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1.
Medicine (Baltimore) ; 99(35): e21903, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871923

RESUMO

INTRODUCTION: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by a relapsing-remitting course owing to recurrent intestinal inflammation. UC often has symptoms such as intermittent rectal bleeding, diarrhea, and abdominal pain. As the precise etiology of UC has not completely clarified, UC has become a public health challenge worldwide. According to an epidemiological survey, there were about 350,000 new cases of IBD in China from 2005 to 2014. By 2025, the number of IBD patients in China will reach 1.5 million. Traditional Chinese medicine (TCM) has been widely used to treat UC in China, however, it is still challenging to systematically determine the efficacy of in UC. Therefore, this trial aims to evaluate the clinical efficacy and safety of CHM in the treatment of mild active UC patients. METHODS: A multi-center, double-blinding, double-dummy, active-controlled, randomized trial will be established. A total of 240 patients in 6 centers with mild active UC (Mayo score is 3-5 points) and TCM syndrome of damp-heat stasis blocking and spleen-qi deficiency will be randomly allocated in the ratio of 1:1 to 2 groups: the experimental group and the control group. The experimental group will receive Hudi enteric-coated capsules (HEC) and enteric-coated mesalazine tablets placebo; the control group will receive enteric-coated mesalazine tablets and HEC placebo. Each group will be treated for 8 weeks. The primary therapeutic outcome: the rate of clinical efficacy and clinical remission at 8 weeks of treatment (last survey point) according to the modified Mayo score. The secondary outcomes: individual symptom score, TCM syndrome score, endoscopic response rate, mucosal healing rate, and quality of life scale score. Outcomes will be assessed at baseline and the end of the trial. Besides, intestinal mucosa, stools and blood biopsies from the mild active UC patients before and after treatment will be collected to reveal the underlying mechanisms. DISCUSSION: The results of this trial will provide compelling evidence of the efficacy and safety of HEC for treatment of mild active UC and preliminarily show the potential mechanism of how HEC acts. Finally, it will widen treatment options for patients with mild active UC.


Assuntos
Colite Ulcerativa/terapia , Medicina Tradicional Chinesa , Método Duplo-Cego , Humanos , Medicina Tradicional Chinesa/efeitos adversos , Resultado do Tratamento
3.
Medicine (Baltimore) ; 99(31): e21319, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756115

RESUMO

BACKGROUND: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the colonic mucosa. Herb-partitioned moxibustion (HPM) treatment has been demonstrated to be effective in the treatment of UC. However, there is still a lack of high-quality evidence to support the effectiveness and safety of HPM on patients with UC. This study will aim to systematically explore the efficacy of HPM for the treatment of UC. METHODS: We will search the electronic databases of Embase, MEDLINE, PubMed, Cochrane Library Central Register of Controlled Trials, China national knowledge infrastructure database (CNKI), Wan fang database, Chongqing VIP information, and SinoMed from their inception to June 2020. Randomized controlled trials (RCTs) of HPM for the treatment of UC will be included. RevMan 5.3 software (The Nordic Cochrane Center, The Cochrane Collaboration, Copenhagen, Denmark) will be applied for statistical analysis. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: The conclusion of our systematic review will provide more appropriate evidence-based decisions to assist clinicians during the decision-making process when dealing with UC.


Assuntos
Colite Ulcerativa/terapia , Medicamentos de Ervas Chinesas/uso terapêutico , Moxibustão/métodos , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
4.
Medicine (Baltimore) ; 99(34): e21812, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846819

RESUMO

BACKGROUND: Ulcerative colitis is a recurring digestive disease characterized by inflammation in the intestinal tract, which seriously affects the life of the patient. In recent years, it has played a role in obesity, osteoporosis, and gastrointestinal disorders, and has received more and more attention. However, there are no clear conclusions about its effectiveness and safety in the treatment of UC. METHOD AND ANALYSIS: This systematic review will collect 7 databases, including Web of science, Pubmed, Embase, VIP, Wanfang, CNKI, and the Chinese Biomedical Literature Database (CBM), to collect all eligible RCTs from database inception to December 31, 2019. The 2 researchers will rigorously follow the selection process, including study screening, data extraction, and quality assessment. The primary outcome is clinical effectiveness. The main software used in this study is Review Manager V5.3 software. RESULT: This study will provide a meaningful and comprehensive evaluation on the effectiveness and safety of acupoints embedding for UC. CONCLUSION: This meta-analysis was designed to provide clinicians with valid evidence regarding acupoint embedding for UC. INPLASY REGISTRATION NUMBER: INPLASY202040166.


