Impact of an intervention program on drug adherence in patients with ulcerative colitis: Randomized clinical trial.

AIMS: Evaluate the impact of an intervention program in non-adherent patients with ulcerative colitis. METHODS: Parallel controlled randomized clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registered at The Brazilian Clinical Trials Registry (No. RBR-79dn4k). Non-adherent ulcerative colitis patients according to the Morisky-Green-Levine-test were included. Recruitment began in August 2019 until August 2020, with 6-month follow-up. All participants received standard usual care, and additionally the intervention group received educational (video, educational leaflet, verbal guidance) and behavioral interventions (therapeutic scheme, motivational and reminder type short message services). Researchers were blinded for allocation prior to data collection at Visits 1 and 2 (0 and 6 months). Primary outcome: 180-day adherence rate, with relative risk 95%CI. Secondary outcome: 180-day quality of life according to SF-36 domains, using Student's t test. Variables with p<0.20 were selected for regression. Analysis included data from August/2019 to May/2021. RESULTS: Forty-six and 49 participants were allocated in control and intervention groups, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control and intervention groups. There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (unintentional/both/intentional) as confounder, or if considered as adherent the intervention group participants lost in follow-up. Interventions promoted better quality of life scores even after multivariate analysis for "Pain", when adjusted for ulcerative colitis severity, sex, and marital status (ß = 18.352, p = 0.004), "Vitality", when adjusted for ulcerative colitis severity (ß = 10.568, p = 0.015) and "Emotional Aspects", when adjusted for disease severity, income, and education (ß = 24.907, p = 0.041). CONCLUSIONS: The intervention program was not able to produce a significant medication adherence rate difference between comparative groups, however, there was a significant improvement in quality of life. Study limitations may include: sample size calculated to identify differences of 30%, leading to a possible insufficient power; non blinded participants, exposing the results to the risk of performance bias; outcomes based on self-reported data.

Thiopurines are an independent risk factor for active tuberculosis in inflammatory bowel disease patients.

The use of thiopurines is an independent risk factor for active tuberculosis in patients with inflammatory bowel disease.

Endoscopic and Histopathological Findings of the Esophagus, Stomach, and Duodenum in Patients with Crohn's Disease from a Reference Center in Bahia, Brazil.

(1) The aim of the present study was to describe the endoscopic and histopathological findings in the esophagus, stomach, and duodenum in patients with Crohn's disease. (2) Methods: This was a cross-sectional study that included patients receiving treatment from the inflammatory bowel disease outpatient clinic. Esophagogastroduodenoscopies with biopsies of the stomach and proximal duodenum were performed. Presence of Helicobacter pylori bacteria was assessed by Giemsa staining. (3) Results: We included 58 patients. Erosive esophagitis was identified in 25 patients (43.1%), gastritis was diagnosed in 32 patients (55.2%) and erosive duodenitis was found in eight (13.8%). The most frequent histopathological finding in the H. pylori-positive group was increased inflammatory activity in the gastric body and antrum, with a predominance of mononuclear and polymorphonuclear cells. In turn, the most frequent finding in the H. pylori-negative group was chronic inflammation with predominance of mononuclear cells. Focally enhanced gastritis was identified in four patients (6.9%), all of whom were negative for H. pylori. Granulomas were not observed. H. pylori infection was present in 19 patients (32.8%). (4) Conclusions: Nonspecific endoscopic and histological findings were frequent in patients with Crohn's disease. Focally enhanced gastritis was uncommon and observed only in H. pylori-negative patients. The time from the diagnosis, patient age, and therapy in use may have influenced the nondetection of epithelioid granuloma.

