A University of Michigan-led study has delved into the efficacy of standard treatments for individuals with multiple sclerosis, mainly focusing on the impact of medical and behavioural interventions on fatigue. This pervasive symptom significantly disrupts daily life. The study employed a randomised clinical trial framework to evaluate the effectiveness of modafinil — a medication that promotes wakefulness and is typically prescribed for sleep disorders — and cognitive behavioural therapy (CBT) in reducing fatigue among over 300 adults with multiple sclerosis whose daily activities were hampered by this condition.
The research revealed that modafinil and CBT, administered individually over the phone, significantly reduced fatigue over 12 weeks. Interestingly, while combining these treatments did not enhance the fatigue scores beyond the results of the singular interventions, it affirmed the effectiveness of each approach. These findings have been published in The Lancet Neurology, contributing valuable insights into the comparative benefits of medication and behavioural therapy in managing multiple sclerosis symptoms.
Tiffany J. Braley, M.D., M.S., the study’s first author and a prominent figure at the University of Michigan Health, highlighted the prevalent challenge of fatigue in multiple sclerosis management, noting the uncertainty surrounding the optimal use of available treatments. She pointed out that the study provides compelling evidence that both CBT and modafinil are comparably effective in addressing MS-related fatigue, potentially influencing future treatment protocols for one of the disease’s most debilitating symptoms.
The significance of fatigue in the lives of those with multiple sclerosis cannot be overstated, with up to 90% of the nearly 3 million people affected worldwide experiencing fatigue, and almost half of them citing it as their most disabling symptom. The research adopted a real-world approach that mirrors actual clinical practices more closely than traditional clinical trials, incorporating inputs from stakeholders with MS who participated in designing the study.
The effectiveness of the treatments was notable, with more than 60% of participants in each treatment group reporting a clinically meaningful improvement in fatigue, assessed using the Modified Fatigue Impact Scale. According to Anna L. Kratz, Ph. D., senior author and professor at the U-M Medical School, both standalone and combined treatments were recommended as viable options for managing chronic fatigue in multiple sclerosis patients.
The study also highlighted the role of patient-centric outcomes and the importance of shared decision-making in treatment selection, considering patient characteristics and broader treatment goals. Interestingly, trial participants who only received CBT reported lower fatigue scores even 12 weeks post-treatment, underscoring CBT’s long-term efficacy in fatigue management previously evidenced in other studies.
Kratz emphasised the potential of telehealth in extending the reach of behavioural health care like CBT to more patients, especially those with limited access to such services. The study confirmed that CBT is not only a feasible option but also imparts fatigue management skills that patients can continue to use indefinitely, offering lasting benefits beyond the treatment period.
However, the study also found that the participants’ sleep habits could influence the efficacy of the treatments. For instance, those with poor sleep hygiene experienced better outcomes with CBT, while those with good sleep hygiene benefitted more from modafinil. This suggests that while modafinil could worsen sleep quality in patients with behaviourally induced sleep issues, behavioural treatments incorporating sleep education are more suitable for individuals with poor sleep habits.
In sum, this comprehensive study not only reaffirms the efficacy of modafinil and CBT in treating fatigue in multiple sclerosis but also underscores the nuanced approach needed in selecting and applying these treatments, considering the individual’s specific circumstances and broader health objectives.
More information: Tiffany J Braley et al, Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial, The Lancet Neurology. DOI: 10.1016/S1474-4422(24)00354-5
Journal information: The Lancet Neurology Provided by Michigan Medicine – University of Michigan
