The addition of omega-3 fish oil and a Manuka honey lozenge to the standard of care treatment for beta thalassemia improved oxidative stress markers, according to the results of a phase 2 study.
The addition also reduced hemolytic activity as indicated by a decrease in lactate dehydrogenase (LDH) levels. The study results were published in the European Review for Medical and Pharmacological Sciences.
The multicenter, double-blind study (ClinicalTrials.gov identifier: NCT04292314) randomly assigned 165 pediatric patients with beta thalassemia to receive standard of care, which included deferasirox, blood transfusion, and L-carnitine, alone or in combination with Manuka honey with or without omega-3 fish oil for 10 months. The fish oil contained 350 mg of eicosatetraenoic acid (EPA) and 250 mg of docosahexaenoic acid (DHA). The primary endpoint was F2-isoprostane status and secondary endpoints included lipid profile, C-reactive protein, serum iron, and serum ferritin levels.
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The mean age at baseline was 10.8, and 57.3% of patients were male. The median blood transfusion frequency was 8.3 sessions. F2-isoprostane, a marker of oxidative stress, was significantly decreased from baseline with the addition of omega-3 fish oil and Manuka honey with a mean change of 118 pg/mL compared with 480 pg/mL with standard of care alone or 156 pg/mL with Manuka honey (both P <.05).
The combination of omega-3, Manuka honey, and standard of care improved lipid levels. The LDL-C was 90 mg/dL compared with 58 mg/dL with standard of care alone or 76 mg/dL with standard of care plus Manuka honey (P <.05). The HDL-C increased from 39 mg/dL with standard of care alone to 40 mg/dL with the addition of Manuka honey and 44 mg/dL with the addition of omega-3 and Manuka honey (P <.05).
The greatest decrease from baseline in serum iron or ferritin levels was with Manuka honey plus the standard of care, with a change of 79 μg/dL and 659 ng/mL, respectively, compared with 84 μg/dL and 670 ng/mL, respectively, with omega-3 and manuka honey plus the standard of care or 125 μg/dL and 1310 ng/mL, respectively, with the standard of care alone (all P <.05).
CRP was also lowest with the addition of Manuka honey only at 1.2 mg/dL compared with 1.9 mg/dL with omega-3 and manuka honey and 2.6 mg/dL with standard of care only (all P <.05).
The frequency of blood transfusion decreased from a median of 7.3 sessions with standard of care to 4.5 sessions with the addition of Manuka honey and 3 sessions with the addition of omega-3 and Manuka honey (P <.05).
“Omega-3 plus Manuka honey was more effective than Manuka alone or the conventional treatment alone in managing oxidative stress of beta-thalassemic patients,” the authors concluded in their report.
Reference
Gamaleldin M, Abraham I, Meabed M, et al. Comparative effectiveness of adding omega-3 and Manuka honey combination to conventional therapy in preventing and treating oxidative stress in pediatric β-thalassemia major – a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2023;27:6058-6070. doi:10.26355/eurrev_202307_32960
