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F Morisco,
F Castiglione,
A Rispo,
T Stroffolini,
S Sansone,
R Vitale,
M Guarino,
L Biancone,
A Caruso,
R D'Inca, [......],
A Orlando, G Riegler,
L Donnarumma,
S Camera,
F Zorzi,
S Renna,
V Bove,
G Tontini,
M Vecchi,
N Caporaso
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ABSTRACT: Viral hepatitis reactivation has been widely reported in patients undergoing immunosuppressive therapy; however, few data are available about the risk of HBV and HCV reactivation in patients with inflammatory bowel disease, receiving immunosuppressive drugs. The aim of our study was to assess the prevalence of HBV and HCV infection in a consecutive series of patients with inflammatory bowel disease and to value the effects of immunosuppressive therapy during the course of the infection. Retrospective observational multicenter study included all consecutive patients with inflammatory bowel disease who have attended seven Italian tertiary referral hospitals in the last decade. A total of 5096 patients were consecutively included: 2485 Crohn's disease and 2611 Ulcerative Colitis. 30.5% and 29.7% of the patients were investigated for HBV and HCV infection. A total of 30 HBsAg positive, 17 isolated anti-HBc and 60 anti-HCV-positive patients were identified. In all, 20 patients with HBV or HCV infection received immunosuppressive therapy (six HBsAg+; four isolated anti-HBc+ and 10 anti-HCV+). One of six patients showed HBsAg+ and one of four isolated anti-HBc+ experienced reactivation of hepatitis. Two of six HBsAg patients received prophylactic therapy with lamivudine. Only one of 10 anti-HCV+ patients showed mild increase in viral load and ALT elevation. Screening procedures for HBV and HCV infection at diagnosis have been underused in patients with inflammatory bowel disease. We confirm the role of immunosuppressive therapy in HBV reactivation, but the impact on clinical course seems to be less relevant than previous reported.
Journal of Viral Hepatitis 03/2013; 20(3):200-8. · 4.09 Impact Factor
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A Bortoli,
N Pedersen,
D Duricova,
R D'Inca,
P Gionchetti,
M R Panelli,
S Ardizzone,
A L Sanroman,
J P Gisbert,
I Arena, G Riegler,
M Marrollo,
D Valpiani,
A Corbellini,
S Segato,
F Castiglione,
P Munkholm
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ABSTRACT: Inflammatory bowel disease (IBD) frequently affects women during their reproductive years. Pregnancy outcome in women with IBD is well described, particularly in retrospective studies.
To evaluate the pregnancy outcome in patients with IBD in a prospective European multicentre case-control study.
Inflammatory bowel disease pregnant women from 12 European countries were enrolled between January 2003 and December 2006 and matched (1:1) to non-IBD pregnant controls by age at conception and number of previous pregnancies. Data on pregnancy and newborn outcome, disease activity and therapy were prospectively collected every third month using a standard questionnaire. Logistic regression analysis with odds ratio was used for statistical analyses. P value<0.05 was considered significant.
A total of 332 pregnant women with IBD were included: 145 with Crohn's disease (CD) and 187 with ulcerative colitis (UC). Median age (range) at conception was 31 years (15-40) in CD and 31 (19-42) in UC patients. No statistically significant differences in frequency of abortions, preterm deliveries, caesarean sections, congenital abnormalities and birth weight were observed comparing CD and UC women with their non-IBD controls. In CD, older age was associated with congenital abnormalities and preterm delivery; smoking increased the risk of preterm delivery. For UC, older age and active disease were associated with low birth weight; while older age and combination therapy were risk factors for preterm delivery.
In this prospective case-control study, women with either Crohn's disease or ulcerative colitis have a similar pregnancy outcome when compared with a population of non-inflammatory bowel disease pregnant women.
