Randomized, placebo-controlled trial of gastric acid-lowering therapy on duodenal polyposis and relative adduct labeling in familial adenomatous polyposis.
OBJECTIVE
Bile has been implicated in the pathogenesis of duodenal polyps in patients with familial adenomatous polyposis. In vitro experiments have shown that familial adenomatous polyposis bile is capable of producing DNA adducts. This effect can be ameliorated by increasing the pH of the incubate. The aim of this double-blind randomized placebo-controlled trial was to examine the effect of oral ranitidine on duodenal polyposis in a group of patients with familial adenomatous polyposis.


METHODS
Twenty-six patients with familial adenomatous polyposis were randomly assigned to ranitidine 300 mg daily or placebo for six months after baseline endoscopy. Polyp counts were performed and biopsy specimens taken to detect DNA adducts by 32P-postlabeling.


RESULTS
No difference was seen in polyp numbers (P = 0.9) or relative adduct labeling (P = 0.7) after treatment with ranitidine or placebo.


CONCLUSIONS
Acid suppression therapy does not seem to improve duodenal polyposis despite in vitro findings. On the other hand, ranitidine does not exacerbate actual (or markers of) neoplasia in this highly tumor-prone condition.
Wallace
M H
MH
ICRF Colorectal Cancer Unit and The Polyposis Registry and the Academic Institute, St. Mark's Hospital, Northwick Park, Harrow, United Kingdom.
Forbes
A
A
Beveridge
I G
IG
Spigelman
A D
AD
Hewer
A
A
Venitt
S
S
Phillips
R K
RK
D011125:Adenomatous Polyposis Coli / Q000188:drug therapy* / Q000235:genetics; D000284:Administration, Oral; D000328:Adult; D000897:Anti-Ulcer Agents / Q000494:pharmacology*; D001646:Bile / Q000737:chemistry; D018736:DNA Adducts; D004311:Double-Blind Method; D004379:Duodenal Neoplasms / Q000188:drug therapy* / Q000235:genetics; D004724:Endoscopy; D005260:Female; D005744:Gastric Acid; D006801:Humans; D007417:Intestinal Polyps / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D011899:Ranitidine / Q000494:pharmacology*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D018736:DNA Adducts; D011899:Ranitidine