Recurrence of Helicobacter pylori following successful eradication and clinical outcomes in Korean patients.

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) infections can recur as either recrudescence or reinfection. At a time when the decline in the eradication rate is becoming evident, increases in the rate of recurrence are concerning. In addition, there are no guidelines for selecting an eradication regimen for H. pylori recurrence. MATERIALS AND METHODS: A total of 996 H. pylori-infected patients treated with proton-pump inhibitor-based triple eradication therapy between 2017 and 2022 were enrolled in the study, and successful eradication therapies were confirmed by the 13 C-urea breath test. When retested within 1 year after successful eradication, analysis related to recrudescence was performed, and when retested after 1 year, analysis related to reinfection was performed. We reviewed the medical records and treatment outcomes of patients with H. pylori reinfection after successful eradication. RESULTS: The recrudescence rate was 3.9% (9/228), and the reinfection rate was 3.7% (36/970 person-year). The frequency of reinfection reached 5.9% per person-year within the first 24 months and 2.0%-2.4% per person-year thereafter. In multivariate factor analysis, reinfection was significantly higher in patients with non-ulcer dyspepsia (p < 0.01). At first-line therapy for reinfection, the eradication rate of standard triple therapy (STT) was 50.0% (16/32). The eradication rate of second-line bismuth quadruple therapy was 81.3% (13/16), and levofloxacin-based rescue therapy was 66.7% (2/3). CONCLUSION: Re-treatment of patients with H. pylori reinfection with STT had limited efficacy. Prospective research is needed to determine whether patients with non-ulcer dyspepsia are vulnerable to reinfection.

Helicobacter pylori-associated Chronic Atrophic Gastritis and Progression of Gastric Carcinogenesis.

Chronic inflammation due to a Helicobacter pylori (H. pylori) infection is a representative cause of gastric cancer that can promote gastric carcinogenesis by abnormally activating immune cells and increasing the inflammatory cytokines levels. H. pylori infections directly cause DNA double-strand breaks in gastric epithelial cells and genetic damage by increasing the enzymatic activity of cytidine deaminase. Eventually, gastric cancer is induced through dysplasia. Hypermethylation of tumor suppressor genes is an important cause of gastric cancer because of a H. pylori infection. In addition, the changes in gastric microbiota and the mucosal inflammatory changes associated with a co-infection with the Epstein-Barr virus are associated with gastric cancer development. DNA damage induced by H. pylori and the subsequent responses of gastric stem cells have implications for gastric carcinogenesis. Although the pathogenesis of H. pylori has been established, many uncertainties remain, requiring more study.

[The Present Status and Improvement Directions for Gastrointestinal Fellows and Residents in Korea].

The Korean Society of Gastroenterology (KSG) and the Korean Society of Gastrointestinal Endoscopy (KSGE) have tried to promote high-quality patient care, and safety in the field of gastrointestinal (GI) diseases. In 2017, the training guidelines for GI fellows have been made, and the education board of KSGE revised 2 year- program of GI fellows. The guideline includes the total number of assigned patients, the number of GI endoscopy procedures, attendance of academic conferences, and research presentations. The traditional training model of GI fellowship is known as an "apprenticeship". Unfortunately, it might increase confusion between what trainees are observing and prior information. Now, practical hands-on training system using simulator helps to provide a support program for GI fellowship education. In order to facilitate training program, trainers will need to carefully plan the teaching. Therefore, it improves knowledge and performance for trainers. What we should keep in mind is that this hands-on program has the goal of making a good gastroenterologist, not just making an endoscopist. At same time, the application of cognitive education in GI fellow training must be performed. On the other side, the privileging and credentialing for endoscopic subspecialty should be made. The provision of benefits could serve as an important foundation for maintaining GI specialist board system.

[Gastrointestinal Disease in the Population Aged 80 Years and above in Korea during Recent Decades: Multi-center Cross-sectional Study].

