Hybrid, High-Dose Dual and Bismuth Quadruple Therapies for First-Line Treatment of Helicobacter pylori Infection in Taiwan: A Multicenter, Open-Label, Randomized Trial.

INTRODUCTION: The study aimed to compare the efficacies and safety of 14-day hybrid therapy, 14-day high-dose dual therapy, and 10-day bismuth quadruple therapy in the first-line treatment of Helicobacter pylori infections. METHODS: In this multicenter, open-label, randomized trial, we recruited adult H. pylori -infected patients from 9 centers in Taiwan. Subjects were randomly assigned (1:1:1) to 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy. Eradication status was determined by the 13 C-urea breath test. The primary outcome was the eradication rate of H. pylori assessed in the intention-to-treat population. RESULTS: Between August 1, 2018, and December 2021, 918 patients were randomly assigned in this study. The intention-to-treat eradication rates were 91.5% (280/306; 95% confidence interval [CI] 88.4%-94.6%) for 14-day hybrid therapy, 83.3% (255/306; 95% CI 87.8%-95.0%) for 14-day high-dose dual therapy, and 90.2% (276/306; 95% CI 87.8%-95.0%) for 10-day bismuth quadruple therapy. Both hybrid therapy (difference 8.2%; 95% CI 4.5%-11.9%; P = 0.002) and bismuth quadruple therapy (difference 6.9%; 95% CI 1.6%-12.2%; P = 0.012) were superior to high-dose dual therapy and were similar to one another. The frequency of adverse events was 27% (81/303) with 14-day hybrid therapy, 13% (40/305) with 14-day high-dose dual therapy, and 32% (96/303) with 10-day bismuth quadruple therapy. Patients receiving high-dose dual therapy had the fewest adverse events (both P < 0.001). DISCUSSION: Fourteen-day hybrid therapy and 10-day bismuth quadruple therapy are more effective than 14-day high-dose dual therapy in the first-line treatment of H. pylori infection in Taiwan. However, high-dose dual therapy has fewer adverse effects than hybrid bismuth quadruple therapies.

REAP-HP survey 2020: Comparing the real-world practice and expectation in Helicobacter pylori eradication of the Taiwanese gastroenterologists in 2015 and 2020.

BACKGROUND: REAP-HP study (Real-world practice and Expectation of Asia-Pacific physicians and patients in Helicobacter Pylori eradication) was the pioneer study investigating the expectation and preference of physicians across Asia-Pacific in H. pylori eradication in 2015. This study is the first follow-up study of REAP-HP in Taiwan. AIMS: (1) To investigate the preference in regimens for the first-line anti-H. pylori therapy of Taiwanese gastroenterologist in 2020, (2) To survey the factor that cause the most concern when prescribing anti-H. pylori regimens in clinical practice, and (3) to compare REAP-HP survey data in 2020 and those surveyed in 2015 regarding the abovementioned end-points. METHODS: A questionnaire for H. pylori eradication survey of physicians was distributed to the gastroenterologists who attended the Taiwan Digestive Disease Week 2020. Data of most commonly used first-line anti-H. pylori regimens and concerned factors when prescribing anti-H. pylori regimens between 2015 and 2020 were compared. RESULTS: A total of 258 physicians from different districts of Taiwan participated in the REAP-HP Survey in 2020. The top three most commonly used anti-H. pylori regimens in Taiwan in 2020 were 14-day standard triple therapy (36.8%; 95% confidence interval [CI]: 30.9%-42.7%), 7-day standard triple therapy (17.8%; 95% CI: 13.1%-22.5%) and 14-day reverse hybrid therapy (14.7%; 95% CI: 10.4%-19.0%) respectively. The top two factors that cause the most concern during prescribing anti-H. pylori therapy were eradication rate (82.3%; 95% CI: 77.6%-87.0%) and side effect (10.4%; 95% CI: 6.7%-15.1%). In 2015, the top three most commonly used regimens in Taiwan were 7-day standard triple therapy (62%; 95% CI: 56.2%-67.8%), 14-day standard triple therapy (21%; 95% CI: 16.1%-25.9%) and 10-day sequential therapy (7%; 95% CI: 4%-10%). A remarkable difference of the most commonly used anti-H. pylori regimens between 2015 and 2020 existed (p < .001). The top two factors that cause the most concern during prescribing anti-H. pylori therapy in 2015 were eradication rate (84.1%) and side effect (7.0%). There were no differences in the factors that cause the most concern during prescribing anti-H. pylori regimens between 2015 and 2020. CONCLUSION: 14-day standard triple therapy has replaced 7-day standard triple therapy as the most commonly used first-line anti-H. pylori therapy among Taiwanese gastroenterologists in 2020. 14-day reverse hybrid therapy is on rise to the third place as the most commonly used anti-H. pylori regimen in Taiwan.

Real-world practice and Expectation of Asia-Pacific physicians and patients in Helicobacter Pylori eradication (REAP-HP Survey).