Assuntos
Terapia por Acupuntura/métodos , Categute , Colite Ulcerativa/terapia , Terapia por Acupuntura/efeitos adversos , Colite Ulcerativa/sangue , Citocinas/sangue , Humanos , Metanálise como Assunto , Próteses e Implantes , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Índice de Gravidade de Doença , Revisões Sistemáticas como Assunto
5.
Medicine (Baltimore) ; 99(28): e21219, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32664174

RESUMO

BACKGROUND: The incidence of ulcerative colitis (UC) is increasing year by year worldwide, and it is listed as one of the refractory diseases by World Health Organization. In addition to typical intestinal manifestations such as abdominal pain, diarrhea, mucus, pus, and bloody stool, it can also accompany multiorgan and multisystem extraintestinal manifestations, seriously affecting the life and work of patients. Furthermore, UC patients with a tremendous psychological pressure and affects their physical and mental health. In recent years, many complementary and alternative therapies have been used for treatment of UC, but only pair-wised drugs have been evaluated in the traditional meta-analyses and some results are inconsistent. Consequently, it is essential to propose a protocol for systematic review and meta-analysis to discuss the efficacy and safety of complementary and alternative therapies in the treatment of UC. METHODS: We will search Chinese and English databases comprehensively and systematically from the establishment of databases to May 2020, free of language or publication restrictions. All randomized controlled trials on complementary and alternative therapies for UC will be included. Two researchers will independently screen titles, abstracts, full texts, and extract data, then assess the bias risk of each study. We will conduct pairwise meta-analyses and Bayesian network meta-analyses to the relative outcomes of the efficacy and safety. Data analysis will use STATA and WinBUGs 1.4.3 software in this meta-analysis. RESULTS: This study will evaluate the efficacy and safety of complementary and alternative therapies for UC based on changes in symptoms, clinical efficacy, quality of life and adverse events. CONCLUSION: This study will provide evidence for whether complementary and alternative therapies are beneficial to the treatment of UC. In order to provide reliable evidence-based medicine for clinical practice. INPLASY REGISTRATION NUMBER: INPLASY202060015.


Assuntos
Colite Ulcerativa/terapia , Terapias Complementares/métodos , Adulto , Teorema de Bayes , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Humanos , Masculino , Metanálise em Rede , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Resultado do Tratamento
9.
Inflamm Bowel Dis ; 26(7): 971-973, 2020 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-32393973

RESUMO

First detected in Wuhan, China, the novel 2019 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an enveloped RNA beta-coronavirus responsible for an unprecedented, worldwide pandemic caused by COVID-19. Optimal management of immunosuppression in inflammatory bowel disease (IBD) patients with COVID-19 infection currently is based on expert opinion, given the novelty of the infection and the corresponding lack of high-level evidence in patients with immune-mediated conditions. There are limited data regarding IBD patients with COVID-19 and no data regarding early pregnancy in the era of COVID-19. This article describes a patient with acute severe ulcerative colitis (UC) during her first trimester of pregnancy who also has COVID-19. The case presentation is followed by a review of the literature to date on COVID-19 in regard to inflammatory bowel disease and pregnancy, respectively.


