A new study funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases will measure the effectiveness of gabapentin, an anticonvulsant medication, in reducing symptoms of fibromyalgia syndrome (FMS). Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain and fatigue. Gabapentin has been found to relieve chronic pain caused by nervous system disorders, and it was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of persistent, severe pain that can follow an episode of shingles.
The new study will be conducted by Lesley M. Arnold, M.D., and her colleagues at the University of Cincinnati College of Medicine and two Boston-area sites, McLean Hospital of Harvard University and Newton-Wellesley Hospital.
Approximately 150 study participants with FMS will be assigned randomly to take either gabapentin or placebo for a 12-week period. The medication's effectiveness will be measured using questionnaires that assess the participants' fatigue, stiffness, sleep, mood, "tender-point" pain threshold and quality of life. Tender points are specific places on the body--located on the neck, shoulders, back, hips, and upper and lower extremities-- where people with fibromyalgia often feel pain in response to slight pressure.
Treatment of fibromyalgia usually requires a comprehensive approach. Patients may benefit from a combination of exercise, medication, and physical therapy.
Currently, there are no medications specifically approved by the FDA for the treatment of FMS. Many people with FMS take nonsteriodal anti-inflammatory drugs, and some physicians prescribe muscle relaxants and antidepressants to treat the symptoms of FMS. Depending on the results of this study, gabapentin may become another treatment option. Available data suggest that 3 to 6 million Americans are affected by FMS. It primarily occurs in women, but children and men also may be affected.