Mesalazine For Ulcerative Colitis Research Articles

Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis: A meta-analysis and trial sequential analysis.

The benefits and risks of Xileisan (XLS) in the treatment of ulcerative colitis (UC) remain unclear. The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC. We searched eight databases for clinical trials evaluating the combination of XLS and mesalazine in the treatment of UC, up to January 2024. Meta-analysis and trial sequential analysis (TSA) were performed using Revman 5.3 and TSA 0.9.5.10 beta, respectively. The present study included 13 clinical studies involving 990 patients, of which 501 patients received XLS combined with mesalazine while 489 patients received mesalazine alone. The meta-analysis showed that, in terms of efficacy, the combination of XLS and mesalazine significantly improved the clinical efficacy rate by 22% [risk ratio (RR) = 1.22; 95%CI: 1.15-1.28; P < 0.00001] and mucosal improvement rate by 25% (RR = 1.25; 95%CI: 1.12-1.39; P = 0.0001), while significantly reducing the duration of abdominal pain by 2.25 days [mean difference (MD) = -2.25; 95%CI: -3.35 to -1.14; P < 0.0001], diarrhea by 2.06 days (MD = -2.06; 95%CI: -3.92 to -0.20; P = 0.03), hematochezia by 2.32 days (MD = -2.32; 95%CI: -4.02 to -0.62; P = 0.008), tumor necrosis factor alpha by 16.25 ng/mL (MD = -16.25; 95%CI: -20.48 to -12.01; P < 0.00001), and interleukin-6 by 14.14 ng/mL (MD = -14.14; 95%CI: -24.89 to -3.39; P = 0.01). The TSA indicated conclusiveness in the meta-analysis of the efficacy endpoints. In terms of safety, the meta-analysis revealed that the combination of XLS and mesalazine did not increase the occurrence of total and gastrointestinal adverse events, abdominal distension, and erythema (P > 0.05). The TSA showed non conclusive findings in the meta-analysis of the safety endpoints. Harbord's test showed no publication bias (P = 0.734). Treatment with XLS alleviated the clinical symptoms, intestinal mucosal injury, and inflammatory response in patients with UC, while demonstrating good safety.

Retracted: Systematic Evaluation of Randomized Clinical Trials of Huangqin Tang in Combination with Mesalazine for Ulcerative Colitis.

[This retracts the article DOI: 10.1155/2022/2175913.].

Systematic Evaluation of Randomized Clinical Trials of Huangqin Tang in Combination with Mesalazine for Ulcerative Colitis.

Objective To systematically evaluate the efficacy and safety of Huangqin Tang (HQT) combined with mesalazine for the treatment of ulcerative colitis (UC). Methods The China Knowledge Network, Wanfang Data, VIP, PubMed, SinoMed, Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs) of UC with HQT in Chinese and English. The search time was from the establishment of the database to October 2021. The included literature was evaluated for data extraction and risk of bias, efficacy and safety were evaluated using the RevMan5.3 software, and the quality of evidence was evaluated using GRADE. Results Six studies with a total of 565 subjects were included, and a meta-analysis showed that HQT combined with mesalazine for UC significantly improved the cure rate (RR = 1.56, 95% CI [1.23, 1.98), P=0.0003) and overall efficacy rate (RR = 1.24, 95% CI [1.14, 1.35], P=0.00001), which significantly reduced the clinical symptom scores; however, all had high heterogeneity. HQT combined with mesalazine modulated the patients' serum IL-6, IL-10, IgA, and IgG levels. HQT combined with mesalazine for UC tended to reduce adverse effects; however, the difference was not statistically significant. All GRADE ratings of the quality of evidence were of low quality. Conclusions HQT combined with mesalazine in the treatment of UC significantly improved the cure rate and overall treatment efficiency and regulated the expression levels of serum IL-6, IL-10, IgA, and IgG.

