Clinical trial: levofloxacin-based quadruple therapy was inferior to traditional quadruple therapy in the treatment of resistant Helicobacter pylori infection.
BACKGROUND
The efficacy of levofloxacin-based quadruple therapy in resistant Helicobacter pylori infection is not known.


OBJECTIVE
To test the efficacy of levofloxacin-based quadruple therapy and traditional quadruple therapy in resistant H. pylori infection.


METHODS
One hundred and two patients with resistant H. pylori infection were randomized to 1 week of either EBAL (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., amoxicillin 1 g b.d. and levofloxacin 500 mg b.d.) or EBMT (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., metronidazole 400 mg t.d.s. and tetracycline 500 mg q.d.s.). (13)C-urea breath test was performed at week 12 to assess post-treatment H. pylori status.


RESULTS
In intention-to-treat analysis H. pylori eradication was achieved in 37 of 51 (73%) subjects in EBAL and 45 of 51 (88%) subjects in EBMT groups, respectively (P = 0.046). Per-protocol eradication rates of EBAL and EMBT groups were 78% and 94%, respectively (P = 0.030). The intention-to-treat eradication rate was statistically lower for EBAL than EMBT (56% vs. 90%, P = 0.013) among those who had failed more than one course of eradication therapy. Previous levofloxacin triple therapy did not affect the efficacy of either protocol significantly.


CONCLUSIONS
Levofloxacin-based quadruple therapy was inferior to traditional quadruple therapy for resistant H. pylori infection.
Yee
Y K
YK
Department of Medicine, University of Hong Kong, Kong Kong.
Cheung
T K
TK
Chu
K-M
KM
Chan
C K
CK
Fung
J
J
Chan
P
P
But
D
D
Hung
I
I
Chan
A O O
AO
Yuen
M F
MF
Hsu
A
A
Wong
B C Y
BC
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000494:pharmacology / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001944:Breath Tests; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000378:metabolism; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D064098:Esomeprazole