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Therapies for Children With Autism Spectrum Disorders

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Summary of the literature-other interventions. The RCT of amantadine, 251 conducted at six<br />

academic clinics in the US and UK and including 39 children, showed no effect of daily<br />

amantadine over four weeks on parent-rated ABC-C behavior scores and clinician-rated CGI<br />

rating of overall improvement (Table 22). However, children in the amantadine arm improved<br />

significantly more than those receiving placebo in clinician-rated ABC-C subscales <strong>for</strong><br />

hyperactivity and inappropriate speech. There were no differences in harms, and no serious<br />

complications.<br />

Table 22. Outcomes of RCTs of other medical interventions <strong>for</strong> the treatment of ASDs<br />

Author, year,<br />

country<br />

Groups, N<br />

enrollment/N final<br />

Study quality<br />

Akhondzadeh et al. 253<br />

2010, Iran<br />

G1:<br />

risperidone+pentoxifylline,<br />

20/20<br />

G2:<br />

risperidone+placebo,<br />

20/20<br />

Quality: Fair<br />

Handen et al. 64<br />

2009, US<br />

G1a: IGOH, 32/27<br />

G1b: IGOH, 31/23<br />

G1c: IGOH, 31/24<br />

G2: placebo, 31/26<br />

Quality: Good<br />

Rossignol et al. 254<br />

2009, US<br />

G1: hyperbaric oxygen,<br />

33/30<br />

G2: pressurized room<br />

air, 29/26<br />

Quality: Good<br />

Chez et al. 257<br />

2003, US<br />

G1: DH, 23/17<br />

G2: placebo, 20/17<br />

Quality: Fair<br />

Mean age,<br />

years ± SD<br />

G1: 8.05 ±<br />

2.01<br />

G2: 7.37 ±<br />

2.41<br />

G1a: 7.4 ± 3.1<br />

G1b: 8 ± 4.1<br />

G1c: 7.6 ± 3.5<br />

G1d: 6.2 ± 3.3<br />

G1: 4.97 ± 1.29<br />

G2: 4.86 ± 1.13<br />

G1: 6.8<br />

G2: 6.9<br />

Mean IQ ±<br />

SD<br />

75<br />

Key outcomes<br />

NR • Significant improvements on the<br />

lethargy/social withdrawal, stereotypic<br />

behavior, hyperactivity/noncompliance, and<br />

inappropriate speech ABC-C subscales <strong>for</strong> the<br />

risperidone+pentoxifylline group (P ≤ 0.0001).<br />

• Scores on the Extrapyramidal Symptoms.<br />

Rating Scale and frequency of side effects did<br />

not differ between groups.<br />

• Harms in either group included gastrointestinal<br />

symptoms, restlessness, drowsiness, weight<br />

gain/increased appetite, and fatigue.<br />

NR • No significant difference between groups in the<br />

primary endpoint, overall clinical response to<br />

treatment based on MGIS (140 mg/day, p=0.39;<br />

420 mg/day, p=0.19; 840 mg/day, p=0.44).<br />

• No significant benefit of all active treatments<br />

combined compared with placebo (p=0.22).<br />

NR • Significant improvements on ABC total score<br />

(p=0.0118); in the treatment group only, indicating<br />

improvements in challenging behaviors.<br />

• Significant improvements on the ATEC<br />

sensory/cognitive awareness subscale in the<br />

treatment group compared with the control group.<br />

NR • Speech and language (EOWPVT & ROWPVT)<br />

improved in the treatment group relative to baseline<br />

scores but not when compared with the placebo<br />

group.

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