Kaohsiung Journal of Medical Sciences (2016) 32, 397e402 Available online at www.sciencedirect.com ScienceDirect journal homepage: http://www.kjms-online.com ORIGINAL ARTICLE First-line Helicobacter pylori eradication among patients with chronic liver diseases in Taiwan Cheng-En Tsai a,b, Chih-Ming Liang a,b, Chen-Hsiang Lee b,c, Yuan-Hung Kuo a,b, Keng-Liang Wu a,b, Yi-Chun Chiu a,b, Wei-Chen Tai a,b,*, Seng-Kee Chuah a,b a Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan b College of Medicine, Chang Gung University, Taoyuan, Taiwan c Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan Received 18 April 2016; accepted 26 May 2016 Available online 30 June 2016 KEYWORDS Abstract Helicobacter pylori eradication in patients with chronic liver diseases (CLDs) and chronic liver disease; liver cirrhosis is seldom reported. This study aimed to assess the efficacy of 7-day standard tri- Helicobacter pylori ple therapy in patients with CLD including cirrhosis and to investigate the clinical factors influ- eradication encing the success of eradication. A total of 592 H. pylori-infected patients, who received 7- day standard first-line triple therapy between January 1, 2014, and December 31, 2014, were recruited. Patients were divided into two groups: CLD group (N Z 136) and non-CLD group (N Z 456). The eradication rates attained by the CLD and non-CLD groups were 86.0% and 84.2%, respectively, in the per-protocol analysis (p Z 0.606). The eradication rates of liver cirrhosis and noncirrhosis CLD were 88.5% and 84.3%, respectively (p Z 0.783). The adverse events were similar between the two groups (8.8% vs. 9.2%, p Z 0.891). Compliance between the two groups was good (99.3% vs. 99.6%, p Z 0.670). The univariate analysis showed male sex to be the significant clinical factor in the non-CLD group (p Z 0.001) and alcohol consumption to be the significant clinical factor influencing H. pylori eradication rate in patients with CLD (p Z 0.022). Alcohol consumption was the only significant factor influencing H. pylori eradica- tion in multivariate analysis (odds ratio Z 3.786, p Z 0.031). The results of this study suggest that H. pylori eradication rates in patients with CLD may be comparable with non-CLD Conflicts of interest: All authors declare no conflicts of interest. * Corresponding author. Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Road, Niao-Song District, Kaohsiung City 833, Taiwan; Chang Gung University College of Medicine, No. 123, Dapi Road, Niao- Song District, Kaohsiung City 833, Taiwan. E-mail address: [email protected] (W.-C. Tai). http://dx.doi.org/10.1016/j.kjms.2016.05.012 1607-551X/Copyright ª 2016, Kaohsiung Medical University. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 398 C.-E. Tsai et al. patients. Alcohol consumption was the significant factor influencing H. pylori eradication in patients with CLD. Copyright ª 2016, Kaohsiung Medical University. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/ by-nc-nd/4.0/). Introduction Methods Helicobacter pylori infection is one of the most common Patients bacterial infections in the world [1]. This pathogen is the major risk factor in peptic ulcer disease and it could slowly A total of 784 H. pylori-infected patients who received induce chronic gastritis, which progresses through the standard first-line triple therapy (PPI twice daily, 500 mg premalignant stages of atrophic gastritis, intestinal meta- clarithromycin twice daily, and 1 g amoxicillin twice daily plasia, and dysplasia, and then finally to gastric cancer for 7 days) were retrospectively studied between January [2,3]. Fortunately, successful eradication of H. pylori has 1, 2014, and December 31, 2014, at outpatient clinics in greatly reduced the recurrence of peptic ulcers and gastric Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, cancers [4e6]. Recent studies have explored the significant Taiwan. Eventually, 592 patients were recruited into the association between this bacterium and extragastric dis- per-protocol (PP) study after we strictly excluded 192 pa- eases such as cardiovascular disease, metabolic syndrome, tients with incomplete chart recording. All patients were at and some liver diseases such as nonalcoholic fatty liver least 18 years of age and had received endoscope exami- disease, nonalcoholic steatohepatitis, liver fibrosis, and nations that showed either peptic ulcers or gastritis. Pa- cirrhosis [7]. The possibly related pathogenesis is chronic tients were then divided into two groups: CLD group and inflammation and immune responses at the local and sys- non-CLD group. temic level [8]. Patients with CLDs were defined as follows: having a Current evidence to correlate H. pylori infection and medical history of hepatitis B and/or hepatitis C, with chronic liver diseases (CLDs) is still inconsistent, and abnormal results in liver function