Hyperbaric Oxygen Therapy for Radionecrosis of the Jaw: A Randomized, Placebo-Controlled, Double-Blind Trial From the ORN96 Study Group

Purpose To determine the efficacy and safety of hyperbaric oxygen therapy (HBO) for overt mandibular osteoradionecrosis. Patients and Methods This prospective, multicenter, randomized, double-blind, placebo-controlled trial was conducted at 12 university hospitals. Ambulatory adults with overt osteoradionecrosis of the mandible were assigned to receive 30 HBO exposures preoperatively at 2.4 absolute atmosphere for 90 minutes or a placebo, and 10 additional HBO dives postoperatively or a placebo. The main outcome measure was 1-year recovery rate from osteoradionecrosis. Secondary end points included time to treatment failure, time to pain relief, 1-year mortality rate, and treatment safety. Results At the time of the second interim analysis, based on the triangular test, the study was stopped for potentially worse outcomes in the HBO arm. A total of 68 patients were enrolled and analyzed. At 1 year, six (19%) of 31 patients had recovered in the HBO arm and 12 (32%) of 37 in the placebo arm (relative risk = 0.60; 95% CI, 0.25 to 1.41; P = .23). Time to treatment failure (hazard ratio = 1.33; 95% CI, 0.68 to 2.60; P = .41) and time to pain relief (hazard ratio = 1.00; 95% CI, 0.52 to 1.89; P = .99) were similar between the two treatment arms. Conclusion Patients with overt mandibular osteoradionecrosis did not benefit from hyperbaric oxygenation.

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May Hyperbaric Oxygen Therapy Play a Role in the Treatment of Allergic Rhinitis? A Double- Blind Experimental Study in Rat Model Hyperbaric Oxygen Therapy on Allergic Rhinitis

Journal of Otology & Rhinology ◽

10.4172/2324-8785.1000335 ◽

2017 ◽

Vol 07 (01) ◽

Author(s):

Erkan Vuralkan ◽

Hatice Bengu Cobanoglu ◽

Bengusu Mirasoglu ◽

Sevdegul Mungan ◽

Abdullah Arslan ◽

...

Keyword(s):

Experimental Study ◽

Allergic Rhinitis ◽

Hyperbaric Oxygen ◽

Rat Model ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Double Blind

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Effects of topical nasal steroids and diclofenac on the nasal mucosa during hyperbaric oxygen therapy: a double-blind experimental study

European Archives of Oto-Rhino-Laryngology ◽

10.1007/s00405-013-2863-8 ◽

2013 ◽

Vol 271 (8) ◽

pp. 2213-2217 ◽

Cited By ~ 1

Author(s):

Erkan Vuralkan ◽

Hatice Bengu Cobanoglu ◽

Abdullah Arslan ◽

Selcuk Arslan ◽

Sevdegul Mungan ◽

...

Keyword(s):

Experimental Study ◽

Hyperbaric Oxygen ◽

Nasal Mucosa ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Double Blind ◽

Nasal Steroids

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Effectiveness of Repeat Glycerol Rhizotomy in Treating Recurrent Trigeminal Neuralgia

Neurosurgery ◽

10.1227/neu.0b013e31823f5eb6 ◽

2011 ◽

Vol 70 (5) ◽

pp. 1125-1134 ◽

Cited By ~ 13

Author(s):

Matthew Bender ◽

Gustavo Pradilla ◽

Sachin Batra ◽

Alfred See ◽

Neal Bhutiani ◽

...

