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OBJECTIVE: Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. The aim of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) in the management of chronic diabetic foot ulcers. RESEARCH DESIGN AND METHODS: The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers (HODFU) study was a randomized, single-center, double-blinded, placebo-controlled clinical trial. The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air. Treatments were given in a multi-place hyperbaric chamber for 85-min daily (session duration 95 min), five days a week for eight weeks (40 treatment sessions). The study was performed in an ambulatory setting. RESULTS: Ninety-four patients with Wagner grade 2, 3, or 4 ulcers, which had been present for >3 months, were studied. In the intention-to-treat analysis, complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up: 25/48 (52%) in the HBOT group and 12/42 (29%) in the placebo group (P = 0.03). In a sub-analysis of those patients completing >35 HBOT sessions, healing of the index ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group (P = 0.009). The frequency of adverse events was low. CONCLUSIONS: The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes.

Fibromyalgia is a chronic pain syndrome with unsatisfactory response to current treatments. Physical trauma, including traumatic brain Injury (TBI) is among the etiological triggers. Hyperbaric Oxygen therapy (HBOT) is an intervention that combines 100% oxygen with elevated atmospheric pressure. HBOT has been applied as a neuro-modulatory treatment in central nervous system–related conditions. The current study investigated the utility of HBOT for TBI–related fibromyalgia. Fibromyalgia patients with a history of TBI were randomized to either HBOT or pharmacological intervention. HBOT protocol comprised 60 daily sessions, breathing 100% oxygen by mask at 2 absolute atmospheres (ATA) for 90 minutes. Pharmacological treatment included Pregabalin or Duloxetine. The primary outcome was subjective pain intensity on visual analogue scale (VAS); Secondary endpoints included questionnaires assessing fibromyalgia symptoms as well as Tc-99m-ECD SPECT brain imaging. Pain threshold and conditioned pain modulation (CPM) were also assessed. Results demonstrated a significant group-by-time interaction in pain intensity post-HBOT compared to the medication group (p = 0.001), with a large net effect size (d = -0.95) in pain intensity reduction following HBOT compared to medications. Fibromyalgia related symptoms and pain questionnaires demonstrated significant improvements induced by HBOT as well as improvements in quality of life and increase in pain thresholds and CPM. SPECT demonstrated significant group-by-time interactions between HBOT and medication groups in the left frontal and the right temporal cortex. In conclusion, HBOT can improve pain symptoms, quality of life, emotional and social function of patients suffering from FMS triggered by TBI. The beneficial clinical effect is correlated with increased brain activity in frontal and parietal regions, associated with executive function and emotional processing.

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. \"Mindstreams\" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

The SARS-CoV-2 pandemic has resulted in 762 million infections worldwide from 2020 to date, of which approximately ten percent are suffering from the effects after infection in 2019 (COVID-19) [ 1 , 40 ]. In Germany, it is now assumed that at least one million people suffer from post-COVID condition with long-term consequences. These have been previously reported in diseases like Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). Symptoms show a changing variability and recent surveys in the COVID context indicate that 10–30 % of outpatients, 50 to 70% of hospitalised patients suffer from sequelae. Recent data suggest that only 13% of all ill people were completely free of symptoms after recovery [ 3 , 9 ]. Current hypotheses consider chronic inflammation, mitochondrial dysfunction, latent viral persistence, autoimmunity, changes of the human microbiome or multilocular sequelae in various organ system after infection. Hyperbaric oxygen therapy (HBOT) is applied since 1957 for heart surgery, scuba dive accidents, CO intoxication, air embolisms and infections with anaerobic pathogens. Under hyperbaric pressure, oxygen is physically dissolved in the blood in higher concentrations and reaches levels four times higher than under normobaric oxygen application. Moreover, the alternation of hyperoxia and normoxia induces a variety of processes at the cellular level, which improves oxygen supply in areas of locoregional hypoxia. Numerous target gene effects on new vessel formation, anti-inflammatory and anti-oedematous effects have been demonstrated [ 74 ]. The provision of intermittently high, local oxygen concentrations increases repair and regeneration processes and normalises the predominance of hyperinflammation. At present time only one prospective, randomized and placebo-controlled study exists with positive effects on global cognitive function, attention and executive function, psychiatric symptoms and pain interference. In conclusion, up to this date HBO is the only scientifically proven treatment in a prospective randomized controlled trial to be effective for cognitive improvement, regeneration of brain network and improvement of cardiac function. HBOT may have not only theoretical but also potential impact on targets of current pathophysiology of Post COVID condition, which warrants further scientific studies in patients.

