Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)

Carol Angela Howell; Anu Kemppinen; Victoria Allgar; Matthew Dodd; Charles H. Knowles; John Mclaughlin; Preeti Pandya; Peter Whorwell; Elena Markaryan; Yan Yiannakou

doi:10.1136/gutjnl-2022-327293

Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)

Carol Angela Howell, Anu Kemppinen, Victoria Allgar, Matthew Dodd, Charles H. Knowles, John Mclaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan, Yan Yiannakou^*

^*Corresponding author for this work

Peninsula Medical School

Research output: Contribution to journal › Article › peer-review

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Abstract

ObjectiveIrritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.DesignAfter a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period.Results440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect −0.32 (−0.62 to −0.02)) and urgency (treatment effect −0.59 (−0.85 to −0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.ConclusionEnterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options.Trial registration numberISRCTN17149988.

Original language	English
Number of pages	0
Journal	Gut
Volume	0
Issue number	0
Early online date	27 Jun 2022
DOIs	https://doi.org/10.1136/gutjnl-2022-327293
Publication status	Published - 27 Jun 2022

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Gutjnl-2022-327293

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@article{f106a3ba29a7414db44f2726d0d56d9f,

title = "Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)",

abstract = "ObjectiveIrritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.DesignAfter a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period.Results440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect −0.32 (−0.62 to −0.02)) and urgency (treatment effect −0.59 (−0.85 to −0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.ConclusionEnterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options.Trial registration numberISRCTN17149988.",

author = "Howell, {Carol Angela} and Anu Kemppinen and Victoria Allgar and Matthew Dodd and Knowles, {Charles H.} and John Mclaughlin and Preeti Pandya and Peter Whorwell and Elena Markaryan and Yan Yiannakou",

year = "2022",

month = jun,

day = "27",

doi = "10.1136/gutjnl-2022-327293",

language = "English",

volume = "0",

journal = "Gut",

issn = "0017-5749",

publisher = "BMJ Publishing Group",

number = "0",

}

TY - JOUR

T1 - Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)

AU - Howell, Carol Angela

AU - Kemppinen, Anu

AU - Allgar, Victoria

AU - Dodd, Matthew

AU - Knowles, Charles H.

AU - Mclaughlin, John

AU - Pandya, Preeti

AU - Whorwell, Peter

AU - Markaryan, Elena

AU - Yiannakou, Yan

PY - 2022/6/27

Y1 - 2022/6/27

N2 - ObjectiveIrritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.DesignAfter a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period.Results440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect −0.32 (−0.62 to −0.02)) and urgency (treatment effect −0.59 (−0.85 to −0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.ConclusionEnterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options.Trial registration numberISRCTN17149988.

AB - ObjectiveIrritable bowel syndrome with diarrhoea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhoea. This randomised controlled multicentre trial aimed to investigate its safety and efficacy in patients with IBS-D.DesignAfter a 2-week screening phase, participants were randomised into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least one stool of BSFS type 6 or 7) score during at least 4 weeks of the treatment period.Results440 patients with IBS-D were randomised to the double-blind phase with 393 continuing to the open-label phase. The Primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% vs 24.3% (OR 1.95, NNT 8, p=0.002). Enterosgel also improved stool consistency (48.5% vs 32.5%, p<0.0001) abdominal pain (53.3% vs 40.2%, p=0.003), stool frequency (treatment effect −0.32 (−0.62 to −0.02)) and urgency (treatment effect −0.59 (−0.85 to −0.33)). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.ConclusionEnterosgel is safe and effective in IBS-D, providing an alternative to the limited current treatment options.Trial registration numberISRCTN17149988.

U2 - 10.1136/gutjnl-2022-327293

DO - 10.1136/gutjnl-2022-327293

M3 - Article

SN - 0017-5749

VL - 0

JO - Gut

JF - Gut

IS - 0

ER -

Double-blinded randomised placebo controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhoea (IBS-D)

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