Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study.
BACKGROUND: The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE, no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RB...
| Publicado en: | Clinical Therapeutics Vol. 23; no. 5; pp. 761 - 771 |
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| Autores principales: | , , , , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Elsevier B.V.
2001 May
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106850236&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106850236 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01492918 H3L jtl: Clinical Therapeutics issn: 01492918 maglogo: N pubinfo: dt: 2001 May vid: 23 iid: 5 pid: 82545 pub: Elsevier B.V. place: Philadelphia, Pennsylvania artinfo: ui: 106850236 106850236 2003095406 NLM11394734 106850236 ppf: 761 ppct: 10 formats: tig: atl: Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study. aug: au: Luzza F Giglio A Ciliberto E Belmonte A Cavaliere C Saccà N Frandina C Fiocca R Trimboli V Pallone F sug: subj: Antiulcer Agents Therapeutic Use Duodenal Ulcer Drug Therapy Helicobacter Infections Drug Therapy Adolescence Adult Aged Antiulcer Agents Adverse Effects Chi Square Test Clarithromycin Adverse Effects Clarithromycin Therapeutic Use Clinical Trials Comparative Studies Confidence Intervals Drug Therapy, Combination Female Fisher's Exact Test Male Mann-Whitney U Test Questionnaires Ranitidine Adverse Effects Ranitidine Therapeutic Use Spearman's Rank Correlation Coefficient T-Tests Funding Source Human Adolescent: 13-18 years Adult: 19-44 years Aged: 65+ years Female Male ab: BACKGROUND: The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE, no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)-based dual therapy regimen, both containing clarithromycin. OBJECTIVE: This study was undertaken to compare the efficacy of lansoprazole (LAN)-based triple therapy with that of RBC-based dual therapy in H pylori-infected patients with duodenal ulcer. METHODS: Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 mg BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination > or =4 weeks after the end of treatment. Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-to-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analysis (OBS), which included patients with an evaluable result after treatment, regardless of compliance. RESULTS: One hundred eighty-five patients (126 men, 59 women; age range, 18-76 years; mean age, 43 years) were enrolled and randomized to treatment. In the LAN and RBC groups, respectively, H. pylori eradication rates were 92.6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP (P = 0.02), OBS (P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing rates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these differences were not statistically significant. Side effects were mild, occurring in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms. CONCLUSION: Based on the results of the PP and OBS analyses, LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H. pylori in patients with duodenal ulcer. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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