A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome

INTRODUCTION: Selective serotonin reuptake inhibitors (SSRIs) are frequently used in the treatment of irritable bowel syndrome (IBS) although evidence of their efficacy is scarce. AIM: Twenty three non-depressed IBS patients were recruited from a tertiary care centre and included in a crossover trial comparing six weeks of treatment with the SSRI citalopram (20 mg for three weeks, 40 mg for three weeks) with placebo. IBS symptom severity was the primary outcome measure, and depression and anxiety scores were also measured. The effect of acute administration of citalopram on colonic sensitivity and on colonic response to feeding was investigated as a putative predictor of symptomatic response to the drug. RESULTS: After three and six weeks of treatment, citalopram significantly improved abdominal pain, bloating, impact of symptoms on daily life, and overall well being compared with placebo. There was only a modest effect on stool pattern. Changes in depression or anxiety scores were not related to symptom improvement. The effect of acute administration of citalopram during a colonic barostat study did not predict clinical outcome. Analysis of the first treatment period as a double blind parallel arm study confirmed the benefit of citalopram over placebo. CONCLUSIONS: The SSRI citalopram significantly improves IBS symptoms, including abdominal pain, compared with placebo. The therapeutic effect is independent of effects on anxiety, depression, and colonic sensorimotor function.     

Partially hydrolyzed guar gum in pediatric functional abdominal pain

AIM:To assess the effects of partially hydrolyzed guar gum(PHGG) diet supplement in pediatric chronic abdominal pain(CAP) and irritable bowel syndrome(IBS).METHODS:A randomized,double-blind pilot study was performed in sixty children(8-16 years) with functional bowel disorders,such as CAP or IBS,diagnosed according to Rome Ⅲ criteria.All patients underwent ultrasound,blood and stool examinations to rule out any organic disease.Patients were allocated to receive PHGG at dosage of 5 g/d(n = 30) or placebo(fruitjuice n = 30) for 4 wk.The evaluation of the efficacy of fiber supplement included IBS symptom severity score(Birmingham IBS Questionnaire),severity of abdominal pain(Wong-Baker Face Pain Rating Score) and bowel habit(Bristol Stool Scale).Symptom scores were completed at 2,4,and 8 wk.The change from baseline in the symptom severity scale at the end of treatment and at 4 wk follow-up after treatment was the primary endpoint.The secondary endpoint was to evaluate compliance to supplementation with the PHGG in the pediatric population.Differences within groups during the treatment period and follow-up were evaluated by the Wilcoxon signed-rank test.RESULTS:The results of the study were assessed considering some variables,such as frequency and intensity of symptoms with modifications of the bowel habit.Both groups were balanced for baseline characteristics and all patients completed the study.Group A(PHGG group) presented a higher level of efficacy compared to group B(control group),(43% vs 5%,P = 0.025) in reducing clinical symptoms with modification of Birmingham IBS score(median 0 ± 1 vs 4 ± 1,P = 0.025),in intensity of CAP assessed with the Wong-Baker Face Pain Rating Score and in normalization of bowel habit evaluated with the Bristol Stool Scale(40% vs 13.3%,P = 0.025).In IBS subgroups,statistical analysis shown a tendency toward normalization of bowel movements,but there was no difference in the prevalence of improvement in two bowel habit subsets.PHGG was therefore better tolerated without any advers     

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.     

Prevalence of irritable bowel syndrome and its relationship with psychological stress status in Chinese university students

