Efficacy of amitriptyline in pediatric functional abdominal pain disorders: A randomized placebo‐controlled trial

Abstract

Background and Aim: Amitriptyline improves symptoms in functional abdominal pain disorders (FAPD) in adults with variable results in pediatric studies. The study aims to evaluate the efficacy of amitriptyline in pediatric FAPD. Methods:In this open-label trial, children (≤ 18 years) diagnosed as FAPD based on ROME IV criteria were randomized to amitriptyline or placebo for 12 weeks. Post-treatment improvement of pain and quality of life (QOL) from the baseline were compared between the two groups. Results: The mean age of 149 children (amitriptyline 75, placebo 74) was 11.3 ± 3.5 years (79 boys). There was a significant difference in pain improvement in terms of reduction in scores for intensity (3.4 vs 0.9), frequency (3.6 vs 0.6), duration (3.5 vs 0.9), and QOL (2.3 vs 0.9) between amitriptyline and placebo group (P < 0.001 in all). Responders (> 50% reduction) in pain was seen in 76% in amitriptyline compared with 14.9% in the placebo group (P < 0.001). On multivariate analysis, the use of amitriptyline was the only factor predictive of response (odds ratio 24.1, 95% confidence interval: 9.1-64.6, P < 0.001). Minor adverse events were comparable between the groups (25.3% vs 13.5%, respectively, P = 0.07). Eighty-nine percent of children (24/27) who had extended treatment duration (6.8 ± 1.8 months) had pain improvement. After discontinuation of amitriptyline, 70% had sustained response over a mean follow up of 15.84 ± 5.6 months. Conclusions: A 3-month trial of amitriptyline gives sustained relief of pain in two-thirds of children with FAPD. The safety profile of the drug and its efficacy necessitate more frequent use in the clinical settings.

Pharmacological Management for Pediatric Irritable Bowel Syndrome: A Review

“…In Saps et al (2009), the duration of treatment was four weeks shorter than in Seetharaman et al (2022) [ 38 ], with a duration of 12 weeks. Also, the number of participants in Seetharaman et al (2022) [ 38 ] was 168, more than the 90 patients in Saps et al (2009) [ 39 ]. According to these data, amitriptyline can reduce pain in patients with irritable bowel disease.…”

“…Quality of life is an important item affected by IBS as it causes some psychological disorders like stress, anxiety, depression, and somatization [ 41 ]. In Seetharaman et al (2022) [ 38 ], the baseline mean quality of life score in the amitriptyline group was 2.7±1.9 versus 2.6±1.7 in the placebo group. However, post-treatment, there was a significant improvement in the quality of life score in the amitriptyline group (2.3±1.6), but in the placebo group, it became 0.9±1.6.…”

What is new with irritable bowel syndrome

“…The study was statistically significant for pain improvement with amitriptyline compared with placebo (76–14.9%) along with improved quality of life and with no adverse events. This study, compared with others, had a larger sample size of 154 patients and longer treatment duration but limited as it was conducted in India and not necessarily reflective of other countries [19 ▪ ].…”

“…One recent RCT aimed to assess the efficacy of amitriptyline, a tricyclic antidepressant, in those with functional abdominal pain, including IBS [19 ▪ ]. The study was statistically significant for pain improvement with amitriptyline compared with placebo (76–14.9%) along with improved quality of life and with no adverse events.…”

Italian guidelines for the management of irritable bowel syndrome in children and adolescents

“…The efficacy of amitriptyline was recently evaluated in pediatric FAPD patients diagnosed according to Rome IV criteria [ 178 ]. In this open-label trial, children were randomized to amitriptyline or placebo for 12 weeks.…”