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

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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., 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. 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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