Hyperbaric oxygen therapy was effective, safe and well tolerated in hospitalized patients with ulcerative colitis experiencing moderate-to-severe disease flares, according to data from a randomized, double blind, sham-controlled trial presented at the 12th Congress of the European Crohn’s and Colitis Organization.
As dysregulated tissue hypoxia response plays a key role in the pathogenesis of ulcerative colitis, and because hospitalized UC patients often require a second-line therapy, such as colectomy or biologics, for non-response to steroids, Corey Siegel, MD, MS, director of the Dartmouth-Hitchcock Inflammatory Bowel Disease Center in New Hampshire, Parambir Dulai, MD, a research fellow at University of California San Diego, and colleagues sought to evaluate the therapeutic potential of hyperbaric oxygen therapy in this setting.
They enrolled 18 patients with UC hospitalized across three centers for moderate-to-severe flares, and randomly assigned 10 of them to receive steroids plus a daily hyperbaric oxygen therapy session, and eight to receive steroids plus a daily sham hyperbaric air session.
“The patients underwent treatments daily for a least 5 days, and each treatment lasted 90 minutes,” Siegel told Healio Gastroenterology. “Patients in the sham group used a validated sham protocol where they were briefly pressurized to mimic hyperbaric treatment, but were then brought back to normal pressure and given room air as opposed to 100% oxygen.”
Patients in the hyperbaric oxygen therapy group had higher median C-reactive protein levels at baseline compared with the sham group (81 vs. 10; P = .07) but similar Mayo scores (9.9 vs. 10.9).
By day 5, half of the hyperbaric oxygen therapy group achieved clinical remission compared with none of the sham group (P = .04), and the study therefore met its primary endpoint.
Patients responded to hyperbaric oxygen therapy as early as day 3 (60% vs. 13%; P = .07) and significantly more of them had clinical response at day 10 (80% vs. 25%; P = .05) and clinical remission at day 10 (50% vs. 0%; P = .04) compared with the sham group.
Moreover, patients treated with hyperbaric oxygen therapy were less likely to require any second-line therapy (10% vs. 63%; P = .04) or colectomy specifically (0% vs. 38%; P = .07) during their hospitalization.
Finally, the researchers observed no adverse events, concluded that hyperbaric oxygen therapy was safe and well tolerated, and called for further randomized trials to confirm their findings.
“This project potentially has huge clinical significance,” Siegel said. “Although we have made great advances for the treatment of [UC], there is still a high rate of morbidity for hospitalized patients with UC. We need more effective and safer options for this patient population. If we are right about the efficacy and safety of hyperbaric oxygen for UC, this could change the treatment paradigm for these patients. We are currently starting a follow-up study to further define the optimal treatment regimen, with plans for a large randomized trial in the near future.” – by Adam Leitenberger
Dulai P, et al. Abstract OP021. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Disclosures: Siegel reports financial relationships with CCFA, AHRQ(1R01HS021747), AbbVie, Janssen, Takeda, UCB, Salix, Amgen, Lilly, Pfizer, Prometheus, Theradiag and Bristol-Meyers Squibb, and has a patent System and Method of Communicating Predicted Medical Outcomes pending to Dartmouth-Hitchcock Medical Center and Cedars-Sinai Medical Center. Dulai reports no relevant financial disclosures. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures.