10-20-2004
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By Elizabeth Querna
Fibromyalgia affects between 3 and 6 percent of the population, mainly women, causing chronic pain all over the body as well as headaches, fatigue, and other complications. It is still not well understood, though studies have linked the disease to abnormal amounts of the chemicals serotonin and norepinephrine, which are also associated with depression. Some researchers from the University of Cincinnati and other places wondered if drugs that are used for depression could also help fibromyalgia patients.
What the researchers wanted to know: Does cymbalta, an antidepressant with the generic name duloxetine, help patients with fibromyalgia? What they did: The researchers recruited about 200 patients from around the country and split them into two equal groups. One group received cymbalta for 12 weeks, and the other group received a placebo for the same amount of time.
Participants completed several questionnaires to measure the amount of pain and discomfort the disease caused them at the beginning of the study, and then at the end of each of the first two weeks and every second week for the remaining 12 weeks of the study. Researchers also tested the participants for depression.
What they found: Women who took cymbalta had significantly less pain and discomfort than those who took the placebo. For men, who made up only 11 percent of the study, there was no effect from taking the medication compared with a placebo. Depression played no part in whether or not the drug worked to control pain. The change in the level of women's pain was particularly pronounced after a month of taking the drug, then leveled off a bit before dropping again near the end of the study.
What it means to you: cymbalta could be a good therapy for people suffering from fibromyalgia. Because the disease is not well understood, no one knows the best way to treat it or why certain drugs work and others don't. Other antidepressants, including Prozac, Elavil, and Endep, have also been shown to reduce symptoms of the disease, so those types of drugs may become a standard treatment.
Caveats: In most tests, cymbalta improved the score of participants.
However, in one of the primary measures of pain there was no significant difference between the two groups at the end of the 12-week trial. Also, because the trial lasted only 12 weeks, it is impossible to tell how well the drug would control treatment for a longer period of time. Lastly, the primary researcher on the project has received more than $10,000 in consulting fees from Eli Lilly, the manufacturer of cymbalta, and other researchers also have ties to the company.
Reference: Arnold, L.M. et al. "A Double-Blind, Multicenter Trial Comparing Duloxetine With Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder." Arthritis and Rheumatism. September 2004, Vol. 50, No. 9, pp. 2974–2984.
Source: U.S. News & World Report