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Rapporten - SBU

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Table 3.2.25 Exclusion diet.<br />

Author<br />

Year<br />

Reference<br />

Country<br />

Whiteley<br />

et al<br />

2010<br />

[86]<br />

United<br />

Kingdom,<br />

Denmark,<br />

Norway<br />

Study design<br />

Aim<br />

Design<br />

RCT with waitlist<br />

comparison group.<br />

Randomisation<br />

stratified for age<br />

and VABS com-<br />

posite score<br />

Aim<br />

To evaluate the<br />

effect of gluten- and<br />

casein-free diet on<br />

the developmental<br />

outcome in children<br />

with ASD<br />

Population<br />

characteristics<br />

Diagnosis<br />

Previous diagnose<br />

of ASD according to<br />

ICD-10 (ADOS and<br />

ADI-R completed)<br />

No of participants<br />

73 intended to treat,<br />

55 remaining after<br />

12 months, 35 after<br />

24 months<br />

Gender<br />

I: Males 21, females 5<br />

C: Males 28, females 1<br />

Age<br />

4 years–10 year<br />

and 11 months<br />

IQ<br />

Developmental<br />

age >24 months<br />

248 Autismspektrumtillstånd – diAgnostik och insAtser,<br />

KAPITEL 3 • sysTEmATIsK LITTErATurövErsIKT – insAtser vid Ast<br />

249<br />

vårdens orgAnisAtion och pAtientens delAktighet<br />

Intervention Follow up period<br />

Drop-out rate<br />

I: Strict gluten- and<br />

casein-free diet.<br />

n=38<br />

C: Non-diet group<br />

for 12 months,<br />

strict gluten- and<br />

casein-free diet<br />

during months<br />

12 to 24.<br />

n=34<br />

ADHD = Attention deficit hyperactivity disorder; ADI-R = Autism diagnostic interview-<br />

Revised; ADOS = Autism diagnostic observation schedule; ASD = Autism spectrum<br />

disorder; C = Control group; GARS = Gilliam autism rating scale; I = Intervention group;<br />

ICD-10 = International classification of diseases and related health problems, version 10;<br />

IQ = Intelligence quotient; n = Number of patients; ns = Non significant; p = Probability<br />

coefficient; RCT = Randomised controlled trial; VABS = Vineland adaptive behaviour<br />

scales<br />

Follow up period<br />

24 months<br />

Drop-outs<br />

n=73 available<br />

for randomisation,<br />

1 drop-out before<br />

randomisation<br />

Drop-outs during<br />

the first 12 months:<br />

I: 11/38 (incl. 4 children<br />

because lack of effect)<br />

+ 1 excluded.<br />

C: 4/34 + 1 excluded<br />

Drop-out<br />

months 12–24.<br />

I: n=8<br />

C: n=12<br />

Main results Study quality<br />

Comments<br />

Assessment at 12 months,<br />

difference between groups<br />

(I: n=26; C: n=29)<br />

Observation<br />

ADOS communication score:<br />

I>C (p=0.0022)<br />

ADOS social and repetitive scores: ns<br />

Questionnaires (parent reports)<br />

GARS social score: I>C (p=0.0001)<br />

GARS communication and stereo-<br />

typed behaviour: ns<br />

VABS communication<br />

and social score: ns<br />

VABS daily living: I>C (p=0.02)<br />

For group C (n=17), comparison<br />

of assessments at 12 and 24 months<br />

(12 months without, 12 months<br />

with diet):<br />

ADOS, GARS social, VABS, ADHD<br />

inattention: no significant changes<br />

GARS communication and stereo-<br />

typed behaviour: improvement<br />

(p=0.03 and 0.02, respectively)<br />

Moderate<br />

Except for the<br />

ADOS, outcome<br />

data consisted of<br />

parent reports<br />

(not blinded)<br />

Large drop-out<br />

rate; no intendedto-treat-analysis<br />

performed

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