A double blind randomized controlled trial of a probiotic combination in 100 patients with irritable bowel syndrome

OBJECTIVES: The purpose of this study was to evaluate the effects of a probiotic combination on symptoms in patients with irritable bowel syndrome (IBS). METHODS: We investigated the efficiency of a probiotic dietary supplement, containing four strains of lactic acid bacteria, on symptoms of IBS. One hundred and sixteen patients with IBS fulfilling the Rome II criteria were randomized in a parallel group, double-blind study to receive a placebo or a probiotic combination (1 x 10(10) cfu once daily) for four weeks. The symptoms that were monitored weekly included discomfort, abdominal pain, and stool frequency and quality. Quality of life was assessed before and at the end of the treatment using the SF36 and FDD-quality-of-life questionnaires. RESULTS: One hundred subjects completed the study (48 probiotic combination, 52 placebo). The probiotic combination was not superior to the placebo in relieving symptoms of IBS (42.6 versus 42.3% improvement). However, the decrease of abdominal pain between the first and the fourth week of treatment was significantly higher in probiotic treated patients (-41.9 versus -24.2%, P=0.048). Interesting findings from the IBS sub-groups were also observed such as a lower pain score at end point in patients with alternating bowel habits (P=0.023) and an increase of stool frequency in the constipated sub-group from the first week of probiotic treatment (P=0.043). CONCLUSIONS: The probiotic combination was not significantly superior to the placebo in relieving symptoms of IBS. Despite the apparent high placebo response, interesting findings from IBS sub-groups were observed in the field of abdominal pain and stool frequency.     

Food elimination based on IgG antibodies in irritable bowel syndrome: a randomised controlled trial

BACKGROUND: Patients with irritable bowel syndrome (IBS) often feel they have some form of dietary intolerance and frequently try exclusion diets. Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies. AIMS: To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food. PATIENTS: A total of 150 outpatients with IBS were randomised to receive, for three months, either a diet excluding all foods to which they had raised IgG antibodies (enzyme linked immunosorbant assay test) or a sham diet excluding the same number of foods but not those to which they had antibodies. METHODS: Primary outcome measures were change in IBS symptom severity and global rating scores. Non-colonic symptomatology, quality of life, and anxiety/depression were secondary outcomes. Intention to treat analysis was undertaken using a generalised linear model. RESULTS: After 12 weeks, the true diet resulted in a 10% greater reduction in symptom score than the sham diet (mean difference 39 (95% confidence intervals (CI) 5-72); p = 0.024) with this value increasing to 26% in fully compliant patients (difference 98 (95% CI 52-144); p<0.001). Global rating also significantly improved in the true diet group as a whole (p = 0.048, NNT = 9) and even more in compliant patients (p = 0.006, NNT = 2.5). All other outcomes showed trends favouring the true diet. Relaxing the diet led to a 24% greater deterioration in symptoms in those on the true diet (difference 52 (95% CI 18-88); p = 0.003). CONCLUSION: Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research.     

A randomised controlled trial of self-help interventions in patients with a primary care diagnosis of irritable bowel syndrome

INTRODUCTION: Functional abdominal symptoms are very common and account for nearly two million primary care consultations in Britain every year and produce significant morbidity. The aims of this study were to evaluate the impact of two self-help interventions on consultation rates and symptom severity in patients with a primary care diagnosis of irritable bowel syndrome. METHODS: A total of 420 patients from 54 primary care centres were randomised either to receive self-help information in the form of a guidebook or the guidebook plus a "self-help" group meeting or to be in a control group receiving neither intervention. Data were collected using questionnaires and primary care records. RESULTS: At one year, patients in the guidebook group had a 60% reduction in primary care consultations (p < 0.001) and a reduction in perceived symptom severity (p < 0.001) compared with controls. Allocation to the self-help group conferred no additional benefit. Actual symptom scores did not change significantly in any group. Costs per patient were reduced by Pounds 73 (confidence interval Pounds 43, Pounds 103) or 40% per year. CONCLUSION: Introduction of a self-help guidebook results in a reduction in primary care consultations, a perceived reduction in symptoms, and significant health service savings. This suggests that patients attending their primary care physician with functional abdominal symptoms should be offered self-help information as part of their management.     

