Gallego-Vilar
The subsequent use of hyperbaric oxygen in women with interstitial cystitis who responded to DMSO installation may improve symptoms and extend the response time
Clinical bottom line:
|
1. In those women who respond to DMSO instillation, a subsequent course of hyperbaric oxygen further improved symptoms and general health measures. 2. Similarly, hyperbaric oxygen maintained improvements for longer. 3. Statistical methods used in the paper found these effects significant but individual analyses here did not. |
Citation/s:1. Gallego-Vilar D, García-Fadrique G, Povo-Martin I, Salvador-Marin M, Gallego-Gomez J. Maintenance of the response to dimethyl sulfoxide treatment using hyperbaric oxygen in interstitial cystitis /painful bladder syndrome: a prospective, randomized, comparative study. Urologia internationalis. 2013;90(4):411-6
Lead author's name and fax: Daniel Gallego-Vilar dagalvi@hotmail.com
Three-part Clinical Question:For patients with interstitial cystitis (painful bladder syndrome - PBS), does the administration of hyperbaric oxygen after the use of intravesical dimethyl sulfoxide (DMSO), compared to DMSO alone, result in a better maintenance of the therapeutic response?
Search Terms: Interstitial cystitis; DMSO; painful bladder syndrome
The Study:Placebo controlled randomised trial with intention-to-treat.
The Study Patients: Women with a diagnosis of IC/PBS
Control group (N = 7; 7 analysed): DMSO 50% solution with heparin, hydrocortisone + sodium bicarbonate: 500 ml total solution by intra-vesical instillation, applied weekly for six weeks. If the patient responded favourably they entered the study and received placebo exposures in a hyperbaric chamber breathing oxygen at 1 ATA for 60 minutes daily to a total of 20 exposures.
Experimental group (N = 7; 7 analysed): As above, but breathing 100% oxygen at 2.5 ATA.
The Evidence:
Measure |
Placebo Group |
HBOT Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Pain at 1 month (VAS 0 to 10) |
7.4 |
2.2 |
4.3 |
4.1 |
-3.1 |
-15.7 to 9.5 |
|
Pain at 12 months (VAS 0 to 10) |
8.9 |
1.7 |
7.1 |
2.2 |
-1.8 |
-6.3 to 2.7 |
|
General health status on Kings Health Questionnaire (0 to 100 [worst] scale) |
26.4 |
13.2 |
43.2 |
10.1 |
16.8 |
177 to -144 |
|
Months of sustained improvement in months (measure unclear) |
3.1 |
2.7 |
9.3 |
4.3 |
6.2 |
21.2 to -8.8 |
Comments:
1. Interesting two-phase trial. We report only the randomised portion. Six of 20 did not respond initially to DMSO and were not randomised.
2. All patients were sub-classified according to the type of IC/PBS but results not given
3. Many patients had received multiple treatments in the past including NSAIDs, tricyclic antidepressants and anti-histamines.
4. The results are presented in a rather confusing fashion but generally said to show a more permanent response in the HBO treated group. Authors used multiple linear regression over time and reported statistical significance. Our analyses are individual elements at fixed times.
6. KHQ is an assessment of health-related quality of life related to a specific condition (bladder problems).
7. All patients receiving HBOT responded further, while it is not clear how many of those having placebo responded further.
8. Not clear if the placebo group were blinded and they seem to have received 100% oxygen.
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Wednesday, 10 June 2020
Kill or Update By: June 2023
