Findings back therapies to abate multiple sclerosis fatigue

Treatment with the medication modafinil or telephone-delivered cognitive behavioral therapy (CBT), alone or in combination, can significantly reduce fatigue due to multiple sclerosis (MS), a new study has found.

“The findings show that we have options of effective interventions and can give patients a choice,” said Kevin Alschuler, professor of rehabilitation medicine and adjunct professor of neurology at the University of Washington School of Medicine in Seattle. He is a co-author on the paper, published Oct. 16 in The Lancet Neurology. 

The study was led by researchers at the University of Michigan Medical School in Ann Arbor. About half of the study participants were patients at the UW Medicine Multiple Sclerosis Center.

Multiple sclerosis is a disabling neurological disease that affects nearly 3 million people worldwide.  For many years, difficulty with movement was considered the most disabling feature of the disease.  But in the 1980s, Dr. George Kraft, a UW professor of rehabilitation medicine, demonstrated that fatigue was the most common MS symptom. Today it is known that 90% of people with MS experience fatigue, with nearly half saying fatigue is their most disabling symptom. 

Over the past decade, Dr. Dawn Ehde, a UW professor of rehabilitation medicine, led the development of a telehealth CBT program to help MS patients cope with common symptoms. The goal of CBT is to teach patients ways to think about and deal with fatigue and related challenges, and to provide strategies to overcome them. 

Although no drug has been approved by the U.S. Food and Drug Administration to treat MS-related fatigue, modafinil, a drug used to treat excess daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, is often used off-label to treat MS patients.

“Both CBT and modafinil have been shown to reduce symptoms of fatigue,” Alschuler said, “but we didn’t really know which one works better, which works best for which patients, and whether combining the two might have a better effect than we get when we only used one or the other.”

To find out, the researchers randomly assigned 336 patients to three treatment arms: In one group, enrollees participated in a 12-week, phone-based CBT program.  A second group of participants received treatment with modafinil, and the third group  participated in CBT and took the drug. 

The researchers found that than 65% of participants in each group of the study reported clinically meaningful improvement in fatigue. A follow-up assessment conducted 12-weeks after the CBT training was completed found the CBT benefit persisted.

“We also found a very high rate of adherence to CBT, with 85-90% of participants attending all eight telephone treatment sessions. These findings highlight how valuable telehealth is for improving access to CBT and similar behavioral health interventions in people with MS,” Ehde said.

Although the three treatments all improved symptoms of fatigue, “the participants’ sleep habits appeared to affect how well different treatments worked,” said Alschuler. “Those with poor sleep habits had better outcomes with CBT, while those with good sleep habits did better with modafinil.”

“The finding suggests that if you have a patient who could improve their behavior around sleep, CBT might be best to try first, while if you have a patient who already has good sleep habits, you might try modafinil first,” he said.

Dr. Tiffany J. Braley, associate professor of neurology, was the paper’s first author and Anna L. Kratz, professor of physical medicine and rehabilitation, was senior author.  Both are with the University of Michigan. 

Ehde and UW Medicine colleague Gloria von Geldern, associate professor of neurology, were co-authors. Other collaborators represented the National Multiple Sclerosis Society, Ohio State Wexner Medical Center and the University of Virginia.

This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (1234-56789) and the National MS Society (#R-1803-30557). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the PCORI, its board of governors or methodology committee.

Michael McCarthy wrote this news release.

For details about UW Medicine, please visit http://uwmedicine.org/about.