In:
United European Gastroenterology Journal, Wiley, Vol. 10, No. 2 ( 2022-03), p. 160-168
Abstract:
Previously published short‐term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy‐refractory perianal fistulas after treatment with hyperbaric oxygen therapy. Objective To assess the long‐term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease. Methods Crohn's disease patients with high perianal fistula(s) failing conventional treatment 〉 6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60. Results Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co‐primary outcomes) decreased from 7.5 (95% CI 6–9) to 4 (95% CI 3–6, p 〈 0.001) and 9.2 (95% CI 7.3–11.2) to 7.3 (95% CI 6.9–9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3–7, p 〈 0.001) and 7.7 (95% CI 5.2–10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C‐reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60. Conclusions The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1‐year follow‐up.
Type of Medium:
Online Resource
ISSN:
2050-6406
,
2050-6414
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2728585-6
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