PT  - JOURNAL ARTICLE
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
TI  - A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)
AID  - 10.1136/jnnp-2017-317101
DP  - 2018 Apr 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - 330--338
VI  - 89
IP  - 4
4099  - http://jnnp.bmj.com/content/89/4/330.short
4100  - http://jnnp.bmj.com/content/89/4/330.full
SO  - J Neurol Neurosurg Psychiatry2018 Apr 01; 89
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.