{Reference Type}: Journal Article
{Title}: Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K-CREATE Study.
{Author}: Kim JS;Kim BW;Kim JI;Chung WC;Jung SW;Bang CS;Kim GH;Jeon SW;Joo MK;Lee SH;Lim YJ;Sung JK;Seo SY;Park SY;Lee WS;Lee HL;Kim KB;Kim HU;
{Journal}: Helicobacter
{Volume}: 29
{Issue}: 4
{Year}: 2024 Jul-Aug
{Factor}: 5.182
{DOI}: 10.1111/hel.13126
{Abstract}: <B>BACKGROUND: </B>The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.<BR><B>OBJECTIVE: </B>This study was a nationwide, multicenter, randomized trial comparing empirical therapy with tailored therapy based on genotypic resistance for first-line eradication of Helicobacter pylori. We also compared the eradication rates of 7- and 14-day regimens for each group.<BR><B>METHODS: </B>Patients with H. pylori infection were first randomized to receive empirical or tailored therapy. Patients in each group were further randomized into 7- or 14-day regimens. Empirical therapy consisted of a triple therapy (TT) regimen (twice-daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg) for 7 or 14 days. Tailored therapy consisted of TT of 7 or 14 days in patients without genotypic resistance. Patients with genotypic resistance were treated with bismuth quadruple therapy (BQT) regimens (twice-daily doses of pantoprazole 40 mg, three daily doses of metronidazole 500 mg, and four times daily doses of bismuth 300 mg and tetracycline 500 mg) for 7 or 14 days. A 13C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.<BR><B>RESULTS: </B>A total of 593 patients were included in the study. The eradication rates were 65.7% (201/306) in the empirical therapy group and 81.9% (235/287) in the tailored therapy group for intention-to-treat analysis (p < 0.001). In the per-protocol analysis, the eradication rates of the empirical therapy and tailored groups were 70.3% (201/286) and 85.5% (235/274) (p < 0.001), respectively. There was no difference in compliance between the two groups. The rate of adverse events was higher in the tailored group compared to the empirical group (p < 0.001).<BR><B>CONCLUSIONS: </B>Our study confirmed that tailored therapy based on genotypic resistance was more effective than empirical therapy for H. pylori eradication in Korea. However, no significant difference was found between 7- and 14-day regimens for each group. Future studies are needed to determine the optimal duration of therapy for empirical and tailored therapy regimens.