Dulai PS, Raffals LE, Hudesman D, Chiorean M, Cross R, Ahmed T, Winter M, Chang S, Fudman D, Sadler C, Chiu EL, Ross FL, Toups G, Murad MH, Sethuraman K, Holm JR, Guilliod R, Levine B, Buckey JC Jr, Siegel CA, et al.
Alimentary pharmacology & therapeutics. Date of publication 2020 Sep 1;volume 52(6):955-963.
1. Aliment Pharmacol Ther. 2020 Sep;52(6):955-963. doi: 10.1111/apt.15984. Epub
2020 Aug 3.
A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis
patients hospitalised for moderate to severe flares.
Dulai PS(1), Raffals LE(2), Hudesman D(3), Chiorean M(4), Cross R(5), Ahmed
T(6), Winter M(7), Chang S(3), Fudman D(6), Sadler C(1), Chiu EL(3), Ross FL(3),
Toups G(2), Murad MH(2), Sethuraman K(5), Holm JR(4), Guilliod R(6), Levine
B(6), Buckey JC Jr(7), Siegel CA(7).
Author information:
(1)University of California San Diego, La Jolla, CA, USA.
(2)Mayo Clinic, Rochester, MN, USA.
(3)NYU Langone Health, New York, NY, USA.
(4)Virginia Mason, Seattle, WA, USA.
(5)University of Maryland, Baltimore, MD, USA.
(6)University of Texas Southwestern Medical Center, Dallas, TX, USA.
(7)Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.
BACKGROUND: Hyperbaric oxygen has been reported to improve disease activity in
hospitalised ulcerative colitis (UC) patients.
AIM: To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC
patients.
METHODS: We enrolled UC patients hospitalised for acute flares (Mayo score
6-12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4
atmospheres (90 minutes with two air breaks) in addition to intravenous
steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and
rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs
3 days of hyperbaric oxygen.
RESULTS: We treated 20 patients with hyperbaric oxygen (75% prior biologic
failure). Day 3 response was achieved in 55% (n = 11/20), with significant
reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more
significant reduction in disease activity was observed with 5 days vs 3 days of
hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three
patients (15%) despite a predicted probability of 80% for second-line therapy.
Day 3 hyperbaric oxygen responders were less likely to require
re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%,
P = 0.002). No treatment-related adverse events were observed.
CONCLUSION: Hyperbaric oxygen appears to be effective for optimising response to
intravenous steroids in UC patients hospitalised for acute flares, with low
rates of re-hospitalisation or colectomy at 3 months. An optimal clinical
response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are
needed to confirm efficacy and obtain labelled approval.
© 2020 John Wiley & Sons Ltd.
DOI: 10.1111/apt.15984
PMID: 32745306 [Indexed for MEDLINE]
