A Medical Food That Reduces Leukotriene Synthesis Improves Quality of Life in Adult Subjects With Asthma

Abstract

RationaleThe impact on quality of life (QOL) of a medical food that decreases leukotriene synthesis, Efficas Care, has not previously been evaluated in asthmatic subjects using validated QOL instruments during a randomized, double-blind, placebo-controlled trial.MethodsAdult subjects with mild to moderate persistent asthma (N = 21 ITT) were randomized to receive either the medical food emulsion (supplying 0.75 g gamma linolenic acid [GLA] and 0.5 g eicosapentaenoic acid [EPA] per serving) or placebo emulsion (50% sunflower oil) daily for 28 days in addition to using their standard medications. QOL was evaluated with the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and Asthma Control Questionnaire (ACQ), at baseline and 4 weeks. Fatty acid levels were analyzed at baseline and weeks 2 and 4 to determine the bioavailability of the medical food's active ingredients as well as compliance, and leukotriene concentrations were measured at baseline and 4 weeks.ResultsQOL scores, FEV1 and other baseline characteristics did not differ across groups. Mean total MiniAQLQ scores at 4 weeks changed by 0.73 ± 0.38 and −0.22 ± 0.36 in the active and placebo groups respectively, (p < 0.04). The MiniAQLQ symptom domain score was improved (p < 0.04) and rescue bronchodilator use decreased (p < 0.02) in the active group compared to placebo.ConclusionsA significant improvement in the asthma-related QOL was observed for subjects with asthma when the medical food Efficas Care was taken daily for 4 weeks, as part of the overall asthma treatment regimen. RationaleThe impact on quality of life (QOL) of a medical food that decreases leukotriene synthesis, Efficas Care, has not previously been evaluated in asthmatic subjects using validated QOL instruments during a randomized, double-blind, placebo-controlled trial. The impact on quality of life (QOL) of a medical food that decreases leukotriene synthesis, Efficas Care, has not previously been evaluated in asthmatic subjects using validated QOL instruments during a randomized, double-blind, placebo-controlled trial. MethodsAdult subjects with mild to moderate persistent asthma (N = 21 ITT) were randomized to receive either the medical food emulsion (supplying 0.75 g gamma linolenic acid [GLA] and 0.5 g eicosapentaenoic acid [EPA] per serving) or placebo emulsion (50% sunflower oil) daily for 28 days in addition to using their standard medications. QOL was evaluated with the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and Asthma Control Questionnaire (ACQ), at baseline and 4 weeks. Fatty acid levels were analyzed at baseline and weeks 2 and 4 to determine the bioavailability of the medical food's active ingredients as well as compliance, and leukotriene concentrations were measured at baseline and 4 weeks. Adult subjects with mild to moderate persistent asthma (N = 21 ITT) were randomized to receive either the medical food emulsion (supplying 0.75 g gamma linolenic acid [GLA] and 0.5 g eicosapentaenoic acid [EPA] per serving) or placebo emulsion (50% sunflower oil) daily for 28 days in addition to using their standard medications. QOL was evaluated with the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and Asthma Control Questionnaire (ACQ), at baseline and 4 weeks. Fatty acid levels were analyzed at baseline and weeks 2 and 4 to determine the bioavailability of the medical food's active ingredients as well as compliance, and leukotriene concentrations were measured at baseline and 4 weeks. ResultsQOL scores, FEV1 and other baseline characteristics did not differ across groups. Mean total MiniAQLQ scores at 4 weeks changed by 0.73 ± 0.38 and −0.22 ± 0.36 in the active and placebo groups respectively, (p < 0.04). The MiniAQLQ symptom domain score was improved (p < 0.04) and rescue bronchodilator use decreased (p < 0.02) in the active group compared to placebo. QOL scores, FEV1 and other baseline characteristics did not differ across groups. Mean total MiniAQLQ scores at 4 weeks changed by 0.73 ± 0.38 and −0.22 ± 0.36 in the active and placebo groups respectively, (p < 0.04). The MiniAQLQ symptom domain score was improved (p < 0.04) and rescue bronchodilator use decreased (p < 0.02) in the active group compared to placebo. ConclusionsA significant improvement in the asthma-related QOL was observed for subjects with asthma when the medical food Efficas Care was taken daily for 4 weeks, as part of the overall asthma treatment regimen. A significant improvement in the asthma-related QOL was observed for subjects with asthma when the medical food Efficas Care was taken daily for 4 weeks, as part of the overall asthma treatment regimen.