Assuntos
Aborto Espontâneo , Colite Ulcerativa , Infecções por Coronavirus , Ciclosporina/administração & dosagem , Metilprednisolona/administração & dosagem , Pandemias , Pneumonia Viral , Complicações na Gravidez , Indução de Remissão/métodos , Adulto , Antivirais/administração & dosagem , Betacoronavirus/isolamento & purificação , Proteína C-Reativa/análise , Técnicas de Laboratório Clínico/métodos , Colite Ulcerativa/sangue , Colite Ulcerativa/complicações , Colite Ulcerativa/fisiopatologia , Colite Ulcerativa/terapia , Infecções por Coronavirus/complicações , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Feminino , Humanos , Imunossupressores/administração & dosagem , Gravidade do Paciente , Pneumonia Viral/complicações , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Gravidez , Complicações na Gravidez/fisiopatologia , Complicações na Gravidez/terapia , Sigmoidoscopia/métodos , Resultado do Tratamento
12.
PLoS One ; 15(5): e0233238, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32407408

RESUMO

BACKGROUND: The incidence and prevalence of ulcerative colitis (UC) varies geographically. The risk of colorectal cancer (CRC) and possibly some other malignancies is increased among patients with UC. It is still debated if patients with UC are at a greater risk of dying compared with the general population. Our aim was to describe the epidemiology and mortality of the Hungarian UC population from 2010 to 2016 and to analyze the associated malignancies with a special focus on CRC. METHODS: This is an observational, descriptive, epidemiological study based on the National Health Insurance Fund social security databases from 2010 to 2016. All adult patients who had at least two events in outpatient care or at least two medication prescriptions, or at least one inpatient event with UC diagnosis were analyzed. Malignancies and CRC were defined using ICD-10 codes. We also evaluated the survival of patients suffering from UC compared with the general population using a 3 to 1 matched random sample (age, gender, geography) from the full population of Hungary. RESULTS: We found the annual prevalence of UC 0.24-0.34%. The incidence in 2015 was 21.7/100 000 inhabitants. Annual mortality rate was 0.019-0.023%. In this subpopulation, CRC was the most common cancer, followed by non-melanotic skin and prostate cancer. 8.5% of the UC incident subpopulation was diagnosed with CRC. 470 (33%) of the CRC patients died during the course of the study (25% of all deaths were due to CRC), the median survival was 9.6 years. UC patients had significantly worse survival than their matched controls (HR = 1.65, 95% CI: 1.56-1.75). SUMMARY: This is the first population-based study from Eastern Europe to estimate the different malignancies and mortality data amongst Hungarian ulcerative colitis patients. Our results revealed a significantly worse survival of patients suffering from UC compared to the general population.


Assuntos
Colite Ulcerativa/epidemiologia , Neoplasias Colorretais/epidemiologia , Adulto , Idoso , Colite Ulcerativa/terapia , Feminino , Humanos , Hungria/epidemiologia , Incidência , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Fatores de Risco , Análise de Sobrevida , Adulto Jovem
13.
J Med Vasc ; 45(2): 67-71, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32265017

RESUMO

GOAL OF THE STUDY: Inflammatory bowel disease (IBD) is associated with an increased risk of thromboembolic events (TEE) during outbreaks, increasing morbidity and mortality. The aim of our study was to specify the prevalence of TEE in IBD patients and to determine their epidemiological, clinical and evolutionary characteristics. MATERIEL AND METHODS: This is a retrospective study collecting all patients with IBD, who had a thromboembolic complication confirmed by imagery, between January 2012 and December 2018. RESULTS: One hundred patients with IBD were diagnosed during the study period. A TEE occurred in 6 patients (5.9%). These patients had an average age of 41 years, divided into 4 women and 2 men. Five patients had Crohn's disease and one patient had ulcerative colitis. The IBD was active in all patients. Five patients were already hospitalized and under preventive heparin therapy. Patients had deep venous thrombosis of the lower limbs in 3 cases, associated with pulmonary embolism in 1 case, cerebral venous thrombosis in 2 cases and pulmonary embolism isolated in 1 case. Thrombophilia investigations were negative in all patients. Evolution under medical treatment was favorable in 4 patients and fatal in 2 patients. CONCLUSION: In our study, the prevalence of TEE in patients with IBD was 5.9%. Thrombosis occurred during the active phase of IBD in all cases.


