Subtyping the irritable bowel syndrome by predominant bowel habit: Rome II versus Rome III

BACKGROUND: The agreement between subtyping irritable bowel syndrome (IBS) patients based on Rome II criteria versus Rome III criteria is unknown. AIM: To compare IBS subtyping based on Rome II versus III criteria. METHODS: The Rome II Modular Questionnaire and the Bristol Stool Form Scale (one-week diary cards) were completed by 249 IBS patients. Based on the Rome II criteria, patients were defined as having diarrhoea- or constipation-predominant IBS, or alternating IBS. Based on the Rome III criteria, patients were divided into IBS with constipation, IBS with diarrhoea, mixed IBS or unsubtyped IBS. Agreement between Rome II and Rome III was assessed with kappa statistics. RESULTS: Based on Rome II there were 92 diarrhoea-predominant IBS, 45 constipation-predominant IBS and 112 alternating IBS, and based on Rome III 97 IBS with diarrhoea, 77 IBS with constipation, 16 mixed IBS and 59 unsubtyped IBS. The agreement between Rome II and Rome III subgroups was 46% (kappa = 0.19). Changes from the constipation to the diarrhoea subgroups and vice versa were uncommon (8% of patients). The majority of changes occurred from/to the alternating IBS, mixed IBS and unsubtyped IBS subgroups. CONCLUSION: There is poor agreement between subtyping of IBS patients based on Rome II versus Rome III criteria.     

Costs of health care for irritable bowel syndrome, chronic constipation, functional diarrhoea and functional abdominal pain

AIM: To provide estimates of actual costs to deliver health care to patients with functional bowel disorders, and to assess the cost impact of symptom severity, recency of onset, and satisfaction with treatment. METHODS: We enrolled 558 irritable bowel (IBS), 203 constipation, 243 diarrhoea and 348 abdominal pain patients from primary care and gastroenterology clinics at a health maintenance organization within weeks of a visit. Costs were extracted from administrative claims. Symptom severity, satisfaction with treatment and out-of-pocket expenses were assessed by questionnaires. RESULTS: Average age was 52 years, 27% were males, and 59% participated. Eighty percent were seen in primary care clinics. Mean annual direct health care costs were $5049 for IBS, $6140 for diarrhoea, $7522 for constipation and $7646 for abdominal pain. Annual out-of-pocket expenses averaged $406 for treatment of IBS symptoms, $294 for diarrhoea, $390 for constipation and $304 for abdominal pain. Lower gastrointestinal costs comprised 9% of total costs for IBS, 9% for diarrhoea, 6.5% for constipation and 9% for abdominal pain. In-patient care accounted for 17.5% of total costs (15.2% IBS). CONCLUSION: Costs were affected by disease severity (increased), recent exacerbation of bowel symptoms (increased), and whether the patient was consulting for the first time (decreased).     

Short-term stability of subtypes in the irritable bowel syndrome: prospective evaluation using the Rome III classification

Background In irritable bowel syndrome (IBS) subtyping is used in research and clinical practice. Knowledge of subtype stability is needed for proper design of trials and treatment strategies. Aims To evaluate the stability of Rome III IBS subtypes over time and to determine the optimal time period for prospective, diary‐based subtyping. Methods Rome III IBS patients aged 18–70 years enrolled in two identical, randomised, placebo‐controlled trials of probiotics, were included. No difference was found on stool pattern, thus patients were analysed as one group. Patients scored defaecations according to Bristol Stool Form Scale for 10 weeks. IBS subtypes were determined for all 1‐ and 2‐week periods. Subtype distribution and stool pattern over time were determined. The proportions of patients having the same subtype all weeks (stable patients) or having a predominant subtype (same subtype ≥60% of time) were determined. Results A total of 126 patients, mean age 46 ± 15 years, 72% women were included. Subtype distribution was similar over time with IBS with constipation, IBS with diarrhoea and IBS unsubtyped constituting one‐third of the population each. Even though only 18–35% had the same subtype all weeks, the majority of patients had the same subtype for ≥60% of time (82–98%). Sixty‐nine per cent had the same predominant and baseline subtypes. Two‐week data increased the proportion of stable patients, of patients with a predominant subtype, and of patients who had similar baseline and predominant subtype. Conclusions Most IBS patients change subtype over time. However, an underlying stool pattern stability was demonstrated in the majority of patients. To increase stability, we recommend 2‐week data for IBS subtyping.     