Background and Aims: Although irritable bowel syndrome (IBS) is a common disorder in the West, information on the prevalence of IBS in university students is relatively scant, especially in Asia. The aims of the present study were to investigate the prevalence and pattern of symptoms of IBS and its relationship with psychological stress status in Chinese university students. Methods: Basic demographic data and IBS symptoms were sought using the Rome II criteria and a validated bowel symptom questionnaire. Another questionnaire used related to psychosomatic symptoms of depression and anxiety. Results: In total, 491 of the 530 students in the trial met the selected criteria, which included 241 men. The participants were medical college students (313/491) and non‐medical college students (178/491). The apparent prevalence of IBS was 15.7%, with a prevalence of 14.5% in men and 16.8% in women. The most common symptom was abdominal pain associated with change in the consistency of stool (36.9%), followed by altered stool frequency (16.3%), and abdominal pain relieved by defecation (12.4%), predominantly in women. The self‐reported psychological and psychosomatic symptoms of anxiety (P < 0.001) and depression (P < 0.001) were encountered more frequently in participants with IBS. The depression (P = 0.03) and anxiety measures (P = 0.02) significantly predicted IBS status. Conclusion: The prevalence of IBS in Chinese university students is often compared with university students in developed countries and the general Chinese population. Depression and anxiety could potentially induce IBS. Medical education should be considered when aiming to reduce stress of university students who are susceptible to IBS.     

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.     

The Effect of Enteric-Coated,Delayed-Release Peppermint Oil on Irritable Bowel Syndrome

Herbal remedies, particularly peppermint, have been reported to be helpful in controlling symptoms of irritable bowel syndrome (IBS). We conducted a randomized double-blind placebo-controlled study on 90 outpatients with IBS. Subjects took one capsule of enteric-coated, delayed-release peppermint oil (Colpermin) or placebo three times daily for 8 weeks. We visited patients after the first, fourth, and eighth weeks and evaluated their symptoms and quality of life. The number of subjects free from abdominal pain or discomfort changed from 0 at week 0 to 14 at week 8 in the Colpermin group and from 0 to 6 in controls (P < 0.001). The severity of abdominal pain was also reduced significantly in the Colpermin group as compared to controls. Furthermore, Colpermin significantly improved the quality of life. There was no significant adverse reaction. Colpermin is effective and safe as a therapeutic agent in patients with IBS suffering from abdominal pain or discomfort.     

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 peripheral kappa agonist fedotozine versus placebo in treatment of irritable bowel syndrome

The efficacy and safety of the peripheral kappa agonist fedotozine was evaluated in a double-blind, multicenter study involving 238 patients with the irritable bowel syndrome. After a two-week washout, patients were assigned to one of four groups to receive either placebo or fedotozine three times a day at doses of 3.5, 15, or 30 mg for six weeks. Patient assessment of mean symptom intensity indicated that the 30-mg dose of fedotozine was superior to placebo in relieving maximal daily abdominal pain (P=0.01), mean daily pain (P=0.007), and abdominal bloating (P=0.02). Changes in bowel function and defecation disorders could not be evaluated reliably. According to the investigators, the highest dose of fedotozine markedly reduced overall disease severity (P=0.003) and the pain component of the symptomatic profile (P=0.009). Clinical and laboratory safety was very good. Fedotozine 30 mg three times a day therefore appears to be effective and safe in the treatment of the abdominal pain and bloating associated with IBS.Participating investigators: [France] Bataillon, Beaujard, Beranger, Boisson. Boboc, Bour, Bourry, Boyer, Cambon, Cassan, Chambon, Chery, Cosmidis, Dahlab, Dapoigny, Daudet, Debat, Delette. Delvaux, Desechalliers, Diez, Dumas, Faucher, Girard, Gislon, Hamelin, Hayek. Hecketsweiler, Joliot, Kornhauser, Lafon, Lamouliatte, Larche, Le Bihan, Legoux, Lirzin. Ljunggren, Marcheta, Marquier, Milon, Molinie, Monneris, Montoya, Morichau-Beauchant, Naudy, Pillegand, Raud Regeard, Renson, Richieri, Rouison, Rumeau, Salas, Staub, Vandermolen, Verbiese, Veyres, Wagner, Weber, Yousfi, Zani: [Tunisia] Ben Amar, Ben Kahlifa, Garoui, Hamza: [Belgium] Lamy, Lienard, Peeters.     