Researching Interventions to Improve Medication Adherence in Ulcerative Colitis Patients / Pesquisando intervenções para a melhoria da adesão à medicação em pacientes com colite ulcerativa

Abstract The purpose of this review was to identify interventions that improve adherence to medications in patients with ulcerative colitis (UC). The literature search was carried out between April and June 2020 in the PubMed/MEDLINE database, with the combination of MeSH terms medication adherence; intervention; ulcerative colitis; and inflammatory bowel disease.We restricted our search to articles published in English and Portuguese between March 2010 and March 2020. After the selection, recovery of fulltext articles and analysis of the defined criteria, the interventions described in the studies were classified into four domains: educational; behavioral, cognitive behavioral, and multicomponent. In total, six clinical trials met the inclusion criteria and were analyzed. Half of the studies (3; 50%) used multicomponent interventions, 2 (33.3%) focused on behavioral interventions, and 1 (16.7%) applied isolated educational interventions. All studies used indirect methods to measure adherence, with an emphasis on scales and questionnaires. Half of the studies (3; 50%) showed a positive impact on adherence in patients with UC, with evidence that multicomponent interventions, when properly implemented in a clinical trial combining direct and indirect methods to measure medication adherence, appear to increase the chances of better results. We believe that future studies focusing on improving adherence in patients with UC are necessary.

Resumo O objetivo desta revisão foi identificar intervenções para a melhoria da adesão a medicamentos em pacientes com colite ulcerativa (CU). A busca na literatura foi realizada entre abril e junho de 2020 na base de dados do PubMed/MEDLINE, com a combinação dos descritores medication adherence; intervention; ulcerative colitis; e inflammatory bowel disease. Restringimos a busca aos artigos publicados em inglês e português entre março de 2010 e março de 2020. Após a seleção, recuperação dos textos dos artigos, e análise dos critérios definidos, as intervenções descritas nos estudos foram classificadas em quatro domínios: educacional; comportamental, cognitivo comportamental, e multicomponente. No total, seis ensaios clínicos atenderam aos critérios de inclusão e foram analisados. Metade dos estudos (3; 50%) usaram intervenções do tipo multicomponente, 2 (33.3%) centraram-se em intervenções comportamentais, e 1 (16.7%) aplicou intervenções educacionais isoladamente. Todos os estudos utilizaram métodos indiretos para mensurar a adesão, comênfase em escalas e questionários. Metade dos estudos (3; 50%) demonstraram impacto positivo na adesão em pacientes com CU, com indícios de que intervenções do tipo multicomponente, quando apropriadamente implementadas em ensaio clínicos que associam métodos diretos e indiretos para a mensuração da adesão a medicamentos, parecem aumentar as chances de melhores resultados. Consideramos que estudos futuros centrados na melhoria da adesão em pacientes com CU se fazem necessários.

Active tuberculosis in inflammatory bowel disease patients under treatment from an endemic area in Latin America.

BACKGROUND: There has been an increase in cases of inflammatory bowel disease (IBD) in recent years. There is also greater access and availability of immunosuppressive and biological agents, which increase the risk of opportunistic infection despite improving the quality of life and promoting mucosal healing. Tuberculosis (TB) remains a public health problem, and it has a high incidence in several countries. Therefore, knowledge of the risk of developing TB in patients with IBD is important. AIM: To evaluate the risk of active TB in patients with IBD under treatment from an endemic area in Latin America. METHODS: A standard questionnaire included demographic variables, clinical aspects of IBD disease, history of active TB during treatment, active TB characteristics and evolution, initial screening and results and time from the start of anti-tumor necrosis factor alpha (TNFα) to TB development. RESULTS: Azathioprine, anti-TNFα and the combination of these two drugs were associated with a higher risk of active TB incidence. The TNFα blockers increased the relative risk of developing active TB compared to other treatments. All four multivariable models showed that the use of TNFα blockers alone or in combination with azathioprine was an important risk factor for the incidence of active TB. After adjustment for sex, age, type of IBD and latent TB, anti-TNFα with azathioprine increased the relative risk to 17.8 times more than conventional treatment. Late TB, which was diagnosed 3 mo after the start of anti-TNFα, was the most frequent. CONCLUSION: Treatment with anti-TNFα increased the risk of active TB in IBD patients from an endemic area in Latin America. This risk was increased when anti-TNFα was combined with azathioprine. The time from the beginning of the treatment to the active TB diagnosis suggests a new TB infection.

Adherence to Medical Treatment in Inflammatory Bowel Disease Patients from a Referral Center in Bahia-Brazil.

