Study confirms benefit of surgery for gastroesophageal reflux disease

Evaluation of: Pimentel M, Lembo A, Chey WD et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N. Engl. J. Med. 364(1), 22–32 (2011).

Alterations in gut flora may play an important role in the pathophysiology of bowel symptoms, especially in patients with irritable bowel syndrome (IBS). If so, antibiotics that affect gut flora may offer a novel approach for the management of patients with IBS. Here, we discuss the results of two identically designed, double-blind, placebo-controlled trials (TARGET 1 and TARGET 2) of a poorly absorbed antibiotic, rifaximin, in patients with IBS. In these studies, 1260 patients (females 76.1 and 72.1%, respectively) who had IBS without constipation were randomized to receive either rifaximin 550 mg or placebo, three-times daily for 2 weeks. Subsequently, daily symptoms were assessed and patients were followed up for 10 weeks. The primary outcome measure – adequate relief of global IBS symptoms during the first 4 weeks after treatment – was met in significantly more patients who received rifaximin than placebo (p < 0.001). In addition, more patients in the rifaximin group than in the placebo group (p < 0.001) reported an adequate relief of bloating, and an improvement in abdominal pain and stool consistency – secondary outcome measures. The incidence of adverse events with rifaximin was similar to placebo, and the drug was well tolerated. In summary, a 2-week course of rifaximin provided significant relief of IBS symptoms, as well as bloating and abdominal pain.     

Treatment of diarrhea-predominant irritable bowel syndrome with traditional Chinese herbal medicine: a randomized placebo-controlled trial

BACKGROUND:  As there is no effective treatment for irritable bowel syndrome (IBS), many patients turn to traditional Chinese medicine (TCM) for possible cure. We investigated the therapeutic efficacy of an ancient herbal Chinese formula in patients with diarrhea-predominant IBS.
METHODS:  This was a randomized double-blinded placebo-controlled trial. Chinese IBS patients with predominant diarrhea symptoms that fulfilled Rome II criteria were recruited. The diagnosis was verified by a TCM herbalist using TCM criteria. Eligible patients were randomized to receive a standard preparation of TCM extracts that contained 11 herbs or placebo with similar appearance and taste for 8 wk after a 2-wk run-in period. Patients were followed up for an additional 8 wk post-treatment. Primary outcome was patient's global symptom assessment. Other outcome measures included individual IBS symptom scores and health-related quality of life (short form 36).
RESULTS:  One hundred nineteen patients were randomized: 60 to receive TCM and 59 to receive placebo. There was no significant difference in the proportion of patients with global symptom improvement between the TCM and placebo groups at week 8 (35% vs 44.1%, p = 0.38) and at week 16 (31.7% vs 33.9%, p = 0.62). Moreover, there was no difference in individual symptom scores and the quality-of-life assessment between the two groups at all time points.
BACKGROUND:  The use of this herbal formulation for diarrhea-predominant IBS did not lead to global symptom improvement. Further controlled clinical studies may be necessary to characterize the role of TCM in the management of IBS.     

Lactose intolerance in patients with irritable bowel syndrome from northern India: a case-control study

BACKGROUND AND AIM: Symptoms of irritable bowel syndrome (IBS) and lactose intolerance (LI) overlap. Data on the frequency of LI in patients with IBS from India are scanty. The aim of this study was to evaluate: (i) the frequency of LI in patients with IBS and its various subtypes as compared with healthy subjects (HS) from northern India; (ii) the relationship between self-reported milk intolerance and laboratory evidence of LI; and (iii) the role of small intestinal bacterial overgrowth in LI in patients with IBS. METHODS: 124 patients with IBS (Rome II criteria) and 53 age- and gender-matched HS were studied for LI using the lactose hydrogen breath test (LHBT) and the lactose tolerance test (LTT). Symptoms following lactose ingestion (diarrhea, bloating or distension) during the test and history of milk intolerance were recorded. Sixty-nine of the patients with IBS also underwent a glucose hydrogen breath test (GHBT). Patients with IBS were classified into those with diarrhea (IBS-D; >3 loose stools/d), constipation predominant (IBS-C; <3 stools/week) and indeterminate (IBS-I; between >or=3/week and 相似文献   

