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    A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares

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    Author
    Dulai, Parambir S.
    Raffals, Laura E.
    Hudesman, David
    Chiorean, Michael
    Cross, Raymond
    Ahmed, Tasneem
    Winter, Michael
    Chang, Shannon
    Fudman, David
    Sadler, Charlotte
    Chiu, Ernest L.
    Ross, Frank L.
    Toups, Gary
    Murad, M. Hassan
    Sethuraman, Kinjal
    Holm, James R.
    Guilliod, Renie
    Levine, Benjamin
    Buckey, Jay C.
    Siegel, Corey A.
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    Date
    2020-08-03
    Journal
    Alimentary Pharmacology and Therapeutics
    Publisher
    Wiley-Blackwell
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1111/apt.15984
    Abstract
    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.
    Sponsors
    Crohn's and Colitis Foundation
    Keyword
    Colitis, Ulcerative--therapy
    Hyperbaric Oxygenation
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/13543
    ae974a485f413a2113503eed53cd6c53
    10.1111/apt.15984
    Scopus Count
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