Liou, Jyh-MingJyh-MingLiouChen, Po-YuehPo-YuehChenLuo, Jiing-ChyuanJiing-ChyuanLuoLee, Ji-YuhJi-YuhLeeCHIEH-CHANG CHENYang, Tsung-HuaTsung-HuaYangYU-JEN FANGChang, Chi-YangChi-YangChangBair, Ming-JongMing-JongBairHsu, Yao-ChunYao-ChunHsuMEI-JYH CHENWEN-FENG HSUChang, Chun-ChaoChun-ChaoChangJAW-TOWN LINEl-Omar, Emad M.Emad M.El-OmarCHIA-TUNG SHUNMING-SHIANG WULiou, Jyh-MingJyh-MingLiouLin, Jaw-TownJaw-TownLinYI-CHIA LEEWu, Chun-YingChun-YingWuWu, Jeng-YihJeng-YihWuLin, Chun-HungChun-HungLinFang, Yu-RenYu-RenFangLuo, Jiing-ChyuanJiing-ChyuanLuoChang, Chun-ChaoChun-ChaoChangPING-HUEI TSENGYu, Chien-ChunChien-ChunYuHAN-MO CHIUTSU-YAO CHENGChiu, Min-ChinMin-ChinChiuChou, Chu-KuangChu-KuangChouYEN-NIEN CHENTai, Chi-MingChi-MingTaiLee, Ching-TaiChing-TaiLeeWEN-HAO HUWang, Wen-LunWen-LunWangChang, Wen-ShiungWen-ShiungChangTaiwan Gastrointestinal Disease and Helicobacter ConsortiumHelicobacter ConsortiumCHING-CHOW CHEN2021-03-102021-03-102018-100016-5085https://scholars.lib.ntu.edu.tw/handle/123456789/551383https://www.scopus.com/record/display.uri?eid=2-s2.0-85054164338&doi=10.1053%2fj.gastro.2018.06.047&origin=inward&txGid=0fa7ecffa4afc72946125fc01d30b9c7Background & Aims: We aimed to compare the efficacy of genotypic resistance–guided therapy vs empirical therapy for eradication of refractory Helicobacter pylori infection in randomized controlled trials. Methods: We performed 2 multicenter, open-label trials of patients with H pylori infection (20 years or older) failed by 2 or more previous treatment regimens, from October 2012 through September 2017 in Taiwan. The patients were randomly assigned to groups given genotypic resistance–guided therapy for 14 days (n = 21 in trial 1, n = 205 in trial 2) or empirical therapy according to medication history for 14 days (n = 20 in trial 1, n = 205 in trial 2). Patients received sequential therapy containing esomeprazole and amoxicillin for the first 7 days, followed by esomeprazole and metronidazole, with levofloxacin, clarithromycin, or tetracycline (doxycycline in trial 1, tetracycline in trial 2) for another 7 days (all given twice daily) based on genotype markers of resistance determined from gastric biopsy specimens (group A) or empirical therapy according to medication history. Resistance-associated mutations in 23S ribosomal RNA or gyrase A were identified by polymerase chain reaction with direct sequencing. Eradication status was determined by 13C-urea breath test. The primary outcome was eradication rate. Results: H pylori infection was eradicated in 17 of 21 (81%) patients receiving genotype resistance–guided therapy and 12 of 20 (60%) patients receiving empirical therapy (P =.181) in trial 1. This trial was terminated ahead of schedule due to the low rate of eradication in patients given doxycycline sequential therapy (15 of 26 [57.7%]). In trial 2, H pylori infection was eradicated in 160 of 205 (78%) patients receiving genotype resistance–guided therapy and 148 of 205 (72.2%) patients receiving empirical therapy (P =.170), according to intent to treat analysis. The frequencies of adverse effects and compliance did not differ significantly between groups. Conclusions: Properly designed empirical therapy, based on medication history, is an acceptable alternative to genotypic resistance–guided therapy for eradication of refractory H pylori infection after consideration of accessibility, cost, and patient preference. ClinicalTrials.gov ID: NCT01725906. ? 2018 AGA Institute[SDGs]SDG3amoxicillin; clarithromycin; DNA topoisomerase (ATP hydrolysing) A; doxycycline; esomeprazole; levofloxacin; metronidazole; RNA 23S; tetracycline; urea c 13; amoxicillin; antiinfective agent; clarithromycin; doxycycline; esomeprazole; levofloxacin; metronidazole; proton pump inhibitor; tetracycline; abdominal pain; adult; antibiotic resistance; Article; bloating; breath analysis; comparative effectiveness; constipation; controlled study; diarrhea; dizziness; empirical therapy; eradication therapy; female; gene mutation; genotype; headache; Helicobacter infection; human; human tissue; intention to treat analysis; intermethod comparison; major clinical study; male; marker gene; multicenter study; nausea; patient compliance; polymerase chain reaction; priority journal; randomized controlled trial; rash; resistance guided therapy; sequence analysis; single blind procedure; stomach biopsy; Taiwan; taste disorder; treatment failure; treatment outcome; vomiting; aged; clinical decision making; clinical trial; combination drug therapy; comparative study; drug administration; drug effect; genetics; Helicobacter infection; Helicobacter pylori; microbiological examination; microbiology; middle aged; pathogenicity; predictive value; time factor; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Bacteriological Techniques; Breath Tests; Clarithromycin; Clinical Decision-Making; Doxycycline; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Genotype; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Metronidazole; Middle Aged; Predictive Value of Tests; Proton Pump Inhibitors; Taiwan; Tetracycline; Time Factors; Treatment Outcomejournal article10.1053/j.gastro.2018.06.047299640362-s2.0-85054164338