[Hydrotalcite in the treatment of reflux esophagitis: a multicenter clinical study].

OBJECTIVE

To investigate the effect of hydrotalcite on reflux esophagitis.

METHODS

45 patients with endoscopically proven reflux esophagitis were enrolled in 6 Chinese hospitals. All the patients were randomly divided into two groups. 25 patients were allocated to a study group; hydrotalcite was given 1.0 g four times daily for 6 weeks. The remaining 20 patients were allocated to a control group; omeprazole was given 20 mg twice daily in the first 2 weeks and 20 mg once daily in the following 4 weeks. Reflux symptoms including heartburn, regurgitation and chest pain were evaluated during visits after 1, 2, 4 and 6 weeks. At the end of 6 weeks, endoscopy was performed to study the healing rate. Monitoring of esophageal 24-hour pH and bilirubin was performed in 17 patients of the study group and 13 patients of the control group respectively.

RESULTS

Both hydrotalcite and omeprazole could improve the reflux symptoms. One week after treatment the symptom scores of heartburn, regurgitation and chest pain were significantly decreased in both groups (P < 0.01) and symptom scores were decreased even more after 6 weeks. There was no significant difference between the two groups (P > 0.05). At the end of the treatment, endoscopic healing rate and effective rate was 64.28% and 78.57% respectively in the study group, being similar to that of 66.67% and 93.33% in the control group. Combined monitoring of 24-hour esophageal pH and bilirubin showed that both hydrotalcite and omeprazole could greatly decrease the total time of pH < 4, total time percentage of pH < 4, total time of bilirubin absorption > or = 0.14 and total time percentage of bilirubin absorption > or = 0.14. After treatment, the results of 24-hour esophageal pH and bilirubin combined monitoring became normal in 5 patients (29.41%) of the study group, while the results became normal in 10 patients (76.92%) of the control group (P < 0.05).

CONCLUSION

Hydrotalcite is an effective medication for the treatment of reflux esophagitis.