A new review in the Cochrane Library finds these medications left 21% of participants evaluated in the studies review having to stop the drug regime due to adverse events including headaches, dizziness and insomnia.
Fibromyalgia is a disorder that causes muscle pain and fatigue and tender points on the body. Symptoms of fibromyalgia include problems sleeping, memory and thinking and tingling or numbness in hands and feet. The causes of fibromyalgia are unknown. Scientists estimate that fibromyalgia affects 5 million Americans 18 or older. Between 80 and 90 percent of people diagnosed with fibromyalgia are women. However, men and children also can have the disorder. Most people are diagnosed during middle age, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
The authors reviewed ten high quality studies that included 6,038 participants. Five of the studies examined investigated duloxetine against placebo, and five investigated milnacipran against placebo. A total of 3611 participants were included into duloxetine or milnacipran groups and 2427 participants into placebo groups for up to six months.
By using Disease-related Quality of Life Scales on a scale of 0 to 100, the review revealed quality of life ratings lower than 15 even among the participants taking the medications.
Participants who took duloxetine or milnacipran instead of a placebo were likely to have reduced pain and only a slight improvement of quality of life and reduced fatigue. There were no improvements for sleep problems however, there were more drug induced side effects and a greater likelihood of stopping the medication.
In their conclusion the researchers write “duloxetine and milnacipran provided a small incremental benefit over placebo in reducing pain. The superiority of duloxetine and milnacipran over placebo in reducing fatigue and limitations of QOL was not substantial. Duloxetine and milnacipran were not superior to placebo in reducing sleep problems. The dropout rates due to adverse events were higher for duloxetine and milnacipran than for placebo. The most frequently reported symptoms leading to stopping medication were nausea, dry mouth, constipation, headache, somnolence/dizziness and insomnia. Rare complications of both drugs may include suicidality, liver damage, abnormal bleeding, elevated blood pressure and urinary hesitation.”
Dr. Winfried Häuser, MD, Clinic and Polyclinic of Psychosomatic Medicine and Psychotherapy of Technische Universität München and lead reviewer stated "A frank discussion between the physician and patient about the potential benefits and harms of both drugs should occur.”
Dr. Fred Wolfe, MD, Clinical Professor of Internal Medicine, the National Data Bank for Rheumatic Diseases, commented “This is a very important study.” "There's an enormous amount of advertising suggesting that these drugs really help, whereas the research data show that the improvement is really minimal."
The reviews add treatments with medications alone "should be discouraged.” They suggest a multi-faceted treatment approach including medications for those who find them helpful, exercises to improve mobility and psychological counseling to improve coping skills.
Dr. Brian Walitt, MD, MPH, associate professor of Medicine, Georgetown University Medical Center, research director and associate director of the Division of Rheumatology at Washington Hospital Center, and co-author of this review states "The medical field does poorly with the treatment of fibromyalgia in general.” "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 Dr. 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.
The new review is published online in The Cochrane Library.
According to the FDA, Lyrica may cause; Serious, even life-threatening, allergic reactions, Suicidal thoughts or actions, Swelling of your hands, legs and feet and Dizziness and sleepiness.
The complete FDA listing can be read online at the FDA Drug Safety.