A randomized controlled trial of imipramine in patients with irritable bowel syndrome

AIM： To study the efficacy of low-dose imipramine in relieving symptoms associated with the irritable bowel syndrome （IBS）. METHODS： A randomized, double-blind trial of 25 mg imipramine vs matched placebo for 12 wk was performed. Doubling the dose was allowed once at week 2 in case of an unsatisfactory early response. Primary efficacy variables were subjective global symptom relief and quality of life （QoL） using SF-36 at week 12. RESULTS： One hundred and seven patients were enrolled by advertisement or referral by general practitioners and 56 （31 imipramine： 25 placebo） completed the 16-wk study. Baseline characteristics were comparable. A high overall dropout rate was noted in the imipramine and placebo arms （47.5% vs 47.9%, P 〉 0.05）, a mean of 25.0 and 37.4 d from enrollment, respectively （P 〈 0.05）. At the end of 12 wk, there was a significant difference in global symptom relief with imipramine over placebo （per-protocol： 80.6% vs 48.0%, P = 0.01） and a trend on intent-to-treat （ITT） analysis （42.4% vs 25.0%, P = 0.06）. This improvement was evident early and persisted to week 16 （P = 0.024 and 0.053 by per-protocol and ITT analyses, respectively）. Mean cumulative and componentspecific SF-36 scores improved in the imipramine group only （per-protocol, P 〈 0.01）. Drug-related adverse events leading to patient dropout were more common in the imipramine group （25.4% vs 12.5%, P 〉 0.05）. CONCLUSION： Imipramine may be effective in the treatment of IBS patients and is associated with improved QoL. Careful patient selection, initiation of a low dose with gradual escalation and monitoring for side effects may result in an improved therapeutic response.     

Stress management for irritable bowel syndrome: a controlled trial.

Thirty-five patients with irritable bowel syndrome were randomized to receive treatment in a stress management programme or conventional therapy which included the antispasmodic Colpermin. The stress management programme involved a median of six 40-min sessions with a physiotherapist during which patients were helped to understand the nature of their symptoms, their relationship to stress and were taught relaxation exercises. Two thirds of those in the stress management programme found the programme effective in relieving symptoms and experienced fewer attacks of less severity. This benefit was maintained for at least 12 months. Few of those given conventional management had any benefit. A stress management programme would appear to be of value for patients with irritable bowel syndrome.     

针刺治疗腹泻型肠易激综合征的随机对照试验

目的:客观评价针刺治疗腹泻型肠易激综合征(IBS)的临床疗效.方法:采用前瞻性、随机、平行对照设计,将120例符合诊断标准、纳入标准的D-IBS患者,按1∶1随机分为两组,每组60例.治疗组予针刺结合得舒特处理;对照组予假针刺结合得舒特处理,连续4wk.记录治疗前、治疗后2及4wk两组患者腹痛、腹部不适、大便性状等症状变化,应用ELISA技术检测治疗前、后患者血浆血管活性肠肽(VIP)的变化.结果:从总体疗效分析,治疗组疗效明显优于对照组(96%vs76%).治疗组能有效改善患者腹痛、腹部不适及大便性状改变等症状,经统计学比较,治疗组优于对照组(1.32±0.17vs3.37±0.49,P=0.000;0.95±0.06vs3.34±0.24,P=0.000;0.48±0.15vs3.64±0.78,P=0.000).治疗前,两组患者血浆VIP表达均呈上升趋势,VIP变化无明显差异(P=0.891);治疗后,治疗组血浆VIP表达呈下降趋势,与治疗前比较有统计学意义(42.72μg/L±12.78μg/Lvs105.12μg/L±21.01μg/L,P=0.000).对照组治疗后血浆VIP表达未见明显变化,与治...     

A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation

BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. PATIENTS: Women (> or = 18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. RESULTS: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.     

A controlled trial of psychological treatment for the irritable bowel syndrome

One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy, relaxation, and standard medical treatment compared with standard medical treatment alone. Patients were only selected if their symptoms had not improved with standard medical treatment over the previous 6 months. At 3 months, the treatment group showed significantly greater improvement than the controls on both gastroenterologists' and patients' ratings of diarrhea and abdominal pain, but constipation changed little. Good prognostic factors included overt psychiatric symptoms and intermittent pain exacerbated by stress, whereas those with constant abdominal pain were helped little by this treatment. This study has demonstrated that psychological treatment is feasible and effective in two thirds of those patients with irritable bowel syndrome who do not respond to standard medical treatment.     