Background/Aims: Globally, the population aged 80 years or older is growing faster due to the rising life expectancy. Korea has already entered into an advanced aged society, and a post-aged society is expected in 2025. This study evaluated the patterns of gastrointestinal disease in the population aged 80 years or older during the recent decade in Korea. Method: This study retrospectively reviewed the medical records of patients admitted to the gastrointestinal department of Suwon St. Vincent's hospital, Incheon St. Mary's hospital, and Uijeongbu St. Mary's Hospital - general hospitals of Seoul-Gyeonggi province in Korea. It was a repeated cross-sectional study in 2009 and 2019. Results: The number of admitted patients aged 80 years or older increased from 549 (9.0%) in 2009 to 1,073 (14.4%) in 2019 (p<0.01). As for the in-hospital mortality, there was no significant difference (p=0.25). On the other hand, the combined morbidities increased, and the duration of admission also increased (7.2±7.8 days vs. 8.1±8.2 days, p=0.03). The number of upper gastrointestinal hemorrhage and patients who are bleeding associated with drugs users increased (p<0.01). The proportion of lower gastrointestinal disease decreased (p<0.01) because of the decrease in procedure-related admissions (p<0.01). The number of those with pancreaticobiliary tract disease increased markedly (p<0.01), and the rate of cases that could not perform the procedure decreased (p=0.04). Conclusion: The patterns of gastrointestinal disease in the population aged 80 years or older have changed in the recent decade in Korea. Hence, more preparation for this medical environment is needed.

Clinical outcomes of metachronous recurrence of gastric epithelial neoplasia based on Helicobacter pylori infection status and microsatellite stability.

BACKGROUND/AIMS: Helicobacter pylori eradication may prevent the recurrence of gastric epithelial neoplasia after endoscopic treatment. However, H. pylori eradication therapy is unlikely to prevent gastric cancer. This study determined the longterm results and clinical outcomes of patients with gastric epithelial neoplasia based on H. pylori infection status and microsatellite stability (MSS). METHODS: Patients diagnosed with gastric epithelial neoplasia who underwent an endoscopic mucosal resection or submucosal dissection between 2004 and 2010 were included in this retrospective study. During the follow-up period (range, 4 to 14 years), disease recurrence was monitored, and tissue examinations were conducted for seven sets of microsatellite loci initially linked to the tumour suppressor gene locus. When H. pylori infection was identified, patients underwent eradication therapy. RESULTS: The patients (n = 120) were divided into three groups: H. pylori-negative with MSS, H. pylori-positive with MSS, and microsatellite instability (MSI). After H. pylori eradication, the rate of metachronous recurrence was significantly different in the MSI (28.2%) and MSS groups (3.7%, p < 0.01). The mean duration of recurrence was 77 months (range, 24 to 139) in the MSI group. There was no recurrence after eradication therapy in patients who were positive for H. pylori in the MSS group. CONCLUSION: H. pylori eradication could help prevent gastric cancer recurrence in patients with stable microsatellite loci. Careful, long-term monitoring is required in patients with unstable microsatellite loci.

The Influence of Past Metronidazole Exposure on the Outcome of Helicobacter pylori Eradication.

Background: Bismuth quadruple therapy (BQT) is recommended as empirical first-line therapy because it is not affected by antibiotic resistance. We examined whether past exposure to metronidazole affected BQT outcomes. Methods: The records of seven hospitals were searched for patients who received BQT for Helicobacter pylori eradication between 2009 and 2020. The association between past metronidazole exposure and the eradication rate was evaluated. Results: This study was a multicenter retrospective study. Around 37,602 people tested for H. pylori infection were identified, and 7,233 received BQT. About 2,802 (38.7%) underwent a 13C-urea breath test to confirm eradication. The BQT efficacy was 86.4% among patients without metronidazole exposure and 72.8% among patients with exposure (p < 0.001). The eradication rate of BQT 14 days in patients with past exposure was higher than that of BQT <14 days (85.5 vs. 66.0%, p = 0.009). Multivariate analysis revealed that past metronidazole exposure [odds ratio (OR) 2.6, 95% CI 1.8-3.7; p < 0.001] and BQT <14 days (OR 1.5, 95% CI 1.2-2.0; p = 0.002) were independent risk factors for eradication failure. Conclusion: Past metronidazole exposure significantly lowered the BQT eradication rate. BQT 14 days should be recommended for patients with suspected metronidazole exposure.

Vonoprazan non-inferior to lansoprazole in treating duodenal ulcer and eradicating Helicobacter pylori in Asian patients.

