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Chicago, IL. — A preliminary study with paroxetine HCI (Paxil, SmithKline Beecham), presented today at the 153rd annual meeting of the American Psychiatric Association, shows that breast cancer survivors taking the antidepressant experienced a substantial reduction in both frequency and severity of hot flashes and demonstrated significant improvement in related symptoms such as depression, anxiety and sleep.
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) that is used to treat a range of mood and anxiety disorders. Paroxetine was recently approved by the U.S. Food and Drug Administration as the first and only drug indicated to treat social anxiety disorder. It is also indicated for depression, panic disorder and obsessive compulsive disorder.
"Due to the importance of quality-of-life issues for cancer survivors, it is imperative that we continue to research and make treatment options available for these patients," said lead clinical investigator, Vered Stearns, M.D., Instructor of Medicine in the Hematology/Oncology division of Georgetown University Medical Center’s Lombardi Cancer Research Center. "This study, one of the first of its kind, provides compelling, initial data that suggests paroxetine may be effective in alleviating hot flashes, a misery felt among more than half of breast cancer survivors."
Promising News for Breast Cancer Survivors
Participants in the study, which included women with prior breast cancer who suffered at least two hot flashes a day, kept daily diaries of hot flash frequency and severity for a total of six weeks. The women received no treatment for one week of the study, followed by receiving 10 mg/daily of paroxetin for one week and 20 mg/daily of paroxetine for four weeks. In addition to the daily hot flash diaries, the participants completed a health-related symptom-assessment questionnaire and a quality-of-life rating scale during the first and sixth week of the study.
The key findings of this pilot trial showed that two-thirds (67 percent) of patients reported having half as many hot flashes after taking paroxetine and three-quarters (75 percent) said the hot flashes were less severe. The women also reported less depression, less anxiety and less trouble sleeping. Additionally, 25 (83 percent) of the women chose to continue paroxetine therapy after the study had been completed. Therapy was well-tolerated among participants. The most common side effects included drowsiness, nausea and dry mouth. A controlled study, comparing paroxetine to placebo, is currently being conducted to confirm these findings.
A Struggle to Find Suitable Treatments
In 2000, over 180,000 new cases of breast cancer will be diagnosed among women, with an additional 1,400 cases among men. The good news is that more of these cases are being detected and treated earlier. However, most survivors experience some uncomfortable symptoms that will continue to affect their daily lives. Hot flashes represent one of the most prominent complaints and are encountered by approximately 55 percent of breast cancer survivors. Estrogen replacement therapy is the usual treatment for relieving hot flashes symptoms, but many fear taking it because some studies found it may raise the risk of a relapse of breast cancer.
"We need to continue looking for effective ways to improve the lives of these survivors, so they can make the hope of resuming normal lives a reality. This study suggesting that paroxetine relieves hot flashes is an important step in improving the quality-of-lives of patients and shedding some light on the physiology of hot flashes," said Dr. Stearns.
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