A randomized, double-blind, placebo-controlled trial of st john's wort for treating irritable bowel syndrome

Yuri Ann Saito Loftus, Enrique Rey, Ann E. Almazar-Elder, W. Scott Harmsen, Alan R. Zinsmeister, G. Richard Locke, Nicholas J. Talley

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

OBJECTIVES:St John's wort (SJW) is known to effectively treat patients with mild-to-moderate depression. Antidepressants are frequently used to treat irritable bowel syndrome (IBS). To date, no study that examines the efficacy of SJW in IBS has been carried out. The aim of this study was to evaluate the efficacy of SJW in IBS after 12 weeks.METHODS:In this randomized, double-blind, placebo-controlled trial, 70 participants with an established diagnosis of IBS were randomized and assigned by concealed allocation to either SJW or placebo. Both treatment arms were balanced on symptom subtype. The primary end point was self-reported overall bowel symptom score (BSS) at 12 weeks. Secondary end points were individual BSS for diarrhea (D-BSS), constipation (C-BSS), pain or discomfort, and bloating; adequate relief (AR) of IBS on at least 50% of the last 4 weeks of therapy; and IBS quality-of-life score at 12 weeks.RESULTS:In all, 86% of the participants were women, and the median age was 42 years. Overall, 29% had C-IBS, 37% D-IBS, and 31% had mixed IBS. Both groups reported decreases in overall BSS from baseline, with the placebo arm having significantly lower scores at 12 weeks (P0.03) compared with SJW. These patterns of improvement were mirrored in the secondary end points with the placebo group faring better than the SJW-treated group, with significant differences observed at week 12 for D-BSS (P0.03) and percent with AR (P0.02). A similar proportion of subjects in each treatment group (SJW: 51% vs. placebo: 54%) believed that the study drug they received decreased IBS life interferences (P0.79).CONCLUSIONS:SJW was a less effective treatment for IBS than placebo.

Original languageEnglish (US)
Pages (from-to)170-177
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume105
Issue number1
DOIs
StatePublished - Jan 2010

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Irritable Bowel Syndrome
Placebos
Constipation
Therapeutics
Antidepressive Agents
Diarrhea
Quality of Life
Depression
Pain

ASJC Scopus subject areas

  • Gastroenterology

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A randomized, double-blind, placebo-controlled trial of st john's wort for treating irritable bowel syndrome. / Saito Loftus, Yuri Ann; Rey, Enrique; Almazar-Elder, Ann E.; Harmsen, W. Scott; Zinsmeister, Alan R.; Locke, G. Richard; Talley, Nicholas J.

In: American Journal of Gastroenterology, Vol. 105, No. 1, 01.2010, p. 170-177.

Research output: Contribution to journalArticle

Saito Loftus, Yuri Ann ; Rey, Enrique ; Almazar-Elder, Ann E. ; Harmsen, W. Scott ; Zinsmeister, Alan R. ; Locke, G. Richard ; Talley, Nicholas J. / A randomized, double-blind, placebo-controlled trial of st john's wort for treating irritable bowel syndrome. In: American Journal of Gastroenterology. 2010 ; Vol. 105, No. 1. pp. 170-177.
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abstract = "OBJECTIVES:St John's wort (SJW) is known to effectively treat patients with mild-to-moderate depression. Antidepressants are frequently used to treat irritable bowel syndrome (IBS). To date, no study that examines the efficacy of SJW in IBS has been carried out. The aim of this study was to evaluate the efficacy of SJW in IBS after 12 weeks.METHODS:In this randomized, double-blind, placebo-controlled trial, 70 participants with an established diagnosis of IBS were randomized and assigned by concealed allocation to either SJW or placebo. Both treatment arms were balanced on symptom subtype. The primary end point was self-reported overall bowel symptom score (BSS) at 12 weeks. Secondary end points were individual BSS for diarrhea (D-BSS), constipation (C-BSS), pain or discomfort, and bloating; adequate relief (AR) of IBS on at least 50{\%} of the last 4 weeks of therapy; and IBS quality-of-life score at 12 weeks.RESULTS:In all, 86{\%} of the participants were women, and the median age was 42 years. Overall, 29{\%} had C-IBS, 37{\%} D-IBS, and 31{\%} had mixed IBS. Both groups reported decreases in overall BSS from baseline, with the placebo arm having significantly lower scores at 12 weeks (P0.03) compared with SJW. These patterns of improvement were mirrored in the secondary end points with the placebo group faring better than the SJW-treated group, with significant differences observed at week 12 for D-BSS (P0.03) and percent with AR (P0.02). A similar proportion of subjects in each treatment group (SJW: 51{\%} vs. placebo: 54{\%}) believed that the study drug they received decreased IBS life interferences (P0.79).CONCLUSIONS:SJW was a less effective treatment for IBS than placebo.",
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AU - Saito Loftus, Yuri Ann

