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

Parambir S. Dulai, Jay C. Buckey, Laura E. H. Raffals, Jason M. Swoger, Paul L. Claus, Kevin O’Toole, Judy A. Ptak, Michael W. Gleeson, Christella E. Widjaja, John T. Chang, Jeffery M. Adler, Nihal Patel, Laurie A. Skinner, Shawn P. Haren, Kimberly Goldby-Reffner, Kimberly D. Thompson, Corey A. Siegel

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalAmerican Journal of Gastroenterology
DOIs
StateAccepted/In press - Feb 16 2018

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Hyperbaric Oxygenation
Ulcerative Colitis
Hospitalization
Steroids
Colectomy
Therapeutics
Biological Therapy
Air
Hemorrhage
Oxygen

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

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, Parambir S.; Buckey, Jay C.; Raffals, Laura E. H.; Swoger, Jason M.; Claus, Paul L.; O’Toole, Kevin; Ptak, Judy A.; Gleeson, Michael W.; Widjaja, Christella E.; Chang, John T.; Adler, Jeffery M.; Patel, Nihal; Skinner, Laurie A.; Haren, Shawn P.; Goldby-Reffner, Kimberly; Thompson, Kimberly D.; Siegel, Corey A.

In: American Journal of Gastroenterology, 16.02.2018, p. 1-8.

Research output: Contribution to journalArticle

Dulai, PS, Buckey, JC, Raffals, LEH, Swoger, JM, Claus, PL, O’Toole, K, Ptak, JA, Gleeson, MW, Widjaja, CE, Chang, JT, Adler, JM, Patel, N, Skinner, LA, Haren, SP, Goldby-Reffner, K, Thompson, KD & Siegel, CA 2018, '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', American Journal of Gastroenterology, pp. 1-8. https://doi.org/10.1038/s41395-018-0005-z
Dulai, Parambir S. ; Buckey, Jay C. ; Raffals, Laura E. H. ; Swoger, Jason M. ; Claus, Paul L. ; O’Toole, Kevin ; Ptak, Judy A. ; Gleeson, Michael W. ; Widjaja, Christella E. ; Chang, John T. ; Adler, Jeffery M. ; Patel, Nihal ; Skinner, Laurie A. ; Haren, Shawn P. ; Goldby-Reffner, Kimberly ; Thompson, Kimberly D. ; Siegel, Corey A. / 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. In: American Journal of Gastroenterology. 2018 ; pp. 1-8.
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abstract = "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.",
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T1 - Hyperbaric oxygen therapy is well tolerated and effective for ulcerative colitis patients hospitalized for moderate–severe flares

T2 - a phase 2A pilot multi-center, randomized, double-blind, sham-controlled trial

AU - Dulai, Parambir S.

AU - Buckey, Jay C.

AU - Raffals, Laura E. H.

AU - Swoger, Jason M.

AU - Claus, Paul L.

AU - O’Toole, Kevin

AU - Ptak, Judy A.

AU - Gleeson, Michael W.

AU - Widjaja, Christella E.

AU - Chang, John T.

AU - Adler, Jeffery M.

AU - Patel, Nihal

AU - Skinner, Laurie A.

AU - Haren, Shawn P.

AU - Goldby-Reffner, Kimberly

AU - Thompson, Kimberly D.

AU - Siegel, Corey A.

PY - 2018/2/16

Y1 - 2018/2/16

N2 - 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.

AB - 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.

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