Alimentary Pharmacology & Therapeutics 08/2011; 34(7):724-34. · 3.77 Impact Factor
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ABSTRACT: The aim of this intervention study is to determine whether long-term infliximab therapy can decrease the proctectomy rate in patients with failed total colectomy and ileorectal anastomosis (IRA) for Crohn's disease (CD). Twelve patients (5 females) - with a median age of 36.6 years (range 18-56 years), previously treated with IRA (5 in our institution and 7 referred) for colorectal and perianal CD (median Crohn's Disease Activity Index 334.5, range 220-426), with rectal disease recurrence requiring proctectomy, no responders to conventional therapy but infliximab-naïve - were treated with infliximab infusions (Remicade™ 5 mg/kg at 0, 2, 6 weeks and then every 8 weeks) to avoid proctectomy. The main outcome measures consisted of IRA preservation and bowel function at study end. Mortality and major adverse reactions have not been observed. At the time of the median follow-up (57.4 months, range 36-92), the rectum was preserved in 10 patients (83.3%). One patient underwent proctectomy 6 weeks after the beginning of the treatment for unresponsiveness to drugs and another after 26 weeks for rectal stenosis. Anorectal function (maximum tolerated volume: 239 ± 43 vs. 294 ± 36 ml) and quality of life (Inflammatory Bowel Disease Questionnaire score 89.2 ± 20.6 vs. 173.8 ± 31.9) improved, and the Wexner Continence score (4.4 ± 2.4 vs. 1.7 ± 1.0) and daily defecations (5.2 ± 1.03 vs. 2.7 ± 1.05) decreased in 10 patients. Our results, although preliminary, are encouraging and seem to justify a less aggressive approach in patients with rectal and perianal recurrence after IRA for CD.
European Surgical Research 03/2011; 46(4):163-8. · 0.93 Impact Factor
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ABSTRACT: The purpose of this study was to evaluate the efficacy of policosanols in the treatment of associated hyperlipidemia in patients with non-alcoholic fatty liver disease (NAFLD).
We conducted a retrospective study on 52 patients with NAFLD. Pretreatment patients' data (total cholesterol, LDL cholesterol, triglycerides, ALT, and AST) were collected and analyzed. Furthermore, based on weight and height, we calculated the Body Mass Index (BMI) and, based on blood glucose and insulin levels, we estimated the Human Omeostatic Assesment Index (HOMA). After that, all patients were treated with a policosanols' supplement (Frilipid®) and a hypocaloric balanced diet, and then followed over time with quarterly inspections. We collected and analyzed data on three subsequent quarterly monitoring during treatment.
The collected and analyzed data showed a significant reduction in total cholesterol, LDL cholesterol and HOMA index (P<0.002). It was also found a trend not statistically significant for a marked reduction in ALT, AST, triglycerides, and BMI.
The use of policosanols is shown effective in the treatment of associated hyperlipidemia and insulin resistance in patients with fatty liver disease.
Minerva gastroenterologica e dietologica 12/2010; 56(4):389-95.
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Ilaria Esposito,
Mario de Bellis,
Annalisa de Leone,
Giovan Battista Rossi,
Francesco Selvaggi,
Massimo Di Maio,
Dario Musto,
Maura C Tracey,
Pietro Marone,
Pasquale Esposito,
Alfonso Tempesta, Gabriele Riegler
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ABSTRACT: Surveillance in hereditary non-polyposis colorectal cancer (HNPCC) family members recommends baseline colonoscopy starting at age 20 and then surveillance colonoscopy every 1-2 years.
To verify adherence to the guidelines for HNPCC family members enrolled in endoscopic surveillance.
Data regarding 11 HNPCC families was retrieved from our database. Excluding 11 probands, 106 family members were evaluated and 40 underwent surveillance.
At baseline colonoscopy, 7 colorectal cancers (CRC), 14 polyps (PO) [1 inflammatory, 2 hyperplastic, 10 adenomas with low grade dysplasia (LGD-AD) and 1 adenoma with high-grade dysplasia (HGD-AD)] were diagnosed in sixteen individuals. Twenty-eight HNPCC family members underwent endoscopic surveillance, with a total of 94 surveillance colonoscopies. Of these, 45 were positive (4 CRC, 3 inflammatory PO, 34 hyperplastic PO, 21 LGD-AD and 5 HGD-AD). Mean time between two consecutive surveillance colonoscopies was 24.6 months (range 4-168). Median time to first positive surveillance colonoscopy was 84 months for HNPCC family members with negative baseline colonoscopy, and 60 months for those with positive baseline colonoscopy (p=0.21).
