Ricerche di medicina complementare in Lombardia
Challenges for clinical study in the field of traditional medicine
Dr Xiaorui Zhang
Traditional Medicine Team, WHO, Geneva
1. The situation in the use of traditional medicine
Traditional medicine (TM), also called complementary and alternative medicines (CAM) in some countries, has been increasingly used by both developing and developed countries. In some countries it is used by up to 80% of the population to fulfill primary health care needs, while in other cases, such as Germany and Canada in the last two decades, around 70% to 90% of the population uses CAM. According to a survey conducted by the Italian National Institute of Statistics in cooperation with the National Health Service at the end of 1999, around 9 million Italians have turned to non-conventional medicine (NCM) practices at least once in the 1997-1999 period. This number tripled between 1991-1999. Nearly 70% of people that have tried some NCM therapy said that they benefited from it. The report also showed that the NCM therapies most often used are homeopathy, followed by manual therapy, phytotherapy and acupuncture.
2. Overview the challenges
TM/CAM have many positive features including: diversity and flexibility; accessibility and affordability in many parts of the world; broad acceptance among many populations in developing countries; increasing popularity in developed countries; comparatively low cost; low level of technological input; and growing economic value. These can all be seen as opportunities to be maximized.
Conversely, other features of this type of health care such as: the varying degree with which it is recognized by governments; lack of sound scientific evidence concerning efficacy; difficulties relating to the protection of intellectual and cultural property; problems in ensuring its proper use; and the growing need to ensure sustainable use of raw materials used in herbal medicines can be seen as challenges to be overcome.
The most urgent issues to be tackled relate to: policy; safety, efficacy and quality; access; and rational use.
3. WHO Strategy for traditional medicine
In order to meet the growing needs and challenges that have arisen due to widespread use of TM/CAM, WHO developed the WHO Traditional Medicine Strategy: 2002-2005 (1, 2). The Strategy has four main objectives, in line with the objectives of WHO’s Medicines Strategy : (1) Policy: Integrate relevant TM/CAM with national health care systems by developing and implementing national TM/CAM policies and programmes; (2) Safety, efficacy and quality: Promote the safety, efficacy and quality of TM/CAM therapy by providing guidance on regulatory and quality assurance standards; (3) Access: Increase availability and affordability of TM/CAM; (4) Rational use: Promote sound use of TM/CAM by providers and consumers.
4. Difficulties specific to TM/CAM research
The development of TM is generally influenced by local history and culture. The philosophy, theory, diagnosis and treatment methods of TM varies greatly from country to country, even region to region. Their common basis is a holistic approach to life, equilibrium between the mind, body and the external environment with an emphasis on overall health. TM/CAM is not only very different from conventional medicines because it does not typically focus on specific diseases, but it is also comprised of unique components that make it difficult to provide specific information that is typically necessary in the evaluation of conventional medicines. For example, many herbal medicines preparation often contain several medicinal plants, therefore it is difficult to identify which specific chemical compounds are active ingredients. Another example would be acupuncture, where we still do not know what the mechanism. For this reason, there is a lack of international standards on approaches for research and evaluation for traditional medicine.
Among all different types of research, clinical studies are the key step necessary to prove the safety and efficacy of a product and/or therapy. In conventional medical science, the randomized, double blind placebo controlled trial is considered the "gold standard" for clinical studies. However, there are some instances that it may not be possible for TM/CAM clinical studies to meet this "gold standard".
For example, difficulties may occur in establishing a placebo for clinical studies of herbal medicines. This is because patients who have been treated previously with the herbal medicine under investigation that has a characteristic organoleptic property, cannot be randomized into control groups. In the case of herbal medicines with a strong flavor, placebo substances with the same flavor may have a similar function if the flavor is caused by a similar active ingredient.
Another example, it is also impossible to design a double blind trial with acupuncture and manual therapies. It is also often too difficult for patients to be randomized into placebo control groups due to personal knowledge, previous experience and/or preference for a therapy. Furthermore, it is hard to identify 'placebo' points in acupuncture and 'placebo' treatment in manual therapies.
These factors make it very difficult for health authorities and health professionals trained in conventional medicine to understand TM/CAM or to include TM/CAM into the mainstream healthcare systems. This leads to the second important factor, which is that TM/CAM research often does not receive large amounts of support through funding or appropriate research structures, to a point where in some countries, TM/CAM research cannot be conducted in hospitals. This serves as a barrier to both the quantity and quality of research in TM/CAM. In this regard, the Regional Government of Lombardy has thankfully been supportive of TM/CAM clinical studies in both private and public sectors.
Therefore, it is necessary to develop the appropriate research methodology for clinical studies of TM/CAM which could meet the characteristics of TM/CAM and also these approaches could be acceptable by the scientific community.
5. Appropriate methodology for clinical study
In order to meet the above-mentioned difficulties and challenges, WHO, over the past ten years, has developed a series of technical guidelines on appropriate approaches for the research and evaluation of TM/CAM, which respected the characteristics of TM/CAM and can be understood within the framework of the conventional medicine. The purpose of these guidelines and documents was to serve as a bridge to facilitate the communication and understanding between traditional medicine and conventional medicine. For instance, WHO general guidelines for methodologies on the research and evaluation of traditional medicine describe the difficulties outlined above and provides some solutions to overcome them.
In order to improve the research methods and quality of the research of TM/CAM, it is crucial to build on past experience to guide future research. In this regard, WHO has published a document on review and analysis of acupuncture clinical reports based on control trials while another two reviews and analyses of clinical reports related to SARS and homeopathy are on the way to being finalized. The results of the research that will be presented today will also contribute to this endeavor.
6. Conclusion
TM/CAM is increasingly used worldwide. Safe and effective use of TM/CAM has become a great concern. Clinical studies represent the key step in proving safety and efficacy for herbal medicine products or TM/CAM therapies among different types of research. However, because of complicated political and technical issues, the clinical studies are still far from meeting requirements to ensure effective use of TM/CAM worldwide. The Regional Government of Lombardy is already aware of the importance of clinical studies for TM/CAM and therefore began and continues to further support this endeavour. These efforts up to now have resulted in the completion of several studies, which will be reviewed today. These studies will definitely facilitate and improve research of TM/CAM, subsequently contributing to the safe and effective use of TM/CAM, not only in the Region of Lombardy, but also the whole of Italy and other countries worldwide.
Edited by Aldo Campana,