抗抑郁药治疗肠易激综合征疗效荟萃分析及治疗适应证探讨

目的通过对抗抑郁药疗效的荟萃分析来探讨抗抑郁药治疗肠易激综合征(IBS)的适应证。方法检索MEDLINE、EMBASE和Cochrane对照研究登记库中IBS患者抗抑郁药治疗的随机对照研究(文献发表时间为2000-01-01-2018-03-31)。以成年IBS患者为研究人群,将抗抑郁药与安慰剂或常规治疗进行对比。以IBS的总体症状或腹痛症状无改善为结局指标,获得抗抑郁药治疗后IBS症状无改善的相对危险度(RR)和95%可信区间(CI),并根据危险差的倒数计算出所需要治疗的患者数(NNT)。对可能影响疗效的主要临床特征(即是否合并心理障碍、腹痛或腹部不适的严重程度、是否难治性IBS)和疗程进行亚组分析。结果纳入12项高质量的随机对照研究进行荟萃分析。与安慰剂或常规治疗相比,当合并抑郁或焦虑时,抗抑郁药治疗后IBS症状无改善的相对危险度是0.45(95%CI 0.26~0.80),NNT为3.7。在抑郁和焦虑未知组,难治性IBS患者抗抑郁药治疗后IBS症状无改善的相对危险度是0.58(95%CI 0.46~0.73),NNT为3.6;中-重度腹痛或腹部不适患者抗抑郁药治疗后IBS症状无改善的相对危险度是0.64(95%CI 0.44~0.93),NNT为4.7。抗抑郁药疗程≥3个月时,治疗后IBS症状无改善的相对危险度是0.66(95%CI0.54~0.81)。结论 IBS患者抗抑郁药治疗的适应证为合并抑郁或焦虑、难治性IBS、表现为中-重度腹痛或腹部不适的IBS患者;推荐疗程至少为3个月。     

The Efficacy of an Herbal Medicine, Carmint, on the Relief of Abdominal Pain and Bloating in Patients with Irritable Bowel Syndrome: A Pilot Study

Carmint contains total extracts of Melissa officinalis, Mentha spicata, and Coriandrum sativum, which have antispasmodic, carminative, and sedative effects. As abdominal pain/discomfort and bloating are commonly observed in patients with irritable bowel syndrome, we decided to evaluate the effectiveness of Carmint in relieving these symptoms in irritable bowel syndrome patients. We randomly assigned 32 irritable bowel syndrome patients to receive either Carmint or placebo, plus Loperamide or psyllium (based on their predominant bowel function), for 8 weeks. T-test analysis of the results showed that the severity and frequency of abdominal pain/discomfort were significantly lower in the Carmint group than the placebo group at the end of the treatment (P=0.016 and P=0.001, respectively), as were the severity and frequency of bloating (P=0.02 and P=0.002, respectively). This pilot study suggests that Carmint plus loperamide or Carmint plus psyllium (depending on the irritable bowel syndrome subtype) might be effective in these patients.     

Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves symptoms of irritable bowel syndrome

AIM: To assess the symptomatic efficacy of Lactobacillus plantarum 299v (L. plantarum 299v) (DSM 9843) for the relief of abdominal symptoms in a large subset of irritable bowel syndrome (IBS) patients fulfilling the Rome III criteria.METHODS: In this double blind, placebo-controlled, parallel-designed study, subjects were randomized to daily receive either one capsule of L. plantarum 299v (DSM 9843) or placebo for 4 wk. Frequency and intensity of abdominal pain, bloating and feeling of incomplete rectal emptying were assessed weekly on a visual analogue scale while stool frequency was calculated.RESULTS: Two hundred and fourteen IBS patients were recruited. After 4 wk, both pain severity (0.68 + 0.53 vs 0.92 + 0.57, P < 0.05) and daily frequency (1.01 + 0.77 vs 1.71 + 0.93, P < 0.05) were lower with L. plantarum 299v (DSM 9843) than with placebo. Similar results were obtained for bloating. At week 4, 78.1 % of the patients scored the L. plantarum 299v (DSM 9843) symptomatic effect as excellent or good vs only 8.1 % for placebo (P < 0.01).CONCLUSION: A 4-wk treatment with L. plantarum 299v (DSM 9843) provided effective symptom relief, particularly of abdominal pain and bloating, in IBS patients fulfilling the Rome III criteria.     

