Hyperbaric Oxygen for Patients With Chronic Bowel Dysfunction After Pelvic Radiotherapy
The Lancet Oncology
When I began flight school we were pretty high in a two seated fighter and apparently my mask had a tiny leak ,We landed I felt great and then got in a vigorous volleyball game The it hit, the chokes or the bends multiple nitrogen air emboli through my lung and blood Felt like had been run over by a Mac Truck Fortunately I was in the best cardiovascular shape in my life, riding about 40 miles each evening and 56-60 on weekends in my bike. fortunately I was only 6-7 minutes away from the HBO chamber–8 hours later 0fine 48 hours truly felt great and scans still show no damage It is important to realize when you have a negative study and to learn from it Most studies do not have huge steps forward but that us how it goes , We are now approaching almost 50% of stage three correctly done studies are getting corroborated positives
So beside saving my life does it work????
- In this double-blind, sham-controlled, phase III trial, adults with chronic gastrointestinal symptoms following pelvic radiotherapy were randomized to receive hyperbaric oxygen (n = 46) or sham therapy (n = 23). There was no difference in the change of Inflammatory Bowel Disease Questionnaire (IBDQ) score or IBDQ rectal bleeding score from baseline to 12 months between the two groups. Common adverse effects reported in both groups included eye refractive changes, increased fatigue, and ear pain. The treatment group experienced six serious adverse events versus two serious adverse events in the control group, but none were considered treatment-related effects.
- There was no evidence to suggest that hyperbaric oxygen therapy improves radiation-induced chronic gastrointestinal symptoms, including rectal bleeding. Further evidence is needed to justify the clinical use of hyperbaric oxygen therapy in this setting.
Anecdotal evidence has been cited to justify the use of hyperbaric oxygen therapy (HBOT) in patients with chronic bowel dysfunction after pelvic radiation therapy. This prospective randomized trial now shows no evidence of any beneficial effect of HBOT in this situation. Even though this trial is rather small for a phase III study, it provides some of the best data regarding the usefulness, or rather lack thereof, of HBOT.
Hyperbaric oxygen has been used as a therapy for patients experiencing chronic intestinal syndromes after pelvic radiotherapy for decades, yet the evidence to support the use of this therapy is based almost exclusively on non-randomised studies. We aimed to provide conclusive results for the clinical benefits of hyperbaric oxygen in patients with chronic bowel dysfunction after radiotherapy for pelvic malignancies.
HOT2 was a double-blind, sham-controlled, phase 3 randomised study of patients (≥18 years) with chronic gastrointestinal symptoms for 12 months or more after radiotherapy and which persisted despite at least 3 months of optimal medical therapy and no evidence of cancer recurrence. Participants were stratified by participating hyperbaric centre and randomly assigned (2:1) by a computer-generated list (block size nine or 12) to receive treatment with hyperbaric oxygen therapy or sham. Participants in the active treatment group breathed 100% oxygen at 2·4 atmospheres of absolute pressure (ATA) and the control group breathed 21% oxygen at 1·3 ATA; both treatment groups received 90-min air pressure exposures once daily for 5 days per week for a total of 8 weeks (total of 40 exposures). Staff at the participating hyperbaric medicine facilities knew the allocated treatment, but patients, clinicians, nurse practitioners, and other health-care professionals associated with patients’ care were masked to treatment allocation. Primary endpoints were changes in the bowel component of the modified Inflammatory Bowel Disease Questionnaire (IBDQ) score and the IBDQ rectal bleeding score 12 months after start of treatment relative to baseline. The primary outcome was analysed in a modified intention-to-treat population, excluding patients who did not provide IBDQ scores within a predetermined time-frame. All patients have completed 12 months of follow-up and the final analysis is complete.
Between Aug 14, 2009, and Oct 23, 2012, 84 participants were randomly assigned: 55 to hyperbaric oxygen and 29 to sham control. 75 (89%) participants received 40 pressure exposures, all participants returned the IBDQ at baseline, 75 (89%) participants returned the IBDQ at 2 weeks post-treatment, and 79 (94%) participants returned the IBDQ at 12 months post-start of treatment. Patients were excluded from analyses of co-primary endpoints if they had missing IBDQ scores for intestinal function or rectal bleeding at baseline or at 12 months. In an analysis of 46 participants in the active treatment group and 23 participants in the control group, we found no significant differences in the change of IBDQ bowel component score (median change from baseline to 12 months of 4 (IQR −3 to 11) in the treatment group vs 4 (−6 to 9) in the sham group; Mann-Whitney U score 0·67, p=0·50). In an analysis of 29 participants in the active treatment group and 11 participants in the sham group with rectal bleeding at baseline, we also found no significant differences in the change of IBDQ rectal bleeding score (median change from baseline to 12 months of 3 [1 to 3] in the treatment group vs 1 [1 to 2] in the sham group; Uscore 1·69, p=0·092). Common adverse events in both groups were eye refractive changes (three [11%] of 28 patients in the control group vs 16 [30%] of 53 patients in the treatment group), increased fatigue (three [11%] vs two [4%]), and ear pain (six [21%] vs15 [28%]). Eight serious adverse events were reported in eight patients: two were reported in two patients in the control group (tonsillitis requiring surgery [grade 3]; recurrent cancer of the vulva [grade 4]) and six serious adverse events were reported in six patients in the treatment group (malignant spinal cord compression requiring surgery [grade 3]; malignant paraortic lymph node involvement requiring surgery [grade 3]; recurrence of vomiting and dehydration [grade 3]; diarrhoea and fever associated withCampylobacter infection [grade 3]; recurrence of abdominal pain, bloating, diarrhoea, and urinary tract infection [grade 3]; aneurysm [grade 4]), none of which were deemed treatment-related.
We 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.