Korean J Gastroenterol.  2015 Jul;66(1):17-26. 10.4166/kjg.2015.66.1.17.

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

• Shim YK
• Lee JY
• Kim N
• Park YH
• Yoon H
• Shin CM
• Park YS
• Lee DH

• KMID: 2373307
• DOI: http://doi.org/10.4166/kjg.2015.66.1.17

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.)(R) is a new prokinetic herbal medicine. The aim of the present study is to determine the efficacy and safety of Benachio Q soln.(R) 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.(R) 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.(R) seems to improve the symptoms of PDS subtype in FD and could be used safely. Further larger trial is needed in the future.

Keyword

Functional dyspepsia; Herbal medicine; Efficacy; Safety

MeSH Terms

Adult
Double-Blind Method
Drug Administration Schedule
Dyspepsia/*drug therapy/pathology
Female
Gastrointestinal Agents/*therapeutic use
*Herbal Medicine
Humans
Male
Middle Aged
Pilot Projects
Placebo Effect
Postprandial Period
Severity of Illness Index
Treatment Outcome
Gastrointestinal Agents

Figure

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  Fig. 1. Flow chart of pilot study. ITT, intention-to-treat; PP, per-protocol.

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  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.

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  Fig. 3. Changes in severity (A) and total score (B) of postprandial fullness in Benachio group and placebo group.

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  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.

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  Fig. 5. Changes in severity (A) and total score (B) of epigastric pain in Benachio group and placebo group.

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  Fig. 6. Gastric emptying times in Benachio group and placebo group. There was no significantly difference.

Reference

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