Assessing and Improving Measures of Hot Flashes:
Summary of an NIH Workshop

Introduction

Vasomotor symptoms, including hot flashes and night sweats, are the most frequently reported symptom of the menopausal transition. However, menopausal women are not the only ones who experience this symptom. Breast cancer survivors, women with chemotherapy-induced ovarian  failure, oopherectomized women, women being treated for endometriosis or infertility with Lupron,  and men undergoing androgen ablation therapy all report hot flashes. This translates into millions of  people living with hot flashes at any point in time. While this symptom varies in its presentation,  frequency, and severity, it can be very disruptive and unpleasant. Sweating, chills, and palpitations  often follow a sudden wave of heat, and the quality of life can be diminished. Some women report several hot flashes a week while others experience much more frequent events, as many as 36 in a single day. The period of duration for a given hot flash varies from seconds to 10 minutes or more while occurrence of the phenomenon can persist for five years or more (Kronenberg 1990). Estrogen or hormone therapy is effective in treating hot flashes. Yet the recent findings of the Women’s Health Initiative (WHI) indicate that the benefits of taking estrogen plus progestin are  outweighed by risks, including coronary heart disease, stroke, pulmonary embolism, breast cancer, and dementia. Moreover, hormone therapy for hot flashes is not appropriate for individuals with a history of hormone-dependent tumors. Many people have turned to complementary and alternative  medicine (CAM) to manage this symptom, with varying degrees of success. Some CAM therapies are less potent than hormone therapies; others are less potent than placebo. And yet even partial relief may be sufficient for some people. Unfortunately, the empirical base from scientifically sound clinical trials to assess the efficacy and even safety of various CAM modalities is neither extensive  nor very strong. Some people who find their hot flashes to be unmanageable are thus returning to hormone therapy. Current medical advice calls for use of hormones at the lowest dosage and for the shortest period of time. But we know little about risks and benefits for smaller doses, shorter treatment times, and different routes of administration. Thus, it is likely that the National Center for Complementary and Alternative Medicine (NCCAM) and other NIH institutes and centers (ICs) will  be supporting clinical trials of a range of treatments to reduce hot flashes in the diverse populations in which they occur.

The current status of our knowledge about hot flashes and their treatment raises several questions about how NIH can move forward to address this public health problem and prepare for future research. Early in 2005, NIH will convene a State of the Science meeting to review what is known    about existing therapies for the management of the menopausal transition and what is needed to improve therapy of various symptoms and syndromes, including hot flashes. In the mean time, in preparation for future clinical trials of hot flash treatments, we began thinking about the quality of existing measures for this critical outcome. Many studies of hot flashes rely on self-reported measures of symptom frequency and severity, using questionnaires or diaries.