Randomized Controlled Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Feb 6, 2017; 8(1): 74-80
Published online Feb 6, 2017. doi: 10.4292/wjgpt.v8.i1.74
Itopride for gastric volume, gastric emptying and drinking capacity in functional dyspepsia
Shahab Abid, Wasim Jafri, Maseeh Uz Zaman, Rakhshanda Bilal, Safia Awan, Aamir Abbas
Shahab Abid, Wasim Jafri, Safia Awan, Aamir Abbas, Department of Medicine, Aga Khan University, Karachi 74800, Pakistan
Maseeh Uz Zaman, Department of Radiology, Aga Khan University, Karachi 74800, Pakistan
Rakhshanda Bilal, Pakistan Atomic Energy Commission, Islamabad 44000, Pakistan
Author contributions: Abid S and Jafri W designed the study and supervised the execution of the study; Zaman MU and Bilal R contributed to the research protocol to measure gastric accommodation, gastric emptying and conduct satiety drinking capacity test; Zaman MU and Bilal R also supervised the execution of these measurements during this study; Awan S did the statistical analysis of the data; Abbas A contributed to the design and execution of the study; all contributed to the write up of the manuscript.
Supported by Higher Education Commission Pakistan, No. 20-1051/R&D/2007.
Institutional review board statement: The study is given an approval for a period of one year.
Clinical trial registration statement: The study is registered at https://clinicaltrials.gov/ct2/show/NCT01226134?term=itopride&rank=2. Registration number is NCT01226134.
Informed consent statement: All the subjects included in this study gave an informed consent before getting recruited for this study.
Conflict-of-interest statement: None.
Data sharing statement: Technical appendix and dataset available from corresponding author at shahab.abid@aku.edu.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Shahab Abid, Professor of Medicine, Head (Section of Gastroenterology), Department of Medicine, Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan. shahab.abid@aku.edu
Telephone: +92-34-930051-4656
Received: July 1, 2016
Peer-review started: August 2, 2016
First decision: September 2, 2016
Revised: October 11, 2016
Accepted: November 1, 2016
Article in press: November 2, 2016
Published online: February 6, 2017
Processing time: 175 Days and 18.3 Hours
Abstract
AIM

To study the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in functional dyspepsia (FD).

METHODS

Randomized controlled trial was conducted to check the effect of itopride on gastric accommodation, gastric emptying, capacity of tolerating nutrient liquid and symptoms of FD. We recruited a total of 31 patients having FD on the basis of ROME III criteria. After randomization, itopride was received by 15 patients while 16 patients received placebo. Gastric accommodation was determined using Gastric Scintigraphy. 13C labeled octanoic breadth test was performed to assess gastric emptying. Capacity of tolerating nutrient liquid drink was checked using satiety drinking capacity test. The intervention group comprised of 150 mg itopride. Patients in both arms were followed for 4 wk.

RESULTS

Mean age of the recruited participant 33 years (SD = 7.6) and most of the recruited individuals, i.e., 21 (67.7%) were males. We found that there was no effect of itopride on gastric accommodation as measured at different in volumes in the itopride and control group with the empty stomach (P = 0.14), at 20 min (P = 0.38), 30 min (P = 0.30), 40 min (P = 0.43), 50 min (P = 0.50), 60 min (P = 0.81), 90 min (P = 0.25) and 120 min (P = 0.67). Gastric emptying done on a sub sample (n = 11) showed no significant difference (P = 0.58) between itopride and placebo group. There was no significant improvement in the capacity to tolerate liquid in the itopride group as compared to placebo (P = 0.51). Similarly there was no significant improvement of symptoms as assessed through a composite symptom score (P = 0.74). The change in QT interval in itopride group was not significantly different from placebo (0.10).

CONCLUSION

Our study found no effect of itopride on gastric accommodation, gastric emptying and maximum tolerated volume in patients with FD.

Keywords: Itopride; Gastric emptying; Gastric accommodation; Functional dyspepsia; Dyspepsia

Core tip: Through this study we wanted to find the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in patients with functional dyspepsia (FD) in Pakistani population. The strength of our study was that we used objective measures, i.e., gastric scintigraphy and 13C labeled octanoic acid breath test to measure gastric accommodation and gastric emptying. Diagnosis of FD was based on ROME III criteria and was done after using extensive investigations to rule out organic cause for the symptoms. We found no effect of itopride on gastric accommodation, gastric emptying and maximum tolerated volume in patients with FD in our study.