Quality of RCTs exploring Helicobacter pylori eradication for the prevention of gastric cancer and preneoplastic lesions

Expert Review of Anticancer Therapy

Volumn 11, Issue 10, 2011, Pages 1509-1519

  Sun, Tian Tian ^a   Wang, Ji Lin ^a   Fang, Jing Yuan ^a  

^a SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

Author keywords

gastric cancer; Helicobacter pylori eradication; methodological quality; preneoplastic lesion; reporting quality

Indexed keywords

AMOXICILLIN; ASCORBIC ACID; BETA CAROTENE; BISMUTH SALICYLATE; CLARITHROMYCIN; CLAVULANATE POTASSIUM; LANSOPRAZOLE; METRONIDAZOLE; OMEPRAZOLE; PLACEBO; PROTON PUMP INHIBITOR;

ADULT; AGED; CANCER PREVENTION; CANCER RISK; CLINICAL STUDY; CONTROLLED STUDY; ERADICATION THERAPY; FEMALE; HELICOBACTER INFECTION; HUMAN; INTESTINE METAPLASIA; MAJOR CLINICAL STUDY; MALE; PEPTIC ULCER; PRECANCER; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STOMACH CANCER; STUDY DESIGN; SYSTEMATIC REVIEW; VALIDATION PROCESS;

HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; META-ANALYSIS AS TOPIC; PRECANCEROUS CONDITIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; STOMACH NEOPLASMS;

EID: 80054769171     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.11.124     Document Type: Review

References (45)

