title: Impact of endoscopy-based research on quality of life in healthy volunteers.
abstract: OBJECTIVE
  To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers (HV).
  
  
  METHODS
  Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15 endoscopic examinations per person in 5 different drug phases. Participants completed short form-36 (SF-36) and visual analog scale-based questionnaires (VAS) for different abdominal symptoms at days 0, 7 and 14 of each drug phase. Analyses were performed according to short- and long-term changes and compared to the control group.
  
  
  RESULTS
  All HV completed the study with duration of more than 6 mo. Initial quality of life score was comparable to a general population. Analyses of the SF-36 questionnaires showed no significant changes in physical, mental and total scores, either in a short-term perspective due to different medications, or to potentially endoscopic procedure-associated long-term cumulative changes. Analogous to SF-36, VAS revealed no significant changes in total scores for pathological abdominal symptoms and remained unchanged over the time course and when compared to the control population.
  
  
  CONCLUSIONS
  This study demonstrates that quality of life in HV is not significantly affected by a long-term endoscopy-based study with multiple endoscopic procedures.
authors.affiliation: Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Leipziger St. 44, 39120 Magdeburg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Link
authors.forename: Gerhard
authors.initials: G
authors.lastname: Treiber
authors.forename: Brigitte
authors.initials: B
authors.lastname: Peters
authors.forename: Thomas
authors.initials: T
authors.lastname: Wex
authors.forename: Peter
authors.initials: P
authors.lastname: Malfertheiner
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004724:Endoscopy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D055815:Young Adult