A Rare Case of Mesalazine-Induced Acute Myocarditis in a 19-Year-Old Female With Ulcerative Colitis

Mesalazine is a commonly used first-line therapy to treat acute mild to moderate ulcerative colitis (UC). Myocarditis is a rare complication of inflammatory bowel disease. This is a case report of a 19-year-old female with myocarditis induced after commencing mesalazine for UC. She was admitted with pleuritic-type chest pain associated with severe dyspnoea and was hemodynamically unstable during admission. She had elevated troponin and N-terminal pro-B-type natriuretic peptide. Transthoracic echocardiogram (TTE) results suggested there was evidence of myocarditis with reduced ejection fraction, which was later confirmed by cardiac magnetic resonance imaging. There was a rapid improvement of cardiac status after stopping mesalazine within two weeks.

A comparative study evaluating the efficacy and safety of once daily versus three times daily mesalazine in ulcerative colitis

Background: Ulcerative Colitis (UC) is an inflammatory disease affecting the colonic mucosa. Oral Mesalazine is one of the established treatments for UC and the conventional dosing regimen is 3 times a day. However, medical management favors lesser dosing frequency and the evidence of once daily dosing efficacy is not established by randomized controlled trials. Aim and Objective: Aim and objective of the study was to assess the efficacy and safety of once daily versus 3 times daily Mesalazine in UC. Materials and Methods: This prospective study was carried out in a sample of patients newly diagnosed with mild to moderately active UC. Patients were grouped into to once daily and 3 times daily groups. Outcomes were measured by Partial Mayo score, Individual Symptom Assessment, endoscopy and Histological score at the end of 8th week. Primary endpoint was proportion of patients achieving clinical remission and response with Partial Mayo score at the end of 8th week from start of treatment. Analysis was done using Epi Info Version 7. Results: Sixty patients were assessed (31 patients in OD group and 29 patients in TID group). 61.3% patients in OD group and 62.1% in TID group achieved remission, whereas 71% in the OD group and 58.6% in the TID group achieved clinical response to treatment at the end of 8th week with Partial Mayo score. Conclusion: The study concludes that once daily dosing regimen of Mesalazine is as efficacious and safe as 3 times daily dosing regimen in inducing remission in mild to moderate UC.

Systematic review: safety of mesalazine in ulcerative colitis.

Mesalazine is the most commonly prescribed medication for mild to moderate ulcerative colitis. It is generally well tolerated with some reported side effects. To summarise adverse drug events to mesalazine and recommend techniques for management. Furthermore, to determine if there is a dose-dependent relationship between high (>2.4g/day) vs low dosing (≤2.4g/day) and occurrence of adverse drug events. A literature search for relevant studies from inception to 1 December 2017 of the MEDLINE database was conducted. Two reviewers screened all titles identified. Data obtained from randomised controlled trials was used to estimate incidence rates of each adverse event. Two reviewers independently assessed methodological risk of bias and performed data extraction. 3581 articles were initially considered. Of these, 3573 were screened, 622 reviewed and 91 included. Adverse events attributed to mesalazine included inflammatory reactions, pancreatitis, cardiotoxicity, hepatotoxicity, musculoskeletal complaints, respiratory symptoms, nephropathies and sexual dysfunction. There does not appear to be a dose-dependent relationship of mesalazine and occurrence of adverse events. Patients on mesalazine should be monitored for worsening of ulcerative colitis and development of new onset organ dysfunction. High-dose mesalazine appears to have similar safety profile as low dose, and is not associated with greater risk of adverse events. Prior to placing a patient on mesalazine, baseline liver and renal function should be evaluated. Renal function should be periodically assessed, whereas other testing should be performed depending on development of symptoms.

Adherence, risk factors of non-adherence and patient’s preferred treatment strategy of mesalazine in ulcerative colitis: multicentric observational study

Objectives: Compliance to therapy is a key factor in the efficacy of treatment in clinical practice. The aim of our study was to evaluate the rate of compliance with mesalazine in patients with ulcerative colitis (UC), to examine risk factors of noncompliance and especially find ways on how adherence can be improved.Materials and methods: A total of 198 outpatients with UC completed two anonymous questionnaires including information on basic demographics, details of patient´s disease and the use of mesalazine medication and quality of life.Results: We found noncompliance (percentage of used medication per day less than 80%) with 5-ASA in 21.2% patients. Our study proved that the education level of patients significantly influenced the compliance of patients using mesalazine. A significant difference (p = .014) was found between the compliance of patients with secondary school education (84.1 ± 16.73) and those with university education (94.1 ± 9.9). The majority of patients preferred mesalazine once daily and are less likely to forget to take medication in the morning. Better quality of life was observed based on our data from WHOQOL-BREF questionnaire in statistically significant way in patients using concomitant therapy of immuosuppressive or biological therapy, lower daily doses and using sachets not tablets.Conclusions: Our study proved that compliance with mesalazine in patients with UC was related only to education level. If we target mesalazine therapy based on patient’s preferences, we can improve the adherence with mesalazine. Our data could be beneficial for the treatment strategy in clinical practice.