Assuntos
Doença de Crohn/epidemiologia , Trombose Intracraniana/epidemiologia , Embolia Pulmonar/epidemiologia , Tromboembolia/epidemiologia , Trombose Venosa/epidemiologia , Adulto , Idoso , Anticoagulantes/uso terapêutico , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/epidemiologia , Colite Ulcerativa/mortalidade , Colite Ulcerativa/terapia , Doença de Crohn/diagnóstico , Doença de Crohn/mortalidade , Doença de Crohn/terapia , Feminino , Heparina/uso terapêutico , Humanos , Trombose Intracraniana/diagnóstico por imagem , Trombose Intracraniana/tratamento farmacológico , Trombose Intracraniana/mortalidade , Masculino , Prevalência , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/tratamento farmacológico , Embolia Pulmonar/mortalidade , Estudos Retrospectivos , Fatores de Risco , Tromboembolia/diagnóstico por imagem , Tromboembolia/tratamento farmacológico , Tromboembolia/mortalidade , Fatores de Tempo , Tunísia/epidemiologia , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/tratamento farmacológico , Trombose Venosa/mortalidade
15.
PLoS One ; 15(3): e0228846, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32182248

RESUMO

BACKGROUND: Fecal microbiota transplantation is an effective treatment for many gastrointestinal diseases, such as Clostridium difficile infection and inflammatory bowel disease, especially ulcerative colitis. Changes in colonic microflora may play an important role in the pathogenesis of ulcerative colitis, and improvements in the intestinal microflora may relieve the disease. Fecal bacterial transplants and oral probiotics are becoming important ways to relieve active ulcerative colitis. PURPOSE: This systematic review with meta-analysis compared the efficacy and safety of basic treatment combined with fecal microbiota transplantation or mixed probiotics therapy in relieving mild to moderate ulcerative colitis. METHODS: The PubMed, Embase, and Cochrane libraries (updated September 2019) were searched to identify randomized, placebo-controlled, or head-to-head trials assessing fecal microbiota transplantation or probiotic VSL#3 as induction therapy in active ulcerative colitis. We analyze data using the R program to obtain evidence of direct comparison and to generate intermediate variables for indirect treatment comparisons. RESULTS: Seven randomized, double-blind, placebo-controlled trials were used as the sources of the induction data. All treatments were superior to placebo. In terms of clinical remission and clinical response to active ulcerative colitis, direct comparisons showed fecal microbiota transplantation (OR = 3.47, 95% CI = 1.93-6.25) (OR = 2.48, 95% CI = 1.18-5.21) and mixed probiotics VSL#3 (OR = 2.40, 95% CI = 1.49-3.88) (OR = 3.09, 95% CI = 1.53-6.25) to have better effects than the placebo. Indirect comparison showed fecal microbiota transplantation and probiotic VSL#3 did not reach statistical significance either in clinical remission (RR = 1.20, 95% CI = 0.70-2.06) or clinical response (RR = 0.95, 95% CI = 0.62-1.45). In terms of safety, fecal microbiota transplantation (OR = 1.15, 95% CI = 0.51-2.61) and VSL #3 (OR = 0.90, 95% CI = 0.33-2.49) showed no statistically significant increase in adverse events compared with the control group. In terms of serious adverse events, there was no statistical difference between the fecal microbiota transplantation group and the control group (OR = 1.29, 95% CI = 0.46-3.57). The probiotics VSL#3 seems more safer than fecal microbiota transplantation, because serious adverse events were not reported in the VSL#3 articles. CONCLUSIONS: Fecal microbiota transplantation or mixed probiotics VSL#3 achieved good results in clinical remission and clinical response in active ulcerative colitis, and there was no increased risk of adverse reactions. There was no statistical difference between the therapeutic effect of fecal microbiota transplantation and that of mixed probiotics VSL#3. However, the use of fecal microbiota transplantation and probiotics still has many unresolved problems in clinical applications, and more randomized controlled trials are required to confirm its efficacy.


