Febrasgo's position on hormonal modulation treatment for anti-aging

Wednesday, 17 October 2018 18:16

Febrasgo, through its National Specialized Climacterium Committee, herein presents to its members and the general community its position on the ruling of the Second Division of the Federal Regional Court of the 5th Region on “hormonal modulation” treatment for anti-aging.

This publication contains the position of the Federal Council of Medicine, the ruling of the Second Division of the Federal Regional Court of the 5th Region and, lastly, Febrasgo’s position.

1. Position of the Federal Council of Medicine (CFM):

As published on CFM's website page, “It has been noted, according to the Federal Council of Medicine, that the lack of scientific evidence on the benefits and risks and harms to health does not permit the use of hormonal therapies to delay, modulate or prevent the aging process.” The judge also explains on the website that the CFM believes that so-called “anti-aging therapy” presents risks to the health of the population, which is why it edited the contested regulatory act.

Resolution:

Resolution 1999/2012 is set forth on CFM's website. Following are some highlights (to see the full text, click here).

Physicians who prescribe anti-aging methods can be punished through loss of their professional license.

Brazilian physicians who prescribe treatments for specific anti-aging purposes will be subject to penalties specified in ethical disciplinary proceedings.

It is prohibited to use and propagate the following procedures and respective indications of anti-aging medicine:

I. Use of ethylenediaminetetraacetic acid (EDTA), procaine, vitamins, and antioxidants referred to as anti-aging, anticancer or anti-atherosclerosis therapies or for treating chronic degenerative diseases;

II. Any anti-aging, anticancer, anti-atherosclerosis therapies or for treating chronic degenerative diseases, except in cases of diagnosed deficiencies where the benefits of replacement have been scientifically proven;

III. Use of hormones, in any formulation, including growth hormones, except in cases of diagnosed deficiencies where the benefits of replacement have been scientifically proven;

According to CFM Resolution 1999/2012, replacement of deficient hormones and other essential elements shall only be done in the case of a proven specific deficiency and that there are scientifically proven benefits:

IV. Treatments based on hormone replacement, supplementation or modulation to prevent, delay, modulate and/or reverse the aging process, prevent functional loss from aging, prevent chronic diseases and promote healthy aging;

V. Prescription of hormones known as “bioidentical” for anti-aging treatment, to prevent, delay and/or modulate the aging process, prevent functional loss from aging, prevent chronic diseases and promote healthy aging;

VI. Saliva tests for dehydroepiandrosterone (DHEA), estrogen, melatonin, progesterone, testosterone or cortisol used for the purpose of screening, diagnosis or monitoring menopause or diseases related to aging, since there is no scientific evidence for use in daily clinical practice.

II. Publication from the Second Division of the Federal Regional Court of the 5th Region:

The Second Division of the Federal Regional Court of the 5th Region (TRF-5) hereby unanimously rejects the appeal filed against Resolution No. 1999/2012, of the Federal Council of Medicine (CFM). This CFM resolution (No. 1999/2012) fights the practice of anti-aging hormonal replacement without scientific proof, used to delay, modulate or prevent the aging process. It was legally challenged by an association, which filed a class action lawsuit (in the 1st Federal Court of the Judicial Section of Ceará - SJCE), for a ruling that would require the CFM to abstain from applying the resolution to physicians affiliated with the association. The CFM's right to regulate and prevent the practice, which some have called “hormonal modulation”, was recognized.

III. Febrasgo's position:

Febrasgo, through the National Specialized Climacterium Committee, states that the practices called “anti-aging” or “hormonal modulation” lack scientific evidence. It also clarifies that these prohibited anti-aging practices should not be confused with hormonal treatment for climacterium, which, provided its contraindications are respected, continues to the treatment of choice for menopause symptoms. The effectiveness and safety of this menopause treatment are known and accepted by the scientific community and societies for the specialty around the world.

References:

1] Resolução 1999/2012 CFM- acessível - http://portal.cfm.org.br/index.php?option=com_content&id=23324 . acessado em 24/10/2018.

[1] The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-53.

[1] ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol. 2014;123(1):202-16.

[1] Baber RJ, Panay N, Fenton A, Writing IMS. 2016 IMS Recommendations on women ’ s midlife health and menopause hormone therapy. Climacteric. 2016 Apr;19(2):109-50.


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