Compounded Bioidentical Hormone Therapy: Identifying Use Trends and Knowledge Gaps Among US Women

JoAnn V. Pinkerton, MD; Nanette Santoro, MD

Disclosures

Menopause. 2015;22(9):926-936. 

In This Article

Results

Response Rates and Demographic Information

The Harris survey invited 10,781 women aged 45 to 60 years, via e-mail, to participate in an online survey between June 24 and July 10, 2013 (Figure 1). A total of 1,099 women responded (participation rate, 10%). Of these women, 855 had experienced or were experiencing menopausal symptoms and were thus eligible (qualification rate, 78%). The cooperation rate was 94%, with 801 of 855 eligible women completing the survey.

Figure 1.

Survey sample and disposition for the Harris and Rose surveys.

An invitation to take the Rose survey was e-mailed to 90,210 individuals during a 3-week period in April 2014, and 17,897 invitees responded (participation rate, 20%). Seventy-two respondents were men and were excluded. Screening of the remaining 17,825 Rose respondents identified 2,369 women aged 40 years or older who were currently using or had previously used HT and were eligible to complete the survey (qualification rate, 13%). The cooperation rate was 86%, with 2,044 of 2,369 eligible women completing the survey. Subset analysis in the Rose survey included 855 respondents aged 50 to 64 years, of whom 839 completed the survey and 714 were asked about CHT use. The cooperation rates among eligible women were very high (94% for the Harris survey and 86% for the Rose survey), with the number of dropoffs in each survey too low to draw meaningful conclusions about differences between eligible completers and noncompleters.

Most completers in the Harris and Rose surveys were white, had some postsecondary education or vocational training, and had public or private healthcare coverage ( Table 1 ). Approximately three quarters of completers in each survey were postmenopausal, having indicated that their last menstrual cycle occurred more than 12 months earlier. We considered the remaining Harris completers perimenopausal because all had experienced menopausal symptoms. In the Rose survey, 5% of completers stated that they had just started menopause, and 7% stated that they had been going through menopause for less than 1 year; these women were considered perimenopausal. Another 15% stated that they had yet to go through menopause and were categorized as nonmenopausal. Among Rose completers aged 50 to 64 years, 84% were postmenopausal, 13% were perimenopausal, and 4% had yet to go through menopause.

Prevalence, Cost, and Knowledge of CHT

We used a four-step process to estimate the prevalence of CHT use among US women. In step 1, we calculated the estimated number of US women aged 40 years or older who are currently using menopausal HT (compounded and FDA-approved). First, we determined the rate of current HT use for Rose respondents per age range: 40 to 44, 45 to 49, 50 to 54, 55 to 59, 60 to 69, 70 to 74, 75 to 79, and 80 years or older. Next, we multiplied the current use rate for each age range by the total number of same-age US women per US Census Bureau population estimates for 2012 ( Table 2 ).[21] This shows that approximately 3.7 million US women aged 40 years or older currently use HT.

In step 2, we calculated the number of HT prescriptions (compounded and FDA-approved) dispensed annually. We multiplied the estimated 3.7 million current HT users by the mean number of HT products taken per month in the Rose survey (1.7) by the estimated duration of use, which we assumed to range from 9 to 12 months. This suggests that 57 million to 75 million prescriptions for HT are filled annually (Figure 2).

Figure 2.

Extrapolation of Rose survey data to quantify the annual amount and cost of compounded hormone therapy (CHT) in the United States. HT, hormone therapy; Est., estimated; FDA, Food and Drug Administration.

In step 3, we estimated the number of CHT prescriptions dispensed annually. According to PHAST 2.0 prescription data, approximately 36 million prescriptions for FDA-approved HT were filled in 2012; a small percentage may have been filled for men and for women younger than 40 years (<1%).[6] Subtracting the 36 million annual prescriptions of FDA-approved HT from the 57 million to 75 million annual prescriptions for all HT indicates that 21 million to 39 million prescriptions for CHT may be filled annually, accounting for 28% to 68% of HT use.

In step 4, we determined the number of US women aged 40 years or older using CHT annually by dividing the number of CHT prescriptions filled annually by the mean 1.7 HT products taken per month in the Rose survey (1.7) by assumed duration of use (9-12 mo). This suggests that 1 million to 2.5 million women may use CHT annually.

To calculate the estimated amount spent on CHT annually, we multiplied the number of CHT prescriptions filled annually by the average price of US$49 that Rose completers reported paying out of pocket for HT. Results show that between US$1 billion and US$2 billion may be spent on CHT each year in the United States.

Reported Prevalence of CHT Use. Two percent (16 of 801) of Harris completers affirmed that they had used CHT. Assuming that the 16 CHT users belong to the subset of HT ever users (n=123), CHT use would account for 13% of the total HT used by Harris completers. Twenty-one percent (378 of 1,771) of Rose completers reported current or prior use of personalized CHT, with no difference in the rate of CHT use observed among the subset of women aged 50 to 64 years (153 of 714). Rates of CHT use were higher in the younger age groups and lower in the older age groups compared with the overall population of Rose completers (Figure 3). Rose completers taking CHT were more than twice as likely as women using conventional HT to obtain it through their physician's office (15% vs 6%, respectively), although women in both groups were most likely to obtain their HT products from a local pharmacy (59% vs 54%, respectively; Figure 4).

Figure 3.

Use of personalized hormone therapy (HT) among Rose completers, by age (n=378).

Figure 4.

Sources of hormone therapy (HT) products as self-reported by women belonging to the subset of Rose ever users questioned about compounded hormone therapy (CHT) use (n=1,771).

