Chemoprevention of colonic polyps with balsalazide: an exploratory, double-blind, placebo-controlled study.
Dig Dis Sci
; 54(11): 2488-96, 2009 Nov.
Article
en En
| MEDLINE
| ID: mdl-19757048
ABSTRACT
BACKGROUND:
A number of agents, including aspirin, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, folic acid, calcium, and vitamins, have been evaluated for their potential in chemoprevention of sporadic colorectal adenomas or cancer. Preclinical data suggest that 5-aminosalicylates also may have a chemopreventive effect.AIM:
To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug.METHODS:
In this randomized, double-blind, placebo-controlled study, adults diagnosed with small polyps in the rectosigmoid colon were treated with either balsalazide 3 g/d or placebo for 6 months. Follow-up lower endoscopy was performed, and all polyps were measured and analyzed histologically. The primary endpoint was reduction in mean size of the largest polyp per subject.RESULTS:
Among 241 participants screened, 86 were randomized to treatment, with 75 subjects evaluable. Balsalazide 3 g/d (n = 38) did not significantly reduce the mean size of the largest colonic polyp or the number of polyps compared with placebo (n = 37). Although not significant, post-hoc analysis revealed that total adenoma burden per subject, calculated as the sum of the volumes of all adenomas in mm3, increased by 55% in the balsalazide group compared with 95% in the placebo group.CONCLUSIONS:
Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fenilhidrazinas
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Fármacos Gastrointestinales
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Pólipos del Colon
/
Mesalamina
Tipo de estudio:
Clinical_trials
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Observational_studies
Límite:
Aged
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2009
Tipo del documento:
Article