Hp eradication: about a large therapeutic trial in Linqu (China)Éradication d’Hp : à propos d’un vaste essai thérapeutique au Linqu (Chine) Wei-Cheng You1, Meinhard Classen21. President and Professor Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital N° 52 Fu-Cheng Road Haidian District Beijing, China 100142 2. IDCA, Professor Dr., Technische Universität München Klinikum rechts der Isar Ismaninger Str. 22, D-81675 München (Germany) exclusion criteria. The Hp status will be determined by 13 C-urea It is well known that gastric cancer (GC) is the second leading breath test (13C-UBT). We estimate the 140.000 participants will cause of cancer deaths in the world. In China, there is conside- be positive. These subjects will be enrolled in the intervention rably geographic variation with very high rates in northern and the study and randomized for two different antimicrobial treatment central parts of the country. In Linqu County/Shandong province, regimens with high or low dosage of omeprazole, tetracycline, one of the highest rates not only in China but in the world is found, metronidazole and bismuth by villages with 70.000 in each arm.
in 1980 – 1982 the age adjusted (world standard) death rate of All participants in both antimicrobial treatment groups will be GC was 70/100.000 in males and 25/100.000 in females. A followed for at least 10 years to assess the incidence and morta- recent study indicated that the crude mortality rates remained at lity rates of GC. This study has a power of 90% to determine this level since then. GC accounts for 40% of cancer deaths in whether eradication of Hp can effectively reduce the incidence by at least 21% at the 0.05 significance level.
We describe shortly a randomized, controlled trial among The results of this study will have worldwide public health implica- 200.000 adult participants to prevent GC in Linqu County. The tions for all countries having a high incidence of GC. The study main target of this large population based intervention trial is to has been approved by the Institutional Review Board of PUSO assess whether GC can be prevented by eradication of Helicobacter pylori (Hp) in the high-risk population. Secondaryaims include the identification of genetic and serologic risk factors ❚ References
for Hp associated GC and neoplastic lesions.
There is growing evidence that treating Hp infection may lead to 1. You WC, Blot WJ, Chang YS, Ershow AG, Yang ZT, An Q, a reduced risk of subsequent GC. Combined data from previous Henderson B, Xu GW, Fraumeni JF Jr, Wang TG. Diet and the high risk of stomach cancer in Shandong. Cancer Res 1988;48: trials seems to indicate this assumption. However, the protective effect is suggestive but not statistically significant. Thus a large 2. You WC, Brown LM, Zhang L, Li JY, Jin ML, Chang YS, Ma JL, population-based randomized trial is needed to prove that eradi- Pan KF, Liu WD, Hu Y, Crystal-Mansour S, Pee D, Blot WJ, cation of Hp reduces GC incidence rate.
Fraumeni JF Jr, Xu GW, Gail MH. Randomized double-blind facto- This new study was launched in March 2011 – is a collaborative rial trial of three treatments to reduce the prevalence of precan- study between the Peking University School of Oncology (PUSO), cerous gastric lesions. J Natl Cancer Inst 2006;98:974-83.
the International Digestive Cancer Alliance (IDCA), Technische 3. Ma J, Liu W, Zhang L, Pan K, Zhao H, Zhou T, Winawer S, Universitaet Muenchen and Charles University (Prague).
Zauber A, Classen M, You W. A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori We will screen approximately 200.000 residents aged 25 – 54 infection; a pilot study for the large trial Linqu county trial. Eur J from 900 villages in Linqu County fulfilling the inclusive and Gastroenterol Hepatol 2010;2:597-601.


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