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Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome.
Am J Gastroenterol. 2006; 101(7):1581-90 (ISSN: 0002-9270)
Whorwell PJ; Altringer L; Morel J; Bond Y; Charbonneau D; O'Mahony L; Kiely B; Shanahan F; Quigley EM
Department of Medicine, University of Manchester, Manchester, UK.
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.
http://www.medscape.com/medline/abstract/16863564
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Dig Liver Dis. 2007 Apr 7;
Peppermint oil (Mintoil((R))) in the treatment of irritable bowel syndrome: A prospective double blind placebo-controlled randomized trial.
Cappello G, Spezzaferro M, Grossi L, Manzoli L, Marzio L.
Section of Digestive Sciences, Department of Medicine, G.d'Annunzio University, Chieti-Pescara, Italy.
INTRODUCTION: The use of peppermint oil in treating the irritable bowel syndrome has been studied with variable results probably due to the presence of patients affected by small intestinal bacterial overgrowth, lactose intolerance or celiac disease that may have symptoms similar to irritable bowel syndrome.
AIM: The aim of the study was to test the effectiveness of enteric-coated peppermint oil in patients with irritable bowel syndrome in whom small intestinal bacterial overgrowth, lactose intolerance and celiac disease were excluded.
METHODS: Fifty-seven patients with irritable bowel syndrome according to the Rome II criteria, with normal lactose and lactulose breath tests and negative antibody screening for celiac disease, were treated with peppermint oil (two enteric-coated capsules twice per day or placebo) for 4 weeks in a double blind study. The symptoms were assessed before therapy (T(0)), after the first 4 weeks of therapy (T(4)) and 4 weeks after the end of therapy (T(8)). The symptoms evaluated were: abdominal bloating, abdominal pain or discomfort, diarrhoea, constipation, feeling of incomplete evacuation, pain at defecation, passage of gas or mucus and urgency at defecation. For each symptom intensity and frequency from 0 to 4 were scored. The total irritable bowel syndrome symptoms score was also calculated as the mean value of the sum of the average of the intensity and frequency scores of each symptom.
RESULTS: At T(4), 75% of the patients in the peppermint oil group showed a >50% reduction of basal (T(0)) total irritable bowel syndrome symptoms score compared with 38% in the placebo group (P<0.009). With peppermint oil at T(4) and at T(8) compared with T(0) a statistically significant reduction of the total irritable bowel syndrome symptoms score was found (T(0): 2.19+/-0.13, T(4): 1.07+/-0.10*, T(8): 1.60+/-0.10*, *P<0.01 compared with T(0), mean+/-S.E.M.), while no change was found with the placebo.
CONCLUSION: A 4 weeks treatment with peppermint oil improves abdominal symptoms in patients with irritable bowel syndrome.
PMID: 17420159
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17420159&query_hl=2&itool=pubmed_DocSum
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Bacterial flora in irritable bowel syndrome: role in pathophysiology, implications for management
Author: QUIGLEY, Eamonn M M
Source: Chinese Journal of Digestive Diseases, Volume 8, Number 1, February 2007, pp. 2-7(6)
Publisher: Blackwell Publishing
Abstract:
Irritable bowel syndrome (IBS) may, in part at least, result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa which, in turn, leads to immune activation in the colonic mucosa. Some propose a role for bacterial overgrowth as a common causative factor in the pathogenesis of symptoms in IBS; other evidence points to more subtle qualitative changes in the colonic flora; both hypotheses remain to be confirmed but the likelihood that bacterial overgrowth will prove to be a major factor in IBS now seems remote. Nevertheless, short-term therapy with either antibiotics or probiotics does seem to reduce symptoms among IBS patients. It seems most likely that the benefits of antibiotic therapy are mediated through subtle and, perhaps, localized, quantitative and/or qualitative changes in the colonic flora. How probiotics exert their effects remain to be defined but an anti-inflammatory effect seems likely. While this approach to the management of IBS is in its infancy, it is evident that manipulation of the flora, whether through the administration of antibiotics or probiotics, deserves further attention in IBS.
