Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea 2020

Abstract

Helicobacter pylori infection is one of the most common infectious diseases worldwide. Although the prevalence of H. pylori is gradually decreasing, approximately half of the world's population still becomes infected with this disease. H. pylori is responsible for substantial gastrointestinal morbidity worldwide, with a high disease burden. It is the most common cause of gastric and duodenal ulcers and gastric cancer. Since the revision of the H. pylori clinical practice guidelines in 2013 in Korea, the eradication rate of H. pylori has gradually decreased with the use of a clarithromycin-based triple therapy for 7 days. According to a nationwide randomized controlled study conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research released in 2018, the intention-to-treat eradication rate was only 63.9%, which was mostly due to increased antimicrobial resistance, especially from clarithromycin. The clinical practice guidelines for the treatment of H. pylori were updated according to evidence-based medicine from a meta-analysis conducted on a target group receiving the latest level of eradication therapy. The draft recommendations developed based on the meta-analysis were finalized after an expert consensus on three recommendations regarding the indication for treatment and eight recommendations for the treatment itself. These guidelines were designed to provide clinical evidence for the treatment (including primary care treatment) of H. pylori infection to patients, nurses, medical school students, policymakers, and clinicians. These may differ from current medical insurance standards and will be revised if more evidence emerges in the future.

Keywords: Helicobacter pylori; Guidelines; Meta-analysis; Microbial sensitivity tests; Treatment.

Fig. 1

Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flowchart showing the selection process for key question 1.

Fig. 2

Comparison of the occurrence of metachronous gastric cancer after endoscopic resection of gastric adenoma between Helicobacter pylori (Hp) eradication and placebo treatment. M-H, Mantel-Haenszel test; CI, confidence interval.

Fig. 3

Forest plot of studies reporting the impact of Helicobacter pylori eradication on gastric cancer from studies involving the general population. M-H, Mantel-Haenszel test; CI, confidence interval.

Fig. 4

Time trends of pooled Helicobacter pylori eradication rates of standard triple therapy from randomized controlled trials performed in Korea (by years). The overall eradication rates of standard triple therapy were 71.6% (95% confidence interval [CI], 69.9% to 73.3%) in ITT analysis and 79.6% (95% CI, 76.6% to 82.2%) in PP analysis. The eradication rates from 2007 to 2011 were 72.3% (95% CI, 71.2% to 74.4%) in ITT analysis and 81.5% (95% CI, 79.9% to 82.9%) in PP analysis. The eradication rates from 2012 to 2016 were 70.3% (95% CI, 68.4% to 72.1%) in ITT analysis and 77.4% (95% CI, 75.6% to 79.2%) in PP analysis. ITT, intention-to-treat; PP, per protocol. *p<0.01.

Fig. 5

Comparison between 10-day sequential therapy and standard triple therapy (TT) according to the treatment duration of TT in intention-to-treat analysis. M-H, Mantel-Haenszel test; CI, confidence interval. *Risk of bias: A, random sequence generation (selection bias); B, allocation concealment (selection bias); C, blinding of participants and personnel (performance bias); D, blinding of outcome assessment (detection bias); E, incomplete outcome data (attrition bias); F, selective reporting (reporting bias); G, other bias.

Fig. 6

Comparison between 10-day concomitant therapy (CT) and 10-day/14-day standard triple therapy in intention-to-treat analysis. ST, standard triple therapy; M-H, Mantel-Haenszel test; CI, confidence interval.

Fig. 7

Comparison of the eradication rate of PBMT as first-line therapy in intention-to-treat analysis. (A) 10-day/14-day PBMT versus 14-day TT; (B) 10-day/14-day PBMT versus 10-day SQT; and (C) 10-day/14-day PBMT versus 10-day CCT. M-H, Mantel-Haenszel test; CI, confidence interval; PBMT, bismuth quadruple therapy; TT, standard triple therapy; SQT, sequential therapy; CCT, concomitant therapy. *Risk of bias: A, random sequence generation (selection bias); B, allocation concealment (selection bias); C, blinding of participants and personnel (performance bias); D, blinding of outcome assessment (detection bias); E, incomplete outcome data (attrition bias); F, selective reporting (reporting bias); G, other bias.

Fig. 8

Meta-analysis of nine studies comparing bismuth quadruple therapy with other regimens after failure of first-line standard triple therapy. The pooled eradication rate of bismuth quadruple therapy as a second-line therapy was 75.5% (95% confidence interval [CI], 71.6% to 79.1%).

Fig. 9

Meta-analysis of eight studies that compared levofloxacin triple therapy with other regimens after failure of first-line line clarithromycin triple therapy. The pooled eradication rate of levofloxacin triple therapy as a second-line therapy was 73.1% (95% confidence interval [CI], 68.4% to 77.3%).

Fig. 10

Proposed algorithm for Helicobacter pylori treatment in Korea. Bismuth quadruple therapy as a first-line therapy is dotted because it is less preferred than other regimens. CM, clarithromycin; PPI, proton pump inhibitor. *The PAM regimen consists of PPI, amoxicillin, and metronidazole.