Jacqueline Díaz-Luis MD MS, Silvia Menéndez-Cepero PhD, Consuelo Macías-Abraham MD PhD, Lucía Fariñas-Rodríguez MS
INTRODUCTION IgA defi ciency is a primary immunodeficiency predominantly due to an antibody defect, for which there is no replacement therapy. Treatment consists of prevention and treatment of infections and other associated conditions. Given the immunomodulatory and regulatory properties of the redox balance of ozone therapy in infectious and infl ammatory conditions, evaluation of its effect on IgA defi ciency is of interest.
OBJECTIVE Assess the benefits and possible adverse effects of ozone treatment in patients with IgA deficiency.
METHODS A mono centric randomized controlled phase 2 clinical trial (RPCEC 00000236) was carried out, after approval by the Institutional Ethics Committee of the Roberto Rodríguez Fernández Provincial General Teaching Hospital in Morón, Ciego de Ávila Province, Cuba.
Included were 40 patients aged 5–50 years, distributed in 2 groups of 20, after agreeing to participate and signing informed consent. The experimental group received 2 cycles of ozone by rectal insufflation for 20 days (5 times a week for 4 weeks each cycle) with a 3-month interval between cycles, for a total of 40 doses, with age-adjusted dose
ranges. The control group was treated with leukocyte transfer factor (Hebertrans), 1 U per m2 of body surface area subcutaneously, once weekly for 12 weeks. Frequency of appearance and severity of clinical symptoms and signs of associated diseases, serum immunoglobulin concentrations and balance of pro-oxidant and antioxidant biomarkers
were recorded at treatment initiation and one month after treatment completion. Therapeutic response was defined as complete, partial, stable disease or progressive disease. Descriptive statistics and significance were calculated to compare groups and assess effect size.
RESULTS One month after treatment completion, 70% of patients in the experimental group experienced significant increases in IgG (p = 0.000) and IgM (p = 0.033). The experimental group also displayed decreased pro-oxidation biomarkers, glutathione modulation and increased antioxidant enzymes, with reduced oxidative stress; none of
these occurred in the control group. Complete therapeutic response was achieved in 85% of patients in the experimental group and only 45% in the control group. Mild, transient adverse events were reported in both groups.
CONCLUSIONS Ozone therapy by rectal insufflation is a suitable therapeutic option for treating IgA deficiency because it produces antioxidant and immunomodulatory effects and is feasible, safe and minimally invasive.
KEYWORDS Ozone therapy, IgA defi ciency, primary immunodeficiency, oxidative stress, antioxidants, pro-oxidants, Cuba
CONTRIBUTION OF THIS RESEARCH This paper introduces in Cuba a new treatment a for IgA deficiency, with immunomodulatory and antioxidant effects offering substantial clinical benefits to patients with this immunodeficiency.
Jacqueline Díaz-Luis (Corresponding author: firstname.lastname@example.org), physician specializing in immunology, with a master’s degree in infectious diseases, doctoral candidate. Associate professor and researcher Roberto Rodríguez
Fernández Provincial General Teaching Hospital, Morón, Cuba.
Silvia Menéndez-Cepero, chemist. Senior researcher, National Scientific Research Center, Havana, Cuba.
Consuelo Macías-Abraham, physician specializing in immunology, with a doctorate in medical sciences. Full professor and senior researcher, Hematology and Immunology Institute, Havana, Cuba.
Lucía Fariñas-Rodríguez, biologist with a master’s degree in anthropology. Adjunct professor and head, Oxidative Stress Laboratory, National Medical Genetics Center, Havana, Cuba.