BACKGROUND AND AIM: Duodenal ulcers, especially caused by increasingly drug-resistant Helicobacter pylori, are a concern in Asia. We compared oral vonoprazan versus lansoprazole for efficacy (healing duodenal ulcers) and safety in non-Japanese Asian patients. METHODS: In this phase 3, randomized (1:1), double-blind, double-dummy, parallel-group, non-inferiority study (April 5, 2017, to July 19, 2019), patients with ≥ 1 endoscopically confirmed duodenal ulcer, at 52 hospitals (China, South Korea, and Taiwan), received vonoprazan 20 mg once daily (QD) or lansoprazole 30 mg QD for 6 weeks maximum. Patients with H. pylori received bismuth-containing quadruple therapy including vonoprazan 20 mg twice daily (BID) or lansoprazole 30 mg BID, for 2 weeks, followed by vonoprazan or lansoprazole monotherapy QD (4 weeks maximum). Endpoints were endoscopically confirmed duodenal ulcer healing (Week 4/6; primary) and H. pylori eradication (4 weeks post-treatment; secondary); non-inferiority margins were -6% and -10%, using a two-sided 95% confidence interval (CI). RESULTS: Of 533 enrolled patients, one was lost to follow-up and one withdrew (full analysis set: 531 patients [vonoprazan, n = 263; lansoprazole, n = 268]; 85.4% = H. pylori positive). Vonoprazan was non-inferior to lansoprazole for duodenal ulcer healing (96.9% vs 96.5%; difference 0.4% [95% CI -3.00, 3.79]). H. pylori eradication rates were 91.5% (vonoprazan) and 86.8% (lansoprazole; difference 4.7% [95% CI -1.28, 10.69]). Vonoprazan and lansoprazole were well tolerated, with similar safety profiles, no new safety signals; no deaths occurred. CONCLUSIONS: Vonoprazan was well tolerated and non-inferior to lansoprazole for duodenal ulcer healing and achieved H. pylori eradication above the clinically meaningful threshold (90%), in non-Japanese Asian patients.

Safety/Efficacy of Prucalopride in Korean Patients with Chronic Constipation: Post-marketing Surveillance.

Background/Aims: Constipation is a common gastrointestinal disorder. Prucalopride is a dihydrobenzofurancarboxamide derivative with gastrointestinal prokinetic activities and is recommended as an appropriate choice in patients unresponsive to laxatives. This study assessed the safety and efficacy of prucalopride in Korean patients with chronic constipation, in whom laxatives were ineffective. Methods: This prospective, non-interventional post-marketing surveillance of prucalopride was conducted from 2012 to 2018 at 28 hospitals in Korea. Adults who received prucalopride for the symptomatic treatment of chronic constipation were included. The patients received 2 mg of prucalopride once daily or 1 mg once daily in patients older than 65 years. The baseline characteristics, adverse events (AEs), and seven-point scale of Clinical Global Impression-Improvement were collected. Results: Of 601 patients, 67.7% were female, and the mean age was 62.3 years. Three hundred patients (49.9%) were older than 65 years. At the baseline, 70.0% of patients reported less than two instances of spontaneous complete bowel movements per week. AEs were reported in 107 patients (17.7%), including headache (3.2%) and diarrhea (2.8%). Seven serious AEs (SAEs) were reported in five patients (0.8%). The SAEs were resolved without complications; there were no cases of death. All SAEs were assessed as 'unlikely' causality with prucalopride. In 72.7% of patients, chronic constipation was improved by the prucalopride treatment during the study period. Conclusions: This study demonstrated the promising safety and efficacy profile of prucalopride in clinical practice. Thus, prucalopride should be considered in patients with chronic constipation when bowel symptoms are refractory to simple laxatives.

HER-2 positivity is a high risk of recurrence of stage I gastric cancer.

BACKGROUND/AIMS: The treatment of gastric cancer remains unsatisfactory. We aimed to investigate the prognostic value of immunohistochemical staining in gastric cancer. METHODS: We analyzed 505 (279 early staged, 226 advanced-staged) gastric cancer tissues from patients who underwent radical gastric resection between January 2014 and December 2016. Available surgical specimens immunohistochemically stained for p53, epidermal growth factor receptor (EGFR), human EGFR 2 (HER-2), E-cadherin, and Ki-67 were reviewed. We evaluated the association between positivity to various biomarkers and disease recurrence, disease-free survival, lymph node metastasis, and microscopic lymphovascular invasion. RESULTS: The median follow-up duration was 32.5 months (range, 7 to 70). Advanced gastric cancer cases showed high Ki-67 expression; other cases showed unremarkable expression. Concerning disease recurrence, lymphatic invasion, and disease-free interval, all biomarkers had no prognostic effects. HER-2-positive stage I gastric cancer tended to occur in old patients and in the upper one-third of the stomach (p = 0.01). HER-2 positivity was significantly correlated with disease recurrence (p = 0.01), lymphatic invasion (p = 0.03), and vascular invasion (p = 0.03) in stage I cases. CONCLUSION: Only HER-2 was associated with the recurrence of stage I gastric cancer. HER-2-positive stage I gastric cancer requires additional therapy despite curative resection.

