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OP021 Hyperbaric oxygen therapy is safe and effective for hospitalized ulcerative colitis patients suffering from moderate-severe flares: a multi-center, randomized, double-blind, sham-controlled trial

Dulai P.*1,2, Buckey Jr. J.2, Raffals L.3, Swoger J.4, Claus P.3, O'Toole K.4, Ptak J.2, Gleeson M.2, Widjaja C.1, Adler J.2, Patel N.2, Skinner L.2, Haren S.3, Goldby-Reffner K.4, Thompson K.2, Knight R.1, Chang J.1, Siegel C.2

1University of California San Diego, La Jolla, CA, United States 2Dartmouth Hitchcock Medical Center, Lebanon, NH, United States 3Mayo Clinic, Rochester, MN, United States 4University of Pittsburgh Medical Center, Pittsburgh, PA, United States

Background

A dysregulated tissue hypoxia response is central to ulcerative colitis (UC) pathogenesis. Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen delivery and case series suggest a potential therapeutic benefit in UC. Hospitalized UC patients often require 2nd line therapy (colectomy or biologics) for non-responsiveness to steroids. We investigated the therapeutic potential of HBOT as an adjunct to steroids for UC patients hospitalized for moderate-severe flares.

Methods

UC patients hospitalized for moderate-severe flares (Mayo score ≥6, endoscopic sub-score ≥2) were block randomized across 3 sites in a 1:1 fashion to either steroids + daily HBOT (2.4 ATA @ 100% oxygen, 90 minute, 10 sessions) or steroids + daily sham hyperbaric air (1.2 ATA @ 21% oxygen, 90 minutes, 10 sessions). Sham patients were pressurized to 1.34 ATA to mimic pressure changes observed with HBOT, and then decompressed to 1.2 ATA for the remainder of the treatment. Patient blinding was maintained by covering all consoles and valves, and the hyperbaric teams followed an a priori established script to ensure similarity when treating both groups. The treating medical team, gastroenterologist, and surgeon were blinded to study assignment. Clinical assessments were performed by a blinded gastroenterologist. The primary outcome was the clinical remission rate at study day 5 (partial Mayo score ≤2 with no sub-score >1). Secondary outcomes were: clinical response (reduction in partial Mayo score ≥2, rectal bleeding sub-score of 0–1) and progression to 2nd line therapy (colectomy, anti-TNF therapy, cyclosporine).

Results

A total of 18 patients (10 HBOT, 8 Sham) were randomized and treated. HBOT patients had a higher median baseline CRP level (81 vs. 10, p=0.07) with comparable mean baseline Mayo scores (9.9 vs. 10.9, p=0.14). The study met its primary end-point of clinical remission at study day 5 for HBOT vs sham (50% vs. 0%, p=0.04). Response to HBOT was observed as early as day 3 (60% vs. 13%, p=0.07), and a significantly higher proportion of HBOT patients achieved day 10 response (80% vs. 25%, p=0.05) and remission (50% vs. 0%, p=0.04). HBOT patients less often required progression to 2nd line therapy (10% vs. 63%, p=0.04) or colectomy specifically (0% vs. 38%, p=0.07) while hospitalized. There were no adverse events.

Conclusion

The use of HBOT as an adjunct to steroids for hospitalized UC patients suffering from moderate-severe flares resulted in higher rates of response and remission, and a reduction in rates of colectomy or progression to anti-TNF therapy while hospitalized. HBOT is safe and well tolerated, and further randomized trials are needed to confirm our findings. #NCT02144350.