Medical costs in community subjects with irritable bowel syndrome

Costs of management of irritable bowel syndrome (IBS) are unknown. The direct medical charges in community subjects with IBS were estimated. An age- and sex-stratified random sample of residents of Olmsted County, Minnesota, ranging in age from 20 to 95 years, was mailed a valid self-report questionnaire. Subjects were categorized as having IBS, having some symptoms but inadequate criteria for IBS, and controls. All charges (in 1992 U.S. dollars) for health services rendered in the year before completing the survey were obtained (except outpatient medications). A total of 88% of subjects with IBS, 86% of subjects with some symptoms of IBS, and 83% of controls incurred direct medical charges during the study year. The odds of incurring charges were 1.6 times greater in subjects with IBS relative to those without symptoms (P < 0.01) adjusting for age, sex, education, marital status, and employment. Overall median charges incurred by subjects with IBS were $742 compared with $429 for controls and $614 for subjects with some symptoms. Among those subjects with nonzero charges, there were significant positive associations with age, higher education, and symptom groups (all P < 0.01) but not sex. The economic impact of IBS is significant. A better understanding of the determinants of these costs is needed so that cost-saving strategies can be implemented.     

Lipi Guben decoction in treating diarrheal irritable bowel syndrome: A study protocol for a randomized controlled trial

Background:Irritable bowel syndrome (IBS) is a common functional bowel disorder. The global incidence of IBS is as high as 9% to 23%, accounting for about 50% of outpatients in gastroenterology, and the new case detection rate is 0.2% every year. IBS has become a global gastrointestinal functional disease. Although IBS is not a life-threatening disease, it seriously affects the quality of life of patients, causing huge economic and mental burden to individuals, society and families. Lipi Guben decoction (LPGBD) is an important auxiliary treatment for IBS, but lack of robust Evidence-based medicine evidence proving its efficacy. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of LPGBD in the treatment of IBS.Methods:In this randomized controlled trial, a total of 100 eligible patients will be allocated to the blank control group or LPGBD group in a ratio of 1:1. The treatment period was 12 weeks. The primary outcome measure will be the total clinical effective rate. The Secondary outcomes will include IBS clinical symptom scores, IBS-Severity Scoring System, IBS-Quality of life, Hamilton Rating Scale for Anxiety, Hamilton Rating Scale for Depression, and Bristol Stool Form Scale. The safety outcome will include Echocardiogram, blood examination (including blood routine test, liver function test, and renal function test), urine routine test and stool routine test. The evaluation indicators and all safety results will be performed at baseline, week 4, week 8 and week 12.Results:This study will be helpful to evaluate the efficacy and safety of LPGBD in the treatment of IBS.Conclusion:LPGBD may improve the clinical efficacy of patients with IBS, which has important value in practical applicationTrial registration:Chictr20000039617, registration time: November 3, 2020     

Longterm treatment of irritable bowel syndrome with cimetropium bromide: a double blind placebo controlled clinical trial.

The aim of this study was to evaluate the efficacy of cimetropium bromide, a new antimuscarinic compound, in relieving symptoms of patients with irritable bowel syndrome over a three month period. Seventy consecutive outpatients were given cimetropium (50 mg tid) or placebo according to a double blind, randomised, parallel groups design. Symptoms were evaluated initially and at monthly intervals up to the end of the study period. One patient receiving placebo withdrew because of treatment failure. Pain score decreased by 40, 66, 85% in the cimetropium group, at the end of the first, second and third months respectively, compared with 26, 32 and 52% reductions among controls (p = 0.0005). At the end of treatment there was a 86% reduction in the number of abdominal pain episodes per day in the cimetropium group compared with 50% in the placebo group (p = 0.001). Constipation and diarrhoea scores decreased by 59 and 49% in the cimetropium treated patients, compared with 37 and 39% in controls, the differences between being not significant. At the end of the study 89% of the patients treated with cimetropium considered themselves as globally improved as opposed to 69% in the placebo group (p = 0.039). The corresponding 95% confidence intervals for the differences between the proportion of improved patients in the two groups were from 11% to 29%. Six patients taking cimetropium complained of slight dry mouth. The results of this study showed that cimetropium bromide is effective in relieving pain in patients with irritable bowel syndrome.