In this double-blind randomized trial, adults with persistent symptoms following non-stroke brain injury received 40 hyperbaric oxygen (HBO 2 ) sessions or 40 sham sessions over 12 weeks. Three months later, all were offered 40 unblinded HBO 2 sessions. Participants completed the Neurobehavioral Symptom Inventory (NSI) at baseline, 13 weeks (after 40 chamber sessions), 6 months, 9 months (after the second chamber series), and 12 months, with prime outcome at 13 weeks, and additional questionnaires, neuropsychological tests, and functional measures. We enrolled 49 participants and analyzed 47 due to drop-out/exclusion (26 males, 40 with traumatic brain injury). Baseline NSI was 35.9 ± 15.8 in the HBO 2 group ( n =  26) and 30.7 ± 16.9 in the sham group ( n =  21) ( p  = 0.28). Mean 13-week change scores were 10.6 ± 10.6 (HBO 2 group) and 3.6 ± 5.9 (sham group) (mean difference 7.0, 95% CI 1.7–12.3, p  = 0.01). The HBO 2 group improved on measures of olfaction, anxiety, sleep difficulties, and vestibular complaints. Both groups reported improvements in depression, headaches, PTSD symptoms, physical quality of life, and degree to which difficulties interfere with daily life. With an additional 40 HBO 2 sessions, the original HBO 2 group reported additional improvements on NSI at 12 months. Only 15 original sham participants completed the second chamber series, limiting conclusions from that data.

Post-traumatic stress disorder (PTSD) is characterized by changes in both brain activity and microstructural integrity. Cumulative evidence demonstrates that hyperbaric oxygen therapy (HBOT) induces neuroplasticity and case-series studies indicate its potentially positive effects on PTSD. The aim of the study was to evaluate HBOT's effect in veterans with treatment resistant PTSD. Veterans with treatment resistant PTSD were 1:1 randomized to HBOT or control groups. All other brain pathologies served as exclusion criteria. Outcome measures included clinician-administered PTSD scale-V (CAPS-V) questionnaires, brief symptom inventory (BSI), BECK depression inventory (BDI), brain microstructural integrity evaluated by MRI diffuse tensor imaging sequence (DTI), and brain function was evaluated by an n-back task using functional MRI (fMRI). The treatment group underwent sixty daily hyperbaric sessions. No interventions were performed in the control group. Thirty-five veterans were randomized to HBOT (N = 18) or control (n = 17) and 29 completed the protocol. Following HBOT, there was a significant improvement in CAPS-V scores and no change in the control (F = 30.57, P<0.0001, Net effect size = 1.64). Significant improvements were also demonstrated in BSI and BDI scores (F = 5.72, P = 0.024 Net effect size = 0.89, and F = 7.65, P = 0.01, Net effect size = 1.03). Improved brain activity was seen in fMRI in the left dorsolateral prefrontal, middle temporal gyri, both thalami, left hippocampus and left insula. The DTI showed significant increases in fractional anisotropy in the fronto-limbic white-matter, genu of the corpus callosum and fornix. HBOT improved symptoms, brain microstructure and functionality in veterans with treatment resistant PTSD.

This study aims to investigate the effect of hyperbaric oxygen therapy (HBOT) on muscle damage and inflammatory responses after total knee arthroplasty (TKA). This study selected 80 patients requiring TKA for primary knee osteoarthritis from July 2023 to December 2023 and equally randomized them into two groups—the HBOT and control groups—with 40 patients in each group. The HBOT group received standard treatment supplemented with HBOT, whereas the control group received normobaric oxygen therapy. Muscle damage markers, including glutamic oxaloacetic transaminase (GOT), creatine kinase (CK), lactate dehydrogenase (LDH), and myoglobin (Mb), as well as inflammatory responses were compared preoperatively and 1, 3, and 14 days postoperatively. Additionally, limb circumference, quadriceps muscle strength, and the range of motion (ROM) of the affected limb were measured preoperatively and postoperatively. Any adverse events were documented. The HBOT group demonstrated a significant reduction in muscle damage 3 days post-TKA compared with the control group. A statistically significant acceleration in the recovery of quadriceps muscle strength and a decrease in the ratio of postoperative limb swelling accompanied this reduction. The HBOT group demonstrated a statistically significant alleviation of inflammatory responses 3 days postoperatively compared to the control group. Additionally, the visual analog scale (VAS) scores decreased for both rest and motion 2 and 3 days postoperatively, indicating an improved early ROM. Notably, no significant differences in postoperative adverse events were found between the two groups. The use of HBOT in the postoperative care of patients undergoing TKA has proven to be effective in mitigating muscle damage and alleviating inflammatory responses. Trial registration: Chinese Clinical Trial Registry (ChiCTR2300072685). Registered 21/6/2023, ULR of trial registry: https://www.chictr.org.cn/bin/project/edit?%20pid=198904 .

