Symptom Science: Clinical Trials to Address Menopausal Hot Flashes
Carpenter, Janet S.
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Session presented on Saturday, July 23, 2016: Vasomotor symptoms, also called hot flashes or flushes or night sweats, are sudden transient experiences of heat and sweating resulting from neuroendocrine disruptions during the menopausal transition. Vasomotor symptoms are prevalent, persistent, and severe physiological disruptions affecting quality of life outcomes for many menopausal women worldwide. A variety of non-hormonal, non-herbal therapies have been investigated to alleviate these bothersome symptoms. The purpose of this presentation is to illustrate how a program of research has contributed to strengthening the empirical evidence base for vasomotor symptom management and subsequently influenced policy statements. A variety of clinical trial designs and their outcomes will be discussed in relation to their impact on the field over the past 20 years. Impact will be discussed in terms of the following three areas. First, the degree to which the generated evidence has been incorporated into systematic reviews will be discussed. Second, the impact of innovations related to the subjective, objective, and ecological momentary assessment of vasomotor symptoms and their incorporation into national guidelines will be discussed. Third, the impact of the totality of this work and work by other authors in guiding an international position statement will be presented. Clinical trial findings show that while some therapies were not found to be effective, others that initially appeared promising were less so when carefully tested in rigorously designed trials. Although evidence suggests a 50% reduction in vasomotor symptoms is clinically meaningful to women, some therapies did not meet this threshold. Knowing which therapies are likely to be the most effective can help alleviate frustration for symptomatic women and their health care providers as they search for and try various methods of alleviating hot flashes. The information in this presentation is designed to stimulate additional advances in the science of menopausal symptom management as well guide health care providers' and menopausal women's treatment decision making.