Two Fibro Meds Offer Little Relief for Most
Researchers say fibromyalgia should be treated with a combination of therapies.
A recent review found that, for most fibromyalgia patients, two commonly prescribed medications either didn’t provide relief or were stopped due to side effects. The authors suggest patients should look beyond drugs to other treatment options, like exercise and therapy, for better relief of the widespread pain, fatigue and sleep problems that are hallmarks of the condition.
“The effects of drugs – on average – are poor compared to placebo on fibromyalgia symptoms,” explains lead author Winfried Häuser, MD, associate professor of psychosomatic medicine and pschyotherapy at Technische Universität München in Germany.
Dr. Häuser led the new review, published online recently in The Cochrane Library, which looked at 10 studies involving more than 6,000 patients given a placebo and either duloxetine (Cymbalta) or milnacipran (Savella) for anywhere from 12 to 27 weeks. Patients were typically between the ages of 47 and 51 and most were women – a reflection of the fact that between 80 and 90 percent of the estimated five million Americans with fibromyalgia are women.
Researchers say after an average of 18 weeks, “the drugs had a small, incremental effect over placebo in reducing pain” with 29 percent of patients taking one of the medications reporting at least a 50 percent pain reduction compared to 19 percent taking placebo. The medications did not “reduce fatigue substantially (2.5 percent relative improvement) … and did not improve [quality of life] substantially (4.6 percent relative improvement) … compared to placebo.” There was no difference in improvement of sleep problems between the drug and placebo group.
But 20 percent taking the drugs and 11 percent on placebo stopped the medications because of side effects, such as nausea, headache and constipation – a statistically significant difference. Serious problems like liver damage and abnormal bleeding were rare, with no statistically significant difference between those taking the active drug and those taking placebo.
This review didn’t include an analysis of pregabalin (Lyrica), another FDA approved fibromyalgia treatment, but The Cochrane Library plans to release a review of that medication later this year.
“Patients and doctors should be realistic about the possibilities of drugs in fibromyalgia,” says Dr. Häuser. “Drugs do not cure fibromyalgia. [But] a minority of patients are real treatment responders – that is, they experience a substantial relief of symptoms with no or slight and tolerable side effects.”
Dr. Häuser says if a patient isn’t responding to drug treatment after four weeks, it should be stopped. And he says he believes physicians should be discouraged from treating fibromyalgia with medication alone – instead making sure they also incorporate exercise and counseling into their approach.
Carmen Gota, MD, a rheumatologist at the Cleveland Clinic in Ohio says this study verifies and confirms what we already know about the importance of a multidisciplinary approach. But she says she doesn’t want patients to get the message that drugs shouldn’t be used at all. Though they don’t help the vast majority of patients, she says they still have a role to play in treatment for some.
“They probably work better in patients with depression than those without it,” Dr. Gota says. “But the drugs alone are not sufficient. You have to look at the whole patient and combine treatment with aerobic exercise and a comprehensive approach that includes cognitive behavioral therapy and occupational therapy.”
Fibromyalgia patients with great amounts of pain often find it incomprehensible that they could engage in aerobic exercise. But Dr. Gota says in fibromyalgia management programs around the country, like the one at Cleveland Clinic, physical therapists assess a patient and proceed with the philosophy “start low and go slow.”
“Without exercise it’s hard to improve,” Dr. Gota says. “A lot of patients with this condition, when they exercise they get better. We always tell the patients to start gradually and the physical therapist designs a program that is gradual and they can follow.”
Dr. Gota says extensive literature shows exercise stimulates and improves brain function and helps in the areas that affect sleep and emotions. It increases endorphins (which have energizing effects), provides a psychological boost because it allows people to take control of their health, and also improves muscle tone, which makes it easier to continue to exercise.
She says counseling reassures patients that their condition is real, even if other doctors have been doubtful. It helps them understand that fibromyalgia is the nervous system working overtime, causing patients to be hypersensitive to a variety of stimuli – from medication to light and noises. And it focuses on identifying an individual’s stressors and learning how to shut down their body’s over-response to stress. It can also help patients learn how to cope with their pain to keep it from controlling their life.
“This a treatable condition but it’s only treatable because of a partnership between the patient and doctor,” Dr. Gota says. “If you also do these other things, you will get better. You will feel better and function better. So the message is just taking pills and doing nothing else is insufficient.”