When Treatment Can Make Things Worse

Fibromyalgia drug treatment just as likely to worsen symptoms as relieve them

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Relief from fibromyalgia symptoms can appear elusive. For some, the side effects that come with treatment of fibromyalgia symptoms make the cure seem worse than the disorder itself.

A recent study looked at the use of medication to treat fibromyalgia.

Results showed that fibromyalgia patients on medication were just as likely to have improvement in their symptoms as they were to have negative side effects that cause them to quit treatment.

The researchers suggested fibromyalgia patients treat their symptoms with a combination of medication, exercise and counseling instead of medication alone.

"Discuss the pros and cons of fibromyalgia Rx with your doctor."

Winfried Hauser, MD, of Technische Universität München, and colleagues examined five studies that compared the use of duloxetine to placebo and five studies that compared the use of milnacipran to placebo.

Duloxetine (Cymbalta) and milnacipran (Savella) are two of three drugs approved for fibromyalgia treatment in the United States. 

Fibromyalgia is a condition that causes pain, sleep problems and fatigue in more than five million Americans. The condition mostly affects women.

"Fibromyalgia is a tough disease for patients who suffer the pain it causes and the skepticism with which it’s often approached by doctors," said Steven Kussin, MD, FACP, patient advocate and author of the book, Doctor, Your Patient Will See You Now. "Patients appear healthy, there are no abnormalities on physical examination, and laboratory and x-ray studies are normal."

There is no known cause or cure for fibromyalgia. Current medications for fibromyalgia are used to treat the symptoms caused by the condition, not the condition itself.

The studies involved a total of 6,038 people with fibromyalgia. Of this total, 3,611 were on medication and 2,427 were on placebo.

The researchers found that 22 percent of study participants on medication for fibromyalgia reported improvement in their condition. However, 21 percent quit the medication due to negative side effects.

The most common side effects were nausea, dry mouth, constipation, headache, dizziness and insomnia.

The medications were not shown to significantly improve quality of life, sleep or fatigue when compared to placebo.

The medication reduced pain slightly better than placebo.

The Number Needed to Treat (NNT) and the Number Needed to Harm (NNTH) are measures of the usefulness of a medication.

NNT is the number of patients who must receive a particular therapy before one patient sees a benefit. NNTH is the number of people who are typically treated before one person experiences harm.

"When, as in this study, the NNTB and the NNTH are almost the same, there can be little enthusiasm for the two agents studied," said Dr. Kussin.

The researchers commented that this study was important to balance the advertising claims that these prescription drugs improve fibromyalgia symptoms. The study authors recommended combined treatment of medication and non-drug treatment methods over medication alone.

The study was published in The Cochrane Library. The authors reported no conflicts of interest.

Reviewed by: 
Review Date: 
March 11, 2013
Last Updated:
March 19, 2013