HIGH PREVALENCE OF NON-ADHERENCE TO ULCERATIVE COLITIS THERAPY IN REMISSION: KNOWING THE PROBLEM TO PREVENT LOSS.

BACKGROUND: Ulcerative colitis (UC) is a chronic inflammatory disease whose manifestations can drastically affect the individual's quality of life, and therefore adherence to treatment is important in order to keep it in remission. OBJECTIVE: To verify the prevalence of non-adherence and the influence of sociodemographic, clinical and pharmacotherapeutic characteristics associated with non-adherence to treatment of UC in remission. METHODS: Cross-sectional study conducted with 90 individuals diagnosed with UC in remission. The information was collected through interviews during medical consultations at Medical Clinic of Gastroenterology of Hospital Universitário da Universidade Federal de Juiz de Fora. To verify the association of the variables under study with the outcome of interest and its measure of association, Student's t-test or Pearson's chi-square non-parametric test (P<0.05) was used and prevalence ratio and confidence interval were calculated. RESULTS: A high prevalence of non-adherence (77.8%) was found among patients with UC in remission. The individuals most likely to not adhere to the treatment were those aged less than 50 years, who were not engaged in paid work, with high scores for anxiety and who used more than one medication as part of the treatment of UC. CONCLUSION: These findings reinforce that acknowledging the factors that influence the non-adherence behavior is of paramount importance for the development of strategies by health care professionals, assuring that those will be really effective to prolong, as much as possible, one of the most successful ways to maintain the UC remission period: the use of medications.

Elevada prevalência de não adesão ao tratamento da colite ulcerativa em remissão: conhecer o problema para prevenir o prejuízo / High prevalence of non-adherence to ulcerative colitis therapy in remission: knowing the problem to prevent loss

ABSTRACT Background Ulcerative colitis (UC) is a chronic inflammatory disease whose manifestations can drastically affect the individual's quality of life, and therefore adherence to treatment is important in order to keep it in remission. Objective To verify the prevalence of non-adherence and the influence of sociodemographic, clinical and pharmacotherapeutic characteristics associated with non-adherence to treatment of UC in remission. Methods Cross-sectional study conducted with 90 individuals diagnosed with UC in remission. The information was collected through interviews during medical consultations at Medical Clinic of Gastroenterology of Hospital Universitário da Universidade Federal de Juiz de Fora. To verify the association of the variables under study with the outcome of interest and its measure of association, Student's t-test or Pearson's chi-square non-parametric test (P<0.05) was used and prevalence ratio and confidence interval were calculated. Results A high prevalence of non-adherence (77.8%) was found among patients with UC in remission. The individuals most likely to not adhere to the treatment were those aged less than 50 years, who were not engaged in paid work, with high scores for anxiety and who used more than one medication as part of the treatment of UC. Conclusion These findings reinforce that acknowledging the factors that influence the non-adherence behavior is of paramount importance for the development of strategies by health care professionals, assuring that those will be really effective to prolong, as much as possible, one of the most successful ways to maintain the UC remission period: the use of medications.

RESUMO Contexto Colite ulcerativa é uma doença inflamatória crônica que pode apresentar manifestações graves que afetam drasticamente a qualidade de vida do indivíduo e, dessa maneira, a adesão ao tratamento é importante a fim de manter a doença em remissão. Objetivo Verificar a prevalência de não adesão e a influência de características sociodemográficas, clínicas e farmacoterapêuticas associadas a não adesão ao tratamento da colite ulcerativa em remissão. Métodos Estudo transversal envolvendo 90 indivíduos diagnosticados com colite ulcerativa em remissão. As entrevistas foram conduzidas durante as consultas médicas realizadas na Clínica Médica de Gastroenterologia do Hospital Universitário da Universidade Federal de Juiz de Fora. Para verificar a associação entre as variáveis com o desfecho de interesse, foi aplicado teste-t de Student ou teste não-paramétrico qui-quadrado de Pearson (P<0,05) e também razão de prevelência e intervalos de confiança foram calculados. Resultados Uma elevada prevalência de não adesão (77,8%) foi encontrada dentre os pacientes com colite ulcerativa em remissão. Os indivíduos mais propensos ao comportamento em questão foram aqueles com menos de 50 anos, sem trabalho remumerado, com escores mais elevados no teste de ansiedade e que utilizavam mais de um medicamento para o tratamento da colite ulcerativa. Conclusão Estes achados reforçam que o conhecimento de fatores que influenciam o comportamento de não adesão é de grande importância para o desenvolvimento de estratégias para a equipe de saúde, garantindo que estas sejam realmente eficazes para prolongar, tanto quanto possível, uma das formas mais bem-sucedidas de manter o período de remissão da colite ulcerativa: o uso de medicamentos.

