In 2019, the Health Institute Carlos III (ISCIII) assessed the effectiveness of hyperbaric oxygen therapy (HBOT) in the treatment of fibromyalgia, peripheral vascular disease, neurological disease, and others. The report was published online in 2020. The previous assessment, performed in 2018, was related to the use of HBOT in patients with Complex Regional Pain Syndrome (CRPS).
Therapy with hyperbaric oxygen is a rarely-used therapy due to the high economic cost and the lack of accessibility since there are not many centers where hyperbaric medicine is practiced.
The assessment was based on the systematic review of scientific studies evaluating the efficacy of using HBOT (clinical guidelines, randomized control trials (RCT), systematic reviews (SR), meta-analyses and health technology assessment (HTA) reports). A critical reading of the selected literature and an extraction of the most important data, as well as a synthesis of the evidence, were then carried out. Selected studies include the open baseline period to December 2018.
Eventually, ISCIII selected only 34 references were included for all indications involving RCTs, SRs, or HTA Reports. The results were summarized for each of the indications:
- Fibromyalgia: Three RCTs were included, in which significant improvements were obtained in patients in the HBOT group for the variables pain, sensitivity to pain and quality of life;
- Neurological Disease: One SR in stroke and three in RCT have been selected, but no studies related to refractory migraine have been found. In the case of stroke, SR does not show significant differences between HBOT and the usual treatment. For brain injury, the evidence is obtained in relation to the effectiveness of HBOT in improving the Glasgow scale and mortality;
- Multiple Sclerosis: An SR showing significant improvements in the disability level scale variable (EDSS) was included, but there were no differences between groups for the number of exacerbations, functional impairment, or functional scale FSS;
- Peripheral Vascular Disease: The result of screening studies allowed including one SR and two RCTs in varicose ulcers and four RCTs, two SRs, and an HTA report for the indication of diabetic foot. The results are very heterogeneous, but overall HBOT has proved to be more effective than control therapies for wound healing and amputation avoidance; although these results do not appear to be reflected in the quality of life measures that do not show significant differences, except in the pain-related dimension of any study;
- Post-Radiation Injuries: Ten RCTs were included after the screening of the identified references. The improvements were proved for patients treated with HBOT related to alveolar necrosis, the improvement of the Lent / SOMA scale to assess the effects of radiation on quality of life for dimensions of pain, physical and psychoemotional.
- The introduction of HBOT is not a substitutive treatment, but an additional co-adjuvant intervention, which significantly improves the therapeutic results in some very specific cases;
- Effectiveness was demonstrated for HBOT in treatment of:
- Fibromyalgia, because the sensitivity to pain and quality of life were improved;
- Brain injury because Glasgow Scale values and mortality were improved;
- Multiple sclerosis with restricted efficacy to the improvement of the EDSS scale and pyramidal function;
- Vascular disease with the improvement of cure and healing rates and, in some cases, amputations, whether major or minor;
- Mandibular osteonecrosis in short-term healing;
- Post-radiation injuries in bladder voiding, Lent/Soma scale and pain in the short term (3-6 months), alveolar necrosis or patients with necrosis, and some dimensions of quality of life in the long term (12 months).
- The efficacy of HBOT in the indications of refractory migraine, stroke, compartment syndromes, osteomyelitis, and soft tissue infection was not proved;
- If there are no contraindications, HBOT appears to be effective for selected individuals and with minimal margin for side effects;
- On the basis of the available evidence, HBOT is not a single first-line treatment in the pathologies studied;
- For some conditions stronger evidence (RCTs) about the efficacy of HBOT are needed to conclude the effectiveness of this method as co-adjuvant therapy for the assessed indications;
- Cost studies are very insufficient, so it is not possible to conclude whether it is cost-effective therapy.
The full details in Spanish can be found here.
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