Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease
© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
BACKGROUND: Positive effects of hyperbaric oxygen on perianal fistulas in Crohn's disease have been reported.
AIM: To assess efficacy, safety and feasibility of hyperbaric oxygen in Crohn's disease patients with therapy-refractory perianal fistulas.
METHODS: Twenty consecutive patients were recruited at the out-patient fistula clinic of the Amsterdam UMC. Crohn's disease patients with high perianal fistula(s) failing conventional treatment for over 6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received treatment with 40 hyperbaric oxygen sessions and outcome parameters were assessed at Week 16.
RESULTS: Seven women and 13 men were included (median age 34 years). At Week 16, median scores of perianal disease activity index and modified van Assche index (co-primary outcome parameters) decreased from 7.5 (95% CI 6-9) to 4 (95% CI 3-6, P < 0.001), and from 9.2 (95% CI 7.3-11.2) to 7.3 (95% CI 6.9-9.7, P = 0.004) respectively. Perianal disease activity index scores ≤4 (representing inactive perianal disease) were observed in 13/20 patients (65%). Twelve patients showed a clinical response (60%) and four (20%) clinical remission, assessed with fistula drainage assessment. Median C-reactive protein and faecal calprotectin levels decreased from 4.2 mg/mL (95% CI 1.6-8) to 2.2 (95% CI 0.9-4.3, P = 0.003) and from 399 µg/g (95% CI 52-922) to 31 (95% CI 16-245, P = 0.001), respectively.
CONCLUSIONS: We found significant clinical, radiological and biochemical improvement in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen.
CLINICAL TRIAL REGISTRATION: www.trialregister.nl/trial/6489.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2021 Mar;53(5):667-668. - PMID 33566415 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:53 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 53(2021), 5 vom: 15. März, Seite 587-597 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lansdorp, Corine A [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial |
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| Anmerkungen: |
Date Completed 31.03.2021 Date Revised 31.05.2022 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2021 Mar;53(5):667-668. - PMID 33566415 Citation Status MEDLINE |
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| doi: |
10.1111/apt.16228 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM318916894 |
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| 245 | 1 | 0 | |a Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease |
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| 500 | |a Date Revised 31.05.2022 | ||
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| 500 | |a CommentIn: Aliment Pharmacol Ther. 2021 Mar;53(5):667-668. - PMID 33566415 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Positive effects of hyperbaric oxygen on perianal fistulas in Crohn's disease have been reported | ||
| 520 | |a AIM: To assess efficacy, safety and feasibility of hyperbaric oxygen in Crohn's disease patients with therapy-refractory perianal fistulas | ||
| 520 | |a METHODS: Twenty consecutive patients were recruited at the out-patient fistula clinic of the Amsterdam UMC. Crohn's disease patients with high perianal fistula(s) failing conventional treatment for over 6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received treatment with 40 hyperbaric oxygen sessions and outcome parameters were assessed at Week 16 | ||
| 520 | |a RESULTS: Seven women and 13 men were included (median age 34 years). At Week 16, median scores of perianal disease activity index and modified van Assche index (co-primary outcome parameters) decreased from 7.5 (95% CI 6-9) to 4 (95% CI 3-6, P < 0.001), and from 9.2 (95% CI 7.3-11.2) to 7.3 (95% CI 6.9-9.7, P = 0.004) respectively. Perianal disease activity index scores ≤4 (representing inactive perianal disease) were observed in 13/20 patients (65%). Twelve patients showed a clinical response (60%) and four (20%) clinical remission, assessed with fistula drainage assessment. Median C-reactive protein and faecal calprotectin levels decreased from 4.2 mg/mL (95% CI 1.6-8) to 2.2 (95% CI 0.9-4.3, P = 0.003) and from 399 µg/g (95% CI 52-922) to 31 (95% CI 16-245, P = 0.001), respectively | ||
| 520 | |a CONCLUSIONS: We found significant clinical, radiological and biochemical improvement in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: www.trialregister.nl/trial/6489 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Gecse, Krisztina B |e verfasserin |4 aut | |
| 700 | 1 | |a Buskens, Christianne J |e verfasserin |4 aut | |
| 700 | 1 | |a Löwenberg, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Stoker, Jaap |e verfasserin |4 aut | |
| 700 | 1 | |a Bemelman, Willem A |e verfasserin |4 aut | |
| 700 | 1 | |a D'Haens, Geert R A M |e verfasserin |4 aut | |
| 700 | 1 | |a van Hulst, Rob A |e verfasserin |4 aut | |
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