Infliximab-induced remission improves physical activity in patients with active Crohn's disease.

AIM: To compare the level of physical activity (PA), exercise capacity, and body composition before and after infliximab-induced clinical remission in patients with Crohn's disease (CD). METHODS: This prospective longitudinal study evaluated 44 adult outpatients with active CD before infliximab administration and 24 weeks after infliximab therapy. The patients were evaluated for PA in daily life, exercise capacity, muscle strength, and body composition. RESULTS: 38 (86.4%) patients achieved infliximab-induced remission at 24 weeks and presented an increment in the number of steps taken of 1092 (7440±2980 vs. 6348±3177, respectively; p=0.006). The inactive time was reduced when compared to the baseline value (454.2±106.3 vs. 427.9±97.8, respectively; p=0.033). There was no difference in the distance walked before and after infliximab therapy, while there was an increase in the fat mass index in responders to infliximab compared to the baseline (19.1±7.6 vs. 14.9±5.8; p=0.001). CONCLUSIONS: Infliximab-induced remission was shown to be effective for increasing physical activity by improving the number of steps and reducing inactive time. The maintenance of clinical remission associated with incentives to regular PA may contribute to making these patients reach an ideal level of PA.

Infliximab-induced remission improves physical activity in patients with active Crohn's disease

SUMMARY AIM: To compare the level of physical activity (PA), exercise capacity, and body composition before and after infliximab-induced clinical remission in patients with Crohn's disease (CD). METHODS: This prospective longitudinal study evaluated 44 adult outpatients with active CD before infliximab administration and 24 weeks after infliximab therapy. The patients were evaluated for PA in daily life, exercise capacity, muscle strength, and body composition. RESULTS: 38 (86.4%) patients achieved infliximab-induced remission at 24 weeks and presented an increment in the number of steps taken of 1092 (7440±2980 vs. 6348±3177, respectively; p=0.006). The inactive time was reduced when compared to the baseline value (454.2±106.3 vs. 427.9±97.8, respectively; p=0.033). There was no difference in the distance walked before and after infliximab therapy, while there was an increase in the fat mass index in responders to infliximab compared to the baseline (19.1±7.6 vs. 14.9±5.8; p=0.001). CONCLUSIONS: Infliximab-induced remission was shown to be effective for increasing physical activity by improving the number of steps and reducing inactive time. The maintenance of clinical remission associated with incentives to regular PA may contribute to making these patients reach an ideal level of PA.

RESUMO OBJETIVO: Comparar o nível de atividade física (AF), capacidade de exercício e composição corporal antes e após remissão clínica induzida por infliximabe em pacientes com doença de Crohn (DC). MÉTODOS: Neste estudo longitudinal prospectivo, foram envolvidos 44 pacientes ambulatoriais adultos com DC ativa avaliados antes e depois de 24 semanas de terapia com infliximabe. Os pacientes foram avaliados quanto à AF, capacidade de exercício, força muscular e composição corporal. RESULTADOS: 38(86,4%) pacientes alcançaram remissão induzida por infliximabe em 24 semanas e apresentaram aumento no número de passos de 1092 (7440±2980 vs. 6348±3177, respectivamente; p=0,006). O tempo de inatividade foi reduzido quando comparado ao basal (454,2±106,3 vs. 427,9±97,8, respectivamente; p=0,033). Não houve diferença na distância percorrida antes e após a terapia com infliximabe, enquanto houve aumento no índice de massa gorda nos respondedores ao infliximabe em comparação ao basal (19,1±7,6 vs. 14,9±5,8; p=0,001). CONCLUSÕES: A remissão induzida pelo infliximabe mostrou-se eficaz no aumento da atividade física, melhorando o número de passos e reduzindo o tempo inativo. A manutenção da remissão clínica associada a incentivos à AF regular pode contribuir para que esses pacientes atinjam um nível ideal de AF.

