Underpowered study did not provide evidence for the use of HBOT as an adjunctive treatment in a severe attack of ulcerative colitis.
|# Addition of HBOT to standard treatment for ulcerative colitis flares did not affect symptoms or the chance of remission.|
Citation/s: 1.Pagoldh M, Hultgren E, Arnell P, Eriksson A. Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. Scand J Gastroenterol 2013; 48:1033-40. Lead author's name and fax: Eriksson: email@example.com
Three-part Clinical Question: For patients with severe attacks with Ulcerative colitis, does the addition of HBOT to standard routine treatment improve the clinical outcome? Search Terms: ulcerative colitis, inflammatory bowel disease
The Study: Non-blinded concealed randomised controlled trial without intention-to-treat. The Study Patients: Adults with a severe attack (Mayo score > 10) of extensive or left-sided UC and negative faecal cultures. Control group (N = 8; 8 analysed): Intravenous betamethasone (total 8mg), oral mesalazine (1,200 mg twice daily on day 1-5 and thereafter 2,400 mg twice daily), suppository prednisolone (20 mg once daily) and enema prednisolone (37.5 mg once daily). Experimental group (N = 10; 10 analysed): Drugs as above with the addition of HBOT administered at 2.4 ATA for 90 min, 5 days/week, for 6 weeks (a total of 30 HBOT sessions).
- The Evidence:
|Outcome||Time to Outcome||Control group||Hyperbaric group||Relative risk reduction||Absolute risk reduction||NNT|
|^||95% CIs:||-73% to 273%||-0.18 to 0.68||NNT 6 to INF; NNH 1 to INF|
|Non-Event Outcomes||Time to outcome/s||Control group||Experimental group||P-value|
|Mayo score||180 days||3||0.5||> 0.05|
|Inflammatory Bowel Disease Questionnaire (Bowel subdomain: 10 best to 70 worst)||180 days||65||60.5||>0.05|
1. Very small study with high risk of bias. No power calculation but probably underpowered from the start from the start and there was a loss to follow-up of 50% (attrition bias). Only nine patients reached final follow-up, Larger, well-powered RCTs are needed to investigate the clinical significance.
2. No description of any definitive study in planning.
3. Key baseline characteristics are not provided.
4. Mayo score and IBDQ results at day 180 indicate a potential clinical improvement, but full data is not given so impossible to interpret. According to authors not statistically significant.
Appraised by: Cecilia Bondjers, MD, PhD.; Monday, 22 October 2018
Kill or Update By: July 2021