Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
1 Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan
2 Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
3 Internal Medicine, Matsue Red Cross Hospital, Matsue, Japan
4 Department of Gastroenterology, International Medical Centre, Tokyo, Japan
5 Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata, Japan
6 Department of Gastroenterology, KKR Sapporo Medical Center, Sapporo, Japan
7 Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan
8 Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
9 Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
10 Satoh Gastrointestinal Surgical Hospital, Kurashiki, Japan
11 Nagami Clinic, Unnan, Japan
12 Gastrointestinal Division, Harada Internal Medicine, Tosu, Japan
13 Department of Internal Medicine, Kyoritsu Hospital, Kawanishi, Japan
14 Kusaka Hospital, Bizen, Japan
15 Fujioka Hospital, Saga, Japan
16 Yamaguchi Hospital, Imari, Japan
17 Department of Internal Medicine, Tamano City Hospital, Tamano, Japan
18 Ooumi Clinic, Tsuyama, Japan
19 Department of Internal Medicine, Toshiba Hospital, Tokyo, Japan
20 Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
21 Department of Internal Medicine, Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan
22 Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan
23 Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan
24 Department of General Medicine, Kawasaki Medical School, Kurashiki, Japan
25 Department of Gastroenterology, Hokkaido University, Sapporo, Japan
BMC Gastroenterology 2012, 12:42 doi:10.1186/1471-230X-12-42Published: 1 May 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.