Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease
Journal
World Journal of Gastroenterology
Journal Volume
12
Journal Issue
5
Pages
747-754
Date Issued
2006
Author(s)
Abstract
Aim: To assess the efficacy and safety of a compound containing alginic acid plus antacid (Topaal?) compared to equal-strength antacid (Nacid?) in patients with endoscopy-negative reflux disease (ENRD). Methods: A total of 121 patients with ENRD were randomized to receive Topaal? (65 patients) or Nacid? (56 patients) for 6 weeks, with a consultation every 3 weeks. The primary end-point assessment was the change in the severity of heartburn as evaluated using a visual analog scale (VAS) at 6 weeks. The secondary end-point assessments were the VAS at 3 weeks, the change of frequency of the reflux symptom, the change of quality of life and the adverse effects. Results: Demographics of randomized subjects in each treatment group were comparable except that the Topaal? group included more males. The baseline characteristics between the groups were similar. After 6 weeks of treatment, the reduction of VAS of heartburn was more prominent in the Topaal? group (-6.29 cm vs -4.11 cm). At the 3rd week, Topaal? group showed greater reduction of VAS for heartburn (P = 0.0016), regurgitation (P = 0.0006), vomiting (P = 0.0373), and belching (P<0.0001). The patients of the Topaal? group had lower frequency of heartburn (P = 0.0015) and pain (P = 0.0163) at the end of the 6-week treatment period. From the doctor's point of view, the Topaal? group also showed significant reduction in the severity of heartburn (P = 0.0020), regurgitation (P = 0.0081), vomiting (P = 0.0182), and belching (P = 0.0018) at the end of the treatment. The improvement of the quality of life was more remarkable in the Topaal? group at the end of the 6-week treatment period (P<0.0001). For the adverse effect, there was no difference in both the groups. Conclusion: Topaal? is more effective than Nacid? for the treatment of symptoms presented by patients with ENRD. ? 2006 The WJG Press. All rights reserved.
SDGs
Other Subjects
alginic acid; alginic acid plus aluminum hydroxide plus magnesium hydrocarbonate; aluminum hydroxide; antacid agent; gastrointestinal agent; magnesium derivative; magnesium hydrocarbonate; nacid; topaal; unclassified drug; adult; article; clinical trial; constipation; controlled clinical trial; controlled study; demography; diarrhea; digestive tract endoscopy; disease severity; drug efficacy; drug safety; female; frequency analysis; gastroesophageal reflux; heartburn; human; major clinical study; male; prospective study; quality of life; randomized controlled trial; sex difference; symptomatology; visual analog scale; vomiting
Publisher
WJG Press
Type
journal article