Assuntos
Colite Ulcerativa/terapia , Transplante de Microbiota Fecal/métodos , Probióticos/administração & dosagem , Administração Oral , Terapia Combinada , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Probióticos/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
16.
Cochrane Database Syst Rev ; 3: CD007443, 2020 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-32128794

RESUMO

BACKGROUND: Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first- or second-line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response. OBJECTIVES: The primary objective was to determine the efficacy of probiotics compared to placebo, no treatment, or any other intervention for the maintenance of remission in people with ulcerative colitis. The secondary objective was to assess the occurrence of adverse events associated with the use of probiotics. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 31 October 2019. We contacted authors of relevant studies and manufacturers of probiotics regarding ongoing or unpublished trials that may be relevant to the review, and we searched ClinicalTrials.gov. We also searched references of trials for any additional trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared probiotics against placebo or any other intervention, in both adults and children, for the maintenance of remission in ulcerative colitis were eligible for inclusion. Maintenance therapy had to be for a minimum of three months when remission has been established by any clinical, endoscopic,histological or radiological relapse as defined by study authors. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE methodology. MAIN RESULTS: In this review, we included 12 studies (1473 randomised participants) that met the inclusion criteria. Participants were mostly adults. The studies compared probiotics to placebo, probiotics to 5-aminosalicylic acid (5-ASA) and a combination of probiotics and 5-ASA to 5-ASA. The studies ranged in length from 12 to 52 weeks. The average age of participants was between 32 and 51, with a range between 18 and 88 years. Seven studies investigated a single bacterial strain, and five studies considered mixed preparations of multiple strains. The risk of bias was high in all except three studies due to selective reporting, incomplete outcome data and lack of blinding. This resulted in low- to very low-certainty of evidence. It is uncertain if there is any difference in occurrence of clinical relapse when probiotics are compared with placebo (RR 0.87, 95% CI 0.63 to 1.18; 4 studies, 361 participants; very low-certainty evidence (downgraded for risk of bias, imbalance in baseline characteristics and imprecision)). It is also uncertain whether probiotics lead to a difference in the number of people who maintain clinical remission compared with placebo (RR 1.16, 95% CI 0.98 to 1.37; 2 studies, 141 participants; very low-certainty evidence (downgraded for risk of bias, imbalance in baseline characteristics and imprecision)). When probiotics are compared with 5-ASA, there may be little or no difference in clinical relapse (RR 1.01, 95% CI 0.84 to 1.22; 2 studies, 452 participants; low-certainty evidence) and maintenance of clinical remission (RR 1.06, 95% CI 0.90 to 1.25; 1 study, 125 participants; low-certainty evidence). It is uncertain if there is any difference in clinical relapse when probiotics, combined with 5-ASA are compared with 5-ASA alone (RR 1.11, 95% CI 0.66 to 1.87; 2 studies, 242 participants; very low-certainty evidence (downgraded due to risk of bias and imprecision)). There may be little or no difference in maintenance of remission when probiotics, combined with 5-ASA, are compared with 5-ASA alone (RR 1.05, 95% CI 0.89 to 1.24; 1 study, 122 participants; low-certainty evidence). Where reported, most of the studies which compared probiotics with placebo recorded no serious adverse events or withdrawals due to adverse events. For the comparison of probiotics and 5-ASA, one trial reported 11/110 withdrawals due to adverse events with probiotics and 11/112 with 5-ASA (RR 1.02, 95% CI 0.46 to 2.25; 222 participants; very low-certainty evidence). Discontinuation of therapy was due to gastrointestinal symptoms. One study (24 participants) comparing probiotics combined with 5-ASA with 5-ASA alone, reported no withdrawals due to adverse events; and two studies reported two withdrawals in the probiotic arm, due to avascular necrosis of bilateral femoral head and pulmonary thromboembolism (RR 5.29, 95% CI 0.26 to 107.63; 127 participants; very low-certainty evidence). Health-related quality of life and need for additional therapy were reported infrequently. AUTHORS' CONCLUSIONS: The effectiveness of probiotics for the maintenance of remission in ulcerative colitis remains unclear. This is due to low- to very low-certainty evidence from poorly conducted studies, which contribute limited amounts of data from a small number of participants. Future trials comparing probiotics with 5-ASA rather than placebo will better reflect conventional care given to people with ulcerative colitis. Appropriately powered studies with a minimum length of 12 months are needed.


