Limited efficacy of omeprazole-based dual and triple therapy for Helicobacter pylori: a randomized trial employing "optimal" dosing.
OBJECTIVE
To evaluate the efficacy and side effects of dual omeprazole/amoxicillin therapy for Helicobacter pylori given in "optimal" fashion (omeprazole twice a 3 g of amoxicillin daily, drugs started concurrently, 2 wk of therapy) and to assess the utility of adding a second antibiotic, tetracyline.


METHODS
Sixty healthy volunteers with H. pylori infection documented by 13C-urea breath test were randomly assigned to receive 2 wk of therapy with either 1) omeprazole 20 mg b.i.d. and amoxicillin 1 g t.i.d. (OA), or 2) OA plus tetracycline 500 mg t.i.d. (OAT). Patients returned after 2 wk for pill count and clinical assessment, and 13C-urea breath test was repeated 4 wk after the end of therapy.


RESULTS
H. pylori was eradicated in 15 (50%) of 30 patients receiving OA therapy and in nine (30%) of 30 given OAT (p = 0.19). Side effects occurred in five (17%) patients in the OA group [two (7%) discontinued therapy due to side effects] and eight (27%) of the OAT group [three (10%) stopped therapy due to side effects]. Good compliance (> 80% of prescribed study drugs taken) was seen in 87% of each group, and eradication rates were 54% and 35% among patients with good compliance in the OA and OAT groups (p = 0.26).


CONCLUSIONS
Dual therapy with omeprazole and amoxicillin, when given in "optimal" fashion, had limited efficacy, with an eradication rate of 50%. The addition of tetracycline to the dual therapy did not improve the rate of cure. Because virtually all of our subjects were from minority groups, with over three-fourths Hispanic, we speculate that differences in H. pylori strains or host factors may explain, at least in part, the discrepancy between our results and those in Northern European populations.
Laine
L
L
University of Southern California School of Medicine, Los Angeles, USA.
Stein
C
C
Neil
G
G
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage*; D001944:Breath Tests; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage*; D010349:Patient Compliance; D011446:Prospective Studies; D013752:Tetracycline / Q000008:administration & dosage*; D013997:Time Factors
D000658:Amoxicillin; D013752:Tetracycline; D009853:Omeprazole