RCT 2015
From the library

Hyperbaric oxygen therapy can diminish fibromyalgia syndrome — prospective clinical trial

Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M, Buskila D

PLoS ONE n = 60 2 ATA 40 sessions
Plain English

Efrati et al. (2015, PLoS ONE) is a prospective, active-control crossover trial of HBOT for fibromyalgia syndrome (FMS) in 60 female patients aged 21–67 who had been diagnosed with FMS for at least 2 years. The first-author misattribution to Boussi-Gross in the slug is a legacy of an earlier, fuzzier site copy; the actual first author is Efrati S, and the published author list does not include Boussi-Gross at all. What the trial measured. The study used a deliberate crossover design with the control arm switching into HBOT after the comparator period, so each patient could serve as their own control. Primary outcomes were dolorimeter-measured pain thresholds, tender-point counts, and standardized life-quality scales (FMS questionnaire, SCL-90, SF-36). The objective backbone was SPECT brain imaging, included specifically to rule out a self-report-only effect. Protocol parameters. 40 sessions at 2.0 ATA, 100% oxygen, 90-minute sessions, 5 days per week — the same protocol shape used in the Israeli group's Efrati 2013 stroke and Boussi-Gross 2013 TBI trials, allowing cross-trial mechanism comparison. Results (verbatim from abstract). The dolorimeter threshold tripled following HBOT (rising from approximately 0.5 to 1.5). Tender-point count reduced by a factor of 2 in the treated group and a factor of 3 in the crossover group. Life-quality scores improved significantly across the FMS, SCL-90, and SF-36 instruments. SPECT analysis showed rectification of abnormal brain activity — decreased hyperactivity mainly in posterior regions, and elevation of reduced activity mainly in frontal areas. The control (no-treatment) period produced no improvement on any parameter, providing a within-trial null comparator. Limitations. All-female cohort (FMS has a 9:1 female-to-male incidence ratio, but the trial does not directly extend to male patients). Sample size (n=60) is modest. The 2.0 ATA protocol requires a clinical chamber; soft-shell home chambers cannot replicate it. Long-term durability beyond the protocol's immediate post-treatment window was not the focus of this paper. What it means in practice. For the Saturate Lyme & Chronic Fatigue condition page, this trial is the closest verified analog to HBOT for chronic-fatigue-cluster conditions. There is no published HBOT-for-Lyme RCT — Efrati 2015 fibromyalgia is the strongest available proxy because fibromyalgia is a frequent comorbid or differential diagnosis in the chronic Lyme population, and the underlying mitochondrial / neuroinflammatory / microcirculatory mechanisms overlap. Source: PubMed PMID 26010952.

Key findings

What the trial documented.

  • Dolorimeter pain threshold tripled following the HBOT protocol
  • Tender point count reduced by a factor of 2 in the treated group and a factor of 3 in the crossover group
  • Significant improvement in life-quality measures (FMS, SCL-90, SF-36)
  • SPECT imaging showed rectification of abnormal brain activity — decreased hyperactivity in posterior regions, elevated activity in frontal regions
  • No improvement in any parameter during the control (no-treatment) period

Efrati et al. (2015, PLoS ONE) is a prospective, active-control crossover trial of HBOT for fibromyalgia syndrome (FMS) in 60 female patients aged 21–67 who had been diagnosed with FMS for at least 2 years. The first-author misattribution to Boussi-Gross in the slug is a legacy of an earlier, fuzzier site copy; the actual first author is Efrati S, and the published author list does not include Boussi-Gross at all.

What the trial measured. The study used a deliberate crossover design with the control arm switching into HBOT after the comparator period, so each patient could serve as their own control. Primary outcomes were dolorimeter-measured pain thresholds, tender-point counts, and standardized life-quality scales (FMS questionnaire, SCL-90, SF-36). The objective backbone was SPECT brain imaging, included specifically to rule out a self-report-only effect.

Protocol parameters. 40 sessions at 2.0 ATA, 100% oxygen, 90-minute sessions, 5 days per week — the same protocol shape used in the Israeli group’s Efrati 2013 stroke and Boussi-Gross 2013 TBI trials, allowing cross-trial mechanism comparison.

Results (verbatim from abstract). The dolorimeter threshold tripled following HBOT (rising from approximately 0.5 to 1.5). Tender-point count reduced by a factor of 2 in the treated group and a factor of 3 in the crossover group. Life-quality scores improved significantly across the FMS, SCL-90, and SF-36 instruments. SPECT analysis showed rectification of abnormal brain activity — decreased hyperactivity mainly in posterior regions, and elevation of reduced activity mainly in frontal areas. The control (no-treatment) period produced no improvement on any parameter, providing a within-trial null comparator.

Limitations. All-female cohort (FMS has a 9:1 female-to-male incidence ratio, but the trial does not directly extend to male patients). Sample size (n=60) is modest. The 2.0 ATA protocol requires a clinical chamber; soft-shell home chambers cannot replicate it. Long-term durability beyond the protocol’s immediate post-treatment window was not the focus of this paper.

What it means in practice. For the Saturate Lyme & Chronic Fatigue condition page, this trial is the closest verified analog to HBOT for chronic-fatigue-cluster conditions. There is no published HBOT-for-Lyme RCT — Efrati 2015 fibromyalgia is the strongest available proxy because fibromyalgia is a frequent comorbid or differential diagnosis in the chronic Lyme population, and the underlying mitochondrial / neuroinflammatory / microcirculatory mechanisms overlap.

Source: PubMed PMID 26010952.

Protocol used

2.0 ATA, 100% oxygen, 90-minute sessions, 5 days/week for 40 sessions

Full citation

Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M, Buskila D. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome — prospective clinical trial. PLoS ONE. 2015.