The Impact of Spirituality and Religiosity on Mental Health and Quality of Life of Patients with Active Crohn's Disease.

We aim to investigate the association among religious/spiritual coping (RSC), quality of life (QOL), and mental health in patients with active Crohn's disease (CD). This cross-sectional study included 102 patients with active CD. Religious and spiritual beliefs were common among patients, being positive RSC higher than negative RSC. Negative coping was associated with mood disorders (depressive or anxiety symptoms) through the Hospital Anxiety and Depression Scale (ß = 0.260, p < 0.01) but not with QOL (Inflammatory Bowel Disease Questionnaire) (ß = - 0.105, p = NS) after adjustments. Positive coping and other religious/spiritual beliefs and behaviors were not associated with either QOL or mental health. This study suggests that a negative RSC is associated with worse mental health outcomes. This may detrimentally impact adaptations to deal with CD in the active phase, although patients generally tend to use more common positive strategies. These findings may increase the awareness of health professionals while dealing with spiritual beliefs in patients with CD.

Impact of superimposed Clostridium difficile infection in Crohn's or ulcerative colitis flares in the outpatient setting.

PURPOSE: The prospective assessment of Clostridium difficile infection (CDI) impact in inflammatory bowel disease (IBD) flare in outpatient setting has been poorly investigated. We aimed to evaluate the prevalence and the associated factors with CDI in IBD outpatients presenting colitis flares as well as the outcomes following treatment. METHODS: In this prospective cohort study, conducted from October, 2014, to July, 2016, 120 IBD patients (55% presenting colitis flare) and 40 non-IBD controls were assessed for CDI. Multivariate regression analysis was performed to identify predictors of CDI. Outcome analysis was estimated for recurrent CDI, hospitalization, colectomy, and CDI-associated mortality. RESULTS: The number of patients with CDI was significantly higher in IBD patients experiencing flares than in both inactive IBD and non-IBD groups (28.8 vs. 5.6 vs. 0%, respectively; p = 0.001). Females (OR = 1.39, 95% CI, 1.13-17.18), younger age (OR = 0.77, 95% CI, 0.65-0.92), steroid treatment (OR = 7.42, 95% CI, 5.17-40.20), and infliximab therapy (OR = 2.97, 95% CI, 1.99-24.63) were found to be independently associated with CDI. There was a dose-related increase in the risks of CDI on patients which had taken prednisone. Those treated with vancomycin had a satisfactory response to therapy, but 21% presented recurrent CDI and 16% were hospitalized. Neither necessity of colectomy nor mortality was noticed in any patient during the investigation. CONCLUSIONS: In IBD outpatients presenting colitis flares, CDI is highly prevalent. Females, younger age, infliximab, and notably steroid therapy were independently associated with CDI. Most patients with CDI experienced mild-to-moderate disease, and prompt treatment with vancomycin was highly effective, which seems to reduce the serious complication risks.

Impact of biological therapy on body composition of patients with Chron's disease.

