Padole Prateek, Ranjan Piyush, Sachdeva Munish, Kumar Mandhir
Institute of Liver, Gastroenterology and Pancreaticobiliary Sciences, Sir Ganga Ram Hospital, New Delhi , 110 060, India.
Indian J Gastroenterol. 2021 Oct;40(5):492-501. doi: 10.1007/s12664-021-01195-3. Epub 2021 Oct 27.
Helicobacter pylori (H. pylori) is implicated in the pathogenesis of functional dyspepsia (FD). There is conflicting data regarding the benefit of H. pylori eradication for symptom relief in FD.
To study the benefit of eradicating H. pylori in patients with FD as compared to standard medical treatment (SMT). Secondary aims were to find efficacy of H. pylori eradication therapy, recurrence of H. pylori after eradication, and predictors of efficacy.
Consecutive adult patients of FD (ROME IV) with H. pylori infection presenting in the outpatient department of our hospital were enrolled. Patients with Global Overall Symptom (GOS) scale > 2 and H. pylori infection were included. Patients were randomized into two groups: group 1 received H. pylori eradication therapy and group 2 received SMT. Treatment success was defined as symptom relief (GOS score < 2 and reduction by at least 2 points at 6 months) and H. pylori eradication was defined as stool antigen negative at 4 weeks.
Of 329 participants with FD, 253 were H. pylori positive (rapid urease test and stool antigen test) (76.89%). After exclusions, 202 were randomized into two groups of 101 each. Thirty-two patients in group 1 and 31 in group 2 had treatment success (31.7% vs. 30.7%, p=1.000). The efficacy of H. pylori eradication therapy was 74.46% (70/94). H. pylori reinfection rate was 26.02% (19/73).
H. pylori eradication therapy does not provide additional benefit in symptom relief in patients with FD as compared with SMT.
NCT04697641 (retrospectively registered on www.clinicaltrials.gov in January 2021).
幽门螺杆菌（H. pylori）与功能性消化不良（FD）的发病机制有关。关于根除幽门螺杆菌对FD症状缓解的益处，数据存在冲突。
研究与标准药物治疗（SMT）相比，根除幽门螺杆菌对FD患者的益处。次要目的是确定幽门螺杆菌根除治疗的疗效、根除后幽门螺杆菌的复发情况以及疗效的预测因素。
纳入我院门诊就诊的连续成年FD患者（罗马IV标准）且伴有幽门螺杆菌感染。纳入全球总体症状（GOS）量表评分>2且伴有幽门螺杆菌感染的患者。患者被随机分为两组：第1组接受幽门螺杆菌根除治疗，第2组接受SMT。治疗成功定义为症状缓解（GOS评分<2且在6个月时降低至少2分），幽门螺杆菌根除定义为4周时粪便抗原阴性。
在329例FD参与者中，253例幽门螺杆菌阳性（快速尿素酶试验和粪便抗原试验）（76.89%）。排除后，202例被随机分为两组，每组101例。第1组32例患者和第2组31例患者治疗成功（31.7%对30.7%，p = 1.000）。幽门螺杆菌根除治疗的疗效为74.46%（70/94）。幽门螺杆菌再感染率为26.02%（19/73）。
与SMT相比，根除幽门螺杆菌治疗对FD患者的症状缓解没有额外益处。
NCT04697641（于2021年1月在www.clinicaltrials.gov上进行回顾性注册）。