Knowledge of CHT. All Harris completers (N =801) were asked, "Do you believe that bioidentical hormone therapies compounded at a specialty pharmacy are FDA-approved?" Only 14% correctly answered "no," whereas 10% answered "yes" and 76% stated that they were not sure (Figure 5). When Rose completers (N=2,044) were asked whether their HT had been personalized or compounded for them, 27% of the women stated that they did not know.

Figure 5.

Responses of Harris completers (N=801) to the question, "Do you believe that bioidentical hormone therapies compounded at a specialty pharmacy are FDA-approved?"

General Findings on Menopause Symptoms and Treatment

Any HT Use. In the Harris survey, 15% of completers were ever users of HT, 6% were current users of HT, and 9% were prior users of HT. Patterns of HT use among Rose respondents (n=17,825) were similar, with 13% reporting ever use of HT. Approximately 5% of Rose respondents were current HT users, suggesting that 8% were prior users. In the subset of Rose respondents aged 50 to 64 years, 4% were current users and 6% were prior users. The mean duration of HT use among ever users in the Harris survey was 50 months (Figure 6A). The Rose survey expressed duration of use as a range. Based on the midpoint for each range, the approximate median use for Rose completers was 28 months (Figure 6B).

Figure 6.

Duration of hormone therapy use in (A) Harris ever users (n=123) and (B) Rose completers, by history of hormone therapy use.

Both surveys showed that HT was generally effective in relieving menopausal symptoms. Approximately 89% of ever users in the Harris survey stated that HT provided moderate or significant relief; 83% of ever users in the Rose survey stated that HT was extremely effective, very effective, or somewhat effective.

Most ever users in the Harris and Rose surveys stated that their physician had recommended HT (91% and 63%, respectively). Rose completers were more likely to have received a prescription for HT from an ob-gyn than from a general practitioner or other types of physician (57% vs 33% vs 8%, respectively).

Use of Nonhormonal Treatments. Harris completers were asked about various nonhormonal treatments. Responses showed that 42% of Harris completers had tried lifestyle changes (eg, exercise, diet, and stress reduction), 26% had tried natural therapies and dietary supplements (eg, black cohosh, ginseng, and phytoestrogens), and 10% had tried nonhormonal prescription medications such as gabapentin and antidepressants. More than one third of Harris completers never received any treatment of menopausal symptoms. Most women who had used nonhormonal treatments stated that the treatments provided moderate to significant relief, including 78% of women who made lifestyle changes, 66% of women who tried natural therapies and dietary supplements, and 82% of women who used nonhormonal prescriptions.

History of Menopausal Symptoms

Seventy-eight percent of Harris respondents reported that they had experienced or were experiencing menopausal symptoms. Almost half (47%) of the women who had experienced menopausal symptoms were symptomatic at the time the survey was taken. Rose completers were not asked directly whether they had ever had menopausal symptoms, but the survey's use of adaptive questioning allowed us to determine that 15% had no history of symptoms. In both surveys, the mean age at menopausal symptom onset was 47 years.

Harris and Rose completers were asked about specific menopausal symptoms and asked to rate symptoms they had experienced as mild, moderate, or severe. All completers in the Harris survey had experienced menopausal symptoms (a requisite for eligibility): 91% of women had a history of hot flashes (of whom 67% described hot flashes as moderate to severe), 65% had vaginal dryness, 85% had sleep disturbance, 48% had urinary complaints, and 48% had sexual dysfunction (Figure 7A).

Figure 7.

Percentages of (A) Harris completers (N=801) who experienced moderate to severe menopausal symptoms and (B) Rose completers who experienced moderate to severe symptoms (overall, stratified by perimenopause/postmenopause status, and among women aged 40-65 y).

When Rose completers (including the 15% who reported that they have not yet entered the menopausal transition) were questioned about specific menopausal symptoms, 59% of women acknowledged a history of hot flashes (of whom 62% indicated hot flashes to be moderate to severe), 49% had experienced vaginal dryness, 66% had sleep disturbance, 44% had urinary complaints, and 28% had sexual dysfunction (Figure 7B). In the subset of 1,743 Rose completers considered perimenopausal and postmenopausal, 61% reported experiencing hot flashes (of whom 64% considered hot flashes to be moderate to severe), 51% had vaginal dryness, 65% had sleep disturbance, 45% had urinary complaints, and 29% had sexual dysfunction. The experience of menopausal symptoms among all Rose completers aged 50 to 64 years approached that of the overall population in the Harris survey, with similar rates of hot flashes (71%), vaginal dryness (59%), sleep disturbance (73%), urinary complaints (46%), and sexual dysfunction (35%).

Knowledge of and Information on HT

Most Harris completers (63%) recalled consulting their physician about their menopausal symptoms and treatment options. Two thirds of women who spoke with a physician had also discussed the issues with a family member or friend (Figure 8). Another 14% of completers stated that they had only talked to a family member or friend, and 23% never spoke with anyone about the topics.

Figure 8.

Parties with whom Harris completers (N=801) reported discussing their menopausal symptoms and/or treatment options.

Before starting HT, only 22% of Rose completers considered themselves very familiar or extremely familiar with HT. Another 35% of Rose completers stated that they were somewhat familiar with HT, and the rest were not very familiar (26%) or not at all familiar (18%) with HT. Among women who were somewhat familiar to extremely familiar with HT before they consulted a physician (n=1,147), 42% stated that their information came from friends and family. Other sources of information included brochures at the physician's office (28%), the Internet (14%), television (11%), and print publications (6%); almost one quarter (21%) were not sure where they had obtained their information (Figure 9).

Figure 9.

Sources of hormone therapy information among Rose completers who stated that they were already somewhat familiar to extremely familiar with hormone therapy even before they visited their physician to seek treatment (n=1,147).

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