Dulai PS, Buckey JC Jr, Raffals LE, Swoger JM, Claus PL, OʼToole K, Ptak JA, Gleeson MW, Widjaja CE, Chang JT, Adler JM, Patel N, Skinner LA, Haren SP, Goldby-Reffner K, Thompson KD, Siegel CA, et al.
The American journal of gastroenterology. Date of publication 2018 Oct 1;volume 113(10):1516-1523.
1. Am J Gastroenterol. 2018 Oct;113(10):1516-1523. doi: 10.1038/s41395-018-0005-z.
Epub 2018 Feb 16.
Hyperbaric oxygen therapy is well tolerated and effective for ulcerative colitis
patients hospitalized for moderate-severe flares: a phase 2A pilot multi-center,
randomized, double-blind, sham-controlled trial.
Dulai PS(1)(1), Buckey JC Jr(1), Raffals LE(1), Swoger JM(1), Claus PL(1),
OʼToole K(1), Ptak JA(1), Gleeson MW(1), Widjaja CE(1), Chang JT(1), Adler JM(1),
Patel N(1), Skinner LA(1), Haren SP(1), Goldby-Reffner K(1), Thompson KD(1),
Siegel CA(1).
Author information:
(1)University of California at San Diego, La Jolla, CA, USA. Dartmouth Hitchcock
Medical Center, Lebanon, NH, USA. Mayo Clinic, Rochester, MN, USA. University of
Pittsburgh Medical Center, Pittsburgh, PA, USA.
Comment in
Am J Gastroenterol. 2018 Oct;113(10):1432-1434.
BACKGROUND: Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen
delivery. Case series suggest it may have a potential therapeutic benefit in
ulcerative colitis (UC). We investigated the therapeutic potential of HBOT as an
adjunct to steroids for UC flares requiring hospitalization.
METHODS: The study was terminated early due to poor recruitment with 18 of the
planned 70 patients enrolled. UC patients hospitalized for moderate-severe flares
(Mayo score ≥6, endoscopic sub-score ≥2) were block randomized to
steroids + daily HBOT (n = 10) or steroids + daily sham hyperbaric air (n = 8).
Patients were blinded to study assignment, and assessments were performed by a
blinded gastroenterologist. Primary outcome was the clinical remission rate at
study day 5 (partial Mayo score ≤2 with no sub-score >1). Key secondary outcomes
were: clinical response (reduction in partial Mayo score ≥2, rectal bleeding
sub-score of 0-1) and progression to second-line therapy (colectomy or biologic
therapy) during the hospitalization.
RESULTS: A significantly higher proportion of HBOT-treated patients achieved
clinical remission at study day 5 and 10 (50 vs. 0%, p = 0.04). HBOT-treated
patients less often required progression to second-line therapy during the
hospitalization (10 vs. 63%, p = 0.04). The proportion requiring in-hospital
colectomy specifically as second-line therapy for medically refractory UC was
lower in the HBOT group compared to sham (0 vs. 38%, p = 0.07). There were no
serious adverse events.
CONCLUSION: In this small, proof-of-concept, phase 2A trial, the use of HBOT as
an adjunctive therapy to steroids for UC patients hospitalized for
moderate-severe flares resulted in higher rates of clinical remission, and a
reduction in rates of progression to second-line therapy during the
hospitalization. Larger well-powered trials are needed, however, to provided
definitive evidence of therapeutic benefit.
DOI: 10.1038/s41395-018-0005-z
PMID: 29453383 [Indexed for MEDLINE]
