The effect of sequential therapy with lansoprazole and ecabet sodium in treating iatrogenic gastric ulcer after endoscopic submucosal dissection: a randomized prospective study
Abstract
OBJECTIVE: Ecabet sodium (ES) is a new non-systemic anti-ulcer agent belonging to the category of gastroprotective agents. In this study we aimed to compare the efficacy of a combination therapy with lansoprazole (LS) followed by ES with LS alone in treating endoscopic submucosal dissection (ESD)-induced iatrogenic gastric ulcers.
METHODS: Patients diagnosed with gastric adenomas or early gastric cancer were randomly divided into either the LS group (30 mg once daily for 4 weeks; n = 45) or the LS + ES group (LS 30 mg once daily for one week followed by ES 1500 mg twice daily for 3 weeks; n = 45). Four weeks after ESD, a follow-up endoscopy was conducted to evaluate the proportions of ulcer reduction and ulcer stages in the two groups.
RESULTS: In all, 79 patients were included in the final analyses. Both treatment modalities were well-tolerated in most patients, with a drug compliance of over 80%. There were no significant differences between the two groups in terms of the proportions of ulcer reduction (0.9503 ± 0.1215 in the LS group vs 0.9192 ± 0.0700 in the LS + ES group, P = 0.169) or ulcer stage (P = 0.446). The prevalence of adverse events related to drugs and bleeding were also similar between the two groups.
CONCLUSION: Sequential therapy with LS + ES is as effective as LS alone against ESD-induced gastric ulcers.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 79 participants or records.
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