Assuntos
Colite Ulcerativa/terapia , Probióticos/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/uso terapêutico , Humanos , Mesalamina/uso terapêutico , Pessoa de Meia-Idade , Probióticos/efeitos adversos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Indução de Remissão , Adulto Jovem
17.
Cochrane Database Syst Rev ; 3: CD005573, 2020 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-32128795

RESUMO

BACKGROUND: Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first- or second-line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response. OBJECTIVES: To assess the efficacy of probiotics compared with placebo or standard medical treatment (5-aminosalicylates, sulphasalazine or corticosteroids) for the induction of remission in people with active ulcerative colitis. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 31 October 2019. We contacted authors of relevant studies and manufacturers of probiotics regarding ongoing or unpublished trials that may be relevant to the review, and we searched ClinicalTrials.gov. We also searched references of trials for any additional trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) investigating the effectiveness of probiotics compared to standard treatments or placebo in the induction of remission of active ulcerative colitis. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors DATA COLLECTION AND ANALYSIS: Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE methodology. MAIN RESULTS: In this review, we included 14 studies (865 randomised participants) that met the inclusion criteria. Twelve of the studies looked at adult participants and two studies looked at paediatric participants with mild to moderate ulcerative colitis, the average age was between 12.5 and 47.7 years. The studies compared probiotics to placebo, probiotics to 5-ASA and a combination of probiotics plus 5-ASA compared to 5-ASA alone. Seven studies used a single probiotic strain and seven used a mixture of strains. The studies ranged from two weeks to 52 weeks. The risk of bias was high for all except two studies due to allocation concealment, blinding of participants, incomplete reports of outcome data and selective reporting. This led to GRADE ratings of the evidence ranging from moderate to very low. Probiotics versus placebo Probiotics may induce clinical remission when compared to placebo (RR 1.73, 95% CI 1.19 to 2.54; 9 studies, 594 participants; low-certainty evidence; downgraded due to imprecision and risk of bias, number needed to treat for an additional beneficial outcome (NNTB) 5). Probiotics may lead to an improvement in clinical disease scores (RR 2.29, 95% CI 1.13 to 4.63; 2 studies, 54 participants; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.04, 95% CI 0.42 to 2.59; 7 studies, 520 participants). Reported adverse events included abdominal bloating and discomfort. Probiotics did not lead to any serious adverse events in any of the seven studies that reported on it, however five adverse events were reported in the placebo arm of one study (RR 0.09, CI 0.01 to 1.66; 1 study, 526 participants; very low-certainty evidence; downgraded due to high risk of bias and imprecision). Probiotics may make little or no difference to withdrawals due to adverse events (RR 0.85, 95% CI 0.42 to 1.72; 4 studies, 401 participants; low-certainty evidence). Probiotics versus 5-ASA There may be little or no difference in the induction of remission with probiotics when compared to 5-ASA (RR 0.92, 95% CI 0.73 to 1.16; 1 study, 116 participants; low-certainty evidence; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.33, 95% CI 0.53 to 3.33; 1 study, 116 participants). Reported adverse events included abdominal pain, nausea, headache and mouth ulcers. There were no serious adverse events with probiotics, however perforated sigmoid diverticulum and respiratory failure in a patient with severe emphysema were reported in the 5-ASA arm (RR 0.21, 95% CI 0.01 to 4.22; 1 study, 116 participants; very low-certainty evidence). Probiotics combined with 5-ASA versus 5-ASA alone Low-certainty evidence from a single study shows that when combined with 5-ASA, probiotics may slightly improve the induction of remission (based on the Sunderland disease activity index) compared to 5-ASA alone (RR 1.22 CI 1.01 to 1.47; 1 study, 84 participants; low-certainty evidence; downgraded due to unclear risk of bias and imprecision). No information about adverse events was reported. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes (progression to surgery, need for additional therapy, quality of life scores, or steroid withdrawal) were reported in any of the studies. AUTHORS' CONCLUSIONS: Low-certainty evidence suggests that probiotics may induce clinical remission in active ulcerative colitis when compared to placebo. There may be little or no difference in clinical remission with probiotics alone compared to 5-ASA. There is limited evidence from a single study which failed to provide a definition of remission, that probiotics may slightly improve the induction of remission when used in combination with 5-ASA. There was no evidence to assess whether probiotics are effective in people with severe and more extensive disease, or if specific preparations are superior to others. Further targeted and appropriately designed RCTs are needed to address the gaps in the evidence base. In particular, appropriate powering of studies and the use of standardised participant groups and outcome measures in line with the wider field are needed, as well as reporting to minimise risk of bias.


