Introduction

Prolonged use of menopausal hormone therapy (HT) is common despite prescribing guidelines recommending that it be used no longer than 5 years at the lowest dose possible to relieve symptoms of menopause. [1] Prolonged HT is not recommended because use of HT more than 5 years is associated with increased risk for cardiovascular disease; breast, ovarian, and endometrial cancers; thromboembolic stroke; gallbladder disease; dementia; and urinary incontinence.[1–4]

Over a third of HT prescriptions in the US in 2015 were written for women over age 60, when the prevalence of systemic HT among women in the United States (US) with commercial health insurance ranged from 6.8 percent in women 60–64 years and 1.6 percent in women over age 74.[5] Similar prevalence data have been reported in northern European countries.[6] The US data underestimated HT prevalence due to omission of Medicare insurance data and because prescriptions for vaginal estrogen and compounded hormones were not included.

A review of the literature on HT decision making (reported elsewhere) found no studies addressing the phenomenon of long-term use, although all studies examined perception of risks and benefits.[7] Concern about increased risk for breast cancer was a dominant theme in this body of literature.[8–12] Because of this finding, we anticipated that users of prolonged HT would be concerned about their risk for breast cancer. Women in the reviewed studies expressed confusion about HT risks and benefits, citing conflicting information in the media.[8–12]

The cumulative lifetime incidence of breast cancer in the US is one in eight women.[13] Primary risk factors are age and timing of initiation and duration of HT.[14, 15] The most recent meta-analysis of worldwide evidence concluded that for lean women on HT 5 years, breast cancer incidence would increase at ages 50–69 by 1 in 50 among users of estrogen-progestin HT and 1 in 200 among users of estrogen-only HT. Excess risk at 10 years on HT would be twice as great.[15]

This paper reports findings from a qualitative study exploring reasons why women continue using HT despite risks. The study’s purpose was to inform efforts to reduce prolonged HT and associated disease. To explore reasons why some women persist in using HT more than 5 years despite known health risks, two questions were addressed: “What do long-term users perceive to be the benefits and risks of HT?” and “Who and what influence women’s decisions about HT?” A qualitative approach was selected to broadly explore thought processes and social phenomena underlying long-term users’ decisions not to discontinue HT.

Methods

The institutional review board (IRB) of the University of California San Francisco (UCSF) approved the study titled “Hormone Therapy Decision Making in Older Women.” The IRB study number is 13–11474. The UCSF IRB also approved all associated study documents, including the recruitment flyer and written consent form. This research report is an analysis of study data that has not previously been published.

We anticipated that a sample of 30 participants would be an adequate number for a qualitative study of HT use in older women, as participants would be drawn from a population with potentially similar demographic and personal characteristics. Demographic characteristics of the sample are presented in Table 1 at the beginning the Results section.

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Table 1. Participant characteristics.

https://doi.org/10.1371/journal.pone.0233703.t001

Thirty women were recruited from an urban area in northern California and a small city in the Rocky Mountain region, areas likely to offer a range of social and cultural perspectives. Participants responded to flyers left in public places and posted on Internet list servers including Nextdoor^™ and Craigslist^™. To be eligible, women had to be over age 60 or older, born female, to have taken systemic oral or transdermal HT (pills or patches) more than 5 years, to be currently using systemic HT, and to be able to read and speak English. Since there may be a unique clinical rationale for long-term HT to treat severe osteoporosis in women who cannot tolerate bisphosphonates, no women with severe osteoporosis were enrolled.

Women responding to fliers were screened for eligibility in telephone conversations, and all respondents who met inclusion criteria were invited to complete hour-long interviews with the first author. Each interview was conducted in a private space chosen by the participant following the signing of a written consent document. Each woman was asked to share what she recalled thinking and feeling as she approached menopause. A rationale for requesting this narrative was to give the participant an opportunity to guide the tone and content of the interview. This approach elicited a discussion of reasons for starting and continuing HT. The direction of each narrative was influenced somewhat by the interviewer in that prompts such as “can you tell me more about that?” were used. If a participant did not volunteer her thoughts about health risks, the interviewer asked the question, “What concerns do you have about risks associated with HT?”

Interviews were audio-recorded, transcribed verbatim, and analyzed using conventional grounded theory methods. The first author analyzed and assigned initial thematic codes to interview data after which co-authors reviewed transcript citations and provided input about themes arising from the data. Coded passages were organized using NVivo 10 software (QSR International).

Results

Of 30 participants, the mean age was 68, with a range of 60–80 years. Mean duration of HT was 18 years, with a range of 5–45. Participants included a practicing internist, a nurse practitioner specializing in menopause treatment, two retired nurses, and two other retired medical professionals in addition to 24 women with no medical training or background. All but one was White, one was Asian, and all had some college education. Recruitment for a pilot study began in November 2013, and study recruitment ended in December 2017. Interviews were completed by December 2017. Demographic characteristics of participants are summarized in Table 1.