Restless Legs Syndrome in Patients with Irritable Bowel Syndrome: Response to Small Intestinal Bacterial Overgrowth Therapy

Background Small intestinal bacterial overgrowth (SIBO) occurs in irritable bowel syndrome (IBS) and fibromyalgia. Since restless legs syndrome (RLS) occurs with fibromyalgia, a link between IBS, SIBO, and RLS was studied. Methods BS patients with abnormal lactulose breath tests received rifaximin 1,200 mg day⁻¹ for 10 days, followed by tegaserod 3 mg, long-term, and 1 month of zinc 220 mg day⁻¹ and once-daily probiotic (N = 11) or rifaximin monotherapy (N = 2). IBS symptom improvement was assessed after rifaximin. RLS symptoms, IBS symptoms, and overall IBS global improvement were assessed at last posttreatment visit: 8/10 patients were followed long-term (mean, 139 days; range, 54–450 days). Results Ten of 13 patients exhibited ≥80% improvement from baseline in RLS symptoms. Five maintained complete resolution of RLS symptoms. Global gastrointestinal symptom improvement was great (n = 6), moderate (n = 5), or mild (n = 2). Conclusion This study suggests that SIBO associated with IBS may be a factor in some RLS patients and SIBO therapy provides long-term RLS improvement.     

Effectiveness of probiotics in irritable bowel syndrome:Updated systematic review with meta-analysis

AIM:To investigate the efficacy of probiotics in irritable bowel syndrome(IBS) patients.METHODS:Pub Med,Cochrane library,Scopus,Google Scholar,and Clinicaltrial.gov databases were searched for literature published between September 2007 and December 2013.The applied Mesh terms were "probiotics," "irritable bowel syndrome," and "irritable bowel syndrome treatment." The collected data contained24 clinical trials,of which 15 were eligible for meta-analysis and nine were reviewed systematically.All studies were randomized placebo-controlled trials in patients with IBS that investigated the efficacy of probiotics in IBS improvement.The Jadad score was used to assess the methodological quality of trials.The quality scale ranges from 0 to 5 points,with a score ≤ 2 indicating a low quality report,and a score of ≥3 indicating a high quality report.Relative risk(RR),standardized effect size,and 95%CI were calculated using the Der Simonian-Laird method.The Cochran Q test was used to test heterogeneity with P 0.05.Funnel plots were constructed and Egger's and BeggMazumdar tests were performed to assess publication bias.RESULTS:A total of 1793 patients were included in the meta-analysis.The RR of responders to therapies based on abdominal pain score in IBS patients for two included trials comparing probiotics to placebo was 1.96(95%CI:1.14-3.36;P = 0.01).RR of responders to therapies based on a global symptom score in IBS patients for two included trials comparing probiotics with placebo was 2.43(95%CI:1.13-5.21;P = 0.02).For adequate improvement of general symptoms in IBS patients,the RR of seven included trials(six studies) comparing probiotics with placebo was 2.14(95%CI:1.08-4.26;P = 0.03).Distension,bloating,and flatulence were evaluated using an IBS severity scoring system in three trials(two studies) to compare the effect of probiotic therapy in IBS patients with placebo,the standardized effect size of mean differences for probiotics therapy was-2.57(95%CI:-13.05--7.92).CONCLUSION:Probiotics reduce pain and symptom severity scores.The results demonstrate the beneficial effects of probiotics in IBS patients in comparison with placebo.     

