1 Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center , Oklahoma City, Oklahoma.
2 Graduate College of Biomedical Sciences, Western University of Health Sciences , Pomona, California.
J Womens Health (Larchmt). 2018 Jul;27(7):859-866. doi: 10.1089/jwh.2017.6637. Epub 2018 Mar 27.
It is estimated that 1-2.5 million U.S. women use compounded bioidentical menopausal hormone therapy (MHT). However, the proportion of American physicians prescribing compounded bioidentical hormones remains unknown. This study aims to evaluate obstetrician-gynecologists' (OB/GYNs) and family medicine physicians' decisions reflected in prescribing practices of MHT in Kansas, and level of agreement with the American College of Obstetricians and Gynecologists (ACOG) recommendations.
An Internet-based 38-item survey was electronically disseminated to OB/GYNs and family medicine physicians identified through the Kansas State Board of Healing Arts licensure list.
Out of 1349 physicians contacted, 164 (12.2%) responded to the survey. There were 128 (9.5%) responses included in the final analysis. In the past year, 96.1% (123/128) of respondents prescribed conventional MHT, 93.0% (119/128) prescribed Food and Drug Administration (FDA)-approved bioidentical MHT, and 66.1% (84/127) prescribed compounded bioidentical MHT. Of factors influencing MHT-prescribing practices, FDA regulation was not important to 16.7% (21/126) of physicians, whereas customization was important to 68.5% (87/127). There was a significant difference between specialties, 37.7% of OB/GYNs compared with 56.9% of family medicine physicians, regarding the ACOG statement that "patients should be counseled that conventional MHT is more appropriate than compounded preparations" (p = 0.031). Respondents disagreed with ACOG regarding the statements that "the practice of compounding makes it difficult to identify the active agent responsible for various effects" (41.0% of OB/GYNs and 34.8% of family medicine physicians) and "the practice of custom blending commercially available drug products lacks both a strong biological rationale and medical evidence for effectiveness" (36.1% of OB/GYNs and 37.9% of family medicine physicians).
Prescribing practices for MHT vary between specialties. This study identifies a meaningful level of disagreement with ACOG recommendations regarding prescription of compounded rather than FDA-approved MHT. Further research is needed to better understand this level of discordance.
据估计,美国有 100 万至 250 万女性使用复方生物等同绝经激素治疗(MHT)。然而,开处复方生物等同激素的美国医生比例尚不清楚。本研究旨在评估堪萨斯州妇产科医生(OB/GYN)和家庭医学医生在处方 MHT 时的决策,并评估他们与美国妇产科医师学会(ACOG)建议的一致性。
通过堪萨斯州治疗艺术许可证清单,向 OB/GYN 和家庭医学医生发送了一项基于互联网的 38 项调查。
在联系的 1349 名医生中,有 164 名(12.2%)对调查做出了回应。最终分析中包括 128 名(9.5%)的回复。在过去的一年中,96.1%(123/128)的受访者开了传统 MHT,93.0%(119/128)开了美国食品和药物管理局(FDA)批准的生物等同 MHT,66.1%(84/127)开了复方生物等同 MHT。在影响 MHT 处方实践的因素中,有 16.7%(21/126)的医生认为 FDA 监管不重要,而 68.5%(87/127)的医生认为定制很重要。OB/GYN 与家庭医学医生之间存在显著差异,37.7%的 OB/GYN 认为 ACOG 的声明“患者应被告知,传统 MHT 比复方制剂更合适”,而 56.9%的家庭医学医生则认为这一说法“患者应被告知,传统 MHT 比复方制剂更合适”(p=0.031)。受访者不同意 ACOG 的以下声明:“复方制剂的做法使得难以确定导致各种效果的活性成分”(41.0%的 OB/GYN 和 34.8%的家庭医学医生)和“对市售药物产品进行定制混合的做法既缺乏强有力的生物学依据,也缺乏有效性的医学证据”(36.1%的 OB/GYN 和 37.9%的家庭医学医生)。
MHT 的处方实践在不同专业之间存在差异。本研究发现,在开处方时,与 ACOG 建议相比,使用复方制剂而非 FDA 批准的制剂存在显著差异。需要进一步研究以更好地了解这种不一致性。