Discrepancy between recalled and recorded bowel habits in irritable bowel syndrome

Aliment Pharmacol Ther 2010; 32: 282ash;288

Summary

Background A discrepancy between recalled and recorded bowel habit subtypes has been reported in irritable bowel syndrome (IBS), but the reasons for it remain unclear. Aim To assess the agreement between recalled and recorded bowel habit subtypes; to determine whether any discrepancy is related to stool form variability or psychological factors; and to test the correlations of recalled and recorded stool form with colonic transit time. Methods Bowel habit subtype was established in 54 IBS patients at the enrolment visit (recalled) and with the aid of diary cards (recorded). Colonic transit time, the variability of stool form and the patients’ psychological profiles were also recorded. Results Recalled and recorded bowel habit subtypes agreed in only 54% of the patients (kappa = 0.28). Stool form variability was greater among the patients whose recalled and recorded bowel habit subtypes were discordant (P = 0.03), whereas the psychological profiles were not different. Colonic transit time significantly correlated with stool form only when it was recorded on diary cards. Conclusion The discrepancy between recalled and recorded bowel habits in IBS patients is related more to stool form variability than an altered psychological profile. Diary cards should be used to ensure that stool form reflects colonic transit time.     

Systematic review: the efficacy of treatments for irritable bowel syndrome--a European perspective

BACKGROUND: Irritable bowel syndrome (IBS) is a common, chronic disorder, characterized by abdominal pain/discomfort, bloating and altered bowel habit. AIM: To conduct a systematic evidence-based review of pharmacological therapies currently used, or in clinical development, for the treatment of IBS in Europe. The safety and tolerability of these therapies are the subject of an accompanying review. METHODS: A literature search was completed for randomized controlled studies which included adult patients with IBS and an active or placebo control, assessed IBS symptoms, and were published in English between January 1980 and June 2005. The level of evidence for efficacy was graded according to the quality of the trial design and the study outcome. RESULTS: There is some evidence for improvement of individual IBS symptoms with antidiarrhoeals (diarrhoea), antispasmodics (abdominal pain/discomfort), bulking agents (constipation), tricyclic antidepressants (abdominal pain/discomfort) and behavioural therapy. In contrast, there is strong evidence for the improvement of global IBS symptoms with two new serotonergic agents: the 5-HT4 selective agonist tegaserod (IBS with constipation) and the 5-HT3 antagonist alosetron (IBS with diarrhoea). Further data are required for the 5-HT3 antagonist, cilansetron, and the mixed 5-HT3 antagonist/5-HT4 agonist renzapride before their utility in IBS can be appraised. CONCLUSIONS: There is limited evidence for the efficacy, safety and tolerability of therapies currently available in Europe for the treatment of IBS. Overall, there is an absence of pharmacological agents licensed specifically for the treatment of IBS subtypes, and new agents are awaited in Europe that will allow changes in clinical practice to focus on and improve global IBS symptoms.     

Disturbed bowel habits in patients with non-ulcer dyspepsia

BACKGROUND; Emerging medications for non-ulcer-dyspepsia, such as the serotonin-receptor modulators, also affect bowel habits by altering colonic transit. If drugs that alter colonic function were to prove useful in non-ulcer dyspepsia, knowledge of baseline bowel habit disturbances would be potentially critical. AIM: To estimate the rate of non-ulcer dyspepsia patients with clinically relevant constipation or diarrhoea potentially precluding use of motility agents. METHODS: Consecutive patients with non-ulcer dyspepsia (n = 79), gastro-oesophageal reflux disease (n = 135) and organic upper gastrointestinal disease (upper gastrointestinal disease; n = 36) completed a validated symptom questionnaire evaluating predominant bowel habits in the last year. RESULTS: Prevalence of constipation was higher in non-ulcer dyspepsia (34%) than in gastro-oesophageal reflux disease (P = 0.01) and organic upper gastrointestinal disease (P = 0.01), prevalence of alternating diarrhoea/constipation (24%) and diarrhoea (22%) was similar, while prevalence of normal bowel habits was significantly less in non-ulcer dyspepsia (20%; P = 0.01 vs. gastro-oesophageal reflux disease and P < 0.01 vs. organic upper gastrointestinal disease). Constipation was particularly frequent in ulcer-like and dysmotility-like non-ulcer dyspepsia, while prevalence of diarrhoea was lowest in dysmotility-like non-ulcer dyspepsia. A normal bowel habit was equally uncommon in male (21%) and female non-ulcer dyspepsia patients (20%). CONCLUSIONS: Only one of five non-ulcer dyspepsia patients had normal bowel habits based on clinical symptoms; constipation is particularly prevalent. Patients with functional dyspepsia who are prescribed motility altering drugs should be evaluated by taking a thorough bowel habit history.     

