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Journal of Neurology

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09-12-2023 | Metformin | Original Communication

The impact of metformin use on the outcomes of relapse-remitting multiple sclerosis patients receiving interferon beta 1a: an exploratory prospective phase II open-label randomized controlled trial

Authors: Mohamed Y. Abdelgaied, Mohamed Hamed Rashad, Hend M. El-Tayebi, Mohamed H. Solayman

Published in: Journal of Neurology | Issue 3/2024

Abstract

Background

Multiple sclerosis (MS) is a chronic demyelinating neurodegenerative disorder. Elevated levels of pro-inflammatory mediators and some oxidative stress parameters can accelerate the demyelination process. We aimed to investigate the efficacy and safety of metformin as an adjuvant therapy to interferon beta 1a (IFNβ-1a) in relapsing–remitting multiple sclerosis (RRMS) patients.

Method

Eighty RRMS patients were equally divided into 2 groups: the intervention group receiving IFNβ-1a plus 2 gm of metformin once daily and the control group receiving IFNβ-1a alone. Interleukin 17 (IL17), interleukin 22 (IL22), malondialdehyde (MDA), T2 lesions in magnetic resonance imaging (MRI) and expanded disability status scale (EDSS) were assessed at the baseline and then after 6 months.

Results

At baseline, there were no statistically significant differences between the two groups (p > 0.05). After 6 months, the change in the median (interquartile range) of the results for both the intervention and control group were; IL17 (− 1.39 (4.19) vs − 0.93 (5.48), p = 0.48), IL22 (− 0.14 (0.48) vs − 0.09 (0.6), p = 0.53), and EDSS (0 vs 0, p = 1), respectively. The mean (standard deviation) change in MDA for the intervention and control group was − 0.93 (2.2) vs − 0.5 (2.53), p = 0.038, respectively. For MRI results, 21 patients had stationary and regressive course and 1 patient had a progressive course in the intervention arm vs 12 patients had stationary and regressive course and 4 had a progressive course in the control arm, p = 0.14.

Conclusion

Adding metformin to IFNβ-1a demonstrated a potential effect on an oxidative stress marker (MDA). However, there is no statistically significant effect on immunological, MRI and clinical outcomes. We recommend larger scale studies to confirm or negate these findings.

Trial registration

ClinicalTrials.gov number: NCT05298670, 28/3/2022.

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Title: The impact of metformin use on the outcomes of relapse-remitting multiple sclerosis patients receiving interferon beta 1a: an exploratory prospective phase II open-label randomized controlled trial
Authors: Mohamed Y. Abdelgaied
Mohamed Hamed Rashad
Hend M. El-Tayebi
Mohamed H. Solayman
Publication date: 09-12-2023
Publisher: Springer Berlin Heidelberg
Keywords: Metformin
Multiple Sclerosis
Interferon
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Published in: Journal of Neurology / Issue 3/2024
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI: https://doi.org/10.1007/s00415-023-12113-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The impact of metformin use on the outcomes of relapse-remitting multiple sclerosis patients receiving interferon beta 1a: an exploratory prospective phase II open-label randomized controlled trial

Abstract

Background

Method

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method

Results

Conclusion

Trial registration

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