TTP7.07 Levofloxacin based therapy vs Hybrid therapy in the eradication of Helicobacter pylori : A randomized controlled trial
Abstract
To compare the efficacy of Helicobacter pylori (H.pylori ) eradication, compliance and adverse effects between levofloxacin based therapy (LBT) and hybrid therapy (HT).
This was a single-centre, open-label, non-inferiority randomised controlled study. Patients more than 18 years of age with dyspeptic symptoms were included. Sample size was calculated to be 67 in each arm, total 134 (10% non-inferiority margin). Upper GI endoscopy, biopsy for urease testing and histopathology were carried out. If positive for H.pylori, participants were randomised to either LBT or HT arm. In patients with ulcer disease, a follow up endoscopy was done, and for non-ulcer disease, stool antigen test was done after 6 weeks to determine eradication of H.pylori. Compliance and side effects of both the regimens were also assessed during follow-up.
A total of 134 participants were included in the study. Eradication rates of both LBT and HT were similar at 89.5% by intention-to-treat analysis (ITT), 92.1% and 89.2% by modified ITT analysis (p-value=0.763), and 95% and 93.5 % by per protocol analysis (p-value=0.730) respectively. Compliance, as measured by pill count was also comparable in HT group (92%) and LBT (91%) by ITT analysis (p-value =0.753). Arthralgia was significantly high in LBT group, which is a known complication of levofloxacin (p-value= <0.01). Other side effects were comparable in both groups.
H. pylori eradication rates, compliance and side effects in LBT and HT were comparable and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 134 participants or records.
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