Peptic Ulcer Disease Associated with Helicobacter pylori Infection / 대한소화기학회지

Although the global prevalence of peptic ulcer disease (PUD) is decreasing, PUD is still one of the most common upper gastrointestinal diseases in the world due to Helicobacter pylori infection and increased use of non-steroidal anti-inflammatory drugs. In Korea, the prevalence of H. pylori infection is also declining, but it is still the major cause of PUD. The outcomes of H. pylori infection are caused by imbalances between bacterial virulence factors, host factors, and environmental influences. In this review, we describe the prevalence trends of H. pylori infection in Korea, the mechanism of H. pylori infection-related PUD, and treatment strategies.

A wide variation of the quality of colonoscopy reporting system in the real clinical practice in southeastern area of Korea

BACKGROUND/AIMS: Establishment of a colonoscopy reporting system is a prerequisite to determining and improving quality. This study aimed to investigate colonoscopists' opinions and the actual situation of a colonoscopy reporting system in a clinical practice in southeastern area of Korea and to assess the factors predictive of an inadequate reporting system. METHODS: Physicians who performed colonoscopies in the Daegu-Gyeongbuk province of Korea and were registered with the Korean Society of Gastrointestinal Endoscopy (KSGE) were interviewed via mail about colonoscopy reporting systems using a standardized questionnaire. RESULTS: Of 181 endoscopists invited to participate, 125 responded to the questionnaires (response rate, 69%). Most responders were internists (105/125, 84%) and worked in primary clinics (88/125, 70.4%). Seventy-one specialists (56.8%) held board certifications for endoscopy from the KSGE. A median of 20 colonoscopies (interquartile range, 10–47) was performed per month. Although 88.8% of responders agreed that a colonoscopy reporting system is necessary, only 18.4% (23/125) had achieved the optimal reporting system level recommended by the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. One-third of endoscopists replied that they did not use a reporting document for the main reasons of "too busy" and "inconvenience." Non-endoscopy specialists and primary care centers were independent predictive factors for failure to use a colonoscopy reporting system. CONCLUSIONS: The quality of colonoscopy reporting systems varies widely and is considerably suboptimal in actual clinical practice settings in southeastern Korea, indicating considerable room for quality improvements in this field.

A wide variation of the quality of colonoscopy reporting system in the real clinical practice in southeastern area of Korea

BACKGROUND/AIMS: Establishment of a colonoscopy reporting system is a prerequisite to determining and improving quality. This study aimed to investigate colonoscopists' opinions and the actual situation of a colonoscopy reporting system in a clinical practice in southeastern area of Korea and to assess the factors predictive of an inadequate reporting system. METHODS: Physicians who performed colonoscopies in the Daegu-Gyeongbuk province of Korea and were registered with the Korean Society of Gastrointestinal Endoscopy (KSGE) were interviewed via mail about colonoscopy reporting systems using a standardized questionnaire. RESULTS: Of 181 endoscopists invited to participate, 125 responded to the questionnaires (response rate, 69%). Most responders were internists (105/125, 84%) and worked in primary clinics (88/125, 70.4%). Seventy-one specialists (56.8%) held board certifications for endoscopy from the KSGE. A median of 20 colonoscopies (interquartile range, 10–47) was performed per month. Although 88.8% of responders agreed that a colonoscopy reporting system is necessary, only 18.4% (23/125) had achieved the optimal reporting system level recommended by the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. One-third of endoscopists replied that they did not use a reporting document for the main reasons of "too busy" and "inconvenience." Non-endoscopy specialists and primary care centers were independent predictive factors for failure to use a colonoscopy reporting system. CONCLUSIONS: The quality of colonoscopy reporting systems varies widely and is considerably suboptimal in actual clinical practice settings in southeastern Korea, indicating considerable room for quality improvements in this field.