Our data suggests that surveillance colonoscopy every 2 years is adequate to diagnose advanced lesions in HNPCC family members, and improves their compliance with surveillance.
Digestive and Liver Disease 04/2010; 42(10):698-703. · 3.05 Impact Factor
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Endoscopy 01/2010; 42 Suppl 2:E299. · 5.21 Impact Factor
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ABSTRACT: To estimate the prevalence of small intestine bacterial overgrowth (SIBO) among patients with an earlier diagnosis of irritable bowel disease (IBS) in our geographical area, and to collect information on the use of locally acting non-absorbable antibiotics in the management of SIBO.
A non-interventional study was conducted in 73 consecutive patients with a symptom-based diagnosis.
When the patients underwent a "breath test", 33 (45.2%) showed the presence of a SIBO. After treatment with rifaximin 1,200 mg/d for seven days in 32 patients, 19 (59.4%) showed a negative "breath test" one week later as well as a significant reduction of symptoms, thus confirming the relationship between SIBO and many of the symptoms claimed by patients. In the other 13 patients, "breath test" remained positive, and a further cycle of treatment with ciprofloxacin 500 mg/d was given for 7 additional days, resulting in a negative "breath test" in one patient only.
(1) about half of the patients with a symptomatic diagnosis of IBS have actually SIBO, which is responsible for most of the symptoms attributed to IBS; (2) only a "breath test" with lactulose (or with glucose in subjects with an intolerance to lactose) can provide a differential diagnosis between IBS and SIBO, with almost identical symptoms; and (3) the use of non-absorbable antibiotics may be useful to reduce the degree of SIBO and related symptoms; it must be accompanied, however, by the correction of the wrong alimentary habits underlying SIBO.
World Journal of Gastroenterology 01/2008; 13(45):6016-21. · 2.47 Impact Factor
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A Kohn,
M Daperno,
A Armuzzi,
M Cappello,
L Biancone,
A Orlando,
A Viscido,
V Annese, G Riegler,
G Meucci,
M Marrollo,
R Sostegni,
A Gasbarrini,
S Peralta,
C Prantera
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ABSTRACT: Severe ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy.
To evaluate short- and long-term effectiveness and safety of infliximab in severe refractory ulcerative colitis.
Eighty-three patients with severe ulcerative colitis (i.v. glucocorticoids treatment-refractory) were treated with infliximab in 10 Italian Gastroenterology Units. Patients underwent one or more infusions according to the choice of treating physicians. Short-term outcome was colectomy/death 2 months after the first infusion. Long-term outcome was survival free from colectomy. Safety data were recorded.
Twelve patients (15%) underwent colectomy within 2 months. One died of Legionella pneumophila infection 12 days after infliximab. Early colectomy rates were higher in patients receiving one infusion (9/26), compared with those receiving two/more infusions (3/57, P = 0.001, OR = 9.53). Seventy patients who survived colectomy and did not experience any fatal complications were followed-up for a median time of 23 months; 58 patients avoided colectomy during the follow-up. Forty-two patients were maintained on immunosuppressive drugs. No clinical features were associated with outcomes.
Infliximab is an effective and relatively safe therapy to avoid colectomy and maintain long-term remission for patients with severe refractory ulcerative colitis. In the short term, two or more infusions seem to be more effective than one single infusion.
Alimentary Pharmacology & Therapeutics 10/2007; 26(5):747-56. · 3.77 Impact Factor
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Digestive and Liver Disease 03/2006; 38(2):151-2. · 3.05 Impact Factor
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L Biancone,
A Orlando,
A Kohn,
E Colombo,
R Sostegni,
E Angelucci,
F Rizzello,
F Castiglione,
L Benazzato,
C Papi,
G Meucci, G Riegler,
C Petruzziello,
F Mocciaro,
A Geremia,
E Calabrese,
M Cottone,
F Pallone
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ABSTRACT: The widespread use of anti-tumour necrosis factor alpha antibody (Infliximab) in Crohn's disease (CD) raises concerns about a possible cancer risk in the long term. In a matched pair study, we assessed whether Infliximab is associated with an increased risk of neoplasia.
