Abstract
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.
Original language | English |
---|---|
Pages (from-to) | 587-597 |
Number of pages | 11 |
Journal | Alimentary Pharmacology and Therapeutics |
Volume | 53 |
Issue number | 5 |
DOIs | |
Publication status | Published - Mar 2021 |
Access to Document
Other files and links
Cite this
- APA
- Author
- BIBTEX
- Harvard
- Standard
- RIS
- Vancouver
}
In: Alimentary Pharmacology and Therapeutics, Vol. 53, No. 5, 03.2021, p. 587-597.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn’s disease
AU - Lansdorp, Corine A.
AU - Gecse, Krisztina B.
AU - Buskens, Christianne J.
AU - Löwenberg, Mark
AU - Stoker, Jaap
AU - Bemelman, Willem A.
AU - D’Haens, Geert R.A.M.
AU - van Hulst, Rob A.
N1 - Funding Information: We would like to thank the Instituut voor Hyperbare Geneeskunde/the Da Vinci Clinic, Hyperbaar Geneeskundig Centrum Rijswijk and Antonius Hypercare Sneek for their cooperation and facilitation of the treatment of the study population with hyperbaric oxygen therapy. Declaration of personal interests: CAL has no conflicts of interest to declare. KBG has received consultancy fees and/or speaker's honoraria from AbbVie, Celltrion, Ferring, Immunic Therapeutics, Janssen, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda and Tillotts. CJB has received speakers' honoraria from Takeda and Tillotts. She has an unrestricted grant from Boehringer Ingelheim, and is part of the advisory board of Johnson & Johnson energy devices. ML has served as speaker and/or principal investigator for: Abbvie, Celgene, Covidien, Dr Falk, Ferring Pharmaceuticals, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Robarts Clinical Trials, Takeda, Tillotts and Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Achmea healthcare and ZonMW. JS has a research agreement with Takeda on a nonrelated topic. WAB has served as speaker for Takeda, Johnson and Johnson and Braun. He has received research grants from Braun and Vifor. GDH has served as advisor for Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics; Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma; Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences; Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill; Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor; received speaker fees from Abbvie, Biogen, Ferring, Galapagos/Gilead, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millenium/Takeda, Tillotts and Vifor. RAH has no conflicts of interest to declare. Funding Information: : CAL has no conflicts of interest to declare. KBG has received consultancy fees and/or speaker's honoraria from AbbVie, Celltrion, Ferring, Immunic Therapeutics, Janssen, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda and Tillotts. CJB has received speakers' honoraria from Takeda and Tillotts. She has an unrestricted grant from Boehringer Ingelheim, and is part of the advisory board of Johnson & Johnson energy devices. ML has served as speaker and/or principal investigator for: Abbvie, Celgene, Covidien, Dr Falk, Ferring Pharmaceuticals, Gilead, GlaxoSmithKline, Janssen‐Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Robarts Clinical Trials, Takeda, Tillotts and Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Dr Falk, Achmea healthcare and ZonMW. JS has a research agreement with Takeda on a nonrelated topic. WAB has served as speaker for Takeda, Johnson and Johnson and Braun. He has received research grants from Braun and Vifor. GDH has served as advisor for Abbvie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics; Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma; Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences; Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Kintai Therapeutics, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus laboratories/Nestle, Progenity, Protagonist, RedHill; Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor; received speaker fees from Abbvie, Biogen, Ferring, Galapagos/Gilead, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millenium/Takeda, Tillotts and Vifor. RAH has no conflicts of interest to declare. Declaration of personal interests Funding Information: This research has been awarded with a Grant from the European Crohn's and Colitis Organisation and this Grant funded the research. The funder did not have any role in the study design, collection, management, analysis or interpretation of data, or writing of the report or the decision to submit the report for publication. Publisher Copyright: © 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85097536371&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/apt.16228
DO - https://doi.org/10.1111/apt.16228
M3 - Article
C2 - 33326623
SN - 0269-2813
VL - 53
SP - 587
EP - 597
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 5
ER -