Taking hormones has been shown in research studies to carry risks. It can increase the risk of blood clots, strokes, and gallbladder diseases. The risk of heart disease and breast cancer may also increase if you are older or if you use hormone therapy for a long period of time. Many health care providers who use bioidentical hormones say they are safer than traditional hormone therapy treatments.
However, there have been no large research studies on bioidentical hormones to demonstrate evidence of this. High-quality data on the safety and efficacy of bioidentical hormone therapy with personalized compounds for the treatment of menopausal symptoms is lacking. Bioidentical composite hormone therapy for menopause should not be routinely prescribed when there are FDA-approved formulations. Menopausal medications approved by the Food and Drug Administration (FDA) that use bioidentical hormones or synthetic, or both.
Data on the safety of composite bioidentical menopausal hormone therapy are also minimal and only evaluate surrogate markers. Bioidentical hormone treatments are primarily creams and progesterone is not absorbed through the skin. None of the RCTs (the longest study was 1 year) to evaluate endometrial thickness showed a significant difference between composite bioidentical hormone therapy for menopause and placebo or FDA-approved products. On the contrary, treatments with bioidentical hormones are combined individually and usually contain a mixture of substances, a potpouri.
In addition, the lack of FDA oversight of compound hormones creates additional risks with respect to the purity and safety of bioidentical composite hormones. Compound bioidentical hormones are advertised as a safer, more effective, natural and individualized alternative to conventional hormone therapy. However, the data were insufficient to assess the risk of breast cancer, endometrial cancer, or cardiovascular disease with the use of composite bioidentical hormone therapy for menopause. As the National Academies of Sciences, Engineering and Medicine have pointed out, the influence of the media and marketing aimed at both patients and doctors play a fundamental role in the popularity of bioidentical compound hormone therapy for menopause, as well as in the unfounded perception that they are safe and effective.
1.Regulated bioidentical hormones are often referred to as “body identical hormones” (rBHRT) to reduce the confusion caused by composite bioidentical hormones (cbHRT).Patients, many of whom may not know that there are FDA-approved menopausal hormone therapies that are bioidentical, may seek composite products based on the perception that they are more “natural” and, therefore, safer than FDA-approved drugs. To truly understand the benefits and harms of bioidentical composite hormone therapy for menopause, high-quality randomized placebo-controlled trials with long-term follow-up comparing personalized composite products with FDA-approved menopausal hormone therapy are needed. The evaluation of published data on the efficacy and safety of bioidentical composite hormone therapy for menopause is hampered by the general lack of high-quality evidence. Some pharmacies that manufacture composite drugs have tried to standardize the composition of bioidentical hormone therapy for menopause, requiring participating pharmacies to send random quarterly samples to a laboratory.
independent of external analysis. Bioidentical composite hormones are made with a prescription and are available in several routes of administration, including oral, sublingual and percutaneous, or as implants, injectables and suppositories. Physicians should inform patients that FDA-approved menopausal hormone therapies are more recommended for treating menopausal symptoms than composite bioidentical hormonal therapy preparations for menopause.
