title: Association of baseline plasma des-acyl ghrelin level with the response to rikkunshito in patients with functional dyspepsia.
abstract: OBJECTIVE
  We recently conducted a randomized placebo-controlled trial on the efficacy and safety of rikkunshito, a standardized Japanese herbal medicine, for the treatment of functional dyspepsia (FD). The present post-hoc study aimed to evaluate the differences in clinical characteristics between responders and non-responders among FD patients who received rikkunshito for 8 weeks.
  
  
  METHODS
  Rikkunshito responders were defined by using a global patient assessment. Candidate predictors included age, gender, smoking, alcohol consumption, body mass index, comorbidity, Helicobacter pylori infection, plasma levels of acyl ghrelin and des-acyl ghrelin, severity of dyspeptic symptoms, FD subgroup, previous medication, and the type of recruiting institution (clinic or hospital). We calculated hazard ratios (HRs) by using Cox regression analysis with the factors that were indicated to be associated with responders.
  
  
  RESULTS
  We assigned 83 and 42 patients to responder and non-responder categories, respectively. Lack of alcohol consumption (HR, 2.04; 95% confidence interval, 1.08-3.88) and low plasma des-acyl ghrelin levels (< 177 fmol/mL; HR, 2.42; 95% confidence interval, 1.24-4.73) were significantly associated with the efficacy of rikkunshito. Lack of alcohol consumption was associated with the efficacy of rikkunshito especially among H. pylori-infected participants. On the other hand, the low plasma des-acyl ghrelin was associated with the efficacy of rikkunshito especially among H. pylori-negative participants.
  
  
  CONCLUSIONS
  A low baseline level of plasma des-acyl ghrelin was associated with an increased treatment efficacy of rikkunshito against FD. Lack of alcohol consumption was also clinically useful for predicting the response to rikkunshito.
authors.affiliation: Rikkunshito Study Group, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Togawa
authors.affiliation: Rikkunshito Study Group, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Juntaro
authors.initials: J
authors.lastname: Matsuzaki
authors.affiliation: National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Kobayakawa
authors.affiliation: Tokyo Eki Center Building Clinic, Tokyo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Fukushima
authors.affiliation: Yokohama Minami Kyosai Hospital, Yokohama, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Suzaki
authors.affiliation: Department of Gastroenterology, Aichi Medical University, Nagakute, Japan.
authors.forename: Kunio
authors.initials: K
authors.lastname: Kasugai
authors.affiliation: Division of Gastroenterology, National Tokyo Medical Center, Tokyo, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nishizawa
authors.affiliation: Department of Gastroenterology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Naito
authors.affiliation: Hayakawa Clinic, Tokai, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Hayakawa
authors.affiliation: Department of Gastroenterology, Nagoya City University School of Medicine, Nagoya, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kamiya
authors.affiliation: Division of Gastroenterology, Social Insurance Kyoto Hospital, Kyoto, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Andoh
authors.affiliation: Division of Gastroenterology, Eiju General Hospital, Tokyo, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Yoshida
authors.affiliation: Tokura Yoshifumi Gastroenterology Clinic, Kameoka, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Tokura
authors.affiliation: Department of Internal Medicine, Keiyu Hospital, Yokohama, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nagata
authors.affiliation: Ogikubo GI Clinic, Tokyo, Japan.
authors.forename: Mikiji
authors.initials: M
authors.lastname: Mori
authors.affiliation: Meito Hospital, Nagoya, Japan.
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Kato
authors.affiliation: Department of Biochemistry, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hosoda
authors.affiliation: Department of Public Health, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Takebayashi
authors.affiliation: Department of Gastroenterology, National Defense Medical College, Tokorozawa, Japan.
authors.forename: Soichiro
authors.initials: S
authors.lastname: Miura
authors.affiliation: Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Ichikawa, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Uemura
authors.affiliation: Department of Gastroenterology, Nagoya City University School of Medicine, Nagoya, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Joh
authors.affiliation: Rikkunshito Study Group, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
authors.affiliation: Rikkunshito Study Group, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Suzuki
mesh_terms: D000328:Adult; D000368:Aged; D000428:Alcohol Drinking / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000627:therapeutic use*; D004415:Dyspepsia / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D054439:Ghrelin / Q000097:blood*; D016481:Helicobacter Infections; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010043:Outcome and Process Assessment, Health Care; D008517:Phytotherapy; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D004365:Drugs, Chinese Herbal; D054439:Ghrelin; C084136:liu-jun-zi-tang
keywords: alcohol; dyspepsia; ghrelin; herbal medicine