title: The efficacy, safety and cost-effectiveness of hydrotalcite versus esomeprazole in on-demand therapy of NERD: A multicenter, randomized, open-label study in China.
abstract: OBJECTIVE
  The aim of the study was to investigate whether hydrotalcite was comparable to esomeprazole, a proton pump inhibitor, in on-demand therapy for non-erosive reflux disease (NERD).
  
  
  METHODS
  This was a multicenter, randomized, open-label clinical trial with initial and on-demand therapy. Patients who had complete symptom relief in the initial therapy were randomized to either hydrotalcite or esomeprazole in the on-demand therapy. The percentage of patients who quit on-demand therapy in the two groups and the cost-effectiveness of the treatment were evaluated as primary end points. The rate of symptom relief and the improvement of symptom score for initial therapy and the weekly average symptom score and weekly average number of days on treatment for on-demand therapy were evaluated as secondary end points.
  
  
  RESULTS
  In total, 398 patients were recruited in the initial therapy group, among whom 253 were included in on-demand therapy, with 127 patients in the hydrotalcite group and the remaining 126 in the esomeprazole group. 14 (11.0%) patients in the hydrotalcite group and six (4.8%) in the esomeprazole group quit the on-demand therapy due to unsatisfactory symptom control (P = 0.065). Cost-effectiveness calculated as the ratio of the cost of hydrotalcite to that of esomeprazole (per person/day) was 35.3% in the on-demand therapy. Similar number of patients achieved symptom relief in both groups.
  
  
  CONCLUSIONS
  Hydrotalcite is a good option of on-demand therapy for NERD patients due to its cost-effectiveness and speed of action.
authors: Department of Gastroenterology and Hepatology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China.
authors: Ying Lian
authors: YL
authors: Xiao
authors: Yu Qiang
authors: YQ
authors: Nie
authors: Xiao Hua
authors: XH
authors: Hou
authors: Peng Yan
authors: PY
authors: Xie
authors: Jing Yuan
authors: JY
authors: Fang
authors: Yao Zong
authors: YZ
authors: Yuan
authors: Li Ya
authors: LY
authors: Zhou
authors: Nai Qing
authors: NQ
authors: Zhao
authors: Min Hu
authors: MH
authors: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000863:Antacids / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D008276:Magnesium Hydroxide / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000863:Antacids; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; C010467:hydrotalcite; D000536:Aluminum Hydroxide; D064098:Esomeprazole; D008276:Magnesium Hydroxide
keywords: effectiveness; esomeprazole sodium; gastroesophageal reflux; hydrotalcite; non-erosive reflux disease; on-demand therapy