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

Clinical Outcomes of the Endoscopic Submucosal Dissection of Early Gastric Cancer Are Comparable between Absolute and New Expanded Criteria

BACKGROUND/AIMS: Advances in endoscopic submucosal dissection (ESD) techniques have led to the development of expanded criteria for endoscopic resection of early gastric cancer (EGC). The aim of this study was to evaluate the short- and long-term outcomes for ESD using indication criteria. METHODS: A total of 1,105 patients underwent ESD for EGC at six medical centers. The patients were classified into the following two groups based on the lesion size, presence of ulceration and pathological review: an absolute criteria group (n=517) and an expanded criteria group (n=588). RESULTS: The curative resection rates (91.1% vs 91.3%, p=0.896) were similar in the absolute criteria group and the expanded criteria group. The en bloc resection rates (93.4% and 92.3%, respectively; p=0.488) and complete resection rates (98.3% and 97.4%, respectively; p=0.357) did not differ between the groups. The cumulative disease-free survival rates and the overall survival rates were similar between the groups (p=0.778 and p=0.654, respectively). Independent factors for the curative resection of EGC included tumor location (upper vs middle and lower, 2.632 [1.128-6.144] vs 3.497 [1.560-7.842], respectively) and en bloc resection rate 12.576 [7.442-21.250]. CONCLUSIONS: The expanded criteria for ESD in cases of EGC is comparable with the widely accepted pre-existing criteria.

Clinical Outcomes of the Endoscopic Submucosal Dissection of Early Gastric Cancer Are Comparable between Absolute and New Expanded Criteria

BACKGROUND/AIMS: Advances in endoscopic submucosal dissection (ESD) techniques have led to the development of expanded criteria for endoscopic resection of early gastric cancer (EGC). The aim of this study was to evaluate the short- and long-term outcomes for ESD using indication criteria. METHODS: A total of 1,105 patients underwent ESD for EGC at six medical centers. The patients were classified into the following two groups based on the lesion size, presence of ulceration and pathological review: an absolute criteria group (n=517) and an expanded criteria group (n=588). RESULTS: The curative resection rates (91.1% vs 91.3%, p=0.896) were similar in the absolute criteria group and the expanded criteria group. The en bloc resection rates (93.4% and 92.3%, respectively; p=0.488) and complete resection rates (98.3% and 97.4%, respectively; p=0.357) did not differ between the groups. The cumulative disease-free survival rates and the overall survival rates were similar between the groups (p=0.778 and p=0.654, respectively). Independent factors for the curative resection of EGC included tumor location (upper vs middle and lower, 2.632 [1.128-6.144] vs 3.497 [1.560-7.842], respectively) and en bloc resection rate 12.576 [7.442-21.250]. CONCLUSIONS: The expanded criteria for ESD in cases of EGC is comparable with the widely accepted pre-existing criteria.

Comparison between Intravenous Pantoprazole and Oral Lansoprazole about the Prevention against Bleeding after Endoscopic Submucosal Dissection

BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.

Comparison between Intravenous Pantoprazole and Oral Lansoprazole about the Prevention against Bleeding after Endoscopic Submucosal Dissection

BACKGROUND/AIMS: Proton pump inhibitor (PPI) is generally prescribed to prevent post endoscopic submucosal dissection (ESD) bleeding. However, there was no consensus about the effectiveness of intravenous (IV) or oral PPI. We conducted this investigation to evaluate whether oral PPI can be also safely and effectively used to prevent post-ESD bleeding by measurement of intragastric pH. MATERIALS AND METHODS: Patients were assigned in the fixed order to IV pantoprazole by 40 mg every 12 hours and oral lansoprazole fast disintegrating tablet (LFDT) by 30 mg every 8 hours. We checked intragastric pH and hemoglobin (Hb) levels at pre and post-ESD procedure. RESULTS: A total of 10 patients (LFDT group: 6 patients, IV pantoprazole group: 4 patients) were included. There was no difference of baseline Hb level between two groups (LFDT, 14.38+/-0.46 mg/dL; IV pantoprazole, 13.85+/-0.83 mg/dL; P=0.18). After 24 hours, change of Hb level was not different between LFDT (0.95+/-0.30 mg/dL) and IV pantoprazole group (0.98+/-0.45 mg/dL; P=0.96). Baseline intragastric pH was 3.72+/-0.19 with LFDT and 4.31+/-0.41 with IV pantoprazole group (P=0.18). After 24 hours, there was no significant difference of the extent of pH increase between LFDT (2.38+/-0.28) and IV pantoprazole group (2.17+/-0.21; P=0.60). CONCLUSIONS: There was no difference in both the increase of post-24 hour intragastric pH and decrease of post-24 hour Hb between LFDT and IV pantoprazole group. Oral PPI regimen may be able to replace IV PPI therapy for the prevention of post-ESD bleeding and LFDT might be superior to IV PPIs in the aspect of cost-effectiveness.

