The stimulant methylphenidate has been used for decades to treat attention deficit and hyperactivity disorder (ADHD). However, a Cochrane Review last month looked at 185 pediatric clinical trials of methylphenidate (Ritalin, Concerta and other brands) and found that the evidence for benefit has generally been of poor quality.
Collectively, the trials involved more than 12,000 children or adolescents with an ADHD diagnosis. Most compared methylphenidate to placebo, with treatment durations ranging from 1 to 425 days (average, 75). Of the 185 trials, 72 (40 percent) were industry-funded.
While the collective data indicate that the drug reduced hyperactivity and impulsivity and increased children’s ability to concentrate, most trials were small and judged to be low quality. For example, methylphenidate’s side effects may have compromised blinding in many studies. While short-term data indicated no life-threatening harms, the drug was associated with an increased risk of side effects such as sleeping problems and decreased appetite.
So should we now be questioning Ritalin? Notes checked in with Elizabeth Harstad, MD, MPH, of the Developmental Medicine Center at Boston Children’s Hospital, who is involved in an ongoing analysis of practice patterns for ADHD management.
Q. How does this review jive with your clinical experience?
A. I think the review was well intentioned, and it’s always important to review the current literature and see what results are showing. However, limitations to the studies that exist limit the conclusions we’re able to draw. Methylphenidate is one of the most studied medications, yet many of the studies in the review were fairly small, some were not blinded and many were of short duration.
Clinically, we find that stimulants effectively reduce ADHD symptoms 70 to 80 percent of the time, when you try them with care and monitor the patient closely to make sure they’re working. Parent and teacher ADHD rating scales can help, together with close clinical follow-up to screen for side effects and make any dose changes that are needed. Patients vary in their individual response — it often takes a trial of a few different types of stimulant medications and/or doses before finding one that reduces ADHD symptoms and doesn’t have significant side effects.
Because methylphenidate has been used for so long and has been shown to effectively reduce ADHD symptoms, I don’t think another randomized controlled trial would be appropriate.
Q. How concerning are the side effects? Do you worry about effects on the developing brain?
Clinically, we find that stimulants effectively reduce ADHD symptoms 70 to 80 percent of the time, when you try them with care and monitor the patient closely.
A. All medications potentially have side effects, and it’s an important discussion to have with the family. The most common side effects of methylphenidate are difficulty falling asleep at night and decreased appetite, usually around lunchtime. These are not extremely serious and often behavioral and other approaches can be used to overcome them. But that said, children should be monitored closely to make sure they don’t need a change of medication.
As for the developing brain, there is some evidence that rather than being harmful, stimulants may in fact be protective. If ADHD is better controlled, your brain may be more available for learning — and that has continued positive benefits. Longer-term, you would expect to see academic improvement and improvement in social and emotional functioning. But you’d need a longer term study to observe those outcomes.
Concerns have also been raised about stimulants’ impact on height. In our longitudinal study, when children were treated with ADHD medications for three or more years, there was no difference between children treated with simulants and those who weren’t in terms of adult height. However, we did find a delayed onset of the growth spurt in boys.
Q. What about alternative medications? Is the quality of the evidence any better?
A. All stimulants are similar in terms of their reported likelihood of effectiveness and side effect profile. There is lots of individual variation in terms of response, likely mediated by patients’ underlying genetics. It’s hard to determine in advance who will respond to which medication.
Different people have different practice patterns in terms of which medications they try first. Methylphenidate has a great deal of evidence supporting it, and some evidence that suggests it has fewer side effects than amphetamines, so I usually start with that.
Q. Is there a place for giving Ritalin to kids? What would be your guidance?
A. My usual recommendations have been consistent with the AAP’s 2011 guidelines. For preschoolers up to age 6, behavioral accommodations are recommended first; if those are ineffective you can consider medications. For age 6 and above, stimulant medications should be considered first-line together with behavioral accommodations and therapies, in consultation with the family.
It is important to appropriately make the diagnosis through a thorough evaluation. Children benefit from full neuropsychological testing at the time of assessment. Comorbid learning disorders should be identified and addressed, as well as anxiety or depression and other mood concerns. Any of these can cause ADHD-like symptoms, and if you have ADHD, you’re at increased risk of having any of these as well.
Once the diagnosis is made, children should have close clinical follow-up with recommendations for home and school accommodations and consideration of stimulant medications. Once this plan is implemented, it’s important to continue to monitor to make sure recommendations are effective.