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- Title
Adding Acotiamide to Gastric Acid Inhibitors Is Effective for Treating Refractory Symptoms in Patients with Non-erosive Reflux Disease.
- Authors
Yamashita, Hiroshi; Okada, Akihiko; Naora, Kohji; Hongoh, Masafumi; Kinoshita, Yoshikazu
- Abstract
<bold>Background: </bold>Approximately 30% of patients who are treated with proton pump inhibitors (PPIs) for gastroesophageal reflux disease (GERD) experience persistent symptoms. No prokinetic agent regiments are useful for symptom relief.<bold>Aims: </bold>This study was conducted to examine the effect of adding acotiamide to PPI or vonoprazan refractory GERD.<bold>Methods: </bold>This was a randomized, prospective, double-blind, placebo-controlled trial. Seventy-one patients were enrolled. Patients underwent upper endoscopy before initial therapy [15 reflux esophagitis and 55 non-erosive reflux disease (NERD)]. Patients with persistent reflux symptoms were administered 300 mg/day acotiamide or placebo for 2 weeks. The primary endpoint was overall treatment effect (OTE), and gastrointestinal symptoms were evaluated. High-resolution manometry (HRM) and 24-h multiple intraluminal impedance-pH (MII-pH) monitoring were conducted before and after treatment when possible.<bold>Results: </bold>Seventy patients were randomized (35 acotiamide and 35 placebo). Sixteen and 10 patients in the acotiamide and placebo groups, respectively, completed MII-pH and HRM. The OTE improvement rates were 28.6% and 14.3% in patients administered acotiamide and placebo, respectively (p = 0.145). In patients with NERD, however, the OTE improvement rate and responder rate for regurgitation in the acotiamide group was significantly higher than those in the placebo group (29.6 vs. 7.1%; p = 0.030, 37.0 vs. 10.7%; p = 0.021, respectively). Acotiamide significantly reduced the total reflux episodes (p = 0.001), acid (p = 0.020), proximal reflux (p = 0.007), and liquid reflux (p = 0.013) episodes.<bold>Conclusion: </bold>Adding acotiamide to gastric acid inhibitors can improve symptoms in patients with refractory NERD.
- Subjects
JAPAN; HEARTBURN; NON-erosive reflux disease; GASTRIC acid; SYMPTOMS; PROTON pump inhibitors; RESEARCH; COMBINATION drug therapy; MANOMETERS; TIME; RESEARCH methodology; EVALUATION research; TREATMENT effectiveness; PATIENT monitoring; COMPARATIVE studies; RANDOMIZED controlled trials; BLIND experiment; BENZAMIDE; ESOPHAGUS diseases; THIAZOLES; LONGITUDINAL method; DISEASE remission; DISEASE complications
- Publication
Digestive Diseases & Sciences, 2019, Vol 64, Issue 3, p823
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-018-5377-9