The Association between the Therapeutic Agent and the Compliance of the Patients with Inflammatory Bowel Diseases / 대한소화기학회지

BACKGROUND/AIMS: Adherence of the patients with inflammatory bowel diseases is important to maintain the remission. However, the patients do not always keep their appointments for treatment. The aim of this study was to investigate the clinical factors associated with adherence of patients in terms of appointment keeping. METHODS: A total of 73 subjects were retrospectively investigated from September 2005 to January 2012 at Dongguk University Ilsan Hospital (Goyang, Korea). We reviewed medical records including the age, sex, residence, medications, the disease activity, and the rate of keeping the date. A punctual visit was defined as outpatient visit on the scheduled date +/-7 days. Punctual patients for the visit were defined as their punctual visit rates exceed 90%. RESULTS: Male to female ratio was 2.4:1. Mean age was 41.5+/-15.4 years (range, 20 to 78 years). Ulcerative colitis was 53 cases (72.6%) and Crohn's disease was 20 cases (27.4%). Mean duration of disease was 42.0+/-41.6 months (range, 4 to 226 months). Mean puntual visit rate was 86.7+/-16.0% (range, 27 to 100). Thirty-eight patients (52.1%) were punctual patients for the visit. Azathioprine/6-mercaptopurine treatment was associated with punctual patients for the visit (odd ratio, 3.19; 95% confidence interval, 1.12 to 9.09; p=0.03). However, other clinical factors did not influence the punctual visit rates. CONCLUSIONS: Our study demonstrated that the use of azathioprine/6-mercaptopurine was associated with keeping the appointment for meeting the doctor. Further prospective study would be necessary.

Comparison of Complications between Endoscopic and Percutaneous Replacement of Percutaneous Endoscopic Gastrostomy Tubes

When replacing percutaneous endoscopic gastrostomy (PEG) tubes, an internal bolster may be retrieved either percutaneously or endoscopically. The aim of this study was to compare the complications of percutaneous and endoscopic method during PEG tube replacement. The medical records of 330 patients who received PEG tube replacement were retrospectively analyzed. According to the removal method of internal bolster, we categorized as endoscopic group and percutaneous group. Demographic data, procedure-related complications and risk factors were investigated. There were 176 cases (53.3%) in endoscopic group and 154 cases (46.7%) in percutaneous group. The overall immediate complication rate during PEG tube replacement was 4.8%. Bleeding from the stoma (1.3%) occurred in percutaneous group, whereas esophageal mucosal laceration (7.4%) and microperforation (0.6%) occurred in endoscopic group. The immediate complication rate was significantly lower in the percutaneous method (OR, 6.57; 95% CI, 1.47-29.38, P=0.014). In multivariate analysis, old age was a significant risk factor of esophageal laceration and microperforation during PEG tube replacement (OR, 3.83; 95% CI, 1.04-14.07, P=0.043). The percutaneous method may be more safe and feasible for replacing PEG tubes than the endoscopic method in old patients.

Guidelines for Bowel Preparation before Video Capsule Endoscopy

The preparation for video capsule endoscopy (VCE) of the bowel suggested by manufacturers of capsule endoscopy systems consists only of a clear liquid diet and an 8-hour fast. While there is evidence for a benefit from bowel preparation for VCE, so far there is no domestic consensus on the preparation regimen in Korea. Therefore, we performed this study to recommend guidelines for bowel preparation before VCE. The guidelines on VCE were developed by the Korean Gut Image Study Group, part of the Korean Society of Gastrointestinal Endoscopy. Four key questions were selected. According to our guidelines, bowel preparation with polyethylene glycol (PEG) solution enhances small bowel visualization quality (SBVQ) and diagnostic yield (DY), but it has no effect on cecal completion rate (CR). Bowel preparation with 2 L of PEG solution is similar to that with 4 L of PEG in terms of the SBVQ, DY, and CR of VCE. Bowel preparation with fasting or PEG solution combined with simethicone enhances the SBVQ, but it does not affect the CR of VCE. Bowel preparation with prokinetics does not enhance the SBVQ, DY, or CR of VCE.