1. Correa P. Human gastric carcinogenesis: a multistep and multifactorial process-First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 52, 6735-6740 (1992). (Pubitemid 23006271)
2. Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst. Rev. 2, MR000012 (2007).
3. Moher D, Pham B, Jones A et al. Does quality of reports of randomised trials affect estimates of intervention effcacy reported in meta-analyses? Lancet 352, 609-613 (1998). (Pubitemid 28380142)
4. Moher D, Jones A, Lepage L; for the CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285, 1992-1995 (2001). (Pubitemid 32366952)
5. Moher D, Schulz KF, Altman DG; for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357, 1191-1194 (2001). (Pubitemid 32378696)
6. Ogura K, Hirata Y, Yanai A et al. The effect of Helicobacter pylori eradication on reducing the incidence of gastric cancer. J. Clin. Gastroenterol. 42, 279-283 (2008). (Pubitemid 351301494)
7. Fuccio L, Zagari RM, Minardi ME et al. Systematic review: Helicobacter pylori eradication for the prevention of gastric cancer. Aliment Pharmacol. Ther. 25, 133-141 (2007). (Pubitemid 46046370)
8. Ito M, Takata S, Tatsugami M et al. Clinical prevention of gastric cancer by Helicobacter pylori eradication therapy: a systematic review. J. Gastroenterol. 44, 365-371 (2009).
9. Ito M. Helicobacter pylori eradication for gastric cancer prevention. Expert Rev. Anticancer Ther. 10 (1), 1-3 (2010).
10. Murakami K, Kodama M, Sato R et al. Helicobacter pylori eradication and associated changes in the gastric mucosa. Expert Rev. Anti. Infect. Ther. 3(5), 757-764 (2005). (Pubitemid 41535397)
11. Jiini P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 323, 42-46 (2001). (Pubitemid 32682008)
12. Schulz KF, Altman DG, Moher D; for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340, c332 (2010).
13. Rennie D. CONSORT revised-improving the reporting of randomized trials. JAMA 285(15), 2006-2007 (2001). (Pubitemid 32366956)
14. Fuccio L, Zagari RM, Eusebi LH et al. Meta-analysis: can Helicobacter pylori eradication treatment reduce the risk for gastric cancer? Ann. Intern. Med. 151(2), 121-128 (2009).
15. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2. Wiley-Blackwell, NJ, USA (2009).
16. Moher D, Hopewell S, Schulz KF et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340, c869 (2010).
17. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann. Intern. Med. 134, 657-662 (2001). (Pubitemid 32322244)
18. Zhou L, Sung JJ, Lin S et al. A fve-year follow-up study on the pathological changes of gastric mucosa after H. pylori eradication. Chin. Med. J. (Engl.) 116(1), 11-14 (2003). (Pubitemid 36432713)
19. Ley C, Mohar A, Guarner J et al. Helicobacter pylori eradication and gastric preneoplastic conditions: a randomized, double-blind, placebo-controlled trial. Cancer Epidemiol. Biomarkers Prev. 13(1), 4-10 (2004). (Pubitemid 38116614)
20. Wong BC, Lam SK, Wong WM et al. Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial. JAMA 291(2), 187-194 (2004). (Pubitemid 38082812)
21. Sung JJ, Lin SR, Ching JY et al. Atrophy and intestinal metaplasia one year after cure of H. pylori infection: a prospective, randomized study. Gastroenterology 119(1), 7-14 (2000). (Pubitemid 30452573)
22. Gail MH, You WC, Chang YS 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 19(4), 352-369 (1998). (Pubitemid 28355759)
23. Schenk BE, Kuipers EJ, Nelis GF et al. Effect of Helicobacter pylori eradication on chronic gastritis during omeprazole therapy. Gut 46(5), 615-621 (2000). (Pubitemid 30305777)
24. Kuipers EJ, Nelis GF, Klinkenberg-Knol EC et al. Cure of Helicobacter pylori infection in patients with refux oesophagitis treated with long term omeprazole reverses gastritis without exacerbation of refux disease: results of a randomised controlled trial. Gut 53(1), 12-20 (2004). (Pubitemid 38083004)
25. Yang HB, Sheu BS, Wang ST et al. H. pylori eradication prevents the progression of gastric intestinal metaplasia in refux esophagitis patients using long-term esomeprazole. Am. J. Gastroenterol. 104 (7), 1642-1649 (2009).
26. Witteman EM, Mravunac M, Becx MJ et al. Improvement of gastric infammation and resolution of epithelial damage one year after eradication of Helicobacter pylori. J. Clin. Pathol. 48(3), 250-256 (1995).
27. Ruiz B, Garay J, Correa P et al. Morphometric evaluation of gastric antral atrophy: improvement after cure of Helicobacter pylori infection. Am. J. Gastroenterol. 96(12), 3281-3287 (2001). (Pubitemid 34016649)
28. Kamada T, Haruma K, Hata J et al. The long-term effect of Helicobacter pylori eradication therapy on symptoms in dyspeptic patients with fundic atrophic gastritis. Aliment. Pharmacol. Ther. 18(2), 245-252 (2003). (Pubitemid 36951662)
29. Lu B, Chen MT, Fan YH et al. Effects of Helicobacter pylori eradication on atrophic gastritis and intestinal metaplasia: a 3-year follow-up study. World J. Gastroenterol. 11(41), 6518-6520 (2005). (Pubitemid 43136891)
30. Arkkila PE, Seppälä K, Färkkilä MA et al. Helicobacter pylori eradication in the healing of atrophic gastritis: a one-year prospective study. Scand. J. Gastroenterol. 41(7), 782-790 (2006).
31. Miehlke S, Kirsch C, Dragosics B et al. Helicobacter pylori and gastric cancer: current status of the Austrian Czech German gastric cancer prevention trial (PRISMA Study). World J. Gastroenterol. 7(2), 243-247 (2001). (Pubitemid 32377478)
32. Saita H, Murakami M, Takahashi Y et al. Factors infuencing Helicobacter pylori eradication with 2 week combination therapy of lansoprazole and amoxycillin: intragastric distribution of colonization and gastric mucosal atrophy. J. Gastroenterol. Hepatol. 13(7), 725-731 (1998). (Pubitemid 28407346)
33. Befrits R, Sjöstedt S, Tour R et al. Long-term effects of eradication of Helicobacter pylori on relapse and histology in gastric ulcer patients: a two-year follow-up study. Scand. J. Gastroenterol. 39(11), 1066-1072 (2004). (Pubitemid 39536394)
34. Correa P, Fontham ET, Bravo JC et al. Chemoprevention of gastric dysplasia: randomized trial of antioxidant supplements and anti-Helicobacter pylori therapy. J. Natl Cancer Inst. 92(23), 1881-1888 (2000). (Pubitemid 32036918)
35. Miwa H, Hirai S, Nagahara A et al. Cure of Helicobacter pylori infection does not improve symptoms in non-ulcer dyspepsia patients-a double-blind placebo-controlled study. Aliment. Pharmacol. Ther. 14(3), 317-324 (2000). (Pubitemid 30145320)
36. De Leest HT, Steen KS, Bloemena E et al. Helicobacter pylori eradication in patients on long-term treatment with NSAIDs reduces the severity of gastritis: a randomized controlled trial. J. Clin. Gastroenterol. 43(2), 140-146 (2009).
37. Fukase K, Kato M, Kikuchi S et al. Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomized controlled trial. Lancet 372, 392-397 (2008).
38. Schulz KF, Chalmers I, Hayes RJ et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273, 408-412 (1995).
39. Chalmers TC, Celano P, Sacks HS, Smith H. Bias in treatment assignment in controlled clinical trials. N. Engl. J. Med. 309, 1358-1361 (1983). (Pubitemid 14246558)
40. Gibson CA, Kirk EP, LeCheminant JD et al. Reporting quality of randomized trials in the diet and exercise literature for weight loss. BMC Med. Res. Methodol. 5(1), 9 (2005).
41. Correa P, Houghton J. Carcinogenesis of Helicobacter pylori. Gastroenterology 133, 659-672 (2007). (Pubitemid 47187360)
42. Ito M, Tanaka S, Kamada T et al. Causal role of Helicobacter pylori infection and eradication therapy in gastric carcinogenesis. World J. Gastroenterol. 12(1), 10-16 (2006). (Pubitemid 43126076)
43. Deeks JJ, Altman DG. Inadequate reporting of controlled trials as short reports. Lancet 352(9144), 1908 (1998). (Pubitemid 28561259)
44. Egger M, Jüni P, Bartlett C et al. Value of fow diagrams in reports of randomized controlled trials. JAMA 285(15), 1996-1999 (2001). (Pubitemid 32366953)
45. Soares HP, Daniels S, Kumar A et al. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 328, 22-24 (2004). (Pubitemid 38067738)