Cost-effectiveness analysis of Manuka honey-Omega-3 combination treatments in treating oxidative stress of pediatric ß-thalassemia major.

OBJECTIVE: Oxidative stress represents a ruthless complication of ß-thalassemia that worsens the severity of that medical condition. There is no conclusive evidence on the best antioxidant used for that issue. Our earlier clinical study concluded that omega-3 and Manuka honey add-on to the conventional therapy had a potential therapeutic impact on reducing oxidative stress. However, there is no research evaluating their cost-effectiveness. This paper compares the cost-effectiveness of Omega-3 and Manuka honey supplementation to conventional therapy in treating oxidative stress among children with ß-thalassemia major. SUBJECTS AND METHODS: Cost-effectiveness evaluation of daily supplementation of Omega-3-Manuka honey and Manuka honey alone to the conventional therapy was performed. The economic evaluation was performed on data from a prospective 10-month randomized clinical trial. Fifty patients were recruited into the Omega-3-Manuka honey plus conventional therapy group, 50 patients were included in the Manuka honey alone plus conventional therapy group, and 50 patients receiving the conventional therapy alone served as a control group. Effectiveness measures from the randomized clinical trial were used to determine incremental effectiveness. Cost estimates were calculated from the healthcare payer's perspective. The analysis considered the improvement in oxidative stress biomarkers presented here as a percent change from baseline to determine the incremental effectiveness and cost for the treatment by both interventions. RESULTS: Adding Omega-3 or Manuka honey to conventional therapy was a more cost-effective add-on than conventional treatment alone. Omega-3-Manuka honey was more cost-effective than Manuka honey alone in treating oxidative stress in that condition. Oxidative stress biomarkers were significantly reduced with both experimental medications compared to the conventional therapy alone. CONCLUSIONS: The present study showed that using Manuka honey and Omega-3 as add-on treatments for oxidative stress in pediatric ß-thalassemia disease could have significant cost-saving and clinical improvement.

Comparative effectiveness of adding omega-3 and Manuka honey combination to conventional therapy in preventing and treating oxidative stress in pediatric ß-thalassemia major - a randomized clinical trial.

OBJECTIVE: ß-thalassemia major is an inherited hematological disorder with significant oxidative stress and iron overload. Oxidative stress results in several pathological complications, including cell death, tissue injury, organ dysfunction, and thyroid dysfunction. The present study examined the effectiveness of omega-3 and Manuka honey combination or Manuka honey alone to the conventional therapy (deferasirox, blood transfusion, and L-carnitine) used for preventing and managing oxidative stress or iron overload-induced oxidative stress conditions in pediatric ß-thalassemic patients (type major). PATIENTS AND METHODS: 165 patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design multisite trial. The patients were randomly allocated into three groups, receiving either 1,000 mg omega-3 fish oil [350 mg eicosapentaenoic acid (EPA) and 250 mg docosahexaenoic acid (DHA)] combined with Manuka honey lozenge (344 mg) daily or Manuka honey alone plus the conventional therapy for ten months. Plasma 8-iso-prostaglandin F2α (8-iso-PGF2α), Lactate dehydrogenase (LDH), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), CRP (C-reactive protein), ferritin level, and serum iron were determined at baseline and month 10. RESULTS: Omega-3 and Manuka honey combination were a significant add-on to conventional therapy of ß-thalassemia in reducing the oxidative stress condition. The combination of Omega-3 and Manuka honey reduced the level of F2-isoprostane(8-iso-PGF2α) significantly compared to the Manuka alone and the control groups. Additionally, they showed an antihemolytic action measured by reduced LDH level. The combination restored the patient's lipid profile (LDL-C and HDL-C) significantly compared to the control group. Manuka honey enhanced the action of omega-3 in reducing oxidative stress by reducing serum iron significantly compared to the control group. CONCLUSIONS: Results showed that omega-3 + Manuka honey was more effective than Manuka alone or the conventional treatment alone in managing oxidative stress of ß-thalassemic patients.

Cost-effectiveness analysis of adding omega-3 or vitamin D supplementation to standard therapy in treating painful crises of pediatric sickle cell disease patients.

