Catherine Cornu1,2,3,4, Catherine Mercier5,6,7, Tiphanie Ginhoux8, Sandrine Masson8, Julie Mouchet5, Patrice Nony9,10, Behrouz Kassai8,9,10, Valérie Laudy8, Patrick Berquin11, Nathalie Franc12, Marie-France Le Heuzey13, Hugues Desombre14, Olivier Revol15. 1. INSERM, CIC1407, 69500, Bron, France. catherine.cornu@chu-lyon.fr. 2. Laboratoire de Biométrie et Biologie Evolutive, CNRS, UMR 5558, Equipe EME, 69100, Lyon, France. catherine.cornu@chu-lyon.fr. 3. Service de Pharmacologie Clinique, Hospices Civils de Lyon, 69500, Bron, France. catherine.cornu@chu-lyon.fr. 4. Centre d'Investigation Clinique - Hôpital Louis Pradel, 28, Avenue du Doyen Lépine, 69500, Bron, France. catherine.cornu@chu-lyon.fr. 5. Université Claude Bernard Lyon 1, 69100, Lyon, France. 6. Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, 69003, Lyon, France. 7. Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, CNRS, UMR 5558, 69100, Villeurbanne, France. 8. INSERM, CIC1407, 69500, Bron, France. 9. Laboratoire de Biométrie et Biologie Evolutive, CNRS, UMR 5558, Equipe EME, 69100, Lyon, France. 10. Service de Pharmacologie Clinique, Hospices Civils de Lyon, 69500, Bron, France. 11. Service de Neurologie Pédiatrique, Hôpital Nord, 80054, Amiens, France. 12. Service de Médecine Psychologique Enfants et Adolescents, Hôpital Saint-Eloi, 34295, Montpellier, France. 13. Service de psychiatrie de l'enfant et de l'adolescent, Hôpital Robert Debré, 75935, Paris, France. 14. Unité de Psychologie Médicale et de Liaison, Hôpital femme-Mère-Enfant, 69500, Bron, France. 15. Service de Psychopathologie de l'enfant et de l'adolescent, Hôpital Pierre Wertheimer, 69500, Bron, France.
Abstract
OBJECTIVE: Clinical trials and inconclusive meta-analyses have investigated the effects of omega-3 supplements in children with Attention-Deficit Hyperactivity Disorder (ADHD). We performed a randomised placebo-controlled trial to evaluate the efficacy of omega-3 fatty acids. METHODS:Children aged 6-15 years with established diagnosis of ADHD were randomised 1:1 to receive either supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or a placebo for 3 months. Psychotropic or omega-3-containing treatments were not authorised during the study. The primary outcome was the change in the Attention-Deficit Hyperactivity Disorder Rating Scale version 4 (ADHD-RS-IV). Other outcomes included safety, lexical level (Alouette test), attention (Test of Attentional Performance for Children-KiTAP), anxiety (48-item Conners Parent Rating Scale-Revised-CPRS-R), and depression (Children's Depression Inventory-CDI). RESULTS:Between 2009 and 2011, 162 children were included in five French child psychiatry centres. The mean age was 9.90 (SD 2.62) years and 78.4% were boys. The inclusion ADHD-RS-IV at was 37.31 (SD 8.40). The total ADHD-RS-IV score reduction was greater in the placebo group than in the DHA-EPA group: -19 (-26, -12) % and -9.7 (-16.6, -2.9) %, respectively, p = 0.039. The other components of the Conners score had a similar variation but the differences between groups were not significant. Two patients in the DHA-EPA group and none in the placebo group experienced a severe adverse event (hospitalisation for worsening ADHD symptoms). CONCLUSION: This study did not show any beneficial effect of omega-3 supplement in children with mild ADHD symptoms.
RCT Entities:
OBJECTIVE: Clinical trials and inconclusive meta-analyses have investigated the effects of omega-3 supplements in children with Attention-Deficit Hyperactivity Disorder (ADHD). We performed a randomised placebo-controlled trial to evaluate the efficacy of omega-3 fatty acids. METHODS:Children aged 6-15 years with established diagnosis of ADHD were randomised 1:1 to receive either supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or a placebo for 3 months. Psychotropic or omega-3-containing treatments were not authorised during the study. The primary outcome was the change in the Attention-Deficit Hyperactivity Disorder Rating Scale version 4 (ADHD-RS-IV). Other outcomes included safety, lexical level (Alouette test), attention (Test of Attentional Performance for Children-KiTAP), anxiety (48-item Conners Parent Rating Scale-Revised-CPRS-R), and depression (Children's Depression Inventory-CDI). RESULTS: Between 2009 and 2011, 162 children were included in five French child psychiatry centres. The mean age was 9.90 (SD 2.62) years and 78.4% were boys. The inclusion ADHD-RS-IV at was 37.31 (SD 8.40). The total ADHD-RS-IV score reduction was greater in the placebo group than in the DHA-EPA group: -19 (-26, -12) % and -9.7 (-16.6, -2.9) %, respectively, p = 0.039. The other components of the Conners score had a similar variation but the differences between groups were not significant. Two patients in the DHA-EPA group and none in the placebo group experienced a severe adverse event (hospitalisation for worsening ADHD symptoms). CONCLUSION: This study did not show any beneficial effect of omega-3 supplement in children with mild ADHD symptoms.
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