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

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.