Background

Prescribing and counseling practices in hormone therapy (HT) since publication of the Women's Health Initiative (WHI) trials have changed. Our objective was to compare changes by practice field and region.

Methods

Between December 2005 and May 2006, we mailed surveys to 938 practitioners from two large integrated health systems in the Northeastern and Northwestern United States. We received 736 responses and excluded 144 who do not prescribe/counsel about HT, leaving 592. Data included prescriber characteristics, knowledge about HT trials, and self-reported HT counseling and prescribing changes. We compared provider characteristics and HT counseling and prescribing by region and practice field (obstetrician/gynecology [OB/GYN] or primary care).

Results

Respondents included 79 OB/GYNs and 513 primary care providers. OB/GYNs were more likely, than primary care providers to consider themselves experts regarding the Heart and Estrogen/progestin Replacement Study (HERS) and WHI trials (30.4% vs. 8.2%, p < 0.001). The majority (87%) were cautious about HT use, especially primary care providers (p < 0.01 compared to OB/GYNs). Respondents reported prescribing less oral unopposed estrogen (64%) and combination estrogen/progestin (81%) post-WHI. OB/GYNs were less likely to report decreases in oral unopposed estrogen use (p = 0.006). Use of lower-dose and transdermal products (low-dose estrogen, vaginal estrogen, estradiol vaginal ring) increased, especially by OB/GYNs.

Conclusions

Our study highlights numerous HT prescribing and counseling differences between primary care and OB/GYN providers. Reasons for these differences are unknown but may be related to self-reported WHI/HERS knowledge. HT formulations used in the WHI trials are being replaced by low-dose and alternate formulations. Studies to support this practice are needed.

Objective

Black cohosh (Actaea racemosa) is an herb commonly used to treat menopausal symptoms. Little is known about its effect on other physiologic parameters that could result in untoward events. This study examines the effect of black cohosh on lipids, fibrinogen, glucose and insulin.

Methods

Three hundred and fifty-one, 45-55 years old, peri or post-menopausal women experiencing vasomotor symptoms participated in a 3-month, double blind trial with randomization to: (1) black cohosh (160 mg daily); (2) multibotanical including black cohosh (200 mg daily); (3) multibotanical plus soy diet counseling; (4) conjugated equine estrogen .625 mg, with or without medroxyprogesterone acetate 2.5mg daily, for women with or without a uterus, respectively; (5) placebo. Baseline and month 3 total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), triglyceride, insulin, glucose, and fibrinogen serum concentrations were measured in 310 women. Baseline information was also collected on medical history, demographic characteristics, and diet.

Results

There were no statistically significant differences in the adjusted mean change from baseline to 3 months between the herbal groups and placebo in total cholesterol, LDL, HDL, triglycerides, glucose, and insulin. Adjusted fibrinogen levels appear to increase in the multibotanical treatment group in comparison with the other herbal groups and placebo overall (P = .02), but there was no statistically significant difference in the pairwise test against placebo (P = .11).

Conclusions

Black cohosh containing therapies had no demonstrable effects on lipids, glucose, insulin or fibrinogen.

Background

Herbal supplements are widely used for vasomotor symptoms.

Objective

To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo.

Design

1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004.

Setting

Group Health, Washington State.

Participants

351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal.

Measurements

Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale.

Interventions

1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo.

Results

Vasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was -4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, -5.93 to -2.19 symptoms per day; P < 0.001).

Limitations

The trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out.

Conclusion

Black cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms.

Clinical trials registration number

NCT00169299.

