Recent treatments for women in menopause include the multi-phasic rhythmic dosing of bio-mimetic hormone replacement therapy (BHRT) using natural hormones. More than two million women in the U.S. use customized hormones for menopause symptoms.
“Natural hormones are not bio-mimedic unless the body can recognize them as hormones, and they are not considered restoration unless what has been lost is truly restored,” said Author T.S. Wiley.
“If hormone restoration was made of real bio-mimedic hormones and dosed to mimic the ups and downs of the hormone blood levels in a normal menstrual cycle in a young woman, would all of the symptoms aging decline or disappear?”
Currently an accepted standard for compounded bio-identical hormone replacement protocol or therapy does not exist. However, she has created a registered pharmacy system to circumvent the current lack of legitimacy and availability of bio-mimetic, currently known as bio-identical hormones, for testing and study.
Further, a new study is underway at University of Texas and its multi-phasic physiologic dosing will be called Bioidentical Hormones On Trial, or B.H.O.T., a comparison of patterns of administration and dosing of compounded bio-identical hormone therapy (BHT). This study will be the first of its kind to track and quantify outcomes based on dosing and patterns of administration of BHT. The main objective of the study will be to examine clinical outcomes and quality of life indicators of patients receiving BHT at 10 to 12 primary care provider’s practices.
The results of the study will be used to help establish which dosage and pattern of BHT administration is most effective. Results will be used to design a prospective, randomized clinical trial with the goal of standardizing BHT dosing and administration patterns.
The study is an observational, prospective study of women ages 35 to 60 who are current users of compounded bioidentical hormone therapy (BHT). Clinical care of the study participants will not be changed as a result of participation in the study. The duration of the study is three years. Outcomes to be monitored include quality of life, symptom relief, and impact of BHT on physical health including breast, endometrial, and cardiovascular measures.
These critically needed study results will be presented at national and international meetings, and will be submitted for publication in professional journals to share the findings with women’s health care professionals. Results will be used to design a prospective, randomized clinical trial with the goal of standardizing BHT dosing and administration patterns.
The primary objectives of the study are to: examine the outcomes clinically and quality of life indicators of those patients receiving bio-identical hormone replacement therapy at primary ten to twelve practices of primary care providers; compare the effectiveness and safety, and quality of life of participants using one of three dosing patterns for bio-identical hormones: multi-phasic physiologic, bi-phasic or continuous dosing; monitor lab and imaging data of women using these bio-identical hormones; evaluate the safety of the hormone regimens by tracking adverse events experienced by women using bioidentical hormone therapy prescribed by their PCP’s; and assess the performance of compounding pharmacies in standardizing the products.
By: Kristin Gabriel
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