INTRODUCTION:: Protein-energy malnutrition in Crohn's disease (CD) has been reported in 20 to 92% of patients, and is associated with increased morbidity and mortality and higher costs for the health system. Anti-TNF drugs are a landmark in the clinical management, promoting prolonged remission in patients with CD. It is believed that the remission of this disease leads to nutritional recovery. The effect of biological therapy on body composition and nutritional status is unclear. METHOD:: Prospective study of body assessment by bioelectrical impedance method in patients with moderate to severe CD undergoing treatment with infliximab. The main outcome was the body composition before and after 6 months of anti-TNF therapy. RESULTS:: There was a predominance of females (52%) with a mean age of 42±12 years. Most patients were eutrophic at baseline and remained so. There was an increase in all parameters of body composition after anti-TNF treatment: BMI (22.9±3.2 versus 25±3.8; p=0.005), waist circumference (88.1±6.7 versus 93.9±7.7; p=0.002), lean mass index (17.5±2.2 versus 18.2±2.3; p=0.000) and fat mass index (5.5±2.3 versus 6.8±2.3; p=0.000). Phase angle remained unchanged (6.2 versus 6.8; p=0.94). CONCLUSION:: After therapy with IFX, all components of body composition increased, except for phase angle. The substantial increase in fat mass index and waist circumference led to concern regarding cardiovascular risk and, thus, to the need for further studies.

Severe hypoproteinemia as a harbinger of Ménétrier's disease in autoimmune pancreatitis.

Ménétrier's disease is an extremely rare disease of unknown etiology causing gastric mucosal hypertrophy and protein-losing gastropathy. Rare cases of this condition have been reported in patients with autoimmune diseases. However, to the best of our knowledge, Ménétrier's disease associated with autoimmune pancreatitis (AIP) has never been reported. We described a case of severe hypoproteinemia as a harbinger of Ménétrier's disease associated with AIP. The patient was successfully treated with octreotide and high-protein diet, which led to symptomatic remission and significant improvement in serum levels of albumin and recovery of the nutritional status. Thus, in AIP patients presenting with severe and persistent hypoproteinemia without apparent cause, clinicians need to consider Ménétrier's disease in the differential diagnosis. In this setting, endoscopic evaluation with histological examination of gastric biopsy material, including a full-thickness mucosal biopsy of involved mucosa, may be helpful in promptly establishing the diagnosis and allowing appropriate and timely therapy.

Impact of biological therapy on body composition of patients with Chron's disease / Impacto da terapia biológica em portadores de doença de Crohn: Um estudo prospectivo

Summary Introduction: Protein-energy malnutrition in Crohn's disease (CD) has been reported in 20 to 92% of patients, and is associated with increased morbidity and mortality and higher costs for the health system. Anti-TNF drugs are a landmark in the clinical management, promoting prolonged remission in patients with CD. It is believed that the remission of this disease leads to nutritional recovery. The effect of biological therapy on body composition and nutritional status is unclear. Method: Prospective study of body assessment by bioelectrical impedance method in patients with moderate to severe CD undergoing treatment with infliximab. The main outcome was the body composition before and after 6 months of anti-TNF therapy. Results: There was a predominance of females (52%) with a mean age of 42±12 years. Most patients were eutrophic at baseline and remained so. There was an increase in all parameters of body composition after anti-TNF treatment: BMI (22.9±3.2 versus 25±3.8; p=0.005), waist circumference (88.1±6.7 versus 93.9±7.7; p=0.002), lean mass index (17.5±2.2 versus 18.2±2.3; p=0.000) and fat mass index (5.5±2.3 versus 6.8±2.3; p=0.000). Phase angle remained unchanged (6.2 versus 6.8; p=0.94). Conclusion: After therapy with IFX, all components of body composition increased, except for phase angle. The substantial increase in fat mass index and waist circumference led to concern regarding cardiovascular risk and, thus, to the need for further studies.

