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Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome?
BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) is a chronic relapsing disorder characterized by abdominal pain-discomfort and altered bowel habits. The IBS-diarrhoea predominant subtype (IBS-D) is defined as >25% of bowel movements representing type 6 or 7 of the Bristol Stool Form Scale. Ma...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857390/ https://www.ncbi.nlm.nih.gov/pubmed/31742138 http://dx.doi.org/10.4103/jfmpc.jfmpc_522_19 |
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author | Chakraborty, Dwaipayan Sarathi Hazra, Avijit Sil, Amrita Pain, Shantasil |
author_facet | Chakraborty, Dwaipayan Sarathi Hazra, Avijit Sil, Amrita Pain, Shantasil |
author_sort | Chakraborty, Dwaipayan Sarathi |
collection | PubMed |
description | BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) is a chronic relapsing disorder characterized by abdominal pain-discomfort and altered bowel habits. The IBS-diarrhoea predominant subtype (IBS-D) is defined as >25% of bowel movements representing type 6 or 7 of the Bristol Stool Form Scale. Management of IBS-D is mainly symptomatic, including lifestyle modification. Due to absence of standard treatment, multiple drugs are used. A controlled release (CR) form of mebeverine, recommended for spasmodic gastrointestinal disorders (including IBS) has recently been introduced in Indian market. We have conducted a placebo-controlled double blind randomized controlled trial [CTRI/2018/03/012897] to evaluate the effectiveness and safety of this product. METHODS: 40 patients of IBS-D were recruited from medicine out-patient department (OPD) of a tertiary care hospital and randomized to two parallel groups. One received mebeverine 200 mg CR tablets twice daily for 8 weeks, while other received matching placebo. Outcome parameters were number of bowel movements per day over past 7 days (NoBM7d), severity of abdominal cramps and IBS quality of life (IBSQoL) score. Medication adherence record and treatment emergent adverse events were captured. RESULTS: Mebeverine group showed modest but statistically significant improvement in NoBM7d, cramps and IBSQoL from baseline to 4 and 8 weeks. The changes within the placebo group were not statistically significant. Also, the intergroup differences at both 4 and 8 weeks were not statistically significant. Adherence was better in mebeverine group and both interventions were well tolerated. CONCLUSIONS: Mebeverine 200 mg CR twice daily has modest effect in IBS-D and therefore will not be a good choice for patients with severe symptoms. |
format | Online Article Text |
id | pubmed-6857390 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Wolters Kluwer - Medknow |
record_format | MEDLINE/PubMed |
spelling | pubmed-68573902019-11-18 Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? Chakraborty, Dwaipayan Sarathi Hazra, Avijit Sil, Amrita Pain, Shantasil J Family Med Prim Care Original Article BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) is a chronic relapsing disorder characterized by abdominal pain-discomfort and altered bowel habits. The IBS-diarrhoea predominant subtype (IBS-D) is defined as >25% of bowel movements representing type 6 or 7 of the Bristol Stool Form Scale. Management of IBS-D is mainly symptomatic, including lifestyle modification. Due to absence of standard treatment, multiple drugs are used. A controlled release (CR) form of mebeverine, recommended for spasmodic gastrointestinal disorders (including IBS) has recently been introduced in Indian market. We have conducted a placebo-controlled double blind randomized controlled trial [CTRI/2018/03/012897] to evaluate the effectiveness and safety of this product. METHODS: 40 patients of IBS-D were recruited from medicine out-patient department (OPD) of a tertiary care hospital and randomized to two parallel groups. One received mebeverine 200 mg CR tablets twice daily for 8 weeks, while other received matching placebo. Outcome parameters were number of bowel movements per day over past 7 days (NoBM7d), severity of abdominal cramps and IBS quality of life (IBSQoL) score. Medication adherence record and treatment emergent adverse events were captured. RESULTS: Mebeverine group showed modest but statistically significant improvement in NoBM7d, cramps and IBSQoL from baseline to 4 and 8 weeks. The changes within the placebo group were not statistically significant. Also, the intergroup differences at both 4 and 8 weeks were not statistically significant. Adherence was better in mebeverine group and both interventions were well tolerated. CONCLUSIONS: Mebeverine 200 mg CR twice daily has modest effect in IBS-D and therefore will not be a good choice for patients with severe symptoms. Wolters Kluwer - Medknow 2019-10-31 /pmc/articles/PMC6857390/ /pubmed/31742138 http://dx.doi.org/10.4103/jfmpc.jfmpc_522_19 Text en Copyright: © 2019 Journal of Family Medicine and Primary Care http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. |
spellingShingle | Original Article Chakraborty, Dwaipayan Sarathi Hazra, Avijit Sil, Amrita Pain, Shantasil Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title | Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title_full | Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title_fullStr | Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title_full_unstemmed | Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title_short | Will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
title_sort | will controlled release mebeverine be able to surpass placebo in treatment of diarrhoea predominant irritable bowel syndrome? |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6857390/ https://www.ncbi.nlm.nih.gov/pubmed/31742138 http://dx.doi.org/10.4103/jfmpc.jfmpc_522_19 |
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