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A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)

Standard

A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial). / Stürner, Klarissa Hanja; Stellmann, Jan-Patrick; Dörr, Jan; Paul, Friedemann; Friede, Tim; Schammler, Sven; Reinhardt, Stefanie; Gellissen, Susanne; Weissflog, Gainet; Faizy, Tobias Djamsched; Werz, Oliver; Fleischer, Sabine; Vaas, Lea A I; Herrmann, Frank; Pless, Ole; Martin, Roland; Heesen, Christoph.

in: J NEUROL NEUROSUR PS, Jahrgang 89, Nr. 4, 04.2018, S. 330-338.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Stürner, KH, Stellmann, J-P, Dörr, J, Paul, F, Friede, T, Schammler, S, Reinhardt, S, Gellissen, S, Weissflog, G, Faizy, TD, Werz, O, Fleischer, S, Vaas, LAI, Herrmann, F, Pless, O, Martin, R & Heesen, C 2018, 'A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)', J NEUROL NEUROSUR PS, Jg. 89, Nr. 4, S. 330-338. https://doi.org/10.1136/jnnp-2017-317101

APA

Stürner, K. H., Stellmann, J-P., Dörr, J., Paul, F., Friede, T., Schammler, S., Reinhardt, S., Gellissen, S., Weissflog, G., Faizy, T. D., Werz, O., Fleischer, S., Vaas, L. A. I., Herrmann, F., Pless, O., Martin, R., & Heesen, C. (2018). A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial). J NEUROL NEUROSUR PS, 89(4), 330-338. https://doi.org/10.1136/jnnp-2017-317101

Vancouver

Stürner KH, Stellmann J-P, Dörr J, Paul F, Friede T, Schammler S et al. A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial). J NEUROL NEUROSUR PS. 2018 Apr;89(4):330-338. https://doi.org/10.1136/jnnp-2017-317101

Bibtex

@article{ca0a55d37dbb4d0dacb0808177fdc596,
title = "A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)",
abstract = "OBJECTIVE: To investigate whether oral administration of a standardised frankincense extract (SFE) is safe and reduces disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: We performed an investigator-initiated, bicentric phase IIa, open-label, baseline-to-treatment pilot study with an oral SFE in patients with RRMS (NCT01450124). After a 4-month baseline observation phase, patients were treated for 8 months with an option to extend treatment for up to 36 months. The primary outcome measures were the number and volume of contrast-enhancing lesions (CEL) measured in MRI during the 4-month treatment period compared with the 4-month baseline period. Eighty patients were screened at two centres, 38 patients were included in the trial, 28 completed the 8-month treatment period and 18 of these participated in the extension period.RESULTS: The SFE significantly reduced the median number of monthly CELs from 1.00 (IQR 0.75-3.38) to 0.50 (IQR 0.00-1.13; difference -0.625, 95% CI -1.25 to -0.50; P<0.0001) at months 5-8. We observed significantly less brain atrophy as assessed by parenchymal brain volume change (P=0.0081). Adverse events were generally mild (57.7%) or moderate (38.6%) and comprised mainly gastrointestinal symptoms and minor infections. Mechanistic studies showed a significant increase in regulatory CD4+ T cell markers and a significant decrease in interleukin-17A-producing CD8+ T cells indicating a distinct mechanism of action of the study drug.INTERPRETATION: The oral SFE was safe, tolerated well and exhibited beneficial effects on RRMS disease activity warranting further investigation in a controlled phase IIb or III trial.CLINICAL TRIAL REGISTRATION: NCT01450124; Results.",
keywords = "Administration, Oral, Adult, Atrophy, Brain/diagnostic imaging, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Female, Frankincense/therapeutic use, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging, Pilot Projects, Plant Extracts/therapeutic use, Treatment Outcome",
author = "St{\"u}rner, {Klarissa Hanja} and Jan-Patrick Stellmann and Jan D{\"o}rr and Friedemann Paul and Tim Friede and Sven Schammler and Stefanie Reinhardt and Susanne Gellissen and Gainet Weissflog and Faizy, {Tobias Djamsched} and Oliver Werz and Sabine Fleischer and Vaas, {Lea A I} and Frank Herrmann and Ole Pless and Roland Martin and Christoph Heesen",
year = "2018",
month = apr,
doi = "10.1136/jnnp-2017-317101",
language = "English",
volume = "89",
pages = "330--338",
journal = "J NEUROL NEUROSUR PS",
issn = "0022-3050",
publisher = "BMJ PUBLISHING GROUP",
number = "4",

}

RIS

TY - JOUR

T1 - A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)

