Bio-Identical Hormone Replacement Therapy for Women : Confusing Research

The findings of numerous studies on hormone replacement therapy (HRT) conflict and, as a result, have raised serious questions regarding the appropriateness of HRT. Hormone replacement is an approved therapy for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal atrophy. Numerous studies have confirmed that estrogen replacement decreases the risk of colon cancer, estrogen and progesterone decrease fracture risk, and various hormones increase energy levels and enhance libido. Reputable sources offer conflicting reports regarding issues such as memory, Alzheimer’s disease, and stroke.

With the exception of the Postmenopausal Estrogen/Progestin Intervention (PEPI) study, major studies have either failed to distinguish among types and dosages of HRT used in the study, or examined only the use of synthetic HRT preparations (as in the case of the Women’s Health Initiative). The Women’s Health Initiative (WHI) study was designed to identify the potential risks and benefits of HRT. The estrogen-progestin portion of the clinical trial was stopped in 2002 after results showed that a synthetic hormone combination containing conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) increased the women’s risks of developing invasive breast cancer, heart disease, stroke, and pulmonary embolism. The data and safety monitoring board concluded that the risks outweighed the evidence of benefit for fractures and colon cancer. Utilizing data from the WHI, researchers later concluded that synthetic CEE plus MPA does not improve mental functioning and may increase the risk of dementia in women over age 65. They suggest these hormones increase the risk of stroke, which is known to increase the risk of dementia. With regard to the risk of dementia, typical HRT users are in their 50s and the WHI study focused on women aged 65 and over, who have a higher risk for dementia. The “estrogen-only” portion of the WHI study was halted in March 2004 after analysis of data suggested that synthetic CEE alone had no impact either way on heart disease (the main focus of the study), but may increase the risk of stroke.

Many patients and medical professionals are unaware of the availability of bio-identical alternatives. In reality, women's experiences and clinical outcomes of HRT differ vastly depending on the dose, dosage form, and route of administration, and most importantly, whether the hormones are synthetic or bio-identical. As a result of concerns and doubts generated by studies that use synthetic hormones, many women who could substantially benefit from bio-identical hormone replacement may never have the opportunity.

Published research delineating the differences between natural bio-identical and synthetic HRT is now more abundant, but studies of bio-identical HRT will probably never be as plentiful as those dealing with patented synthetic hormones. Our pharmacy welcomes your questions.