Eradication of Helicobacter pylori infection after ranitidine bismuth citrate, metronidazole and tetracycline for 7 or 10 days.
BACKGROUND
We assessed the efficacy, tolerance, and compliance of twice-daily triple therapy for Helicobacter pylori with ranitidine bismuth citrate, metronidazole and tetracycline for 7 or 10 days.


METHODS
105 subjects with H. pylori infection documented by the 13C-urea breath test were randomly assigned to a 7 or 10-day course of ranitidine bismuth citrate 400 mg b.d., metronidazole 500 mg b.d. and tetracycline 500 mg b.d. Subjects returned at the end of therapy for assessment of side-effects and pill count. A repeat 13C-urea breath test was obtained 4 or more weeks after completion of therapy and cure of infection was defined as a negative test result.


RESULTS
Poor compliance (< 80% of medications) was seen in 2% of subjects randomized to 7 days of therapy and in 10% randomized to 10 days of therapy (P = N.S.). Intention-to-treat eradication rates were 56% for 7-day and 60% for 10-day therapy (P = N.S.). Per protocol eradication rates were 58% for 7-day and 61% for 10-day therapy (P = N.S.). The 10-day intention-to-treat eradication rate for males was 78% and 32% for females (P < 0.01) and per protocol eradication rates were 79% and 31%, respectively (P < 0.01).


CONCLUSIONS
Despite excellent compliance and tolerance, neither 7 nor 10 days of therapy with twice-daily ranitidine bismuth citrate, metronidazole and tetracycline are adequate as a treatment of H. pylori infection.
Knigge
K
K
Veterans Affairs Medical Center and Oregon Health Sciences University, Portland, Oregon, USA.
Kelly
C
C
Peterson
W L
WL
Fennerty
M B
MB
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013752:Tetracycline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014508:Urea / Q000378:metabolism
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D014508:Urea; D013752:Tetracycline; D001729:Bismuth