In a multicentre matched pair study, 404 CD patients treated with Infliximab (CD-IFX) were matched with 404 CD patients who had never received Infliximab (CD-C). Cases and controls were matched for sex, age (+/-5 years), site of CD, age at diagnosis (+/-5 years), immunosuppressant use, and follow up. New diagnoses of neoplasia from April 1999 to October 2004 were recorded.
Among the 404 CD-IFX, neoplasia was diagnosed in nine patients (2.22%) while among the 404 CD-C, seven patients developed neoplasia (1.73%) (odds ratio 1.33 (95% confidence interval 0.46-3.84); p=0.40). The survival curve adjusted for patient year of follow up showed no differences between CD-IFX and CD-C (p=0.90; log rank test). In the CD-IFX group, there was one cholangiocarcinoma, three breast cancers, one skin cancer, one leukaemia, one laryngeal cancer, and two anal carcinomas. Among the 7/404 (1.73%) CD-C, there were three intestinal adenocarcinomas (two caecum, one rectum), one basalioma, one spinalioma, one non-Hodgkin's lymphoma, and one breast cancer. Age at diagnosis of neoplasia did not differ between groups (CD-IFX v CD-C: median 50 (range 40-70 years) v 45 (27-72); p=0.50).
In our multicentre matched pair study, the frequency of a new diagnosis of neoplasia in CD patients treated with Infliximab was comparable with CD patients who had never received Infliximab.
Gut 03/2006; 55(2):228-33. · 10.11 Impact Factor
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G Riegler,
L Caserta,
F Castiglione,
I Esposito,
D Valpiani,
V Annese,
G Zoli,
P Gionchetti,
A Viscido,
G C Sturniolo,
A Rispo,
F R De Filippo,
A de Leone,
R Carratu
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ABSTRACT: Increased rates of colorectal cancer have been reported in patients with ulcerative colitis as well as with Crohn's colitis. This risk could be the result of shared genetic susceptibility and could be co-inherited rather than being just secondary to a long-standing, extensive mucosal inflammation.
To assess the prevalence of all malignancies in first-degree relatives of Crohn's disease patients in order to establish whether any association exists.
A total of 632 outpatients with a diagnosis of Crohn's disease and 632 control subjects were recruited. Information concerning the presence of malignancies was collected in 3,292 first-degree relatives of Crohn's disease patients and in 3,303 first-degree relatives of controls.
Two hundred and fourteen (6.5%) subjects were found to be affected by malignancy in the first-degree relatives of Crohn's disease patients and 180 (5.5%) in the first-degree relatives of controls. Forty-seven (7.4%) of Crohn's disease patients had a first-degree relative with IBD, but none of them had cancer. The frequency of extra-intestinal malignancies was higher in first-degree relatives of Crohn's disease patients than in those of controls (p=0.011). Frequency of breast cancer in female relatives of Crohn's disease patients, mainly in mothers, was two-fold higher than that in controls (0.91% versus 0.42%; odds ratio=2.16; 95% confidence interval=1.14-4.08; p=0.015). The presence of breast cancer showed no association with any specific phenotype of disease in Crohn's patients.
These results did not corroborate the hypothesis about a common genetic susceptibility between Crohn's disease and colorectal cancer. An unexpected finding was the more frequent occurrence of extra-digestive malignancies. The prevalence of breast cancer in first-degree relatives of Crohn's disease patients, in particular the mothers, was more than double than in those of controls. This association, if confirmed, would suggest that there may exist common genetic and/or environmental factors for Crohn's disease and breast cancer.
Digestive and Liver Disease 02/2006; 38(1):18-23. · 3.05 Impact Factor
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Minerva gastroenterologica e dietologica 10/2005; 51(3):261-2.
