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Erschienen in: Journal of Neurology 3/2024

09.12.2023 | 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

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

Erschienen in: Journal of Neurology | Ausgabe 3/2024

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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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Metadaten
Titel
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
verfasst von
Mohamed Y. Abdelgaied
Mohamed Hamed Rashad
Hend M. El-Tayebi
Mohamed H. Solayman
Publikationsdatum
09.12.2023
Verlag
Springer Berlin Heidelberg
Erschienen in
Journal of Neurology / Ausgabe 3/2024
Print ISSN: 0340-5354
Elektronische ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-023-12113-2

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