tests for at least 6 months, therefore this is an area worth further investigation. One and/or with liver cirrhosis. The diagnosis of cirrhosis was of the etiologies of CLD is viral infections. Taiwan is an confirmed by clinical, laboratory, abdominal ultrasono- endemic area for chronic hepatitis B virus (HBV) and graphic, or histological findings [19]. Diagnosis of HBV- or chronic hepatitis C virus (HCV) infections, which are HCV-related liver disease was determined using specific viral mostly transmitted perinatally. The prevalence rates of markers (HBsAg or anti-HCV). Alcohol-related liver disease hepatitis B and hepatitis C in Taiwan’s general population was defined as daily alcohol consumption over 80 g in men are approximately 8% and 4%, respectively [9,10].Those and over 40 g in women for at least 10 years with negative infected individuals are at an increased risk of developing viral, metabolic, and autoimmune markers [20]. hepatic decompensation, cirrhosis, and hepatocellular The confirmation of H. pylori eradication failure was carcinoma. When the infection progresses to the cirrhotic defined as patients with either one positive 13C-UBT or any stage, patients with peptic ulcer bleeding have a fivefold two positive results of the rapid urease test, histology, and higher risk of complications or death [11]. H. pylori culture after first-line eradication therapy. According to our infection in the stomach of cirrhosis patients has a sig- hospital requirements, all registered patients were fol- nificant association with hyperammonemia [12], portal lowed up to assess drug compliance and adverse effects as hypertension [13], and peptic ulcer disease. The preva- soon as they finished their medications. Then, these pa- lence rate of H. pylori infection in cirrhotic patients with tients underwent either an endoscopy or a urea breath test peptic ulcers varied between 43% and 95%, which was 4e8 weeks later. Poor compliance was defined as failure to higher than that reported in the general population finish 80% of all medication due to adverse effects [21]. [14e17]. Early identification and eradication of H. pylori Demographic data including age, sex, social history of infection are associated with a lower risk of recurrent smoking, alcohol consumption, previous peptic ulcer his- peptic ulcers in cirrhotic patients, according to a Taiwan tory, laboratory data (aspartate transaminase, alanine population-based study [18]. The metabolism of certain transaminase, total bilirubin, albumin, blood urea nitrogen, drugs such as proton-pump inhibitor (PPI) and antibiotics creatinine, and prothrombin time) were collected via could be altered in patients with CLD. However, whether it electrical medical records. This study was approved by both makes a difference in the result of H. pylori eradication the Institutional Review Board and the Ethics Committee of rate and adverse events of triple therapy require further Chang Gung Memorial Hospital (IRB 201600030B0D001). The studies. Ethics Committee waived the requirement for informed To our knowledge, only limited reports are available on consent, and each patient’s medical records were anony- H pylori eradication among patients with CLD. This study mized and deidentified prior to access. All patients pro- aimed to assess the efficacy of 7-day standard triple ther- vided their written informed consent before endoscopic apy in patients with CLD including cirrhosis and to investi- interventions. None of our patients belonged to the minors/ gate the clinical factors influencing the success of children age groups. eradication. H. pylori eradication and chronic liver disease 399 Statistical analysis Table 1 Demographic data and endoscopic findings of the two patient groups. The primary outcome variables were the eradication rate, presence of adverse events, and level of patient compli- CLD Control p ance. Using the SPSS program (version 18; SPSS Inc., Chi- (including LC) non-CLD Z Z cago, IL, USA), Chi-square tests with or without Yates’ (n 136) (n 456) correction for continuity and Fisher’s exact tests were used Age (y) 57.1 Æ 11.3 58.5 Æ 12.4 0.272 when appropriate to compare the major outcomes between Sex (male/female) 68/68 237/219 0.686 groups. Eradication rates were analyzed by PP approaches. Smoking 16 (11.8) 70 (15.4) 0.426 The PP analysis excluded patients with unknown H. pylori Alcohol consumption 15 (11.0) 75 (16.4) 0.231 status following therapy and those with major protocol vi- Previous history of 10 (7.4) 60 (13.2) 0.069 olations. A p value < 0.05 was considered statistically sig- peptic ulcer nificant. To determine the independent factors that Endoscopic findings 0.543 affected treatment response, the clinical and laboratory Gastritis 44 (33.3) 132 (29.1) parameters were analyzed by univariate and multivariate Gastric ulcer 40 (30.3) 161 (35.5) analyses.