Abnormalities of GI transit in bloated irritable bowel syndrome: effect of bran on transit and symptoms

OBJECTIVES: Bloating is an important but poorly understood symptom in irritable bowel syndrome (IBS) that is often aggravated by bran. The aim of our study was to determine whether IBS patients with bloating responded to bran differently from healthy controls. METHODS: A total of 12 patients with IBS (according to Rome I criteria), all with moderate to severe bloating, and 12 healthy controls participated in a two way, double blind, randomized, cross-over trial of bran versus placebo (crushed biscuits) 15 g b.i.d. An average daily pain index and bloating score were derived from daily symptom diaries. On day 14, gastric emptying, small bowel transit, percent remaining in ascending colon, and geometric center of a meal marker at 24 h were calculated from scintigraphic images obtained after ingesting a Tc99m-labeled rice pudding meal with 15 g of either placebo or coarse bran. RESULTS: Results are given as median (range). Bran significantly increased the pain index and bloating (p < 0.02) in IBS patients but not controls. The most striking finding was that the small bowel transit time of the meal without bran was markedly faster in IBS patients than in controls, being 203 min (range 109-313) versus 367 min (219-543), p < 0.001. Although in controls bran accelerated small bowel transit time to 262 min (180-380), p = 0.03, and significantly reduced % remaining in the ascending colon from 22% (0-46) to 3% (0-25), p = 0.03, this was not seen in the IBS patients. Bran accelerated whole gut transit as assessed by geometric center at 24 h in both IBS patients and controls. CONCLUSIONS: Bran accelerates small bowel transit and ascending colon clearance without causing symptoms in controls. Small bowel transit is rapid in IBS patients with bloating and, unlike in healthy control subjects, cannot be further accelerated by bran, which nevertheless aggravates symptoms of pain and bloating. We speculate that bran-induced bloating may originate in the colon rather than the small bowel.     

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.     

Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome

BACKGROUND: Probiotic bacteria exhibit a variety of properties, including immunomodulatory activity, which are unique to a particular strain. Thus, not all species will necessarily have the same therapeutic potential in a particular condition. We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome (IBS). OBJECTIVES: This study was designed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale, multicenter, clinical trial of women with IBS. A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation. METHODS: After a 2-wk baseline, 362 primary care IBS patients, with any bowel habit subtype, were randomized to either placebo or freeze-dried, encapsulated B. infantis at a dose of 1 x 10(6), 1 x 10(8), or 1 x 10(10), cfu/mL for 4 wk. IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort. A composite symptom score, the subject's global assessment of IBS symptom relief, and measures of quality of life (using the IBS-QOL instrument) were also recorded. RESULTS: B. infantis 35624 at a dose of 1 x 10(8) cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating, bowel dysfunction, incomplete evacuation, straining, and the passage of gas at the end of the 4-wk study. The improvement in global symptom assessment exceeded placebo by more than 20% (p < 0.02). Two other doses of probiotic (1 x 10(6) and 1 x 10(10)) were not significantly different from placebo; of these, the 1 x 10(10) dose was associated with significant formulation problems. No significant adverse events were recorded. CONCLUSIONS: B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1 x 10(8) cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use. The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice.     

Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: a randomized, double-blind study

AIM: To assess the effects and safety of Lactobacillus casei rhamnosus LCR35 complete freeze-dried culture (LCR35) in patients suffering from irritable bowel syndrome (IBS).METHODS: A randomized, double-blind pilot study was performed in 50 patients complaining of IBS symptoms complying with Rome III criteria. Patients were allocated to receive either LCR35 (n = 25) at a minimum daily dose of 6 × 10⁸ colony forming units or placebo (n = 25) for 4 wk. At inclusion, after treatment and 2 wk later, patients completed the IBS severity scale. Change from baseline in the IBS severity score at the end of treatment was the primary efficacy criterion. Changes were compared between groups in the whole population and in IBS subtypes (IBS with predominance of constipation, IBS with predominance of diarrhoea, mixed IBS, unsubtyped IBS). The presence of lactobacillus casei rhamnosus in stools was investigated at inclusion and at the end of treatment. The gastrointestinal quality of life questionnaire and the hospital anxiety and depression (HAD) scale were also completed.RESULTS: Both groups were balanced for baseline characteristics. In 85% of patients, stool analyses showed that lactobacillus casei rhamnosus able to survive in the digestive tract. In the whole population, improvements in the IBS severity score did not differ significantly between treatments with a 25% decrease after 4-wk treatment, and a 15% decrease from baseline 2 wk later in both groups. In IBS subgroups, statistical analysis could not be performed due to small sample size, but a clinical response in favour of LCR35 was observed in IBS patients with predominance of diarrhoea: no change in the symptom severity score was seen with the placebo after 4 wk treatment, whereas a clinically relevant decrease occurred with LCR35 (-37% vs -3%). Furthermore, in spite of an increase in symptom intensity, the IBS severity score was maintained below the baseline value 2 wk later with LCR35 (-19% from baseline), whilst a slight 5% increase from baseline was observed with placebo. In the IBS subgroup with predominance of diarrhoea only, a clinically relevant decrease in abdominal pain severity score (-36%) was observed with LCR35, whereas no change occurred with placebo. In mixed IBS patients, the 20% and 30% decreases in the IBS severity score observed after treatment with LCR35 and placebo, respectively, were maintained 2 wk later in both groups. A clinical response slightly in favour of placebo was observed at the end of the treatment period in IBS patients with predominance of constipation (-41% vs -20%) and unsubtyped IBS patients (-47% vs -17%), with the same value maintained 2 wk later. In both groups, no clinically relevant changes were observed either for the gastrointestinal quality of life index or HAD score. Thus, these results suggest that sub-grouping of IBS patients may be important for optimizing treatment responses by the physician.CONCLUSION: This pilot study suggests that LCR35 could have some efficacy in IBS patients complaining of diarrhoea. These preliminary results need to be confirmed in larger studies.     

Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome

OBJECTIVES: Bowel urgency is one of the most bothersome symptoms for nonconstipated IBS patients. The efficacy of alosetron in control of bowel urgency and Global Improvement of IBS symptoms were evaluated in a multicenter double-blind, randomized, placebo-controlled study. METHODS: Female IBS patients with lack of satisfactory control of bowel urgency were randomized 2:1 to alosetron 1 mg twice daily or placebo treatment groups. The primary endpoint was the proportion of days with satisfactory control of bowel urgency during the 12-wk treatment period and 2-wk follow-up period. Secondary endpoints included IBS Global Improvement (responder defined as patient-reported moderate or substantial improvement in IBS symptoms) and improvements in bowel function (stool frequency, consistency, and sensation of incomplete evacuation). RESULTS: A total of 801 women were randomized to the alosetron (n = 532) or placebo groups (n = 269). Physicians classified 98% of patients with diarrhea-predominant IBS. Patients treated with alosetron had a significantly greater proportion of days with satisfactory control of urgency compared to placebo for the treatment period (73% vs 57%, p < 0.001). A significantly greater number of patients treated with alosetron were IBS Global Improvement responders compared to placebo at week 12 (76% vs 44%, p < 0.001). IBS Global Improvement responders had more days with satisfactory control of urgency at week 12 (88% vs 48%) as well as firmer stools, fewer stools/day, and fewer days with incomplete evacuation compared with nonresponders. Alosetron-treated patients showed improvements in bowel functions compared to placebo-treated patients. Constipation was the most commonly reported adverse event.     

Paroxetine to treat irritable bowel syndrome not responding to high-fiber diet: a double-blind, placebo-controlled trial

OBJECTIVES: The purpose of the trial was to determine whether a high-fiber diet (HFD) alone or in combination with paroxetine or placebo was effective treatment for patients with irritable bowel syndrome (IBS). METHODS: Design: Trial of HFD alone (Group 1) followed by a randomized, double-blind trial of HFD with paroxetine or placebo (Group 2). Setting: Gastroenterology office in a 524-bed university-affiliated community hospital in Pittsburgh. Patients: Men and women, aged 18-65 yr, previously diagnosed with IBS but otherwise healthy. Intervention: Institution of HFD in 98 participants consuming low- or average-fiber diets. Allocation of paroxetine to 38 and placebo to 43 symptomatic participants consuming HFDs. Measurements: Overall well-being, abdominal pain, and abdominal bloating (Groups 1 and 2); food avoidance, work functioning, and social functioning (Group 2). RESULTS: In Group 1, overall well-being improved in 26% patients, and abdominal pain and bloating decreased in 22% and 26% patients, respectively, with an HFD. In Group 2, overall well-being improved more with paroxetine than with placebo (63.3%vs 26.3%; p= 0.01), but abdominal pain, bloating, and social functioning did not. With paroxetine, food avoidance decreased (p= 0.03) and work functioning was marginally better (p= 0.08). Before unblinding, more paroxetine recipients than placebo recipients wanted to continue their study medication (84%vs 37%; p < 0.001). CONCLUSIONS: The difference in overall well-being found in our paroxetine/placebo trial is greater than that found in previously published drug/placebo trials for IBS. Moreover, the difference in well-being applied to nondepressed recipients of paroxetine.     