http://www.ingentaconnect.com/content/bsc/cdd/2007/00000008/00000001/art00002;jsessionid=1sugnl2qgrwj9.henrietta
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Probiotics and irritable bowel syndrome: a rationale for their use and an assessment of the evidence to date
Authors: quigley, e. m. m.1; flourie, b.2
Source: Neurogastroenterology and Motility, Volume 19, Number 3, March 2007, pp. 166-172(7)
Abstract:
 
Probiotics, defined as live organisms that, when ingested in adequate amounts, exert a health benefit on the host, have been used for almost a century in the management of a variety of medical disorders, usually on the basis of little evidence. Advances in our understanding of the gut flora and of its relationship to the host, together with progress in microbiology, molecular biology and clinical research have identified important biological properties for probiotics and demonstrated efficacy in a number of gastrointestinal disorders. The clear delineation of a post-infective variety of irritable bowel syndrome (IBS), as well as the description, in a number of studies, of evidence of low-grade inflammation and immune activation in IBS, suggest a role for a dysfunctional relationship between the indigenous flora and the host in IBS and, accordingly, provide a clear rationale for the use of probiotics in this disorder. Other modes of action, including bacterial displacement and alterations in luminal contents, are also plausible. While clinical evidence of efficacy is now beginning to emerge, a review of available trials emphasises the importance of clear definition of strain selection, dose and viability. This is evidently an area of great potential in IBS and deserves further study at all levels.
http://www.ingentaconnect.com/content/bsc/ngem/2007/00000019/00000003/art00002;jsessionid=2nfe9c9ti2pt1.alice
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April 13, 2007 — Peppermint oil is effective in treating digestive disorders and other conditions including headaches, although high dosages may cause adverse effects, according to the results of a review reported in the April 1 issue of American Family Physician.
"The medicinal use of peppermint and other mint plants probably dates back to the herbal pharmacopoeia of ancient Greece, where peppermint leaf traditionally was used internally as a digestive aid and for management of gallbladder disease; it also was used in inhaled form for upper respiratory symptoms and cough," write Benjamin Kligler, MD, MPH, from the Albert Einstein College of Medicine of Yeshiva University in New York, and Sapna Chaudhary, DO, from the Beth Israel Continuum Center for Health and Healing in New York. "Peppermint oil, which is extracted from the stem, leaves, and flowers of the plant, has become popular as a treatment for a variety of conditions, including irritable bowel syndrome (IBS), headache, and non-ulcer dyspepsia."
Specific applications of note are as follows:
Peppermint leaf and oil have a long history of use for digestive disorders.
Enteric-coated peppermint oil is a safe alternative to effectively reduce some IBS symptoms, recent evidence suggests, although some evidence is conflicting (evidence rating, B).
Peppermint oil combined with caraway oil appears moderately effective in treating nonulcer dyspepsia (evidence rating, B).
Peppermint oil applied topically may effectively treat tension headache (evidence rating, B).
Peppermint oil has relaxant effects on smooth muscle. When given via enema, it has been shown to be modestly effective in relieving colonic spasm in patients undergoing barium enemas (evidence rating, B).
Although peppermint oil is well tolerated at the commonly recommended dosage, it may cause significant adverse effects at higher dosages. Common adverse effects include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Interstitial nephritis and acute renal failure are rare.
Because peppermint oil may inhibit the cytochrome P450 1A2 system, it may interact with drugs metabolized via this system.
Peppermint oil is contraindicated in patients with hiatal hernia, severe gastroesophageal reflux, and gallbladder disorders and should be used with caution in pregnant and lactating women.
The recommended dosage is 0.2 to 0.4 mL of peppermint oil 3 times daily in enteric-coated capsules for adults, and 0.1 to 0.2 mL of peppermint oil 3 times daily for children older than 8 years.
"Peppermint oil should not be used internally or on or near the face in infants and young children because of its potential to cause bronchospasm, tongue spasms, and, possibly, respiratory arrest," the authors conclude. "However, the amount of peppermint in over-the-counter medications, topical preparations, and herbal teas is likely safe in pregnant and lactating women and in young children."
The authors have disclosed no relevant financial relationships.
Am Fam Physician. 2007;75:1027-1030.
Clinical Context
Peppermint has been used as a medicinal substance for thousands of years. Most modern preparations of peppermint use its oil, which usually is provided with an enteric coating to prevent gastroesophageal reflux. This oil contains menthol, menthone, cineol, and other oils, and there is evidence that this combination of compounds can relax gastrointestinal smooth muscle as well as lower esophageal sphincter pressure.
