Table 1 Pharmacological Interventions
From: Systematic review of interventions for children with Fetal Alcohol Spectrum Disorders
Study quality | Participants (n), age, inclusion criteria and setting | Interventions and follow-up | Outcome measures |
|---|---|---|---|
Oesterheld et al, 1998[12] Cross-over RCT Randomized (method unclear); allocation concealment unclear; blinding (researchers, outcome assessors); follow-up 100%; ITT analysis unclear; study power not provided. | n = 4 5 to 12 years FAS or partial FAS[4] & ADHD (DSM-IV) Native American residential school | 0.6 mg/kg methylphenidate per dose to nearest 2.5 mg or lactose placebo or Vitamin C placebo Interventions were given 3 times per day for 5 days with a 2 day washout period prior to each intervention. Follow-up: Day 5 of each intervention | Hyperactivity-Impulsivity score on CPRS-48: significant improvement in methylphenidate group (F = 4.34, df = 2, p < 0.05) Hyperactivity-Impulsivity score on CTRS-39: significant improvement in methylphenidate group (F = 6.42, df2, p < 0.02) Daydreaming-Attention score on Conners Teacher Rating Scale-39: no significant difference (F = 1.429, df2, p = 0.289) Adverse events: three children experienced decreased appetite; two, mild stomach aches; and two, headaches. |
Snyder et al, 1997[13] Cross-over RCT Randomized (method unclear); allocation concealment unclear; blinding (researchers, outcome assessors); follow-up 92%; ITT analysis unclear; study power not provided. | n = 12 6 to 16 years FAS[4] & ADHD (DSM-IV) & reported positive response to stimulant medication Selected from a child development unit database, Canada | Usual dose of medication (methylphenidate: 8 children; pemoline: 2 children; dexedrine: 1 child) or colour matched capsule (placebo) Interventions were given for 3 days with a 1 day washout prior to each intervention. Usual medication was given for 3 days between the 2 interventions. Follow-up: Day 3 of each intervention | Attention: No significant difference between groups on vigilance task and no significant difference on Underlining Test. Hyperactivity: scores on the Abbreviated Symptoms Questionnaire – Parents were significantly improved for stimulant medication (68.36, SD 17.4) compared to placebo (84.4, SD 14.0) (F = 8.66; p = 0.016) Adverse events: not reported |