P852 A metabolomics approach to discover biomarkers of chronic intestinal inflammation associated with gut microbiota dysbiosis in ulcerative colitis and Celiac Disease

The effect of gut microbiota dysbiosis on human metabolome and the potential of microbial and endogenous metabolites as biomarkers of chronic intestinal inflammation (CII) are not clear. Forty ulcerative colitis (UC) patients, 43 celiac disease (CD) patients and 42 healthy volunteers (HV) were enrolled. The qRT-PCR was used for fecal microbiota assessment. Serum metabolomic assays were conducted using the GC-MS. UC patients were randomised into A1 and A2 groups and CD patients were randomised into B1 and B2 groups. A1 and B1 groups received oral calcium butyrate plus inulin for 28 days as supplement to oral mesalazine in UC or gluten-free diet (GFD) in CD. A2 and B2 groups received standard treatment or GFD. Butyrate-producing bacteria (BPB) were depleted in UC compared with HV. CD patients had lower Bifidobacterium spp. counts than HV or UC. Taxonomic dysbiosis in both UC and CD was characterised by a higher Bacteroides fragilis/Faecalibacterium prausnitzii ratio compared with HV. Significant changes in gut microbiota in both UC and CD were accompanied by changes in serum microbial metabolites levels. In UC serum lactic acid, 2-hydroxybutyric acid (2-HBA), 3-hydroxyisobutyric acid (3-HIBA), 2-hydroxyisovaleric acid (2-HIVA), 3-hydroxycinnamic acid, succinic acid (SA), benzoic acid (BA) and 4-hydroxyphenylacetic acid (4-HPAA) levels were significantly increased compared with HV. Serum levels of caproic acid, linoleic acid (LA) and eicosadienoic acid (EDA) in UC were significantly lower than in HV. Serum of CD patients showed significant increases in stearic acid (StA), 2-HIVA, SA, fumaric acid and BA compared with HV. De novo lipogenesis index (DNL) (C16:0/C18:2n-6) was significantly elevated in UC compared with both HV and CD. The ELOVL6 elongase activity index (C18:0/C16:0) and the StA/lA ratio (C18:0/C18:2n-6) in UC were significantly increased compared with HV. AA/EDA ratio (C20:4n-6/C20:2n-6) was increased in both UC and CD. Oral butyrate plus inulin significantly enhanced fecal BPB, reduced elevated B. fragilis/F. prausnitzii ratio, lowered serum pro-inflammatory SA and 2-HIVA and restored the initially lowered LA and EDA. 85% of UC patients in A1 (butyrate) group demonstrated significant improvement in rectal bleeding and stool frequency by day 14, compared with 55% in A2 group. The changes in serum metabolome, reflecting metabolic pathways disturbances (glycolysis, TCA cycle, fatty acid metabolism, ketone body metabolism, phenylalanine, tyrosine and tryptophan metabolism, microbial metabolism) are observed in both UC and CD. Some of metabolites and a new metabolomic index (AA/EDA ratio) may be considered as candidate biomarkers of CII. Oral butyrate plus inulin has a prebiotic (butyrogenic) effect, restoring BPB.

P607. Histologic activity after acute treatment with multimatrix mesalazine for ulcerative colitis may predict long-term remission status

P607. Histologic activity after acute treatment with multimatrix mesalazine for ulcerative colitis may predict long-term remission status

The role of Escherichia coli strain Nissle 1917 in the gastro-intestinal diseases

