Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up: In Regard to Clarke et al. ( Int J Radiat Oncol Biol Phys 2008 Mar 12)

Abstract

To the Editor: We read the article by Clarke et al. with interest and congratulate the authors in completing a large study in this difficult area and for attempting to quantify the benefit to patients. The management of anorectal injuries, including radiation proctitis, after pelvic radiotherapy remains a challenging area, and we are unaware of any major therapy breakthrough since we formally reviewed the subject >6 years ago ( 1 Hayne D. Vaizey C. Boulos P.B. Anorectal injury following pelvic radiotherapy. Br J Surg. 2001; 88: 1037-1048 Crossref PubMed Scopus (101) Google Scholar ). Radiation proctitis is a remitting and relapsing condition, often showing an unpredictable course. Its most disabling long-term sequelae, such as rectal stricture and fistula formation, have been reported to have developed as long as 30 years after treatment ( 2 Lucarotti M.E. Mountford R.A. Bartolo D.C. Surgical management of intestinal radiation injury. Dis Colon Rectum. 1991; 34: 865-869 Crossref PubMed Scopus (88) Google Scholar ). The study by Clarke et al. as performed gives useful insight into the immediate effects of hyperbaric oxygen for radiation proctitis. However, we have concerns regarding the unblinding of patients immediately on treatment completion with subsequent crossover. This removes all the benefits of randomization for subsequent follow-up and thus no clear conclusions can be drawn concerning any potential medium and long-term benefits of hyperbaric oxygen therapy. In a time in which the role of hyperbaric oxygen as a useful therapy for radiation injury even in its most established roles is being questioned ( 3 Annane D. Depondt J. Aubert P. et al. Hyperbaric oxygen therapy for radionecrosis of the jaw: A randomized, placebo-controlled, double-blind trial from the ORN96 Study Group. J Clin Oncol. 2004; 22: 4893-4900 Crossref PubMed Scopus (267) Google Scholar ), only randomized studies that include long-term follow-up will provide the answers we all seek. In Reply to Drs. Hayne and SmithInternational Journal of Radiation Oncology, Biology, PhysicsVol. 72Issue 5PreviewTo the Editor: We thank Drs. Hayne and Smith for their interest in our research and appreciate their encouraging remarks. We also appreciate the opportunity to respond to their concern regarding possible premature unblinding and patient crossover. If our investigation had involved a potentially new treatment, study design would have likely involved blinding throughout the patient follow-up, with no crossover. However, we were dealing with a de facto standard of care. Despite the absence of robust evidence of efficacy (an unfortunate shortcoming of all alternative therapies), hyperbaric oxygen (HBO) therapy is a widely recommended treatment for late radiation injury involving both bone and soft tissue. Full-Text PDF