Clinical Question: Which patients with normal upper endoscopy and negative Helicobacter pylori study results are likely to benefit from a proton pump inhibitor?
Bottom Line: Among dyspeptic patients who are negative for Helicobacter pylori (HP) and have a normal endoscopy, approximately half of those who are overweight or obese and one fifth of those who are normal weight will respond to a proton pump inhibitor (PPI). (Level of Evidence: 1b)
Reference: Fletcher J, Derakhshan MH, Jones GR, Wirz AA, McColl KE. BMI is superior to symptoms in predicting response to proton pump inhibitor: randomised trial in patients with upper gastrointestinal symptoms and normal endoscopy. Gut 2011;60(4):442-448.
Study Design: Randomized controlled trial (nonblinded)
Funding Source: Industry
Setting: Outpatient (specialty)
Synopsis: You've referred your patient with dyspepsia for endoscopy and the result is normal. Her HP results were normal, as well. Will a PPI help? This study identified 105 similar patients and randomized them in a 2:1 ratio to receive lansoprazole 30 mg per day or placebo. The primary outcome was the Glasgow Dyspepsia Severity Score, measured 2 weeks later. Patients and outcome assessors were masked, allocation was concealed, and analysis was by intention to treat. Most patients had a chief complaint of retrosternal pain or regurgitation (43%), epigastric pain (42%), or nausea and vomiting (9%). Not terribly surprisingly, patients receiving the PPI were more likely to experience a clinically meaningful 50% reduction in their symptom score (36% vs 6%; P < .001; number needed to treat [NNT] = 3). More interesting, the only noninvasive predictor of response to PPI was increasing body mass index (BMI). Patients with a BMI of at least 25 kg/m2 had a 53% response rate, compared with only 23% of those with a BMI below that cutoff (NNT = 3). In general, symptoms were found to be of little value in predicting response to a PPI in this group of patients.
MARK H. EBELL, MD, MS
University of Georgia
Clinical Question: Can probiotic treatment decrease the symptoms of irritable bowel syndrome?
Bottom Line: The probiotic Bifidobacterium bifidum MIMBb75 is a normal gastrointestinal tract inhabitant (along with several hundred other commensal organisms). This strain, found in some probiotic formulations, decreases overall symptoms in patients with irritable bowel symptoms and is an inexpensive and safe alternative to medications. (Level of Evidence: 1b)
Reference: Guglielmetti S, Mora D, Gschwender M, Popp K. Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life -- a double-blind, placebo controlled study. Alimen Pharmacol Ther 2011;33(10):1123-1132.
Study Design: Randomized controlled trial (double-blinded)
Setting: Outpatient (primary care)
Synopsis: The German investigators conducting this study recruited 132 adults with mild to moderate irritable bowel syndrome (IBS; Rome III criteria) to participate in the study. Placebo and control groups were well matched for IBS subtype, with 23% of control patients having the diarrhea-predominant type, 15% having the constipation-predominant type, and 62% having the alternating type. During the first 2 weeks patients did not receive any treatment but kept symptom diaries. Patients with at least 2 days of mild to moderate pain during the second week of the study (n = 122) were randomly assigned (allocation concealment not specified) to receive 4 weeks of treatment with placebo (maltodextrin, which uncommonly causes diarrhea) or B bifidum 1 billion units followed by 2 weeks of observation without treatment. The main outcome was a rating on a 7-point scale asking about symptoms in the past 24 hours. Scores at baseline were approximately 2.8 of a possible 6 in both groups (moderate symptoms). After treatment, these scores dropped by an average 0.88 in the treated group as compared with 0.16 in the placebo group (P < .0001). Differences in scores appeared in the first week of treatment and continued to be different throughout the treatment period. The percent of patients responding -- that is, experiencing an improvement of at least 1 point on the Likert scale in at least 2 of the 4 weeks -- was significantly higher in the treatment group (57% vs 21%; P = .0001). Scores were not significantly different in the 2 weeks after treatment was discontinued.
ALLEN F. SHAUGHNESSY, PharmD, MMedEd
Professor of Family Medicine
Clinical Question: Are dried plums as effective as psyllium for the treatment of chronic constipation in adults?
Bottom Line: Dried plums -- or prunes, as our grandmothers called them -- are at least as effective as treatment with the bulk laxative psyllium (Metamucil) in patients with chronic constipation. Bowel movement frequency will double with 6 dried plums eaten twice daily, with improvements in stool consistency and constipation symptoms. Prunes are calorie dense; a dozen contain approximately 260 calories, though the glycemic index is low (10). (Level of Evidence: 1b)
Reference: Attaluri A, Donahoe R, Valestin J, Brown J, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther 2011;33(7):822-828.
Setting: Outpatient (any)
Synopsis: This study compared the effectiveness of equivalent fiber doses of dried plums and psyllium in 40 patients, almost all women, with chronic constipation. To be enrolled, patients had to have at least 3 months of symptoms, consisting of difficult and infrequent bowel movements, a sensation of incomplete evacuation, or a sensation of anorectal blockage (ROME III criteria). After a 1-week run-in to document baseline symptoms, the patients were randomly assigned to receive 6 plums twice a day or 1 tablespoon of psyllium (6 g fiber) per day for 3 weeks. Following 1 week of no treatment the same patients were assigned to the opposite treatment for another 3 weeks. This crossover design allows each patient to serve as his or her own control and decreases the number of participants needed to find a benefit if one exists. The number of complete spontaneous bowel movements was significantly higher with dried plum treatment, increasing from an average 1.7 per week to 3.5 per week with plums and 2.8 per week with psyllium (P = .001). Stool consistency scores were also significantly improved, though straining and global constipation symptoms did not differ between treatments. All scores reverted to baseline at the 6-week follow-up after the discontinuation of all treatment. A dozen plums adds approximately 260 calories to the daily diet; 1 tablespoon of psyllium adds 50 to 90 calories per day, depending on the product.
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).
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Top 20 POEMs of 2011