BACKGROUND: Sequential treatment for Helicobacter pylori (H. pylori) appears to achieve a better eradication rate than triple therapy. However, most of the data have been reported from the Italy, and studies from different population are needed before it is recommended in clinical practice. The present study aimed to assess and compare the efficacy of two separate clarithromycin including sequential regimens in Turkey which is well known with high clarithromycin and metronidazole resistance to H. pylori. METHODS: Consecutive H. pylori -positive patients with non-ulcer dyspepsia were randomly allocated to one of the two sequential regimens; the first group was given lansoprazole 30 mg b.i.d. plus amoxicillin 1 g b.i.d. for the first week, followed by lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg t.i.d. for the second week (LA-CM). The second arm was given the same regimen but tetracycline500 g q.i.d. instead of metronidazole (LA-CT). H. pylori was detected with urea breath test (UBT) and histology before enrollment. UBT was repeated at 6th weeks after treatment. RESULTS: A total of 200 patients were enrolled in groups and 179 of them completed their protocols. The cumulative per protocol ("PP") and intention-to-treat ("ITT") eradication rates were 74.3% and 66.5% in all patients, respectively. Both "PP" (78.2% vs 70.1%) and "ITT" (72% vs 61%) eradication rates were better in LA-CT group than LA-CM group, but the differences were not statistically significant (p > .05). Both regimens were well tolerated, and the incidence of adverse effects was comparable. CONCLUSION: Two weeks clarithromycin including sequential regimens with metronidazole or tetracycline were not achieved acceptable eradication rates in Turkey.
RCT Entities:
BACKGROUND: Sequential treatment for Helicobacter pylori (H. pylori) appears to achieve a better eradication rate than triple therapy. However, most of the data have been reported from the Italy, and studies from different population are needed before it is recommended in clinical practice. The present study aimed to assess and compare the efficacy of two separate clarithromycin including sequential regimens in Turkey which is well known with high clarithromycin and metronidazole resistance to H. pylori. METHODS: Consecutive H. pylori -positive patients with non-ulcer dyspepsia were randomly allocated to one of the two sequential regimens; the first group was given lansoprazole 30 mg b.i.d. plus amoxicillin 1 g b.i.d. for the first week, followed by lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg t.i.d. for the second week (LA-CM). The second arm was given the same regimen but tetracycline500 g q.i.d. instead of metronidazole (LA-CT). H. pylori was detected with urea breath test (UBT) and histology before enrollment. UBT was repeated at 6th weeks after treatment. RESULTS: A total of 200 patients were enrolled in groups and 179 of them completed their protocols. The cumulative per protocol ("PP") and intention-to-treat ("ITT") eradication rates were 74.3% and 66.5% in all patients, respectively. Both "PP" (78.2% vs 70.1%) and "ITT" (72% vs 61%) eradication rates were better in LA-CT group than LA-CM group, but the differences were not statistically significant (p > .05). Both regimens were well tolerated, and the incidence of adverse effects was comparable. CONCLUSION: Two weeks clarithromycin including sequential regimens with metronidazole or tetracycline were not achieved acceptable eradication rates in Turkey.
Authors: Kadir Öztürk; Ömer Kurt; Gürkan Çelebi; Hakan Şarlak; Muhammed Fatih Karakaya; Hakan Demirci; Ali Kılınç; Ahmet Uygun Journal: Turk J Gastroenterol Date: 2020-03 Impact factor: 1.852