THURSDAY, Oct. 1, 2009 (HealthDay News) -- Contradicting some previous research in adults, a new study suggests that the antidepressant amitriptyline (Elavil), is no better than a placebo at treating painful gastrointestinal disorders in children.
"The high placebo effect we identified in this study suggests that further studies of the use of certain antidepressants in children with functional bowel disorders are needed. While several trials have demonstrated a beneficial effect of antidepressants, including amitriptyline, for the treatment of irritable bowel syndrome in adults, more research is needed to determine how effective this drug is, if at all, in children," study author Dr. Miguel Saps of Children's Memorial Hospital in Chicago, said in a news release from the American Gastroenterological Association.
The drug is used to treat depression, but it is sometimes prescribed on an "off-label" basis to children who have certain painful gastrointestinal disorders. The drug is thought to reduce pain, the researchers noted.
"Off label" means that the drug is not federally approved for use to treat a condition. However, doctors can still prescribe it for that purpose.
In the study, 83 children with painful gastrointestinal disorders were randomly assigned to take the drug or a placebo. Of those who took the drug, 63 percent reported feeling better, while 5 percent felt worse. Among those taking the placebo, 57.5 reported feeling better and 2.5 percent felt worse, the study authors reported.
The study findings appear online in advance of publication in an upcoming print issue of the journal Gastroenterology.
"Many pharmaceutical products are prescribed for off-label use in children due to the lack of clinical trials testing the efficacy of the drugs in children and adolescents," Saps explained in the news release. "Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," he added.
More information
Learn more about abdominal pain in children from the American College of Gastroenterology.
