BETHESDA, Md -- October 2, 2009 -- When used off-label, amitriptyline works just as well as placebo in treating pain-predominant functional gastrointestinal disorders (FGIDs) in children, according to a study published in Gastroenterology.
In children, the use of drugs to treat pain-predominant FGIDs is mostly empirical and based on adult data. There have been only a few small randomised clinical trials evaluating the efficacy of drugs for the treatment of pain-predominant FGIDs in children.
"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. Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," said lead author Miguel Saps, MD, Children's Memorial Hospital, Chicago, Illinois.
"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 (IBS) in adults, more research is needed to determine how effective this drug is, if at all, in children."
The large prospective, multicentre, randomised, placebo-controlled trial included children aged 8 to 17 years with IBS, functional abdominal pain or functional dyspepsia. Children were randomised to placebo or amitriptyline for 4 weeks.
Of the 83 children who completed the study, 63% of those who took amitriptyline reported feeling better, while 5% reported feeling worse. Of the patients who were given a placebo, 57.5% felt better, while 2.5% felt worse.
Pain relief was excellent (7%) and good (38%) in children on placebo and excellent (15%) and good (35%) in children on amitriptyline.
Both amitriptyline and placebo were associated with excellent therapeutic response, although patients with mild to moderate intensity of pain responded better to treatment. There was no significant difference between amitriptyline and placebo after 4 weeks of treatment.
SOURCE: American Gastroenterological Association
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