Efficacy of bismuth added to standard triple therapy as the first-line eradication regimen for Helicobacter pylori infection.

BACKGROUND: Addressing the increasing antibiotic resistance, including clarithromycin resistance, which affects Helicobacter pylori eradication therapy, is a challenge for clinicians. The objective of this study was to determine the efficacy of bismuth added to standard triple therapy as a first-line treatment regimen for Helicobacter pylori infection. The secondary outcome was the treatment efficacy for clarithromycin-resistant strains. MATERIAL AND METHODS: A prospective study was undertaken from January to December 2019. A total of 107 patients with Helicobacter pylori infection were enrolled and received Helicobacter pylori eradication therapy with bismuth added to standard triple therapy for 14 days. We also evaluated the clarithromycin resistance rate by dual-priming oligonucleotide-based multiplex PCR and treatment efficacy. RESULTS: A total of 104 patients completed standard triple therapy with bismuth added for Helicobacter pylori eradication. The eradication rates in the intention to treat and per-protocol analyses were 87.9% and 90.4%, respectively. The frequency of clarithromycin resistance was 33.6% (35/104), and the eradication rate was 77.1% in resistant strains (27/35). CONCLUSION: Bismuth added to standard triple therapy could be acceptable as a first-line treatment regimen for Helicobacter pylori eradication in patients with clarithromycin-resistant strains. In particular, in areas with high clarithromycin tolerance, it is advisable to consider bismuth add-on therapy as the first-line treatment regimen.

Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial.

BACKGROUND AND AIMS: Prophylactic application of a hemoclip has been suggested as an alternative to the use of an endoloop for the prevention of postpolypectomy bleeding (PPB) when resecting large, pedunculated colorectal polyps. Therefore, this multicenter, randomized controlled trial investigated the efficacy of prophylactic hemoclip application to reduce PPB during the resection of large pedunculated polyps. METHODS: Large pedunculated polyps (≥10 mm in head diameter) were eligible for inclusion. Polyps were randomized into a study arm (where clips were applied before resection) and a control arm (without pretreatment). The primary outcome was the rate of PPB in each group. PPB included immediate PPB (IPPB) and delayed PPB (DPPB). IPPB was defined as blood oozing (≥1 minute) or active spurting occurring immediately after polyp resection. DPPB was defined as rectal bleeding, occurring after completion of the colonoscopy. RESULTS: In total, 238 polyps from 204 patients were randomized into the clip arm (119 polyps) or the control arm (119 polyps). Overall bleeding adverse events were observed in 20 cases (IPPB, 16; DPPB, 4). The rate of overall PPB, IPPB, and DPPB was 8.4%, 6.7%, and 1.7%, respectively, for all polyps. The rate of overall PPB (clip 4.2% vs control 12.6%, P = .033) and IPPB (clip 2.5% vs control 10.9%, P = .017) was significantly lower in the clip arm than the control arm. CONCLUSIONS: Prophylactic clipping before resecting large pedunculated polyps can reduce overall PPB and IPPB compared with no prior treatment. Therefore, prophylactic clipping may be considered before resection of large pedunculated polyps. (Clinical trial registration number: NCT02156193.).

Improved classification and localization approach to small bowel capsule endoscopy using convolutional neural network.

BACKGROUND: Although great advances in artificial intelligence for interpreting small bowel capsule endoscopy (SBCE) images have been made in recent years, its practical use is still limited. The aim of this study was to develop a more practical convolutional neural network (CNN) algorithm for the automatic detection of various small bowel lesions. METHODS: A total of 7556 images were collected for the training dataset from 526 SBCE videos. Abnormal images were classified into two categories: hemorrhagic lesions (red spot/angioectasia/active bleeding) and ulcerative lesions (erosion/ulcer/stricture). A CNN algorithm based on VGGNet was trained in two different ways: the combined model (hemorrhagic and ulcerative lesions trained separately) and the binary model (all abnormal images trained without discrimination). The detected lesions were visualized using a gradient class activation map (Grad-CAM). The two models were validated using 5,760 independent images taken at two other academic hospitals. RESULTS: Both the combined and binary models acquired high accuracy for lesion detection, and the difference between the two models was not significant (96.83% vs 96.62%, P = 0.122). However, the combined model showed higher sensitivity (97.61% vs 95.07%, P < 0.001) and higher accuracy for individual lesions from the hemorrhagic and ulcerative categories than the binary model. The combined model also revealed more accurate localization of the culprit area on images evaluated by the Grad-CAM. CONCLUSIONS: Diagnostic sensitivity and classification of small bowel lesions using a convolutional neural network are improved by the independent training for hemorrhagic and ulcerative lesions. Grad-CAM is highly effective in localizing the lesions.

