Citalopram for pediatric functional abdominal pain: a randomized, placebo-controlled trial

Abstract

Background: Antidepressants are effective in adults with pain-related functional gastrointestinal disorders. We investigated the effectiveness of citalopram in the treatment of childhood functional abdominal pain (FAP).

Methods: Children with FAP, based on the Rome III criteria (n = 115, aged 6-18 years), were randomized to receive either citalopram 20 mg/day or placebo for 4 weeks. Treatment response was defined as ≥ 2 point reduction in the 6-point Faces pain rating scale or 'no pain'. Depression, anxiety, somatization, and physician-rated global severity and improvement were also evaluated. Patients were followed up for 8 weeks after medication period.

Key results: Eighty-six patients completed the medication (43 in each group). Response rate in the citalopram and placebo groups based on per-protocol (intention-to-treat) analysis was 55.8% (40.6%) and 39.5% (30.3%) at week 4 (p = 0.097 [0.169]) and 72.0% (52.5%) and 53.4% (41.0%) at week 12 (p = 0.059 [0.148]), respectively. In per-protocol analysis, more reduction was observed in pain (F = 3.84, p = 0.024) and global severity scores (F = 4.12, p = 0.021) in the citalopram group compared with the placebo group over the study period. Such differences were not present in the intention-to-treat analysis. No difference was found between the two groups regarding change in depression, anxiety, or somatization score over the study.

Conclusions & inferences: Overall, we found a trend toward the effectiveness of citalopram in the treatment of children with FAP. Trials with longer treatment duration in larger samples of patients are required in this regard.

Keywords: abdominal pain; antidepressive agents; child; randomized controlled trial; serotonin reuptake inhibitors.