title: Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome.
abstract: BACKGROUND
  Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon.
  
  
  METHODS
  In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome.
  
  
  RESULTS
  Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed.
  
  
  CONCLUSIONS
  The use of aspirin, resistant starch, or both for up to 4 years has no effect on the incidence of colorectal adenoma or carcinoma among carriers of the Lynch syndrome. (Current Controlled Trials number, ISRCTN59521990.)
authors.affiliation: Institute of Human Genetics, Newcastle University, International Centre for Life, Central Pkwy., Newcastle upon Tyne NE1 3BZ, United Kingdom. john.burn@ncl.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Burn
authors.forename: D Timothy
authors.initials: DT
authors.lastname: Bishop
authors.forename: Jukka-Pekka
authors.initials: JP
authors.lastname: Mecklin
authors.forename: Finlay
authors.initials: F
authors.lastname: Macrae
authors.forename: Gabriela
authors.initials: G
authors.lastname: Möslein
authors.forename: Sylviane
authors.initials: S
authors.lastname: Olschwang
authors.forename: Marie-Luise
authors.initials: ML
authors.lastname: Bisgaard
authors.forename: Raj
authors.initials: R
authors.lastname: Ramesar
authors.forename: Diana
authors.initials: D
authors.lastname: Eccles
authors.forename: Eamonn R
authors.initials: ER
authors.lastname: Maher
authors.forename: Lucio
authors.initials: L
authors.lastname: Bertario
authors.forename: Heikki J
authors.initials: HJ
authors.lastname: Jarvinen
authors.forename: Annika
authors.initials: A
authors.lastname: Lindblom
authors.forename: D Gareth
authors.initials: DG
authors.lastname: Evans
authors.forename: Jan
authors.initials: J
authors.lastname: Lubinski
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Morrison
authors.forename: Judy W C
authors.initials: JW
authors.lastname: Ho
authors.forename: Hans F A
authors.initials: HF
authors.lastname: Vasen
authors.forename: Lucy
authors.initials: L
authors.lastname: Side
authors.forename: Huw J W
authors.initials: HJ
authors.lastname: Thomas
authors.forename: Rodney J
authors.initials: RJ
authors.lastname: Scott
authors.forename: Malcolm
authors.initials: M
authors.lastname: Dunlop
authors.forename: Gail
authors.initials: G
authors.lastname: Barker
authors.forename: Faye
authors.initials: F
authors.lastname: Elliott
authors.forename: Jeremy R
authors.initials: JR
authors.lastname: Jass
authors.forename: Ricardo
authors.initials: R
authors.lastname: Fodde
authors.forename: Henry T
authors.initials: HT
authors.lastname: Lynch
authors.forename: John C
authors.initials: JC
authors.lastname: Mathers
mesh_terms: D000236:Adenoma / Q000453:epidemiology / Q000517:prevention & control*; D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000453:epidemiology / Q000517:prevention & control*; D015179:Colorectal Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D003123:Colorectal Neoplasms, Hereditary Nonpolyposis / Q000188:drug therapy* / Q000235:genetics; D053843:DNA Mismatch Repair / Q000235:genetics; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012306:Risk; D013213:Starch / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D013213:Starch; D001241:Aspirin