Resumo Introdução: Desnutrição proteico-calórica em pacientes de doença de Crohn (DC) tem sido relatada em 20 a 92% dos casos associando-se a maior morbimortalidade e maiores custos para o sistema de saúde. Agentes anti-TNF são um marco no controle clínico, promovendo remissão prolongada em portadores de DC. Acredita-se que a remissão da doença leve à recuperação nutricional desses pacientes. O efeito da terapia biológica na composição corporal e no estado nutricional é pouco conhecido. Método: Estudo prospectivo de avaliação corporal por método de bioimpedância em portadores de DC moderada a grave submetidos a terapia com infliximabe (IFX). O desfecho principal foi a composição corporal antes e após 6 meses de terapia anti-TNF. Resultados: Houve predomínio do sexo feminino (52%), com média de idades de 42±12 anos. A maioria dos pacientes era eutrófica na inclusão do estudo e assim permaneceu. Houve aumento de todos os parâmetros da composição corporal após o tratamento anti-TNF: IMC (22,9±3,2 versus 25±3,8; p=0,005), circunferência abdominal (88,1±6,7 versus 93,9±7,7; p=0,002), índice de massa magra (17,5±2,2 versus 18,2±2,3; p=0,000) e índice de massa gorda (5,5±2,3 versus 6,8±2,3; p=0,000). O ângulo de fase manteve-se inalterado (6,2 versus 6,8; p=0,94). Conclusão: Após terapia com IFX, observou-se aumento de todos os componentes da composição corporal, exceto no ângulo de fase. O aumento substancial do índice de massa gorda e da circunferência abdominal levantam a preocupação de aumento nos riscos cardiovasculares e necessidade de estudos complementares.

Severe hypoproteinemia as a harbinger of Ménétrier's disease in autoimmune pancreatitis / Hipoproteinemia grave como indicador de doença de Ménétrier na pancreatite autoimune

Summary Ménétrier's disease is an extremely rare disease of unknown etiology causing gastric mucosal hypertrophy and protein-losing gastropathy. Rare cases of this condition have been reported in patients with autoimmune diseases. However, to the best of our knowledge, Ménétrier's disease associated with autoimmune pancreatitis (AIP) has never been reported. We described a case of severe hypoproteinemia as a harbinger of Ménétrier's disease associated with AIP. The patient was successfully treated with octreotide and high-protein diet, which led to symptomatic remission and significant improvement in serum levels of albumin and recovery of the nutritional status. Thus, in AIP patients presenting with severe and persistent hypoproteinemia without apparent cause, clinicians need to consider Ménétrier's disease in the differential diagnosis. In this setting, endoscopic evaluation with histological examination of gastric biopsy material, including a full-thickness mucosal biopsy of involved mucosa, may be helpful in promptly establishing the diagnosis and allowing appropriate and timely therapy.

Resumo A doença de Ménétrier é uma condição extremamente rara, de etiologia desconhecida, caracterizada por hipertrofia da mucosa gástrica e gastropatia perdedora de proteína. Casos raros dessa patologia têm sido relatados em pacientes com doenças autoimunes. Até o momento, desconhecemos qualquer relato dessa doença associada à pancreatite autoimune (PAI). Descrevemos um caso de hipoproteinemia grave como indicador de doença de Ménétrier associada à PAI. O paciente foi tratado de forma satisfatória com octreotide e dieta hiperproteica, alcançando remissão sintomática, melhora significativa das concentrações de albumina e recuperação do estado nutricional. Portanto, em pacientes com PAI e hipoproteinemia grave e persistente, deve-se considerar a doença de Ménétrier como um diagnóstico diferencial. Nesses casos, a avaliação endoscópica com biópsia gástrica, incluindo biópsia de toda a espessura da mucosa, pode ser útil no estabelecimento do diagnóstico e do pronto início da terapêutica.

Azathioprine is more effective than mesalazine at preventing recurrent bowel obstruction in patients with ileocecal Crohn's disease.

BACKGROUND: Patients with subocclusive Crohn's disease (CD) who received azathioprine (AZA) therapy had lower re-hospitalization rates due to all causes and for surgical management of CD compared to those treated with mesalazine during a 3-year period. We investigated whether AZA also was effective for prevention of recurrent bowel obstruction. MATERIAL/METHODS: Rates of recurrent bowel occlusion were compared between patients treated with AZA and those treated with mesalazine. We assessed the time interval-off intestinal obstruction as well as the occlusion-free survival for both groups. RESULTS: There was a significantly lower cumulative rate of patients with recurrent subocclusion in the AZA group (56%) compared with the mesalazine group (79%; OR 3.34, 95% CI 1.67-8.6; P=0.003), with the number needed to treat in order to prevent 1 subocclusion episode of 3.7 favoring AZA. The occlusion-free time interval was longer in the AZA group compared with the mesalazine group (28.8 vs. 18.3 months; P=0.000). The occlusion-free survival at 12, 24, and 36 months was significantly higher in the AZA group (91%, 81%, and 72%, respectively) than in the mesalazine group (64.7%, 35.3%, and 23.5%, respectively; P<0.05 for all comparisons). CONCLUSIONS: In an exploratory analysis of patients with subocclusive ileocecal CD, maintenance therapy with AZA is more effective than mesalazine for eliminating or postponing recurrent intestinal obstruction during 3 years of therapy.

