Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis
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Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis : A Randomized, Placebo-Controlled Trial. / Bellmann-Strobl, Judith; Paul, Friedemann; Wuerfel, Jens; Dörr, Jan; Infante-Duarte, Carmen; Heidrich, Elmira; Körtgen, Benedict; Brandt, Alexander; Pfüller, Caspar; Radbruch, Helena; Rust, Rebekka; Siffrin, Volker; Aktas, Orhan; Heesen, Christoph; Faiss, Jürgen; Hoffmann, Frank; Lorenz, Mario; Zimmermann, Benno; Groppa, Sergiu; Wernecke, Klaus-Dieter; Zipp, Frauke.
In: NEUROL-NEUROIMMUNOL, Vol. 8, No. 3, e981, 05.2021.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis
T2 - A Randomized, Placebo-Controlled Trial
AU - Bellmann-Strobl, Judith
AU - Paul, Friedemann
AU - Wuerfel, Jens
AU - Dörr, Jan
AU - Infante-Duarte, Carmen
AU - Heidrich, Elmira
AU - Körtgen, Benedict
AU - Brandt, Alexander
AU - Pfüller, Caspar
AU - Radbruch, Helena
AU - Rust, Rebekka
AU - Siffrin, Volker
AU - Aktas, Orhan
AU - Heesen, Christoph
AU - Faiss, Jürgen
AU - Hoffmann, Frank
AU - Lorenz, Mario
AU - Zimmermann, Benno
AU - Groppa, Sergiu
AU - Wernecke, Klaus-Dieter
AU - Zipp, Frauke
N1 - Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
PY - 2021/5
Y1 - 2021/5
N2 - OBJECTIVE: To assess the safety and efficacy of epigallocatechin-3-gallate (EGCG) add-on to glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: We enrolled patients with RRMS (aged 18-60 years, Expanded Disability Status Scale [EDSS] score 0-6.5), receiving stable GA treatment in a multicenter, prospective, double-blind, phase II, randomized controlled trial. Participants received up to 800 mg oral EGCG daily over a period of 18 months. The primary outcome was the proportion of patients without new hyperintense lesions on T2-weighted (T2w) brain MRI within 18 months. Secondary end points included additional MRI and clinical parameters. Immunologic effects of EGCG were investigated in exploratory experiments.RESULTS: A total of 122 patients on GA were randomly assigned to EGCG treatment (n = 62) or placebo (n = 60). We could not demonstrate a difference between groups after 18 months for the primary outcome or other radiologic (T2w lesion volume, T1w hypointense lesion number or volume, number of cumulative contrast-enhancing lesions, percent brain volume change), or clinical (EDSS, MS functional composite, and annualized relapse rate) parameter. EGCG treatment did not affect immune response to GA. Pharmacologic analysis revealed wide ranging EGCG plasma levels. The treatment was well tolerated with a similar incidence of mostly mild adverse events similar in both groups.CONCLUSION: In RRMS, oral EGCG add-on to GA was not superior to placebo in influencing MRI and clinical disease activity over 18 months. The treatment was safe at a daily dosage up to 800 mg EGCG. It did not influence immune parameters, despite indication of EGCG being bioavailable in patients.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, EGCG added to GA did not significantly affect the development of new hyperintense lesions on T2-weighted brain MRI.TRIAL REGISTRATION INFORMATION: Clinical trial registration number: NCT00525668.
AB - OBJECTIVE: To assess the safety and efficacy of epigallocatechin-3-gallate (EGCG) add-on to glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: We enrolled patients with RRMS (aged 18-60 years, Expanded Disability Status Scale [EDSS] score 0-6.5), receiving stable GA treatment in a multicenter, prospective, double-blind, phase II, randomized controlled trial. Participants received up to 800 mg oral EGCG daily over a period of 18 months. The primary outcome was the proportion of patients without new hyperintense lesions on T2-weighted (T2w) brain MRI within 18 months. Secondary end points included additional MRI and clinical parameters. Immunologic effects of EGCG were investigated in exploratory experiments.RESULTS: A total of 122 patients on GA were randomly assigned to EGCG treatment (n = 62) or placebo (n = 60). We could not demonstrate a difference between groups after 18 months for the primary outcome or other radiologic (T2w lesion volume, T1w hypointense lesion number or volume, number of cumulative contrast-enhancing lesions, percent brain volume change), or clinical (EDSS, MS functional composite, and annualized relapse rate) parameter. EGCG treatment did not affect immune response to GA. Pharmacologic analysis revealed wide ranging EGCG plasma levels. The treatment was well tolerated with a similar incidence of mostly mild adverse events similar in both groups.CONCLUSION: In RRMS, oral EGCG add-on to GA was not superior to placebo in influencing MRI and clinical disease activity over 18 months. The treatment was safe at a daily dosage up to 800 mg EGCG. It did not influence immune parameters, despite indication of EGCG being bioavailable in patients.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, EGCG added to GA did not significantly affect the development of new hyperintense lesions on T2-weighted brain MRI.TRIAL REGISTRATION INFORMATION: Clinical trial registration number: NCT00525668.
U2 - 10.1212/NXI.0000000000000981
DO - 10.1212/NXI.0000000000000981
M3 - SCORING: Journal article
C2 - 33762428
VL - 8
JO - NEUROL-NEUROIMMUNOL
JF - NEUROL-NEUROIMMUNOL
SN - 2332-7812
IS - 3
M1 - e981
ER -
