Randomized comparison of two rescue therapies for Helicobacter pylori infection.
BACKGROUND
Bismuth salts are not available worldwide. It remains unknown whether clarithromycin can replace bismuth salts as an adjuvant agent in the rescue regimens for Helicobacter pylori infection. We therefore designed the prospective study to compare the efficacies of two rescue therapies for H. pylori infection after standard triple therapies.


METHODS
Ninety-three patients who failed H. pylori eradication using proton pump inhibitor plus clarithromycin and amoxicillin were randomly assigned to undergo rescue therapy with esomeprazole, clarithromycin, tetracycline and metronidazole (ECTM group, n = 46) or esomeprazole, bismuth subcitrate, tetracycline and metronidazole (EBTM group, n = 47). Follow-up endoscopy was performed at 8 weeks after the end of treatment to assess the treatment response.


RESULTS
Intention-to-treat analysis demonstrated both groups had similar eradication rates (ECTM 74% vs. EBTM 77%; P = 0.76) and drug compliance (ECTM 94% vs. EBTM 96%; P = 0.68). However, the frequency of adverse events in the ECTM group was higher than that in EBTM group (ECTM 57% vs. EBTM 36%, P = 0.05). In the EBTM group, eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (67%[8/12] vs. 100%[9/9], P = 0.05). However, eradication rates were similar between metronidazole-susceptible and metronidazole-resistant strains in ECTM group (69%[9/13] vs. 70%[7/10], P = 1.00).


CONCLUSIONS
The new ECTM second-line therapy can achieve similar eradication rate as standard EBTM therapy. It may be very useful in countries where bismuth salts are not available.
Wu
D C
DC
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Hsu
P I
PI
Chen
A
A
Lai
K H
KH
Tsay
F W
FW
Wu
C J
CJ
Lo
G H
GH
Wu
J Y
JY
Wu
I C
IC
Wang
W M
WM
Tseng
H H
HH
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D013752:Tetracycline / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D008795:Metronidazole; D000658:Amoxicillin; D013752:Tetracycline; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D064098:Esomeprazole