A study has found that bioidentical pelleted hormone therapy—man-made hormones like testosterone or estradiol that are inserted under the skin in the hip area—may offer a significant amount of negative side effects from mood swings to heart attacks.
In a study conducted by the North American Menopause Society, serum levels of estradiol and testosterone were measured in women who had participated in bioidentical pellet hormone therapy (BHRT) versus women who had participated in regular hormone replacement therapy (HRT). Ultimately, the scientists found that the mean serum estradiol and total testosterone levels for women undergoing the pellet therapy were 237.7 pg/mL and 192.84 pg/mL compared to 93.45 pg/mL and 15.59 pg/mL in women undergoing regular hormone therapy. “These high levels of hormones can be very concerning,” associate professor of obstetrics and gynecology at Sydney Kimmel Medical College of Thomas Jefferson University and conductor of the study Xuezhi (Daniel) Jiang, MD, PhD tells EndocrineWeb. This data exemplifies that the risks of pellet therapy are completely different than the risks associated with receiving oral plant-based hormone replacement.
Dr. Jiang also says the amount of negative side effects associated with this specific type of therapy are “significantly higher” when compared to the side effects of regular hormone therapy. “Among the issues reported by the women who had pelleted hormones were abnormal bleeding, mood swings, anxiety, breast tenderness, changes in hair patterns, acne, and weight gain,” he says.
According to EndocrineWeb, “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 [FDA] regulation that standard HRT is required to meet.” Patients should also be informed that there is a possibility of known drug interactions for hormone pellets and that they cannot be removed or reversed once inserted into the skin.
A statement from the director of drug evaluation and research at the FDA Janet Woodcock, MD furthers Dr. Jiang’s skepticism, but also sheds more light on the life-threatening affects this type of hormone therapy can have: “During an inspection in 2018 of BioTE Medical, our investigators uncovered information about 4,202 adverse events that had never been reported to the agency,” says Woodcock. “The adverse event information our investigators found suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion.”
While bioidentical hormone replacement therapy has little peer-reviewed scientific data and is not FDA-approved for the treatment of medical conditions, Woodcock says that it’s still used. “Some compounders market BHRT products as superior to FDA-approved drugs by making assertions that they are more natural, safer or better for patients than FDA-approved drug products,” she says. “FDA-approved hormone therapy treatments have been reviewed for safety and effectiveness for specific uses, and the FDA has measures in place to ensure quality during manufacturing. However, because, compounded BHRT products are not approved by the agency, there is no assurance of safety and efficacy. Outsourcing facilities, such as those that produced these products, are required to report certain adverse events to the FDA.” Full disclosure of the appropriate hormonal mixtures and doses is also crucial for patient health and overall knowledge.
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