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Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia
BACKGROUND/AIMS: The role of Helicobacter pylori eradication in patients with functional dyspepsia (FD) is still uncertain. We originally planned a randomized clinical study to observe dyspeptic symptoms after H. pylori eradication therapy. However, we failed to complete the study; therefore, we ana...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Korean Society of Gastroenterology; the Korean Society of Gastrointestinal Endoscopy; the Korean Association for the Study of the Liver; the Korean Society of Neurogastroenterology and Motility; Korean Association for the Study of Intestinal Diseases; Korean College of Helicobacter and Upper Gastrointestinal Research; Korean Society of Pancreatobiliary Diseases
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3240790/ https://www.ncbi.nlm.nih.gov/pubmed/22195245 http://dx.doi.org/10.5009/gnl.2011.5.4.468 |
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author | Hong, Su Jin Sung, In Kyung Kim, Jae Gyu Lee, Sang Woo Choi, Suck Chei Yang, Chang Hun Lee, Sang In Lee, Dong Ho Kim, Gwang Ha Jeon, Seong Woo Park, Moo In Park, Sue K. Park, Byung Joo Seol, Sang Young |
author_facet | Hong, Su Jin Sung, In Kyung Kim, Jae Gyu Lee, Sang Woo Choi, Suck Chei Yang, Chang Hun Lee, Sang In Lee, Dong Ho Kim, Gwang Ha Jeon, Seong Woo Park, Moo In Park, Sue K. Park, Byung Joo Seol, Sang Young |
author_sort | Hong, Su Jin |
collection | PubMed |
description | BACKGROUND/AIMS: The role of Helicobacter pylori eradication in patients with functional dyspepsia (FD) is still uncertain. We originally planned a randomized clinical study to observe dyspeptic symptoms after H. pylori eradication therapy. However, we failed to complete the study; therefore, we analyzed the factors that affected the failure of the study. METHODS: Interviews and questionnaire surveys were conducted to analyze the factors that induced early termination from the study. RESULTS: Many patients were screened by gastroenterologists at 11 tertiary referral hospitals between July 2009 and August 2010; however, only 4 patients met the enrollment criteria. Most patients who visited our clinics had been experiencing FD symptoms for less than 6 months or were already taking medication. They also demanded to continue taking medications and using other drugs. Only 3 of the 4 patients signed informed consent. CONCLUSIONS: The application of the current Rome III criteria to FD is difficult to evaluate in Korean patients with dyspeptic symptoms because of the early medical evaluation. Most Korean patients who were diagnosed with FD by the Rome III criteria did not overcome their fear of being unable to use rescue medications during the study period. |
format | Online Article Text |
id | pubmed-3240790 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | The Korean Society of Gastroenterology; the Korean Society of Gastrointestinal Endoscopy; the Korean Association for the Study of the Liver; the Korean Society of Neurogastroenterology and Motility; Korean Association for the Study of Intestinal Diseases; Korean College of Helicobacter and Upper Gastrointestinal Research; Korean Society of Pancreatobiliary Diseases |
record_format | MEDLINE/PubMed |
spelling | pubmed-32407902011-12-22 Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia Hong, Su Jin Sung, In Kyung Kim, Jae Gyu Lee, Sang Woo Choi, Suck Chei Yang, Chang Hun Lee, Sang In Lee, Dong Ho Kim, Gwang Ha Jeon, Seong Woo Park, Moo In Park, Sue K. Park, Byung Joo Seol, Sang Young Gut Liver Original Article BACKGROUND/AIMS: The role of Helicobacter pylori eradication in patients with functional dyspepsia (FD) is still uncertain. We originally planned a randomized clinical study to observe dyspeptic symptoms after H. pylori eradication therapy. However, we failed to complete the study; therefore, we analyzed the factors that affected the failure of the study. METHODS: Interviews and questionnaire surveys were conducted to analyze the factors that induced early termination from the study. RESULTS: Many patients were screened by gastroenterologists at 11 tertiary referral hospitals between July 2009 and August 2010; however, only 4 patients met the enrollment criteria. Most patients who visited our clinics had been experiencing FD symptoms for less than 6 months or were already taking medication. They also demanded to continue taking medications and using other drugs. Only 3 of the 4 patients signed informed consent. CONCLUSIONS: The application of the current Rome III criteria to FD is difficult to evaluate in Korean patients with dyspeptic symptoms because of the early medical evaluation. Most Korean patients who were diagnosed with FD by the Rome III criteria did not overcome their fear of being unable to use rescue medications during the study period. The Korean Society of Gastroenterology; the Korean Society of Gastrointestinal Endoscopy; the Korean Association for the Study of the Liver; the Korean Society of Neurogastroenterology and Motility; Korean Association for the Study of Intestinal Diseases; Korean College of Helicobacter and Upper Gastrointestinal Research; Korean Society of Pancreatobiliary Diseases 2011-12 2011-11-21 /pmc/articles/PMC3240790/ /pubmed/22195245 http://dx.doi.org/10.5009/gnl.2011.5.4.468 Text en Copyright © 2011 The Korean Society of Gastroenterology, the Korean Society of Gastrointestinal Endoscopy, the Korean Society of Neurogastroenterology and Motility, Korean College of Helicobacter and Upper Gastrointestinal Research, the Korean Association for the Study of Intestinal Diseases, Korean Association for the Study of the Liver and Korean Society of Pancreatobiliary Diseases http://creativecommons.org/licenses/by-nc/3.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Hong, Su Jin Sung, In Kyung Kim, Jae Gyu Lee, Sang Woo Choi, Suck Chei Yang, Chang Hun Lee, Sang In Lee, Dong Ho Kim, Gwang Ha Jeon, Seong Woo Park, Moo In Park, Sue K. Park, Byung Joo Seol, Sang Young Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title | Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title_full | Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title_fullStr | Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title_full_unstemmed | Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title_short | Failure of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of H. pylori Eradication in H. pylori-Infected Patients with Functional Dyspepsia |
title_sort | failure of a randomized, double-blind, placebo-controlled study to evaluate the efficacy of h. pylori eradication in h. pylori-infected patients with functional dyspepsia |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3240790/ https://www.ncbi.nlm.nih.gov/pubmed/22195245 http://dx.doi.org/10.5009/gnl.2011.5.4.468 |
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