Work package 7:
The Roadmap for CAM research in Europe
Leading beneficiary: University Medical Center Berlin (Charité)
The main objectives of WP7 were to:
- to analyse the research methods already used to identify prevalence and use of CAM in the EU,
- to develop research methods and strategies for CAM that take into account the needs and attitudes of EU citizens and providers,
- and to develop research strategies and a road map to enable future clinical and epidemiological research in the field of CAM regarding effectiveness, efficacy, cost effectiveness and safety.
Description of work:
WP7 collected data and expert opinions on research into CAM. The working group conducted a systematic literature search for papers published between 1990 and 2010 in 7 electronic databases (Medline, Web of Science, PsychArticles, PsycInfo, CINAHL, EMBASE and Cochrane library). Additionally, experts were asked to nominate relevant papers. Inclusion criteria were publication dealing with research methodology, priorities or complexities in the scientific evaluation of CAM. All references were assessed in a multistage process to identify relevant papers.
Furthermore, methodological aspects of WPs 3, 4 and 5 were reviewed. Based on these findings, we organised a workshop (Sept 2011) with international, distinguished experts. The workshop developed methodological recommendations in a consensus process. These recommendations were formulated into the Roadmap for CAM research in Europe within WP7 and approved by the CAMbrella final consensus conference and CAMbrella’s scientific steering committee.
Reviewing the literature revealed that from 3.279 references derived and 98 references contributed by CAM experts, 170 papers fulfilled the criteria and were included in the analysis. The following key issues have been identified: difficulties in past CAM research (e.g. randomisation, blinding), utility of quantitative and qualitative research methods in CAM, priority setting in CAM research and specific issues in regard to various CAM modalities (Fischer F et al. Key issues in clinical and epidemiological research in Complementary and Alternative Medicine – a systematic literature review. Forsch Komplementmed 2012;19(suppl 2):51-60).87
Furthermore, it is evident that the majority of previous clinical trials have assessed the efficacy rather than the effectiveness of CAM, meaning that there is a lack of data on the clinical outcomes of CAM treatments in comparison with conventional treatments in realworld settings. It can also be shown that unspecific effects seem to have significant value in CAM treatments and that reliable data about safety and adverse effects of CAM in realworld settings are scarce.
The current situation can also be characterized that there is too little knowledge about the prevalence of use of CAM in most European countries, the needs and attitudes of EU citizens, patients and providers regarding CAM, and about the types and ways of CAM provision in Europe.
There is considerable heterogeneity within CAM in the EU and these differences have hampered the development of combined European research efforts. The challenges now are
a) to gather comparable information about the real situation as regards provision, use and regulation of CAM in all countries of Europe,
b) to identify and address the areas in which CAM could play a role in the improvement of health care to European citizens, and c) to establish a scientific knowledge base that enables all stakeholders including policy makers, researchers, health care providers and citizens to make informed decisions about CAM.
Conclusions and recommendations:
In order to consider employing CAM as part of the solution to the health care challenges we face in 2020, it is vital to obtain reliable information on its prevalence of use, effectiveness, safety and cost in real world settings. This research strategy aims to provide the EU and its citizens with valuable scientific information for stakeholder decisions about CAM treatments.
1) European research in the field of CAM is limited and our knowledge about CAM is very poor. There is almost no significant investment in any EU country in a CAM research structure or strategy. The CAM industry is small and there are no major financial or/and industrial interests driving research efforts in this field. Scientific bias hampers the free exchange of ideas, concepts, treatment techniques and comparison of clinical outcomes. CAM is organised mostly in private provider settings (medical and non-medical), thus the academic experience among CAM providers is scarce and there are few academic centres of research, resulting in a substantial lack of funding for research programmes. Career opportunities in an academic setting are limited. In order to pay proper attention to the real situation of use and provision of CAM in Europe, and to understand why CAM is so popular within the EU, structural and sufficient financial support is needed at all levels: private, university bound, national and European.
2) An EU research strategy for CAM must reflect the needs of the citizens, patients, providers and other stakeholders. CAM is frequently employed in prevention, health literacy and self-management of chronic long-term conditions. Therefore it could contribute to meet the upcoming health care challenges in Europe. Consequently, it is needed to
a) establish a European-wide approach to assess the prevalence of use of core CAM disciplines,
b) address the diversity of training, education and provision of CAM across Europe,
c) identify the most promising CAM treatment options for the most prevalent health conditions in Europe (obesity, chronic diseases like diabetes, cancer, musculoskeletal problems, healthy ageing and others),
d) quantify the economic effects of CAM in European health care. Stakeholders might have different views on CAM which should be taken into account in order to achieve meaningful research and to allow informed decisions for future health planning. Consequently, following approaches should be taken into account:
e) identify the citizens’ access to and preferences for CAM provision as well as their perspectives on education, training and practice of CAM providers,
f) determine how best to disseminate scientifically sound information about CAM to the European public, in line with the EU objective to enhance the ability of citizens to make better and informed decisions about their health care,
g) give clear guidance on CAM safety issues, and
h) explore and evaluate different models of integration of CAM into routine care programmes.
3) Research methods must reflect the real-world settings of health care in Europe. Everyone needs to know in what situation CAM is a reasonable choice. Therefore we recommend a clear emphasis on concurrent evaluation of CAM as an additional or alternative treatment strategy in real-world settings. In general, CAM should be considered along the same scientific lines that apply to medical research in general. However, the strategy for the investigation of CAM should include a broad range of mixed-method research strategies including comparative effectiveness research, qualitative and quantitative designs. Stakeholders such as citizens, patients and providers should be closely involved to ensure real world relevance for the research. This would imply a) to implement comparative effectiveness research (CER) and concurrent health economic evaluation of different treatment strategies including CAM, b) to put emphasis on the investigation of CAM safety in clinical contexts, e.g. by support of country-wide registers, observational studies, single case studies or case histories, and c) to address the impact of context and meaning factors (generally known as non-specific effects and may include the “placebo effect”) such as preferences and expectations in clinical research.
4. Currently there is little research on CAM in Europe and no structure through which research can be co-ordinated within the EU. There is a widely recognised need to ensure high quality research to enable scientific knowledge that is considered adequate for informed decision making by both providers and patients of CAM.
CAMbrella proposes that the EU actively supports an EU-wide strategic approach to facilitate the development of CAM research, through the funding of an EU centre for CAM that looks into the situation of CAM and gives research-based guidelines on how to address it. The aim of such a European centre for CAM would be to actively stimulate high quality research on CAM in the EU based on pan-European collaboration, through an independent research strategy aligned with EU health policy.