title: [Registration of drug-associated lesions of the mucosa of the upper gastrointestinal tract. The problem of characterizing the health status of healthy subjects].
abstract: OBJECTIVE
  Investigations with regard to toxic effects of drugs on the upper gastrointestinal tract depend on healthy volunteers with normal mucosal conditions. Because of the high prevalence of Helicobacter pylori infection it is mandatory to exclude infected volunteers without abdominal history as early as possible. This study was to compare the power of non-invasive and invasive tests in the selection of volunteers without gastric disease.
  
  
  METHODS
  85 healthy volunteers (age 18-35 years) without abdominal history underwent both gastroduodenoscopy and specific tests for Helicobacter pylori infection (IgA- and IgG-antibodies, ureasetest, culture, HE-staining). In the case of pathological findings, the biopsies were performed without including the subjects into the study with a non-steroidal anti-inflammatory drug (NSAIDs) (Diclofenac, CAS 15307-86-5). The invasive tests of volunteers, who were selected, were performed at the end of drug period, because biopsies would influence the outcome of a 7-day treatment with diclofenac
  
  
  RESULTS
  Initially 25/85 volunteers without any history of abdominal disease must be excluded. In 15 subjects there were abnormal concentrations of IgG- and/or IgA- antibodies against Helicobacter pylori. Endoscopically in 10 persons severe lesions were found (6 ulcer and/or erosions and/or reflux disease). In 18 subjects histologically the Helicobacter pylori infection was confirmed. At the end of the treatment period in 17/60 volunteers a positive Helicobacter pylori staining was found. Comparing five Helicobacter pylori tests there were no significant correlations between non-invasive and invasive procedures.
  
  
  CONCLUSIONS
  The endoscopic investigation (gastroduodenoscopy) was the only valid method to differentiate between healthy volunteers and subjects with mucosal lesions. With regard to Helicobacter pylori infection neither the non-invasive nor the invasive tests were significantly correlated. Therefore, in investigations on the toxic effect of drugs the infection rate must be determined after treatment to prove the homogeneity of and between the groups. Most important is a subtile endoscopic technique which depends on high resolution video-endoscopes, chromoscopy as well as inter- and intra-observer variation procedures.
authors.affiliation: Institute for Applied Diagnostic International (IAD International Ltd.), Mahone Bay, Nova Scotia, Canada.
authors.forename: Hans Jörg
authors.initials: HJ
authors.lastname: Wildgrube
authors.forename: Gerd
authors.initials: G
authors.lastname: Kierschke
authors.forename: Ingo
authors.initials: I
authors.lastname: Weigmann
authors.forename: Bernd
authors.initials: B
authors.lastname: Terhaag
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000032:analysis; D004064:Digestive System / Q000187:drug effects* / Q000473:pathology; D016145:Endoscopy, Digestive System; D004992:Ethics, Medical; D005260:Female; D006305:Health Status Indicators; D016481:Helicobacter Infections / Q000175:diagnosis / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology; D006801:Humans; D007073:Immunoglobulin E / Q000032:analysis; D008297:Male; D012107:Research Design
chemical_list: D000907:Antibodies, Bacterial; D007073:Immunoglobulin E