AU - Rey, Enrique

AU - Almazar-Elder, Ann E.

AU - Harmsen, W. Scott

AU - Zinsmeister, Alan R.

AU - Locke, G. Richard

AU - Talley, Nicholas J.

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N2 - OBJECTIVES:St John's wort (SJW) is known to effectively treat patients with mild-to-moderate depression. Antidepressants are frequently used to treat irritable bowel syndrome (IBS). To date, no study that examines the efficacy of SJW in IBS has been carried out. The aim of this study was to evaluate the efficacy of SJW in IBS after 12 weeks.METHODS:In this randomized, double-blind, placebo-controlled trial, 70 participants with an established diagnosis of IBS were randomized and assigned by concealed allocation to either SJW or placebo. Both treatment arms were balanced on symptom subtype. The primary end point was self-reported overall bowel symptom score (BSS) at 12 weeks. Secondary end points were individual BSS for diarrhea (D-BSS), constipation (C-BSS), pain or discomfort, and bloating; adequate relief (AR) of IBS on at least 50% of the last 4 weeks of therapy; and IBS quality-of-life score at 12 weeks.RESULTS:In all, 86% of the participants were women, and the median age was 42 years. Overall, 29% had C-IBS, 37% D-IBS, and 31% had mixed IBS. Both groups reported decreases in overall BSS from baseline, with the placebo arm having significantly lower scores at 12 weeks (P0.03) compared with SJW. These patterns of improvement were mirrored in the secondary end points with the placebo group faring better than the SJW-treated group, with significant differences observed at week 12 for D-BSS (P0.03) and percent with AR (P0.02). A similar proportion of subjects in each treatment group (SJW: 51% vs. placebo: 54%) believed that the study drug they received decreased IBS life interferences (P0.79).CONCLUSIONS:SJW was a less effective treatment for IBS than placebo.

AB - OBJECTIVES:St John's wort (SJW) is known to effectively treat patients with mild-to-moderate depression. Antidepressants are frequently used to treat irritable bowel syndrome (IBS). To date, no study that examines the efficacy of SJW in IBS has been carried out. The aim of this study was to evaluate the efficacy of SJW in IBS after 12 weeks.METHODS:In this randomized, double-blind, placebo-controlled trial, 70 participants with an established diagnosis of IBS were randomized and assigned by concealed allocation to either SJW or placebo. Both treatment arms were balanced on symptom subtype. The primary end point was self-reported overall bowel symptom score (BSS) at 12 weeks. Secondary end points were individual BSS for diarrhea (D-BSS), constipation (C-BSS), pain or discomfort, and bloating; adequate relief (AR) of IBS on at least 50% of the last 4 weeks of therapy; and IBS quality-of-life score at 12 weeks.RESULTS:In all, 86% of the participants were women, and the median age was 42 years. Overall, 29% had C-IBS, 37% D-IBS, and 31% had mixed IBS. Both groups reported decreases in overall BSS from baseline, with the placebo arm having significantly lower scores at 12 weeks (P0.03) compared with SJW. These patterns of improvement were mirrored in the secondary end points with the placebo group faring better than the SJW-treated group, with significant differences observed at week 12 for D-BSS (P0.03) and percent with AR (P0.02). A similar proportion of subjects in each treatment group (SJW: 51% vs. placebo: 54%) believed that the study drug they received decreased IBS life interferences (P0.79).CONCLUSIONS:SJW was a less effective treatment for IBS than placebo.

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