Older adults with type 2 diabetes (T2D) and mild cognitive impairment (MCI) are at increased risk for dementia. Hyperbaric oxygen therapy (HBOT) has shown vascular and metabolic effects that may benefit brain health. This randomized, double-blind, sham-controlled trial assessed the impact of HBOT on cognitive function, cerebral blood flow (CBF), and glucose metabolism in this high-risk group. A total of 155 participants were recruited and randomized to HBOT (N =77) and sham (N =78) between 2017 and 2023. Cognitive outcomes were assessed at baseline, 3, 6, and 12 months. Imaging (ASL-MRI for CBF and FDG-PET for glucose metabolism) was conducted at baseline, 3, and 12 months. The primary outcomes included global cognition (composite z-score), CBF, and FDG-PET. SUVR values were calculated using a global cortical ROI as the target region, normalized to the pons as the reference region. Secondary cognitive measures included domain-specific cognition (executive functions and episodic memory) and CDR-SOB. Analyses used linear mixed-effects models under intent-to-treat (ITT) and per-protocol (PP) approaches, without adjustment for multiple comparisons. Across all timepoints, participants improved in cognition compared to baseline. At 3 months, global cognition and executive function significantly favored sham (p <0.05), with no sustained group differences at later timepoints (see Figure). Memory improved over time in both groups, with no significant group differences. There were no differences in CBF or FDG-PET SUVR between groups. Sex and baseline cognition (median CDR-SOB) had no significant effects on treatment response. PP analyses suggested lower SUVR at 3 months in the HBOT group across several brain regions (p -values: 0.014-0.048). No group differences were seen in correlations between changes in cognition and CBF or SUVR. Adverse event analysis showed three times more serious adverse events (SAEs) in the HBOT group (N =25) comparing to sham (N =8), distributed across multiple organ systems. AEs distribution was similar between groups. HBOT did not improve cognitive or brain imaging outcomes compared to sham in older adults with T2D and MCI. A transient cognitive benefit was observed in the sham group immediately post-intervention. The higher rate of SAEs in the HBOT group for this population with high comorbidities warrants further investigation.

Fibromyalgia Syndrome (FMS) is a persistent and debilitating disorder estimated to impair the quality of life of 2-4% of the population, with 9:1 female-to-male incidence ratio. FMS is an important representative example of central nervous system sensitization and is associated with abnormal brain activity. Key symptoms include chronic widespread pain, allodynia and diffuse tenderness, along with fatigue and sleep disturbance. The syndrome is still elusive and refractory. The goal of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) on symptoms and brain activity in FMS. A prospective, active control, crossover clinical trial. Patients were randomly assigned to treated and crossover groups: The treated group patients were evaluated at baseline and after HBOT. Patients in the crossover-control group were evaluated three times: baseline, after a control period of no treatment, and after HBOT. Evaluations consisted of physical examination, including tender point count and pain threshold, extensive evaluation of quality of life, and single photon emission computed tomography (SPECT) imaging for evaluation of brain activity. The HBOT protocol comprised 40 sessions, 5 days/week, 90 minutes, 100% oxygen at 2ATA. Sixty female patients were included, aged 21-67 years and diagnosed with FMS at least 2 years earlier. HBOT in both groups led to significant amelioration of all FMS symptoms, with significant improvement in life quality. Analysis of SPECT imaging revealed rectification of the abnormal brain activity: decrease of the hyperactivity mainly in the posterior region and elevation of the reduced activity mainly in frontal areas. No improvement in any of the parameters was observed following the control period. The study provides evidence that HBOT can improve the symptoms and life quality of FMS patients. Moreover, it shows that HBOT can induce neuroplasticity and significantly rectify abnormal brain activity in pain related areas of FMS patients. ClinicalTrials.gov NCT01827683.

Fibromyalgia syndrome (FMS) is a chronic pain syndrome characterized by disruptions in pain processing within the central nervous system. It exhibits a high prevalence among patients with a history of traumatic experiences, notably childhood sexual abuse (CSA). This study compared the efficacy of hyperbaric oxygen therapy (HBOT) to the current pharmacological standard of care for individuals suffering from CSA-related FMS. Forty-eight participants diagnosed with FMS and a history of CSA were randomly assigned to either the HBOT group (60 sessions of 100% oxygen at 2 ATA for 90 min, with air breaks every 5 min) or the medication (MED) group (FDA-approved medications, Pregabalin and Duloxetine). The primary endpoint was the Fibromyalgia impact questionnaire (FIQ) score, while secondary endpoints encompassed emotional status and daily functioning questionnaires, as well as pain thresholds and conditioned pain modulation tests. Brain activity was evaluated through single photon emission computed tomography (SPECT). Results revealed a significant group-by-time interaction for the FIQ score favoring HBOT over MED (p < 0.001), with a large effect size (Cohen's d = − 1.27). Similar findings were observed in emotional symptoms and functional measures. SPECT imaging demonstrated an increase in activity in pre-frontal and temporal brain areas, which correlated with symptoms improvement. In conclusion, HBOT exhibited superior benefits over medications in terms of physical, functional, and emotional improvements among FMS patients with a history of CSA. This associated with increased activity in pre-frontal and temporal brain areas, highlighting the neuroplasticity effect of HBOT.