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A Orlando,
E Colombo,
A Kohn,
L Biancone,
F Rizzello,
A Viscido,
R Sostegni,
L Benazzato,
F Castiglione,
C Papi, [......],
A Cassinotti,
R Cosintino,
A Geremia,
C Morselli,
E Angelucci,
A Lavagna,
A Rispo,
F Bossa,
D Scimeca,
M Cottone
[show abstract]
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ABSTRACT: Almost 20% of patients with active Crohn's disease are refractory to conventional therapy. Infliximab is a treatment of proven efficacy in this group of patients and it is not clear which variables predict a good response. AIMS.: To evaluate the role of infliximab looking at the predictors of response in a large series of patients with Crohn's disease.
Five hundred and seventy-three patients with luminal refractory Crohn's disease (Crohn's Disease Activity Index (CDAI)>220-400) (312 patients) or with fistulising disease (190 patients) or both of them (71 patients) were treated with a dose of 5 mg/kg in 12 Italian referral centres. The primary endpoints of the study were clinical response and clinical remission for luminal refractory and fistulising disease. We evaluated at univariable and multivariable analysis the following variables: number of infusions, sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, and type of fistulas.
Patients with luminal refractory disease: 322 patients (84.1%) had a clinical response and 228 (59.5%) reached clinical remission. Patients with fistulising disease: 187 patients (72%) had a reduction of 50% of the number of fistulas and in 107 (41%) a total closure of fistulas was observed. For luminal disease, single infusion (OR 0.49, 95% CI 0.28-0.86) and previous surgery (OR 0.53, 95% CI 0.30-0.93) predicted a worse response for fistulising disease. Other fistulas responded worse than perianal fistulas (OR 0.57, 95% CI 0.303-1.097).
In Crohn's disease infliximab is effective in luminal refractory and in fistulising disease. A single infusion and previous surgery predicted a worse response in luminal disease whereas perianal fistulas predicted a better response than other type of fistulas.
Digestive and Liver Disease 09/2005; 37(8):577-83. · 3.05 Impact Factor
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G Ponti,
M Ponz de Leon,
L Losi,
C Di Gregorio,
P Benatti,
M Pedroni,
A Scarselli, G Riegler,
L Lembo,
G Pellacani,
S Seidenari,
G Rossi,
L Roncucci
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ABSTRACT: The Muir-Torre syndrome (MTS) is an autosomal dominant genodermatosis characterized by the presence of sebaceous gland tumours, with or without keratoacanthomas, associated with visceral malignancies. We describe and characterize two families in which the ample phenotypic variability of MTS was evident. After clinical evaluation, the skin and visceral tumours of one member of a family with 'classic' MTS and one member of a family with a 'peculiar' MTS phenotype without sebaceous lesions, but with only multiple keratoacanthomas, were analysed for microsatellite instability (MSI) and by immunohistochemistry. Tumours of both individuals showed MSI, with a concomitant lack of MSH2 immunostaining in all evaluated skin and visceral lesions; moreover, in the proband of family 2 a constitutional mutation (C-->T substitution leading to a stop codon) in the MSH2 gene was identified. We conclude that the diagnosis of MTS, which is mainly clinical, should take into account an ample phenotypic variability, which includes both cases with typical cancer aggregation in families and cases characterized by the association of visceral malignancies with multiple keratoacanthomas (without sebaceous lesions), without an apparent family history of cancer.
British Journal of Dermatology 06/2005; 152(6):1335-8. · 3.67 Impact Factor
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ABSTRACT: Intestinal permeability is considered an index of anatomic and functional integrity of the small intestine mucosa. Altered intestinal permeability has been suggested to be a possible cause of pouchitis. Aim of this paper was to assess variations in intestinal permeability during the first year of a pouch reconstruction.
Intestinal permeability (IP) was investigated in 8 ulcerative colitis patients before and after total proctocolectomy, with ileal pouch-anal anastomosis (IPAA), by means of the cellobiose/mannitol test. To each patient a basal test (before surgery) and 3 more tests during a 1 year follow-up were administered.
Individual data were altered despite clinical findings in 9 of 30 IP measured values. An overall pattern of unaffected permeability was however shown and none of our patients, during the first year follow-up, has developed pouchitis.
