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A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

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.

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  • Publisher Full Text
  • 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.

    Source

    The American journal of gastroenterology 111:12 2016 Dec pg 1824-1832

    MeSH

    Abdominal Pain
    Adult
    Aged
    Diarrhea
    Disaccharides
    Female
    Fermentation
    Fructose
    Humans
    Irritable Bowel Syndrome
    Lactose
    Male
    Middle Aged
    Monosaccharides
    Oligosaccharides
    Polymers
    Practice Guidelines as Topic
    Treatment Outcome
    Young Adult

    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 -