A guide to prepare patients with inflammatory bowel diseases for anti-TNF-α therapy.

Current therapy of moderate-to-severe inflammatory bowel disease (IBD) often involves the use of anti-tumor necrosis factor alpha (TNF-α) agents. Although very effective, theses biologics place the patient at increased risk for developing infections and lymphomas, the latter especially when in combination with thiopurines. Appropriate patient selection, counseling, and education are all important features for the successful use of anti-TNF-α therapy. A thorough history to rule-out contraindications of this therapy and emphasis on monitoring guidelines are important steps preceding administration of anti-TNF-α agents. This therapy should only be considered if a recent evaluation has established that the patient has active IBD. In addition, it is important to exclude disease mimickers. Anti-TNF-α agents have been considered to present a globally favorable benefit/risk ratio. However, it is important that in routine practice, initiation of anti-TNF-α therapy be carefully discussed with the patient, extensively explaining the potential benefits and risks of such treatment. Prior to starting anti-TNF-α therapy, the patients need to be screened for latent tuberculosis, hepatitis B virus infection, and (usually) hepatitis C virus and HIV infection. Vaccination schedules of IBD patients should be evaluated and updated prior to the commencement of anti-TNF-α therapy. Ordinarily, immunization in adult patients with IBD should not deviate from recommended guidelines for the general population. With the exception of live vaccines, immunizations can be safely administered in patients with IBD, even those on immunosuppressants or biologics. The purpose of this review is providing an overview of appropriate steps to prepare patients with IBD for anti-TNF-α therapy.

Effect of azathioprine or mesalazine therapy on incidence of re-hospitalization in sub-occlusive ileocecal Crohn's disease patients.

BACKGROUND: Although the cost of Crohn's disease (CD) treatment differs considerably, hospitalization and surgery costs account for most of the total treatment cost. Decreasing hospitalization and surgery rates are pivotal issues in reducing health-care costs. MATERIAL/METHODS We evaluated the effect of azathioprine (AZA) compared with mesalazine on incidence of re-hospitalizations due to all causes and for CD-related surgeries. In this controlled, randomized study, 72 subjects with sub-occlusive ileocecal CD were randomized for AZA (2-3 mg/kg per day) or mesalazine (3.2 g per day) therapy during a 3-year period. The primary end point was the re-hospitalization proportion due to all causes, as well as for surgical procedures during this period evaluated between the groups. RESULTS: On an intention-to-treat basis, the proportion of patients re-hospitalized within 36 months due to all causes was lower in patients treated with AZA compared to those on mesalazine (0.39 vs. 0.83, respectively; p=0.035). The AZA group had also significantly lower proportions of re-hospitalization for surgical intervention (0.25 vs. 0.56, respectively; p=0.011). The number of admissions (0.70 vs. 1.41, p=0.001) and the length of re-hospitalization (3.8 vs. 7.7 days; p=0.002) were both lower in AZA patients. CONCLUSIONS: Patients with sub-occlusive ileocecal CD treated with AZA had lower re-hospitalization rates due to all causes and for surgical management of CD compared to those treated with mesalazine during a 3-year period. The long-term use of AZA in ileocecal CD patients recovering from a sub-occlusion episode can save healthcare costs.

Early onset steroid-dependent ulcerative colitis is a predictor of azathioprine response: a longitudinal 12-month follow-up study.

