Dulai
Hyperbaric oxygen therapy improved remission rate for ulcerative colitis flares
Clinical bottom line
| 1. When HBO was added to standard treatment for UC flares, the rate of remission within five days was increased |
Citation/s: Dulai PS, Buckey JC, Raffals LE, Swoger JM, Claus PL, O’Toole K, Ptak JA, Gleeson MW, Widjaja CE, Chang JT, Adler JM. Hyperbaric oxygen therapy is well tolerated and effective for ulcerative colitis patients hospitalized for moderate–severe flares: a phase 2A pilot multi-center, randomized, double-blind, sham-controlled trial. The American Journal of Gastroenterology 2018; Feb 16:1. Lead author's email: pdulai@ucsd.edu
Three-part Clinical Question: For patients requiring hospital admission for flare-ups of ulcerative colitis, does the addition of HBOT to steroid administration, versus steroids alone, improve the rate of remission? Search Terms: ulcerative colitis, inflammatory bowel disease
The Study: Double-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Adults hospitalized with moderate to severe UC flare as defined by Mayo score ≥6 AND Mayo endoscopic sub-score of 2 or 3.
Control group (N = 8; 8 analysed): Sham hyperbaric air: compressed to 1.34 ATA on room air, then decompressed to 1.2 ATA for 90 min. Daily session x5 days. Steroid to equivalent of 60mg IV methylprednisolone every 24h.
Experimental group (N = 10; 10 analysed): 2.4 ATA breathing 100% oxygen and steroids on same regimen.
The Evidence:
Outcome |
Time to Outcome |
Control group rate |
HBO group rate |
Relative risk reduction |
Absolute risk reduction |
NNT |
|
|
Day 5 |
0 |
0.50 |
0.50 |
2 | |
95% CIs: |
0.81 to 0.19 |
5 to 1 | ||||
|
|
In-hospital |
0.63 |
0.10 |
84% |
0.53 |
2 |
95% CIs: |
23% to 100% |
0.15 to 0.91 |
1 to 7 | |||
|
|
In-hospital |
0.38 |
0 |
100% |
0.38 |
3 |
95% CIs: |
0.04 to 0.72 |
1 to | ||||
Comments:
1. Study terminated early given poor recruitment, changed to proof of concept pilot study. Larger, well-powered RCT’s are needed to investigate clinical significance.
2. Results are interpreted with caution given small study size, possible sampling error.
3. Original primary outcome of 10 treatments was found to be an impedance to recruitment, protocol subsequently changed to 5 treatments.
4. Decision to hospitalize and/or advance to second line therapy was at the discretion of respective treating physicians. Introduces possibility for site to site variability.
5. There was no statistically significant difference in progression to second line therapies (biologics or colectomy) at 6 and 12 month follow ups.
Appraised by: Michael Tom, MD; Wednesday, 15 August 2018
Email: mtom5690@gmail.com
Kill or Update By: August 2021
