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A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.
Am J Gastroenterol 2016; 111(12):1824-1832AJ

Abstract

OBJECTIVES

There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients.

METHODS

This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires.

RESULTS

After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating, consistency, frequency, and urgency than the mNICE diet.

CONCLUSIONS

In this US trial, 40-50% of patients reported adequate relief of their IBS-D symptoms with the low FODMAP diet or a diet based on modified NICE guidelines. The low FODMAP diet led to significantly greater improvement in individual IBS symptoms, particularly pain and bloating, compared with the mNICE diet.

Authors+Show Affiliations

Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.University of Michigan Health System, Michigan Clinical Research Unit and Nutrition Obesity Research Center, Ann Arbor, Michigan, USA.University of Michigan Health System, Nutrition Obesity Research Center, Ann Arbor, Michigan, USA.Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27725652

Citation

Eswaran, Shanti L., et al. "A Randomized Controlled Trial Comparing the Low FODMAP Diet Vs. Modified NICE Guidelines in US Adults With IBS-D." The American Journal of Gastroenterology, vol. 111, no. 12, 2016, pp. 1824-1832.
Eswaran SL, Chey WD, Han-Markey T, et al. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. Am J Gastroenterol. 2016;111(12):1824-1832.
Eswaran, S. L., Chey, W. D., Han-Markey, T., Ball, S., & Jackson, K. (2016). A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. The American Journal of Gastroenterology, 111(12), pp. 1824-1832. doi:10.1038/ajg.2016.434.
Eswaran SL, et al. A Randomized Controlled Trial Comparing the Low FODMAP Diet Vs. Modified NICE Guidelines in US Adults With IBS-D. Am J Gastroenterol. 2016;111(12):1824-1832. PubMed PMID: 27725652.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. AU - Eswaran,Shanti L, AU - Chey,William D, AU - Han-Markey,Theresa, AU - Ball,Sarah, AU - Jackson,Kenya, Y1 - 2016/10/11/ PY - 2016/03/25/received PY - 2016/08/10/accepted PY - 2016/10/12/pubmed PY - 2019/3/21/medline PY - 2016/10/12/entrez SP - 1824 EP - 1832 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 111 IS - 12 N2 - OBJECTIVES: There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. METHODS: This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. RESULTS: After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating, consistency, frequency, and urgency than the mNICE diet. CONCLUSIONS: In this US trial, 40-50% of patients reported adequate relief of their IBS-D symptoms with the low FODMAP diet or a diet based on modified NICE guidelines. The low FODMAP diet led to significantly greater improvement in individual IBS symptoms, particularly pain and bloating, compared with the mNICE diet. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/27725652/full_citation L2 - http://Insights.ovid.com/pubmed?pmid=27725652 DB - PRIME DP - Unbound Medicine ER -