Keyword(s):

Pain Relief ◽

Trigeminal Neuralgia ◽

Treatment Failure ◽

Median Time ◽

Retrospective Cohort ◽

Cox Regression ◽

Time To Treatment ◽

Cox Regression Analysis ◽

Sensory Change ◽

Time To Treatment Failure

Abstract BACKGROUND: Percutaneous glycerol rhizotomy (GR) is used to treat trigeminal neuralgia (TN), with satisfactory pain relief lasting 2 to 3 years in most patients after the first intervention. The efficacy of subsequent GRs, however, has not been studied. OBJECTIVE: To compare the pain relief and durability achieved by the first GR with those obtained after subsequent GRs in a retrospective cohort of TN patients. METHODS: Between 1998 and 2010, 548 patients with TN underwent 708 GRs. After exclusions, 430 initial GRs (GR1) and 114 subsequent GRs (GR2+) were compared in terms of initial pain relief, durability, sensory change, and complications. Durability was assessed by determining median time to treatment failure for all GRs achieving complete pain relief without medications (n = 375: 264 failures, 111 censored). Predictors of initial pain relief were assessed by logistic regression, and predictors of failure were assessed by Cox regression analysis. RESULTS: After GR1, pain relief results were as follows: 285 patients (66%) were pain free without medications, 26 (6%) were pain free with medications, 66 (15%) improved, and 53 (12%) were unchanged. After GR2+, results were as follows: 90 patients (79%) were pain free without medications, 6 (5%) were pain free with medications, 7 (6%) improved, and 11 (10%) were unchanged (P = .03). Median time to treatment failure was 26 months after GR1 and 25 months after GR2+ (P = .34). On multivariate analysis, prior GR was a positive predictor of initial pain relief (odds ratio, 2.067; 95% confidence interval, 1.243-3.437; P = .005) and had no effect on durability. CONCLUSION: TN patients experienced greater pain relief and equivalent durability after GR2+ beyond the initial treatment.

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Double-blind trials in hyperbaric medicine: A narrative review on past experiences and considerations in designing sham hyperbaric treatment

Clinical Trials ◽

10.1177/1740774518776952 ◽

2018 ◽

Vol 15 (5) ◽

pp. 462-476 ◽

Cited By ~ 6

Author(s):

Nina CA Lansdorp ◽

Rob A van Hulst

Keyword(s):

Hyperbaric Oxygen ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Lower Pressure ◽

Controlled Trials ◽

Double Blind ◽

Hyperbaric Treatment ◽

Hyperbaric Medicine ◽

Oxygen Group ◽

Blind Trials

Background Hyperbaric oxygen therapy, which consists of breathing 100% oxygen under a higher atmospheric pressure than normal, is utilized worldwide in the treatment of several diseases. With the growing demand for evidence-based research, hyperbaric oxygen therapy has been criticized for delivering too little high-quality research, mainly in the form of randomized controlled trials. While not always indispensable, the addition of a sham-controlled group to such a trial can contribute to the quality of the research. However, the design of a sham (hyperbaric) treatment is associated with several considerations regarding adequate blinding and the use of pressure and oxygen. This narrative review discusses information on the sham profile and the blinding and safety of double-blind trials in hyperbaric medicine, irrespective of the indication for treatment. Methods MEDLINE, Embase and CENTRAL were searched for sham-controlled trials on hyperbaric oxygen therapy. The control treatment was considered sham if patients were blinded to their allocation and treatment took place in a hyperbaric chamber, with no restrictions regarding pressurization, oxygen levels or indication. Studies involving children or only one session of hyperbaric oxygen were excluded. Information on (the choice of) treatment profile, blinding measures, patient’s perception regarding allocation and safety issues was extracted from eligible studies. Results A total of 42 eligible trials were included. The main strategies for sham treatment were (1) use of a lower pressure than that of the hyperbaric oxygen group, while breathing 21% oxygen; (2) use of the same pressure as the hyperbaric oxygen group, while breathing an adjusted percentage of oxygen; and (3) use of the same pressure as the hyperbaric oxygen group, while breathing 21% oxygen. The advantages and disadvantages of each strategy are discussed using the information provided by the trials. Conclusion Based on this review, using a lower pressure than the hyperbaric oxygen group while breathing 21% oxygen best matches the inertness of the placebo. Although studies show that use of a lower pressure does allow adequate blinding, this is associated with more practical issues than with the other strategies. The choice of which sham profile to use requires careful consideration; moreover, to ensure proper performance, a clear and detailed protocol is also required.

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