MICONAZOLE GEL INCREASES THE CURE RATE OF HELICOBACTER-PYLORI INFECTION WHEN ADDED TO LANSOPRAZOLE AND AMOXICILLIN IN A RANDOMIZED TRIAL

Background. Miconazole is an antimycotic agent with bacteriocidal acti vity against Helicobacter pylori in vitro. Its role in the clinical er adication of H. pylori has not been studied. The objective of this stu dy was to investigate the efficacy and side effect profile of miconazo le for the treatment of H. pylori. Materials and Methods. We studied 6 5 patients with gastritis or peptic ulcer disease in whom H. pylori in fection was confirmed by a rapid urease test and microbiologic assessm ent. In vitro miconazole sensitivity was as sessed for the H. pylori s trains isolated from the enrolled patients. All patients were randomiz ed to receive either dual therapy consisting of lansoprazole 30 mg dai ly and amoxicillin 500 mg three times a day for 14 days (LA, n = 33) o r triple therapy using the LA regimen plus miconazole gel 100 mg three times a day for 14 days (LAM, n = 32). At least 8 weeks after the tre atment, successful therapy was validated by the histological and micro biologic assessment. Adverse effects and drug adherence were monitored by direct questioning. Results. The minimum inhibitory concentrations of miconazole ranged from 3.13 to 6.25 md/L. H. pylori was eradicated in 16 of 33 patients (48%, 95% CI = 31% to 67%) after LA therapy, and 24 of 32 patients (75%, 95% CI = 59% to 91%) after LAM therapy (p < . 03). There was no significant difference in the occurrence of adverse events between the two groups. Conclusion. The addition of miconazole gel to the LA regimen significantly improved the cure rate of H. pylor i without an increase in adverse effects.