, et al
Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders
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Investigators from multiple US institutions completed a randomized controlled trial of amitriptyline for the treatment of pain-predominant functional gastrointestinal disorders (FGID) in pediatric patients. Children 8 to 17 years of age with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were recruited from the pediatric gastroenterology clinics of six US tertiary care centers. Participants were randomized to four weeks of placebo or amitriptyline (10 mg/day, weight <35 kg; 20 mg/ day, weight >35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after the intervention using standardized tools. Pain was assessed daily with self-report diaries.

A total of 83 children (43 in the amitriptyline group) with a mean age of 12.7 years completed the study. Approximately 75% were girls. A similar percentage of patients in each group reported feeling better (63% in the amitriptyline group and 57.5% in the placebo group) or worse (5% in the amitriptyline group and 2.5% in the placebo group). There were no significant differences in the percentage of patients in each group who reported excellent or good pain relief (15% and 35%, respectively, in the amitriptyline group vs 7% and 38% in the placebo group). Children who had more severe pain at baseline in both groups (P=.0065) had worse outcomes. Amitriptyline significantly reduced anxiety scores.

The authors conclude that both amitriptyline and placebo were associated with excellent therapeutic response in children with functional abdominal pain.

Chronic abdominal pain is the most common gastrointestinal complaint in childhood, with the reported prevalence exceeding 15% of school-age children. Amitriptyline is a tricyclic antidepressant medication approved for children over 18 years of age that the FDA warns has been associated with suicidal risks and a wide range of other potentially serious side effects. Amitriptyline is also widely used for the treatment of FGID in children under 18 years. Such off-label use appears to be increasing in recent years because of reports of efficacy for treating children with chronic abdominal pain and a lack of other readily available treatment options.1 The results of the present study demonstrate the apparent efficacy of this medication (63%) but interestingly, comparable efficacy for placebo (58%).

The behavioral and psychological treatments for pediatric functional gastrointestinal disorders have recently been reviewed.2 Psychological and behavioral interventions can be classified into five primary treatment modalities: psychoeducation, behavior therapy/ contingency management, relaxation-based therapies (including biofeedback and hypnotherapy), and cognitive-behavioral therapy (including cognitive-behavioral family therapy). Effective interventions generally involve multiple therapeutic components and include elements of both individual and family treatment. Psychological interventions that combine psychoeducation, relaxation-based therapies, and cognitive-behavioral therapy appear superior to standard care (reassurance or dietary manipulation) in the elimination of pain and reduction in functional disability. To date, there have been no controlled comparisons of...

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