Randomized double-blind factorial trial of three treatments to reduce the prevalence of precancerous gastric lesions

Journal of the National Cancer Institute

Volumn 98, Issue 14, 2006, Pages 974-983

  You, Wei Cheng ^a   Brown, Linda M ^b   Zhang, Lian ^a   Li, Ji You ^a   Jin, Mao Lin ^a   Chang, Yun Shen ^a   Ma, Jun Ling ^a   Pan, Kai Feng ^a   Liu, Wei Dong ^c   Hu, Yuanreng ^d   Crystal Mansour, Susan ^d   Pee, David ^e   Blot, William J ^f,g   Fraumeni, Joseph F ^b   Xu, Guang Wei ^a   Gail, Mitchell H ^b  

^a PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^b NATIONAL CANCER INSTITUTE   (United States)

^c Linqu County Public Health Bureau   (China)

^d WESTAT   (United States)

^e INFORMATION MANAGEMENT SERVICES INC   (United States)

^f INTERNATIONAL EPIDEMIOLOGY INSTITUTE   (United States)

^g VANDERBILT UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; AMOXICILLIN; ANTIBIOTIC AGENT; ASCORBIC ACID; BETA CAROTENE; GARLIC EXTRACT; GARLIC OIL; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; OMEPRAZOLE; PLACEBO; SELENIUM; VITAMIN;

ADULT; ADVANCED CANCER; ARTICLE; ATROPHIC GASTRITIS; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER INCIDENCE; CANCER REGRESSION; CHINA; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET SUPPLEMENTATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DYSPLASIA; FACTORIAL ANALYSIS; FEMALE; GASTROSCOPY; HELICOBACTER INFECTION; HISTOPATHOLOGY; HUMAN; INTESTINE METAPLASIA; LOGISTIC REGRESSION ANALYSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRECANCER; PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; STOMACH BIOPSY; STOMACH CANCER; STOMACH MUCOSA; STUDENT T TEST; VITAMIN SUPPLEMENTATION; DISEASE COURSE; DRUG COMBINATION; DRUG EFFECT; GARLIC; HELICOBACTER PYLORI; HOSPITALIZATION; ISOLATION AND PURIFICATION; MICROBIOLOGY; MIDDLE AGED; PATHOLOGY; PHYTOTHERAPY; STATISTICAL MODEL; STOMACH TUMOR;

ADULT; AMOXICILLIN; ASCORBIC ACID; CHINA; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FACTOR ANALYSIS, STATISTICAL; FEMALE; GARLIC; GASTROSCOPY; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; OMEPRAZOLE; PHYTOTHERAPY; PRECANCEROUS CONDITIONS; PREVALENCE; SELENIUM; SEVERITY OF ILLNESS INDEX; STOMACH NEOPLASMS; VITAMIN E;

EID: 33744514855     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djj264     Document Type: Article

References (34)

