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Randomized Controlled Trial
. 2024 Jul-Aug;29(4):e13126.
doi: 10.1111/hel.13126.

Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K-CREATE Study

Joon Sung Kim  1 , Byung-Wook Kim  1 , Jin Il Kim  2 , Woo Chul Chung  3 , Sung Woo Jung  4 , Chang Seok Bang  5 , Gwang Ha Kim  6 , Seon Woo Jeon  7 , Moon Kyoung Joo  8 , Si Hyung Lee  9 , Yun Jeong Lim  10 , Jae Kyu Sung  11 , Seung Young Seo  12 , Sun Young Park  13 , Wan Sik Lee  14 , Hang Lak Lee  15 , Ki Bae Kim  16 , Heung Up Kim  17
Affiliations
Randomized Controlled Trial

Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K-CREATE Study

Joon Sung Kim et al. Helicobacter. 2024 Jul-Aug.

Abstract

Background: The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.

Aim: 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.

Patients and methods: 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.

Results: 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).

Discussion: 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.

Keywords: Helicobacter; PCR; drug resistance; eradication; tailored therapy.

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References

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