Brief Article
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World J Gastroenterol. Sep 14, 2013; 19(34): 5671-5677
Published online Sep 14, 2013. doi: 10.3748/wjg.v19.i34.5671
Eviendep® reduces number and size of duodenal polyps in familial adenomatous polyposis patients with ileal pouch-anal anastomosis
Carlo Calabrese, Chiara Praticò, Andrea Calafiore, Maurizio Coscia, Lorenzo Gentilini, Gilberto Poggioli, Paolo Gionchetti, Massimo Campieri, Fernando Rizzello
Carlo Calabrese, Chiara Praticò, Andrea Calafiore, Maurizio Coscia, Lorenzo Gentilini, Gilberto Poggioli, Paolo Gionchetti, Massimo Campieri, Fernando Rizzello, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), University of Bologna, 40138 Bologna, Italy
Author contributions: Calabrese C initiated the study, coordinated the conduct of the whole study, performed the endoscopies; Calabrese C, Praticò C and Calafiore A prepared the draft of the manuscript; Calabrese C and Rizzello F re-evaluated all the endoscopy videos and photos in a blinded manner and scored the images separately; Coscia M, Gentilini L and Poggioli G performed the surgical procedures; Gionchetti P and Campieri M reviewed the manuscript; all authors approved the final version of the manuscript.
Correspondence to: Carlo Calabrese, MD, PhD, DIMEC, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), University of Bologna, Via Massarenti 9, 40138 Bologna, Italy. carlo.calabrese2@unibo.it
Telephone: +39-51-6364191 Fax: +39-51-392538
Received: April 29, 2013
Revised: June 13, 2013
Accepted: July 4, 2013
Published online: September 14, 2013
Processing time: 137 Days and 15.6 Hours
Abstract

AIM: To evaluate if 3 mo oral supplementation with Eviendep® was able to reduce the number of duodenal polyps in familial adenomatous polyposis (FAP) patients with ileal pouch-anal anastomosis (IPAA).

METHODS: Eleven FAP patients with IPAA and duodenal polyps were enrolled. They underwent upper gastrointestinal (GI) endoscopy at the baseline and after 3 mo of treatment. Each patient received 5 mg Eviendep twice a day, at breakfast and dinner time, for 3 mo. Two endoscopists evaluated in a blinded manner the number and size of duodenal polyps. Upper GI endoscopies with biopsies were performed at the baseline (T0) with the assessment of the Spigelman score. Polyps > 10 mm were removed during endoscopy and at the end of the procedure a new Spigelman score was determined (T1). The procedure was repeated 3 mo after the baseline (T2). Four photograms were examined for each patient, at T1 and T2. The examined area was divided into 3 segments: duodenal bulb, second and third portion duodenum. Biopsy specimens were taken from all polyps > 10 mm and from all suspicious ones, defined by the presence of a central depression, irregular surface, or irregular vascular pattern. Histology was classified according to the updated Vienna criteria.

RESULTS: At baseline the mean number of duodenal detected polyps was 27.7 and mean sizes were 15.8 mm; the mean Spigelman score was 7.1. After polypectomy the mean number of duodenal detected polyps was 25.7 and mean sizes were 7.6 mm; the mean Spigelman score was 6.4. After 3 mo of Eviendep bid, all patients showed a reduction of number and size of duodenal polyps. The mean number of duodenal polyps was 8 (P = 0.021) and mean size was 4.4 mm; the mean Spigelman score was 6.6. Interrater agreement was measured. Lesions > 1 cm found a very good degree of concordance (kappa 0.851) and a good concordance was as well encountered for smaller lesions (kappa 0.641).

CONCLUSION: Our study demonstrated that short-term (90 d) supplementation with Eviendep® in FAP patients with IPAA and with recurrent adenomas in the duodenal mucosa, resulted effective in reducing polyps number of 32% and size of 51%.

Keywords: Familial adenomatous polyposis; Ileal pouch-anal anastomosis; Duodenal polyps; Eviendep

Core tip: Our open study demonstrated for the first time that short-term (90 d) supplementation with Eviendep® in familial adenomatous polyposis patients with ileal pouch-anal anastomosis and with recurrent adenomas in the duodenal mucosa, resulted effective in reducing polyps number of 32% and size of 51%. Eviendep® was easy to manage and its daily use was well tolerated by the patients. Its safety was guaranteed by its composition. Each ingredient is blended into the composition in a lower dose than the one otherwise needed for the single component to similarly exert the desired effect, thus leading to synergistic and/or potentiating effect, with the added advantage of higher safety, even over long-term exposure.