In this paper a review of the researches on the role of Escherichia coli strain Nissle 1917 (EcN) in gastrointestinal diseases was presented. EcN is a non-pathogenic strain of the Enterobacteriaceae family, which has probiotic properties. In a number of studies conducted among humans and experimental animals the application of EcN in treatment of gastrointestinal diseases was observed. Most studies about EcN has been devoted to this organism efficacy in ulcerative colitis treatment. Comparable results were obtained, by citied authors, in the treatment (sustaining remission) of EcN and mesalazine in ulcerative colitis. Moreover, this probiotic therapy, compared to placebo, contributes to obtaining a faster remission and improvement of intestinal histopathology. The use of EcN in Crohn's disease has not been the subject of as many studies as in the case of ulcerative colitis. Assessing the importance of EcN in treatment of other gastrointestinal disorders, authors of the studies observed, that in patients with irritable bowel syndrome, who receiving this probiotic there was a pain, nausea and bloating reduction. In studies conducted among children a positive impact of EcN in prevention and treatment of diarrhea was demonstrated. Similar results were obtained in studies conducted in experimental animals. Based on the presented review it can be concluded that the strain of Escherichia coli Nissle 1917 is useful in treatment of gastrointestinal diseases, especially in treatment of ulcerative colitis. This probiotic may constitute a part of treatment of irritable bowel syndrome and diarrhea. The effectiveness of this strain in treatment of Crohn's disease is not clearly established and further research are require.

A rare combination of type 3 autoimmune polyendocrine syndrome (APS-3) or multiple autoimmune syndrome (MAS-3).

ContextType 3 autoimmune polyendocrine syndrome (APS-3) is defined by the presence of an autoimmune thyroid disease and another autoimmune illness, excluding Addison’s disease; this is a frequent combination.Case presentationWe report the case of a 55 years old female patient with APS-3, with seven clinical or latent autoimmune manifestations. At 49 years of age she was admitted at the General Hospital for leukopenia, weight loss, tremors, anxiety and diarrhea. The personal history revealed ulcerative colitis and, during the last year, episodes of fever with migrant arthralgia and cutaneous lesions. The patient was evaluated for thyroid function and imaging, mielobiopsy, glycaemic control, gastrointestinal and rheumatologic disorders with specific biochemical tests, imaging and endoscopic procedures. We concluded that the patient was affected by APS-3, characterized by the association of Graves’ disease, autoimmune leukopenia, latent autoimmune diabetes of the adult (LADA), autoimmune gastritis, ulcerative colitis, Sjögren’s and anti-phospholipid syndromes. The patient started low doses of corticosteroid drugs for leukopenia, underwent 131I therapy for hyperthyroidism and later started substitutive thyroid therapy with l-thyroxine, insulin therapy for LADA, mesalazine for ulcerative colitis and artificial tears for Sjögren’s syndrome.ConclusionsIn this article we report a complex case of APS-3, characterized by the association of seven different autoimmune diseases, which required a complex therapeutic strategy.

Pneumopathie organisée apparue sous mésalazine

The distinction between extra-intestinal manifestations of ulcerative colitis (UC) and drug-induced pneumonia can often be difficult.We describe the case of a 72-year-old male who presented fever and sub-acute respiratory insufficiency, after 4 months of treatment with mesalazine for ulcerative colitis (UC). Initial tests found serum C-reactive protein, eosinophil count and total IgE to be elevated. Routine bacteriological, fungal and mycobacterial cultures were negative. Bronchoalveolar lavage fluid cellularity was normal with elevated lymphocyte, neutrophil, and eosinophil counts (35 % mononuclear cells, 23 % lymphocytes, 28 % neutrophils, 14 % eosinophils). The diagnosis of organizing pneumonia (OP) with eosinophilic pneumonia component was confirmed after examination of a lung biopsy specimen. Clinical improvement occurred after cessation of mesalazine and initiation of prednisolone (1mg/kg/day). Nine months later, a recurrence of gastrointestinal symptoms required a 5 months reintroduction of an amino salicylate by topical therapy (4- acide aminosalicylique [ASA enemas]). There was no resurgence of the pneumonia.Organizing pneumonia is a rare extra-intestinal manifestation of UC. There was no resurgence of OP after amino salicylate enemas rechallenge but mesalazine-induced pneumonia cannot be excluded.

Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine

Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, and prevents colitis in animal models. To determine the efficacy and safety of HMPL-004 in patients with mild-to-moderate ulcerative colitis. A randomised, double-blind, multicentre, 8-week parallel group study was conducted using HMPL-004 1200 mg/day compared with 4500 mg/day of slow release mesalazine (mesalamine) granules in patients with mild-to-moderately active ulcerative colitis. Disease activity was assessed at baseline and every 2 weeks for clinical response, and at baseline and 8 weeks by colonoscopy. One hundred and twenty patients at five centres in China were randomised and dosed. Clinical remission and response were seen in 21% and 76% of HMPL-004-treated patients, and 16% and 82% of mesalazine-treated patients. By colonoscopy, remission and response were seen in 28% and 74% of HMPL-004-treated patients and 24% and 71% of mesalazine-treated patients, respectively. There was no significant difference between the two treatment groups. HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.

Reporting of relapse rates in a trial of mesalazine for ulcerative colitis

Reporting of relapse rates in a trial of mesalazine for ulcerative colitis

Reporting of relapse rates in a trial of mesalazine for ulcerative colitis: authors’ reply

Reporting of relapse rates in a trial of mesalazine for ulcerative colitis: authors’ reply

Mesalazine for ulcerative colitis: evidence for use

Ulcerative colitis is a chronic, idiopathic inflammatory disease of the colon characterized by periods of exacerbation and remission. Medical treatment aims to provide rapid effective relief from symptoms, modify the disease process and improve quality of life. Many oral preparations use multiple daily dosing regimens which can be inconvenient and affect treatment adherence leading to increased morbidity and risk of symptomatic relapse. This article examines the issues surrounding the use of mesalazine in ulcerative colitis, focusing on Mezavant XL (MMX mesalazine), a once-daily dosing formulation with patented multi-matrix system. The reader will gain an understanding of the pharmacology of the drug, evidence base for its use and implications for prescribing practice.

Delayed-Release Multi Matrix System (MMX™) Mesalazine in Ulcerative Colitis

Delayed-Release Multi Matrix System (MMX™) Mesalazine in Ulcerative Colitis

Delayed-Release Multi Matrix System (MMX™) Mesalazine in Ulcerative Colitis

Delayed-Release Multi Matrix System (MMX™) Mesalazine in Ulcerative Colitis

MMX makes the most of mesalazine in ulcerative colitis

MMX makes the most of mesalazine in ulcerative colitis

Editorial: mesalazine in ulcerative colitis – is it time to revise treatment guidelines in the UK?

In 2004, the British Society of Gastroenterology (BSG) published a set of guidelines for the management of inflammatory bowel disease (IBD), following an extensive review of the available evidence.1 These guidelines included the management of ulcerative colitis (UC) and reflected best practice and knowledge at that time. Recognizing that therapy for UC is rapidly evolving, the BSG recommended that the content and evidence base of the guidelines should be revised within 3 years of publication.1 It is also important that developments are kept under continuous review so that current management strategies can be summarized and shortcomings identified. The mainstay of therapy for UC is 5-aminosalicylic acid (5-ASA). This supplement is the product of a systematic review of clinical trials on 5-ASA using Medline, Embase and the Cochrane Database of Systematic Reviews, using MESH/EMTREE terms for mesalazine as major terms (mj) and UC (mj) restricting to clinical trials. All years and languages were included. The total number of unique papers from Medline was 64 and from Embase was 116. The Embase search was further refined by using the linking term ‘clinical trial and mesalazine’ (mesalazine with ct). The topics selected reflect those areas in which there have been advances since the publication of the BSG guidelines. These include the mechanism of action of 5-ASA, the mode of delivery to the colon and induction therapy using doses beyond the conventional. Strategies for maintaining remission, including the evidence base for higher maintenance dose strategies, are also addressed, as well as an examination of the evidence that 5-ASA might protect against colorectal cancer, stimulated by the understanding of the mechanism of action. We have limited our deliberations to UC, rather than IBD as a whole, to provide a practical evaluation of the current management of UC. This is an evidence-based update suggesting that revision of the 2004 BSG guidelines would be timely. We thank Dr J. R. Carpenter (a member of the European Medical Writers’ Association) for his medical writing services on behalf of Procter & Gamble Pharmaceuticals, UK, Ltd, who provided an unrestricted educational grant to support the writing of the supplement and the meeting from which it was developed. The supplement was developed in adherence with the guidelines of the European Medical Writers’ Association.2