Meguid et al., 2008

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Meguid et al., 2008
Country:
Egypt
Practice setting:
Academic
Intervention setting:
Clinic
Enrollment period:
NR
Funding:
NR
Author industry relationship disclosures:
NR
Design:
Non-randomized controlled trial
Intervention:
Efalex supplement (blend of high DHA fish oil and evening primrose oil containing both omega 3 and 6 fatty acids as well as vitamin E)
Children with autism (G1) received 2 capsules twice per day for 3 months; the controls (G2) were healthy and received no treatment or placebo
Assessments:
Blood levels of free PUFAs estimated from dried blood spot using tandem mass spectrometry; CARS at baseline and follow-up (3 months after treatment)
Groups:
G1: children with autism
G2: healthy children, same age and gender
Co-interventions held stable during treatment:
NR
Frequency of contact during study:
NR
Concomitant therapies:
None
N at enrollment:
G1: 30 (28 families)
G2: 30
N at follow-up:
G1: 30
G2: NA
Inclusion criteria:
  • Autism based on DSM-IV criteria and CARS scores
  • Good physical health
  • Not currently taking medications or essential fatty acid supplements during study
  • Agree not to make changes in treatments for autism (medical, nutritional, behavioral, dietary) during the three months of the study
Exclusion criteria:
  • See inclusion criteria
Age, yrs (range):
NR (3–11)
Mental age:
NR
Gender, n (%):
Male: 18 (60)
Female: 12 (40)
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
Referral Department of Children with Special Needs
Diagnostic tool/method:
DSM-IV and CARS
Diagnostic category, n (%):
Autism: 30 (100)
Other characteristics:
NR
Overall ratings:
CARS score, mean ± SD:
G1: 39.5 ± 3.86
Medical:
PUFA levels, mean ± SD:
Linolenic:
G1: 0.86 ± 0.44
G2: 3.2 ± 0.72
G1/G2: P < 0.0001
DHA:
G1: 0.95 ± 0.2
G2: 2.85 ± 0.65
G1/G2: P < 0.0001
Linoleic:
G1: 1.75 ± 0.46
G2: 2.77 ± 0.64
G1/G2: P < 0.0001
Arachidonic:
G1: 2.5 ± 0.5
G2: 4.65 ± 0.5
G1/G2: P < 0.0001
AA/DHA:
G1: 2.77 ± 0.84
G2: 1.71 ± 0.4
G1/G2: P < 0.0001
Overall ratings:
CARS score, mean ± SD:
G1: 32.7 ± 3.37
G1/BL: P < 0.0001
Medical:
PUFA levels, mean ± SD:
Linolenic:
G1: 1.76 ± 0.56
G1/BL: P < 0.0001
DHA:
G1: 1.69 ± 0.42
G1/BL: P < 0.0001
Linoleic:
G1: 2.32 ± 0.41
G1/BL: P < 0.0001
Arachidonic:
G1: 3.23 ± 0.49
G1/BL: P < 0.0001
AA/DHA:
G1: 2.01 ± 0.53
G1/BL: P < 0.0001
Harms:
NR
Modifiers:
Correlation between CARS and baseline PUFA level, no significant improvement in autistic behavior (n=10):
Linolenic: −0.471 (P > 0.05)
DHA: −0.670 (P < 0.05)
Linoleic: −0.118 (P > 0.05)
AA: 0.115 (P > 0.05)
Correlation between CARS and post-treatment PUFA level, no significant improvement in autistic behavior (n=10):
Linolenic: 0.395 (P > 0.05)
DHA: −0.541 (P > 0.05)
Linoleic: −0.287 (P > 0.05)
AA: 0.262 (P > 0.05)

From: Appendix C, Evidence Tables

Cover of Therapies for Children With Autism Spectrum Disorders
Therapies for Children With Autism Spectrum Disorders.
Comparative Effectiveness Reviews, No. 26.
Warren Z, Veenstra-VanderWeele J, Stone W, et al.

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