Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine

Background: Randomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of tri...

Full description

Bibliographic Details
Main Authors: Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni, Petra Weiermayer
Format: Article
Language:English
Published: Elsevier 2023-09-01
Series:Complementary Therapies in Medicine
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S0965229923000481
_version_ 1827862941934813184
author Katharina Gaertner
Klaus von Ammon
Philippa Fibert
Michael Frass
Martin Frei-Erb
Christien Klein-Laansma
Susanne Ulbrich-Zuerni
Petra Weiermayer
author_facet Katharina Gaertner
Klaus von Ammon
Philippa Fibert
Michael Frass
Martin Frei-Erb
Christien Klein-Laansma
Susanne Ulbrich-Zuerni
Petra Weiermayer
author_sort Katharina Gaertner
collection DOAJ
description Background: Randomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking. Objectives: This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy. Methods: Identification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy. Results: Recommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented. Conclusions: The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.
first_indexed 2024-03-12T14:01:46Z
format Article
id doaj.art-5f8c84a956624d84bee998e3a7a5449c
institution Directory Open Access Journal
issn 0965-2299
language English
last_indexed 2024-03-12T14:01:46Z
publishDate 2023-09-01
publisher Elsevier
record_format Article
series Complementary Therapies in Medicine
spelling doaj.art-5f8c84a956624d84bee998e3a7a5449c2023-08-22T04:06:43ZengElsevierComplementary Therapies in Medicine0965-22992023-09-0176102961Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicineKatharina Gaertner0Klaus von Ammon1Philippa Fibert2Michael Frass3Martin Frei-Erb4Christien Klein-Laansma5Susanne Ulbrich-Zuerni6Petra Weiermayer7Institute of Complementary and Integrative Medicine IKIM, University of Bern, Freiburgstr. 46, CH-3010 Bern, Switzerland; Institute of Integrative Medicine, University of Witten/Herdecke, Gerhard-Kienle-Weg 4, DE-58313 Herdecke, GermanyInstitute of Complementary and Integrative Medicine IKIM, University of Bern, Freiburgstr. 46, CH-3010 Bern, SwitzerlandDepartment of Psychology and Pedagogic Science, St Mary’s University, Twickenham, UKem. Medical University of Vienna, Department of Medicine I, A-1090 Vienna, Austria; Institute for Homeopathic Research, Columbusgasse 20, A-1100 Vienna, AustriaInstitute of Complementary and Integrative Medicine IKIM, University of Bern, Freiburgstr. 46, CH-3010 Bern, SwitzerlandLouis Bolk Institute, Health and Nutrition, Kosterijland 3-5, NL-3981 AJ Bunnik, the NetherlandsWissHom: Scientific Society for Homeopathy, Wallstraße 48, DE-06366 Koethen, GermanyWissHom: Scientific Society for Homeopathy, Wallstraße 48, DE-06366 Koethen, Germany; Corresponding author.Background: Randomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking. Objectives: This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy. Methods: Identification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy. Results: Recommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented. Conclusions: The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.http://www.sciencedirect.com/science/article/pii/S0965229923000481Randomised controlled trialRCTHomeopathyVeterinary homeopathyRecommendationsGuidelines
spellingShingle Katharina Gaertner
Klaus von Ammon
Philippa Fibert
Michael Frass
Martin Frei-Erb
Christien Klein-Laansma
Susanne Ulbrich-Zuerni
Petra Weiermayer
Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
Complementary Therapies in Medicine
Randomised controlled trial
RCT
Homeopathy
Veterinary homeopathy
Recommendations
Guidelines
title Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
title_full Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
title_fullStr Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
title_full_unstemmed Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
title_short Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
title_sort recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
topic Randomised controlled trial
RCT
Homeopathy
Veterinary homeopathy
Recommendations
Guidelines
url http://www.sciencedirect.com/science/article/pii/S0965229923000481
work_keys_str_mv AT katharinagaertner recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT klausvonammon recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT philippafibert recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT michaelfrass recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT martinfreierb recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT christienkleinlaansma recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT susanneulbrichzuerni recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine
AT petraweiermayer recommendationsinthedesignandconductionofrandomisedcontrolledtrialsinhumanandveterinaryhomeopathicmedicine