Hyperbaric oxygen therapy for chronic bowel dysfunction after pelvic radiotherapy

Abstract

I congratulate Glover and colleagues 1 Glover M Smerdon GR Andreyev HJ et al. Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial. Lancet Oncol. 2016; 17: 224-233 Summary Full Text Full Text PDF PubMed Scopus (47) Google Scholar for the successful completion of their trial of hyperbaric oxygen therapy for bowel dysfunction following pelvic irradiation (HOT2). It is unfortunate that despite their efforts, the trial failed to achieve the aim to “provide conclusive results for the clinical benefits of hyperbaric oxygen”. 1 Glover M Smerdon GR Andreyev HJ et al. Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial. Lancet Oncol. 2016; 17: 224-233 Summary Full Text Full Text PDF PubMed Scopus (47) Google Scholar It is also disappointing the results are at odds with pre-existing evidence. 2 Clarke RE Tenorio LM Hussey JR et al. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled doubleblind crossover trial with long-term follow-up. Int J Rad Oncol Biol Phys. 2008; 72: 134-143 Summary Full Text Full Text PDF PubMed Scopus (189) Google Scholar , 3 Bennett MH Feldmeier J Hampson N Smee R Milross C Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev. 2012; 5 (CD005005) Crossref Scopus (149) Google Scholar Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trialWe found no evidence that patients with radiation-induced chronic gastrointestinal symptoms, including those patients with rectal bleeding, benefit from hyperbaric oxygen therapy. These findings contrast with evidence used to justify current practices, and more level 1 evidence is urgently needed. Full-Text PDF Open AccessHyperbaric oxygen therapy for chronic bowel dysfunction after pelvic radiotherapy – Authors' replyWe appreciate the correspondence, and concede that there is a risk of cognitive bias in defending our own results, but would some of the points have been raised if we had generated evidence of efficacy? Whatever the answer, “vast experience” and a single positive randomised study (HORTIS) do not justify a conclusion that HOT2 generated a false negative result, especially in light of evidence emphasising the poor reproducibility of clinical studies.1,2 On another important point, the patients were not mildly affected. Full-Text PDF