Van Ophoven
Hyperbaric oxygen therapy reduced pain associated with interstitial cystitis
| Clinical bottom line: 1. Mean pain score reduced following HBOT2. Trend toward benefit from HBOT for urgency, frequency, bladder volume and subjective response, but no statistically significant differences |
Citation/s:1. van Ophoven A, Rossbach G, Pajonk F, Hertle L. Safety and efficacy of hyperbaric oxygen therapy for the treatment of interstitial cystitis a randomised, sham controlled, double blind trial. Journal of Urology 2006; 176:1442-1446. Lead author's name and fax: [| avo@uni-muenster.de]
Three-part Clinical Question: For patients with interstitial cystitis, does the application of hyperbaric oxygen result in any improvement in symptoms? Search Terms: Cysitis, interstitial, pelvic pain
The Study:Double-blinded randomised controlled trial with intention-to-treat. The Study Patients: Adult women with a diagnosis of interstitial cystitis. Control group (N = 7; 7 analysed): Baseline therapy for each individual was continued plus air breathing at 1.3 to 1.4 ATA for 90 minutes daily to 30 sessions over 5 weeks. Experimental group (N = 14; 14 analysed): As above but 100% oxygen breathing at 2.4 ATA.
The Evidence:
| Outcome | Time to Outcome | Sham rate | HBO rate | Relative risk reduction | Absolute risk reduction | NNT |
| Symptomatic responders | 3 months | 0 | 0.21 | INF | 0.21 | 5 |
| ^ | 95% Confidence Intervals: | -0.001 to 0.43 | NNT 2 to INFNNH 1,194 to INF |
| Measure | Sham Group | HBO Group | Difference | 95% CI | ||
| ^ | Mean | SD | Mean | SD | ^ | ^ |
| Interstitial cystitis index at 3 months | 26.7 | 5.8 | 19.9 | 7.9 | 6.8 | -0.28 to 13.88 |
| Pain score (VAS) 3 months (0-100) | 55.7 | 27.8 | 31.2 | 19.8 | 24.5 | 2.57 to 46.43 |
| Bladder volume 3 months (mls) | 118 | 36 | 147 | 49 | 29 | -14.60 to 72.60 |
Comments: 1. The difference in the proportion of symptomatic responders on a subjective scale (3 HBO versus 0 sham) is reported in the paper as statistically significant (P<0.05), but our calculations do not support this finding (P=0.55 by Fisher's exact test, double one-sided P method). {Authors agree with the published figure is incorrect.} 2. Underpowered study with no sample size calculation.
Appraised by: Sean Hopson and Mike Bennett, Sydney; Friday, 10 November 2006Email: [| m.bennett@unsw.edu.au] Kill or Update By: March 2007
