Is Bioidentical Hormone Replacement Therapy Safe?

The landscape of hormone replacement therapy (HRT) has undergone a remarkable transformation in recent years. From the one-size-fits-all synthetic hormones that came into popularity in the 1960s to today’s widely used, personalized bioidentical hormone replacement therapy (BHRT), a lot has changed.

Today, Bioidentical Hormone Replacement Therapy (BHRT) improves the health, well-being, and vitality of millions of women and men every year. But thanks to some outdated studies conducted back in the 1990s, some patients still harbor reservations about hormone therapy.

In this article, the SottoPelle Method BHRT experts explain the journey from older forms of hormone therapy to today’s revolutionary BHRT. We explore the impeccable safety profile of Bioidentical Hormone Replacement Therapy – and share the wealth of clinical evidence supporting BHRT’s transformative health benefits for women and men.

Flaws in Older Hormone Replacement Therapy Studies

Several decades ago, hormone therapy was shrouded in uncertainty due to reliance on synthetic hormones that didn’t mirror the body’s natural counterparts. A pivotal study, the Women’s Health Initiative (WHI), conducted by the US National Library of Medicine National Institutes of Health from the 1970s to the 1990s aimed to assess hormone therapy’s impact on women’s health. That study, which was later revealed to be flawed, erroneously claimed that HRT had more detrimental than beneficial effects. As a result, HRT use dropped dramatically.

However, subsequent scrutiny revealed that the WHI study had limitations in its design and interpretation, which led to conclusions that didn’t fully capture hormone therapy’s safety and effectiveness. This study’s shortcomings resulted in misconceptions about the risks associated with hormone therapy, creating a hesitancy among both medical professionals and patients.

In the following years, a re-analysis of the erroneous WHI trial was performed, and the new results showed that the use of HRT in younger women or in early postmenopausal women had beneficial effect on the cardiovascular system, reducing coronary disease and lowering the likelihood of death from all causes.

Today supporting research has shown that properly administered BHRT also reverses osteoporosis, reduces the risk of metabolic syndrome and type 2 diabetes, improves sexual function, helps stave off cognitive decline and Alzheimer’s disease, and offers a host of other health benefits for both women and men.

Bioidentical Hormone Replacement Therapy (BHRT) Safety

The advent of Bioidentical Hormone Replacement Therapy (BHRT) has further ushered in a new era of hormone therapy, rooted in safety, precision, and efficacy.

BHRT sets itself apart by utilizing hormones that are molecularly identical to the body’s own hormones, ensuring seamless integration with the body’s natural processes. This alignment drastically minimizes the potential for adverse effects while maximizing the therapeutic benefits of hormone therapy.

Though discovered in the 1940’s, plant-based bioidentical hormone therapy was not widely used until much more recently. Previously, doctors relied on one-size-fits-all, standard dosage synthetic hormone pills. Dr. Gina Tutera pioneered the use of bioidentical hormones as early as the 1970s – and in 1992, Dr. Tutera founded SottoPelle® to bring his safe and natural method of BHRT delivery to millions of women and men worldwide.

Because Bioidentical Hormone Replacement Therapy utilizes hormones that are molecularly identical to those naturally produced by the body, it is both safer and more effective than synthetics. The fundamental match between the body’s hormones and BHRT hormones is pivotal in reducing risks and side effects while maximizing results and therapeutic benefits.

Bioidentical Hormone Replacement Therapy Customized Dosing is Safer & More Effective

One of the biggest safety advantages of Bioidentical Hormone Replacement Therapy lies in personalization. Detailed blood tests are conducted to determine each individual patient’s exact hormone levels, imbalances, and deficiencies.

Then a customized BHRT treatment plan is tailored to each individual’s unique hormonal requirements, mirror the body’s innate healthy hormonal state. Unlike standard dose pills, by dosing each patient individually, SottoPelle Method BHRT ensures that each patient gets exactly what they need. This also eliminates any patient getting too much of a hormone – which is why many who take standard pills have unwanted side effects.

This personalized approach enhances both safety and effectiveness, making BHRT a superior choice for individuals seeking hormone balance.

Studies on Bioidentical Hormone Replacement Therapy Safety in Women

Clinical research consistently underscores Bioidentical Hormone Replacement Therapy safety. Notable among these studies is a comprehensive review published in the International Journal of Women’s Health.1 This review compiled findings from various clinical trials and concluded that BHRT, in comparison to synthetic hormone therapy, offers a safer option for women seeking relief from menopausal symptoms. This comprehensive assessment supports BHRT’s safety and effectiveness in addressing hormone-related concerns.

In other articles we have written about clinical studies showing BHRT’s ability to reverse osteoporosis, prevent heart disease, and reduce the risk of Alzheimer’s Disease, and Type 2 Diabetes.

Studies on Bioidentical Hormone Replacement Therapy Safety in Men

And, Bioidentical Hormone Replacement Therapy’s benefits and safety profile extend to men as well. Rigorous clinical studies confirm BHRT’s positive impact on men’s health and well-being. A study published in the Journal of Clinical Endocrinology & Metabolism2 explored the effects of BHRT on aging men. The results indicated that BHRT improved bone density and muscle mass, among other benefits. These findings further validate the safety and efficacy of BHRT, emphasizing its personalized approach in addressing specific hormonal needs.

Bioidentical Hormone Replacement Therapy Reduces Death from All Causes

A groundbreaking study entitled The effect of hormone replacement therapy on the survival of UK women 3 highlights BHRT’s potential to reduce death from all causes. This retrospective study, spanning from 1984 to 2017, investigated the effect of hormone replacement therapy on the survival of women in the UK. The study concluded that BHRT contributed to reduced mortality rates from all causes, providing compelling evidence not only of BHRT’s safety, but of its holistic benefits beyond symptom relief.

Safe, Natural Bioidentical Hormone Replacement Therapy

BHRT’s bioidentical nature, coupled with personalized dosing and extensive clinical evidence, solidifies its safety and efficacy. As individuals seek comprehensive solutions for hormonal imbalances, Bioidentical Hormone Replacement Therapy offers symptom relief, reduces the risk of many serious diseases, and provides hope for a long life of holistic healing and enduring wellness.

Talk to your physician about SottoPelle® Method Bioidentical Hormone Replacement Therapy today. Or you can find a physician in your area who is a Certified SottoPelle® hormone therapy provider using our Physician Finder HERE.

Safe, Bioidentical Hormone Replacement Therapy: (323) 986-5100

IMPORTANT DISCLAIMER: This article is provided as general information only and is not intended to be used as medical advice. While the benefits of hormone replacement are well documented through clinical research, we are not representing that hormone therapy is a “cure” for any disease. Only your treating physician can determine if hormone replacement may be a beneficial part of your healthcare regimen, based on your age, overall health, risk factors, and lifestyle.


1. National Library of Medicine, The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy.

2. Nanette Santoro, et al, Compounded Bioidentical Hormones in Endocrinology Practice. The Journal of Clinical Endocrinology & Metabolism, Volume 101, Issue 4,

3. Nurunnahar Akter et al, The effect of hormone replacement therapy on the survival of UK women: a retrospective cohort study 1984−2017, (2021). DOI: 10.22541/au.162505075.57308701/v2