Pelleted Hormone Therapy—More Risks, Questionable Benefits, Warn Experts

with Xuezhi (Daniel) Jiang, MD, PhD, and Nanette Santoro, MD

Certainly there is great appeal to the notion that you can have a personally formulated hormone cocktail made to address your menopausal symptoms; and, this option has been fueled by the endorsement of some highly visible actors like Angelina Jolie and Suzanne Somers, who touted the benefits of bioidentical supplements for women going through menopause.>

Yet, most doctors worry about women who seek out so-called bioidentical hormones that are customized and compounded for personal use, and now there is reason for renewed concern regarding the newest formulation: Pelleted hormone therapy,1 which was the topic of a presentation at the 2019 annual meeting of the North American Menopause Society in Chicago, Illinois.

Women need to know all the facts before opting to have pelleted HRT.Pelleted hormones are unregulated and appear to raise more questions than offer clear benefits; buyer beware. Photo: istock

Legitimate Health Concerns Demonstrated in Women Taking Pelleted HRT

In this study, Xuezhi (Daniel) Jiang, MD, PhD, and his colleagues examined the medical records of postmenopausal women who were patients at the Reading Hospital in Pennsylvania. Their goal was to compare serum levels of estradiol and total testosterone in women who had taken “bioidentical” pellet hormone therapy compared with women who used regular hormone therapy. The women who received hormones by solid pellet had it inserted under the skin. Dr. Jiang is an obstetrician-gynecologist and associate professor of medicine at Jefferson Medical College, in Reading, Pennsylvania.

The researchers were surprised by their findings; they reported that the mean serum estradiol and total testosterone levels for women using pellet therapy were 237.7 pg/mL and 192.84 pg/mL, respectively, compared to 93.45 pg/mL and 15.59 pg/mL in women receiving traditional hormone therapy.1 These high levels of hormones can be very concerning, Dr. Jiang tells EndocrineWeb.

Pellet therapy users also had “significantly higher incidences of negative side effects,” he says. Among the issues reported by the women who had pelleted hormones were: abnormal bleeding, mood swings and anxiety, breast tenderness, changes in hair patterns, acne, and weight gain.1

Just Because It Seems More Natural, Become Better Informed

Given these significant differences in experiences, Dr. Jiang has serious doubts that women who opt for bioidentical custom compounds are not adequately informed about the lack of clinical evidence regarding the safety and effectiveness of these products. Nor are they sufficiently made aware that this form (pelleted) of hormone delivery is not subjected to the same level of regulation that standard HRT is required to meet.

Pellet therapy and other compounded hormone products are regulated only be the rules governing vitamins and nutritional supplements, which means very little. They don’t have to meet the same rigor as medications reviewed by the Food and Drug Administration (FDA), so there’s no assurance that what is promised in the bottle is what you’ll get, or even that it will work as you expect. Rather, these hormonal products gain the attention of the FDA only after there is evidence of harm demonstrated in the people taking these unregulated products.   

The study findings should “raise red flags” for any woman looking to have her doctor prescribe the compounded pelleted hormone therapy. And if you still decide to go this route, Dr. Jiang says: “Women on pellet therapy need to be carefully monitored for their estrogen and testosterone levels.”  

You should understand that compounded products aren’t the only ones that are bioidentical and offer individualized options to women, he continues. There are FDA-approved hormone supplements available that are identical to human reproductive hormones, in a variety of dosages and delivery methods.

The number of prescriptions written for compounded hormones is closing in on the level of those of FDA-approved hormone replacement therapies, says Dr. Jiang. Along with the lack of science behind pelleted hormone treatment, he worries that we don’t know well enough about the long-term consequences of very high circulating estradiol and testosterone levels. “We are in urgent need of future prospective studies to help develop a clinical guideline for safety monitoring in women on custom-compounded bioidentical hormone therapy.”

Expert Champions Study Results with Emphasis on Risks of Pelleted Hormones

Nanette Santoro, MD, professor of obstetrics and gynecology at the University of Colorado School of Medicine says that this study “helps us to understand the concerns about using non-FDA approved hormones.” And, raises the need for women to discuss the risks as well as the potential benefits of pelleted bioidentical hormones BEFORE committing to their use.

The “legal loophole” through which these treatments have slipped, allowing them to be considered dietary supplements, means that no one has any reason to study their safety and efficacy before marketing them.

“The FDA steps in only when there is evidence of harm,” says Dr. Santoro– something that has happened only three times in 25 years – or if there someone complains that a company is making false claims. “In other words, there’s no real monitoring system. Most suppliers can say what they like, and I’m sure they are experts on how to exactly phrase some of the more impressive claims that allude to anti-aging effects without incurring the wrath of the FDA or any other regulator.”

There is no standardization in the manufacture of these products, Dr. Santoro tells EndocrineWeb, “so if they are prescribed, a patient could have irregular (uneven) absorption, or there could be more or less hormone than what is stated on the label, and no one is any the wiser.”

“Unless these compounds are specifically tested, or the pharmacokinetics are extensively studied, as is the case for FDA-approved estrogen and progesterone hormones,” you don’t really know what you are taking, she said. “Nor is there any requirement to report adverse events to the government, or to use the kinds of warning labels that the FDA-approved hormone therapy options require.”

In the end, while not true—the implication is that these bioidentical pellets are “free from side effects and risks that are required in the labeling for FDA-approved products. All of these issues lure consumers into a universe of ‘alternative facts’—much to their potential peril,” says Dr. Santoro who emphasizes the need to be better educated before choosing this route of HRT.

Pelleted hormones, in particular, cause more specific issues that raise additional concerns for Dr. Santoro, even more than other modes of custom compounds. “Once they are inserted, these hormone-containing pellets are all but impossible to remove and there are stories – I have heard several—of women who have had very high hormone levels for more than one year after a single pellet insertion.”  

Dr. Santoro wants women to better understand the risks you take should you decide to use one of these relatively unregulated options of hormone supplementation. The findings from this study can assist you and your doctor to fully understand the pros and even more so the cons of using these pelleted hormones.

Currently, it is almost impossible to determine any kind of systematic reporting of outcomes, she says. “That is what makes this study so helpful and so important: The authors have been able to demonstrate that pellet use resulted in the need for additional monitoring, higher hormone concentrations, and more adverse reactions.”

“Women should think long and hard before taking on this type of treatment,” Dr. Santoro says. And talk to your doctor so you are fully aware of what you are getting into before you opt for this form of hormone therapy.

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