Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

BMC Gastroenterology

Research Article

Kouichi Sakurai¹  Akihiro Araki²  Yoshikazu Kinoshita³  Junichi Akiyama⁴  Akihito Nagahara⁵  Junichi Suzuki⁶  Yasuki Habu⁷  Tsuyoshi Suzuki⁸  Kazuma Fujimoto⁹  Hiroto Miwa^1,10  Nobuo Tano^1,11  Nobuyuki Shigeto^1,12  Jun Miwa^1,13  Katsuhiro Mabe^1,14  Ken Haruma^1,15  Yasuhiko Fujioka^1,16  Ryosaku Harada^1,17  Kazuhiko Inoue^1,18  Masayasu Kusaka^1,19  Haruhiko Nagami^2,20  Tsuneyo Oumi^2,21  Katsuaki Satoh^2,22  Toshikatsu Fujimura^2,23 

[1] Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, 860-8556, Kumamoto, Japan;Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan;Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan;Department of Gastroenterology, International Medical Centre, Tokyo, Japan;Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan;Department of Gastroenterology, KKR Sapporo Medical Center, Sapporo, Japan;Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan;Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan;Department of Internal Medicine, Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan;Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan;Department of Internal Medicine, Kyoritsu Hospital, Kawanishi, Japan;Department of Internal Medicine, Tamano City Hospital, Tamano, Japan;Department of Internal Medicine, Toshiba Hospital, Tokyo, Japan;Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata, Japan;Department of Gastroenterology, Hokkaido University, Sapporo, Japan;Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan;Fujioka Hospital, Saga, Japan;Gastrointestinal Division, Harada Internal Medicine, Tosu, Japan;Internal Medicine, Matsue Red Cross Hospital, Matsue, Japan;Department of General Medicine, Kawasaki Medical School, Kurashiki, Japan;Kusaka Hospital, Bizen, Japan;Nagami Clinic, Unnan, Japan;Ooumi Clinic, Tsuyama, Japan;Satoh Gastrointestinal Surgical Hospital, Kurashiki, Japan;Yamaguchi Hospital, Imari, Japan;

关键词: Omeprazole;    Famotidine;    Mosapride;    Teprenone;    Uninvestigated upper gastrointestinal symptoms;   

DOI  :  10.1186/1471-230X-12-42

 received in 2011-03-11, accepted in 2012-05-01,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsThis 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.ResultsOf 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.ConclusionsThe 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 registrationUMIN000005399.

【 授权许可】

CC BY   
© Sakurai et al; licensee BioMed Central Ltd. 2012