ABSTRACT
Objective To evaluate the clinical efficacy and safety of hydrotalcite chewable tablets in treatment of patients with functional dyspepsia epigastric pain syndrome(EPS), and to investigate the onset time of hydrotalcite after the first dosage and whether use of hydrotalcite in EPS is a costeffective strategy. Methods A multicenter, randomized, open, positive controlled clinical trial was carried out in 240 patients with EPS. The subjects randomly received eigher hydrotalcite or omeprazole for 2 weeks. The improvemcnt and the disappear time of symptoms were evaluated before and after treatment and cost-effective was analyzed between two groups. Results It was demonstrated that both hydrotalcite and omeprazole could relief symptoms after treatment. After treatment for 2 weeks, the total effective rate was 85. 71% in hydrotalcite group and 90. 43% in omeprazole group with no significant difference (P＞0.05). The median onset time of hydrotalcite after first dosage was 0.417 h. The overall direct cost per patient was RMB ￥122. 29 for hydrotalcite treatment and RMB ￥242.95 for omeprazole treatment. The main adverse events included diarrhea, thirst, bloating,headache and belching. No severe adverse event was found in two groups. Conclusions Hydrotalcite has fast effect on relief of EPS symptoms. Use of hydrotalcite is a cost-effective strategy in the management of EPS. It is a safe and effective medicine in treatment of EPS.