Synopsis

Source of validity: Scientific
Rating (out of 5): 4

Fumaric acid and its esters, particularly dimethyl fumarate (DMF), have scientific validation for use in the treatment of Multiple Sclerosis (MS), specifically relapsing forms of the disease. Dimethyl fumarate is an oral disease-modifying therapy approved by regulatory agencies such as the US FDA and the European Medicines Agency for relapsing-remitting MS. The therapeutic effect is attributed to the immunomodulatory and neuroprotective properties of DMF, which is metabolized in the body to monomethyl fumarate. These compounds activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, leading to increased cellular defense against oxidative stress and reduced inflammation, which are both implicated in MS pathogenesis. Large, randomized, placebo-controlled clinical trials, such as DEFINE and CONFIRM, have demonstrated that dimethyl fumarate significantly reduces relapse rates, delays disability progression, and decreases the number of new or enlarging brain lesions as seen on MRI scans, compared to placebo. Common side effects include flushing and gastrointestinal symptoms, but the overall safety profile is considered acceptable. It should be noted that while "fumaric acid" itself is not directly used, its ester derivative (dimethyl fumarate) is the clinically relevant compound. The supporting evidence for DMF's efficacy and mechanism in MS is robust, with multiple high-quality studies and meta-analyses available in the scientific literature.

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