Clinical Outcomes of Mucinous Gastric Carcinomas Compared with Non-mucinous and Signet Ring Cell Carcinomas.

Background/Aims: This study examined the clinical features and prognosis of patients with mucinous gastric carcinoma (MGC), non-mucinous gastric carcinoma (NMGC), and signet ring cell gastric carcinoma (SRC). Methods: A retrospective cohort study was performed, enrolling 65 patients with MGC from January 2007 to December 2016. During the same period, 1,814 patients with histologically proven gastric cancers underwent curative or palliative operations. One hundred and ninety-five NMGC patients were selected as the 1:3 age- and sex-matched control groups. In addition, 200 SRC patients were identified. This study evaluated the demographic features of the patients, pathologic features of the tumor, and the predictive factors, such as the recurrence-free survival and overall survival. Results: The recurrence rates were significantly high in MGC than in NMGC or SRC (both p<0.01). The proportion of early gastric cancer was lower in the MGC group than in the other groups (p<0.01). In addition, metastatic lymph nodes were found more frequently in the MGC group (p<0.01), and the proportion of initial pT4, M1 stage, was highest in the MGC group. The recurrence-free survival and overall survival in the MGC group were significantly lower than those in the NMGC or SRC. Subgroup analysis showed that patients with the same American Joint Committee on Cancer (AJCC) stage of each cancer group showed a similar prognosis. Conclusions: MGC frequently presents an advanced stage with an unfavorable prognosis compared to NMGC or SRC. On the other hand, MGC of the same AJCC stage had a similar prognosis to NMGC and SRC.

Clinical Impact of Common Bile Duct Angulation on the Recurrence of Common Bile Duct Stone: A Meta-analysis and Review.

Background/Aims: Local and systemic factors, such as diabetes, obesity, and hyperlipidemia, are considered risk factors for the recurrence of choledocholithiasis after successful endoscopic clearance. Local factors include the presence of bile sludge, common bile duct (CBD) diameter, and CBD angulation. Among them, it is unclear if acute CBD angulation is preferable to the recurrence of a CBD stone. Methods: PubMed, EMBASE, CINAHL, the Cochrane Library databases, and google website were searched for randomized controlled trials reported in English and undertaken until August 2019. Meta-analysis was performed on all randomized controlled trials for the recurrence of CBD stones between the patients with acute CBD angulation. Results: Eight randomized trials (1,776 patients) were identified, and the total recurrent rate of CBD stones was 18.8% (334/1,776). A CBD angle ≤145° was significantly associated with an increased risk of recurrent CBD stone (OR=2.65, p<0.01). In two prospective studies, acute CBD angulation was not proven to be associated with a recurrence (p=0.39). Conclusions: Approximately 20% of patients with a CBD stone showed recurrence after the complete clearance of the CBD stone, and a CBD angle ≤145° could increase the risk of recurrence. Overall, a large-scale prospective study should be necessary.

Microbiology and risk factors for gram-positive Cocci bacteremia in biliary infections.

BACKGROUND: The rapid antibiotics treatment targeted to a specific pathogen can improve clinical outcomes of septicemia. We aimed to evaluate the clinical characteristics and outcomes of biliary septicemia caused by cholangitis or cholecystitis according to causative organisms. METHODS: We performed a retrospective cohort study in 151 patients diagnosed with cholangitis or cholecystitis with bacterial septicemia from January 2013 to December 2015. All patients showed clinical evidence of biliary tract infection and had blood isolates that demonstrated septicemia. RESULTS: Gram-negative, gram-positive, and both types of bacteria caused 84.1% (127/151), 13.2% (20/151), and 2.6% (4/151) episodes of septicemia, respectively. The most common infecting organisms were Escherichia coli among gram-negative bacteria and Enterococcus species (Enterococcus casseliflavus and Enterococcus faecalis) among gram-positive bacteria. There were no differences in mortality, re-admission rate, and need for emergency decompression procedures between the gram-positive and gram-negative septicemia groups. In univariate analysis, previous gastrectomy history was associated with gram-positive bacteremia. Multivariate analysis also showed that previous gastrectomy history was strongly associated with gram-positive septicemia (Odds ratio = 5.47, 95% CI: 1.19-25.23; P = 0.029). CONCLUSIONS: Previous gastrectomy history was related to biliary septicemia induced by gram-positive organisms. This information would aid the choice of empirical antibiotics.

