Brief Article
Copyright ©2010 Baishideng. All rights reserved.
World J Gastroenterol. Jan 28, 2010; 16(4): 467-473
Published online Jan 28, 2010. doi: 10.3748/wjg.v16.i4.467
Impact of endoscopy-based research on quality of life in healthy volunteers
Alexander Link, Gerhard Treiber, Brigitte Peters, Thomas Wex, Peter Malfertheiner
Alexander Link, Gerhard Treiber, Thomas Wex, Peter Malfertheiner, Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Leipziger St. 44, 39120 Magdeburg, Germany
Alexander Link, Department of Internal Medicine, Division of Gastroenterology, Baylor Research Institute, Baylor University Medical Center, 3500 Gaston Ave (H-250) Dallas, TX 75246, United States
Gerhard Treiber, Department of Gastroenterology, Oncology and General Internal Medicine, Zollernalb Clinic, Tuebinger St. 30, 72336 Balingen, Germany
Brigitte Peters, Institute for Biometry and Medical Informatics, Otto-von-Guericke University, Leipziger St. 44, 39120 Magdeburg, Germany
Author contributions: Link A and Treiber G contributed equally to this work; Link A, Treiber G, Wex T and Malfertheiner P designed the study; Treiber G performed endoscopic examinations; Link A and Peters B analyzed the data; Link A, Treiber G, Wex T and Malfertheiner P wrote the paper.
Supported by A Research Grant of Astra-Zeneca (Wedel, Germany)
Correspondence to: Dr. Peter Malfertheiner, Professor, Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Leipziger St. 44, 39120 Magdeburg, Germany. peter. malfertheiner@med.ovgu.de
Telephone: +49-391-6713100 Fax: +49-391-6713105
Received: October 5, 2009
Revised: November 13, 2009
Accepted: November 20, 2009
Published online: January 28, 2010
Abstract

AIM: 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.

CONCLUSION: This study demonstrates that quality of life in HV is not significantly affected by a long-term endoscopy-based study with multiple endoscopic procedures.

Keywords: Endoscopy research, Ethics, Healthy volunteers, Quality of life