Six of the 8 investigated patients presented at least 1 altered IP value. A longer follow-up aimed to further investigate patients beyond the first year after IPAA confection as to the occurrence of pouchitis and its possible correlation with a previous permeability alteration of the pouch mucosa is in progress.
Minerva gastroenterologica e dietologica 07/2004; 50(2):155-63.
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V Annese,
O Palmieri,
A Latiano,
S Ardizzone,
F Castiglione,
M Cottone,
R D'Incà,
P Gionchetti,
C Papi, G Riegler,
M Vecchi,
A Andriulli
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ABSTRACT: Three variants of the NOD2/CARD15 gene are strongly associated with susceptibility to Crohn's disease; however, striking racial and geographic differences of their frequency have been described.
We have compared the allele frequencies of familial cases of Crohn's disease recruited in a multicentre study across Italy, in order to disclose possible geographic heterogeneity. Moreover, we also compared the allele frequencies in sporadic cases of Crohn's disease and healthy controls from Southern Italy with those reported in other two populations from Central and Northern Italy.
A total of 731 subjects were genotyped for the polymorphism of three main variants (R702W, G908R and 1007 fs): 152 patients were familial cases of Crohn's disease, 183 were healthy first-degree relatives, 180 were sporadic cases of Crohn's disease, and 216 were unrelated healthy subjects.
The frequency of the frameshift mutation (1007 fs) was significantly higher in both familial and sporadic cases of Crohn's disease (P = 0.000001), and healthy first-degree relatives (P = 0.0001) compared to controls. At least one risk allele was found in 44% of familial Crohn's disease patients, compared to 7% of healthy controls (OR = 4; CI = 2-6.5). Two risk alleles were found in 14% of familial Crohn's disease, compared to less than 1% of controls (OR = 26: CI = 4-129).
Our data confirm the strong correlation between the 1007 fs variant and Crohn's disease, in both familial and sporadic cases. Moreover, no significant difference of allele frequencies was detected in familial cases, sporadic cases and healthy controls among different geographic areas of Italy.
Digestive and Liver Disease 03/2004; 36(2):121-4. · 3.05 Impact Factor
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Gastroenterology 03/2004; 126(2):625-7. · 11.68 Impact Factor
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[show abstract]
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ABSTRACT: Ulcerative colitis is a well-known risk factor for colorectal cancer.
To take a census of the cases of colorectal cancer in ulcerative colitis patients observed in Italy and to evaluate the clinical presentation of neoplastic complication.
Experts from 28 Italian centres specialised in the management of inflammatory bowel disease or malignancies participated to the study. They were invited to send clinical data of patients with ulcerative colitis complicated by colorectal cancer or high-grade dysplasia consecutively observed between 1985 and 2000. One hundred and twelve patients (92 with cancer and 20 with high-grade dysplasia) were collected. Fourteen of them had undergone colectomy and ileo-rectal anastomosis for ulcerative colitis. Data of surgical patients were analysed separately.
The mean age at diagnosis of ulcerative colitis and colorectal cancer patients was 39.3 and 53.2 years, respectively, and the mean duration between diagnosis of ulcerative colitis and cancer was 13.9 years (range 0-53). Inflammation was proximal to the splenic flexure in 71 cases (76.3%). One hundred and three colorectal cancers were registered (93 patients with single lesion and five patients with two synchronous cancers), with 76.7% of cancers being located in the left colon. As to the surgical patients, the mean age at diagnosis of ulcerative colitis and cancer was 28.9 and 47.0 years, respectively, and the mean diagnostic interval for ulcerative colitis and cancer was 18.1 years. Only 51 out of 112 patients were in follow-up. An early diagnosis of neoplasia (high grade dysplasia, stage A or B sec. Dukes) occurred in 72.5% of patients who were subjected to endoscopic surveillance and in 48.0% of patients who did not undergo endoscopic surveillance (p=0.02).
These data show an earlier diagnosis of cancer in patients who had undergone endoscopic surveillance. The poor compliance to the follow-up program, however, reduces its effectiveness. Moreover, total colectomy allows an easier follow-up, with only the rectum being controlled. Colectomy with ileo-rectal anastomosis or proctocolectomy with ileo-anal anastomosis, could represent a valid alternative in patients at high risk of cancer who refuse endoscopic surveillance.