All participants voluntarily used the term “hormone replacement therapy” or “HRT” in interviews, a marketing term that implies “replacement” of a natural or necessary substance. (Although the juxtaposition of the terms HRT and HT may be confusing, this report includes both because “HRT” appears in interview transcripts, whereas HT is the accepted medical term.) The woman quoted below had experienced two mastectomies and a cholecystectomy after starting HT. She had persisted in finding a provider who was willing to prescribe estrogen despite her medical history. She said “Without HRT I would not feel feminine,” and explained further:

So it always seemed to me that estrogen was a natural substance that your body produced, and when you're young and you're healthy you feel well. When you go through menopause and you stop producing estrogen you don't feel as good, so to replace it seemed like a natural thing to me. It didn't seem foreign or harmful, because it was just giving back to you what you had before.

Discussion

This study provides new insight into the thought processes and underlying priorities of women over age 60 who opt for prolonged use of HT. Participants indicated that continuing HT gave them a sense of control over certain aspects of aging. Many had struggled to keep receiving HT prescriptions, and our data suggest such struggles were undertaken to maintain this sense of control.

Differential uptake of HT generally reflects differences between social classes, particularly in regard to the social desirability of a youthful appearance.[16] Aging impacts the self-esteem, social identity, and health of women, and our study demonstrates how fear of aging can drive health-related behavior such as prolonged HT use. Women feared discontinuing a drug purported to help them maintain youthful qualities and overall wellbeing. In many cases, long-term users prioritized the sense of control and perception of youthfulness that HT gave them over better health outcomes.

Based on our review of the literature, we anticipated that users of prolonged HT would be concerned about their risk for breast cancer, so finding that participants paid little attention to HT risk was somewhat surprising. This lack of concern about risk may reflect distrust of inconsistent scientific literature and an unwillingness to accept information that fails to reinforce a decision to initiate HT for other reasons, such as to treat vasomotor symptoms.

The literature review also suggested that women may experience confusion about HT risks and benefits due to the presence of conflicting information in the media.[8–12] Although a large body of research has addressed the risks and benefits of HT, some information on HT risks and benefits in medical literature has been shown to reflect pharmaceutical industry bias.[17–20] Medical literature that reflects industry bias and popular media that quotes this content is a potential source of confusion for users of prolonged HT.

Although our study cannot provide definitive evidence of corporate influence on prolonged use of HT, the findings are interesting in light of prior work identifying themes in industry-sponsored ghost-written literature targeted to gynecology specialists. Ghostwriting refers to the practice of paying researchers and physicians to lend their names to journal articles, abstracts for conferences, and continuing education materials that have been prepared by marketing firms hired by pharmaceutical companies. Concerns about ghostwriting in relation to HT have appeared in articles published in PLOS Medicine and The New York Times, including concerns about ties between advisory board members for gynecology specialty journals and manufacturers of HT.[17–21] Areas of focus in ghostwritten articles on HT that have relevance to our findings are 1) claims of anti-aging efficacy,[22] 2) debunking concerns about breast cancer risk,[22] and 3) HT for disease prevention.[17–20,22,23]

Other research has suggested that ghostwriting has influenced the prescribing practices of gynecology specialists.[18–23] Comments from several participants indicated that their gynecologists had played a role in shaping positive views of HT and downplaying risk. Other studies of HT prescribing practices indicate that gynecology specialists tend to prescribe HT for more women and for longer duration than general practitioners, family practice physicians, or internists.[24, 25] However, our data suggest that participants were primarily motivated by their own beliefs about HT rather than were persuaded to continue by a healthcare provider. Determined to continue HT, they had ignored information contradicting their beliefs and opted to change providers when current prescribers showed resistance.

Conclusions

Findings from this study suggest that prolonged use of HT is driven to a large extent by societal anti-aging views and a belief in HT’s anti-aging efficacy. Our findings provide an additional perspective on previous work suggesting the pharmaceutical industry has leveraged older women’s self-esteem, vanity, and fear of aging to sell hormones through marketing practices designed to shape the beliefs of both clinicians and patients.[17,20] Our results also suggest that long-term users either do not believe evidence of the risks of prolonged HT or place lower priority on these risks relative to what they perceive as benefits, such as youthful appearance, energy, and identity.

Efforts are needed to clarify uses of HT that are efficacious and medically supported and to communicate the risks of prolonged HT. Because marketing messages may masquerade as science, increasing public awareness of drug marketing practices such as ghostwriting is also necessary.