Evaluation of MRI asymptomatic gadolinium-enhancing lesions conversion to persistent black hole with high‑dose methylprednisolone pulse therapy in relapsing remitting multiple sclerosis patients: a randomized trial
Abstract
BACKGROUND
Chronic black holes (CBHs) on T1-weighted MRI signify irreversible axonal damage in multiple sclerosis (MS).
OBJECTIVES
This research evaluated the potential of intravenous methylprednisolone (IVMP) pulse therapy to prevent asymptomatic contrast-enhancing lesions (CELs) from progressing to chronic black hole (CBHs).
METHODS
In a double‑blind controlled randomized trial during the study period of 2019-2021, 102 people with relapsing-remitting MS with at least one symptom-less contrast-enhancing lesion were randomized into two groups to receive an infusion of methylprednisolone (n = 50) or placebo (n = 52). Repeat MRI imaging was performed 6 months later.
RESULTS
Among 161 CELs, 32 (19.9%) converted to CBHs. Conversion rates were similar between IVMP (18.8%) and placebo (21.0%) (OR = 0.88, 95% CI = 0.38-2.04; p = 0.83). EDSS progression did not differ among groups (p = 0.62). CBH distribution across lesion locations showed no significant differences.
CONCLUSIONS
Intravenous methylprednisolone pulse therapy administered for asymptomatic gadolinium-enhancing lesions was not associated with a statistically significant reduction in the formation of chronic T1 black holes over a 6-month follow-up period.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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