Various durations of a standard regimen (amoxycillin, metronidazole, colloidal bismuth sub-citrate for 2 weeks or with additional ranitidine for 1 or 2 weeks) on eradication of Helicobacter pylori in Iranian peptic ulcer patients. A randomized controlled trial.
BACKGROUND
One of the most economical and effective therapeutic regimens for eradication of Helicobacter pylori is the classic triple therapy with amoxycillin or tetracycline, metronidazole and a bismuth derivative. Addition of H2-receptor antagonists to these drugs may heighten the rate of eradication and shorten the duration. We therefore performed a randomized controlled trial comparing twice daily metronidazole, bismuth derivative and amoxycillin for 2 weeks with additional ranitidine for 1 or 2 weeks.


METHODS
In total, 240 adult patients with duodenal ulcer and H. pylori infection were randomly assigned to one of the following regimens: (1) amoxycillin 1 g bid, metronidazole 500 mg bid, bismuth sub-citrate 240 mg bid and ranitidine 300 mg bid for 1 week; (2) triple therapy without ranitidine for 2 weeks; or (3) triple therapy plus ranitidine 300 mg bid for 2 weeks. Side-effects of the drugs were evaluated two weeks after starting the treatment. The rapid urease test and histology from antrum and corpus, and/or 14C- urea breath test were used to determine H. pylori eradication six weeks after starting the treatment.


RESULTS
In total, 195 patients were followed up for 6 weeks. The most frequent drug side-effects were unpleasant taste (46%), dry mouth (41%) and fatigue (26%), which had an equal distribution in all treatment groups. Endoscopy and 14C- urea breath test were performed for 178 and 123 patients, respectively. Eradication of H. pylori was documented in 19/64 (29.7%), 29/63 (46%) and 50/68 (73.5%) of patients in groups 1, 2 and 3, respectively (P < 0.000001 for group 1 versus group 3; P < 0.0014 for group 2 versus group 3; difference not significant for group 1 versus group 2). An intention-to-treat analysis showed eradication rates of 19/80 (23.75%), 29/80 (36.25%) and 50/80 (62.5%) for groups 1, 2 and 3, respectively. At four weeks post-treatment, the most sensitive test for evaluation of eradication of H. pylori was histology.


CONCLUSIONS
Although combined use of an H2-receptor antagonist and twice daily triple therapy in a two-week regimen is more effective than two-week triple or one-week quadruple therapy in Iranian patients, none of these regimens is ideal in countries with a probable high rate of resistant and strongly toxic strains of H. pylori.
Kaviani
M J
MJ
Gastroenterology Division, Internal Medicine Ward, Shiraz University of Medical Sciences, Shiraz, Iran. kavianim@pearl.sums.ac.ir
Malekzadeh
R
R
Vahedi
H
H
Sotoudeh
M
M
Kamalian
N
N
Amini
M
M
Massarrat
S
S
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001707:Biopsy, Needle; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004945:Esophagoscopy; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010406:Penicillins / Q000008:administration & dosage* / Q000009:adverse effects; D010437:Peptic Ulcer / Q000150:complications* / Q000382:microbiology / Q000473:pathology; D011899:Ranitidine / Q000008:administration & dosage* / Q000009:adverse effects; D014508:Urea / Q000032:analysis
D000900:Anti-Bacterial Agents; D006635:Histamine H2 Antagonists; D009942:Organometallic Compounds; D010406:Penicillins; D008795:Metronidazole; D000658:Amoxicillin; D011899:Ranitidine; D014508:Urea; C002791:bismuth tripotassium dicitrate; D001729:Bismuth