Bio-identical Hormones Studies

Bio-identical hormones studies

The FDA would like you to believe that bio-identical hormones are not safer nor as effective as FDA-approved hormone therapy drugs.
The studies below have shown that bio-identical hormones are both safer and as effective as FDA-approved therapy, and that they provide additional positive benefits for patients with Alzheimer’s, heart disease, and other health issues.


Estriol and Endometrial Cancer Risk – 1993: This study showed that low dose bio-identical estradiol and progesterone treatment did not cause endometrial overgrowth, (associated with cancer risk) after 5 years of treatment.

Moyer DL, de Lignieres B, Driguez P, Pez JP. Prevention of endometrial hyperplasia by progesterone during long-term estradiol replacement: influence of bleeding pattern and secretory changes. Fertil Steril.  1993 May;59(5):992-7.


Endometrial Protection: This study showed no endometrial overgrowth (associated with cancer risk), with bio-identical estrogen combined with progesterone.

Gillet JY, Andre G, et al. Induction of amenorrhea during hormone replacement therapy: optimal micronized progesterone dose. A multicenter study. Maturitas. 1994 Aug;19(2):103-15.


Estriol and Breast Cancer Prevention: This 35 year study showed a significant protective role of estriol against breast cancer.

Pentii K. Siiteri, Robert I. Sholtz, Piera M. Cirillo, Richard D. Cohen, Roberta E. Christianson, Barbara J. van den Berg, William R. Hopper, and Barbara A. Cohn – Prospective Study Of Estrogens During Pregnancy And Risk Of Breast Cancer- Public Health Institute
The U.S. Army Medical Research and Materiel Command under DAMD17-99-1-9358 supported this work.


Estradiol and Progesterone and Hypertension: This study showed positive effects for women with hypertension and high cholesterol on bio-identical HRT.

Spritzer PM, Vitola D, Vilodre LC, Wender MC, Reis FM, Ruschel S, Castro I. One year follow-up of hormone replacement therapy with percutaneous estradiol and low-dose vaginal natural progesterone in women with mild to moderate hypertension. Exp Clin Endocrinol Diabetes. 2003 Aug;111(5):267-73.


CNS Protection – PDF: This review discusses the protective role of bio-identical estradiol against neurodegenerative diseases such as Alzheimer’s.
Wise PM, Dubal DB, Rau SW, Brown CM, Suzuki S. Are estrogens protective or risk factors in brain injury and neurodegeneration? Reevaluation after the Women’s Health Initiative. Endocr Rev. 2005 May;26(3):308-12. Epub 2005 Apr 25.


Estradiol and Alzheimer’s Protection: This study showed a protective effect of bio-identical estradiol against Alzheimer’s disease markers in postmenopausal women.

Baker LD, Sambamurti K, Craft S, Cherrier M, Raskind MA, Stanczyk FZ, Plymate SR, Asthana S. 17beta-estradiol reduces plasma Abeta40 for HRT-naive postmenopausal women with Alzheimer disease: a preliminary study. Am J Geriatr Psychiatry. 2003 Mar-Apr;11(2):239-44.


Estriol and Alzheimer’s: This study shows the protective effect of estrogen against the accumulation of Alzheimer’s associated peptides in human and rat brain cells.
Xu H, Gouras GK, Greenfield JP, Vincent B, Naslund J, Mazzarelli L, Fried G, Jovanovic JN, Seeger M, Relkin NR, Liao F, Checler F, Buxbaum JD, Chait BT, Thinakaran G, Sisodia SS, Wang R, Greengard P, Gandy S. Estrogen reduces neuronal generation of Alzheimer beta-amyloid peptides. Nat Med. 1998 Apr;4(4):447-51.


These two studies show a possible benefit of Estriol on patients with Multiple Sclerosis.

Nancy L. Sicotte, MD, Stephanie M. Liva, PhD, Rochelle Klutch, RN, Paul Pfieffer, BS, Seth Bouvier, BS, Sylvia Odesa, BS, T. C. Jackson Wu, MD, PhD, and Rhonda R. Voskuhl, MD


Immune Modulation in Multiple Sclerosis Patients Treated with the Pregnancy Hormone Estriol – PDF


Samantha S. Soldan, Ana Isabel Alvarez Retuerto, Nancy L. Sicotte, and Rhonda R. Voskuhl


