OBJECTIVE: To evaluate clinical, Quality of Life (QoL) and medical cost outcomes in patients with symptomatic reflux esophagitis (RE) receiving different "triple combination therapy". METHODS: A multicenter medical effectiveness trial conducted in 10 hospitals of 5 regions in Zhejiang Province. 248 patient-volunteers were assigned to 8 weeks of "triple combination therapy" with Lansoprazole plus Cisapride and Sucralfate or Ranitidine plus Cisapride and Sucralfate. Main outcomes assessment included symptoms scale scores, RE severity, QoL at baseline and 8 weeks. Medical cost data were collected with cost analysis questionnaire. RESULTS: (1) More Lansoprazole group patients noted RE symptoms resolution than Ranitidine group (92.3% vs 78.4%, P<0.01). There was no striking difference between two groups in RE healing rate (90.8% vs 82.9%, P>0.05). (2) RE significantly impaired QoL of patients (P<0.001). Compared with Ranitidine group, QoL in Lansoprazole group had significant improvement (rate of "good" QoL 64.5% vs 45.6%, P<0.01). (3) There was close correlation between symptomic effectiveness and QoL rating scale in both the Lansoprazole and Ranitidine group (P<0.01, r=0.235 and 0.353 respectively). There were no statistical difference of medical cost between the two groups (P>0.05). CONCLUSION:RE significantly impaired QoL of patients. "Triple combination therapies" can significantly improve RE symptoms and QoL. Lansoprazole combination therapy was more cost-effective than Ranitidine combination group.
RCT Entities:
OBJECTIVE: To evaluate clinical, Quality of Life (QoL) and medical cost outcomes in patients with symptomatic reflux esophagitis (RE) receiving different "triple combination therapy". METHODS: A multicenter medical effectiveness trial conducted in 10 hospitals of 5 regions in Zhejiang Province. 248 patient-volunteers were assigned to 8 weeks of "triple combination therapy" with Lansoprazole plus Cisapride and Sucralfate or Ranitidine plus Cisapride and Sucralfate. Main outcomes assessment included symptoms scale scores, RE severity, QoL at baseline and 8 weeks. Medical cost data were collected with cost analysis questionnaire. RESULTS: (1) More Lansoprazole group patients noted RE symptoms resolution than Ranitidine group (92.3% vs 78.4%, P<0.01). There was no striking difference between two groups in RE healing rate (90.8% vs 82.9%, P>0.05). (2) RE significantly impaired QoL of patients (P<0.001). Compared with Ranitidine group, QoL in Lansoprazole group had significant improvement (rate of "good" QoL 64.5% vs 45.6%, P<0.01). (3) There was close correlation between symptomic effectiveness and QoL rating scale in both the Lansoprazole and Ranitidine group (P<0.01, r=0.235 and 0.353 respectively). There were no statistical difference of medical cost between the two groups (P>0.05). CONCLUSION: RE significantly impaired QoL of patients. "Triple combination therapies" can significantly improve RE symptoms and QoL. Lansoprazole combination therapy was more cost-effective than Ranitidine combination group.