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% CIs: |
-0.001 to 0.43 |
NNT 2 to INF; NNH1,194 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 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
