HOTFy: ensaio clínico randomizado sobre a eficácia da oxigenoterapia hiperbárica no tratamento da fibromialgia e análise de custo-efetividade da tecnologia

Abstract

Introduction: Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain and associated multisystem symptoms, including fatigue, sleep disturbances, and neuropsychiatric manifestations. It affects approximately 2.5% of the Brazilian population and significantly impacts functional capacity, work productivity, and healthcare utilisation. Although multimodal management is the current standard of care, many patients experience persistent symptoms, warranting investigation of adjunctive interventions such as hyperbaric oxygen therapy (OHB). OHB may modulate inflammatory and immunological pathways involved in fibromyalgia-associated neuroinflammation, and its economic value also warrants evaluation. Objectives: To evaluate the clinical impact of OHB on somatic and neuropsychiatric symptoms of fibromyalgia and to assess its economic feasibility as an adjunctive therapeutic strategy. Methods: This study, approved by a Research Ethics Committee and registered in the Brazilian Registry of Clinical Trials, integrated clinical outcomes from the HOTFy randomised clinical trial into a cost-effectiveness analysis. Standard multimodal treatment alone was compared with standard treatment combined with OHB in 56 participants with fibromyalgia. Assessments conducted at weeks 8 and 16 employed validated instruments to measure disease impact (FIQR-Br), psychopathological symptoms (EAS-40), and health-related quality of life (SF12), alongside appropriate statistical analyses and deterministic, univariate sensitivity analyses. Results: The addition of OHB to standard treatment resulted in statistically significant and clinically meaningful improvements in functional and symptomatic outcomes, as well as a reduction in the overall impact of fibromyalgia. Exploratory analyses suggested greater benefit when the intervention was initiated earlier. The economic evaluation demonstrated a favourable incremental cost-effectiveness ratio, remaining below the acceptability thresholds adopted in Brazil. Conclusions: Hyperbaric oxygen therapy was a clinically effective and cost-effective adjunct for treating fibromyalgia, supporting its consideration for inclusion in multimodal therapeutic strategies within healthcare systems.