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.     

Identification of Patients with Non-D,Non-C Irritable Bowel Syndrome and Treatment with Renzapride: An Exploratory,Multicenter, Randomized,Double-Blind,Placebo-Controlled Clinical Trial

This was an exploratory study of renzapride in 168 male and female patients with non-D, non-C irritable bowel syndrome (IBS). Patients were randomized to placebo or renzapride (1, 2, or 4 mg/day) for 8 weeks. The primary efficacy variable was patient-reported satisfactory relief of IBS symptoms. Secondary variables included relief of abdominal pain/discomfort. The proportion of patients reporting satisfactory relief of their IBS symptoms for at least 50% of the time did not differ significantly from those on placebo. However, post hoc analysis in women showed differences in responder rate on renzapride versus placebo of 18.2% (95% CI −5% to 42%; P = 0.066) during weeks 1–4 and 6% (95% CI −21% to 33%; P = 0.339) during weeks 5–8. Renzapride was well tolerated and most adverse events were mild to moderate in intensity. Further studies are warranted to determine whether renzapride is beneficial in this patient population.     

Primary autoimmune haemolytic anaemia and coeliac disease

Background: Irritable bowel syndrome is a common cause of abdominal pain and discomfort and may be related to disordered gastrointestinal motility. Our aim was to assess the effects of long-term treatment with a prokinetic agent, cisapride, on postprandial jejunal motility and symptoms in the irritable bowel syndrome (IBS). Methods: Thirty-eight patients with IBS (constipation-predominant, n = 17; diarrhoea-predominant, n = 21) underwent 24-h ambulatory jejunal manometry before and after 12 week's treatment {cisapride, 5mg three times daily (n = 19) or placebo (n = 19)}. Results     

选择性5-羟色胺再摄取抑制剂治疗肠易激综合征疗效的系统评价

目的:系统评价选择性5-羟色胺再摄取抑制剂(selective serotonin reuptake inhibitor,SSRI)治疗肠易激综合征(irritable bowel syndrome,IBS)的有效性及安全性.方法:计算机检索PubMed、Embase、Cochrane图书馆临床对照试验数据库、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI),查找SSRI治疗肠易激综合征的所有随机对照试验(randomized controlledtrials,RCTs),应用Cochrane协作网提供的Revman5.0软件进行分析评价.结果:共纳入5项试验,共300例患者.治疗使用的药物包括氟西汀、西酞普兰、帕罗西汀.RCT表明,SSRI改善IBS总体症状缓解率无统计学意义[RR=2.09,95%CI=(0.97,4.47),P<0.05];严重不良反应的发生率与安慰剂组相比无明显统计学差异[RR=1.38,95%CI=(0.68,2.82),P>0.05].结论:SSRI对缓解IBS患者的总体症状与安慰剂相比未见明显疗效差别,不良事件发生率无统计学意义.     

Does oral α-galactosidase relieve irritable bowel symptoms?

Objective. Abdominal bloating is reported by a majority of irritable bowel syndrome (IBS) patients. Excess colonic fermentation may cause gaseous symptoms. Several foodstuffs contain oligosaccharides with an α-galactosidic linkage that is resistant to mammalian hydrolases. Assisted hydrolysis by exogenous α-galactosidase enzyme (AG) could offer a way of controlling IBS symptoms by reducing colonic fermentation and gas production. The aim of this study was to assess the effect of AG on symptom severity and quality of life in IBS patients with abdominal bloating or flatulence. Methods. A total of 125 subjects with IBS received AG or placebo at meals for 12 weeks. IBS-Symptom Severity Score (IBS-SSS) and quality of life (QoL) were assessed at baseline, during the treatment and at 4-week follow-up. Results. AG showed a trend toward a more prominent decrease in IBS-SSS. The responder rate at week 16 was higher for the AG group. No difference was detected in QoL between AG and placebo groups. A total of 25 patients (18 in AG group and 7 in placebo group, p = 0.016) withdrew from the study. Abdominal pain and diarrhea were more often reported as reason for withdrawal in AG group. Conclusions. We found no evidence to support the use of AG routinely in IBS patients. Improvement of clinical response at 4-week follow-up may suggest a long-term effect of unknown mechanism, but could also be attributed to non-responder drop out. Gastrointestinal (GI) side effects may be a coincidence in this study, but irritation of GI tract by AG administration cannot be excluded.     

