Aim: The efficacy of two most frequently used triple-therapy regimes, of 7, 10, and 14 days duration, was investigated in patients with gastric (GU), duodenal ulcer (DU) and non-ulcer dyspepsia (NUD).
Methods: 103 GU (M/F 60/43, mean age 57), 155 DU patients (M/F 92/63, mean age 49) and 87 NUD (M/F 39/48, mean age 52) who were positive for H.pylori underwent endoscopy, urease test, histology and serology at the beginning of the study and 4 weeks after the end of the treatment. They were randomly assigned to six treatments groups: A) Omeprazole 20 mg b.d., Amoxicillin 1g b.d. for 14 days, Metronidazole 500 b.d. for 10 days (n=62), B) Omeprazole 20 mg b.d., Amoxicillin 1 g b.d., Metronidazole 500 b.d. for 10 days (n=58), C) same drugs as in A. and B. for 7 days (n=60), D) Omeprazole 20 mg b.d., Amoxicillin 1 g b.d., Clarithromycin 500 mg b.d. for 14 days (n=52), E) same drugs as in D. for 10 days (n=58), F) same drugs as in E. and D. for 7 days (n=55). 329 patients (95%) completed the study.
Results:
Th- Eradicat. Healing of ulcer Clinical improvement
groups (%) GU (%) DU (%) Ulcers (%) NUD (%)
A 47/61 (78)* 11/14 (79) 24/28 (86) 40/42 (95) 17/19 (89)
B 40/56 (71) 18/21 (86) 22/23 (96) 42/44 (95) 10/12 (83)
C 35/58 (60) 16/18 (89) 25/27 (93) 39/45 (87) 11/13 (85)
D 43/46 (94)* 16/16 (100) 25/26 (96) 41/42 (98) 13/14 (93)
E 45/55 (81) 17/18 (94) 26/27 (96) 40/45 (89) 12/12 (100)
F 40/53 (75) 16/16 (100) 24/24 (100) 37/40 (92) 12/13 (92)
TOTAL 250/329 (76) 94/103 (91) 146/155 (94) 239/258 (93) 111/133 (83)
(*p<0.05, A and D in comparison with C and F)
Conclusion: In all tested groups (7, 10, 14 days), the triple-therapy containing clarithromycin had greater H. pylori eradication rate than that with metronidazole. The eradication rate exceeding 90% was achieved only by 14-days of omeprazole, amoxicyllin and clarithromycin. Concerning the ulcer healing and clinical improvement, no statistically significant difference was found among these groups.