OBJECTIVE: Painful crises represents a predominant complication of sickle cell disease (SCD). The only approved treatments for painful crises in many countries are hydroxyurea plus potent analgesics. Our earlier clinical trial concluded that omega-3 and vitamin D had a potential therapeutic impact on painful crises. However, there is limited research evaluating their therapeutic applications and cost-effectiveness. This paper aims at comparing the cost-effectiveness of omega-3 and vitamin D supplementation to the standard therapy in treating painful crises among children with SCD. PATIENTS AND METHODS: Cost-effectiveness analyses of daily supplementation of omega-3 and vitamin D were performed. The economic evaluation was based on data derived from a prospective 10-month randomized clinical trial (n = 165 patients; 15 patients dropped). 50 patients were recruited into the omega-3 + standard therapy group (hydroxyurea and folic acid daily with ibuprofen as needed), 50 patients into the vitamin D + standard therapy group, and 50 patients receiving standard therapy alone served as a control group. Outcome measures from the randomized clinical trial were used to determine incremental effectiveness. Cost estimates were calculated from the healthcare payer's perspective. The analysis considered the improvement in various outcome measures and are presented here as percent change from baseline to determine the incremental effectiveness and the incremental cost for the treatment of both interventions. RESULTS: Adding omega-3 or vitamin D to the standard therapy was more cost-effective than standard treatment alone. Vitamin D was a cheaper but less cost-effective alternative for most outcomes between the two treatments, including LDL-C and HDL-C. It was also more cost-effective but less clinically effective in reducing vaso-occlusive crisis episodes and pain severity. Omega-3 supplementation was significantly more cost-effective than vitamin D supplementation and the standard treatment for those measures. CONCLUSIONS: The present study showed that using vitamin D and omega-3 as add-on treatments for a painful crisis in pediatric sickle cell disease could have overall cost-saving and clinical benefits. However, further studies with a longer treatment duration are needed to establish more significant effects of the interventions for better policy and clinical decision-making.

Comparative effectiveness of adding Omega-3 or Vitamin D to standard therapy in preventing and treating episodes of painful crisis in pediatric sickle cell patients.

OBJECTIVE: Sickle Cell Anemia (SCA), also called the Sickle Cell Disease (SCD), is an inherited hematological disorder characterized by a syndrome of acute anemia and a painful crisis. The sickling hemoglobin, Hgb-S causes viscosity and inflammation of blood vessels. Eventually, the red blood cells get eliminated from the circulation process, which leads to hemolytic anemia. This study examined the comparative effectiveness of supplementation of Omega-3 or vitamin-D to standard therapy (hydroxyurea + Ibuprofen) used for prevention and treatment of pain crises in pediatric patients living with SCD. PATIENTS AND METHODS: 165 patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design trial. The patients were randomly divided into three groups, receiving three capsules of either 1,000 mg Omega-3 fish oil (400 mg EPA and 300 mg DHA) or 1.5 mL vitamin-D (2,800 IU/7 ml) daily for 10 months plus the standard therapy. Lactate dehydrogenase, high-density lipoprotein (HDL), low-density lipoprotein (LDL), hematocrit, reticulocyte count, and white-blood-cell count were determined at baseline (month zero) and end of the 10th month. The pain severity was measured using the visual analog scale method (VAS). Therefore, a 10-cm ruler with a VAS design was used to determine the patient pain intensity. The baseline time point was defined as the time spot before starting to deliver the experimental medication to the patients (month zero). At that time, the biodata of the patient on the frequency of pain episodes and the rest of the variables were collected, and the baseline data were one-year retrospective data. RESULTS: Of 165 patients enrolled in the trial, 150 were included in the final analysis. At the end of the study, there was a significant increase in serum LDL and HDL in the Omega-3 group as compared with the control group (mean of 82 mg/dL vs. 57 mg/dL; p < 0.01 and mean of 47 mg/dL vs. 43 mg/dL; p < 0.028, respectively). Other laboratory parameters were significantly influenced. The number of painful crises and pain levels was significantly decreased in the Omega-3 group compared with the control group (mean of one-episode vs. mean of three episodes; p = 0.01, mean of three on pain scale vs. six on pain scale; p = 0.018). CONCLUSIONS: Results showed that Omega-3 was more effective than vitamin-D or standard treatment alone relative to pain crises and most of the other studied items. Vitamin-D was more effective than standard therapy alone. Clinicians should consider the addition of Omega-3 supplements to the standard therapy and a de-escalation dose plan for the hydroxyurea medication.