Clarithromycin as monotherapy for eradication of Helicobacter pylori: a randomized, double-blind trial.
Current regimens to eradicate Helicobacter pylori usually consist of metronidazole plus a bismuth compound, as well as a third agent such as tetracycline. Such regimens are not ideal because organisms may be metronidazole-resistant, side-effects occur, and compliance is often poor. This randomized, double-blind study was designed to assess the ability of clarithromycin, a new macrolide antimicrobial, as monotherapy to eradicate H. pylori. Thirty-seven healthy volunteers who were H. pylori positive by 13C-urea breath test plus histology and/or culture completed 14 days of oral therapy with clarithromycin in one of three dosages. Eradication, defined as all three tests negative at 4-6 wk after the end of therapy, was achieved in 2/13 (15%) with clarithromycin 500 mg bid, 4/11 (36%) with 1000 mg bid, and 7/13 (54%) with 500 mg qid. Isolates of H. pylori were resistant to clarithromycin prior to therapy in 12% of subjects, and became resistant during therapy in 21% of subjects. Taste perversion, the most common side effect, resulted in one subject terminating therapy.


CONCLUSIONS
Whereas clarithromycin is a promising antimicrobial in the eradication of H. pylori, it is not sufficient to be used as monotherapy.
Peterson
W L
WL
Medical Service, Dallas VA Medical Center, Texas.
Graham
D Y
DY
Marshall
B
B
Blaser
M J
MJ
Genta
R M
RM
Klein
P D
PD
Stratton
C W
CW
Drnec
J
J
Prokocimer
P
P
Siepman
N
N
D000328:Adult; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005753:Gastric Mucosa / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests
D017291:Clarithromycin