Objective Patients with a history of Helicobacter pylori-negative idiopathic bleeding ulcers have a considerable risk of recurrent ulcer complications. We hypothesised that a proton pump inhibitor (lansoprazole) is superior to a histamine 2 receptor antagonist (famotidine) for the prevention of recurrent ulcer bleeding in such patients. Design In this industry-independent, double-blind, randomised trial, we recruited patients with a history of idiopathic bleeding ulcers. After ulcer healing, we randomly assigned (1:1) patients to receive oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. The primary endpoint was recurrent upper GI bleeding within 24 months, analysed in the intention-to-treat population as determined by an independent adjudication committee. Results Between 2010 and 2018, we enrolled 228 patients (114 patients in each study group). Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer). The cumulative incidence of recurrent upper GI bleeding in 24 months was 0.88% (95% CI 0.08% to 4.37%) in the lansoprazole arm and 2.63% (95% CI 0.71% to 6.91%) in the famotidine arm (p=0.313; crude HR 0.33, 95% CI 0.03 to 3.16, p=0.336). None of the patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs. Conclusion This 2-year, double-blind randomised trial showed that among patients with a history of H. pylori-negative idiopathic ulcer bleeding, recurrent bleeding rates were comparable between users of lansoprazole and famotidine, although a small difference in efficacy cannot be excluded. Trial registration number NCT01180179; Results.

中文翻译：

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预防复发性特发性胃十二指肠溃疡出血：一项双盲随机试验

目的 有幽门螺杆菌阴性特发性出血性溃疡病史的患者发生溃疡并发症复发的风险相当大。我们假设质子泵抑制剂（兰索拉唑）在预防此类患者复发性溃疡出血方面优于组胺 2 受体拮抗剂（法莫替丁）。设计 在这项独立于行业的双盲随机试验中，我们招募了有特发性出血性溃疡病史的患者。溃疡愈合后，我们随机分配 (1:1) 患者接受口服兰索拉唑 30 mg 或法莫替丁 40 mg，每日 24 个月。主要终点是 24 个月内复发性上消化道出血，在意向治疗人群中进行分析，由独立裁决委员会确定。结果 2010 年至 2018 年，我们招募了 228 名患者（每个研究组 114 名患者）。1 名接受兰索拉唑（十二指肠溃疡）的患者和 3 名接受法莫替丁的患者（2 名胃溃疡和 1 名十二指肠溃疡）发生上消化道反复出血。兰索拉唑组 24 个月内复发性上消化道出血的累积发生率为 0.88%（95% CI 0.08% 至 4.37%），法莫替丁组为 2.63%（95% CI 0.71% 至 6.91%）（p=0.313；粗 HR 0.33，95% CI 0.03 至 3.16，p=0.336）。再出血的患者均未使用阿司匹林、非甾体抗炎药或其他抗血栓药物。结论 这项为期 2 年的双盲随机试验表明，在有幽门螺杆菌阴性特发性溃疡出血病史的患者中，兰索拉唑和法莫替丁使用者之间的复发性出血率相当，虽然不能排除疗效上的微小差异。试验注册号NCT01180179；结果。