Non-Steroidal Anti-Inflammatory Drug-Induced Enteropathy

Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most commonly prescribed drugs in the world. NSAID-induced lower gastrointestinal (GI) complications are increasing while upper GI complications are decreasing. Lower GI events accounted for 40% of all serious GI events in patients on NSAIDs. Capsule endoscopy and device assisted enteroscopy are available for detection of small intestinal lesions. Capsule endoscopy studies have demonstrated that NSAIDs use in healthy volunteers raised the incidence (55% to 75%) of intestinal damage. It appears that selective cyclooxygenase-2 inhibitors (coxibs) improved upper and lower GI safety based on results of clinical trials. Selective coxibs are still capable of triggering GI adverse events and cardiovascular toxicity issues were the main focus of concerns. Unfortunately, definite strategies are not available to prevent or heal NSAID-induced intestinal injuries. Thus, there is still a strong clinical need for effective drugs with improved safety profiles than the existing NSAIDs.

The Distribution of Endoscopic Gastritis in 25,536 Heath Check-up Subjects in Korea

BACKGROUND/AIMS: Chronic gastritis is a common finding during endoscopy and it is very important to describe it correctly. This study was designed to evaluate the distribution of endoscopic gastritis and the differences according to age, sex or area. MATERIALS AND METHODS: A clinical analysis was conducted on 25,536 subjects who had undergone an upper endoscopy for routine health check-up. Endoscopic gastritis was classified into four types, superficial gastritis, erosive gastritis, atrophic gastritis and intestinal metaplasia. The distribution of the four types of gastritis was evaluated according to sex, age and area. RESULTS: 51.6% of the patients had experienced at least one of the symptoms (epigastric pain or discomfort, soarness, dyspepsia, abdominal pain) on at least a few occasions during the previous year. The incidence of normal gastric finding was 3,593 (14.1%). 21,943 (85.9%) subjects have at least more than one of endoscopic gastritis. The number of cases with superficial gastritis was 7,983 (31.3%), erosive gastritis 6,054 (23.7%), atrophic gastritis 6,918 (27.1%), and intestinal metaplasia 1,181 (7.1%). Erosive gastritis, atrophic gastritis and intestinal metaplasia were more frequent in men than women (P or =60 years) than younger age group (P<0.001). CONCLUSIONS: The prevalence of endoscopic gastritis was very common, 85.9%. In addition, erosive gastritis, atrophic gastritis and intestinal metaplasia were more frequent in men and in the older age group, which is similar to gastric cancer or peptic ulcer. Cautious regular endoscopic follow-up might be necessary regardless of gastrointestinal symptoms in Korea.

The Distribution of Endoscopic Gastritis in 25,536 Heath Check-up Subjects in Korea

BACKGROUND/AIMS: Chronic gastritis is a common finding during endoscopy and it is very important to describe it correctly. This study was designed to evaluate the distribution of endoscopic gastritis and the differences according to age, sex or area. MATERIALS AND METHODS: A clinical analysis was conducted on 25,536 subjects who had undergone an upper endoscopy for routine health check-up. Endoscopic gastritis was classified into four types, superficial gastritis, erosive gastritis, atrophic gastritis and intestinal metaplasia. The distribution of the four types of gastritis was evaluated according to sex, age and area. RESULTS: 51.6% of the patients had experienced at least one of the symptoms (epigastric pain or discomfort, soarness, dyspepsia, abdominal pain) on at least a few occasions during the previous year. The incidence of normal gastric finding was 3,593 (14.1%). 21,943 (85.9%) subjects have at least more than one of endoscopic gastritis. The number of cases with superficial gastritis was 7,983 (31.3%), erosive gastritis 6,054 (23.7%), atrophic gastritis 6,918 (27.1%), and intestinal metaplasia 1,181 (7.1%). Erosive gastritis, atrophic gastritis and intestinal metaplasia were more frequent in men than women (P or =60 years) than younger age group (P<0.001). CONCLUSIONS: The prevalence of endoscopic gastritis was very common, 85.9%. In addition, erosive gastritis, atrophic gastritis and intestinal metaplasia were more frequent in men and in the older age group, which is similar to gastric cancer or peptic ulcer. Cautious regular endoscopic follow-up might be necessary regardless of gastrointestinal symptoms in Korea.

