Evangeliou et al., 2003

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Evangeliou et al., 2003

Country:
Greece

Practice setting:
Academic

Intervention setting: Clinic
Enrollment period: May 1999 to May 2000
Funding:
NR
Author industry relationship disclosures:
NR
Design:
Prospective case series
Intervention:
Ketogenic diet (John Radcliffe diet)
Applied for 6 months, with continuous administration for 4 weeks, interrupted by 2 week diet-free intervals

Assessments:
CARS at baseline and following intervention

Groups:
G1: Ketogenic diet

Co-interventions held stable during treatment:
NR

Frequency of contact during study: End of each 4 week diet phase and at the end of each 2 week diet-free phase

Monthly Psychiatric examination at the end of the diet and every month after discontinuation of diet for 6 months

Concomitant therapies, n (%):
Haloperidol: 30 (100)

N at enrollment:
G1: 30
N at follow-up:
G1: 30
Inclusion criteria:
  • 4–10 years of age with autistic behavior as diagnosed by a child psychiatrist according to CARS
  • Mild-moderate cases=CARS 30–36
  • Severe cases= CARS ≥ 37
Exclusion criteria: See inclusion criteria
Age, median/yrs (range):
7 (4–10)
Mental age:
NR
Gender:
M, n (%): 16 (53.3)
F, n (%): 14 (46.7)

Race/ethnicity:
NR

SES:
Maternal education: NR

Household income: NR

Diagnostic approach:
Referral

Diagnostic tool/method:
CARS

Diagnostic category, n (%):
Autism : 30 (100)

Other characteristics:
NR
Overall ratings:
CARS, n, mean ± SD:
Mild/Moderate autistic cases: 2 (CARS=34, 36)

Severe cases: 28 (CARS: 37–54)

Pre-CARS: 2, 35 ± 1.41

Pre-CARS: 8, 41.88 ± 3.14

Pre-CARS: 8, 45.25 ± 2.76

Elevated 3-ohisovaleric acid: 3

Pathologic levels of beta - hydroxybutyrate abnormal (1.05 – 1.45 mmol/L): 6
Overall ratings:
CARS, mean ± SD:
Improvement:
4.77 ± 0.89
P < 0.001 Significant improvement observed in those with lower initial CARS scores

Diet tolerated, n (%): 23 (76.6)

Improvement in Social behavior, interactions, speech, stereotypy & learning, n (%): 18 (60)

Elevated beta-OHb following diet, n (%): 4 (13.3)

Interrupted diet, n (%): 5 (16.7)

Elevated beta-OHb following diet, n (%): 2 (6.7)

Improvement significantly (CARS > 12 units): 2 (CARS=16, 13 units)

Average (CARS > 8–12 units): 8 (CARS mean=7.1 units)

Minor (CARS 2–8 units): 8 (CARS mean =7.1 units)
Among 6 with the pathologic levels of beta - hydroxybutyrate, improvement, n:
Significant: 1
Average: 2
Minor: 1 (2 discontinued the diet)
Harms:
NR

Modifiers:
NR

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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