Efamol

Brain Function-Omega3 &Tourette’s – Gabbay 2012 (128)

Topics: Omega-3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), Tourette’s Syndrome/Disorder (TD), attention deficit hyperactivity disorder (ADHD).

Objective: To investigate the effects of omega-3 fatty acid supplementation in children and adults with TD.

Background: Omega-3 fatty acids are commonly used as complimentary treatments in pediatric psychiatric disorders including ADHD, a condition that often accompanies TD. Clinical observations have suggested that they may provide therapeutic benefit in TD, but no randomized, controlled trials have been reported to date.

Method: This randomised, double-blind, placebo-controlled trial included 33 children and adolescents (ages 6-18) diagnosed with TD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th  Ed.

Depending on age and ability to swallow capsules, children were treated for 20 weeks starting at either  250 mg/day EPA+DHA or 500 mg/day EPA+DHA and gradually titrated upwards by increments of 250 mg/day EPA+DHA to a possible maximum dose of 6000 mg/day. Dose titration depended on the subject’s improvement since the initial visit. For example, if the TD-Clinical Global Impression-Improvement scale (CGI-I) was very much improved or much improved, the dose remained unchanged. If the ratings were minimally improved, no change, or worse, the dose was increased to the next level, but only in the absence of significant adverse effects. Capsules of olive oil (high in monounsaturated fatty acids) provided the placebo control.

Inclusion Criteria: Diagnosed TD with a minimum score of 20 on the Yale Global Tic Severity Scale (YGTSS – Global)

Exclusion Criteria: Those on immune-affecting medications during the previous month, who had immunologic or hematologic disorders, Sydenham chorea, a significant medical or neurologic disorder, bipolar disorder, major depressive disorder, pervasive developmental disorder, intellectual disability, psychotic disorder, a substance related disorder in the past 12 months, or a positive urine test, previous use of omega-3 fatty acids and in females a positive urine test for pregnancy.

NOTE: Concomitant psychotrophic medication was not an exclusion provided there was no alteration during the study.

The following assessments were completed at Baseline, weeks 2, 4, 6, 10, 16 and 20.

Primary Outcomes

  • Yale Global Tic Severity Scale – Tic (YGTSS-Tic): reflects domains of both vocal and motor tic severity including number, frequency, intensity, complexity and interference.

 

Secondary Outcomes

  • YGTSS – Impairment: reflects tic related impairment on self-esteem, school, and social and family functioning.
  • YGTSS – Global: consists of the two subscales YGTSS – Tic and YGTSS – Impairment combined. Obsession Compulsive Disorder Symptoms according to the CY-BOCs.

 

Depressive and Anxiety Symptoms according to the Children’s Depression Rating Scale and the Multidimensional Anxiety Scale were assessed at baseline and week 20.

Tic Improvement Rating was completed by the child and adolescent psychiatrist at each visit by completing the TD-CGI scale.

Adverse Effects were systematically assessed at each visit using the Safety Monitoring Uniform Report. Also heart rate, blood pressure, weight, platelet count, prothrombin time, and partial thromboplastin time.

Findings:  Those treated with omega-3 fatty acids 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 taking omega-3 fatty acids 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 omega-3-treated group than in the placebo group (31.7 ± 2.9 vs 40.9 ± 3.0, P = .04). There were no significant side effects.

Conclusion: Omega-3 fatty acids may reduce tic-related impairment for some children and adolescents with TD. Limitations include the small sample size and the possible therapeutic effects of olive oil.

Relevance to: Efalex, Efalex Concentrate

Reference: Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ.A Double- Blind, Placebo-Controlled Trial of Omega-3 Fatty Acids in Tourette’s Disorder. Pediatrics. 2012 May 14. [Epub ahead of print]

PRESS RELEASE

Omega-3 supplementation reduces tic-impairment in those with Tourette’s Disorder.

Omega-­3 fatty acids may reduce tic-­related impairment in some children and adolescents with Tourette’s Disorder (TD) according to the results of the first double-­blind, placebo-­controlled clinical trial of its kind. The study was a collaboration among NYU Child Study Center and Department of Radiology at NYU School of  Medicine, New York, and the Kline Institute for Psychiatric Disorders, Orangeburg, New York, and was funded by the National Institutes of Health, the Anita Saltz Foundation, the Leon Levy Foundation and the Tourette Syndrome  Association.

TD is a  childhood onset neuropsychiatric disorder involving  multiple  waxing  and  waning  motor and  vocal tics. It is believed to be caused by  a combination  of neurological malfunctions involving  dopamine  and  serotonin, and inflammatory processes. Although drug treatments are available, they either have limited effectiveness or significant side effects. Consequently, alternative treatments such as omega-­3 fatty acids derived from fish [eicospentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely used in TD, particularly since the condition often exists in combination with attention deficit hyperactivity disorder (ADHD) and obsessive-­compulsive disorder (OCD) – conditions often treated successfully omega-­3 fatty acids. EPA is thought to provide benefit through its anti-­inflammatory effects while DHA is more neurotrophic.

The trial included 33 children and adolescents (ages 6-­?18) diagnosed with TD who were treated for 20 weeks with an olive oil placebo or an active treatment starting at either 250 mg/day EPA+DHA or 500 mg/day  EPA+DHA depending on their age, and gradually titrated upwards by increments of 250 mg/day EPA+DHA to a possible  maximum  dose of  6000  mg/day. Dose  titration  depended on the subject’s  improvement  since  the initial visit. For example, if symptoms were very much improved or much improved, the dose remained unchanged. If symptoms were minimally improved, unchanged or worse, the dose was increased to the next  level provided there were no significant adverse effects.  There was no change from baseline at weeks 6, 10 or  16, but benefits were measured at 20 weeks indicating that it takes time for the fatty acids to have an impact similar to results reported in people with ADHD. Results showed that relative to placebo, those treated with omega-­3 fatty acids did not have lower tic scores (includes the number of tics, frequency, intensity, complexity and interference), but they did have significantly less tic impairment (includes negative effects on self-­?esteem, school, social and family functioning). In addition, significantly more subjects taking omega-­3 fatty acids were considered responders when taking into consideration both the tic scores plus the tic impairment. This functional impairment associated with TD is a key  aspect of illness severity  and  therefore, makes the  results of this study noteworthy. Adding to the strength of these results is the fact that many of the patients were being treated with their normal drug medication so that any measured improvement was above that already achieved with conventional treatment. In fact, there was a 26% tic score improvement in the omega-­3 group which is consistent with improvements observed in previously reported drug trials on risperidone (29%) and guanfacine (29.5%). Unfortunately, the olive oil placebo had a minor therapeutic effect probably due to its antioxidant properties making the benefits derived from the omega-­3 treatment less significant. There were no significant side effects.

This study confirmed that omega-­3 fatty acid supplementation may be a safe viable alternative to conventional drug therapy for those suffering from TD and that large scale clinical trials are warranted to confirm these findings.

References:

  1. Gabbay V, Babb JS, Klein RG, Panzer AM, Katz Y, Alonso CM, Petkova E, Wang J, Coffey BJ.A Double- Blind, Placebo-Controlled Trial of Omega-3 Fatty Acids in Tourette’s Disorder. Pediatrics. 2012 May 14. [Epub ahead   of print]

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