CC BY-NC-ND 4.0 · Homeopathy
DOI: 10.1055/s-0040-1708045
Research Review
The Faculty of Homeopathy

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy

1  Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany
,
Harald Walach
2  Department of Pediatric Gastroenterology, Medical University Poznan, Poznan, Poland
3  Department of Psychology, Universität Witten-Herdecke, Witten, Germany
4  Change Health Science Institute, Berlin, Germany
,
Roja Varanasi
5  Central Council for Research in Homoeopathy, New Delhi, India
,
Raj K. Manchanda
5  Central Council for Research in Homoeopathy, New Delhi, India
,
Praveen Oberai
5  Central Council for Research in Homoeopathy, New Delhi, India
,
Elizabeth Thompson
6  National Centre for Integrative Medicine (NCIM), Litfield Medical Centre, Bristol, United Kingdom
,
Susanne Ulbrich-Zürni
7  Institute of Integrative Medicine, Universität Witten-Herdecke, Witten, Germany
› Author Affiliations
Funding This project of Wissenschaftliche Gesellschaft für Homöopathie (WissHom) was supported by Homöopathiestiftung des Deutschen Zentralvereins homöopathischer Ärzte and Robert Bosch Stiftung as part of the Homeopathic Guideline Project.
Further Information

Publication History

07 September 2019

24 January 2019

Publication Date:
14 May 2020 (online)

  

Abstract

Background Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

Highlights

• Observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity, is an important research tool to describe real-world care settings, and can assist with the design and inform the results of RCTs.


• We give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines relevant for homeopathy that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and the ENCePP Guide.


• We add information to the existing statements and guidelines that are specifically meant for homeopathy studies.