The prolongation of triple therapy for Helicobacter pylori does not allow reaching therapeutic outcome of sequential scheme: a prospective, randomised study.
OBJECTIVE
One-week triple therapy for Helicobacter pylori revealed, during these last few years, a decrease in the eradication rate, so that the prolongation of its duration has been proposed. A sequential scheme recently showed very satisfactory results. We performed a prospective randomised study with the aim of either evaluating whether the triple therapy prolongation may improve its effectiveness and comparing its outcome with that of sequential regimen.


METHODS
Three hundred and forty-two H. pylori positive patients completed the study. They were randomised to receive one of the following treatments: (i) a 7-day triple therapy comprising of rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and amoxycillin (1 g, b.i.d.); (ii) a 10-day triple therapy comprising the same scheme; (iii) a 10-day sequential regimen comprising of rabeprazole (20 mg, b.i.d.) plus amoxycillin (1 g, b.i.d.) for 5 days followed by rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and tinidazole (500 mg, b.i.d.) for the next 5 days. Therapeutic results were expressed using both intention-to-treat and per protocol analyses with 95% confidence intervals. A model of multivariate logistic regression analysis was performed using therapeutic outcome as a dependent variable and including endoscopic finding, smoking habit, age and sex as candidates for the model.


RESULTS
Sequential regimen showed a significant gain in the eradication rate as compared to the 7-day (P < 0.0001) and the 10-day (P < 0.01) triple therapies, respectively. Overall eradication was lower in smokers than in non-smokers, but the difference remained significant only in the 7-day triple therapy (P < 0.01). Additionally, the overall eradication was higher in peptic ulcer than dyspepsia (P < 0.01), even if this difference was significant only for both triple therapies.


CONCLUSIONS
Seven-day triple therapy achieves disappointing eradication rates in dyspeptics and smokers. Prolonging triple therapy to 10 days does not significantly improve the eradication rate. The novel 10-day sequential regimen is more effective and equally tolerated than the 10-day triple therapy.
De Francesco
V
V
Gastroenterology Unit, University of Foggia, Riuniti Hospital, Viale L. Pinto, 71100 Foggia, Italy.
Zullo
A
A
Hassan
C
C
Della Valle
N
N
Pietrini
L
L
Minenna
M F
MF
Winn
S
S
Monno
R
R
Stoppino
V
V
Morini
S
S
Panella
C
C
Ierardi
E
E
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D000994:Antitrichomonal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009853:Omeprazole / Q000031:analogs & derivatives; D010349:Patient Compliance; D010437:Peptic Ulcer / Q000188:drug therapy / Q000382:microbiology; D011446:Prospective Studies; D064750:Rabeprazole; D012907:Smoking / Q000453:epidemiology; D014011:Tinidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000994:Antitrichomonal Agents; D001562:Benzimidazoles; D014011:Tinidazole; D064750:Rabeprazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole