A Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acids in Tourette's Disorder

NYU Child Study Center, NYU School of Medicine, New York, New York, USA.
PEDIATRICS (Impact Factor: 5.47). 05/2012; 129(6):e1493-500. DOI: 10.1542/peds.2011-3384
Source: PubMed


Clinical observations have suggested therapeutic effects for ω-3 fatty acids (O3FA) in Tourette's disorder (TD), but no randomized, controlled trials have been reported. In a placebo-controlled trial, we examined the efficacy of O3FA in children and adolescents with TD.
Thirty-three children and adolescents (ages 6-18) with TD were randomly assigned, double-blind, to O3FA or placebo for 20 weeks. O3FA consisted of combined eicosapentaenoic acid and docosahexaenoic acid. Placebo was olive oil. Groups were compared by using (1) intent-to-treat design, with the last-observation-carried-forward controlling for baseline measures and attention-deficit/hyperactivity disorder via (a) logistic regression, comparing percentage of responders on the primary Yale Global Tic Severity Scale (YGTSS)-Tic and secondary (YGTSS-Global and YGTSS-Impairment) outcome measures and (b) analysis of covariance; and (2) longitudinal mixed-effects models.
At end point, subjects treated with O3FA did not have significantly higher response rates or lower mean scores on the YGTSS-Tic (53% vs 38%; 15.6 ± 1.6 vs 17.1 ± 1.6, P > .1). However, significantly more subjects on O3FA were considered responders on the YGTSS-Global measure (53% vs 31%, P = .05) and YGTSS-Impairment measure (59% vs 25%, P < .05), and mean YGTSS-Global scores were significantly lower in the O3FA-treated group than in the placebo group (31.7 ± 2.9 vs 40.9 ± 3.0, P = .04). Obsessive-compulsive, anxiety, and depressive symptoms were not significantly affected by O3FA. Longitudinal analysis did not yield group differences on any of the measures.
O3FA did not reduce tic scores, but it may be beneficial in reduction of tic-related impairment for some children and adolescents with TD. Limitations include the small sample and the possible therapeutic effects of olive oil.

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    • "e Nonblinded f Non-placebo controlled; controlled with methylphenidate pharmacotherapy g Non-placebo controlled; controlled with LA (linoleic acid) 1467 mg h Statistically significant Study Type N Daily dose/length Outcome a Statistic a Serum data [35] Gabbay et al., 2012 "
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    ABSTRACT: No child psychiatric disorder has a single treatment that is completely satisfactory. Combinations are sometimes more beneficial than single treatments. This is well established for medication + behavioral treatment for depression and ADHD. There is wide variability in the evidence base for various treatments, from FDA-approved RCTs to open pilots. In the search for additional or alternative treatments, essential fatty acids seem especially to pass the SECS criterion: a treatment that is safe, easy, cheap, and sensible does not need as much evidence to justify patient trials as one that is risky, unrealistic, difficult, or expensive (RUDE). Not only do omega-3 fatty acids have some RCT evidence for a small effect in several psychiatric disorders, but they also are believed useful in preventing cardiac morbidity and excessive inflammation. Therefore, for ADHD, we recommend a combination of behavioral treatment (e.g., parent training, cognitive-behavioral therapy (CBT) for older patients), FDA-approved medication, (primarily stimulants), an RDI/RDA multivitamin/mineral to compensate for stimulant appetite suppression, and about a gram a day of EPA/DHA, possibly supplemented with 50-100 mg GLA. For mood disorders, we recommend a combination of mood stabilizer or antidepressant (depending on which mood disorder), CBT, RDA/RDI multivitamin/mineral (in view of reported vitamin D deficiencies and vitamin wasting from some anticonvulsant mood stabilizers), and a gram per day of EPA/DHA. For autism, we recommend applied behavior analysis, RDA/RDI multivitamin/mineral in view of the often idiosyncratic unbalanced diet, ADHD medication if a problem with hyperactivity, antipsychotic if a problem with irritability/aggression, and omega-3 for anti-inflammatory effect. For learning disorder and developmental coordination disorder, we recommend remedial tutoring or occupational therapy and EPA/DHA. For children at high risk for psychosis or mood disorder, we recommend counseling, monitoring for early indication of low-dose antipsychotic, and general nutritional support, including EPA/DHA. For Tourette’s and aggression, EPA/DHA and other nutritional support can be added to standard treatment. When using fish oil, it is important to make sure it was refined to eliminate contaminants such as mercury. The effect accumulates gradually over months. There is no convincing evidence of greater benefit but some risk from amounts over a gram or two per day.
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    ABSTRACT: Attention-deficit/hyperactivity disorder (ADHD) is associated with difficulties in learning, behaviour and psychosocial adjustment that persist into adulthood. Decreased omega-3 fatty acids and increased inflammation or oxidative stress may contribute to neuro-developmental and psychiatric disorders such as ADHD. The aim of this study was to determine the effect of n-3 supplementation on hyperactivity, oxidative stress and inflammatory mediators in children with ADHD. In this double blind study, 103 children (6-12 years) with ADHD receiving maintenance therapy were assigned randomly into two groups. The n-3 group received n-3 fatty acids (635 mg eicosapentaenoic acid (EPA), 195 mg docosahexaenoic acid (DHA)), and the placebo group received olive oil capsules which were visually similar to the n-3 capsules. The duration of supplementation was 8 weeks. Plasma C-reactive protein (CRP), interleukin-6 (IL-6) and the activity of glutathione reductase (GR), catalase (CAT) and superoxide dismutase (SOD) were determined before and after the intervention. Likewise the Conners' Abbreviated Questionnaires (ASQ-P) was applied. After 8-week intervention, a significant reduction was observed in the levels of CRP ( P < 0.05, 95% CI = 0.72-2.02) and IL-6 (P < 0.001, 95% CI = 1.93-24.33) in the n-3 group. There was also a significant increase in activity of SOD and GR (P < 0.001). A significant improvement was seen in the ASQ-P scores in the n-3 group (P < 005). Eight weeks of EPA and DHA supplementation decreased plasma inflammatory mediators and oxidative stress in the children with ADHD. These results suggest that n-3 fatty acid supplementation may offer a safe and efficacious treatment for children with ADHD.
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