Use of Antidepressants for Management of Hot Flashes

Dana G. Carroll, Pharm.D.; Kristi W. Kelley, Pharm.D.

Disclosures

Pharmacotherapy. 2009;29(11):1357-1374. 

In This Article

Evaluation of Hot Flashes in Clinical Trials

Several patient-specific characteristics should be considered when assessing results from hot flash studies, as they could affect the response rates to treatment. The severity (frequency and intensity) of patients' hot flashes on enrollment in the study could affect the response rate to therapy, with greater severity resulting in a greater response rate. Women who undergo surgical or chemical (e.g., tamoxifen or raloxifene) menopause typically have more severe hot flashes and a longer duration of symptoms than do women who undergo natural menopause, and may also have a greater response to therapy. The mean age for onset of menopause is 51 years in the United States (range 40-58 yrs). Women who are younger at the onset of menopause usually experience more severe symptoms. Again, this could result in a greater response to therapy. Finally, hot flashes are usually more severe at the onset (within the first 2 yrs) of menopause and tend to decline in severity over time. This also should be considered when assessing patient populations in studies to determine if time out from onset of menopause could increase response to therapy.

One other factor that should be considered when assessing hot flash studies is not related to the type of menopause or to onset, duration, or severity of symptoms—the placebo response rate. This should be considered when assessing therapies for hot flash management, as a very high placebo response rate has been reported in most hot flash studies. In the trials included in this article, placebo response rates ranged from 18-37%. This is similar for trials assessing other therapies for hot flash management.

Typically, studies assessing hot flashes use a diary to assess response to therapy and placebo. Patients are asked to record the number and severity of hot flashes on a daily basis. Many trials report the change in frequency of hot flashes, which is calculated from diary entries. However, a more validated and useful instrument has been developed that can be used to determine hot flash scores. The Hot Flash Score is also calculated from diary entries, and a higher score is indicative of more severe symptoms.[8] The Greene Climacteric Score (GCS) is another validated, commonly used instrument to assess hot flashes and menopausal symptoms.[9] The calculated scores can range from 0-63 overall, with a higher score indicating more severe symptoms. For the vasomotor subcomponent, scores of 0-2 indicate no or mild hot flashes and scores of 3-6 indicate moderate-to-severe hot flashes. The Modified Kupperman Index (MKI) is another validated instrument to assess hot flashes and menopause.[10] The maximum possible calculated score is 51, again with a higher score indicating more severe symptoms. Table 1 summarizes these validated instruments.

Many other instruments are used to assess hot flashes and menopausal symptoms typically as secondary outcomes in trials. Many assess quality of life or some specific aspect of menopause, such as night sweats or sleep quality. Some of the instruments used are validated and yet many others are not. Due to the variability in assessment methods and lack of validation for many instruments used to assess hot flashes, it can be challenging for health care professionals to truly assess as well as compare and contrast results among agents.

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