These two studies show that estrogen maybe effective as a treatment to reduce obesity in post-menopausal women.
Estrogens, Cortisol and Obesity 2003Klopfenstein BJ.  Oregon Health & Science University, Portland, Oregon. 24-hour Cortisol Production Rates, Free Cortisol, and Intra-Abdominal Fat Are Elevated in Postmenopausal Women but Are Similar in Premenopausal and Postmenopausal Women Taking Hormone Replacement Therapy.  Abstract of research presented at Endocrine Society annual meeting Summer 2003

Estrogens, Cortisol and Obesity 2005

Klopfenstein BJ, Samuels MH, Purnell JQ.  Oregon Health & Science University, Portland, Oregon  Estrogen therapy reduces 24-hour free cortisol levels in postmenopausal women. Abstract of research presented at Endocrine Society annual meeting Summer 2005


Estriol, Endothelial Function and Osteoporosis: This study showed that estriol treatment improved bone density and reduced atherosclerosis parameters in elderly females.
Hayashi T, Ito I, Kano H, Endo H, Iguchi A. Estriol (E3) replacement improves endothelial function and bone mineral density in very elderly women. J Gerontol A Biol Sci Med Sci.  2000 Apr;55(4):B183-90; discussion B191-3.


Estriol, Atherosclerosis and Nitric Oxide: This study shows that estriol has anti-atherosclerotic effects.
Kano H, Hayashi T, Sumi D, Matusi-Hirai H, Tsunekawa T, Endo H, Iguchi A. Estriol retards and stabilizes atherosclerosis through an NO-mediated system. Life Sci.  2002 May 24;71(1):31-42.


Estriol and Urogenital Aging Symptoms: This study showed that topical estriol was safe and effective for incontinence and urinary tract infection in elderly women.

Dessole S, Rubattu G, Ambrosini G, Gallo O, Capobianco G, Cherchi PL, Marci R, Cosmi E. Efficacy of low-dose intravaginal estriol on urogenital aging in postmenopausal women. Menopause. 2004 Jan-Feb;11(1):49-56.


Estriol and Urinary Tract Infections: This study shows that estriol is a safe and effective treatment for urinary tract infections in postmenopausal women.
Raz R, Stamm WE. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993 Sep 9;329(11):753-6.



Estriol and Endometrial Cancer Risk 1999: This study showed that when given by the proper “route of administration” (always transdermal, never oral) estriol does not increase risk of endometrial cancer.

Weiderpass E, Baron JA, Adami HO, Magnusson C, Lindgren A, Bergstrom R, Correia N, Persson I. Low-potency estrogen and risk of endometrial cancer: a case-control study. Lancet.  1999 May 29;353(9167):1824-8.




FDA-approved hormone therapies have been associated
with dangerous side effects.

Principal Results From the Women’s Health Initiative: This study found that therapy using conjugated equine estrogens and medroxyprogesterone (neither bio-identical) were associated with increased risk of breast cancer, stroke, blood clot in the lungs, and heart disease. Risk of hip fracture and colorectal cancer were reduced.
Writing Group for the Women’s Health Initiative Investigators: Jacques E. Rossouw, MBChB, MD, National Heart, Lung, and Blood Institute, Bethesda, Md; Garnet L. Anderson, PhD, Ross L. Prentice, PhD, Andrea Z. LaCroix, PhD, and Charles Kooperberg, PhD, Fred Hutchinson Cancer Research Center, Seattle, Wash; Marcia L. Stefanick, PhD, Stanford University Clinical Center, Stanford, Calif; Rebecca D. Jackson, MD, Ohio State University Clinical Center, Columbus; Shirley A. A. Beresford, PhD, Fred Hutchinson Cancer Research Center, Seattle, Wash; Barbara V. Howard, PhD, MedStar Research Institute, Washington, DC; Karen C. Johnson, MD, MPH, University of Tennessee, Memphis; Jane Morley Kotchen, MD, Medical College of Wisconsin, Milwaukee; Judith Ockene, PhD, University of Massachusetts Medical School, Worcester.

Womens Health Initiative – Cancer – PDF: This study found that estrogen therapy (not bio-identical) combined with progestins (artificial, not bio-identical progesterone) are associated with increased risk of breast cancer.

Chelbowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen plus progestin breast cancer and mammography in healthy postmenopausal women. The women’s health initiative randomized trial. JAMA 2003;289:3243–53.


Oral versus Transdermal Estrogen: This study showed an increase in the inflammatory marker CRP, (associated with cardiovascular disease risk) in users of oral non bio-identical HRT compared to transdermal bio-identical estradiol.

VongpatanasinW, Tuncel M,Wang Z, et al. Differential effects of oral versus transdermal estrogen replacement therapy on C-reactive protein in postmenopausal women. J Am Coll Cardiol 2003;41:1358–63.