title: [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].
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Young Kwang
authors.initials: YK
authors.lastname: Shim
authors.affiliation: Department of Internal Medicine, Keimyung University School of Medicine, Daegu,Korea.
authors.forename: Ju Yup
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.|Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Na Young
authors.initials: NY
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Yo Han
authors.initials: YH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Hyuk
authors.initials: H
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Cheol Min
authors.initials: CM
authors.lastname: Shin
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Young Soo
authors.initials: YS
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.|Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004415:Dyspepsia / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D029001:Herbal Medicine; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D015990:Placebo Effect; D019518:Postprandial Period; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents
keywords: Efficacy; Functional dyspepsia; Herbal medicine; Safety