Assuntos
Colite Ulcerativa/terapia , Probióticos/uso terapêutico , Adolescente , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Viés , Criança , Terapia Combinada/métodos , Humanos , Mesalamina/efeitos adversos , Mesalamina/uso terapêutico , Pessoa de Meia-Idade , Números Necessários para Tratar , Probióticos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão/métodos , Tamanho da Amostra , Sulfassalazina/uso terapêutico
18.
Gastroenterol. hepatol. (Ed. impr.) ; 43(3): 155-168, mar. 2020. ilus, graf, tab
Artigo em Espanhol | IBECS | ID: ibc-190792

RESUMO

Las recomendaciones son consejos dados por considerarse beneficiosos y no dejan de ser sugerencias, abiertas por tanto a diferentes interpretaciones. En ese sentido, el objetivo final de la revisión ha sido, con las evidencias disponibles, intentar homogeneizar al máximo la aproximación al diagnóstico y tratamiento medicoquirúrgico de una de las manifestaciones más complejas de la enfermedad de Crohn como son las fístulas perianales simples y complejas


Recommendations are advice that is given and considered to be beneficial; however, they are still suggestions and are therefore open to different interpretations. In this sense, the final objective of the review has been to try to homogenize, with the evidence available, the approach to the diagnosis and medical/surgical treatment of one of the most complex manifestations of Crohn's disease, such as simple and complex perianal fistulas


Assuntos
Humanos , Fístula Retal/terapia , Doença de Crohn/epidemiologia , Colite Ulcerativa/terapia , Doença de Crohn/cirurgia , Doença de Crohn/classificação , Consenso , Índice de Gravidade de Doença
19.
Curr Gastroenterol Rep ; 22(3): 11, 2020 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-32040642

RESUMO

PURPOSE OF REVIEW: In this study, we present the evidence-based management for patients hospitalized for ulcerative colitis (UC) with a special focus on the synergic approach of the two key actors of the inflammatory bowel disease multidisciplinary team (IBD-MDT): gastroenterologist and surgeon. RECENT FINDINGS: Focused treatment by a specialized IBD-MDT and early involvement of the colorectal surgeon in the management of hospitalized UC patients is advocated. The colectomy rate has not changed over the years. Moreover, delayed surgery after admission is burden by increase complication and mortality rates. Thus, it is pivotal to identify the patients who are likely to undergo surgery, by mean of predictors of outcome, and not to prolong ineffective medical treatment. The perfect timing based on clinical close monitoring is crucial. Up to 25% of patients with ulcerative colitis (UC) may require hospitalization. The aim of admission is to evaluate severity of the disease, exclude infections and establish proper treatment while monitoring the response. During admission, the patient has to be closely observed for the possible development of toxic megacolon or perforation, which should prompt emergency colectomy. Up to 30% of UC patients will fail to respond to initial intravenous corticosteroid. Non-responder or partial responder to medical therapy should be evaluated for timely surgery or could be considered for rescue medical therapy.


