Bioidentical Hormone Replacement Therapy Research Articles


Bioidentical hormone replacement therapy (BHRT) is a fascinating field of medicine with enormous amounts of research devoted to it. We have pulled together relevant BHRT articles for those who are interested in a deeper review. The list of scientific studies will help you gain additional insight into the ongoing research and its implications.

Fundamental Concepts Regarding Testosterone Deficiency and Treatment: International Expert Consensus Resolutions

PUBLISHED by Mayo Clinic Proceedings, Diagnosis and Treatment Guidelines, 2016.    AUTHORS: Abraham Morgentaler, MD (Chairman); Michael Zitzmann, MD (Cochairman); Abdulmaged M. Traish, PhD (writing group); Anthony W. Fox, MSc, MD (writing group); T. Hugh Jones, MD (writing group); Mario Maggi, MD (writing group); Stefan Arver, MD; Antonio Aversa, MD; Juliana C.N. Chan, MD; Adrian S. Dobs, MD; Geoffrey I. Hackett, MD; Wayne J. Hellstrom, MD; Peter Lim, MD; Bruno Lunenfeld, MD; George Mskhalaya, MD; Claude C. Schulman, MD; and Luiz O. Torres, MD

An international panel of experts met in October 2015 in an attempt to put together a group of consensus statements on the benefits and safety of testosterone therapy. Following the summit, the panel made 9 resolutions. The abstract clearly defines these 9 resolutions. (1) Testosterone (T) Deficiency (TD) is a well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life; (2) symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying etiology; (3) TD is a global public health concern; (4) T therapy for men with TD is effective, rational, and evidence based; (5) there is no T concentration threshold that reliably distinguishes those who will respond to treatment from those who will not; (6) there is no scientific basis for any agespecific recommendations against the use of T therapy in men; (7) the evidence does not support increased risks of cardiovascular events with T therapy; (8) the evidence does not support increased risk of prostate cancer with T therapy; and (9) the evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes. These resolutions may be considered points of agreement by a broad range of experts based on the best available scientific evidence.

Misperceptions of Testosterone Replacement Therapy and Heart Disease Risk (video)

RECORDED in Madrid, Spain, at the annual meeting of the European Association of Urology (EAU), March 2015.    AUTHORS: Dr. Abraham Morgentaler

Harvard urologist A. Morgentaler, M.D., cites 46 studies that support the cardiovascular and metabolic benefits of testosterone replacement and four studies that do not. Morgentaler identifies and explains the flaws in the four negative studies and the edits that have been made in those studies to correct the untrue statements.

The Mortality Toll of Estrogen Avoidance: An Analysis of Excess Deaths Among Hysterectomized Women Aged 50 to 59 Years

PUBLISHED on American Journal of Public Health, February 2013.   AUTHORS: Philip M. Sarrel MD, Valentine Y. Njike MD MPH, Valentina Vinante MD, David L. Katz MD MPH

Objectives: We examined the effect of estrogen avoidance on mortality rates among hysterectomized women aged 50 to 59 years.

Methods. We derived a formula to relate the excess mortality among hysterectomized women aged 50 to 59 years assigned to placebo in the Women’s Health Initiative randomized controlled trial to the entire population of comparable women in the United States, incorporating the decline in estrogen use observed between 2002 and 2011.

Results: Over a 10-year span, starting in 2002, a minimum of 18 601 and as many as 91 610 postmenopausal women died prematurely because of the avoidance of estrogen therapy (ET).

Conclusions: ET in younger postmenopausal women is associated with a decisive reduction in all-cause mortality, but estrogen use in this population is low and continuing to fall. Our data indicate an associated annual mortality toll in the thousands of women aged 50 to 59 years. Informed discussion between these women and their health care providers about the effects of ET is a matter of considerable urgency.

