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| Item Type: | Article |
|---|---|
| Title: | Epigallocatechin gallate in progressive MS: a randomized, placebo-controlled trial |
| Creators Name: | Rust, R. and Chien, C. and Scheel, M. and Brandt, A.U. and Dörr, J. and Wuerfel, J. and Klumbies, K. and Zimmermann, H. and Lorenz, M. and Wernecke, K.D. and Bellmann-Strobl, J. and Paul, F. |
| Abstract: | OBJECTIVE: To examine whether treatment with epigallocatechin gallate (EGCG) influences progression of brain atrophy, reduces clinical and further radiologic disease activity markers, and is safe in patients with progressive multiple sclerosis (PMS). METHODS: We enrolled 61 patients with primary or secondary PMS in a randomized double-blind, parallel-group, phase II trial on oral EGCG (up to 1,200 mg daily) or placebo for 36 months with an optional open-label EGCG treatment extension (OE) of 12-month duration. The primary end point was the rate of brain atrophy, quantified as brain parenchymal fraction (BPF). The secondary end points were radiologic and clinical disease parameters and safety assessments. RESULTS: In our cohort, 30 patients were randomized to EGCG treatment and 31 to placebo. Thirty-eight patients (19 from each group) completed the study. The primary endpoint was not met, as in 36 months the rate of decrease in BPF was 0.0092 ± 0.0152 in the treatment group and -0.0078 ± 0.0159 in placebo-treated patients. None of the secondary MRI and clinical end points revealed group differences. Adverse events of EGCG were mostly mild and occurred with a similar incidence in the placebo group. One patient in the EGCG group had to stop treatment due to elevated aminotransferases (>3.5 times above normal limit). CONCLUSIONS: In a phase II trial including patients with multiple sclerosis (MS) with progressive disease course, we were unable to demonstrate a treatment effect of EGCG on the primary and secondary radiologic and clinical disease parameters while confirming on overall beneficial safety profile. CLINICALTRIALGOV IDENTIFIER: NCT00799890. CLASSIFICATION OF EVIDENCE: This phase II trial provides Class II evidence that for patients with PMS, EGCG was safe, well tolerated, and did not significantly reduce the rate of brain atrophy. |
| Keywords: | Oral Administration, Atrophy, Brain, Catechin, Disease Progression, Double-Blind Method, Magnetic Resonance Imaging, Chronic Progressive Multiple Sclerosis, Health Care Outcome Assessment, Random Allocation |
| Source: | Neurology Neuroimmunology & Neuroinflammation |
| ISSN: | 2332-7812 |
| Publisher: | American Academy of Neurology |
| Volume: | 8 |
| Number: | 3 |
| Page Range: | e964 |
| Date: | May 2021 |
| Official Publication: | https://doi.org/10.1212/NXI.0000000000000964 |
| PubMed: | View item in PubMed |
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