title: Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS).
abstract: BACKGROUND
  In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms.
  
  
  METHODS
  This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399.
  
  
  RESULTS
  Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events.
  
  
  CONCLUSIONS
  The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy.
  
  
  BACKGROUND
  UMIN000005399.
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto 860-8556, Japan. sakurai@s3.kcn-tv.ne.jp
authors.forename: Kouichi
authors.initials: K
authors.lastname: Sakurai
authors.forename: Akihito
authors.initials: A
authors.lastname: Nagahara
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Inoue
authors.forename: Junichi
authors.initials: J
authors.lastname: Akiyama
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Mabe
authors.forename: Junichi
authors.initials: J
authors.lastname: Suzuki
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Habu
authors.forename: Akihiro
authors.initials: A
authors.lastname: Araki
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Suzuki
authors.forename: Katsuaki
authors.initials: K
authors.lastname: Satoh
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Nagami
authors.forename: Ryosaku
authors.initials: R
authors.lastname: Harada
authors.forename: Nobuo
authors.initials: N
authors.lastname: Tano
authors.forename: Masayasu
authors.initials: M
authors.lastname: Kusaka
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Fujioka
authors.forename: Toshikatsu
authors.initials: T
authors.lastname: Fujimura
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Shigeto
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Oumi
authors.forename: Jun
authors.initials: J
authors.lastname: Miwa
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Kazuma
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.forename: Ken
authors.initials: K
authors.lastname: Haruma
mesh_terms: D000465:Algorithms; D001549:Benzamides / Q000494:pharmacology / Q000627:therapeutic use*; D004224:Diterpenes / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004415:Dyspepsia / Q000188:drug therapy*; D015738:Famotidine / Q000494:pharmacology / Q000627:therapeutic use*; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D019983:Guideline Adherence; D006801:Humans; D007564:Japan; D009025:Morpholines / Q000494:pharmacology / Q000627:therapeutic use*; D009853:Omeprazole / Q000494:pharmacology / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome; D041742:Upper Gastrointestinal Tract / Q000187:drug effects / Q000503:physiopathology*
chemical_list: D001549:Benzamides; D004224:Diterpenes; D009025:Morpholines; D054328:Proton Pump Inhibitors; D015738:Famotidine; C062720:mosapride; D009853:Omeprazole; C031049:geranylgeranylacetone