icnmgrjill
06-26-2006, 09:26 AM
Dr. Jay Burstein (Dekalb Clinic, Dekalb IL) shares his thoughts on the research presented at this year's AUA conference.
SAFETY AND EFFICACY OF HYPERBARIC OXYGEN THERAPY FOR THE
TREATMENT OF INTERSTITIAL CYSTITIS: A RANDOMIZED, SHAMCONTROLLED, DOUBLE-BLIND TRIAL
Arndt Van Ophoven*, Gordon Rossbach, Lothar Hertle, Muenster, Germany
Introduction and Objective: In a recent pilot study, serving as “proof-of-principle”, we reported the therapeutic potential of hyperbaric oxygenation (HBO) for interstitial cystitis (IC) suggesting that HBO has promise as a treatment modality for IC. This study was designed to further evaluate the safety, efficacy and feasibility of HBO for IC.
Methods: We conducted a prospective, randomized, double-blind, sham-controlled study with 21 patients suffering from IC. Patients were randomized to 90 minutes treatment in a multiplace hyperbaric chamber pressurized with 100% O2 to 2.4 atmosphere absolute (ata.) for 30 treatments sessions or 1.3ata. breathing normal air in the control group. Allocation to sham or verum treatment followed a 1:2 distribution. Patients reporting improvement in a Global Response Assessment questionnaire were defined as treatment responders (primary outcomes). Secondary measurements included changes of pain and urgency, functional bladder capacity and frequency. Changes in the O´Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome were reported as well. The code was broken after evaluation at 3 months, efficacy of treatment was assessed at the end of treatment and after a follow-up interval of 1, 3, 6, 9 and 12 months.
Results: 2 verum patients dropped-out of the study. 8 out of 12 verum patients and none of the control patients were identified as responders (p<0.001). At 12 months follow-up 5 verum patients (41.6%) still reported response to HBO treatment. HBO resulted in a decrease of urgency intensity from 60.2 ± 15.0mm. at baseline to 49.4 ± 23.9mm. at 3 months and decrease of pain intensity from 43.1 ± 20.5mm. to 29.0 ± 22.4mm. respectively (p<0.05). The O'Leary/Sant index sum dropped from 25.7 points to 19.6 points in the verum patients. Sham treatment did not result in improvement of any baseline parameters.
Conclusions: 30 treatment sessions of HBO appear to be a safe,
efficacious and feasible therapeutic approach to IC. In the treatment responders, application of HBO resulted in a sustained decrease of IC symptoms with a discordant profile regarding the peak amelioration of the various IC symptoms compared with a normobaric, normoxic sham treatment.
DR. BURSTEIN'S COMMENT: Normal oxygen pressure at sea level is measured as one atmosphere. By increasing the pressure more than two-fold (2.4 atmospheres) patients in this study received significant improvement in IC symptoms. Hyperbaric treatment has been shown to improve wound healing and is currently being utilized for a variety of disorders including autism. The treatment is cumbersome, requiring multiple, relatively long sessions in a sealed chamber. The mechanism of action is thought to be a reduction in cellular inflammation by increasing the local oxygen concentration. This is the first appearance of a properly controlled study utilizing hyperbaric treatment for IC patients and hopefully, further studies will confirm these findings
SAFETY AND EFFICACY OF HYPERBARIC OXYGEN THERAPY FOR THE
TREATMENT OF INTERSTITIAL CYSTITIS: A RANDOMIZED, SHAMCONTROLLED, DOUBLE-BLIND TRIAL
Arndt Van Ophoven*, Gordon Rossbach, Lothar Hertle, Muenster, Germany
Introduction and Objective: In a recent pilot study, serving as “proof-of-principle”, we reported the therapeutic potential of hyperbaric oxygenation (HBO) for interstitial cystitis (IC) suggesting that HBO has promise as a treatment modality for IC. This study was designed to further evaluate the safety, efficacy and feasibility of HBO for IC.
Methods: We conducted a prospective, randomized, double-blind, sham-controlled study with 21 patients suffering from IC. Patients were randomized to 90 minutes treatment in a multiplace hyperbaric chamber pressurized with 100% O2 to 2.4 atmosphere absolute (ata.) for 30 treatments sessions or 1.3ata. breathing normal air in the control group. Allocation to sham or verum treatment followed a 1:2 distribution. Patients reporting improvement in a Global Response Assessment questionnaire were defined as treatment responders (primary outcomes). Secondary measurements included changes of pain and urgency, functional bladder capacity and frequency. Changes in the O´Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome were reported as well. The code was broken after evaluation at 3 months, efficacy of treatment was assessed at the end of treatment and after a follow-up interval of 1, 3, 6, 9 and 12 months.
Results: 2 verum patients dropped-out of the study. 8 out of 12 verum patients and none of the control patients were identified as responders (p<0.001). At 12 months follow-up 5 verum patients (41.6%) still reported response to HBO treatment. HBO resulted in a decrease of urgency intensity from 60.2 ± 15.0mm. at baseline to 49.4 ± 23.9mm. at 3 months and decrease of pain intensity from 43.1 ± 20.5mm. to 29.0 ± 22.4mm. respectively (p<0.05). The O'Leary/Sant index sum dropped from 25.7 points to 19.6 points in the verum patients. Sham treatment did not result in improvement of any baseline parameters.
Conclusions: 30 treatment sessions of HBO appear to be a safe,
efficacious and feasible therapeutic approach to IC. In the treatment responders, application of HBO resulted in a sustained decrease of IC symptoms with a discordant profile regarding the peak amelioration of the various IC symptoms compared with a normobaric, normoxic sham treatment.
DR. BURSTEIN'S COMMENT: Normal oxygen pressure at sea level is measured as one atmosphere. By increasing the pressure more than two-fold (2.4 atmospheres) patients in this study received significant improvement in IC symptoms. Hyperbaric treatment has been shown to improve wound healing and is currently being utilized for a variety of disorders including autism. The treatment is cumbersome, requiring multiple, relatively long sessions in a sealed chamber. The mechanism of action is thought to be a reduction in cellular inflammation by increasing the local oxygen concentration. This is the first appearance of a properly controlled study utilizing hyperbaric treatment for IC patients and hopefully, further studies will confirm these findings