Rifaximin-based regimens for eradication of Helicobacter pylori: a pilot study.
BACKGROUND
Triple therapy is the treatment of choice for Helicobacter pylori-infected patients with an eradication rate ranging from 70 to 85%. Poor compliance and antibiotic resistance are the main causes of treatment failure. The aim of the present study was to assess the efficacy of rifaximin, a poorly absorbed antibiotic, for H. pylori eradication.


METHODS
We enrolled 48 consecutive H. pylori-positive patients affected. They were randomized to receive two 7-day rifaximin-based triple therapies: rifaximin tablets 400 mg t.i.d., esomeprazole 40 mg o.d. and clarithromycin 500 mg b.i.d. (CRE) or levofloxacin 500 mg o.d. (LRE). H. pylori eradication was assessed using a (13)C-urea breath test 4 weeks after the end of therapy. Treatment compliance and the incidence of side effects were also evaluated.


RESULTS
No dropouts were observed. The eradication rate both on intention-to-treat and per-protocol analysis did not show significant differences between groups: 58% (14/24 patients) in group 1 and 42% (10/24 patients) in group 2 (p = 0.24, OR 1.96, 95% CI 0.62-6.18). No significant differences in patients' compliance and incidence of side effects were found between groups.


CONCLUSIONS
Rifaximin-based therapy showed optimal compliance but a limited eradication rate compared to standard first-line treatment. Further investigations are needed to evaluate different dosages and combinations.
Gasbarrini
Antonio
A
Department of Internal Medicine, Gemelli University Hospital, Catholic University of the Sacred Heart, Rome, Italy. agasbarrini@rm.unicatt.it
Lauritano
Ernesto Cristiano
EC
Nista
Enrico Celestino
EC
Candelli
Marcello
M
Gabrielli
Maurizio
M
Santoro
Michele
M
Zocco
Maria Assunta
MA
Cazzato
Alessia
A
Finizio
Rosalba
R
Ojetti
Veronica
V
Cammarota
Giovanni
G
Gasbarrini
Giovanni
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use; D010865:Pilot Projects; D012294:Rifamycins / Q000627:therapeutic use*; D000078262:Rifaximin; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D004791:Enzyme Inhibitors; D012294:Rifamycins; D064704:Levofloxacin; D015242:Ofloxacin; D017291:Clarithromycin; D000078262:Rifaximin; D064098:Esomeprazole