What is the Clinical Relevance of Filiform Polyposis?

No abstract available.

The Clinical Significance of Specialized Intestinal Metaplasia in the Diagnosis of Barrett's Esophagus: Nationwide Prospective Multicenter Study

BACKGROUND/AIMS: The meaning of specialized intestinal metaplasia (SIM) in the diagnosis of Barrett's esophagus (BE) is not clear. This study was designed to determine the clinical significance of SIM in the diagnosis of Barrett's esophagus. MATERIALS AND METHODS: Biopsies were taken from 601 subjects with endoscopically suspected columnar-lined esophagus. Under light microscopy with Alcian-blue stain, SIM was identified. Demographic characteristics, gastroesophageal (GE) reflux symptoms and endoscopic findings were compared between the SIM-present group and the SIM-absent group. RESULTS: Among 601 subjects, 184 (30.6%) were confirmed by pathology to have SIM. Age over 40 years (P<0.001) and a medication history of proton pump inhibitor or H2 blocker were found more frequently in the SIM-present group (P=0.01) than in the SIM-absent group. Any of 7 GE reflux symptoms (heartburn, acid regurgitation, chest pain, hoarseness, globus sensation, cough and epigastric soreness) were more frequent in the SIM-present group than SIM-absent group (P<0.001). Specifically, heartburn, chest pain and cough were significantly more common in the SIM-present group. There was no clinically significant difference associated with endoscopic findings or other clinical characteristics. CONCLUSIONS: When subjects with endoscopically suspected BE are analyzed based on the presence or absence of SIM, the SIM-present group was significantly associated with GE reflux symptoms suggestive of frequent GE reflux. However, the presence of SIM did not correlate with endoscopic findings.

Upper Gastrointestinal Stent

Gastrointestinal (GI) stent has been developed for palliation of obstructive symptoms in various diseases causing obstruction of GI tract. Self-expanding metal stent (SEMS) has replaced old type of plastic stent, and endoscopic insertion of stent has replaced fluoroscopy-guided insertion. Nowadays, newly-designed SEMSs have been developed for prevention of complications such as stent migration and re-obstruction, and indications of stent recently have been widened into benign conditions as well as malignant obstruction. In this review, the types, method of insertion, indications and clinical outcomes of stent in the upper GI tract would be discussed.

Clinical Characteristics of Gastroesophageal Reflux Disease with Esophageal Injury in Korean: Focusing on Risk Factors / 대한소화기학회지

BACKGROUND/AIMS: Recent studies suggest that the prevalence of gastroesophageal reflux disease (GERD) is increasing in Korea. However, studies on risk factors for GERD have yielded inconsistent results. The aims of this study were to compare clinical features between symptomatic syndromes without esophageal injury (=non-erosive disease [NED]) and syndromes with esophageal injury (=erosive disease [ED]), and to determine risk factors associated ED. METHODS: A total of 450 subjects who visited gastroenterology clinics of six training hospitals in Daegu from March 2008 to April 2010 were consecutively enrolled. The subjects were asked to complete a questionnaire which inquired about gastroesophageal reflux symptoms. The questionnaire also included questions about smoking, alcohol drinking, consumption of coffee, use of drugs, exercise, and other medical history. The subjects were subdivided into NED and ED groups. RESULTS: The proportion of subjects in each NED and ED group was 172 (38.2%) and 278 (61.8%). Male gender, smoking, alcohol drinking, consumption of coffee, large waist circumference, infrequent medication of antacids, aspirin and NSAIDs, infrequent and mild GERD symptoms were all significantly associated with ED on univariate analysis. Age, hiatal hernia, diabetes mellitus, body mass index, change in weight during 1 year, and number of typical GERD symptoms were not independent risk factors for ED. However, the association between ED and alcohol drinking, infrequent medication of antacids, mild typical GERD symptoms remained as strong risk factors after adjustments on multivariate logistic analysis. CONCLUSIONS: Independent risk factors associated with ED were alcohol drinking, infrequent medication of antacids and mild typical GERD symptoms.

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 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.