A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis

Abstract

The impact of flavonoids on fatigue has not been investigated in relapsing and remitting multiple sclerosis (RRMS).ObjectiveTo determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS.MethodsA randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley, UK (ISRCTN69897291). During a 6-week intervention participants consumed a high or low flavonoid cocoa beverage daily. Fatigue and fatigability were measured at three visits (weeks 0, 3 and 6). Feasibility and fidelity were assessed through recruitment and retention, adherence and a process evaluation.Results40 people with multiple sclerosis (10 men, 30 women, age 44±10 years) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data were <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size (ES) 0.04, 95% CI −0.40 to 0.48) and a moderate effect on fatigability (6 min walk test: ES 0.45, 95% CI −0.18 to 1.07). There were seven adverse events (four control, three intervention), only one of which was possibly related and it was resolved.ConclusionA flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.

Physical Activity and Fatigue in Multiple Sclerosis: Secondary Outcomes from a Double-blinded Randomized Controlled Trial of Cocoa Flavonoid Drinks

“…

Registration name: A study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing-remitting multiple sclerosis (RRMS).CONSORT Statement: In this study, we adhered to CONSORT guidelines. As this paper is a secondary analysis, we therefore did not repeat some parts in the methods, results, diagrams, or tables that have been published in the first paper authored by Coe et al 2019.

…”

Food of the gods for the treatment of multiple sclerosis related fatigue?

“…As described in the paper,1 fatigue is the most common symptom reported by individuals affected by MS, affecting the majority of patients. It is often present even when neurological disability is low and in the early stages of the disease, but impacts significantly the quality of life in MS patients, diminishing independence in everyday activities.…”

A Scoring Algorithm for Deriving Utility Values from the Neuro-QoL for Patients with Multiple Sclerosis

“…With the NQU, economic models can now incorporate utilities from the broad range of published studies in which patients with MS have completed the Neuro-QoL. 5,9,11,49,50 When choosing whether to use utilities derived from generic or condition-specific measures, researchers should consider the tradeoffs between these approaches. Condition-specific instruments are often thought to be more sensitive to change and disease severity because they focus on relevant constructs.…”

“…The Neuro-QoL item banks and short forms are increasingly used to assess patients with MS. [5][6][7][8][9][10][11][12] As these studies are published, the HRQL results for a wide range of patients with MS are becoming publicly available. If these Neuro-QoL scores could be converted into health state utilities, the resulting values would be useful in costutility analyses (CUAs), which are conducted to inform decisions regarding allocation of health care resources worldwide.…”