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.
- Author:
Young Kwang SHIM
1
;
Ju Yup LEE
;
Nayoung KIM
;
Yo Han PARK
;
Hyuk YOON
;
Cheol Min SHIN
;
Young Soo PARK
;
Dong Ho LEE
Author Information
- Publication Type:Clinical Trial ; English Abstract ; Original Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords: Functional dyspepsia; Herbal medicine; Efficacy; Safety
- MeSH: 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
- From:The Korean Journal of Gastroenterology 2015;66(1):17-26
- CountryRepublic of Korea
- Language:Korean
- 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.
