Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1.

PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials. METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups. RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients. CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.

Myopic shift and lens turbidity following hyperbaric oxygen therapy - a prospective, longitudinal, observational cohort study.

PURPOSE: To examine visual acuity, refraction and ocular status before, during and after hyperbaric oxygen therapy (HBOT). METHODS: Twenty-nine patients underwent 40 standard protocol HBOT treatments. In all subjects, refraction and best corrected visual acuity were measured at baseline and after ten, 20, 30 and 40 treatments, and at a 12-week follow-up. A subgroup (n = 19) were given additional examinations at baseline, after 40 treatments and at follow-up including measuring central corneal thickness (CCT), corneal curvature, anterior chamber depth, lens thickness, axial length, fundus morphology, blood pressure and intraocular pressure (IOP). Lens colour and opalescence were graded using the Lens Opacities Classification System III (LOCS III). RESULTS: Myopic shifts [≥0.5 dioptre (D) spherical equivalent (SE)] occurred in 45 (77.6%) eyes. Median refractive changes of -0.75 D SE (right eye; p < 0.001) and -0.66 D SE (left eye; p < 0.001) were observed between pretreatment and treatment end (Wilcoxon signed rank test). Refraction returned to baseline at follow-up, except for a small persisting change towards myopia, median -0.25 D SE (left eye; p = 0.01). Using the LOCS III, median increases in lens nuclear colour, of 0.6 (right eye; p < 0.001) and 0.7 (left eye; p < 0.001), and opalescence of 0.7 (both eyes; p = 0.01) were found at the last examination. Small reductions were noted in CCT of -6.00 µm (right eye; p = 0.03) and -4.00 µm (left eye; p = 0.03), and IOP of -1.50 mmHg (left eye; p = 0.01). CONCLUSIONS: The transient myopic shift may have been due to lenticular refractive index changes. Reduced lens transparency is a potential consequence of HBOT.

Cerebrospinal fluid markers of central nervous system injury in decompression illness - a case-controlled pilot study.

INTRODUCTION: Decompression sickness (DCS) may cause a wide variety of symptoms, including central nervous system (CNS) manifestations. The main objective of this study was to examine whether DCS is associated with neuronal injury, and whether DCS could result in altered amyloid metabolism. METHODS: Seven, male divers with DCS and seven age-matched controls were included in the study. All the divers were treated by recompression but the controls did not receive hyperbaric oxygen. Cerebrospinal fluid (CSF) samples were collected 7-10 days after the diving injury and at three months follow-up. CSF biomarkers of neuronal injury, astroglial Injury/activation, and a range of markers of amyloid ß (Aß) metabolism, as well as two proinflammatory interleukins, were analysed using immunochemical methods. RESULTS: There were no significant differences in the best-established CSF markers of neuronal injury, total tau (T-tau) and neurofilament light, between DCS patients and controls or between the two sampling time points. Also, there were no significant changes in the astroglial or amyloid (Aß)-related markers between DCS patients and controls. However, the only diver with CNS symptoms had the highest levels of CSF T-tau, Aß38, Aß40 and Aß42. CONCLUSION: The results of our study speak against subclinical CNS injury or induction of inflammation or amyloid build-up in the brain among the six DCS patients without neurological symptoms. Further research, including on divers with CNS DCS, is justified.

[Fewer cases of decompression sickness in Västra Götaland. Eight years of statistics show a reduced number of consultations and treatments]. / Färre fall av dykarsjuka i Västra Götaland. Åtta års statistik visar minskat antal konsultationer och behandlingar.

During the period 2005 to 2012, a total of 340 consultations (phone calls and/or visits) regarding possible decompression illness were recorded at the two hospitals with recompression chambers in the Västra Götaland region, Sweden. An analysis of the data showed a trend towards fewer consultations and recompression treatments. A similar trend has been observed in many other countries. Possible reasons for this reduction in the number of cases are discussed. Most of the patients only present relatively mild signs and symptoms at the time of consultation. This, together with the fact that the number of patients is low, involves a risk that awareness and knowledge regarding correct handling and care in diving accidents might be lost. Since rapid and correct care of decompression illness is important to avoid later sequeale it is important that competence in diving medicine is maintained at hospitals Nationwide.

Hyperbaric oxygen treatment in radiation-induced cystitis and proctitis: a prospective cohort study on patient-perceived quality of recovery.

PURPOSE: In this prospective cohort study, the effects of hyperbaric oxygen treatment (HBOT) were evaluated concerning patient-perceived symptoms of late radiation-induced cystitis and proctitis secondary to radiation therapy for pelvic cancer. METHODS AND MATERIALS: Thirty-nine patients, 35 men and 4 women with a mean age of 71 (range, 35-84) years were included after informed consent and institutional ethics approval. They had all been treated with radiation therapy for prostate (n=34), cervix (n=2), or rectal (n=3) cancer using external beam radiation at a dose of 25 to 75 Gy. Patients with hematuria requiring blood transfusion were excluded. The HBOT was delivered with 100% oxygen for 90 minutes at 2.0 to 2.4 atmospheres (ATA). Mean number of treatments was 36 (28-40). Symptoms were prospectively assessed using the Expanded Prostate Index Composite score before, during, and 6 to 12 months after HBOT. RESULTS: The HBOT was successfully conducted, and symptoms were alleviated in 76% for patients with radiation cystitis, 89% for patients with radiation proctitis, and 88% of patients with combined cystitis and proctitis. Symptom reduction was demonstrated by an increased Expanded Prostate Index Composite score in the urinary domain from 50±16 to 66±20 after treatment (P<.001) and in the bowel domain from 48±18 to 68±18 after treatment (P<.001). For 31% of the patients with cystitis and 22% with proctitis, there were only trivial symptoms after HBOT. The improvement was sustained at follow-up in both domains 6 to 12 months after HBOT. No severe side effects were observed related to HBOT, and treatment compliance was high. CONCLUSIONS: HBOT can be an effective and safe treatment modality for late radiation therapy-induced soft tissue injuries in the pelvic region.

Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study.

BACKGROUND AND AIMS: Complementary therapy options are needed in the treatment of active ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) has been shown to have positive effects in experimental models of colitis and perianal Crohn's disease. METHODS: In the present prospective randomized open-label study, HBOT in addition to conventional medical treatment was compared with conventional treatment alone. The primary objective in this study was improved clinical outcome evaluated by Mayo score, laboratory tests and fecal weight. The secondary objectives were improvement in health-related quality of life, avoidance of colectomy and evaluation of HBOT safety. RESULTS: The authors found no statistically significant differences between the treatment groups in any of the assessed variables. CONCLUSION: The study results do not support the use of HBOT as a treatment option in a severe attack of UC.