Approximately 75% of perimenopausal women (those beginning to experience menopausal symptoms) suffer from hot flashes, or temporary sensations of warmth lasting anywhere from a few minutes to an hour. As many as 20% of these women experience symptoms severe enough to interfere with their daily activities.
To relieve hot flashes and other menopausal symptoms including sleep disturbance, mood swings, and vaginal dryness, doctors have, for years, prescribed hormone replacement therapy (HRT) as the standard treatment. But a
done in 2002 by the Women’s Health Initiative (WHI) called that practice into question, indicating that the risks of long-term HRT use seem to outweigh the benefits. Although hot flashes tend to gradually subside on their own, many women and their physicians are uncomfortable taking HRT even over the short-term.
In response to their earlier findings, WHI investigators conducted a randomized, double-blind, placebo-controlled study to evaluate the use of the antidepressant
paroxetine controlled release
(or paroxetine CR, sold under the brand name Paxil) in treating menopausal symptoms. The results, which are published in the June 4, 2003 issue of the
Journal of the American Medical Association
, indicate that paroxetine CR may be an effective and acceptable alternative to HRT.
About the Study
The researchers randomized 165 menopausal women ages 35 and over (81.2% of whom had experienced hot flashes for at least a year) into one of three groups: those receiving placebo, 12.5 milligrams/day (mg/d) of paroxetine CR, or 25.0 mg/d of paroxetine CR. Paroxetine CR was chosen because it is better tolerated and has lower rates of discontinuation compared to other antidepressants. The study lasted for six weeks.
Women were included in the study if they: met the biologic definition for menopause; experienced at least two to three daily hot flashes or at least 14 bothersome hot flashes per week; discontinued any hormones for at least six weeks; and were not taking any psychiatric medications.
Participants completed questionnaires during weeks one, three, and six, asking them about their symptoms and problems related to menopause as well as potential adverse reactions to study treatment.
The researchers found that both treatment groups showed a significant benefit from paroxetine CR use. Similar reductions were seen in the 12.5 mg/d and 25.0 mg/d groups, but women in the lower dose group experienced fewer adverse reactions to the medication (20% of women compared to 31%).
By week six, the average daily hot flash frequency fell from 7.1 to 3.8 (a 62.2% drop) for those in the 12.5 mg/day group and from 6.4 to 3.2 (a 64.6% drop) for those in the 25.0 mg/day group. Those in the placebo group reported an average decrease of 37.8% hot flash symptoms (from 6.6 to 4.8 per day). What’s more, approximately 30% of women in both paroxetine groups had no hot flashes by the end of the study. The improvements in hot flash symptoms among those taking paroxetine CR were independent of any significant changes in mood or anxiety symptoms.
Although the results are intriguing, the study does have some weaknesses. For one, the authors were not able to determine if the treatment could relieve other symptoms of menopause besides hot flashes. In addition, black and Asian women were not well represented in the study population.
How Does This Affect You?
This study suggests that the antidepressant paroxetine could potentially improve the lives of millions of women worldwide. Because women in the lower-dose group experienced similar benefits but fewer adverse reactions such as headache, nausea, and insomnia compared the higher-dose group, it appears that 12.5 mg/d is an adequate and well-tolerated starting dose for most women. Further research may indicate whether even lower doses of the drug could effectively control hot flashes.
What’s not clear is how paroxetine works to reduce hot flashes, and researchers are unsure how long the benefit of paroxetine CR will last.
Finally, it’s important to remember that paroxetine CR is not a wonder drug. It may not work for everyone who tries it, and it can cause side effects. Plus, at $2 to $3 per pill, the cost might be prohibitive for some. Talk to your doctor about what’s right for you.
Please be aware that this information is provided to supplement the care
provided by your physician. It is neither intended nor implied to be a
substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER
IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the
advice of your physician or other qualified health provider prior to
starting any new treatment or with any questions you may have regarding a