METHODS: Observational, analytical, and cross-sectional studies carried out from June/2017 to July/2018, with questionnaire application and medical record review at a referral center in inflammatory bowel diseases in Salvador, Bahia. The Morisky Green Levine Scale was applied to assess adherence. Mean, standard deviation, and frequency analyses were performed using the statistical package SPSS, and chi-square was used to evaluate the association between categorical variables and adherence degree to treatment. Significant associations were considered with p < 0.05. RESULTS: 302 patients with inflammatory bowel diseases were included. Nonadherence was highlighted in the sample. Most part of the study population was female, declared themselves to be mixed race, claimed to be from urban areas, and married. Nonadherence was more frequent than adherence in most sociodemographic variables of the present study. Nonadherence also stood out among the clinical variables, such as disease activity, drug side effect, and use of more than two additional medications. The association between all studied variables and adherence degree to treatment, considering the general sample, did not show statistical significance. When Crohn's disease and ulcerative colitis patients were evaluated separately, a statistically significant association between nonadherence and female patients with ulcerative colitis was observed. CONCLUSIONS: The high frequency of nonadherence was observed in the studied sample. Female gender was associated to nonadherence in the subpopulation with ulcerative colitis.

Frequency of Hepatobiliary Manifestations and Concomitant Liver Disease in Inflammatory Bowel Disease Patients.

BACKGROUND: In inflammatory bowel disease (IBD) patients there are reports of the occurrence of hepatobiliary manifestations, so the aim of this study was to evaluate the hepatobiliary manifestations in patients with Crohn's disease (CD) and ulcerative colitis (UC) from an IBD reference center. METHODS: Cross-sectional study in an IBD reference center, with interviews and review of medical charts, between July 2015 and August 2016. A questionnaire addressing epidemiological and clinical characteristics was used. RESULTS: We interviewed 306 patients, and the majority had UC (53.9%) and were female (61.8%). Hepatobiliary manifestations were observed in 60 (19.6%) patients with IBD. In the greater part of the patients (56.7%) hepatobiliary disorders were detected after the diagnosis of IBD. In UC (18.2%) patients, the hepatobiliary disorders identified were 11 (6.7%) non-alcoholic fatty liver disease, 9 (5.5%) cholelithiasis, 6 (3.6%) primary sclerosing cholangitis (PSC), 3 (1.8%) hepatotoxicity associated with azathioprine, 1 (0.6%) hepatitis B, and 1 (0.6%) hepatic fibrosis. In CD (21.3%) patients, 11 (7.8%) had cholelithiasis, 11 (7.8%) non-alcoholic fatty liver disease, 4 (2.8%) PSC, 3 (2.1%) hepatotoxicity, 1 (0.7%) hepatitis B, (0.7%) hepatitis C, 1 (0.7%) alcoholic liver disease, and 1 (0.7%) autoimmune hepatitis (AIH). There was one case of PSC/AIH overlap syndrome. CONCLUSION: The frequency of hepatobiliary disorders was similar in both forms of IBD in patients evaluated. The most common nonspecific hepatobiliary manifestations in IBD patients were non-alcoholic liver disease and cholelithiasis. The most common specific hepatobiliary disorder was PSC in patients with extensive UC or ileocolonic CD involvement; this was seen more frequently in male patients.

What nutritional factors influence bone mineral density in Crohn's disease patients?

BACKGROUND/AIMS: Bone mineral density (BMD) is often low in patients with Crohn's disease (CD). This study aimed to evaluate the association between nutritional factors and BMD in a group of CD patients. METHODS: CD patients 18 years of age or older were included. The body mass index (BMI), waist circumference (WC) and dietary intake were evaluated during two 24-hour recalls. Bone densitometry was performed by dual-energy X-ray absorptiometry of the full body to assess body composition and of the lumbar vertebrae and femoral neck to assess BMD. RESULTS: In the 60 patients evaluated, there was no association between BMD and disease activity or between BMD and disease duration. We observed moderate correlations between BMD in at least one of the evaluated sites and BMI, lean mass, WC, and protein, calcium, phosphorus and magnesium dietary intakes (P<0.05). In the linear regression analysis for spinal BMD, only BMI and calcium dietary intake remained associated (P<0.05). In the linear regression analysis for femoral BMD, WC and phosphorus intake continued to be significant in the final model, although they had low explanatory power for BMD (P<0.05). CONCLUSIONS: The prevalence of low BMD was high in CD patients. BMI, WC, calcium and phosphorus dietary intake were positively correlated with BMD.

