Pontifical Catholic University of Rio Grande do Sul
Sao Lucas Hospital, Neurology Department

Author Of 1 Presentation

Symptom Management Late Breaking Abstracts

LB1248 - Proof-of-concept trial of a novel dietary supplement, Multicafe®, for fatigue in multiple sclerosis (ID 2134)

Abstract

Background

Fatigue is a prevalent and disabling symptom of multiple sclerosis (MS). Inflammation and oxidative stress may play a role in the pathophysiology of fatigue. While a few pharmacological and behavioral interventions may be helpful, there remains an unmet need for more effective and affordable options. Multicafe® is a novel dietary supplement composed of coffee, guarana, selenium and L-carnitine, that showed anti-inflammatory and antioxidant effects in preclinical studies.

Objectives

We aimed to investigate the safety of Multicafe®. Secondarily, we aimed to assess the effect of Multicafe® as well as the influence of daytime sleepiness, cognitive processing speed, and walking time on fatigue.

Methods

This was a proof-of-concept, double-blind, controlled trial. Adult patients with relapsing or progressive MS, EDSS up to 5.5 and clinically relevant fatigue were randomized to an oral daily dose of either Multicafe® or placebo, as an add-on therapy, for 12 weeks. The primary endpoint was the Modified Fatigue Impact Scale (MFIS), with a reduction of 10 or more points from the baseline (responders). Secondary endpoints included the Epworth Sleepiness Scale, Symbol Digit Modalities Test (SDMT), and Timed 25-Foot Walk (T25FW).

Results

Among the total of 30 patients recruited, 16 received Multicafe® and 14 received placebo for 12 weeks. Female preponderance was lower (69% vs 93%) and MFIS score at baseline was slightly higher (55.8 vs 48.4) in the Multicafe® arm, with other demographic and clinical features similar between groups. Two patients in each group experienced mild, self-limited gastrointestinal symptoms. No other adverse events were considered related to Multicafe®. There were no serious or unexpected adverse events. Mean reduction in the MFIS score at 12 weeks was greater in the Multicafe® arm compared to placebo (-26% vs -7%); similarly, the proportion of responders was higher with Multicafe® (57% vs 40%). The patients who had greater reduction in the MFIS were younger and had a trend towards lower EDSS scores at baseline. The MFIS scores correlated with the Epworth scale and the T25FW, but not with the SDMT.

Conclusions

Multicafe® was safe and well-tolerated in MS. Our preliminary data suggest a possible benefit in reducing MS-related fatigue, especially in younger patients with lower disability. Future efficacy study may confirm the clinical benefit of this dietary supplement for fatigue in MS.

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