Calcium polycarbophil compared with placebo in irritable bowel syndrome

Calcium polycarbophil was compared with placebo in 23 patients with irritable bowel syndrome in a six-month, randomized double-blind crossover study. Patients received polycarbophil tablets at a dosage of 6 g/day (twelve 0.5-g tablets) or matching placebo tablets. At study end, among patients expressing a preference, 15 of 21 (71%) chose polycarbophil over placebo for relief of the symptoms of irritable bowel syndrome. Statistically significant differences favouring polycarbophil were found among the following patient subgroups: 15 (79%) of 19 with constipation; all six with alternating diarrhoea and constipation; 13 (87%) of 15 with bloating; and 11 (92%) of 12 with two or more symptoms. Polycarbophil was rated better than placebo in monthly global responses to therapy. Patient diary entries showed statistically significant improvement for ease of passage with polycarbophil. Polycarbophil was rated better than placebo for relief of nausea, pain, and bloating. The data suggest that calcium polycarbophil can benefit irritable bowel syndrome patients with constipation or alternating diarrhoea and constipation and may be particularly useful in patients with bloating as a major complaint.     

曲美布汀治疗肠易激综合征的临床疗效

目的 :观察曲美布汀治疗肠易激综合征(IBS)的临床疗效。方法 :参照罗马Ⅱ标准 ,选择 60例IBS病人 ,随机分成治疗组和对照组 ,每组 30例。对照组男性 12例 ,女性 18例 ,年龄 (33±s 16)a。治疗组男性 13例 ,女性 17例 ,年龄 (31± 12 )a。 2组均给予谷维素 (2 0mg ,po ,tid)、维生素B1(2 0mg ,po ,tid)、维生素C (0 .2 g ,po ,tid)。治疗组加用曲美布汀 2 0 0mg ,po ,tid ,疗程 2wk。观察治疗前后IBS腹痛、腹泻、便秘、腹胀的情况。结果 :治疗组wk 1总有效率 67% ,wk 2总有效率 83%。wk 2腹痛缓解率 90 % ,腹泻缓解率 89% ,便秘缓解率77% ,腹胀缓解率 81%。无明显不良反应。结论 :曲美布汀是治疗IBS安全有效的药物     

A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome

BACKGROUND: Irritable bowel syndrome is a common gastrointestinal disorder characterized by abdominal pain and discomfort and altered bowel habit. Antagonism at the 5-HT3 receptor may be of benefit in the treatment of irritable bowel syndrome. AIMS: To evaluate the effect of 12 weeks of treatment with alosetron, a 5-HT3 receptor antagonist at doses of 0.1 mg b.d., 0.5 mg b.d. and 2 mg b.d. in irritable bowel syndrome patients. METHODS: A double-blind, placebo-controlled, parallel-group study with a 2-week screening and a 12-week treatment period was conducted. A total of 462 patients (335 female) recorded details of the severity of their abdominal pain, and bowel function daily on a diary card throughout the study. At monthly clinic visits patients recorded the severity of their abdominal pain/discomfort and diarrhoea on a visual analogue scale. RESULTS: In the total population and in the female subpopulation (but not in males) alosetron 2 mg b.d. significantly increased the proportion of pain-free days and decreased the visual analogue scale score for diarrhoea compared with placebo. Alosetron at doses of 0.5 mg b.d. and 2 mg b.d. led to a significant hardening of stool, and a reduction in stool frequency in the total population. CONCLUSION: Alosetron at a dose of 2 mg b.d. is an effective treatment for female patients with irritable bowel syndrome.     

