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

Item Type:	Article
Title:	A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)
Creators Name:	Stürner, K.H. and Stellmann, J.P. and Dörr, J. and Paul, F. and Friede, T. and Schammler, S. and Reinhardt, S. and Gellissen, S. and Weissflog, G. and Faizy, T.D. and Werz, O. and Fleischer, S. and Vaas, L.A.I. and Herrmann, F. and Pless, O. and Martin, R. and Heesen, C.
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:	Atrophy, Brain, CD4-Positive T-Lymphocytes, Frankincense, Magnetic Resonance Imaging, Oral Administration, Pilot Projects, Plant Extracts, Relapsing-Remitting Multiple Sclerosis, Treatment Outcome
Source:	Journal of Neurology Neurosurgery and Psychiatry
ISSN:	0022-3050
Publisher:	BMJ Publishing Group
Volume:	89
Number:	4
Page Range:	330-338
Date:	15 March 2018
Official Publication:	https://doi.org/10.1136/jnnp-2017-317101
PubMed:	View item in PubMed

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