RCT of Sulindac for Polyp Prevention in Familial Adenomatous Polyposis

Description

Results of a randomized, placebo-controlled trial of sulindac in the reduction of colonic polyps in Familial Adenomatous Polyposis (FAP) (more details available below the variable definitions).

Usage

polyps

Format

A data frame with 22 observations and 7 variables

participant_id

id number for each participant; type: character

sex

participant sex, levels: female, male; type: factor

age

age in years; type: numeric

baseline

number of colonic polyps at baseline; type: numeric

treatment

treatment assignment, levels: sulindac, placebo; type: factor

number3m

number of colonic polyps at 3 months; type: numeric

number12m

number of colonic polyps at 12 months; type: numeric

Details

FAP is an inherited condition caused by mutations in the APC (Adenomatous Polyposis Coli) gene that leads to early and frequent formation of precancerous polyps of the colon at a young age, and invariably leads to the development of colon cancer at a young age.
Early, frequent surveillance colonoscopy and polyp removal is helpful, but this study examined whether there is a beneficial effect of preventive medical therapy with the nonsteroidal pain reliever, sulindac, versus placebo in a RCT vs placebo in 22 participants, with polyp number measured (via colonoscopy) at baseline, 3 months, and 12 months after starting the study drug. Note that one subject did not return for the 12 month colonoscopy.

Source

This data set is from a study published in 1993 in the New England Journal of Medicine,

F. M. Giardiello, S. R. Hamilton, A. J. Krush, S. Piantadosi, L. M. Hylind, P. Celano, S. V. Booker, C. R. Robinson and G. J. A. Offerhaus (1993), Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. New England Journal of Medicine, 328(18), 1313-1316.

This dataset is derived from and improved upon from the HSAUR package.