Digestive and Liver Disease 10/2003; 35(9):628-34. · 3.05 Impact Factor
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P. Vernia,
V. Annese,
G. Bresci,
G. D’Albasio,
R. D’Incà,
S. Giaccari,
M. Ingrosso,
C. Mansi, G. Riegler,
D. Valpiani,
R. Caprilli,
GISC (Gruppo Italiano per lo Studio del Colon and del Retto
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ABSTRACT: Background The treatment of distal ulcerative colitis, refractory to conventional 5-ASA/steroid treatment, is still a matter of debate. The present study aimed at confirming, with adequate statistical power, previous data indicating the usefulness of topical butyrate and 5-ASA in the treatment of this condition.Design Double-blind, placebo-controlled, multicentre study. A total of 51 patients with distal (< 65 cm) ulcerative colitis, refractory to topical 5-ASA/cortisone, were randomly allocated to receive topical 5-ASA 2 g and 80 mM L−1 sodium-butyrate bid (Group A; 24 patients) or 5-ASA 2 g and 80 mL saline bid (Group B; 27 patients) for 6 weeks. Sigmoidoscopy with biopsies, as well as clinical and laboratory evaluations, were carried out at enrollment and at the end of the trial. Primary endpoints: remission or marked improvement in endoscopic, histologic and clinical findings.Results Most parameters showed a significant improvement vs. baseline in both groups. Remission in six patients and improvement in 12 patients in Group A vs. one remission and 13 with improvement in Group B (P < 0·05). A significant difference in favour of Group A was recorded regarding the number of bowel movements (P < 0·01), urgency (P < 0·05) and the patients’ self evaluation (P < 0·01).Discussion The combined treatment with topical butyrate and 5-ASA is significantly more effective than 5-ASA alone in the management of refractory distal colitis. Further improvements in the treatment of refractory distal ulcerative colitis may be feasible based on the identification of patient subgroups and the association of two or more active drugs. Butyrate may well be one of them.
European Journal of Clinical Investigation 03/2003; 33(3):244 - 248. · 3.02 Impact Factor
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P Vernia,
V Annese,
G Bresci,
G d'Albasio,
R D'Incà,
S Giaccari,
M Ingrosso,
C Mansi, G Riegler,
D Valpiani,
R Caprilli
[show abstract]
[hide abstract]
ABSTRACT: The treatment of distal ulcerative colitis, refractory to conventional 5-ASA/steroid treatment, is still a matter of debate. The present study aimed at confirming, with adequate statistical power, previous data indicating the usefulness of topical butyrate and 5-ASA in the treatment of this condition.
Double-blind, placebo-controlled, multicentre study. A total of 51 patients with distal (< 65 cm) ulcerative colitis, refractory to topical 5-ASA/cortisone, were randomly allocated to receive topical 5-ASA 2 g and 80 mM L-1 sodium-butyrate bid (Group A; 24 patients) or 5-ASA 2 g and 80 mL saline bid (Group B; 27 patients) for 6 weeks. Sigmoidoscopy with biopsies, as well as clinical and laboratory evaluations, were carried out at enrollment and at the end of the trial. Primary endpoints: remission or marked improvement in endoscopic, histologic and clinical findings.
Most parameters showed a significant improvement vs. baseline in both groups. Remission in six patients and improvement in 12 patients in Group A vs. one remission and 13 with improvement in Group B (P < 0.05). A significant difference in favour of Group A was recorded regarding the number of bowel movements (P < 0.01), urgency (P < 0.05) and the patients' self evaluation (P < 0.01).
The combined treatment with topical butyrate and 5-ASA is significantly more effective than 5-ASA alone in the management of refractory distal colitis. Further improvements in the treatment of refractory distal ulcerative colitis may be feasible based on the identification of patient subgroups and the association of two or more active drugs. Butyrate may well be one of them.
European Journal of Clinical Investigation 03/2003; 33(3):244-8. · 3.02 Impact Factor