OBJECTIVE: The aims of the study were: 1, to survey the most popular anti-H. pylori regimens in Asia-Pacific region and the real-world effectiveness of these regimens; and 2, to investigate the expectation gaps of eradication rate between physicians and patients. DESIGN: A questionnaire was distributed to Asia-Pacific physicians who attended the Asia-Pacific Digestive Week 2015 meeting. Reported eradication rates from the literatures were compared with real-world rates of surveyed popular regimens within the region. In addition, a questionnaire was distributed to H. pylori-infected patients in three regions of Taiwan. RESULTS: A total of 691 physicians and 539 patients participated in the survey. The top five most commonly used regimens were 7-day clarithromycin-based standard triple therapy (50.4%), 14-day clarithromycin-based standard triple therapy (31.0%), 10-day sequential therapy (6.1%), 14-day bismuth quadruple therapy (3.9%), and 14-day hybrid therapy (3.6%). All countries except for China had a significant gap between the expectation of physicians on anti-H. pylori therapy and the real-world eradication rate of most commonly adopted regimens (all P value <.05). The expectation on minimal eradication rate among patients was higher than that of physicians (91.4% vs 86.5%, P<.001). CONCLUSIONS: It is time for physicians in Asia-Pacific countries to adopt newer and more efficacious anti-H. pylori regimens to meet the Kyoto consensus recommendation and their patients' expectations.

Independent Risk Factors Predicting Eradication Failure of Hybrid Therapy for the First-Line Treatment of Helicobacter pylori Infection.

Hybrid therapy is a recommended first-line anti-H. pylori treatment option in the American College of Gastroenterology guidelines, the Bangkok Consensus Report on H. pylori management, and the Taiwan H. pylori Consensus Report. However, the cure rates of eradication therapy in some countries are suboptimal, and the factors affecting the treatment efficacy of hybrid therapy remain unclear. The aim of this study is to identify the independent risk factors predicting eradication failure of hybrid therapy in the first-line treatment of H. pylori infection. A retrospective cohort study was conducted on 589 H. pylori-infected patients who received 14-day hybrid therapy between September 2008 and December 2021 in ten hospitals in Taiwan. The patients received a hybrid therapy containing a dual regimen with a proton pump inhibitor (PPI) plus amoxicillin for an initial 7 days and a quadruple regimen with a PPI plus amoxicillin, metronidazole and clarithromycin for a final 7 days. Post-treatment H. pylori status was assessed at least 4 weeks after completion of treatment. The relationships between eradication rate and 13 host and bacterial factors were investigated via univariate and multivariate analyses. In total, 589 patients infected with H. pylori infection were included in the study. The eradication rates of hybrid therapy were determined as 93.0% (95% confidence interval (CI): 90.9-95.1%), 94.4% (95% CI: 93.8-97.2%) and 95.5%% (95% CI: 93.8-97.2%) by intention-to-treat, modified intention-to-treat and per-protocol analyses, respectively. Univariate analysis showed that the eradication rate of clarithromycin-resistant strains was lower than that of clarithromcyin-susceptible strains (83.3% (45/54) vs. 97.6%% (280/287); p < 0.001). Subjects with poor drug adherence had a lower cure rate than those with good adherence (73.3% (11/15) vs. 95.5% (534/559); p = 0.005). Other factors such as smoking, alcohol drinking, coffee consumption, tea consumption and type of PPI were not significantly associated with cure rate. Multivariate analysis revealed that clarithromcyin resistance of H. pylori and poor drug adherence were independent risk factors related to eradication failure of hybrid therapy with odds ratios of 4.8 (95% CI: 1.5 to 16.1; p = 0.009) and 8.2 (95% CI: 1.5 to 43.5; p = 0.013), respectively. A 14-day hybrid therapy has a high eradication rate for H. pylori infection in Taiwan, while clarithromycin resistance of H. pylori and poor drug adherence are independent risk factors predicting eradication failure of hybrid therapy.

Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.

BACKGROUND: This nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed. METHODS: Data were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry. RESULTS: Overall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn's disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naïve. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non-reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively. CONCLUSIONS: The findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday.

Unilateral borderzone infarction in a young polytrauma patient.

Although post-traumatic cerebral infarction is a known complication of craniocerebral trauma, borderzone infarction (BZI) after multiple traumas in young adults are uncommon and published data on this are extremely scant. We present an unusual occurrence of unilateral borderzone infarction in a 21-year-old male who sustained multiple traumas in a traffic accident, which included mild head injury, blunt cardiac injury, right traumatic hemopneumothorax, and three long bone open fractures. Initial head scan revealed mild brain edema, and the BZI was uncovered by a repeated brain CT scan since the patient had a delayed neurological deficit which was incompatible for the injury severity of the head. Comprehensive work-up was performed and a narrowed right internal carotid artery was disclosed by CT angiography. Although unilateral BZI is extremely rare in young patients, emergency physicians should still keep in mind to warrant serial examinations for BZI and early recognition to provide appropriate treatment.