Abstract | OBJECTIVE: The etiologies of functional dyspepsia (FD) are unclear, but in some studies, treatment with a proton pump inhibitor has been beneficial. The objective of this study was to evaluate the efficacy of esomeprazole 40 mg once a day compared to placebo in achieving symptom relief in primary care patients with FD. METHODS: This was a randomized, placebo-controlled trial in adult FD patients, who had at least moderate severity of symptoms, defined as a score of > or =4 on a 7-point Global Overall Symptom (GOS) scale. Patients were excluded if they had predominant symptoms of heartburn or regurgitation; after a normal baseline endoscopy, patients were randomized to esomeprazole 40 mg once daily or placebo for 8 wk. The primary outcome measure was symptom relief (GOS < or =2) at 8 wk. RESULTS: Of the 502 enrolled patients, 224 were randomized. The main reasons for exclusion were abnormal endoscopic findings, especially esophagitis. A significantly greater proportion of patients in the esomeprazole group achieved symptom relief at 4 but not at 8 wk compared to placebo: 4 wk esomeprazole 50.5% versus placebo 32.2%, p= 0.009; 8 wk esomeprazole 55.1% versus placebo 46.1%, p= 0.16. A similar relationship at 4 and 8 wk was seen for symptom resolution (GOS = 1) and improvement (DeltaGOS > or =2). CONCLUSION: For the primary outcome measure of symptom relief at 8 wk, there was no statistically significant difference between esomeprazole 40 mg once a day and placebo. However, at 4 wk, esomeprazole was significantly more effective than placebo for symptom relief. The difference in therapeutic gain between 4 and 8 wk was largely due to a higher placebo response rate at 8 wk.
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Authors | Sander Veldhuyzen van Zanten, David Armstrong, Naoki Chiba, Nigel Flook, Robert J White, Bijan Chakraborty, Ally Gasco |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 101
Issue 9
Pg. 2096-106
(Sep 2006)
ISSN: 0002-9270 [Print] United States |
PMID | 16817845
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Ulcer Agents
- Esomeprazole
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Topics |
- Administration, Oral
- Adult
- Aged
- Anti-Ulcer Agents
(administration & dosage, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Dyspepsia
(diagnosis, drug therapy)
- Endoscopy, Gastrointestinal
- Esomeprazole
(administration & dosage, therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Quality of Life
- Severity of Illness Index
- Treatment Outcome
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