No VTE Risk Seen With Testosterone Therapy

PUBLISHED on MedPage and Mayo Clinic Proceedings, July 2015.   AUTHORS Jacques Baillargeon, PhD, Randall J. Urban, MD, Abraham Morgentaler, MD, Charles J. Glueck, MD, Gwen Baillargeon, MS, Gulshan Sharma, MD, MPH, Yong-Fang Kuo, PhD

Several poorly designed observational studies over the last two years have implicated testosterone as a cause for venous thrombosis or blood clots. In addition, these same studies have stated that testosterone increases the risk of having a heart attack in the first three months of use. In response to these article the FDA demanded testosterone manufactures to include a warning.

During the past year, several well designed studies have begun to clear up this misinformation. Not only is there no increased risk in having a clot while on testosterone therapy, there is solid evidence of the cardiac benefit of this treatment. In addition, testosterone therapy decreases the risk of osteoporosis and dementia. I have included a link to a recent publication from the Mayo Clinic Proceedings on this topic.

Estrogen Replacement Therapy in Breast Cancer Survivors: a Matched-Controlled Series

PUBLISHED on Menopause – The Journal of the North American Menopause Society, July 2003, Volume 10, Issue 4, pp 277-285.   AUTHORS Decker, David A. MD; Pettinga, Jane E. MD; VanderVelde, Nancy MD; Huang, Raywin R. PhD; Kestin, Larry MD; Burdakin, John H. MD

In the selected patients, ERT relieved estrogen deficiency symptoms and did not increase the rate or time to an ipsilateral recurrence/new primary, contralateral new primary, local-regional recurrence, or systemic metastases.

Estrogen Replacement Therapy After Breast Cancer: A 12-Year Follow-Up

PUBLISHED on Annals of Surgical Oncology, Dec 2001, Volume 8, Issue 10, pp 828-832.   AUTHORS George N. Peters MD, Tomasina Fodera MD, Jennifer Sabol MD, Stephen Jones MD, David Euhus MD

Use of ERT in a cohort of breast cancer survivors with tumors of generally good prognosis was not associated with increased breast cancer events compared with non-ERT users, even over a long follow-up period.

Study Finds No Convincing Evidence of Increased Cardiovascular Risk with Testosterone Therapy

PUBLISHED on HCPLive Resources, 2015.   AUTHORS Andrew Smith.

“A review of research conducted over the past 75 years finds no definitive answers about the link between testosterone supplements and cardiovascular health, but it does find far more evidence of benefit than harm.”

Testosterone Therapy and Cardiovascular Risk: Advances and Controversies

PUBLISHED on Mayo Clinic Proceedings,, 2015.   AUTHORS Abraham Morgentaler, MD, Martin M. Miner, MD, Monica Caliber, MSc, Andre T. Guay, MD, Mohit Khera, MD, Abdulmaged M. Traish, PhD.

Two recent studies raised new concerns regarding cardiovascular (CV) risks with testosterone (T) therapy. This article reviews those studies as well as the extensive literature on T and CV risks. A MEDLINE search was performed for the years 1940 to August 2014 using the following key words: testosterone, androgens, human, male, cardiovascular,stroke, cerebrovascular accident, myocardial infarction, heart attack, death, and mortality. The weight and direction of evidence was evaluated and level of evidence (LOE) assigned. Only 4 articles were identified that suggested increased CV risks with T prescriptions: 2 retrospective analyses with serious methodological limitations, 1 placebo-controlled trial with few major adverse cardiac events, and 1 meta-analysis that included questionable studies and events. In contrast, several dozen studies have reported a beneficial effect of normal T levels on CV risks and mortality. Mortality and incident coronary artery disease are inversely associated with serum T concentrations (LOE IIa), as is severity of coronary artery disease (LOE IIa). Testosterone therapy is associated with reduced obesity, fat mass, and waist circumference (LOE Ib) and also improves glycemic control (LOE IIa). Mortality was reduced with T therapy in 2 retrospective studies. Several RCTs in men with coronary artery disease or heart failure reported improved function in men who received T compared with placebo. The largest meta-analysis to date revealed no increase in CV risks in men who received T and reduced CV risk among those with metabolic disease. In summary, there is no convincing evidence of increased CV risks with T therapy. On the contrary, there appears to be a strong beneficial relationship between normal T and CV health that has not yet been widely appreciated.