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.     

Antibiotic Treatment of Constipation-Predominant Irritable Bowel Syndrome

Background

The antibiotic rifaximin is used to treat non-constipated irritable bowel syndrome (IBS). Methane production is associated with constipation and its severity in constipation-predominant IBS (C-IBS). A previous retrospective study suggested that rifaximin and neomycin was superior to neomycin alone in improving symptoms in methane-positive subjects.

Aims

To determine the effectiveness of neomycin alone or with rifaximin in improving symptoms in methane-positive C-IBS subjects.

Methods

A double-blind, randomized, placebo-controlled trial was performed from 2010 to 2013 at three tertiary care centers. Subjects aged 18–65 with C-IBS (Rome II criteria) and breath methane (>3 ppm) meeting the inclusion and exclusion criteria were recruited. Subjects completed a baseline symptom questionnaire rating the severity of abdominal and bowel symptoms on a visual analog scale and were randomized to receive neomycin and placebo or neomycin and rifaximin for 14 days. Symptom severity was assessed by weekly questionnaire for 2 weeks of therapy and 4 additional weeks of follow-up.

Results

Thirty-one subjects (16 neomycin and placebo, 15 neomycin and rifaximin) were included in the intention-to-treat analysis. Constipation severity was significantly lower in the neomycin and rifaximin group (28.6 ± 30.8) compared to neomycin alone (61.2 ± 24.1) (P = 0.0042), with greater improvement in constipation (P = 0.007), straining (P = 0.017) and bloating (P = 0.020), but not abdominal pain. In the neomycin and rifaximin group, subjects with methane <3 ppm after treatment reported significantly lower constipation severity (30.5 ± 21.8) than subjects with persistent methane (67.2 ± 32.1) (P = 0.020).

Conclusions

Rifaximin plus neomycin is superior to neomycin alone in improving multiple C-IBS symptoms. This effect is predicted by a reduction in breath methane.     

The effects of probiotics on symptoms of irritable bowel syndrome]

BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) tract disorder that has heterogeneous clinical presentations such as abdominal pain, diarrhea, constipation, and abdominal distension. It is known that several mechanisms are involved in the pathogenesis of IBS. Probiotics may target one or more pathophysiologic pathways in IBS and may improve the symptoms of IBS. However, the results of studies about probiotics on IBS are controversial. Therefore, the aim of this study was to evaluate the effect of probiotics on GI symptoms and intestinal gas volume changes in patients with IBS. METHODS: Forty patients were randomly allocated to be treated with Medilac DS (Bacillus subtilis, Streptococcus faecium) (n=20) or placebo (n=20) in a double-blind, prospective manner. The change in intestinal gas volume and symptom scores after 4-week treatment were evaluated for the efficacy. RESULTS: There was no significant difference in bloating, frequency of gas expulsion, frequency of defecation, and hardness of stool before and after the treatment. However, the severity of abdominal pain and the frequency of abdominal pain decreased significantly in Medilac DS group (2.4+/-1.3 cm/day --> 1.6+/-1.6 cm/day, 1.7+/-1.3/day --> 1.0+/-1.0/day) (p=0.044, p=0.038), but not in placebo group (2.1+/-2.0 cm/day --> 1.8+/-2.1 cm/day, 1.3+/-1.2/day --> 1.4+/-1.9/day). In both groups, intestinal gas volume at baseline, after 2-week treatment, and after 4-week treatment did not show significant change. Medilac DS was well tolerated without adverse events. CONCLUSIONS: Medilac DS is a safe and useful probiotic agent for the treatment of abdominal pain in patients with IBS.