Assuntos
Colite Ulcerativa/diagnóstico , Colite Ulcerativa/terapia , Anti-Inflamatórios/uso terapêutico , Colectomia/métodos , Colite Ulcerativa/complicações , Cirurgia Colorretal , Gerenciamento Clínico , Gastroenterologia , Fármacos Gastrointestinais/uso terapêutico , Glucocorticoides/uso terapêutico , Hospitalização , Humanos , Equipe de Assistência ao Paciente , Protectomia/métodos , Tempo para o Tratamento
20.
Lancet Gastroenterol Hepatol ; 5(5): 454-464, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32061322

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD) places a significant burden on health-care systems because of its chronicity and need for expensive therapies and surgery. With increasing use of biological therapies, contemporary data on IBD health-care costs are important for those responsible for allocating resources in Europe. To our knowledge, no prospective long-term analysis of the health-care costs of patients with IBD in the era of biologicals has been done in Europe. We aimed to investigate cost profiles of a pan-European, community-based inception cohort during 5 years of follow-up. METHODS: The Epi-IBD cohort is a community-based, prospective inception cohort of unselected patients with IBD diagnosed in 2010 at centres in 20 European countries plus Israel. Incident patients who were diagnosed with IBD according to the Copenhagen Diagnostic Criteria between Jan 1, and Dec 31, 2010, and were aged 15 years or older the time of diagnosis were prospectively included. Data on clinical characteristics and direct costs (investigations and outpatient visits, blood tests, treatments, hospitalisations, and surgeries) were collected prospectively using electronic case-report forms. Patient-level costs incorporated procedures leading to the initial diagnosis of IBD and costs of IBD management during the 5-year follow-up period. Costs incurred by comorbidities and unrelated to IBD were excluded. We grouped direct costs into the following five categories: investigations (including outpatient visits and blood tests), conventional medical treatment, biological therapy, hospitalisation, and surgery. FINDINGS: The study population consisted of 1289 patients with IBD, with 1073 (83%) patients from western Europe and 216 (17%) from eastern Europe. 488 (38%) patients had Crohn's disease, 717 (56%) had ulcerative colitis, and 84 (6%) had IBD unclassified. The mean cost per patient-year during follow-up for patients with IBD was €2609 (SD 7389; median €446 [IQR 164-1849]). The mean cost per patient-year during follow-up was €3542 (8058; median €717 [214-3512]) for patients with Crohn's disease, €2088 (7058; median €408 [133-1161]) for patients with ulcerative colitis, and €1609 (5010; median €415 [92-1228]) for patients with IBD unclassified (p<0·0001). Costs were highest in the first year and then decreased significantly during follow-up. Hospitalisations and diagnostic procedures accounted for more than 50% of costs during the first year. However, in subsequent years there was a steady increase in expenditure on biologicals, which accounted for 73% of costs in Crohn's disease and 48% in ulcerative colitis, in year 5. The mean annual cost per patient-year for biologicals was €866 (SD 3056). The mean yearly costs of biological therapy were higher in patients with Crohn's disease (€1782 [SD 4370]) than in patients with ulcerative colitis (€286 [1427]) or IBD unclassified (€521 [2807]; p<0·0001). INTERPRETATION: Overall direct expenditure on health care decreased over a 5-year follow-up period. This period was characterised by increasing expenditure on biologicals and decreasing expenditure on conventional medical treatments, hospitalisations, and surgeries. In light of the expenditures associated with biological therapy, cost-effective treatment strategies are needed to reduce the economic burden of inflammatory bowel disease. FUNDING: Kirsten og Freddy Johansens Fond and Nordsjællands Hospital Forskningsråd.


Assuntos
Produtos Biológicos/economia , Colite Ulcerativa/economia , Doença de Crohn/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Adulto , Produtos Biológicos/uso terapêutico , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/terapia , Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Técnicas e Procedimentos Diagnósticos/economia , Procedimentos Cirúrgicos do Sistema Digestório/economia , Europa (Continente) , Feminino , Seguimentos , Custos de Cuidados de Saúde/tendências , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
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