Treatment and Prevention of Pouchitis After Ileal Pouch-Anal Anastomosis for Chronic Ulcerative Colitis (Review)
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Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis (Review) Holubar SD, Cima RR, Sandborn WJ, Pardi DS This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 6 http://www.thecochranelibrary.com Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 4 Figure1. ..................................... 6 Figure2. ..................................... 7 Figure3. ..................................... 7 Figure4. ..................................... 8 Figure5. ..................................... 9 Figure6. ..................................... 9 Figure7. ..................................... 10 Figure8. ..................................... 10 Figure9. ..................................... 11 Figure10. ..................................... 11 Figure11. ..................................... 12 DISCUSSION ..................................... 12 AUTHORS’CONCLUSIONS . 13 ACKNOWLEDGEMENTS . 14 REFERENCES ..................................... 15 CHARACTERISTICSOFSTUDIES . 17 DATAANDANALYSES. 27 Analysis 1.1. Comparison 1 Acute Pouchitis, Outcome 1 Ciprofloxacin vs. Metronidazole: Achieved Remission (PDAI <7)...................................... 28 Analysis 1.2. Comparison 1 Acute Pouchitis, Outcome 2 Budesonide enema vs. Metronidazole: Achieved Remission (PDAI <7)...................................... 28 Analysis 1.3. Comparison 1 Acute Pouchitis, Outcome 3 Rifaximin vs. Placebo: Achieved Remission (PDAI <7). 29 Analysis 1.4. Comparison 1 Acute Pouchitis, Outcome 4 Lactobacillus GG vs. Placebo: Improved (PDAI reduction ≥ 3). 29 Analysis 2.1. Comparison 2 Chronic Pouchitis, Outcome 1 Glutamine suppositories vs. Butyrate suppositories: Achieved Remission (no recurrence of symptoms). 30 Analysis 2.2. Comparison 2 Chronic Pouchitis, Outcome 2 Bismuth Carbomer Foam Enemas vs. Placebo: Improved (PDAI reduction ≥ 3). .............................. 30 Analysis 2.3. Comparison 2 Chronic Pouchitis, Outcome 3 VSL#3 vs. Placebo: Relapse of Pouchitis (PDAI increase ≥ 2)....................................... 31 Analysis 3.1. Comparison 3 Prevention of Pouchitis, Outcome 1 VSL#3 vs. Placebo: No Episodes of Acute Pouchitis (PDAI ≥ 7)...................................... 31 Analysis 3.2. Comparison 3 Prevention of Pouchitis, Outcome 2 VSL#3 vs. No Treatment: No Episodes of Acute Pouchitis (PDAI ≥ 7)................................... 32 Analysis 3.3. Comparison 3 Prevention of Pouchitis, Outcome 3 Allopurinol vs. Placebo: No Episodes of Pouchitis (clinical diagnosis).................................... 32 WHAT’SNEW..................................... 32 HISTORY....................................... 33 CONTRIBUTIONSOFAUTHORS . 33 DECLARATIONSOFINTEREST . 33 SOURCESOFSUPPORT . 33 INDEXTERMS .................................... 34 Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis (Review) i Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis Stefan D Holubar2, Robert R Cima2, William J Sandborn1, Darrell S Pardi1 1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. 2 Division of Colon and Rectal Surgery, Department of Surgery, Mayo Clinic, Rochester, MN, USA Contact address: Darrell S Pardi, Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. [email protected]. Editorial group: Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 6, 2010. Review content assessed as up-to-date: 4 October 2009. Citation: Holubar SD, Cima RR, Sandborn WJ, Pardi DS. Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis. Cochrane Database of Systematic Reviews 2010, Issue 6. Art. No.: CD001176. DOI: 10.1002/14651858.CD001176.pub2. Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Pouchitis may occur following ileal pouch-anal anastomosis for chronic ulcerative colitis in approximately 30% of patients. Objectives The primary objective was to determine the efficacy of medical therapies for pouchitis (including antibiotic, probiotic, and other agents) as substantiated by data from randomized controlled trials (RCTs). Search strategy A search for RCTs from 1966 to October 2009 was performed using the MEDLINE, Cochrane Library, EMBASE, Web of Science, and Scopus databases. Selection criteria Randomized controlled treatment or prevention trials of adult patients who underwent ileal pouch-anal anastomosis for ulcerative colitis who subsequently developed pouchitis or were at risk for pouchitis were considered for inclusion. Data collection and analysis Extracted data were converted to 2X2 tables and then synthesized in to a summary statistic using the Peto odds ratio (OR) and [95% confidence intervals], or weighted mean difference (WMD), using RevMan-5 for Mac OS 10.6. Main results Eleven RCTs fulfilled the inclusion criteria and were included in the review. The efficacy of 10 different pharmacologic agents was assessed. For the treatment of acute pouchitis (4 RCTS, 5 agents), ciprofloxacin was more effective at inducing remission than metronidazole. Neither rifaximin nor lactobacillus GG were more effective than placebo, while budesonide enemas and metronidazole were similarly effective, for inducing remission of acute pouchitis. For the treatment and maintenance of remission of chronic pouchitis (4 RCTs, 4 agents), glutamine suppositories were not more effective than butyrate suppositories, and bismuth carbomer foam enemas were not more effective than placebo, while VSL#3 was more effective than placebo in maintaining remission of chronic pouchitis in Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis (Review) 1 Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. patients with chronic pouchitis who achieved remission with antibiotics. For the prevention of pouchitis (3 RCTs, 2 agents), in one study VSL#3 was more effective than placebo while in another study VSL#3 was not more effective than no treatment. Allopurinol was not more effective than placebo, while inulin was more effective than placebo but the results were not clinically significant. Authors’ conclusions For acute pouchitis, ciprofloxacin was more effective than metronidazole, while budesonide enemas and metronidazole were similarly effective. For chronic pouchitis, VSL#3 was more effective than placebo. For the prevention of pouchitis, VSL#3 was more effective than placebo. Larger RCTs are needed to determine the optimal agent(s) for the treatment and prevention of pouchitis. PLAIN LANGUAGE SUMMARY Several antibiotic agents, including metronidazole, ciprofloxacin, and rifaximin, as well as oral probiotics, may be effective treatments for pouchitis. Some patients with ulcerative colitis have their colon and rectum removed with construction of a reservoir or pouch (made from a loop of small intestine) to serve in place of the rectum. This is known as an ileal pouch-anal anastomosis (IPAA) surgery. Pouchitis is acute inflammation of the surgically constructed pouch which may cause diarrhea and other problems. The exact cause of pouchitis is not known, but it may be caused by an imbalance in bacteria (similar to an infection) and can be treated by antibiotics, probiotics (bacteria important for the health of the bowel), or other agents that may reduce or prevent inflammation. Metronidazole and Ciprofloxacin (two antibiotics), budesonide enemas (a topical steroid that may decrease inflammation), and oral probiotic therapy with VSL#3 all appear to be effective therapies for acute and/or chronic pouchitis. Current evidence does not support the use of lactobacillus GG (a different probiotic), bismuth (a metal that may be useful in some diarrheal disorders), butyrate and glutamine (two nutrients required by the bowel), allopurinol (a gout medication which may decrease inflammation), or inulin (a non-absorbable sugar which may decrease inflammation). So far the research performed has generally consisted of small studies that were not reproduced, so more research is needed to determine which of these different medications are best for treatment of pouchitis. BACKGROUND ing villous atrophy, crypt hyperplasia, and chronic inflammatory Pouchitis is an idiopathic chronic inflammatory disease that may cell infiltration (Moskowitz 1986; Shepherd 1987). Patients with occur in the ileal pouch after restorative proctocolectomy with ileal pouchitis can be classified according to disease activity and symp- pouch-anal anastomosis (IPAA) or Kock pouch (Sandborn 1994a). tom duration (Sandborn 1997; Pardi 2009). Disease activity can Although