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Study: Fibromyalgia Drugs May Do As Much Harm As Good

Authors discourage use of medications alone (Jan. 31)

Among fibromyalgia patients taking either of two commonly prescribed drugs to reduce pain, 22% experienced substantial improvement while 21% had to drop out because of unpleasant side effects, according to a new online report in The Cochrane Library.

Patients with fibromyalgia syndrome (FMS) experience chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction, and fatigue. FMS can be associated with high disability levels and poor quality of life (QOL). There is no cure for the disorder.

In the new report, the authors reviewed 10 randomized, placebo-controlled trials of serotonin and norepinephrine reuptake inhibitors (SNRIs) in adult patients with FMS. Five studies evaluated duloxetine (Cymbalta, Eli Lilly), and five evaluated milnacipran (Savella, Forest Pharmaceuticals). A total of 3,611 patients received active treatment, and 2,427 patients received placebo.

The authors found that duloxetine and milnacipran provided only a small incremental benefit over placebo in reducing pain (6.1% relative improvement). Moreover, neither drug substantially reduced fatigue or improved QOL compared with placebo, nor was there a significant difference between the active treatments and placebo in reducing sleep problems.

The authors also found that adults with FMS who received duloxetine or milnacipran rather than placebo were likely to have more drug-induced side effects and a greater likelihood of stopping medication. The dropout rate due to adverse events in the duloxetine and milnacipran groups was significantly higher than the rate in the placebo groups (relative risk, 1.83). The most frequently reported symptoms leading to stopping medication were nausea, dry mouth, constipation, headache, somnolence/dizziness, and insomnia.

In the authors’ opinion, the treatment of FMS with drugs alone “should be discouraged.” Instead, clinicians should take a multifaceted treatment approach that includes medications for patients who find them helpful, exercise to improve mobility, and psychological counseling to improve coping skills.

Source: Cochrane Library; January 31, 2013.

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