Does rifaximin offer any promise in Crohn's disease in remission and concurrent irritable bowel syndrome-like symptoms?

Microbiota plays an important role in many diseases including inflammatory bowel diseases. Inflammatory bowel disease patients can have concurrent irritable bowel syndrome symptoms similar to those associated with a flare. The potential role of gut dysbiosis in the pathogenesis of inflammatory bowel disease provides a rationale for treating such patients with rifaximin. This study aimed to assess the efficacy of rifaximin in the management of irritable bowel syndrome-like symptoms (bloating, abdominal pain, stool consistency) and quality of life in patients with Crohn''s disease in remission.The present study included 86 patients with Crohn''s disease in remission (fecal calprotectin <50 μg/g, C-reactive protein <0.5 mg/dL, simple endoscopic score for Crohn''s disease <2) and associated irritable bowel syndrome-like symptoms (bloating, abdominal pain, diarrhea). These patients were randomly assigned to rifaximin treatment group (44 patients) and the control group (42 patients). Besides the baseline inflammatory bowel disease treatment and antispasmodics (as needed), patients in the rifaximin treatment group received 3 repeated courses of treatment, each course being represented by 1200 mg/d of rifaximin for 10 days and 20 days free of treatment (3 months consecutively); patients in the control group also received antispamodics as needed and were observed for 3 months.Monthly analyses of bloating score, abdominal pain score, stool consistency score, and quality of life score showed significant improvement after treatment in the rifaximin group in contrast with control group. Significantly more patients in the rifaximin group than in the control group met the criteria for adequate improvement of bloating score after 3 months of treatment (59.09% vs 19.04%, P = .01), adequate improvement of abdominal pain score (54.5% vs 21.4%, P = .04), stool consistency score (34.09% vs 14.2%, P = .03), and quality of life score (70.4% vs 21.4%, P < .001).Rifaximin in a dose of 1200 mg/d, 10 d/mo, 3 months consecutively is an effective medication for concurrent irritable bowel syndrome-like symptoms in patients with Crohn''s disease in remission.     

Effects of probiotics,lactitol and rifaximin on intestinal flora and fecal excretion of organic acids in cirrhotic patients

AIM: The aim of the present study was to assess fecal organic acid excretion and gut flora changes in a group of patients with compensated liver cirrhosis without hepatic encephalopathy by comparing pro­biotic therapy with more common therapeutic approaches. METHODS: Thirty patients with compensated Child B liver cirrhosis were allocated into one of three matched groups, which were randomly given one of three 3‐week oral treatments: (i) lactitol 20 g t.i.d.; (ii) 400 mg rifaximin b.i.d.; or (iii) the synbiotic SCM‐III (Microflorana‐F, Named, Lesmo, Italy) 10 mL t.i.d. Stool samples were collected at both the time of entry into the study and at the end of the trial period for the assessment of intestinal bacterial flora and for the determination of fecal pH and of organic acid concentration. RESULTS: All three tested compounds significantly increased the total anaerobic bacterial count to the same extent. The change was mainly due to a reduction in the Bacteriodes population and an expansion of the bifidobacteria population. However, only SCM‐III significantly decreased the total count of Bacteroides and Clostridium. Lactitol and SCM‐III decreased (to a similar extent) the fecal pH compared with healthy controls and with pretreatment values (P < 0.05). Both lactitol and SCM‐III produced a significant increase in the fecal concentration of acetic acid and lactic acid. However, only SCM‐III decreased the fecal concentration of toxic short‐chain fatty acids. CONCLUSIONS: In the present clinical study, we confirmed the findings from an in vitro study of enhanced‐non‐toxic organic acid recovery from stools during treatment with nonabsorbable disaccharides. In the present study, we found that lactitol did not produce any significant effect on Bacteroides and Clostridium, whereas the specific bacterial counts of such species significantly decreased only in the group treated with the synbiotic. These data suggest a potential role of synbiotics in the long term treatment of chronic liver disease.     

Retrospective cross‐sectional pilot study of rifaximin dosing for the prevention of recurrent hepatic encephalopathy

Standard treatment for hepatic encephalopathy (HE) includes medications that reduce ammonia and bacterial translocation in the gut. Rifaximin can be used off‐label for the reduction of overt HE. The study purpose was to determine efficacy of traditional rifaximin dosing (400 mg three times daily) compared with newer dosing (550 mg twice daily) via readmission rates for the prevention of recurrent HE. This was a retrospective, observational, cross‐sectional pilot study conducted in a tertiary medical center. A total of 226 patients 18–89 years of age with documentation of HE via ICD‐9 code who started rifaximin therapy while inpatient between April 2009 and June 2014 were evaluated. Data collected included rifaximin dosing, other medications used to treat HE, duration of therapy, time to readmission, and various laboratory values. There were no differences in readmission rates at 30 days, 60 days, or 6 months between treatment groups. Additionally, there was no difference in the odds of readmission between the treatment groups (OR = 0.77, 95% CI: [0.201, 4.365], P = 0.718). Patients had a low overall probability of readmission over the observational period. Based on average wholesale price data, the cost for a 9‐day supply of rifaximin for the 400‐mg dosing regimen is $952.56 versus $605.16 for the 550‐mg dosing regimen. The rifaximin 550‐mg dosing strategy should be utilized in hospitalized patients for the prevention of recurrent HE as there was no difference in readmission rate or time to readmission between dosing groups. The 550‐mg regimen had a lower acquisition cost for a 9‐day duration of treatment in the studied institution.     