Evaluation of drug treatment in irritable bowel syndrome

The irritable bowel syndrome (IBS) remains a therapeutic challenge in part because of the limited understanding of the pathophysiology. The placebo response rate varies in randomized controlled trials from 20 to 70%, and can persist for up to at least 1 year. It is contentious whether dietary fibre and bulking agents relieve the symptoms of IBS; constipation probably improves. Anticholinergic and antispasmodic agents are of questionable benefit in IBS despite positive meta-analyses of poor quality trials. A meta-analysis concluded that the tricyclic antidepressants were superior to placebo in IBS, although the individual trial results were variable. Selective serotonin reuptake inhibitors are of uncertain benefit. Laxatives are used for constipation but probably poorly control the IBS symptom complex. Loperamide is superior to placebo in improvement of diarrhoea but not abdominal pain in IBS. Tegaserod is a well- tolerated aminoguanidine indole derivative of serotonin that is a partial 5HT4-receptor agonist with prokinetic properties; a therapeutic gain over placebo of 5% to 15% has been observed in constipation-predominant IBS in females. Alosetron is a 5HT3-receptor antagonist that is efficacious in females with diarrhoea-predominant IBS, with a 12% to 17% therapeutic gain; the risk of ischaemic colitis is 1 in 350, with very severe constipation occurring in about 1 in 1000. Optimizing study design remains a challenge in IBS. New visceral analgesic and motility modifying agents, as well as anti-inflammatory agents are in trials, and hopefully additional efficacious therapeutic options for patients with IBS will soon emerge.     

马来酸曲美布汀治疗肠易激综合征的疗效及安全性

目的：临床验证马来酸曲美布汀（舒丽启能）治疗肠易激综合征（IBS）的疗效及安全性。方法：多中心开放基础上对照研究。选择IBS患者64例,空白对照治疗2周,15例临床症状缓解,49例进行丽启能治疗组po,200mg,tid疗程2周,观察腹痛、腹泻、排便异常、排便因难症状变化。结果：舒丽启能对腹痛治疗有效率为91．8％。排便异常效率为89．8％,腹泻有效率为86．6％,排便困难有效果率为81．8％,总体评估总有效率为81．6％。安全性研究未发现不良反应。结论：舒丽启能治疗IBS是安全有效。     

A study of fructo oligosaccharides in the prevention of travellers' diarrhoea

BACKGROUND: Prebiotic carbohydrates selectively stimulate the growth of bifidobacteria and lactobacilli in the human colon. These bacteria form part of the gut's inherent defence against invading pathogens. AIM: To test the effectiveness of fructo oligosaccharides in preventing travellers' diarrhoea. METHODS: A total of 244 healthy subjects, travelling to high and medium risk destinations for travellers' diarrhoea, took part in a randomized, double-blind, placebo-controlled study. The protocol comprised a preliminary week for recording bowel habit by diary, a 2-week pre-holiday period with the diary and consumption of 10 g of fructo oligosaccharides or placebo daily, followed by a 2-week holiday with continuation of treatment and diary. A post-study questionnaire was completed by all subjects on their return to the UK. RESULTS: The consumption of fructo oligosaccharides led to a small (6%; P < 0.02) increase in stool frequency in the pre-holiday period and gave a significantly better sense of 'well-being' during the holiday, although subjects reported more flatulence. There were non-significant decreases in episodes of diarrhoea with 20% on placebo and 11% on fructo oligosaccharides recording episodes in the post-study questionnaire (P=0.08) and 46% placebo, 38% fructo oligosaccharides recording episodes in the diary (P > 0.1). No change in bowel frequency, consistency or stool size was recorded. CONCLUSION: Travel to high risk areas increases diarrhoea. Fructo oligosaccharides alone are not sufficient to prevent this, although do have some benefits for the subjects.     

Mebeverine alters small bowel motility in irritable bowel syndrome

Background and Aim : Despite its widespread use in irritable bowel syndrome (IBS), limited clinical data exist on the effects of mebeverine hydrochloride on gastrointestinal motility. Human motor activity in the small bowel is more reproducible than that in the large bowel; therefore the aim of this study was to determine in the small bowel the effects of oral mebeverine in both IBS patients and in healthy controls.
Methods : Twelve IBS patients (11 females/ 1 male, 46±13 years old)—predominant constipation (IBS-C, n =6) and predominant diarrhoea (IBS-D, n =6)—and six healthy controls, underwent continuous 48 h ambulant recording of small bowel motor activity. One low energy (400 kcal) and one high energy (800 kcal) standard meal were administered in each consecutive 24-h period. Subjects received, in blinded fashion, placebo tablets in the first 24 h then mebeverine 135 mg q.d.s. in the second 24 h.
Results : Mebeverine had no effect on parameters of small bowel motility in controls. In contrast, in both IBS-C ( P =0.01) and IBS-D ( P <0.05) patients, phase 2 motility index was increased during mebeverine administration. Also, after mebeverine the proportion of the migrating motor complex cycle occupied by phase 2 was reduced in IBS-D ( P =0.01), while phase 2 burst frequency was reduced in IBS-C ( P <0.05). For phase 3 motor activity in IBS-C patients, the propagation velocity was decreased ( P <0.01), and the duration increased ( P <0.01).
Conclusions : These findings suggest that mebeverine, in the initial dosing period, has a normalizing effect in the small bowel in IBS, enhancing contractile activity in a similar fashion to 'prokinetic' agents, as well as producing alterations in motor activity consistent with an 'antispasmodic' effect.     

Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist

BACKGROUND: No currently available treatment provides consistent relief of irritable bowel syndrome. Colonic sensory and motor function are modulated partly through 5HT3-receptors. AIM: To evaluate effects of the 5HT3-receptor antagonist, alosetron, in irritable bowel syndrome. METHODS: Randomized, double-blind, placebo-controlled, dose-ranging (1, 2, 4, 8 mg b.d. alosetron), 12-week trial in 370 patients with diarrhoea-predominant or alternating constipation and diarrhoea irritable bowel syndrome. Weekly measurement of adequate relief was the key end-point; other irritable bowel syndrome symptoms were collected daily using an electronic phone system. RESULTS: Alosetron (1 mg or 2 mg b.d.) significantly (P < 0.05 vs. placebo) increased the proportion of females, but not males, reporting adequate relief. Stool consistency, frequency and percentage days with urgency improved over placebo (P < 0.05) within the first month with all doses of alosetron, and persisted throughout the trial with all doses in female patients. With 1 mg b.d. alosetron, females had improved stool consistency and urgency within the first week, and adequate relief and improved stool frequency within the first 2 weeks. There was no consistent improvement in bowel function among male patients. CONCLUSION: In female irritable bowel syndrome patients with predominant diarrhoea or alternating constipation and diarrhoea, alosetron is effective in treatment of abdominal pain and discomfort and bowel-related symptoms.     

Safety profile of tegaserod, a 5-HT4 receptor agonist, for the treatment of irritable bowel syndrome.

This article reviews the safety and tolerability profile of tegaserod, a novel selective partial agonist of the serotonin 5-HT(4) receptor. Tegaserod was recently approved for the treatment of women with irritable bowel syndrome (IBS) with constipation.Tegaserod exhibits rapid absorption from the small intestine, and is excreted unchanged in the faeces and as metabolites in the urine. Meal ingestion decreases its bioavailability. There is little effect of age or gender on pharmacokinetics, although plasma levels may be slightly higher in the elderly. Tegaserod has no effect on plasma levels of other drugs metabolised by cytochrome P450 enzyme systems.Gastrointestinal symptoms are the most common adverse effects of tegaserod therapy. In data pooled from phase III randomised controlled trials (RCTs) in IBS with constipation patients, diarrhoea was reported by 8.8% of patients treated with tegaserod 6mg twice daily versus 3.8% of patients receiving placebo. Similar rates have been observed in international post-US marketing RCTs. In most patients, tegaserod-induced diarrhoea was mild and transient. In RCTs, it did not elicit fluid or electrolyte disturbances, and fewer than 3% of IBS patients discontinued tegaserod due to diarrhoea. Since its release, rare cases of more severe diarrhoea and ischaemic colitis have been reported. The incidence of other gastrointestinal symptoms (e.g. abdominal pain, nausea, and flatulence) has been similar among tegaserod-treated patients and placebo-treated patients. Pooled analysis of phase III RCTs and post-US marketing RCTs have not demonstrated significant differences between tegaserod-treated patients and placebo-treated patients in the incidence of abdominal-pelvic surgery. There is no convincing evidence that rebound gastrointestinal symptoms occur upon termination of tegaserod therapy.Pooled analysis of phase III RCTs demonstrated an increase in the incidence of headaches among tegaserod-treated patients (6mg twice daily) compared with placebo-treated patients (15% vs 12.3%, respectively, p < 0.05), although post-US marketing RCTs have not observed this increase. Other extra-gastrointestinal adverse events occur with similar frequency among tegaserod-treated patients and placebo-treated patients. Tegaserod-treated patients in RCTs have not demonstrated significant prolongation of the QTc interval or cardiac arrhythmias compared with placebo-treated patients. Supra-therapeutic doses in healthy volunteers did not effect electrocardiographic parameters. Laboratory parameters are mostly unaffected by tegaserod, although several individuals have exhibited increased eosinophil counts.In summary, tegaserod exhibits a favourable safety and tolerability profile in IBS patients based on data from clinical trials. Diarrhoea is the most common adverse event associated with tegaserod use. Continued post-US marketing surveillance will further define the safety and tolerability profile of tegaserod.     

Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome – results of two randomized, placebo-controlled studies

Background Effective treatments for irritable bowel syndrome with constipation (IBS‐C) are lacking. Aim To assess the efficacy and safety of lubiprostone in IBS‐C. Methods A combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS‐C in two phase‐3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven‐point Likert scale ranging from significantly relieved (+3), to significantly worse (?3), patients responded on their electronic diary to the question: ‘How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?’. The primary efficacy endpoint was the percentage of overall responders. Results Using an intent‐to‐treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone‐treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P = 0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo. Conclusions The percentage of overall responders based on patient‐rated assessments of IBS‐C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.     

Drug treatment of the irritable bowel syndrome.

Irritable bowel syndrome (IBS) is defined as a functional bowel disorder in which abdominal pain is associated with defecation or a change in bowel habit, and with features of disordered defecation and distension. The irritable bowel syndrome occurs in 10 to 20% of people worldwide and is very commonly encountered in clinical practice. This has encouraged the pharmaceutical industry to search for effective drug therapy. So far, a universally effective agent has not been found, and since this is a chronic, benign disorder, beginning in youth, long term drug use should be avoided. Nevertheless, if a specific IBS symptom, such as constipation or abdominal pain dominates, a specific drug may be helpful. However, tests and treatment should be minimised or even avoided in order to do no harm. A largely nonpharmaceutical approach to IBS should be taken. This approach employs drugs sparingly and then only targeted at specific and resistant symptoms.     

肠易激综合征的影像表现及诊断价值分析

目的 探讨肠易激综合征（IBS）的X线影像表现特点及临床诊断价值。方法 利用数字化胃肠机对1080例有IBS临床表现的患者进行全消化道钡餐检查，并对其中317例单纯IBS的X线影像进行综合分析。结果 1080例中小肠、结肠出现器质性病变44例、小肠蛔虫症2例，约占0．43％。慢性胃炎、胃窦炎伴小肠及结肠运动功能异常717例，约占66．4％。单纯肠易激综合征317例，约占29．4％。其中腹泻型192例，约60％；便秘型125例，约40％。结论 根据IBS患者不同临床症状、体征及X线影像的不同表现，在排除器质性疾病基础上，可为临床提供有价值的影像诊断依据。而小肠动力紊乱、结肠动力异常是所有IBS的主要影像征象。     

A randomized controlled trial of a probiotic,VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome

AIM: To investigate the effects of a probiotic formulation, VSL#3, on gastrointestinal transit and symptoms of patients with Rome II irritable bowel syndrome with predominant diarrhoea. METHODS: Twenty-five patients with diarrhoea-predominant irritable bowel syndrome were randomly assigned to receive VSL#3 powder (450 billion lyophilized bacteria/day) or matching placebo twice daily for 8 weeks after a 2-week run-in period. Pre- and post-treatment gastrointestinal transit measurements were performed in all patients. Patients recorded their bowel function and symptoms daily in a diary during the 10-week study, which was powered to detect a 50% change in the primary colonic transit end-point. RESULTS: There were no significant differences in mean gastrointestinal transit measurements, bowel function scores or satisfactory global symptom relief between the two treatment groups, pre- or post-therapy. Differences in abdominal bloating scores between treatments were borderline significant (P = 0.09, analysis of covariance). Further analysis revealed that abdominal bloating was reduced (P = 0.046) with VSL#3 [mean post- minus pre-treatment score, - 13.7; 95% confidence interval (CI), - 2.5 to - 24.9], but not with placebo (P = 0.54) (mean post- minus pre-treatment score, - 1.7; 95% CI, 7.1 to - 10.4). With the exception of changes in abdominal bloating, VSL#3 had no effect on other individual symptoms: abdominal pain, gas and urgency. All patients tolerated VSL#3 well. CONCLUSION: VSL#3 appears to be promising in the relief of abdominal bloating in patients with diarrhoea-predominant irritable bowel syndrome. This is unrelated to an alteration in gastrointestinal or colonic transit.