scholarly journals Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre, parallel-group, randomised placebo-controlled trial

2015 ◽  
Vol 2 (2) ◽  
pp. 1-62 ◽  
Author(s):  
Ching Lam ◽  
Wei Tan ◽  
Matthew Leighton ◽  
Margaret Hastings ◽  
Melanie Lingaya ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Group Analysis ◽  
Underlying Disease ◽  
Stool Frequency ◽  
Stool Consistency ◽  
Research Network ◽  
Double Blind ◽  
Irritable Bowel

BackgroundDiarrhoea-predominant irritable bowel syndrome (IBS-D) is a common outcome after inflammation due to bacterial gastroenteritis. Several studies have shown ongoing immune activation in the mucosa of patients with IBS-D and a number of studies have suggested that mesalazine slow-release granule formulation (2 g; PENTASA®, Ferring Pharmaceuticals Ltd) may provide benefit including a reduction in stool frequency.ObjectivesOur primary aim was to compare the effect of mesalazine with placebo on stool frequency. Our secondary aims were to assess the effect of mesalazine on abdominal pain, stool consistency, urgency and satisfactory relief of irritable bowel syndrome (IBS) symptoms.Design/participants/interventionWe performed a double-blind, randomised placebo-controlled trial of 2 g mesalazine twice daily compared with placebo for 3 months in Rome III criteria patients with IBS-D.SettingsParticipants were recruited from the primary care research network and secondary care hospitals. Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of ‘satisfactory relief of IBS symptoms’. Those recruited in Nottingham had sigmoid biopsies and/or magnetic resonance imaging of the abdomen at the start and end of the trial.ResultsA total of 136 patients with IBS-D (82 female, 54 male) were randomised; 10 patients withdrew from each group. Analysis by intention to treat showed that the mean daily average stool frequency during weeks 11 and 12 was 2.8 [standard deviation (SD) 1.2] in the mesalazine group and 2.7 (SD 1.9) in the placebo group, with a group difference of 0.1 (95% confidence interval –0.33 to 0.53);p = 0.66.ConclusionsMesalazine did not improve abdominal pain, stool consistency or percentage with satisfactory relief compared with placebo during the last 2 weeks’ follow-up. A post hoc analysis in 13 postinfectious patients with IBS appeared to show benefit but this needs confirmation in a larger group. More precise subtyping based on underlying disease mechanisms may allow more effective targeting of treatment in IBS.Trial registrationCurrent Controlled Trials ISRCTN76612274.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.

scholarly journals Treatment of postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with mesalazine

2011 ◽  
Vol 48 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Mauro Bafutto ◽  
José Roberto de Almeida ◽  
Nayle Vilela Leite ◽  
Enio Chaves Oliveira ◽  
Salustiano Gabriel-Neto ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Symptom Score ◽  
Stool Frequency ◽  
Total Symptom Score ◽  
Stool Consistency ◽  
Mucosal Inflammation ◽  
Irritable Bowel Syndrome Group ◽  
Irritable Bowel ◽  
Postinfectious Irritable Bowel Syndrome

CONTEXT: Recent studies support the hypothesis that postinfectious irritable bowel syndrome and some irritable bowel syndrome patients display persistent signs of minor mucosal inflammation. Mesalazine has intestinal anti-inflammatory properties including cyclooxygenase and prostaglandin inhibition. The effects of mesalazine on postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome patients are still unknown. OBJECTIVE: To observe the effects of mesalazine on postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with diarrhea patients. METHODS: Based on Rome III criteria, 61 irritable bowel syndrome with diarrhea patients (18 years old or more) were included in the evaluation. Patients were divided into two groups: postinfectious irritable bowel syndrome group, with 18 patients medicated with mesalazine 800 mg 3 times a day for 30 days; noninfective irritable bowel syndrome group, with 43 patients medicated with mesalazine 800 mg 3 times a day for 30 days. Symptom evaluations at baseline and after treatment were performed by means of a four-point Likert scale including stool frequency, stool form and consistency (Bristol Stool Scale), abdominal pain and distension (maximum score: 16; minimum score: 4). RESULTS: Postinfectious irritable bowel syndrome group presented a statistically significant reduction of the total symptom score (P<0.0001). The stool frequency was significantly reduced (P<0.0001), and stool consistency, improved (P<0.0001). Abdominal pain (P<0.0001) and abdominal distension were significantly reduced (P<0.0001). Noninfective irritable bowel syndrome group presented a statistically significant reduction of total symptom score (P<0.0001). Also, the stool frequency was significantly reduced (P<0.0001) and stool consistency, improved (P<0.0001). Abdominal pain (P<0.0001) and abdominal distention were significantly reduced (P<0.0001). There was no statistical difference between postinfectious irritable bowel syndrome group and noninfective irritable bowel syndrome group on total symptom score results at 30th day of therapy with mesalazine 800 mg 3 times a day. (P = 0.13). CONCLUSION: Mesalazine reduced key symptoms of postinfectious irritable bowel syndrome and noninfective irritable bowel syndrome with diarrhea patients.

