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Pilot Study Says It Works, but Experts Critical.
By Salynn Boyles
WebMD Medical News
Reviewed By Louise Chang, MD
on Tuesday, May 16, 2006
May 16, 2006 – It is a treatment that brings new meaning to the phrase, "When you look good, you feel good."
Researchers say depressed female patients in a small, pilot study showed dramatic improvement when given Botox injections, with nine out of 10 no longer meeting the clinical standards for depression two months after the treatments.
But looking good actually had little to do with it, according to the Maryland dermatologist and cosmetic surgeon who led the study and hopes to patent a botulism treatment for depression.
Eric Finzi, MD, PhD, says the injections prevented the patients from frowning, which, in turn, helped to lift their depression.
"I think there is direct feedback between the facial frown muscles and the depression center of the brain," Finzi tells WebMD. "If you can prevent the negative signals that occur when someone frowns, the brain interprets this as meaning that things are better."
A Patient's Story
Kathleen Delano was skeptical when she entered the study. But after battling depression for more than 20 years, with conventional treatments offering little relief, she thought it was worth a try.
The 45-year-old marketing director and single mom tells WebMD that she gradually began to feel better after receiving the five injections that left her unable to frown.
"There was no dramatic cosmetic change, so that wasn't it," she says. "But I began to feel more like doing the things that I had been avoiding."
Delano says she soon began exercising more and re-established ties with friends. She also became more spiritually active.
"It is ironic that the very things that can help alleviate depression are the things that people want to do the least when they are depressed," she says, adding that she believes the Botox injection put her on the path to recovery.
Study Highly Flawed
The 10 female patients were recruited from Finzi's group dermatology practice, but none had been treated with Botox prior to entering the study.
All the women met the standards for ongoing major depression, based on their responses to standardized depression surveys. Seven of the 10 patients had tried one or more antidepressants, and four had been treated with psychotherapy.
Five Botox injections were given into the frown muscles (between the eyebrows) above the bridge of the nose, which had the effect of keeping the patients from frowning. Two months later, self-reported surveys indicated that nine of the 10 patients were no longer depressed, and the tenth had improved mood but was still depressed.
The study was published in the May issue of Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery (ASDS).
In an accompanying commentary, ASDS president-elect Alastair Carruthers, FRCPC, cited a series of flaws with the study and concluded that its finding must be considered anecdotal.
Specifically, Carruthers expressed concerns about the study's brief follow-up period, small number of participants, and lack of a comparison group. An even bigger concern was that depression assessments were based on reports by the patients themselves.
University of Michigan professor of psychiatry Michelle Riba, MD, was even more critical. Riba is immediate past president of the American Psychiatric Association.
She says the study's lack of a comparison group and small size could have easily influenced the findings. She was especially concerned that the study participants were recruited from Finzi's own group dermatology practice.
"There is no way to know if these findings are real or if they are due to a placebo effect in a study of this design," she tells WebMD.
Finzi acknowledges that the study was limited by fact that he had no outside funding. He hopes that the findings will interest others in doing larger, more rigorously designed clinical trials.
"I came up with this idea and wanted to see if it warranted further testing," he says. "And my conclusion is that it absolutely does."
SOURCES: Finzi, E. Dermatologic Surgery, May 2006; vol 32: pp 645-650. Eric Finzi, MD, PhD, dermatologic surgeon; president, Chevy Chase Cosmetic Center, Chevy Chase, Md. Kathleen Delano, Botox patient, Glendale, Md. Michelle Riba, MD, professor of psychiatry; associate chairwoman for education and academic affairs, department of psychiatry, University of Michigan Health System; immediate past president, American Psychiatric Association.
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