Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study
Borrelli E, Diadori A, Zalaffi A, et al. International Journal of Ophthalmology, 2012.
- Study type
- Randomized controlled trial
- People studied
- 140 people
- Population
- Patients with dry age-related macular degeneration
- Published
- 2012, International Journal of Ophthalmology
- Identifiers
- PMID 23275905, DOI 10.3980/j.issn.2222-3959.2012.06.11
What the authors reported
An open randomized trial of 140 patients compared 27 major ozonated autohemotherapy sessions over 12 months with multivitamins. The primary outcome, mean logMAR acuity change, did not differ significantly between groups (Table 3a). The abstract reports no acuity loss in treated eyes against 16% and 40% of controls losing 2 or more lines at 6 and 12 months, and higher plasma antioxidant potential.
What limits this result
An open trial: by the authors' own description, neither the patients nor the investigator were blinded. The paper's Table 3a marks every comparison of the primary logMAR outcome as not significant, which the abstract does not mention; the line-loss percentages in the abstract are a secondary outcome. The senior author, Velio Bocci, was a leading proponent of ozone therapy.
Other ozone methods, such as major autohemotherapy, that clinics cite in support of EBO2. A result for one method does not transfer automatically to another. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.
How the study was done
- Design
- Single-center, randomized, open, controlled trial
- Setting
- Department of Surgery and Bioengineering, Policlinico Le Scotte, University of Siena, Siena, Italy
- Read from
- Read from the full text of the paper. Read on September 28, 2026.
Study arms
| Group | Participants | What they received |
|---|---|---|
| Experimental group (ozone) | 70 | Major ozonated autohemotherapy (O3-AHT) |
| Control group | 70 | Standard multivitaminic therapy |
Source: Full text on PubMed Central
Procedure as reported
- Ozone concentration
- 50 micrograms/mL gas
A corresponding volume (225mL) of gas was immediately added with an O3 concentration of 50 micrograms/mL gas.
- Blood volume
- 225mL of blood
225mL of blood were drawn by vacuum from an antecubital vein into a sterile glass bottle
- Session length
- The whole procedure approximately 40 minutes (reinfusion about 15-20 minutes)
- Sessions
- Out-patient, twice weekly for the first 7 weeks; twice monthly for a further three months; then monthly until the 12th month
- Anticoagulant
- 25mL of 3.8% Na citrate solution (blood/citrate volume ratio 9:1)
in which 25mL of 3.8% Na citrate solution (Galenica Senese Industries, Siena, Italy) as an anticoagulant, had been previously added so that the blood/citrate volume ratio was 9:1.
In the paper's own units, not converted.
Source: Full text on PubMed Central
What it measured
- Change in best corrected visual acuity, mean logMAR (primary outcome), at 6 months
- Treated group improved by 0.1; control group impaired by 0.2, relative to baseline
- Table 3a note on logMAR changes versus baseline
- Reported as not significant (NS) for all intergroup and intragroup comparison
- Eyes gaining 1 or more lines of visual acuity
- Treated group 4% at 6 months and 25% at 12 months versus 0% in the eyes which received no treatment; P<0.05 at 12 months
Four percent and twenty-five percent of eyes in the group treated with O(3)-AHT gained 1 or more lines after 6 and 12 months respectively compared to 0% in the eyes which received no treatment (P<0.05 at 12 months).
- Treated group: loss of visual acuity in the study eye
- None of the treated patients experienced a loss at 6 and 12 months
- Control group: patients who lost 2 lines or more of visual acuity
- 16% at 6 months and 40% at 12 months; P<0.05 treated versus control group
- Reactive Oxygen Metabolites, treated group, 12 months versus baseline
- 300±10.1 UCARR at 12 months compared to a baseline value of 380±10.4 UCARR; P<0.05
- Biological Antioxidant Potential plasma values, treated group, 12 months versus baseline
- 2100±34.8 micromoles/ C vitamin after 12 months compared to a baseline value of 1610±36.2; P<0.05
- Routine haematochemical laboratory parameters at baseline, 6 and 12 months
- Ozone therapy did not cause significant modifications of the critical parameters measured
Safety as reported
Only temporary face redness in a small percentage of the patients (3%) during treatment
Source: Full text on PubMed Central
Follow-up
Visual acuity compared at baseline, 6 and 12 months; 12 months was the end point of the studyPrimary outcome was the change in best corrected visual acuity (mean logMar change) between the baseline and 6 and 12 months, end point of the study.
Source: Abstract on PubMed
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