1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.
2. WangTG, You WC, Henderson BE, Blot WJ. A case-control study of stomach cancer in Shandong Province. J Natl Cancer Inst Monogr 1985;69:9-10.
3. You WC, Blot WJ, Li JY, Chang YS, Jin ML, Kneller R, et al. Precancerous gastric lesions in a population at high risk of stomach cancer. Cancer Res 1993;53:1317-21.
4. Gail MH, You WC, Chang YS, Zhang L, Blot WJ, Brown LM, et al. Factorial trial of three interventions to reduce the progression of precancerous gastric lesions in Shandong, China: Design issues and initial data. Control Clin Trials 1998;19:352-69.
5. International Agency for Research on Cancer. Monographs on the evaluation of carcinogenic risks to humans. Vol 61: Schistosomes, liver flukes and Helicobacter pylori. Lyon (France): International Agency for Research on Cancer; 1994. p. 177-240.
6. You WC, Li JY, Blot WJ, Chang YS, Jin ML, Gail MH, et al. Evolution of precancerous lesions in a rural Chinese population at high risk of gastric cancer. Int J Cancer 1999;83:615-9.
7. Correa P. The biological model of gastric carcinogenesis. IARC Sci Publ 2004;157:301-10.
8. You WC, Blot WJ, Chang YS, Ershow AG, Yang ZT, An Q, et al. Diet and high risk of stomach cancer in Shandong, China. Cancer Res 1989;49:3518-23.
9. Zhang L, Blot WJ, You WC, Chang YS, Liu XQ, Kneller RW, et al. Serum micronutrients in relation to pre-cancerous gastric lesions. Int J Cancer 1994;56:650-4.
10. You WC, Zhang L, Gail MH, Chang YS, Liu WD, Ma JL, et al. Gastric dysplasia and gastric cancer: Helicobacter pylori, serum vitamin C, and other risk factors. J Natl Cancer Inst 2000;92:1607-12,
11. Blot WJ, Li JY, Taylor PR, Guo W, Dawsey S, Wang GQ et al. Nutrition intervention trials in Linxian, China: Supplementation with specific vitamin/mineral combinations, cancer incidence, and diseasc-specific mortality in the general population. J Natl Cancer Inst 1993;85:1483-92.
12. You WC, Blot WJ, Chang YS, Ershow AG, Yang ZT, An Q, et al. Allium vegetables and reduced risk of stomach cancer. J Natl Cancer Inst 1989;81:162-4.
13. Dixon ME, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis: The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol 1996;20:1161-81.
14. You WC, Chang YS, Heinrich J, Ma JL, Liu WD, Zhang L, et al. An intervention trial to inhibit the progression of precancerous gastric lesions: Compliance, serum micronutrients and S-allyl cysteine levels, and toxicity. Eur J Cancer Prev 2001;10:257-63.
15. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers: The Alpba-Tocopherol, Beta Carotene Cancer Prevention Study Group. N Engl J Med 1994;330:1029-35.
16. Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, et al. Effects of a combination of β-carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 1996;334:1150-5.
17. Correa P, Fontham ET, Bravo JC, Bravo LE, Ruiz B, Zarama G, et al. Chemoprevention of gastric dysplasia: Randomized trial of antioxidant supplements and anti-Helicobacter pylori therapy. J Natl Cancer Inst 2000;92:1881-8.
18. Correa P, Fontham ET, Bravo JC, Bravo LE, Ruiz B, Zarama G, et al. Re: Chemoprevention of gastric dysplasia: Randomized trial of antioxidant supplements and anti-Helicobacter pylori therapy (letter). J Natl Cancer Inst 2001;93:559.
19. Mera R, Fontham ET, Bravo LE, Bravo JC, Piazuelo MB, Camargo MC, et al. Long term follow up of patients treated for Helicobacter pylori infection. Gut 2005;54:1536-40.
20. Kuipers EJ, Nelis GF, Klinkenberg-Knol EC, Snel P, Goldfain D, Kolkman JJ, et al. Cure of Helicobacter pylori infection in patients with reflux oesophagifis treated with long term omeprazole reverses gastritis without exacerbation of reflux disease: Results of a randomised controlled trial. Gut 2004;53:12-20.
21. Ley C, Mohar A, Guarner J, Reffera-Goepfert R, Figueroa LS, Halperin D, et al. Helicobacter pylori eradication and gastric preneoplastic conditions: A randomized, double-blind, placebo-controlled trial. Cancer Epidemiol Biomakers Prev 2004;13:4-10.
22. Sung JJ, Lin SR, Ching JY, Zhou LY, To KF, Wang RT, et al. Atrophy and intestinal metaplasia one year after cure of H. pylori infection: A prospective, randomized study. Gastroenterology 2000; 119:7-14.
23. Sung JJ, Lin SR, Leung W, Ng EK, Ching JY, To KF, et al. Does eradication of H. pylori prevent deterioration of gastric atrophy and intestinal metaplasia? A 5-year follow-up. Gastroenterology 2002;122:A170.
24. Wong BCY, Lam SK, Wong WM, Feng R, Zheng TT, Yuen ST, et al. Eradication of Helicobacter pylori infection significantly slows down the progression of precancerous lesions in high risk population: A 5-year prospective randomized study. Gastroenterology 2002;122:A588.
25. Obkusa T, Fujiki K, Takashimizu I, Kumagai J, Tanizawa T, Eishi Y, et al. Improvement in atrophic gastritis and intestinal metaplasia in patients in whom Helicobacter pylori was eradicated. Ann Intern Med 2001;134: 380-6.
26. Kokkola A, Sipponen P, Rautelin H, Harkonen M, Kosunen TU,Haapiainen R, et al. The effect of Helicobacter pylori eradication on the natural course of atrophic gastritis with dysplasia. Aliment Pharmacol Ther 2002;16: 515-20.
27. Ito M, Haruma K, Kamada T, Mihara M, Kim S, Kitadai Y, et al. Helicobacter pylori eradication therapy improves atrophic gastritis and intestinal metaplasia: A 5-year prospective study of patients with atrophic gastritis. Aliment Pharmacol Ther 2002; 16:1449-56.
28. Wong BC, Lam SK, Wong WM, Chen JS, Zheng TT, Feng RE, et al. Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: A randomized controlled trial. JAMA 2004;291:187-94.
29. Leung WK, Lin SR, Ching JY, To KF, Ng EK, Chan FK, et al. Factors predicting progression of gastric intestinal metaplasia: Results of a randomised trial on Helicobacter pylori eradication. Gut 2004;53:1244-9.
30. Helicobacter and Cancer Collaborative Group. Gastric cancer and Helicobacter pylori: A combined analysis of 12 case control studies nested within prospective cohorts. Gut 2001;49:347-53.
31. Uemura N, Okamoto S, Yamamoto S, Matsumura N, Yamaguchi S, Yamakido M, et al. Helicobacter pylori infection and the development of gastric cancer. N Engl J Med 2001;345:784-9.
32. Ohata H, Kitauchi S, Yoshimura N, Mugitani K, Iwane M, Nakamura H, et al. Progression of chronic atrophic gastritis associated with Helicobacter pylori infection increases risk of gastric cancer. Int J Cancer 2004;109: 138-43.
33. Bjelakovic G, Nikolova D, Simonetti RG, Gluud C. Antioxidant supplements for prevention of gastrointestinal cancers: A systematic review and meta-analysis. Lancet 2004;364:1219-28.
34. Li H, Li HQ, Wang Y, Xu HX, Fan WT, Wang ML, et al. An intervention study to prevent gastric cancer by micro-selenium and large dose of allitridum. Chin Med J 2004;117:1155-60.