Germs, gas and the gut; the evolving role of the enteric flora in IBS

Gas-related symptoms are common in irritable bowel syndrome (IBS), though their pathophysiology remains poorly understood, various studies invoking increased gas production, impaired gas transit, and increased sensitivity to gas. Recent evidence suggests a potential role for bacterial overgrowth in some patients with IBS; the study discussed herein provides further support for this concept by describing an amelioration of bloating and flatulence following a short course of the poorly absorbed antibiotic, rifaximin.     

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.     

Rifaximin is associated with modest,transient decreases in multiple taxa in the gut microbiota of patients with diarrhoea-predominant irritable bowel syndrome

Rifaximin, a non-systemic antibiotic, is efficacious for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D). Given the emerging association between the gut microbiota and IBS, this study examined potential effects of rifaximin on the gastrointestinal microbial community in patients with IBS-D. TARGET 3 was a randomised, double-blind, placebo-controlled, phase 3 study. Patients with IBS-D initially received open-label rifaximin 550 mg 3 times daily (TID) for 2 weeks. Patients who responded to the initial treatment and then relapsed were randomised to receive 2 repeat courses of rifaximin 550 mg TID or placebo for 2 weeks, with each course separated by 10 weeks. Stool samples were collected at the beginning and end of open-label treatment, at the beginning and end of the first double-blind treatment, and at the end of the study. As a secondary analysis to the TARGET 3 trial, the composition and diversity of the gut microbiota were assessed, from a random subset of patients, using variable 4 hypervariable region 16S ribosomal RNA gene sequencing. Samples from 103 patients were included. After open-label rifaximin treatment for 2 weeks, 7 taxa (e.g. Peptostreptococcaceae, Verrucomicrobiaceae, Enterobacteriaceae) had significantly lower relative abundance at a 10% false discovery rate threshold. The effects of rifaximin were generally short-term, as there was little evidence of significantly different changes in taxa relative abundance at the end of the study (up to 46 weeks) versus baseline. The results suggest that rifaximin has a modest, largely transient effect across a broad range of stool microbes. Future research may determine whether the taxa affected by rifaximin are causally linked to IBS-D.

ClinicalTrials.gov identifier number: NCT01543178.     

Symptom differences in moderate to severe IBS patients based on predominant bowel habit

OBJECTIVE: We sought to determine if irritable bowel syndrome (IBS) patients with different bowel habit predominance differ in self-reported viscerosensory symptoms related to the upper and lower gastrointestinal (GI) tract, somatosensory symptoms, and constitutional functions. METHODS: Six hundred and twenty-five Rome criteria-positive IBS patients completed a bowel symptom questionnaire (BSQ), psychological symptom checklist (SCL-90), and health status (SF-36). Bowel habit predominance for IBS patients was determined using the Rome criteria for functional constipation (IBS-C; n = 140) and functional diarrhea (IBS-D; n = 216). The BSQ included questions about viscerosensory symptoms of the upper (chest pressure, bloating, fullness, early satiety, nausea) and lower GI tract (bloating, pain, incomplete evacuation), somatosensory symptoms related to the musculoskeletal system (pain in neck/shoulders, lower back/hip, muscles/joints), and constitutional functions (sleep, appetite, libido). Analysis was further conducted between the IBS-C and IBS-D patients, controlling for gender and quality of sleep, and using the Bonferroni correction to control for multiple comparisons. RESULTS: Female gender was more prevalent among IBS-C than IBS-D (77% vs 56.1%, p < 0.01), whereas age did not differ (40.2 +/- 1.2 yr vs 39.5 +/- 1.0 yr). Symptoms referred to the upper GI were more prevalent in IBS-C than IBS-D: early satiety (56.7% vs 33.9%, p < 0.004), fullness (63.2% vs 38.5%, p < 0.05), and a trend for upper bloating (80.3 vs 62.6%). IBS-C patients reported higher severity ratings for lower GI bloating (p < 0.001). IBS-C more commonly reported musculoskeletal symptoms (92.2% vs 75.4%, p < 0.001), as well as impairment in sleep (31.3 vs 17.5%, p < 0.009), appetite (35.0% vs 18.4%, p < 0.015) and sexual function (45.2% vs 33.1%, p < 0.0021). There were no differences in SCL-90 and SF-36 scores. CONCLUSIONS: Compared with the IBS-D group, the IBS-C patients show greater prevalence of a wide range of symptoms referred to the upper and lower abdomen, musculoskeletal, and constitutional functions. These findings may be related to differences in autonomic or perceptual responses to visceral and somatic stimuli, and are likely to have implications for treatment responses in the two subgroups.     