Manifestações do trato gastrointestinal superior em pacientes com doença inflamatória intestinal atendidos em serviço de referência em Salvador - BA / Upper gastrointestinal tract manifestations in inflammatory bowel disease patients from one reference service in Salvador - BA

Introdução: a Doença Inflamatória Intestinal (DII) se manifesta em duas principais formas: doença de Crohn (DC) e retocolite ulcerativa (RCU). O quadro clínico clássico da DII compreende dor abdominal, diarreia e perda ponderal. Além da apresentação habitual, os pacientes podem apresentar, no decorrer da doença, manifestações do trato gastrointestinal superior (TGS) como: dispepsia, dor epigástrica, plenitude pós-prandial, pirose, náuseas, regurgitação, aftas orais, vômitos, disfagia, odinofagia e hematêmese. Objetivo: descrever as manifestações do TGS em pacientes com DII em um centro de referência da Bahia. Métodos: estudo transversal realizado no período de julho de 2015 a agosto de 2016 no ambulatório de DII do Hospital Geral Roberto Santos (HGRS). A coleta de dados foi por um questionário objetivo e revisão de prontuários. Foram avaliadas variáveis do ponto de vista epidemiológico e clínico. O estudo foi aprovado pelo Comitê de Ética em Pesquisa do Hospital Geral Roberto Santos. As variáveis foram analisadas utilizando o pacote estatístico SPSS versão 21.0. Resultados: foram incluídos 306 pacientes. O sexo feminino foi mais prevalente tanto na DC (63,1%) quanto na RCU (60,6%). Dos 306 pacientes analisados, 141 tinham diagnóstico de DC e 165 tinham diagnóstico de RCU. Da amostra total, 58,5% apresentaram alguma manifestação do TGS, sendo a frequência semelhante entre DC e RCU. Conclusões: mais da metade dos pacientes com DII apresentou pelo menos uma manifestação do TGS, sendo que as manifestações mais frequentes foram: pirose, dor epigástrica, dispepsia e plenitude pós-prandial. DC e RCU apresentaram frequências semelhantes dessas manifestações. Estes sintomas devem ser atentamente questionados, pois é fundamental o seu reconhecimento precoce para o manejo adequado.

Introduction: inflammatory Bowel Disease (IBD) manifests itself in two main forms: Crohns disease (CD) and ulcerative colitis (UC). The classic clinical presentation of IBD includes abdominal pain, diarrhea and weight loss. In addition to the usual presentation, patients may presente upper gastrointestinal tract (UGT) manifestations such as: dyspepsia, epigastric pain, postprandial fullness, heartburn, nausea, regurgitation, oral thrush, vomiting, dysphagia, odynophagia and hematemesis. Objective: to describe the manifestations of the UGT in patients with IBD at a reference center in Bahia. Methods: a cross-sectional study conducted from July 2015 to August 2016 at the Hospital Geral Roberto Santos (HGRS) - IBD unit. Data collection was made by an objective questionnaire and review of medical records. Variables from epidemiological and clinical point of view were evaluated. The study was approved by the Research Ethics Committee of the HGRS (Salvador - BA). Variables were analyzed using the statistical package SPSS version 21.0. Results: we evaluated 306 patients. Female gender was more prevalent in both CD (63.1%) and UC (60.6%). Of the 306 patients analyzed, 141 had been diagnosed with CD and 167 with UC. Of the total sample, 58.5% had some manifestation of the UGT, being similar between CD and UC. Conclusion: more than half of patients with IBD presented at least one manifestation of the UGT, and the most frequent were: heartburn, epigastric pain, dyspepsia and postprandial fullness. CD and UC presented similar frequencies of these manifestations. These symptoms should be carefully questioned, as it is fundamental their early recognition for the adequate management of these patients.