Drugs to treat fibromyalgia just as likely to harm as help, review finds

People with fibromyalgia suffer from chronic widespread pain, sleep problems and fatigue. The illness affects more than 5 million Americans, 80 percent of whom are women. The cause of fibromyalgia is unknown and currently there is no cure. Using a Quality of Life (QOL) scale for fibromyalgia, the studies reviewed reported QOL ratings lower than 15 on a scale of 0 to 100 even among patients on medications. The two medications often prescribed to treat fibromalgia are duloxetine, known by the brand name Cymbalta or milnacipran, commonly known as Savella.

"A frank discussion between the physician and patient about the potential benefits and harms of both drugs should occur," noted the reviewers, led by Winfried Häuser, M.D. of Technische Universität München.

The authors reviewed 10 high-quality studies comprising more than 6,000 adults who received either duloxetine, milnacipran, or a placebo for up to six months. A substantial majority of study participants were middle-aged, white women.

"This is a very important study," says Fred Wolfe, M.D. of the National Data Bank for Rheumatic Diseases. "There's an enormous amount of advertising suggesting that these drugs really help, whereas the research data show that the improvement is really minimal."

Treatment with drugs alone "should be discouraged," the reviewers added. Instead, the review authors recommend a multi-faceted treatment approach including medications for those who find them helpful, exercises to improve mobility and psychological counseling to improve coping skills.

"The medical field does poorly with the treatment of fibromyalgia in general," says Brian Walitt, M.D., M.P.H., a co-author of the review and an expert in pain syndromes at Washington Hospital Center in Washington, D.C. "Chasing [a cure] with medicine doesn't seem to work.The people who seem to me to do best sort of figure it out on their own by thinking about things, getting to know themselves, and making changes in their lives to accommodate who they've become," concludes Walitt.

The only other medication approved for fibromyalgia treatment in the U.S. is the anti-convulsant pregabalin, known by the brand name Lyrica. The Cochrane Library plans to publish a review of its effectiveness later this year.

Intensive neuroscientific research is needed to reveal the underlying causes of fibromyalgia and other pain syndromes, say the researchers. In the meantime, combinations of various medications as well as combinations of drug and non-drug treatments may offer better symptom control for sufferers.