Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori.
BACKGROUND
Both triple therapy with ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days and dual therapy of RBC with clarithromycin for 14 days have been extensively studied; both regimens effectively eradicate Helicobacter pylori. However, few studies have assessed the efficacy of dual therapy given for 7 days.


OBJECTIVE
To compare the efficacy and safety of RBC 400 mg with clarithromycin 500 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for the eradication of H. pylori.


METHODS
This single centre, randomized, double-blind study involved 118 patients with dyspepsia or a history of peptic ulcer disease. H. pylori infection was detected initially by CLO test, and confirmed in 109 patients by urea breath test and/or microbiology culture. H. pylori eradication was assessed 4 and 12 weeks after the end of treatment by urea breath test. H. pylori antibiotic susceptibility was assessed pre-study in all patients, and post-treatment in patients with a positive post-treatment urea breath test. Adverse events were recorded throughout the study.


RESULTS
H. pylori was eradicated in 93% of patients who received RBC with clarithromycin and metronidazole and in 84% of patients who received RBC with clarithromycin (intention-to-treat rates). Per protocol eradication rates were 98% and 90% for triple therapy and dual therapy, respectively. The eradication of metronidazole-resistant H. pylori was achieved in 100% and 88% of patients following dual therapy and triple therapy, respectively, and acquired resistance to clarithromycin occurred in only one patient following treatment failure. Both treatments were well-tolerated; only one patient (2%) was withdrawn from each treatment group due to adverse events.


CONCLUSIONS
RBC with clarithromycin and metronidazole is a highly effective and well-tolerated triple therapy regimen for the eradication of H. pylori. RBC with clarithromycin dual therapy has a similar efficacy, and offers an alternative to triple therapy when there are concerns about treatment with metronidazole or the use of multiple antibiotics. Both regimens are effective against antibiotic-resistant strains of H. pylori.
Bardhan
K D
KD
Rotherham District General Hospitals NHS Trust, UK. pmr3795@gsk.com
Morton
D
D
Perry
M J
MJ
Sanders
D S
DS
Morris
P
P
Rowland
A
A
Thompson
M
M
Mitchell
T R
TR
Roberts
P M
PM
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D001944:Breath Tests; D002247:Carbon Isotopes; D017291:Clarithromycin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000382:microbiology; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis / Q000097:blood; D014510:Urease / Q000096:biosynthesis
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D002247:Carbon Isotopes; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D014508:Urea; D014510:Urease; D017291:Clarithromycin; D001729:Bismuth