Abstract | BACKGROUND & AIMS: METHODS: In this multicenter placebo-controlled trial, children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were randomized to 4 weeks of placebo or amitriptyline (10 mg/d, weight <35 kg; 20 mg/d, weight >35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after intervention. Pain was assessed daily with self-report diaries. The primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes were effect on psychosocial traits and daily functioning. RESULTS: Ninety children were enrolled, and 83 completed the study (placebo, 40 children [30 girls]; drug, 43 children [35 girls]). A total of 63% of patients reported feeling better and 5% feeling worse in the amitriptyline arm compared with 57.5% feeling better and 2.5% feeling worse in the placebo arm (P = .63). 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 (P = .85). Logistic regression analysis of those reporting excellent or good response versus fair, poor, or failed response showed no difference between amitriptyline and placebo (P = .83). Children who had more severe pain at baseline in both groups (P = .0065) had worse outcome. Amitriptyline reduced anxiety scores (P < .0001). CONCLUSIONS: 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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Authors | Miguel Saps, Nader Youssef, Adrian Miranda, Samuel Nurko, Paul Hyman, Jose Cocjin, Carlo Di Lorenzo |
Journal | Gastroenterology
(Gastroenterology)
Vol. 137
Issue 4
Pg. 1261-9
(Oct 2009)
ISSN: 1528-0012 [Electronic] United States |
PMID | 19596010
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics, Non-Narcotic
- Gastrointestinal Agents
- Amitriptyline
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Topics |
- Abdominal Pain
(prevention & control, psychology)
- Activities of Daily Living
- Adolescent
- Amitriptyline
(therapeutic use)
- Analgesics, Non-Narcotic
(therapeutic use)
- Anxiety
(etiology, prevention & control)
- Child
- Dyspepsia
(drug therapy, psychology)
- Female
- Gastrointestinal Agents
(therapeutic use)
- Humans
- Irritable Bowel Syndrome
(drug therapy, psychology)
- Logistic Models
- Male
- Medication Adherence
- Pain Measurement
- Prospective Studies
- Severity of Illness Index
- Surveys and Questionnaires
- Time Factors
- Treatment Outcome
- United States
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