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Logo of bmcgastBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Gastroenterology
BMC Gastroenterol. 2012; 12: 42.
Published online May 1, 2012. doi:  10.1186/1471-230X-12-42
PMCID: PMC3419613
Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
Kouichi Sakurai,corresponding author1 Akihito Nagahara,2 Kazuhiko Inoue,3,24 Junichi Akiyama,4 Katsuhiro Mabe,5,25 Junichi Suzuki,6 Yasuki Habu,7 Akihiro Araki,8 Tsuyoshi Suzuki,9 Katsuaki Satoh,10 Haruhiko Nagami,11 Ryosaku Harada,12 Nobuo Tano,13 Masayasu Kusaka,14 Yasuhiko Fujioka,15 Toshikatsu Fujimura,16 Nobuyuki Shigeto,17 Tsuneyo Oumi,18 Jun Miwa,19 Hiroto Miwa,20 Kazuma Fujimoto,21 Yoshikazu Kinoshita,22 and Ken Haruma23
1Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan
2Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
3Internal Medicine, Matsue Red Cross Hospital, Matsue, Japan
4Department of Gastroenterology, International Medical Centre, Tokyo, Japan
5Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata, Japan
6Department of Gastroenterology, KKR Sapporo Medical Center, Sapporo, Japan
7Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan
8Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
9Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
10Satoh Gastrointestinal Surgical Hospital, Kurashiki, Japan
11Nagami Clinic, Unnan, Japan
12Gastrointestinal Division, Harada Internal Medicine, Tosu, Japan
13Department of Internal Medicine, Kyoritsu Hospital, Kawanishi, Japan
14Kusaka Hospital, Bizen, Japan
15Fujioka Hospital, Saga, Japan
16Yamaguchi Hospital, Imari, Japan
17Department of Internal Medicine, Tamano City Hospital, Tamano, Japan
18Ooumi Clinic, Tsuyama, Japan
19Department of Internal Medicine, Toshiba Hospital, Tokyo, Japan
20Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
21Department of Internal Medicine, Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan
22Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan
23Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan
24Department of General Medicine, Kawasaki Medical School, Kurashiki, Japan
25Department of Gastroenterology, Hokkaido University, Sapporo, Japan
corresponding authorCorresponding author.
Kouichi Sakurai: sakurai/at/; Akihito Nagahara: j-dyspepsia/at/; Kazuhiko Inoue: j-dyspepsia/at/; Junichi Akiyama: j-dyspepsia/at/; Katsuhiro Mabe: j-dyspepsia/at/; Junichi Suzuki: j-dyspepsia/at/; Yasuki Habu: j-dyspepsia/at/; Akihiro Araki: j-dyspepsia/at/; Tsuyoshi Suzuki: j-dyspepsia/at/; Katsuaki Satoh: j-dyspepsia/at/; Haruhiko Nagami: j-dyspepsia/at/; Ryosaku Harada: j-dyspepsia/at/; Nobuo Tano: j-dyspepsia/at/; Masayasu Kusaka: j-dyspepsia/at/; Yasuhiko Fujioka: j-dyspepsia/at/; Toshikatsu Fujimura: j-dyspepsia/at/; Nobuyuki Shigeto: j-dyspepsia/at/; Tsuneyo Oumi: j-dyspepsia/at/; Jun Miwa: j-dyspepsia/at/; Hiroto Miwa: j-dyspepsia/at/; Kazuma Fujimoto: j-dyspepsia/at/; Yoshikazu Kinoshita: j-dyspepsia/at/; Ken Haruma: j-dyspepsia/at/
Received March 11, 2011; Accepted May 1, 2012.
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.
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.
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.
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.
Trial registration
Keywords: Omeprazole, Famotidine, Mosapride, Teprenone, Uninvestigated upper gastrointestinal symptoms
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