BACKGROUND: Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (UC) are scarce. The aim of this study was to assess the long-term efficacy and safety of AZA in patients with steroid-dependent UC, as well as factors associated with sustained response. MATERIAL/METHODS: In this prospective observational study 46 adult subjects with steroid-dependent UC were included for AZA therapy during a 12-month period. AZA dosage was adjusted according to clinical response and occurrence of adverse events. Steroid therapy was tapered according to protocol. The primary endpoint was the rate of steroid-free remission to AZA at the end of 12 months. Secondary endpoints included clinical relapse, cumulative steroid dose and safety of treatment. RESULTS: On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at the end of 12 months was 0.54. The median time until complete steroid withdrawal was 5 months. A significant decrease in the relapse rate and in requirement for steroids were observed during 12 months on AZA compared with the prior year (P=0.000). Demographic, dose of AZA, steroid use, and disease-related data did not correlate with remission. Only disease duration <24 months was associated to steroid-free remission (P=0.03, OR 3.60 95% CI 1.95-9.74). Serious adverse events related to AZA were uncommon. CONCLUSIONS: AZA demonstrated sustained efficacy for maintenance of clinical remission without steroids and steroid sparing through 12 months of therapy in steroid-dependent UC. Patients with early onset UC are those who most probably will achieve sustained steroid-free remission while on AZA.

A full solid diet as the initial meal in mild acute pancreatitis is safe and result in a shorter length of hospitalization: results from a prospective, randomized, controlled, double-blind clinical trial.

GOALS: To compare the safety and length of hospitalization (LOH) between a full solid diet as the initial meal for refeeding after mild acute pancreatitis (AP) as compared with 2 other diets. BACKGROUND: In mild AP, the need for fat restriction during refeeding has not been studied. It was hypothesized that the reintroduction of oral feeding with a full solid diet after mild AP was safe and might result in a shorter LOH. STUDY: Subjects with mild AP were randomized to receive 1 of 3 diets (clear liquid, soft, or full solid) as the initial meal during oral refeeding. Diet progression and hospital discharge were decided by the physicians that were not members of trial team. During hospital stay, patients were monitored for relapse of pain (primary endpoint), dietary intake, LOH (secondary endpoint), and 7 days postdischarge to record pain relapse rates. RESULTS: A total of 210 patients were included, 70 in each arm. On a per-protocol basis, there was no difference in pain relapse rates during refeeding between the 3 diet arms (P=0.80). Subjects initiated on a full solid diet consumed significantly more calories and fats on trial days 1 and 2 (P<0.001). A shorter LOH (median of -1.5 d) was observed among patients receiving a full solid diet without abdominal pain relapse (P=0.000). CONCLUSIONS: Oral refeeding with a full solid diet in mild AP was well tolerated and resulted in a shorter LOH in patients without abdominal pain relapse.

Azathioprine maintains long-term steroid-free remission through 3 years in patients with steroid-dependent ulcerative colitis.

BACKGROUND: Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (SD-UC) are scarce. The purpose of this trial was to explore the efficacy of AZA in maintaining steroid-free remission in SD-UC patients and the factors associated with sustained response. METHODS: In this observational cohort study, 42 subjects with SD-UC were recruited for AZA therapy during a 3-year period. AZA was adjusted for a target dose of 2-3 mg/kg/day. Steroid therapy was tapered off following a standardized regimen. The primary endpoint was the annual rate of steroid-free response to AZA. Secondary endpoints included clinical recurrence, yearly steroid dose, and safety of treatment. RESULTS: On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at 12, 24, and 36 months was 0.55, 0.52, and 0.45, respectively. A significant decrease in the flare-ups rate and in requirement for steroids were observed during 3 years on AZA compared with the previous year (P = 0.000 for both). Patients with and without sustained response were comparable according to demographics, extent of disease, dose of AZA, steroids, and 5-aminosalicylate (5-ASA) use. Only disease duration <36 months was associated with off-steroids remission (P = 0.02, odds ratio [OR] 3.12, 95% confidence interval [CI] 1.89-7.64). The AZA benefit-risk profile was favorable. CONCLUSIONS: In this open-label observational trial AZA showed sustained efficacy for maintenance of clinical remission off steroids and steroid sparing through 3 years of therapy in SD-UC. Patients with earlier UC are those who most probably will have sustained steroid-free remission at the end of 12 months while on AZA.