BACKGROUND:Endoscopic submucosal dissection (ESD) is useful for treating gastric tumors. Several trials have shown the efficacy of 4 or 8 weeks of proton pump inhibitor (PPI) administration for post-ESD ulcers. However, if the size of the post-ESD ulcer is larger than predicted, PPI administration alone might not be sufficient for the ulcer to heal within 4 weeks. We examined the efficacy of a combination therapy of PPI and rebamipide, a mucosal-protective antiulcer drug, on the acceleration of post-ESD ulcer healing. METHODS: Patients were randomly assigned to either the PPI and rebamipide therapy or the PPI alone. Sixty-two consecutive patients with gastric tumors gave informed consent for enrolling in the study. In all cases, the estimated size of the post-ESD ulcer was larger than 20 mm. Oral administration of the drug was started on the 2nd day post-ESD and continued to the 28th day. RESULTS: All patients received the assigned pharmaceuticals and adhered well to the treatment regimen for 28 days. The endpoint ulcers reached S1 (scar stage) in 11/31 (36%) patients in the PPI-only group and in 21/31 (68%) in the combination group (P = 0.010). CONCLUSIONS: The combination of PPI plus rebamipide was more effective than the PPI alone for treating ulcers larger than 20 mm within 4 weeks after ESD.
RCT Entities:
BACKGROUND: Endoscopic submucosal dissection (ESD) is useful for treating gastric tumors. Several trials have shown the efficacy of 4 or 8 weeks of proton pump inhibitor (PPI) administration for post-ESD ulcers. However, if the size of the post-ESD ulcer is larger than predicted, PPI administration alone might not be sufficient for the ulcer to heal within 4 weeks. We examined the efficacy of a combination therapy of PPI and rebamipide, a mucosal-protective antiulcer drug, on the acceleration of post-ESD ulcer healing. METHODS:Patients were randomly assigned to either the PPI and rebamipide therapy or the PPI alone. Sixty-two consecutive patients with gastric tumors gave informed consent for enrolling in the study. In all cases, the estimated size of the post-ESD ulcer was larger than 20 mm. Oral administration of the drug was started on the 2nd day post-ESD and continued to the 28th day. RESULTS: All patients received the assigned pharmaceuticals and adhered well to the treatment regimen for 28 days. The endpoint ulcers reached S1 (scar stage) in 11/31 (36%) patients in the PPI-only group and in 21/31 (68%) in the combination group (P = 0.010). CONCLUSIONS: The combination of PPI plus rebamipide was more effective than the PPI alone for treating ulcers larger than 20 mm within 4 weeks after ESD.
Authors: Y Yamaguchi; N Katsumi; M Tauchi; M Toki; K Nakamura; K Aoki; Y Morita; M Miura; K Morozumi; H Ishida; S Takahashi Journal: Aliment Pharmacol Ther Date: 2005-06 Impact factor: 8.171