Although having a higher rate of complications, the combination of Tetracycline and Levofloxacin is more effective for eliminating Helicobacter pylori (H. pylori) than Clarithromycin and Amoxicillin, according to the findings of a recent multicenter, multinational randomized controlled trial. The purpose of the investigators was to assess the effectiveness of Tetracycline with Levofloxacin in the treatment of H. pylori infection.

All H. pylori-infected subjects were recruited and randomly assigned to receive either Tetracycline with Levofloxacin (Group A) or Clarithromycin with Amoxicillin (Group B) quadruple regimen for 2 weeks throughout six months in 8 referral tertiary centres of 3 different countries. All the volunteers continued Pantoprazole for a further 4 weeks, and then, one to two weeks after stopping the medication, a 13C urea breath test was completed by them to demonstrate complete elimination.

A total of 788 volunteers were incorporated, with 358 men (average age of 44.2 years). Peptic ulcer disease (234 instances, 29.69%), intestinal metaplasia (38 instances, 4.8%), and non-ulcer dyspepsia (516 instances, 65.5%) were the diagnoses made in these patients. Overall, 63.1% of the population was identified as Caucasian, 14.5% as Arab, 15.6% as African, and 6.1% as Asian.

Individuals were divided into groups A and B at random and given either Clarithromycin or Tetracycline plus Levofloxacin. In intention-to-treat and per-protocol analyses, the percentage of participants in groups A and B that achieved eradication were 75.2% and 82.1% (285 cases) and 67.5% and 70.1% (276 instances), respectively. Groups A and B had complete compliance rates of 84.4% and 83.6%, respectively.

During the trial, 33.5% of group A subjects (127 instances) reported side effects. In group B, the complication rate was found to be 27.9% (114 cases). Nausea and vomiting (12.6% and 9.3%) and stomach discomfort (4.48% and 2.68%) were the most frequently reported symptoms in groups A and B, respectively. In groups A and B, the rates of severe complications that led to drug cessation were 2.1% and 1.46%, respectively.

In subgroup analysis, the elimination rates of Tetracycline plus Levofloxacin were 79.4%, 88.1%, and 73.9% among patients with non-ulcer dyspepsia, peptic ulcer disease, and intestinal metaplasia, respectively. These percentages were 71.3%, 67.6%, and 61.5% in group B. Hence, the treatment plan of Levofloxacin+Tetracycline quadruple regimen may be the ideal option for eliminating H. pylori in regions with high levels of Clarithromycin resistance, especially in those with peptic ulcer disease.