Brief Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Nov 14, 2012; 18(42): 6127-6133
Published online Nov 14, 2012. doi: 10.3748/wjg.v18.i42.6127
Treatment of functional dyspepsia with sertraline: A double-blind randomized placebo-controlled pilot study
Victoria PY Tan, Tin K Cheung, Wai M Wong, Roberta Pang, Benjamin CY Wong
Victoria PY Tan, Tin K Cheung, Wai M Wong, Roberta Pang, Benjamin CY Wong, Department of Medicine, University of Hong Kong, Queen Marry Hospital, Hong Kong, China
Author contributions: Tan VPY, Cheung TK and Wong WM designed research; Tan VPY and Wong BCY analyzed data; and Tan VPY, Pang R and Wong BCY wrote the paper.
Supported by The Outstanding Researcher Award 2001-2002 and 2005-2006; the Shun Tak District Min Yuen Tong Gastro-enterology Research Fund; and the Lo Ka Chung Research Fund, University of Hong Kong
Correspondence to: Benjamin CY Wong, Professor, Depart-ment of Medicine, University of Hong Kong, Queen Marry Hospital, Hong Kong, China. bcywong@hku.hk
Telephone: +86-852-22554049 Fax: +86-852-29049443
Received: May 10, 2012
Revised: July 16, 2012
Accepted: July 28, 2012
Published online: November 14, 2012
Abstract

AIM: To evaluate sertraline, a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia.

METHODS: Consecutive tertiary hospital patients with a clinical diagnosis of functional dyspepsia (FD) according to the Rome II criteria with a Hong Kong dyspepsia index (HKDI) of greater than 16 were recruited. Patients commenced enrolment prior to the inception of the Rome III criteria for functional dyspepsia. All patients were ethnic Chinese, had a normal upper endoscopy and were Helicobacter pylori negative prior to enrolment. Study patients were randomized to receive sertraline 50 mg or placebo daily for 8 wk. HKDI symptom scores, quality of life, hospital anxiety and depression (HAD) scale and global symptom relief were evaluated before, during and after treatment. Adverse effects were monitored during and after treatment.

RESULTS: A total of 193 patients were randomized in the intention to treat (ITT), and 150 patients were included in the per protocol (PP) analysis. In both the ITT and PP, there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8. In the ITT analysis, 98 and 95 patients were randomized to the sertraline and placebo groups respectively. A total of 43 patients withdrew from the study (22.3%) by week 8, with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4 (95.8%). In contrast, in the placebo arm, 11 of 19 patients dropped out by week 4 (57.9%). Utilizing the last response carried forward to account for the drop-outs, there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI, HKDI 26.08 ± 6.19 vs 26.70 ± 5.89, P = 0.433; and at week 8, HKDI 22.41 ± 6.36 vs 23.25 ± 7.30, P = 0.352 respectively. In the PP analysis, 74 and 76 patients were randomized to the sertraline and placebo groups respectively. At baseline, there were no statistically significant differences between the sertraline and placebo groups, HKDI 25.83 ± 6.313 vs 27.19 ± 5.929 respectively, P = 0.233; however by week 8, patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo, HKDI 20.53 ± 6.917 vs 23.34 ± 7.199, P = 0.02, respectively). There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the ITT or PP analysis at week 8.

CONCLUSION: This pilot study, the first to examine sertraline, a selective serotonin reuptake inhibitor, for the management of FD, did not find that it was superior to placebo.

Keywords: Dyspepsia; Chinese; Gastrointestinal diseases; Drug therapy; Sertraline; Selective serotonin re-uptake inhibitors