Efficacy of rifaximin, a nonabsorbed oral antibiotic, in the treatment of small intestinal bacterial overgrowth

INTRODUCTION: Rifamixin is an orally administrated, nonabsorbed antibiotic whose utility in eradication of small intestinal bacterial overgrowth (SIBO) is currently being evaluated. PURPOSE: The aim of this study was to investigate efficacy and safety of rifaximin in relieving symptoms and normalizing the glucose breath test (GBT) in patients with SIBO. METHODS: Symptom score assessment, consisting of frequency and severity of bloating, gas, abdominal pain, and bowel movements and the GBT were performed before and after treatment with rifaximin 800 mg/d for 4 weeks. SUBJECTS: Twenty consecutive symptomatic patients (16 women and 4 men; mean age, 47.8 years; range, 19 to 85 years) who had a positive GBT were prospectively studied in an open-labeled fashion. Fourteen patients (70.0%) presented with diarrhea, 3 (15.0%) with bloating and gas, and 3 (15.0%) with constipation as the dominant symptom. RESULTS:: Eleven patients were hydrogen producers, 8 exclusively methane, and 1 patient produced both gases by the GBT. Among patients with diarrhea, 12 of 14 (85.7%) reported improvement in symptom scores of more than 50%; 1 between 25% and 50%, 1 had no response after 4 weeks of rifamixin. Among patients with bloating and gas or constipation as the main symptom: 2 of 6 (33.3%) had improvement between 50% and 75%; 3 (50%) had 25% to 50% improvement, and 1 (16.7%) had no response. Repeat GBT at the end of the 4 weeks showed that 54.5% of hydrogen formers and 50.0% of methane producers were eradicated, and there was a significant reduction (P <0.05) in the area under the concentration-time curve and peak values. No adverse effects were observed. CONCLUSIONS: Rifaximin in a dose of 800 mg per day for 4 weeks: 1) was safe and effective treatment in reducing symptoms in patients with SIBO of multiple etiologies, especially when diarrhea was the dominant symptom; and 2) normalized the GBT in approximately 50% of patients. Data support a future therapeutic role for rifaximin in SIBO.     

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label,partially controlled, 6-month extension of a previously published trial

Background

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul^®) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture.

Methods

This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation).

Results

Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected.

Conclusions

Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.     

An Asia-Pacific,double blind,placebo controlled,randomised study to evaluate the efficacy,safety, and tolerability of tegaserod in patients with irritable bowel syndrome

