Are the Symptoms of an NSAID-Induced Ulcer Truly Milder Than Those of an Ordinary Ulcer?

OBJECTIVE: The percentage of patients with nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin- (LDA-) induced ulcers who complain of gastrointestinal symptoms has generally been considered to be low. The aim of this study was to examine and compare the symptoms and quality of life (QOL) at peptic ulcer onset. METHODS: This study involved 200 patients who were confirmed by endoscopy to be in the acute stage of gastroduodenal ulcer (A1-H1). Patients completed a self-administered questionnaire (Global Overall Symptom score and SF-8) at ulcer onset, and data were compared between NSAIDs/LDA ulcers and non-NSAIDs/LDA ulcers. RESULTS: The upper gastrointestinal symptoms score was significantly lower for patients using LDA only (20.5 ± 9.4 in the nonusing group, 19.6 ± 8.6 in the NSAIDs-only group, 16.7 ± 11.6 in the LDA-only group, and 18.5 ± 7.2 in the NSAIDs/LDA group, P < 0.05). The QOL score (physical summary) was significantly lower in the NSAID group (42.1 ± 9.9) than in the nonusing group (47.6 ± 7.6) (P < 0.05). Patients' characteristics showed no significant differences among the groups, with the exception of age. CONCLUSION: The severity of upper abdominal symptoms at peptic ulcer onset was similar between NSAID users and nonusers.

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

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. TRIAL REGISTRATION: UMIN000005399.

Comparison of the effects of omeprazole and famotidine in treatment of upper abdominal symptoms in patients with reflux esophagitis.

PURPOSE: The purpose of this study was to compare the efficacy of proton pump inhibitor (PPI) with H(2) receptor antagonist (H(2)RA) in treatment of upper abdominal symptoms. METHODS: This was a multi-center, open study conducted at 102 hospitals in Japan. Patients with reflux esophagitis received famotidine 10 mg twice daily for 2 weeks, then omeprazole 10 mg once daily for 2 weeks. Thereafter, patients were switched to famotidine 10 mg twice daily for a third 2-weekperiod, provided those with a medical condition agreed to continue the study. Patients evaluated the treatment response to each gastrointestinal symptom using a predefined patient questionnaire and gastrointestinal symptom rating scale (GSRS). RESULTS: 161 patients entered the study, of whom 8 were excluded from all analyses due to lack of participation following entry. Overall symptom improvement rate (n = 130) at week 4, after the 2-week omeprazole treatment, was 75.4% and this was significantly higher than that after the first 2-week famotidine treatment (41.5%) at week 2. In patients (n = 36) who completed 6 weeks of treatment, 2-week omeprazole treatment at week 4 showed a significantly higher overall symptom improvement rate compared with both the first 2-week and third 2-week famotidine treatments. CONCLUSIONS: Omeprazole was superior to famotidine for treatment of upper abdominal symptoms in patients with reflux esophagitis, which suggested that gastric acid might be a cause not only of reflux symptoms, but also of ulcer symptoms and dysmotility symptoms such as epigastric pain and feeling of fullness in reflux esophagitis.