal estradiol. Gynecol Endocrinol 2005;20:30-5. 8) Washburn S, Burke GL, Morgan T, et al. Effect of soy protein supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in perimenopausal women. Menopause 1999;6:7-13. 9) Scambia G, Mango D, Signorile PG, et al. Clinical effects of a standardized soy extract in postmenopausal women: a pilot study. Menopause 2000;7:105-11 10) Casini ML, Marelli G, et.al. Psychological assessment of the effects of treatment with phytoestrogens on postmenopausal women: a randomized, double-blind, crossover, placebo-controlled study. Erspamer, University La Sapienza, Rome, Italy. Fertil Steril. 2006 Apr;85(4):972-8 11) Lemay A, Dodin S, Kadri N, et al. Flaxseed dietary supplement versus hormone replacement therapy in hypercholesterolemic menopausal women. Obstet Gynecol 2002;100:495-504. 12) Serraino M, Thompson LU. The effect of flaxseed supplementation on early risk markers for mammary carcinogenesis. Cancer Lett 1991;60:135-42 13) Adlercreutz H, Heikkinen R, Woods M, et al. Excretion of the lignans enterolactone and enterodiol and of equol in omnivorous and vegetarian postmenopausal women and in women with breast cancer. Lancet 1982;2:1295-9. 14) Adlercreutz H, Fotsis T, Bannwart C, et al. Determination of urinary lignans and phytoestrogen metabolites, potential antiestrogens and anticarcinogens, in urine of women on various habitual diets. J Steroid Biochem 1986;25:791-7. Hormone Replacement HRT Soy Remifemin Black Cohosh Bio-identical Hormones Bioidentical Hormones Estriol Climacteric Menopause glycine max Cimicifuga racemosa Soy extracts isoflavones flax lignans Brevail BRxevail + These statements have not been approved by the Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any disease. Disclaimer and Privacy Policy Jurisdiction	Shoppe Shop Woman's Health Remifemin brand of Black Cohosh is the brand most often recommended by OBGYNs Buy Remifemin #120 at 20% off! Buy Remifemin #60 at 20% off Remifemin Technical Info BRxevail has flax lignan precursors that may support menopausal relief and breast health Buy Response Cream with l-arginine Buy Soy Isoflavones 50 mg by Vital Nutrients Buy Healthy Cells Breast by PhytoPharmica 20% off Achieving an Optimum Weight Our Commitment to Quality NanoGreens 10 ProGreens