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There are no prospective, multicenter, double-blind, placebo-controlled, randomized pharmacologic trials for the treatment of pain-predominant functional gastrointestinal disorders in children.
In this study, doctors from the United States evaluated the efficacy of amitriptyline in children with pain-predominant functional gastrointestinal disorders.
Dr Miguel Saps and colleagues randomized 90 children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia to 4 weeks of either placebo or amitriptyline.
The team assessed gastrointestinal symptoms, psychological traits, and daily activities both before and after intervention. Pain was assessed daily using self-report diaries.
The team's primary outcome was overall response to treatment. Secondary outcomes were effect on psychosocial traits and daily functioning.
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| Amitriptyline significantly reduced anxiety scores. |
| Gastroenterology |
The doctors found that 63% of patients reported feeling better and 5% worse in the amitriptyline arm compared with 58% feeling better and 3% worse in the placebo arm.
Furthermore, pain relief was excellent in 7% and good in 38% of children receiving placebo, compared with excellent in 15% and good in 35% of children treated with amitriptyline.
Logistic regression analysis showed no difference between the amitriptyline and placebo groups.
The team established that amitriptyline significantly reduced anxiety scores.
Dr Saps' team concluded, "Both amitriptyline and placebo were associated with excellent therapeutic response."
"There was no significant difference between amitriptyline and placebo after 4 weeks of treatment."
"Patients with mild to moderate intensity of pain responded better to treatment."
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