Young Kwang Shim; Ju Yup Lee; Nayoung Kim; Yo Han Park; Hyuk Yoon; Cheol Min Shin; Young Soo Park; Dong Ho Lee

doi:10.4166/kjg.2015.66.1.17

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Shim, Lee, Kim, Park, Yoon, Shin, Park, and Lee: Efficacy and Safety of New Prokinetic Agent Benachio Q Solution® in Patients with Postprandial Distress Syndrome Subtype in Functional Dyspepsia: A Single-center, Randomized, Double-blind, Placebo-controlled Pilot Study

Original Article

Korean J Gastroenterol 2015;66(1):17-26.

Published online: 4 October 2015

DOI: https://doi.org/10.4166/kjg.2015.66.1.17

Efficacy and Safety of New Prokinetic Agent Benachio Q Solution^® in Patients with Postprandial Distress Syndrome Subtype in Functional Dyspepsia: A Single-center, Randomized, Double-blind, Placebo-controlled Pilot Study

Young Kwang Shim^1,^*, Ju Yup Lee^2,^*, Nayoung Kim^1,³, Yo Han Park¹, Hyuk Yoon¹, Cheol Min Shin¹, Young Soo Park¹, Dong Ho Lee^1,³

¹Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

²Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea

³Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea

Correspondence to: Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 463-707, Korea. Tel: +82-31-787-7008, Fax: +82-31-787-4051, E-mail: nayoungkim49@empas.com

^* These two authors have equally contributed to this work.

Financial support: This work was supported by grant no 06–2013–115 from the Seoul National University Bundang Hospital Research fund. Conflict of interest: None.

Received 23 April 2015 Revised 18 May 2015 Accepted 1 June 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims

Functional dyspepsia (FD) is a gastrointestinal disorder in which the patient suffers from chronic abdominal symptoms despite the absence of organic disease. Benachio Q solution (soln.)^® is a new prokinetic herbal medicine. The aim of the present study is to determine the efficacy and safety of Benachio Q soln.^® in patients with postprandial distress syndrome (PDS) subtype in FD.

Methods

A single-center, randomized, double-blind, placebo-controlled pilot study was performed in 20 patients with PDS. Patients were assigned to receive either Benachio Q soln.^® or placebo three times a day. After 4 weeks of treatment, the data on response rates, symptoms severity of PDS and gastric emptying time were analyzed to evaluate its efficacy. Adverse events, laboratory tests and vital sign were analyzed to assess its safety.

Results

Nine patients were assigned to Benachio group and 10 patients to placebo group. The response rate after 4 weeks was 44.4% and 20.0% in Benachio and placebo group, respectively (p=0.350). The response rate during the first week in Benachio group was better compared to that of placebo group with marginal difference (33.3% vs. 0.0%, p=0.087). Changes of severity score in early satiety on second and third week were −1.8±0.6, −1.9±0.4 and −1.3±0.5, −1.4±0.6 in Benachio and placebo group, respectively (p=0.059 vs. p=0.033). No adverse event was observed.^®

Conclusions

The new herbal drug, Benachio Q soln.^® seems to improve the symptoms of PDS subtype in FD and could be used safely. Further larger trial is needed in the future.

Keywords: Functional dyspepsia, Herbal medicine, Efficacy, Safety

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Fig. 1.

Flow chart of pilot study. ITT, intention-to-treat; PP, per-protocol.

Fig. 2.

Response rates in Benachio group and placebo group during 4 weeks (A) and in each week (B). During the first week, the response rate in Benachio group was significantly higher than that in placebo group (p=0.087).*p<0.1.

Fig. 3.

Changes in severity (A) and total score (B) of postprandial fullness in Benachio group and placebo group.

Fig. 4.

Changes in severity (A) and total score (B) of early satiety in Benachio group and placebo group. During second and third weeks, changes in severity of early satiety in Benachio group were significantly larger than in placebo group (p=0.059, p=0.033). *p<0.1, **p<0.05.

Fig. 5.

Changes in severity (A) and total score (B) of epigastric pain in Benachio group and placebo group.

Fig. 6.

Gastric emptying times in Benachio group and placebo group. There was no significantly difference.

Table 1.

Baseline Characteristics of the Study Population

Variable	Benachio group	Placebo group	p-value
Patient (n)	9	10
Age (yr)	50.2±14.9	36.3±10.9	0.032 ^a
Sex
Male	2 (22.2)	0 (0)	0.211 ^b
Female	7 (77.8)	10 (100)
Hight (cm)	159.9±10.7	160±7.5	0.979 ^a
Weight (kg)	59.1±11.4	60.4±13.2	0.935 ^c
BMI (kg/m²)	23.0±2.9	23.5±4.3	0.789 ^a
Smoking
Never	8 (88.9)	10 (100)	0.474 ^b
Ex-smoker	0	0
Current	1 (11.1)	0
Alcohol
None	7 (77.8)	9 (90)	0.721 ^b
Past	1 (11.1)	0 (0)
Current	1 (11.1)	1 (10)
Test of Helicobacter pylori
Rapid urease test	7 (77.8)	8 (80)	1.000 ^b
Urea breath test	2 (22.2)	2 (20)
Result of Helicobacter pylori
Positive	2 (22.2)	4 (40)	0.629 ^b
Negative	7 (77.8)	6 (60)

Values are presented as n only, mean±SD, or n (%).

^a Two sample t-test

^b Fisher's exact test

^c Wilcoxon's rank sum test.

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