Treatment pattern and overall survival in esophageal cancer during a 13-year period: A nationwide cohort study of 6,354 Korean patients.

Using data from the real world to solve clinical questions that cannot be answered using data from clinical trials is attracting more attention. Clinical outcomes for patients with esophageal cancer in a real-world setting might be different from data in randomized controlled trials. This study aimed to provide real world data on treatment and prognosis in Korean patients with esophageal cancer. This retrospective cancer cohort included newly diagnosed cases of esophageal cancer at 19 tertiary hospitals between January 1, 2005 and December 31, 2017. Cancer staging was defined according to the 7th edition of the American Joint Committee on Cancer criteria. We identified 6,354 patients with newly diagnosed esophageal cancer (mean age: 64.9 ± 9.0 years, 96.9% squamous cell carcinoma). The proportion of early esophageal cancer increased from 24.7% in 2005 to 37.2% in 2015 (p<0.001). Among all cases, surgery alone was 31.3%, followed by definitive concurrent chemoradiotherapy (CCRT) (27.0%), neoadjuvant therapy (12.4%), adjuvant therapy (11.1%), and endoscopic resection (5.8%). The 5-year overall survival rate was 45.7 ± 0.7%. Endoscopic resection provided similar median survival relative to surgery for stage Ia cases. Among stage II-III cases, definitive CCRT was associated with poorer survival than neoadjuvant or adjuvant therapy, although there was no survival difference between neo-adjuvant and adjuvant therapy. Early esophageal cancer is gradually becoming more common and endoscopic resection provided similar long-term survival relative to surgery. Surgery with combined therapy provided better survival in locally advanced esophageal cancer, relative to definitive CCRT.

Prognostic effect of different etiologies in patients with gastric cardia cancer.

There are still many controversies about the characteristics and prognosis of gastric cardia cancer. We aimed to evaluate the clinical characteristics and outcome between cardia and noncardia cancer. Also, we evaluated the clinical outcome according to etiologic factors.We performed a retrospective cohort study of 92 patients with gastric cardia cancer from January 2003 to December 2013. The patients with noncardia cancer were selected as age- and sex-matched control.The frequencies of gastroesophageal reflux disease (GERD) and negative Helicobacter pylori infection without atrophy were significantly higher in gastric cardia cancers, but there was no difference in the frequency of obesity. The frequency of early gastric cancers was 40.0%, which was significantly lower than that of noncardia cancer. The rate of recurrence, disease-free survival, and overall survival duration were significantly lower in gastric cardia cancers (P < .01), even though there was no significant difference in the rate of curative resection (R0). In terms of the etiologic factors, there were no differences of disease prognosis, regardless of the presence of GERD, obesity, and H pylori infection with associated gastritis.Gastric cardia cancer showed distinct clinical characteristics and a negative prognostic impact compared with gastric noncardia cancer.

A Meta-Analysis of the Efficacy of Prokinetic Agents against Glycemic Control.

BACKGROUND: Prokinetic agents are used in diabetic gastroparesis patients to improve gastric emptying and upper gastrointestinal (GI) symptoms. However, the efficacy of prokinetic agents against glycemic control is questionable. Therefore, we conducted a systemic review and meta-analysis to determine the efficacy of prokinetic agents against glycemic control. METHODS: Randomized controlled trials (RCTs) evaluating the effect of prokinetics were identified by searching PubMed, Embase, and the Cochrane Library databases until April 2018. The primary outcome was changes in the mean value of glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and fasting serum insulin (FINS). The pooled standardized mean differences (SMD) with 95% confidence intervals (CIs) were calculated by evaluating the strength of the association. We used the random effect models to analyze these markers. The effects of each component of the prokinetic agents on glycemic control were separately analyzed. RESULTS: Five RCTs with 190 patients met the criteria and were included in the meta-analysis. There were statistically significant SMD between prokinetics and placebo-controlled groups with respect to the reduction of HbA1c (-1.141, 95% CI -1.843, -0.438; P < 0.01). No statistically significant differences were noted between the two groups for FBS (-1.270, 95% CI -2.613, -0.074; P = 0.06) and FINS (0.359, 95% CI -1.205~1.923; P = 0.65). CONCLUSIONS: Prokinetics have a positive effect on glycemic control. Further large-scale prospective studies are needed.