Research on Benefits and Risks of Testosterone Replacement Affected by Poorly Done Studies

PUBLISHED on Wiley Online Library by AlphaMed Press, 2014.   AUTHORS Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS.

“…this was an observational study that was retrospective in nature and this type of study is fraught with compounding biases that are difficult to control as expressed in the discussion section of this study. A randomized controlled trial (RCT) would have much more power than this type of study. Also the problem with an observation study is that it does not prove causation as would an interventional study in a blinded fashion. Therefore observational studies can’t prove causation as well as RCTs and what we should take away from the study is that which the researchers state in the last paragraph, that more studies are necessary before definitive conclusions can be made as to cause and effect. Also, treatment decisions should not be based solely on one study but rather on a trend of studies. Unfortunately the editorial comment section did not express this clearly.

Testosterone Therapy May Lower Risk of Heart Disease

PUBLISHED on RTT News, 2013.

Men who receive therapy for testosterone deficiency may be putting themselves at a lower risk for cardiovascular disease, according to research conducted at the Boston University School of Medicine. The study, published in the International Journal of Clinical Practice, noted that testosterone treatment helps restore normal lipid profiles.

Early Initiation of HRT ‘Halves Risk of Death or CVD’

PUBLISHED on Pulse – Atthe Heart of General Practice, 2012   AUTHORS David Swan

GPs should aim to initiate hormone replacement therapy as early as possible after menopause, as it can halve a woman’s risk of death or a serious cardiovascular event, say researchers.

Testosterone Keeps Women’s Brains Sharp

PUBLISHED on MedPage Today, 2013.   AUTHORS Todd Neale

A testosterone gel applied daily may improve cognitive performance in postmenopausal women, a randomized trial suggested.

Testosterone Therapy May Improve Sexual Function for Women

PUBLISHED on Inquisitr.com, 2013.

Clinicians have found that administering high doses of testosterone can significantly improve sexual functioning in women who have undergone a hysterectomy and an oophorectomy.

Estrogen Is a New Weapon Against Urinary Tract Infection in Post Menopausal Woman

PUBLISHED on Science Daily, 2013.   AUTHORS Karolinska Institutet

Estrogen stimulates the production of the body’s own antibiotic and strengthens the cells in the urinary tract, according to a new study. The results show that estrogen supplements may help menopausal women to ward off recurrent urinary tract infections.

Estrogen Can Reduce Risk of Liver and Heart Disease in Women

PUBLISHED on BioOptics World, 2013.   AUTHORS Lee Mather

The research shows the beneficial effect that estrogen (the female hormone) has on liver metabolism by revealing a new type of estrogen receptor, which controls estrogen-responsive genes that regulate cholesterol and fatty acid production.

Estrogen Replacement Therapy May Save Lives After All

 PUBLISHED on Forbes, 2013.   AUTHORS Alice Walton

Women should talk openly with their doctors about the benefits and risks of the HRT, particularly of estrogen, and the timeframe in which it’s begun. “Stated bluntly,” concludes Katz, “we think the mortality toll of estrogen avoidance is not merely a clear, present, and on-going danger, it is a worsening one. More women are dying from this omission every year. And the next one in that calamitous line could be a woman you love; it could be you.”

Testosterone Therapy Does Not Hike Risk of Aggressive Prostate Cancer

PUBLISHED on Renal and Urology News, 2013.   AUTHORS Jody Charnow

Testosterone replacement therapy (TRT) is not associated with aggressive prostate cancer (PCa) and does not increase overall or disease-specific mortality, according to a study that also revealed that TRT use is low among men in the United States.

Hormone Therapy Makes Menopause Easier

PUBLISHED on Get Healthy by The Times, 2013.

“I knew I was in trouble when my 95-year-old patient suddenly got up to get a fan for me—I was sweating that much,” recalls Joanne Cubberly of Chesterton, a physical therapist for an area home health care agency. “That pushed me over the edge (to seek hormone therapy).

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