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Copyright © 2007 Massachusetts Medical Society. All rights reserved.
Stimulant medication is effective for treatment of preschool children with ADHD, but it's associated with a high rate of adverse events.
Results of small studies have reported benefits from methylphenidate (MPH) for treating core ADHD behaviors in preschool children. Now, results of the Preschool ADHD Treatment Study (PATS), a NIMH‐funded, six‐center, randomized trial of the efficacy and safety of MPH in preschool children, have been reported in four articles.
Investigators enrolled 303 children (age range, 3–5.5 years) who met DSM‐IV criteria for combined‐type ADHD in an intensive 10‐week behavioral therapy program with their parents. Children whose behaviors had not improved after behavioral therapy and whose parents agreed to a medication trial entered a 5‐week, placebo‐controlled, double‐blind trial in which 165 children were randomized to receive placebo or 1.25 mg, 2.5 mg, 5.0 mg, or 7.5 mg of immediate‐release MPH three times daily. Outcomes were measured with standardized ADHD questionnaires completed by parents and teachers. Compared with controls, children who received the 2.5 mg, 5.0 mg, and 7.5 mg doses of MPH had significant reductions in ADHD symptoms (P<0.01, P<0.001, P<0.001, respectively). The mean effective total daily dose of MPH was 14.2 (+/−8.1) mg/day.
After the controlled phase, 140 children entered a 10‐month open‐label maintenance trial. By the end of the maintenance phase, the mean effective total daily dose of MPH rose from 14.2 mg/day to 20.5 mg/day. Thirty percent of parents reported moderate‐to‐severe adverse effects (including emotional outbursts, difficulty falling asleep, repetitive behaviors and thoughts, appetite suppression, and irritability). Eleven percent of children in this phase discontinued MPH. Among the 95 children who remained on MPH, annual growth rates were 20% lower than expected for height (−1.38 cm/year) and 55% lower for weight (−1.32 kg/year).
The results of this large, placebo‐controlled trial demonstrate the effectiveness of stimulant medication in the treatment of preschool children with ADHD. The strengths of the study include a meticulous diagnostic process, participation of all parents in an intensive behavioral management program before considering medication, randomization to different medication doses, and long‐term follow‐up to assess safety.
ADHD remains a challenging diagnosis because the core symptoms — hyperactivity, impulsivity, and inattentiveness — are consistent with typical developmental variations in preschool children. Clinicians must decide which children fall outside expected behavioral norms. In preschool children with ADHD, frequent and unremitting disruptive behaviors in the classroom and at home that are not responsive to behavioral management often suggest the diagnosis of ADHD. However, psychosocial deprivation, sexual abuse, autistic spectrum disorder, and early bipolar disease are some other conditions that might be associated with similar behavior patterns. Primary care pediatricians should use caution before prescribing medication for ADHD in a preschool child and should weigh the potential benefits of MPH against the relatively high rate of adverse events.
Published in Journal Watch Pediatrics and Adolescent Medicine January 10, 2007
Kollins S, et al. Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry 2006;45:1275–83.
Greenhill L, et al. Efficacy and safety of immediate‐release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry 2006;45:1284–93.
Wigal T, et al. Safety and tolerability of methylphenidate in preschool children with ADHD. J Am Acad Child Adolesc Psychiatry 2006;45:1294–303.
Swanson J, et al. Stimulant‐related reductions of growth rates in the PATS. J Am Acad Child Adolesc Psychiatry 2006;45:1304–13.
The AAP provides an updated and revised statement.
Lactose intolerance is a clinical syndrome defined as the occurrence of one or more symptoms related to the gastrointestinal tract (e.g., abdominal pain or diarrhea) after ingestion of lactose‐containing foods. Both primary lactase deficiency and secondary lactase deficiency can result in lactose intolerance. Congenital lactase deficiency is rare. The AAP recently released a clinical report about lactose intolerance. Highlights of the report include:
Although helpful, this AAP summary statement is not a formal practice guideline because it is not based on a systematic review of the literature. Lactose intolerance should not be confused with cow's milk protein sensitivity — they are entirely different entities. In contrast with primary lactose intolerance, cow's milk protein allergy affects young infants and usually resolves during the first year. This distinction is important when considering changes in diet, including formula. Although there are many hidden sources of lactose, most older children can tolerate some amount. The lactose content of foods can range from about 12 g for 8 ounces of cow's milk to 1 g for 1 ounce of Swiss cheese (a sample list of lactose content in selected foods is available).
Published in Journal Watch Pediatrics and Adolescent Medicine January 3, 2007
Heyman MB, for the Committee on Nutrition. Lactose intolerance in infants, children, and adolescents. Pediatrics 2006;118:1279–86.
Tympanostomy tubes are not indicated for young children with minimal hearing loss and normal speech and language development.
Controversy remains about the long‐term developmental effects of middle‐ear effusion associated with otitis media. Previously, when children with persistent middle‐ear effusion (90 days of bilateral or 135 days of unilateral disease) were randomly assigned before 3 years of age to prompt or delayed insertion of tympanostomy tubes, investigators reported no significant differences in neurocognitive outcomes at ages 3 to 6.
In a follow‐up study, 391 of 429 children in the original cohort were assessed at ages 9 to 11. Comprehensive assessment included speech and language development, intelligence, academic achievement, and parent and teacher ratings of behavior, including attention and impulsivity. Again, no significant differences were found between prompt and delayed treatment groups.
Does this study end the debate about the usefulness of tympanostomy tubes? For young children with normal speech and language development who develop persistent middle‐ear effusion, with minimal hearing loss, tubes are not indicated. However, as an editorialist notes, this study did not assess the value of tube insertion in young children with speech and language delay, hearing loss of 40 dB or higher, or both. The American Academy of Pediatrics and the American Academy of Family Physicians recommend that tympanostomy tube insertion should be considered in children with substantial hearing loss or those at risk for language delay.
Published in Journal Watch General Medicine February 1, 2007
Paradise JL, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007;356:248–61.
Berman S. The end of an era in otitis research. N Engl J Med 2007;356:300–2.