The severity of vasomotor symptoms and number of menopausal symptoms in postmenopausal women and select clinical health outcomes in the Women's Health Initiative Calcium and Vitamin D randomized clinical trial.
Objective: Custom-compounded hormone therapy (CHT) was found to be associated with a higher incidence of side effects compared with FDA-approved hormone therapy. To reduce the incidence of side effects, we established strict department guidelines on use of CHT including dose and duration of treatment. We aim to compare dosage, blood serum levels, duration of treatment and the incidence of side effects in women on CHT before and after implementation of a departmental practice guideline. Design: A standardized guideline for CHT, to allow uniform practice patterns, was established and implemented in Sep. 2017. A before-and-after study was designed to compare a group of postmenopausal women who were on pellet, a subcutaneous form of CHT, both before and after the guideline was implemented. In June 2020, the patient data were retrieved from the Electronic Medical Records at Reading Hospital, including demographics, treatment duration, dosage of CHT, side effects, serum estradiol (E2), total testosterone (TT), and free testosterone (FT) levels, and frequency of laboratory follow-up. Data were categorized into Before and After groups. Paired t-test and McNemar test were applied to compare continuous data and categorical data, respectively. Results: A group of 106 postmenopausal women were identified with mean (SD) age and body mass index (BMI) on first contact of 56.4 (7.5) years and 28.9 (4.0) kg/m2, respectively. Mean (SD) treatment duration was significantly shorter in the After than the Before group (1.6[0.2] vs. 5.1[2.1] years, p<.0001). The number of E2 (2.7[0.9] vs. 1.1[0.4], p<.0001) and T (2.3[1.0] vs. 0.9 [0.4], p<.0001) measurement per year were significantly higher in After than Before, respectively. In the After group, compared to the before, the degree of serum hormone level fluctuation represented by the difference between the peak and nadir was significantly lower in E2 (81.5 [65.6] vs. 200.8[126.8] pg/mL, p<.0001), TT (73.0[59.2] vs. 105.6[70.0] ng/dL, p=.001), and FT (6.7[6.9] vs. 11.3[20.7] pg/mL, p=.027). There were no significant differences in the mean (SD) highest E2 and T dosages between Before and After. The peak serum levels of E2(193.4[91.9] vs. 289.4[134.3] pg/mL, p<.0001), TT(130.9[50.8] vs. 195.0[72.7] ng/dL, p<.0001), and FT(11.4[7.8] vs. 15.7[21.8] pg/mL, p=0.048) were significantly lower in After than Before. Both the incidence (58 [54.7%] vs. 77[72.6%], p=0.011) and total number (0.9[1.0] vs. 1.8[1.6], p<.0001) of overall side effects were significantly lower in the After group; however, the total number of side effects per year in After was significantly higher than Before (0.6[0.6] vs.0.4[0.4], p=0.015]). Conclusion: Implementation of department practice guidelines markedly increased the frequency of laboratory follow-up during the treatment which significantly reduced the peak and fluctuation of serum hormone levels as well as the incidence and total number of side effects. While considering the length of treatment duration, however, the total number of side effects per year in women on CHT was not significantly reduced after implementation of a standardized practice guideline. Sources of Funding: None
Nudy, M., Jiang, X., Aragaki, A., Manson, J., Shadyab, A., Foy, A., Buerger, J., Kelsey, A., LeBlanc, E., Wild, R., Wactawski-Wende, J., Stefanick, M., Robbins, J., & Schnatz, P. (2020). The severity of vasomotor symptoms and number of menopausal symptoms in postmenopausal women and select clinical health outcomes in the Women's Health Initiative Calcium and Vitamin D randomized clinical trial.. Retrieved from https://scholarcommons.towerhealth.org/gme_ob_gyn_res_read/263