Paediatrica Indonesiana Original Article p-ISSN 0030-9311; e-ISSN 2338-476X; Vol.56 No.5(2016) p.262-6; doi: 10.14238/pi56.5.2016.262-6. 262 • Paediatr Indones, Vol. 56, No. 5, September 2016 Effectiveness of amitriptyline for treating functional dyspepsia in adolescents Abstract Background Functional dyspepsia is common among adolescents. Pain reduces children’s quality of life, psychosocial functioning, and school attendance. Amitriptyline is assumed to be one of the alternative treatments in functional dyspepsia. Objective To investigate the effectiveness of amytriptyline as a treatment for functional dyspepsia in adolescents. Methods We conducted a randomized, single-blind, controlled trial from January to March 2011 in junior and senior high school students in Dobo City, Aru Island District, Maluku Province. Adolescents suffering from functional dyspepsia and who fulfilled the inclusion criteria were eligible for the study. Subjects were randomized into two groups. Each group received 10 mg (for body weight < 35 kg) or 20 mg (for body weight ≥ 35 kg) amitriptyline or placebo once per day for 28 days. Pain frequency was measured in terms of abdominal pain episodes per month, and duration was measured in minutes. Data were analyzed using t-test. Results Eighty-eight students participated in this study: the amitriptyline group (43 subjects) and the placebo group (45 subjects). There were no statistically significant differences between the amitriptyline and placebo groups in frequency (P=0.777; 95%CI -0.846 to 1.129) or duration (P=0.728) of abdominal pain after treatment. Conclusion Amitriptyline is not more effective than placebo for treating functional dyspepsia in adolescents. [Paediatr Indones. 2016;56:262-6 doi: 10.14238/pi56.5.2016.262-6]. Keywords: amitriptyline; functional dyspepsia; adolescent This study was presented at the Kongres Nasional Ilmu Kesehatan Anak/ KONIKA V (The 5 th National Congress of Child Health), Manado, July 11–13, 2011. From the Department of Child Health, University of Sumatera Utara Medical School, H. Adam Malik General Hospital, Medan, North Sumatera, Indonesia. Reprint requests to: Indra Mustawa, MD, Department of Child Health, University of Sumatera Utara Medical School/H. Adam Malik Hospital, Jl. Bunga Lau 17 Medan, 20136, Indonesia. Telp (061) 8361721 – 8365663; Mobile 085297638746; Fax (061) 8361721. E-mail: imustawa@yahoo. co.id. D yspepsia is the most common cause for medical consultations in children. 1 The symptoms of dyspepsia are common, occurring in 26-34% of the general population in the United States. 2 Pain reduces children’s quality of life, psychosocial functioning, and school attendance. 3 Functional dyspepsia is considered to be self- limiting and reported to be associated with anxiety disorders and depression. It may also be accompanied by headache and complaints in other parts of the body, necessitating treatment or health services. Sleep disorders, as well as significantly increased school absences are also consequences of functional dyspepia. 3,4 In children, pharmacologic treatment of functional dyspepsia has been mostly empirical and based on adult data. There have been a few small, Indra Mustawa, Supriatmo, Hakimi, Atan Baas Sinuhaji