Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics

Background: Irritable bowel syndrome (IBS) is a common functional bowel disorder with a worldwide prevalence estimated between 10% and 20%. It has a significant impact on quality of life and societal expense. While there are pharmaceutical options available, few can be reliably recommended. Many IBS...

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Main Authors: Joshua Z. Goldenberg, Amie Steel, Andrew Day, Christina Yap, Ryan Bradley, Kieran Cooley
Format: Article
Language:English
Published: Elsevier 2018-09-01
Series:Integrative Medicine Research
Online Access:http://www.sciencedirect.com/science/article/pii/S2213422017302676
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author Joshua Z. Goldenberg
Amie Steel
Andrew Day
Christina Yap
Ryan Bradley
Kieran Cooley
author_facet Joshua Z. Goldenberg
Amie Steel
Andrew Day
Christina Yap
Ryan Bradley
Kieran Cooley
author_sort Joshua Z. Goldenberg
collection DOAJ
description Background: Irritable bowel syndrome (IBS) is a common functional bowel disorder with a worldwide prevalence estimated between 10% and 20%. It has a significant impact on quality of life and societal expense. While there are pharmaceutical options available, few can be reliably recommended. Many IBS sufferers turn to complementary and alternative medicine including naturopathy. Naturopathic approaches to IBS are poorly studied to date. Methods: We aim to describe naturopathic approaches to IBS as well as establish pilot data on before and after changes in validated IBS instruments. The study will employ a multi-centered, international, prospective, observational, naturalistic design. The uncontrolled before-and-after study will examine the outcomes associated with individualized, whole system naturopathic care as determined by each provider. We will recruit adult patients diagnosed with IBS and presenting to a participating naturopathic academic teaching clinic. Participants’ IBS symptoms will be measured using validated instruments (IBS-SSS and IBS-AR). Quality of life will be measured by using the PROMIS-29 profile. Adverse events will be tracked, as followed for treatment descriptions. Our primary outcomes will be before-and-after differences using week twelve as the primary endpoint. A p values will be set at 0.05, and descriptive and summary data will be presented. Discussion: This study is designed to plug significant evidence gaps and to gather preliminary evidence to guide the design of a follow-up randomized active controlled trial.Australia and New Zealand Clinical Trial Registration Number: ACTRN12617001413314Version 1.1 Keywords: Irritable bowel syndrome, Naturopathy, Complementary therapies, Observational studies, Protocol
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spelling doaj-art-232f7bade3d94a83acb91db4abcac36c2025-08-20T02:11:18ZengElsevierIntegrative Medicine Research2213-42202018-09-017327928610.1016/j.imr.2018.06.001Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinicsJoshua Z. Goldenberg0Amie Steel1Andrew Day2Christina Yap3Ryan Bradley4Kieran Cooley5Bastyr University, Kenmore, USA; University of Technology Sydney, Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, Ultimo, Australia; Corresponding author at: Bastyr University, 14500 Juanita Dr NE,Kenmore, WA 98028,USA.University of Technology Sydney, Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, Ultimo, Australia; Endeavour College of Natural Health, Office of Research, Brisbane, AustraliaBastyr University, Kenmore, USABastyr University, Kenmore, USAUniversity of Technology Sydney, Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, Ultimo, Australia; National University of Natural Medicine, Portland, USA; University of California, San Diego, La Jolla, USAUniversity of Technology Sydney, Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, Ultimo, Australia; Canadian College of Naturopathic Medicine, North York, CanadaBackground: Irritable bowel syndrome (IBS) is a common functional bowel disorder with a worldwide prevalence estimated between 10% and 20%. It has a significant impact on quality of life and societal expense. While there are pharmaceutical options available, few can be reliably recommended. Many IBS sufferers turn to complementary and alternative medicine including naturopathy. Naturopathic approaches to IBS are poorly studied to date. Methods: We aim to describe naturopathic approaches to IBS as well as establish pilot data on before and after changes in validated IBS instruments. The study will employ a multi-centered, international, prospective, observational, naturalistic design. The uncontrolled before-and-after study will examine the outcomes associated with individualized, whole system naturopathic care as determined by each provider. We will recruit adult patients diagnosed with IBS and presenting to a participating naturopathic academic teaching clinic. Participants’ IBS symptoms will be measured using validated instruments (IBS-SSS and IBS-AR). Quality of life will be measured by using the PROMIS-29 profile. Adverse events will be tracked, as followed for treatment descriptions. Our primary outcomes will be before-and-after differences using week twelve as the primary endpoint. A p values will be set at 0.05, and descriptive and summary data will be presented. Discussion: This study is designed to plug significant evidence gaps and to gather preliminary evidence to guide the design of a follow-up randomized active controlled trial.Australia and New Zealand Clinical Trial Registration Number: ACTRN12617001413314Version 1.1 Keywords: Irritable bowel syndrome, Naturopathy, Complementary therapies, Observational studies, Protocolhttp://www.sciencedirect.com/science/article/pii/S2213422017302676
spellingShingle Joshua Z. Goldenberg
Amie Steel
Andrew Day
Christina Yap
Ryan Bradley
Kieran Cooley
Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
Integrative Medicine Research
title Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
title_full Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
title_fullStr Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
title_full_unstemmed Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
title_short Naturopathic approaches to irritable bowel syndrome: protocol for a prospective observational study in academic teaching clinics
title_sort naturopathic approaches to irritable bowel syndrome protocol for a prospective observational study in academic teaching clinics
url http://www.sciencedirect.com/science/article/pii/S2213422017302676
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