Peppermint oil has been used to treat not only gastrointestinal complaints but also headache. The current article reviews the efficacy and safety of peppermint oil for these indications.
Study Highlights
Peppermint oil appears to be mildly effective in reducing symptoms of IBS, particularly flatulence, abdominal pain, and distension, in adults. However, there has been significant heterogeneity among research into this subject.
A study of children between the ages of 8 and 17 years who had IBS found that peppermint oil was more effective than placebo in reducing the severity of abdominal pain.
2 trials have demonstrated that treatment with peppermint oil reduced the risk for gastrointestinal spasm during barium enema, with peppermint associated with up to a 3-fold increase vs placebo in the rate of having a procedure free of spasm.
The combination of 90 mg of peppermint oil plus 50 mg of caraway oil has been demonstrated to reduce symptoms of nonulcer dyspepsia, including fullness, bloating, and spasm. This combination should be used cautiously for patients with dyspepsia, as peppermint oil may promote gastroesophageal reflux.
2 studies have delineated the efficacy of topical peppermint oil in tension headache. In 1 study, a combination of peppermint and ethanol was superior to placebo in terms of analgesia. Another trial demonstrated that topical peppermint oil was similar to acetaminophen in terms of treatment efficacy.
The therapeutic dosage in most trials of peppermint oil and IBS was 0.2 to 0.4 mL taken 3 times daily in enteric-coated capsules. The 1 trial examining its use for childhood IBS used a dosage of 0.1 mL of peppermint oil 3 times daily for children weighing less than 45 kg.
Peppermint oil can be toxic in overdose, leading to interstitial nephritis and acute renal failure. Because it may promote gallstone formation, it should not be used in patients with cholelithiasis or cholecystitis. Peppermint oil also may trigger menstruation and should not be used during pregnancy.
The most common adverse events associated with peppermint oil include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Peppermint oil may inhibit the cytochrome P450 1A2 system.
Pearls for Practice
Peppermint oil contains menthol, menthone, and cineol and may work by relaxing smooth muscle in the gastrointestinal tract. Peppermint oil also may reduce lower esophageal sphincter pressure and therefore usually is supplied with enteric coating.
Peppermint oil offers mild efficacy for symptoms of IBS and may improve colonic spasm associated with barium enema. Topical formulations of peppermint oil may improve tension headache.
http://www.medscape.com/viewarticle/555147
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Clin Ther. 2007 Jun;29(6):1153-60.
Prescript-assist probiotic-prebiotic treatment for irritable bowel syndrome: an open-label, partially controlled, 1-year extension of a previously published controlled clinical trial.
Bittner AC, Croffut RM, Stranahan MC, Yokelson TN.
OBJECTIVE: The aim of this study was to extend a previous 2-week assessment of a probiotic-prebiotic complex in patients with irritable bowel syndrome (IBS).
METHODS: In this open-label, partially controlled, 1-year (14 [2] months) extension study, data were collected from patients with IBS who continued treatment following a 2-week study of the efficacy of the probiotic-prebiotic complex. Data were collected at 2 and approximately 60 weeks after the end of the original study.
RESULTS: A total of 25 patients entered the 2-week extension and 22 completed the approximately 60-week follow-up study (20 women, 2 men; age range, 20-70 years; all white). Results in the control group 2 weeks after crossover to treatment were similar to those from the original study, with reductions in IBS subsyndromes, as follows: general ill feelings/nausea (P < 0.001), indigestion/flatulence (P < 0.001), and marginally colitis (P < 0.03 [1-tailed]). Treatment was associated with a continued reduction in general ill feelings/nausea at 4 weeks (P < 0.007). At >or=52-week follow-up, the rate of remissions was 81.5% to 100% (P < 0.003).
CONCLUSION: Based on the results from the present 1-year extension study, treatment with this probiotic-prebiotic complex may be an option for short-term (2-4 weeks) and long-term ( approximately 60-week) reductions in IBS symptoms.
PMID: 17692729 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17692729&ordinalpos=17&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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Gastroenterol Clin North Am. 2007 Sep;36(3):735-48.