利福昔明胶囊治疗急性细菌感染性腹泻的临床疗效观察

目的:评价利福昔明胶囊治疗急性细菌感染性腹泻的疗效和安全性。方法:采用随机双盲平行对照研究。利福昔明胶囊组,每次口服利福昔明胶囊0.4 g,首日t.i.d,以后b.i.d;对照环丙沙星胶囊组,每次口服环丙沙星0.2 g,首日t.i.d,以后b.i.d,疗程均为3-5 d。治疗前后查血、尿、大便常规、肝肾功能、心电图用于安全性评价。结果:利福昔明胶囊组治疗感染性腹泻16例,有效率93.8%,对照环丙沙星胶囊组治疗感染性腹泻19例,有效率89.5%,两组间疗效差异无显著性(P >0.05)。35例中有11例治疗前粪便细菌培养阳性,阳性率31.4%,治疗后细菌清除率为100%。利福昔明胶囊组未观察到不良反应和严重不良事件发生。结论:对治疗急性细菌感染性腹泻利福昔明胶囊具有与环丙沙星胶囊同等的疗效和安全性。     

Rifaximin and eluxadoline — newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron?

Introduction: Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common functional gastrointestinal condition in which patients experience abdominal pain, diarrhea, bloating, cramps, flatulence, fecal urgency, and incontinence. Areas Covered: We review two recently approved therapies that focus on treating underlying pathogenic mechanisms of IBS-D: (1) the non-absorbable antibiotic rifaximin, and (2) the opioid receptor agonist/antagonist eluxadoline. We compare the safety and efficacy data emerging from rifaximin and eluxadoline registration trials with safety and efficacy data from the alosetron clinical development program. Expert Opinion: The rifaximin and eluxadoline clinical development programs for IBS-D have demonstrated significant improvement in IBS-D endpoints compared to placebo. Direct comparison of primary endpoint results from the alosetron, rifaximin, and eluxadoline pivotal trials is not possible; however, general estimates of efficacy can be made, and these demonstrate similar and significantly greater responses to ‘adequate relief’ and a composite endpoint of abdominal pain/stool form for each agent compared to placebo. With the recent approval in the United States of rifaximin and eluxadoline for IBS-D, how should clinicians employ these agents? We suggest that they be utilized sequentially, taking into consideration patient symptoms and severity, prior medical history, mode of action, cost, availability, managed care coverage, and adverse event profiles.     

利福昔明片治疗急性感染性腹泻的多中心临床研究

目的:观察利福昔明片治疗急性感染性腹泻的临床疗效和安全性.方法:采用多中心随机双盲双模拟平行对照方法,以环丙沙星片作为对照.253例急性感染性腹泻患者被随机分成试验组(127例)和对照组(126例).试验组给利福昔明片,d1为0.4g,po,tid,d2起改为0.4g,bid.对照组给环丙沙星片,d1为0.5g,po,tid,d2起改为0.5g,bid.疗程3～7d.结果:试验组和对照组疗效分别为90.40%和93.55%;无显著性差异(P>0.05).试验组发生不良反应1例1次,发生率为0.79%;对照组5例7次,发生率为3.79% (其中1例因不良事件导致脱落).结论:利福昔明片是治疗急性感染性腹泻有效且安全的口服制剂,不良反应发生率低于环丙沙星片.     

The treatment of gastroparesis,constipation and small intestinal bacterial overgrowth syndrome in patients with Parkinson’s disease

Introduction: Parkinson’s disease (PD) affects the nerves of the entire gastrointestinal (GI) tract and may result in profound gastrointestinal (GI) dysfunction leading to poor patient outcomes. Common GI disturbances in patients with PD include gastroparesis (GP), constipation and small intestinal bacterial overgrowth syndrome (SIBO). In particular, GP is difficult to treat due to the limited options available and precautions, contraindications and adverse effects associated with the approved treatments. Moreover, some commonly used medications can worsen pre-existing PD.

Areas covered: Our review will focus on treatment options for GP and SIBO with motilin agonists, dopamine receptor antagonists, Ghrelin agonists muscarinic agonists, 5-HT₄ receptor agonists, antibiotics, probiotics and herbal formulation such as iberogast. Constipation occurs in the majority of patients with PD and fortunately many treatments are now available. Our review is based on original papers or reviews selected from PUBMED search and Cochrane reviews.

Expert opinion: Motility disorders of the GI tract are found frequently in patients with PD and treating the underlying GI disorders caused by PD with various prokinetics and laxatives is paramount in achieving improvements in patient’s motor function. Various prokinetics and laxatives are now available to provide some relief of the GI morbidity caused by PD leading even to better absorption of even the PD treatments.     

国产利福昔明胶囊治疗急性肠道感染的荟萃分析

目的：探讨利福昔明治疗急性肠道感染的疗效和安全性。方法：按照荟萃分析的要求全面检索了中国数字医院图书馆（www.chkd.cnki.net）、中国医学科学院的中国生物医学文献光盘数据库（CBMdisk）,对符合纳入标准的5篇文献共计794名患者进行了Meta分析。结果：发表性偏倚分析显示5篇文献的倒漏斗图是对称的。异质性检验,利福昔明组与对照组（环丙沙星）具有临床及统计学上的同质性（P=0.52、I2=0%）,可用固定效应模型进行分析。合并分析显示：利福昔明组与环丙沙星组比较,疗效的差异无统计学意义。结论：从现有的临床证据来看,利福昔明治疗急性肠道感染有效,与环丙沙星疗效相当,安全性较高,值得推广应用。     

用于非便秘型肠易激综合征的药物Xifaxan

Salix制药公司近期宣布其开发的广谱抗生素Xifaxan(rifaximin)的两项Ⅲ期临床研究获得了阳性结果.在这两项大规模、多中心、各由600名非便秘型肠易激综合征(IBS)患者参加的研究中,受试者接受Xifaxan 550 mg或安慰剂,每日3次,共2周.