By David Fiore, MD

Professor of Family Medicine, University of Nevada, Reno

Dr. Fiore reports no financial relationships relevant to this field of study.

SYNOPSIS: The U.S. Preventive Services Task Force reissued a statement on hormone replacement therapy for the prevention of chronic conditions that reiterates its D recommendation from 2012. It recommends physicians do not prescribe hormone replacement therapy (HRT) to prevent medical conditions, but leave the question of using HRT for treatment of menopausal symptoms unanswered.

SOURCE: US Preventive Services Task Force, Grossman DC, Curry SJ, Owens DK, et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force Recommendation statement. JAMA 2017;318:2224-2233.

The U.S. Preventive Services Task Force (USPSTF) released a statement on hormone replacement therapy (HRT) for the primary prevention of chronic conditions in postmenopausal women that updates its 2012 statement. Although it was released very recently, the statement already has generated significant controversy, which is especially surprising in that it is not a big change from the 2012 statement.

In 2012, the USPSTF gave HRT for the prevention of chronic conditions a D rating, meaning that the panelists recommended against it.1 The current update was undertaken to include extended data from the Women’s Health Initiative (WHI)4,5 and an analysis of data drawn only from randomized trials, eliminating any analysis of observational trials. Essentially, the revised statement reiterates the findings from 2012, concluding that “The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal women (D recommendation). The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal women who have had a hysterectomy (D recommendation).” In an editorial entitled “Menopausal hormone therapy (MHT) for primary prevention: Why the USPSTF is wrong,” an “ad hoc group of clinical scientists well published in the area of MHT” proclaims the USPSTF misinterprets the WHI (a major randomized trial that was widely publicized for finding overall harm of HRT).2 These editorialists claim that the WHI “was not designed to evaluate mainstream use of MHT” and that the hormone preparations used are not appropriate. In conclusion, the authors stated that the current guidelines “will perpetuate egregious harm to the public health.” In another editorial, Cano et al wrote that “the statement conveys the message that any MHT, at any age, may not be of benefit and could be harmful. This is simplistic and wrong.”3

COMMENTARY

Given this controversy, it is important to read the findings and discussion more carefully to better understand how to incorporate this statement into clinical practice. One thing I found refreshing in this USPSTF statement is the humility of its recommendation. The recommendation is made with “moderate certainty” about the lack of benefit and likely harms. This is a nice way of saying that “we just don’t know for sure.” I am also impressed that the USPSTF included two tables with absolute benefit and harms, rather than just hazard ratios. This puts the likely benefit or harm for a patient in much clearer terms. For example, the hazard ratio for breast cancer found in the estrogen plus progestin WHI trial was 1.26. This can be stated as, “Women treated with estrogen and progestin were 25% more likely to develop breast cancer.” That sounds pretty scary, but the absolute risk was found to be only nine more cases per 10,000 women. Many women might find that risk is something they can accept, especially when suffering from hot flashes and other menopausal symptoms. Most importantly, as the authors make clear, this statement only concerns the use of HRT for prevention, not treatment, of symptoms.

The only part of Cano et al’s conclusion with which I agree is their statement that “this is simplistic and wrong,” but in reference to his (and Langer et al’s) rejection of the USPSTF statement. This statement summarizes thousands of women-years of data demonstrating that clinicians should not use HRT to prevent illness. It does not address the issue of using HRT to treat symptoms, but it does give us reassurance that the potential harms of doing so are rare. Therefore, I will continue to use HRT for women who report severe menopausal symptoms in as low a dose and as short a duration as works for them.

REFERENCES

  1. Moyer VA; U.S. Preventive Services Task Force. Menopausal hormone therapy for the primary prevention of chronic conditions: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2013;158:47-54.
  2. Langer RD, Simon JA, Pines A, et al. Menopausal hormone therapy for primary prevention: Why the USPSTF is wrong. Menopause 2017;24:1101-1112.
  3. Cano A, Rees M, Simoncini T. Comments on the USPSTF draft recommendation statement on menopausal hormone therapy: Primary prevention of chronic conditions. Maturitas 2018;107:A1-A2.
  4. Rossouw JE, Anderson GL, Prentice RL, et al; Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
  5. Anderson GL, Limacher M, Assaf AR, et al; Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Women’s Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712.