scholarly journals Effect of Mentha aquatica L. Extract on Bloating Symptom of Irritable Bowel Syndrome Disease: A Double-Blind Randomized, Placebo-Controlled Study

2022 ◽  
Author(s):  
Farzaneh Assadollah pour ◽  
Assie Jokar ◽  
Mohammad Azadbakht ◽  
Ebrahim Nasiri ◽  
Zohreh Bari ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Gastrointestinal Disorder ◽  
Controlled Study ◽  
Bowel Habit ◽  
Double Blind ◽  
Mentha Aquatica ◽  
Irritable Bowel

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder that causes abdominal pain, distension, change of bowel habit, bloating, constipation, diarrhea, and mucus discharge along with stools. Although the disease causes long-term and agonizing pain, no ideal cure has been found for it so far. This study aimed to investigate the efficacy and compliance of Mentha aquatica L. extract for the treatment of bloating caused by IBS. This double-blind, randomized, placebo-controlled trial study was conducted in Tooba gastroenterology clinic in Sari, Iran, during 2019 (from January to May). A total of 104 patients with IBS in the age range of 20-80 years were randomly divided into two parallel groups of herbal medicine (MAC-330) and placebo. Study period consisted of a 4 weeks of administration, and 2 weeks of follow-up. IBS-associated symptoms including severity of bloating (as primary outcome) and frequency of defecation and abdominal pain were evaluated using a questionnaire before treatment, 1, 2 and 4 weeks after beginning treatment and 2 weeks after stopping treatment. There were no significant differences between the two groups in terms of their baseline characteristics (p > 0.05). The severity of bloating was significantly reduced in the both groups at fourth week (p < 0.030) and 2 weeks after stopping intervention (sixth week) (p < 0.026). The frequency of defecation has increased with the onset of the intervention until the fourth week of the treatment which was not significant. The abdominal pain reduced during the 4 weeks’ intervention, but it was not significant. Based on the obtained results, MAC-330 could not be used as an effective treatment for patients with IBS in short time; however, it reduces the abdominal bloating and pain in these patients, especially in the long-term use.

scholarly journals Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults

2019 ◽  
Author(s):  
Anu Kemppinen ◽  
Carol Howell ◽  
Victoria Allgar ◽  
Matthew Dodd ◽  
John Gregson ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Stool Consistency ◽  
Open Label ◽  
Double Blind ◽  
Multi Centre Study ◽  
Double Blind Placebo ◽  
Centre Study ◽  
Irritable Bowel ◽  
Drug Free

Abstract Background Irritable Bowel Syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. Methods and design 430 participants with IBS-D will be recruited from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period, will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers, and gut-related measurements from magnetic resonance imaging data. Discussion This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.

scholarly journals Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults

2019 ◽  
Author(s):  
Anu Kemppinen ◽  
Carol Howell ◽  
Victoria Allgar ◽  
Matthew Dodd ◽  
John Gregson ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Stool Consistency ◽  
Open Label ◽  
Double Blind ◽  
Multi Centre Study ◽  
Double Blind Placebo ◽  
Centre Study ◽  
Irritable Bowel ◽  
Drug Free

Abstract Background Irritable Bowel Syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D. Methods and design 430 participants with IBS-D will be recruited from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period, will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers, and gut-related measurements from magnetic resonance imaging data. Discussion This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.

scholarly journals The Effect of Phloroglucinol in Patients With Diarrhea-predominant Irritable Bowel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial

2020 ◽  
Vol 26 (1) ◽  
pp. 117-127 ◽  
Author(s):  
Seung Yong Shin ◽  
Bong Ki Cha ◽  
Won-Seok Kim ◽  
Jae Yong Park ◽  
Jeong Wook Kim ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Irritable Bowel
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