Drugs to Treat Fibromyalgia Just as Likely to Harm as Help

Among fibromyalgia patients taking either of two commonly prescribed drugs to reduce pain, 22 percent report substantial improvement while 21 percent had to quit the regimen due to unpleasant side effects, according to a new review in The Cochrane Library.

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.

Suggested by Craig Payne

Fibromyalgia prevalence at 2.1 percent of general German population

Study suggests fibromyalgia is a spectrum disorder

Researchers have determined that fibromyalgia prevalence is 2.1% of the general population in Germany. Results appearing in Arthritis Care & Research, a journal published by Wiley on behalf of the American College of Rheumatology (ACR), suggest that fibromyalgia is a spectrum disorder rather than a categorical illness. Additionally, a number of fibromyalgia cases in the general population satisfy proposed criteria for physical symptom disorder—the presence of one or more physical symptoms that impair function, which cannot be explained by another clinical or psychiatric illness.

Fibromyalgia is a chronic, musculoskeletal syndrome characterized by chronic widespread pain together with fatigue, sleep disturbances, cognitive problems, and multiple somatic symptoms. In 2010 the ACR released modified diagnostic criteria for fibromyalgia, eliminating the tender point count assessment that was part of the 1990 criteria. Shortly after the modified criteria was published it was decided that the widespread pain index and symptom severity score could be combined to form a new measurement of pain and symptom severity termed the polysymptomatic distress scale (PSD).

The lead author of the current study, Dr. Frederick Wolfe with the National Data Bank for Rheumatic Diseases and University of Kansas School of Medicine in Wichita, reported on 2,445 subjects who were randomly selected from the general German population in 2012. The team used the 2010 modified ACR preliminary diagnostic criteria for fibromyalgia to identify patients with the disease.

Findings show fibromyalgia prevalence at 2.1% with occurrence in women and men at 2.4% and 1.8%—a difference that was not statistically significant according to researchers. Furthermore, the team found evidence supporting the hypothesis that fibromyalgia is a spectrum disorder and not a distinct disease. Nearly 40% of fibromyalgia patients met the proposed criteria for a physical symptom disorder.

The authors suggest that fibromyalgia should be considered a spectrum or dimensional disorder by giving the range of polysymptomatic distress experienced by patients. A patient with a widespread pain index of 7 or more out of 19 pain sites and symptom severity score of 5 or more out of 12 will have a PSD scale score of at least 12, a cut point below which fibromyalgia criteria will not be met.

“Given the continuum of symptoms in patients, our study provides important evidence supporting fibromyalgia as a spectrum disorder,” concludes Dr. Wolfe. “Our findings have important implications for epidemiologic and neurobiologic studies, clinical diagnosis and disease management, along with determining disability in those with fibromyalgia.”

Curated: Craig Payne