RT Journal Article
SR Electronic
T1 A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP 330
OP 338
DO 10.1136/jnnp-2017-317101
VO 89
IS 4
A1 Stürner, Klarissa Hanja
A1 Stellmann, Jan-Patrick
A1 Dörr, Jan
A1 Paul, Friedemann
A1 Friede, Tim
A1 Schammler, Sven
A1 Reinhardt, Stefanie
A1 Gellissen, Susanne
A1 Weissflog, Gainet
A1 Faizy, Tobias Djamsched
A1 Werz, Oliver
A1 Fleischer, Sabine
A1 Vaas, Lea A I
A1 Herrmann, Frank
A1 Pless, Ole
A1 Martin, Roland
A1 Heesen, Christoph
YR 2018
UL http://jnnp.bmj.com/content/89/4/330.abstract
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.