LONDON — Severe fatigue related to multiple sclerosis (MS) can be effectively reduced with cognitive behavioral therapy (CBT), a study suggests.

The Treating Fatigue in Multiple Sclerosis (TREFAMS) study also evaluated aerobic exercise training and an energy conservation program as strategies to reduce MS-related fatigue, but did not show such good results with these approaches.

"Our study strongly suggests that CBT tailored to reduce MS-related fatigue is the most effective rehabilitation treatment for MS-related fatigue," lead author Vincent de Groot MD, University Medical Center Amsterdam, the Netherlands, concluded. "The results should influence rehabilitation practice. However, more research is needed on how to maintain this effect in the long term.

Dr de Groot presented the findings here at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016.

"Individually provided energy conservation management was not effective, and aerobic training according to the studied protocol showed a small positive — but not clinically relevant — effect," he added. "But please don't go away with the message that exercise is not beneficial for multiple sclerosis. We know it is. This study just suggested no clinical benefit on fatigue in MS."

Commenting on the study for Medscape Medical News, session cochair Daphne Kos, PhD, University of Leuven, Belgium, said TREFAMS was a well-designed study that confirmed other research that had suggested benefits of CBT for MS fatigue.

She also believes exercise and energy conservation are probably worthwhile, but this is difficult to prove. "Most people do feel better with these interventions, but it is difficult to find the right assessments that pick this up," Dr Kos said.

Dr de Groot explained that fatigue is a common symptom in MS patients that restricts societal participation and is regularly treated during rehabilitation.

He noted that although there is some suggestion in the literature that aerobic training, CBT, and energy conservation management may alleviate MS-related fatigue, studies of these interventions have many limitations including not specifically enrolling participants with MS-related fatigue, not using fatigue as a primary outcome, being under-powered, or not using active control groups.

The TREFAMS research program consists of three single-blinded randomized controlled trials — one for each of the above mentioned interventions — specifically designed to overcome the important limitations in the literature, with fatigue and societal participation as primary outcomes.

In the studies, a total of 270 ambulatory patients with severe MS-related fatigue were randomly allocated to the trial-specific intervention or control intervention (90 in each trial).

The therapy period lasted 16 weeks, and outcomes were assessed up to 1 year. The trial-specific interventions consisted of 12 individual therapist-supervised sessions with additional intervention-specific home exercises. The control intervention consisted of three individual consultations with a specialized MS nurse.

Fatigue was measured using the Checklist Individual Strength (CIS) fatigue scale, with an improvement of ≥ 8 points considered clinically relevant, and societal participation was measured using the Impact on Participation and Autonomy (IPA) scale.

CBT consisted of individualized treatment-formulating goals, analyzing helpful behavior, and advice on how to integrate skills into daily life. These skills could include regulating sleep/wake patterns, changing beliefs about MS and fatigue, reducing the focus on fatigue, regulation of physical, social, and mental activity, addressing the role of the environment, and handling pain.

Results showed an effect size of –0.79 (–1.26 to –0.32), with a number needed to treat (NNT) of 3 for one patient to achieve an 8-point reduction on the fatigue scale.

Aerobic training consisted of 30 minutes of exercise three times a week with 12 supervised and 36 home-based sessions.

Results showed a mean difference between-groups on the CIS fatigue subscale of 4.7, which was not considered clinically meaningful. The effect size was –0.54 (–1.00 to –0.06), with an NNT of 9 for one patient to achieve an 8-point reduction on the fatigue scale. Researchers also found that long-term adherence to the aerobic-training protocol was difficult for patients.

The energy-conservation management intervention consisted of sessions addressing the importance of rest throughout the day, positive communication, body mechanics, modification of the environment, setting priorities, and activity modification.

Results of the study showed very little effect on fatigue (effect size, –0.11; – 0.57 to 0.35), with an NNT of 158 for one patient to achieve an 8-point reduction on the fatigue scale.

Effects on societal participation could not be shown for any of the interventions.

The study was funded by the Fonds NutsOhra. Dr de Groot has reported no relevant financial relationships.

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016. Abstract 145. Presented September 15, 2016.

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