A large randomised controlled intervention trial to prevent gastric cancer by eradication ofHelicobacter pyloriin Linqu County, China: baseline results and factors affecting the eradication

Abstract

Objective To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China. Design A total of 184 786 residents aged 25-54 years were enrolled in this trial and received 13 C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth. Results The prevalence of H. pylori in trial participants was 57.6%. A total of 94 101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baselinevalue of 13 C-urea breath test, missed medication doses, smoking and drinking were independent predictors of eradication failure. The missed doses and high baseline delta over baseline-value were important contributors in men and women (all P trend <0.001). However, a doseresponse relationship between failure rate and smoking or drinking index was found in men (all P trend <0.001), while high body mass index (P trend <0.001) and history of stomach disease were significant predictors in women. The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined. Conclusions This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies. Trial registration number ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements. INTRODUCTIONHelicobacter pylori (H. pylori) is a recognised cause of chronic gastritis and peptic ulcer disease, and may play an important role in the etiology of Significance of this studyWhat is already known on this subject?▸ Gastric cancer is a global public health burden, nearly one million new cases are diagnosed each year worldwide, of which 42% cases occur in China. ▸ Helicobacter pylori infection is the main risk factor for gastric cancer, and it was classified as a class I carcinogen for gastric cancer by International Agency for Research on Cancer in 1994. ▸ The Shandong Intervention Trial launched in Linqu in 1995 yielded a 39% reduction in gastric cancer incidence rate after 15 years follow-up. ▸ Benefits and adverse consequences of strategy for gastric cancer prevention by eradication of H. pylori are still in concern in the community setting.What are the new findings?▸ The large community-based intervention trial to eradicate H. pylori is feasible and acceptable in a high-risk area of gastric cancer in China. It gained an elimination of 72.9% of H. pylori in such community intervention trial without severe side effects among all the subjects during the entire 30-month trial pe...

Management ofHelicobacter pyloriinfection—the Maastricht V/Florence Consensus Report

“…The overall gastric cancer risk reduction can be estimated at 34%. Several trials are ongoing in China, UK, and Korea currently, including a large one with 184 786 participants; these should provide more reliable data relating to any benefit or adverse consequences that accrue from H. pylori eradication in the prevention of gastric cancer 310 311…”

Seroprevalence of Helicobacter pylori in Korea: A multicenter, nationwide study conducted in 2015 and 2016

“…Chronic infection with H. pylori is strongly associated with gastric cancer3 the highest incidence of which is observed in Korea, Mongolia, Japan, and China 4. Eradication of H. pylori has thus been attempted in China and Japan to reduce gastric cancer levels 5, 6. Accordingly, determination of the H. pylori prevalence of normal asymptomatic participants is crucial for the establishment of national health policies in these Eastern Asia countries.…”

The Rationale and Efficacy of Primary and Secondary Prevention in Adenocarcinomas of the Upper Gastrointestinal Tract

“…This demonstrated a 50% risk reduction by eradication treatment (HR 0.50; 95% CI 0.26-0.94, p = 0.03) [121]. Knowledge of further relevant factors that influence the effect of H pylori eradication is expected from the interventional study that is currently being undertaken in the Chinese province of Linqu with international support [122]. The 185,000 inhabitants of this region were tested for H. pylori, and then randomised as to whether they received eradication prior to long-term follow-up.…”