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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...

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Autores principales: 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
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
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.
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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
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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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