BACKGROUND: Tegaserod has been shown to be an effective therapy for the multiple symptoms of irritable bowel syndrome (IBS) in Western populations. However, little information is available regarding the use of tegaserod in the Asia-Pacific population. AIMS: To evaluate the efficacy, safety, and tolerability of tegaserod versus placebo in patients with IBS from the Asia-Pacific region. PATIENTS: A total of 520 patients from the Asia-Pacific region with IBS, excluding those with diarrhoea predominant IBS. METHODS: Patients were randomised to receive either tegaserod 6 mg twice daily (n=259) or placebo (n=261) for a 12 week treatment period. The primary efficacy variable (over weeks 1-4) was the response to the question: "Over the past week do you consider that you have had satisfactory relief from your IBS symptoms?" Secondary efficacy variables assessed overall satisfactory relief over 12 weeks and individual symptoms of IBS. RESULTS: The mean proportion of patients with overall satisfactory relief was greater in the tegaserod group than in the placebo group over weeks 1-4 (56% v 35%, respectively; p<0.0001) and weeks 1-12 (62% v 44%, respectively; p<0.0001). A clinically relevant effect was observed as early as week 1 and was maintained throughout the treatment period. Reductions in the number of days with at least moderate abdominal pain/discomfort, bloating, no bowel movements, and hard/lumpy stools were greater in the tegaserod group compared with the placebo group. Headache was the most commonly reported adverse event (12.0% tegaserod v 11.1% placebo). Diarrhoea led to discontinuation in 2.3% of tegaserod patients. Serious adverse events were infrequent (1.5% tegaserod v 3.4% placebo). CONCLUSIONS: Tegaserod 6 mg twice daily is an effective, safe, and well tolerated treatment for patients in the Asia-Pacific region suffering from IBS and whose main bowel symptom is not diarrhoea.     

A controlled, double-blind, randomized study on the efficacy of Lactobacillus plantarum 299V in patients with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a widespread functional disorder of the digestive tract. Its aetiology is unknown and therapeutic options are limited. Recent reports suggest that probiotics may have a role in regulating the motility of the digestive tract. AIM: To assess the efficacy of Lactobacillus plantarum 299V (LP299V) in patients with IBS. PATIENTS AND METHODS: Forty patients were randomized to receive either LP299V in liquid suspension (20 patients) or placebo (20 patients) over a period of 4 weeks. Clinical examination was performed at baseline and at the end of the study. Additionally, patients assessed their symptoms by applying a scoring system. RESULTS: All patients treated with LP299V reported resolution of their abdominal pain as compared to 11 patients from a placebo group (P = 0.0012). There was also a trend towards normalization of stools frequency in constipated patients in six out of 10 patients treated with LP299V compared with two out of 11 treated with placebo (P = 0.17). With regards to all IBS symptoms an improvement was noted in 95% of patients in the LP299V group vs 15% of patients in the placebo group (P < 0.0001). CONCLUSIONS: LP299V seems to have a beneficial effect in patients with IBS. Further studies on larger cohorts of patients and with longer duration of therapy are required in order to establish the place of L. plantarum in the treatment of IBS.     

Rifaximin improves symptoms of acquired uncomplicated diverticular disease of the colon

BACKGROUND AND AIMS: We examined the efficacy of cyclic long-term administration of rifaximin, a broad spectrum, poorly absorbable antibiotic, in obtaining symptom relief in a large series of patients with uncomplicated diverticular disease, and compared the incidence of episodes of diverticulitis in the group treated with rifaximin to that in a group receiving fiber supplementation only. PATIENTS AND METHODS: In a multicenter, prospective, open trial, 968 outpatients with uncomplicated symptomatic diverticular disease were randomized to either fiber supplementation with 4 g/day glucomannan plus 400 mg rifaximin twice daily for 7 days every month ( n=558) or 4 g/day glucomannan alone ( n=346). Clinical evaluation was performed on admission and at 4-month intervals for 12 months. RESULTS: After 12 months the group treated with glucomannan + rifaximin showed fewer symptoms (abdominal pain/discomfort, bloating, tenesmus, diarrhea, abdominal tenderness) and a lower global symptomatic score. Overall 56.5% of the patients treated with glucomannan + rifaximin and 29.2% of those treated with glucomannan alone were asymptomatic at 12 months ( P<0.001). The rate of complications (diverticulitis and rectal bleeding) was 1.34% in the rifaximin + glucomannan group and 3.22% in the glucomannan alone group ( P<0.05). CONCLUSION: Cyclic administration of rifaximin is effective in obtaining symptom relief in uncomplicated diverticular disease of the colon. The incidence of episodes of diverticulitis in the group treated with rifaximin was lower than that in the group treated with glucomannan alone.