Outcome

This phase 2B randomized trial demonstrates that hyperbaric oxygen therapy (HBOT) at 2.4 atmospheres for 90-minute sessions significantly improves disease activity in hospitalized patients with moderate to severe ulcerative colitis (UC) flares. By Day 3 a 55% response rate was noted characterized by reductions in stool frequency rectal bleeding and C-reactive protein (CRP) levels. Extending HBOT to five days resulted in even greater clinical benefits compared to a three-day regimen.

Introduction

Ulcerative colitis (UC) is a chronic inflammatory condition of the colon that often necessitates hospitalization during acute flare-ups. Current treatments include corticosteroids and immunosuppressants which can be effective but often come with significant side effects and a high chance of requiring surgical intervention. Hyperbaric Oxygen Therapy (HBOT) known for its role in wound healing and infection management has emerged as a potential adjunct treatment for UC. This phase 2B randomized trial investigates the efficacy of HBOT at 2.4 atmospheres in improving disease activity in hospitalized UC patients. Over three days HBOT showed a 55% response rate marked by significant reductions in stool frequency rectal bleeding and C-reactive protein (CRP) levels. Responders were then randomized to continue HBOT for either a total of three or five days with the latter group demonstrating more substantial benefits. Of note only 15% of patients required additional treatments such as infliximab or colectomy markedly lower than the expected 80%. Importantly none of the responders experienced rehospitalization or required colectomy within three months and no adverse events were reported. These promising results indicate that HBOT can effectively complement standard steroid treatment for acute UC flares potentially reducing the need for more invasive interventions. Further phase 3 trials are warranted to confirm these findings and facilitate broader clinical application.

Results

The study reveals that hyperbaric oxygen therapy (HBOT) at 2.4 atmospheres significantly improves clinical outcomes for hospitalized patients with ulcerative colitis (UC). In this phase 2B randomized trial all patients initially received three days of HBOT with notable improvements observed by Day 3 in 55% (11 out of 20) of participants. These responders exhibited significant reductions in stool frequency rectal bleeding and C-reactive protein (CRP) levels.

Responders were then randomized to either continue HBOT for a total of five days or cease after the initial three days. Patients who continued the therapy for five days demonstrated even greater reductions in disease activity compared to those who stopped at three days (P = 0.03). This suggests that extending the treatment period enhances therapeutic benefits.

A striking finding of the study was the dramatic reduction in the need for second-line interventions such as infliximab or colectomy. Despite an initial prognosis indicating an 80% likelihood of requiring these treatments only 15% (3 out of 20) of patients needed them. Furthermore responders had a significantly lower rate of re-hospitalization or colectomy within three months compared to non-responders (0% vs 66% P = 0.002).

Importantly no adverse events related to HBOT were reported highlighting the safety profile of this therapy. These results suggest that HBOT can be a potent adjunctive treatment to standard intravenous steroids optimizing clinical outcomes and reducing the need for more invasive procedures in patients with acute UC flares.

Conclusion

In conclusion the findings of this phase 2B randomized trial demonstrate the promising potential of hyperbaric oxygen therapy (HBOT) in managing moderate to severe ulcerative colitis (UC) flares in hospitalized patients. Administering HBOT at 2.4 atmospheres yielded significant improvements in disease activity exemplified by a 55% response rate within three days characterized by reductions in stool frequency rectal bleeding and CRP levels. Extending HBOT treatment to five days amplified these benefits further lowering disease activity.

Remarkably the need for additional invasive treatments such as infliximab or colectomy was notably reduced to 15% from an anticipated 80%. Furthermore responders showed no rehospitalizations or colectomies within three months compared to a 66% rate among non-responders highlighting the treatment’s efficacy and potential for lasting benefits. The absence of adverse events adds to HBOT’s viability as a safe therapeutic option.

These compelling results advocate for the inclusion of HBOT as an adjunctive therapy alongside standard intravenous steroids to optimize outcomes and reduce the necessity for more aggressive interventions in acute UC flares. Future research should focus on larger phase 3 trials to solidify these findings and facilitate broader clinical adoption potentially transforming the treatment landscape for UC patients.