OBJECTIVES: To evaluate whether single measurements of serum estradiol (E2), estrone (E1) and sex hormone-binding globulin (SHBG) concentration distinguishes between women with and without menopausal symptom bother. STUDY DESIGN: We analyzed baseline data from two clinical trials conducted in 2012-2017: MsFLASH 03 (178 peri-/post-menopausal women aged 40-62 years with bothersome vasomotor symptoms, mean age 54) and MsFLASH 05 (181 post-menopausal women aged 45-70 years with moderate-to-severe vulvovaginal symptoms, mean age 61). MAIN OUTCOME MEASURES: Symptom bother (hot flushes or flashes, night sweats, sweating, aching in muscles and joints, change in sexual desire, vaginal dryness during intercourse, and avoiding intimacy) in the past month was assessed using the Menopause-Specific Quality of Life questionnaire. Using logistic regression, we calculated the area under the receiver operating characteristic curve (AUえーゆーC) values for E1, E2, and SHBG concentration in relation to being at least somewhat bothered (symptom bother score ≥3) by each symptom within each trial study population. RESULTS: AUC values (95% confidence interval) ranged between 0.51 (0.41-0.60) and 0.62 (0.53, 0.72) for MsFLASH 03 and between 0.51 (0.42, 0.59) and 0.64 (0.53, 0.75) for MsFLASH 05. There was little evidence of associations between serum hormone levels and bother by a given menopausal symptom. CONCLUSION: These findings do not support the clinical utility of a single measurement of serum of E1, E2, or SHBG concentrations in differentiating between women who are bothered by a given menopausal symptom and those who are not.

Objective

The objective of the study was to evaluate the association of depression, sleep disturbance, and menopausal symptoms with diminished libido.

Study design

Data from a 2001-2002 baseline survey of 341 peri- and postmenopausal women, aged 45-55 years, participating in a randomized trial, was analyzed. Eligibility included at least 2 hot flashes and/or night sweats per day and no hormone therapy for at least the prior 3 months. The survey evaluated sexual function, depression, sleep, and vasomotor symptoms. We examined the association between these factors, using multivariate regression models.

Results

Of 341 women, 64% had diminished libido, 18% had moderate to severe depression, and 43% had poor sleep quality. Women averaged 4.6 hot flashes and 1.9 night sweats per day. Depressive symptoms (P = .003), poor sleep (P = .02), and night sweats (P = .04) were significantly associated with diminished libido.

Conclusion

Factors associated with diminished libido in midlife are complex but include depression, disturbed sleep, and night sweats, all common symptoms of the menopausal transition and early menopause.

Objective

The aim of this study was to identify provider characteristics associated with hormone therapy prescribing.

Methods

The study design is cross-sectional. In December 2005, we mailed surveys to providers practicing in two integrated healthcare delivery systems located in the northwestern and northeastern United States; 379 responded (74%) and 249 (49% of total) granted access to their automated data. Data included provider demographics, practice characteristics, and perceptions about hormone therapy. Provider-specific annual hormone therapy prescribing frequency was calculated as days supply of hormone therapy filled divided by the number of visits (among women aged 45-80 y). Factors associated with higher rates of hormone therapy prescribing were identified using bivariate and multivariate analyses.

Results

We report results separately for primary care providers (internists and family practitioners) and obstetrician/gynecologists because significant correlates differed in these two groups. For both primary care providers and obstetrician/gynecologists, in multivariate analyses, hormone therapy prescribing varied by site (P < or = 0.002) and years at the healthcare organization (P < or = 0.01). For primary care providers only, higher hormone therapy prescribing was associated with reported expert knowledge of the hormone therapy trials (P < or = 0.001). For obstetrician/gynecologists, higher hormone therapy prescription was related to feeling well prepared to counsel women on hormone therapy (P < or = 0.007), believing that the risks of estrogen with progestogen had been exaggerated (P = 0.04), and seeing younger aged patients (P = 0.03).

Conclusions

After the release of the Women's Health Initiative findings and practicing under similar clinical guidelines, hormone therapy prescribing is associated with providers' confidence, practice location, and time with a healthcare organization.

We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.

Background

Careful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin.

Methods

We invited 2,328 women, aged 45-70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses.

Results

Among 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68-4.08), lack of symptom improvement (OR 4.21, CI 1.50-12.17), vaginal bleeding (OR 5.96, CI 1.44-24.6), and learning to cope with symptoms (OR 3.36, CI 2.21-5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26-0.61) and mood swings or depression (OR 0.63, CI 0.42-0.92).

Conclusions

Doctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.

Objective

Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms.

Methods

A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 μみゅーg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire.

Results

Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence interval [CI] -0.5, 0.0; P = 0.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (-0.4 at 12 weeks; 95% CI -1.0, 0.1; P = 0.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI -0.1, 0.4; P = 0.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire .

Conclusions

Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate-severe vulvovaginal symptoms.