Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease

Abstract

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). 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. 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. Topaal is more effective than Nacid for the treatment of symptoms presented by patients with ENRD.