Bacteria: a new player in gastrointestinal motility disorders-infections, bacterial overgrowth, and probiotics.
Quigley EM.
Department of Medicine, Alimentary Pharmabiotic Centre, University College Cork, Clinical Sciences Building, Cork University Hospital, Cork, Ireland.
Irritable bowel syndrome (IBS) may result from a dysfunctional interaction between the indigenous flora and the intestinal mucosa, which in turn leads to immune activation in the colonic mucosa. Some propose that bacterial overgrowth is a common causative factor in the pathogenesis of symptoms in IBS; others point to evidence suggesting that the cause stems from more subtle qualitative changes in the colonic flora.
Bacterial overgrowth will probably prove not to be a major factor in what will eventually be defined as IBS. Nevertheless, short-term therapy with either antibiotics or probiotics seems to reduce symptoms among IBS patients. However, in the long term, safety issues will favor the probiotic approach; results of long-term studies with these agents are eagerly awaited.
PMID: 17950446 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17950446&ordinalpos=15&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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J Am Coll Nutr. 2007 Dec;26(6):684S-90S.
Probiotics in irritable bowel syndrome: an immunomodulatory strategy?
Quigley EM.
Alimentary Pharmabiotic Centre, University College Cork, Cork, IRELAND.
The clear delineation of a post-infective variety of IBS, as well as the description, in a number of studies, of evidence of low-grade inflammation and immune activation in IBS, suggest a role for a dysfunctional relationship between the indigenous flora and the host in IBS and, accordingly, provide a clear rationale for the use of probiotics in this disorder.
Other modes of action, including bacterial displacement and alterations in luminal contents, are also plausible. While clinical evidence of efficacy is now beginning to emerge, a review of available trials emphasizes the importance of a clear definition of strain selection, dose and viability. The possible roles of co-therapy or sequential therapy with antibiotics, probiotics, prokinetics, or other agents also deserves further study.
The role of the enteric flora is evidently an area of great potential in IBS; we are on the threshold of a new era of research and therapy for this common disorder.
PMID: 18187434 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/18187434?ordinalpos=10&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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Dis Colon Rectum. 2008 May 9.
Efficacy of Probiotics in Irritable Bowel Syndrome: A Meta-Analysis of Randomized, Controlled Trials.
Nikfar S, Rahimi R, Rahimi F, Derakhshani S, Abdollahi M.
Drug Selecting Committee, Food and Drug Organization, Food & Drug Laboratory Research Center, Ministry of Health & Medical Education, Tehran, Iran.
PURPOSE: This study was designed to evaluate whether probiotics improve symptoms in patients with irritable bowel syndrome.
METHODS: PubMed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies that investigated the efficacy of probiotics in the management of irritable bowel syndrome. Clinical improvement was the key outcome of interest. Data were searched within the time period of 1966 through September 2007.
RESULTS: Eight randomized, placebo-controlled, clinical trials met our criteria and were included in the analysis. Pooling of eight trials for the outcome of clinical improvement yielded a significant relative risk of 1.22 (95 percent confidence interval, 1.07-1.4; P = 0.0042).
CONCLUSIONS: Probiotics may improve symptoms of irritable bowel syndrome and can be used as supplement to standard therapy.
PMID: 18465170 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/18465170?ordinalpos=28&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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J Gastroenterol. 2008 May 29.
Gastrointestinal Microbiota in Irritable Bowel Syndrome: Their Role in Its Pathogenesis and Treatment.
Parkes GC, Brostoff J, Whelan K, Sanderson JD.
Diet and Gastrointestinal Health, Nutritional Sciences Division, King's College London, London, United Kingdom.
Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal pain, change in bowel habit, and bloating. It has traditionally been viewed as a disorder of visceral hypersensitivity heavily influenced by stress, and therefore therapeutic strategies to date have largely reflected this. However, more recently, there is good evidence for a role of the gastrointestinal (GI) microbiota in its pathogenesis. Changes in fecal microbiota, the use of probiotics, the phenomenon of postinfectious IBS, and the recognition of an upregulated host immune system response suggest that an interaction between the host and GI microbiota may be important in the pathogenesis of IBS. This article explores the role of the GI microbiota in IBS and how their modification might lead to therapeutic benefit.
PMID: 18513268 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/18513268?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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