Antibacterial Treatment of Gastric Ulcers Associated with Helicobacter pylori
Joseph J.Y. Sung, M.D., S.C. Sydney Chung, M.D., Thomas K.W. Ling, Ph.D., Man Yee Yung, B.N., Vincent K.S. Leung, M.D., Enders K.W. Ng, M.D., Michael K.K. Li, M.D., Augustine F.B. Cheng, M.D., and Arthur K.C. Li, M.D.
Background There is a strong association between infection withHelicobacter pylori and gastric ulcers that are unrelated tothe use of nonsteroidal antiinflammatory medications. We studiedthe efficacy of antibacterial therapy without medication tosuppress gastric acid for the treatment of patients with H.pylori infection and gastric ulcers unrelated to the use ofnonsteroidal agents.
Methods Patients with gastric ulcers seen on endoscopy and withH. pylori infection confirmed by smear or culture were randomlyassigned to receive either a one-week course of antibacterialagents (120 mg of bismuth subcitrate, 500 mg of tetracycline,and 400 mg of metronidazole, each given orally four times aday) or a four-week course of omeprazole (20 mg orally per day).Follow-up endoscopies were performed after five and nine weeks.The patients and their physicians were aware of the treatmentassignments, but the endoscopists were not.
Results A total of 100 patients were randomly assigned to treatment,and 85 completed the trial. At five weeks, H. pylori had beeneradicated in 41 of the 45 patients in the antibacterial-treatmentgroup (91.1 percent; 95 percent confidence interval, 82.9 to99.3) and in 5 of the 40 in the omeprazole group (12.5 percent;95 percent confidence interval, 2.3 to 22.7; P<0.001). Thegastric ulcers were healed in 38 of the patients treated withantibacterial drugs (84.4 percent; 95 percent confidence interval,73.9 to 95.0) and in 29 of those treated with omeprazole (72.5percent; 95 percent confidence interval, 58.6 to 86.4; P = 0.28).At nine weeks, ulcer healing was confirmed in 43 of the patientsreceiving antibacterial therapy and in 37 of those receivingomeprazole (P = 1.0). The mean (±SD) duration of painduring the first week of treatment was 1.9±2.6 days inthe omeprazole group, as compared with 3.6±3.0 days inthe antibacterial-treatment group (P = 0.004). One year aftertreatment, recurrent gastric ulcers were detected in 1 of 22patients (4.5 percent) in the antibacterial-treatment groupand in 12 of 23 (52.2 percent) in the omeprazole group (P =0.001). H. pylori was detected in the 1 patient with a recurrentulcer who had received antibacterial treatment and in 10 ofthe 12 patients with recurrent ulcers who had received omeprazole.
Conclusions In patients with H. pylori infection and gastriculcers unrelated to the use of nonsteroidal antiinflammatorydrugs, one week of antibacterial therapy without acid suppressionheals the ulcers as well as omeprazole and reduces the rateof their recurrence.
Source Information
From the Departments of Medicine (J.J.Y.S., V.K.S.L., M.K.K.L.), Surgery (S.C.S.C., M.Y.Y., E.K.W.N., A.K.C.L.), and Microbiology (T.K.W.L., A.F.B.C.), Prince of Wales Hospital and Chinese University of Hong Kong, Hong Kong.
Address reprint requests to Dr. Sung at the Department of Medicine, Prince of Wales Hospital, Shatin, Hong Kong.
Antibacterial Treatment of Gastric Ulcers
Graham D. Y., Go M. F., Faigel D. O., Metz D. C., Salyards H. E., Harris A., Misiewicz J.J., Fagan T., Sung J. J.Y., Chung S.C. S., Yung M. Y.
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N Engl J Med 1995;
333:190-192, Jul 20, 1995.
Correspondence
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A correction has been published: N Engl J Med 1995;333(3):190.
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