Abstract
The impact of flavonoids on fatigue has not been investigated in Relapsing and Remitting Multiple Sclerosis (RRMS).
Objective: To determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS.
Methods: A randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley (ISRCTN: 69897291). During a six 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.
Results: 40 pwMS (10 men, 30 women, age 44 ± 10 yrs) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data was <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size {ES} 0.04; confidence interval {CI} -0.40-0.48) and a moderate effect on fatigability (six-minute walk test: ES 0.45; CI -0.18 - 1.07). There were seven adverse events (four control, three intervention), only one of which was possibly related and it was resolved.
Conclusion: A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.
Objective: To determine the feasibility and estimate the potential effect of flavonoid-rich cocoa on fatigue and fatigability in RRMS.
Methods: A randomised double-blind placebo-controlled feasibility study in people recently diagnosed with RRMS and fatigue, throughout the Thames Valley (ISRCTN: 69897291). During a six 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.
Results: 40 pwMS (10 men, 30 women, age 44 ± 10 yrs) were randomised and allocated to high (n=19) or low (n=21) flavonoid groups and included in analysis. Missing data was <20% and adherence to intervention of allocated individuals was >75%. There was a small effect on fatigue (Neuro-QoL: effect size {ES} 0.04; confidence interval {CI} -0.40-0.48) and a moderate effect on fatigability (six-minute walk test: ES 0.45; CI -0.18 - 1.07). There were seven adverse events (four control, three intervention), only one of which was possibly related and it was resolved.
Conclusion: A flavonoid beverage demonstrates the potential to improve fatigue and fatigability in RRMS.
| Original language | English |
|---|---|
| Number of pages | 7 |
| Journal | Journal of Neurology Neurosurgery and Psychiatry |
| Volume | 90 |
| Issue number | 5 |
| Early online date | 4 Mar 2019 |
| DOIs | |
| Publication status | E-pub ahead of print - 4 Mar 2019 |
Keywords
- multiple sclerosis
- neuropharmacology
- quality of life
- randomised trials
ASJC Scopus subject areas
- Surgery
- Clinical Neurology
- Psychiatry and Mental health
Access to Document
- Coe_et_al_A_randomised_double-blind_Journal_of_Neurology_Neurosurgery_and_Psychiatry_2019
Checked for eligibility: 25/03/2019 This article has been accepted for publication in Journal of Neurology, Neurosurgery & Psychiatry 2019, following peer review, and the Version of Record can be accessed online at: http://dx.doi.org/10.1136/jnnp-2018-319926 © Authors (or their employer(s)). Reuse of this manuscript version (excluding any databases, tables, diagrams, photographs and other images or illustrative material included where a another copyright owner is identified) is permitted strictly pursuant to the terms of the Creative Commons Attribution-Non Commercial 4.0 International (CC-BY-NC 4.0) http://creativecommons.org