CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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[New ultrashort scheme for helicobacter pylori infection eradication using tetracyline, furazolidone and colloidal bismuth subcitrate in dyspeptic patients with or without peptic ulceration in the National Hospital Cayetano Heredia].

BACKGROUND: Helicobacter pylori (Hp) infection has been associated with the presence of duodenal ulcer, gastric ulcer and chronic active gastritis. It is also speculated that Hp may have a major role in gastric cancer development. Due to rising antibiotic resistance, probably lack of compliance and the expense of the currently used antimicrobial regimens, it's important to develop efficacious, short-duration and low cost therapies, especially for the treatment of low-income populations from underdeveloped countries. The goal of the present study is to asses the efficacy of two ultrashort antibiotic schemes against Hp infection.

METHODS: Patients with diagnosis of Hp infection, found in antral gastric biopsies, were included. They were randomly assigned to receive one of the following therapeutic schemes: tetracycline 500 mg qid, furazolidone 100 mg qid and colloidal bismuth subcitrate 120 mg qid for 3 days (Scheme I) or 4 days (Scheme II). Patients were instructed to come back for follow-up at least 8 weeks after starting medication. At the control visit, an upper endoscopy was performed and an average of 3 antral biopsies was taken. Biopsies were stained with hematoxylin-eosin for histological assessment and with Warthin-Starry silver staining for Hp diagnosis. A single experienced pathologist read all biopsies. In both, the initial biopsy and the control one, we evaluated: presence of Hp; presence, depth and grade of chronic gastritis; presence and grade of inflammatory activity; presence, grade and extent of mucinous damage; presence of glandular atrophy, intestinal metaplasia and lymphoid follicles. We also evaluated dyspeptic symptoms prior and after the treatment, and the presence of adverse events.

RESULTS: 80 patients were enrolled, 2 were excluded because of intense nausea and vomits, 4 patients didn't follow the indications properly and 8 patients couldn't be contacted for the control visit. From the remaining 66 patients, 32 were assigned to Scheme I and 34 to Scheme II, both groups were comparable. Eradication rate was 68.8% (22/32) (CI = 52.1% - 82.7%) for Scheme I and 88.2% (30/34) (CI = 74.9% - 96.2%), significant higher, for Scheme II. There was decrease of dyspeptic symptoms and significant improvement of the histological pattern for both groups, except for presence of chronic gastritis, intestinal metaplasia, glandular atrophy and lymphoid follicles. Hp eradication was associated with significant symptoms decrease, normal endoscopy raising and improvement of all the histological parameters, except for presence of intestinal metaplasia and glandular atrophy. Treatment was well tolerated, 57.6% of the patients reported only mild adverse events, nausea was the most frequent (19.7%) and there was no difference between schemes.

CONCLUSIONS: The triple ultrashort duration scheme including tetracycline, furazolidone and bismuth for 4 days is efficacious against Hp, with a high eradication rate (88.2%). The Hp disappearance is followed by improvement in every histological parameter that we evaluated, except for glandular atrophy and intestinal metaplasia; and it's also accompanied by a decrease in dyspeptic symptoms.

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