AU - Stürner, Klarissa Hanja

AU - Stellmann, Jan-Patrick

AU - Dörr, Jan

AU - Paul, Friedemann

AU - Friede, Tim

AU - Schammler, Sven

AU - Reinhardt, Stefanie

AU - Gellissen, Susanne

AU - Weissflog, Gainet

AU - Faizy, Tobias Djamsched

AU - Werz, Oliver

AU - Fleischer, Sabine

AU - Vaas, Lea A I

AU - Herrmann, Frank

AU - Pless, Ole

AU - Martin, Roland

AU - Heesen, Christoph

PY - 2018/4

Y1 - 2018/4

N2 - OBJECTIVE: To investigate whether oral administration of a standardised frankincense extract (SFE) is safe and reduces disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: We performed an investigator-initiated, bicentric phase IIa, open-label, baseline-to-treatment pilot study with an oral SFE in patients with RRMS (NCT01450124). After a 4-month baseline observation phase, patients were treated for 8 months with an option to extend treatment for up to 36 months. The primary outcome measures were the number and volume of contrast-enhancing lesions (CEL) measured in MRI during the 4-month treatment period compared with the 4-month baseline period. Eighty patients were screened at two centres, 38 patients were included in the trial, 28 completed the 8-month treatment period and 18 of these participated in the extension period.RESULTS: The SFE significantly reduced the median number of monthly CELs from 1.00 (IQR 0.75-3.38) to 0.50 (IQR 0.00-1.13; difference -0.625, 95% CI -1.25 to -0.50; P<0.0001) at months 5-8. We observed significantly less brain atrophy as assessed by parenchymal brain volume change (P=0.0081). Adverse events were generally mild (57.7%) or moderate (38.6%) and comprised mainly gastrointestinal symptoms and minor infections. Mechanistic studies showed a significant increase in regulatory CD4+ T cell markers and a significant decrease in interleukin-17A-producing CD8+ T cells indicating a distinct mechanism of action of the study drug.INTERPRETATION: The oral SFE was safe, tolerated well and exhibited beneficial effects on RRMS disease activity warranting further investigation in a controlled phase IIb or III trial.CLINICAL TRIAL REGISTRATION: NCT01450124; Results.

AB - OBJECTIVE: To investigate whether oral administration of a standardised frankincense extract (SFE) is safe and reduces disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: We performed an investigator-initiated, bicentric phase IIa, open-label, baseline-to-treatment pilot study with an oral SFE in patients with RRMS (NCT01450124). After a 4-month baseline observation phase, patients were treated for 8 months with an option to extend treatment for up to 36 months. The primary outcome measures were the number and volume of contrast-enhancing lesions (CEL) measured in MRI during the 4-month treatment period compared with the 4-month baseline period. Eighty patients were screened at two centres, 38 patients were included in the trial, 28 completed the 8-month treatment period and 18 of these participated in the extension period.RESULTS: The SFE significantly reduced the median number of monthly CELs from 1.00 (IQR 0.75-3.38) to 0.50 (IQR 0.00-1.13; difference -0.625, 95% CI -1.25 to -0.50; P<0.0001) at months 5-8. We observed significantly less brain atrophy as assessed by parenchymal brain volume change (P=0.0081). Adverse events were generally mild (57.7%) or moderate (38.6%) and comprised mainly gastrointestinal symptoms and minor infections. Mechanistic studies showed a significant increase in regulatory CD4+ T cell markers and a significant decrease in interleukin-17A-producing CD8+ T cells indicating a distinct mechanism of action of the study drug.INTERPRETATION: The oral SFE was safe, tolerated well and exhibited beneficial effects on RRMS disease activity warranting further investigation in a controlled phase IIb or III trial.CLINICAL TRIAL REGISTRATION: NCT01450124; Results.

KW - Administration, Oral

KW - Adult

KW - Atrophy

KW - Brain/diagnostic imaging

KW - CD4-Positive T-Lymphocytes

KW - CD8-Positive T-Lymphocytes

KW - Female

KW - Frankincense/therapeutic use

KW - Humans

KW - Magnetic Resonance Imaging

KW - Male

KW - Middle Aged

KW - Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging

KW - Pilot Projects

KW - Plant Extracts/therapeutic use

KW - Treatment Outcome

U2 - 10.1136/jnnp-2017-317101

DO - 10.1136/jnnp-2017-317101

M3 - SCORING: Journal article

C2 - 29248894

VL - 89

SP - 330

EP - 338

JO - J NEUROL NEUROSUR PS

JF - J NEUROL NEUROSUR PS

SN - 0022-3050

IS - 4

ER -