Clinical Research
Copyright ©2006 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Feb 7, 2006; 12(5): 747-754
Published online Feb 7, 2006. doi: 10.3748/wjg.v12.i5.747
Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease
I-Rue Lai, Ming-Shiang Wu, Jaw-Town Lin
I-Rue Lai, Department of Surgery, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan, China
Ming-Shiang Wu, Jaw-Town Lin, Division of Gastroenterology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan, China
First author: I-Rue Lai
Correspondence to: Dr Ming-Shiang Wu, Division of Gastroenterology, Department of Internal Medicine, National Taiwan University Hospital, No. 7, Chun-San South Road, Taipei, Taiwan, China. stanley@ha.mc.ntu.edu.tw
Telephone: +886-2-23123456 extn. 6651
Received: May 4, 2005
Revised: May 9, 2005
Accepted: June 9, 2005
Published online: February 7, 2006
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.

Keywords: Alginic acid; Endoscopy-negative reflux disease