New Antidepressant Aids Fibromyalgia Sufferers

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New Antidepressant Aids Fibromyalgia Sufferers

By Kathleen Doheny

HealthDay Reporter

THURSDAY, Sept. 9 (HealthDayNews) -- A new antidepressant called duloxetine

improved symptoms of fibromyalgia -- a chronic and painful musculoskeletal

disorder -- in women but not in men, researchers report.

Duloxetine (brand name Cymbalta) was recently approved by the U.S. Food and

Drug Administration to treat major depression and nerve pain suffered by

those with diabetes. In the new study, published in the September issue of

Arthritis & Rheumatism, the drug was used " off-label, " which is legal.

" Antidepressants have been used to treat fibromyalgia for over 10 years, "

said study author Dr. Lesley Arnold, an associate professor of psychiatry at

the University of Cincinnati College of Medicine. " The problem has been

those medications are poorly tolerated, " she said, adding that side effects

include weight gain, potential heart problems and excess sedation.

" We have been looking for alternatives, " Arnold said.

Fibromyalgia is marked by body pain and muscle tenderness at several body

sites, and there also can be headaches, sleep disturbances and fatigue. An

estimated 3 percent to 6 percent of the U.S. population has the disorder and

it's far more common in women than in men, according to the National

Fibromyalgia Association.

The cause is not known, but the disorder has been linked to abnormalities in

the brain neurotransmitters serotonin and norepinephrine. Both are linked to

mood and recognized for their role in depression. According to the study

authors, there is no FDA-approved treatment for fibromyalgia.

Duloxetine works differently than some other antidepressants, affecting

levels of both serotonin and norepinephrine rather than just serotonin,

Arnold said. The drug produces the benefits of the other antidepressants

without the downsides, according to Arnold, whose colleagues on the study

included researchers from Eli Lilly and Co., the drug's manufacturer.

In the study, Arnold and her team evaluated 207 patients, mostly women, with

fibromyalgia. About a third had also been diagnosed with depression. The

subjects were randomly assigned to a placebo group or to a treatment group,

which received 60 milligrams of duloxetine twice a day for 12 weeks.

Then they were evaluated using the Fibromyalgia Impact Questionnaire,

commonly used to determine the effect of a treatment. It asks about the

ability to perform common activities such as going to work, shopping, doing

laundry, preparing meals, driving a car and climbing stairs.

Thirty percent of the women in the duloxetine group had a 50 percent or

greater improvement in their pain, Arnold said, compared with just 16.5

percent in the placebo group. And, she said, the improvement in pain

reduction seemed to be independent of the effect on mood.

Those who received duloxetine demonstrated greater improvement on most of

the measures evaluated on the questionnaire, she said.

Why the treatment didn't work for the men isn't clear, Arnold said, but the

answer could lie with the small sample size. Only 23 men were included in

the study.

Dr. J. Clauw, a professor of medicine at the University of Michigan

and an expert on fibromyalgia, called the new research " a well-done study. "

But he noted there was more improvement with daily activities than pain

management. He couldn't predict whether more doctors treating patients with

fibromyalgia would be likely to use the new antidepressant off-label.

But the outlook is getting brighter for those with the condition, Clauw

said. " Nearly every large pharmaceutical company is testing one or more

compounds for fibromylagia, " he said.

More information

To learn more about fibromyalgia, visit the National Fibromyalgia

Association.