Cost-effectiveness of adjunctive hyperbaric oxygen therapy for fibromyalgia: an economic evaluation alongside a single-centre randomised controlled trial in Brazil
Year: 2026
Type: article
Abstract: Background Fibromyalgia is a chronic, polysymptomatic syndrome associated with widespread pain, fatigue, functional impairment and a substantial economic burden. Hyperbaric oxygen therapy has demonstrated neuromodulatory, anti-inflammatory and neuroplastic effects in clinical and preclinical studies; however, no prior evaluation has examined its cost-effectiveness in the treatment of fibromyalgia. Objective To assess the cost-effectiveness of hyperbaric oxygen therapy as an adjunct to standardised clinical care for fibromyalgia in Brazil, using data from a randomised clinical trial and deterministic economic model. Design, setting and participants A cost-effectiveness evaluation was conducted alongside a single-centre, assessor-blinded, sequential-group, randomised clinical trial at the Department of Rheumatology at Juiz de Fora Federal University in Brazil, applying a 4-month decision-tree model and deterministic sensitivity analyses. The subjects were 56 women aged 18 to 70 years with a diagnosis of fibromyalgia according to the 2016 revisions of the American College of Rheumatology criteria. The intention-to-treat analysis included all participants. Interventions Standardised clinical management combined with hyperbaric oxygen therapy at 2.3 atmospheres absolute for 90 min, 5 sessions per week for 32 to 40 sessions. The early start group received the intervention during weeks 0–8, and the delayed start group during weeks 8–16. Outcomes Direct medical and non-medical costs: quality-adjusted life-years derived from utilities obtained through deterministic mapping of the 12-Item Short-Form Health Survey to the European Quality of Life 5 Dimensions instrument using Brazilian valuation weights. Results At 8 weeks, the mean total costs were US$1068.46 for standardised care and US$2477.59 for hyperbaric oxygen therapy, with utilities of 0.477 and 0.630, respectively. The incremental cost was US$1409.13 for a gain of 0.153 quality-adjusted life-years, yielding an incremental cost-effectiveness ratio of US$9210 per quality-adjusted life-year. At 16 weeks, the costs increased to US$2136.93 for standardised care and US$3546.06 for hyperbaric oxygen therapy, with utilities of 0.477 and 0.642, respectively. The incremental cost-effectiveness ratio improved to US$8540 per quality-adjusted life-year, reflecting an incremental gain of 0.165 quality-adjusted life-years. Both incremental cost-effectiveness ratios were below the Brazilian willingness-to-pay threshold of US$9315 per quality-adjusted life-year, although the 8-week estimate was only marginally below this threshold. Deterministic sensitivity analyses confirmed robustness, with treatment costs and utility gains exerting the most significant influence on model outcomes. Conclusions Within the assumptions of this deterministic analysis, hyperbaric oxygen therapy added to standardised clinical management met the Brazilian cost-effectiveness criterion for fibromyalgia from the healthcare provider perspective, although it was not a dominant strategy and the 8-week estimate was close to the applied threshold. Multicentre evaluations incorporating directly measured utilities, probabilistic modelling and longer time horizons are warranted. Ethics and dissemination The study was approved by the institutional ethics committee and assigned the number 53058421.9.0000.5133 (Version 4). Trial registration number This study was registered in the Brazilian Registry of Clinical Trials under RBR-6prps8g, with a Universal Trial Number of U1111-1278-3224.
Source: BMJ Open
Institution: Universidade Federal de Juiz de Fora
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W7223255202