Fibromyalgia syndrome (FMS) is a
chronic condition characterized by widespread
pain, tender points,
fatigue, and sleep disturbance. FMS leads to high disability levels, poor quality of life, and extensive use of medical care. Effective pharmacological treatment options are rare, and treatment effects are often of limited duration.
Duloxetine is a new selective
serotonin and
norepinephrine reuptake inhibitor that is licensed for the treatment of
pain in
diabetic neuropathy. So far two randomized, placebo-controlled trials have investigated the short-term safety and efficacy of
duloxetine 60 mg/day and 120 mg/day in patients suffering from FMS over a period of 12 weeks. Both dosages were superior to placebo in
pain relief, and improvement in quality of life and depressive symptoms. The
analgesic effect was largely independent of the
antidepressant action of
duloxetine. The higher dose of 120 mg/day further reduced the tender point count and elevated the tender point pain thresholds. Only mild to moderate adverse effects were reported.
Duloxetine 60 mg/day and 120 mg/day has proven to be beneficial in the treatment of FMS symptoms. As true for other
antidepressants further studies are needed to assess the long-term efficacy and safety of
duloxetine as an additional pharmacological treatment option in FMS.