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Complex treatments—A challenge for clinical research
ARTICLE IN PRESS Invited lectures / European Journal of Integrative Medicine 1 (2009) 167–171
Complex treatments — A challenge for clinical research
C.M. Witt Institute for Social Medicine, Epidemiology and Health Economics, Charite University Medical Center, Berlin, Germany In complementary medicine, the so-called ‘‘whole medical systems’’ use a complex approach for the diagnosis and treatment, such as Chinese medicine or homeopathy. According to NCCAM whole medical systems are systems that are built upon complete systems of theory and practice and have evolved prior and separate from the conventional medical approach. Clinical research can focus on a variety of different questions, including efficacy and effectiveness. There is an ongoing discussion about the advantages and limitations of both efficacy and effectiveness research. ‘Efficacy’ refers to the extent to which a specific intervention is beneficial under ideal conditions, while ‘effectiveness’ is a measure of whether a specific intervention when applied in a usual care setting has the desired effect. For efficacy studies whole medical systems have to be broken down to single interventions to allow for comparison with a placebo. Furthermore, in these efficacy studies the interventions are mainly applied in a standardized manner, whereas in practice they are usually tailored to the individual patient. The advantage of effectiveness studies is that they allow for an evaluation of whole medical systems by comparing these, for example, with complex conventional standard treatments. When developing a study protocol for an effectiveness study, the theoretical basis of the medical system and the available health service data on the usage in routine care should be considered, to assure that this trial reflects usual care. The relevance for decision making from both efficacy and effectiveness studies is still open to discussion. This is not only a methodological discussion, but also an ethical and political discussion. The core question to be answered is whether the evidence for a specific effect or the evidence that a specific intervention is beneficial in usual care should have more impact, when deciding on the availability of a treatment. 10.1016/j.eujim.2009.08.156
The WHO perspective on integration of traditional medicine into health system
X. Zhang WHO, Traditional Medicine Programme of WHO, Geneva, Switzerland The reality of health care systems is that there is a strong demand for traditional medicine (TM), as shown in the WHA 56.31 resolution on traditional medicine in 2003 the
171
popular use of TM demonstrates that it is widely accessible, affordable, and culturally accepted in large parts of developing countries, especially in Africa, Asia and Latin America, where TM is often deeply rooted in the local culture. In Europe and North America, people are increasingly using TM as complementary to or as an alternative for western medicine (WM) treatments. TM has a distinct appeal to broad populations of people. TM systems often have specific theories, diagnoses and treatments which may be different than the methods and treatments of WM. Recognizing these differences, it is essential to understand that both systems of TM and WM have their advantages and weakness. The advantage of TM may be found in their utilization for chronic diseases, improving quality of life and health maintenance, as well as for some health conditions that could not be treated well with WM. There are significant challenges facing this integration. There is lack of appropriate standards and measures to control the quality of TM, especially herbal medicines. There is also a lack of appropriate accepted research methodology to evaluate TM based on TM characteristics. Therefore, the cooperation and collaboration between the experts of both TM and WM is necessary. WHO encourages countries to integrate TM into health systems so that patients will obtain the health benefits from both TM and WM. In support of integrating TM into their existing health systems, WHA 62.13 resolution on TM adopted in May 2009 urges the Member States to respect, preserve and communicate, as appropriate, the knowledge of traditional medicine, treatments and practices, appropriately based on the circumstances in each country, and on evidence of safety, efficacy and quality; to consider, where appropriate, including traditional medicine into their national health systems based on national capacities, priorities, relevant legislation and circumstances, and on evidence of safety, efficacy and quality; to further develop traditional medicine based on research and innovation, giving due consideration to the specific actions related to traditional medicine in the implementation of the Global strategy and plan of action on public health, innovation and intellectual property resolution which was adopted in 2008. This abstract can be surmised by a statement made by Dr. Margaret Chan, Director-General of WHO, during the WHO Congress on Traditional Medicine in 2008. ‘‘The two systems of traditional and western medicine need not clash. Within the context of primary health care, they can blend together in a beneficial harmony, using the best features of each system, and compensating for certain weaknesses in each.’’ 10.1016/j.eujim.2009.08.157
Complex treatments — A challenge for clinical research
C.M. Witt Institute for Social Medicine, Epidemiology and Health Economics, Charite University Medical Center, Berlin, Germany In complementary medicine, the so-called ‘‘whole medical systems’’ use a complex approach for the diagnosis and treatment, such as Chinese medicine or homeopathy. According to NCCAM whole medical systems are systems that are built upon complete systems of theory and practice and have evolved prior and separate from the conventional medical approach. Clinical research can focus on a variety of different questions, including efficacy and effectiveness. There is an ongoing discussion about the advantages and limitations of both efficacy and effectiveness research. ‘Efficacy’ refers to the extent to which a specific intervention is beneficial under ideal conditions, while ‘effectiveness’ is a measure of whether a specific intervention when applied in a usual care setting has the desired effect. For efficacy studies whole medical systems have to be broken down to single interventions to allow for comparison with a placebo. Furthermore, in these efficacy studies the interventions are mainly applied in a standardized manner, whereas in practice they are usually tailored to the individual patient. The advantage of effectiveness studies is that they allow for an evaluation of whole medical systems by comparing these, for example, with complex conventional standard treatments. When developing a study protocol for an effectiveness study, the theoretical basis of the medical system and the available health service data on the usage in routine care should be considered, to assure that this trial reflects usual care. The relevance for decision making from both efficacy and effectiveness studies is still open to discussion. This is not only a methodological discussion, but also an ethical and political discussion. The core question to be answered is whether the evidence for a specific effect or the evidence that a specific intervention is beneficial in usual care should have more impact, when deciding on the availability of a treatment. 10.1016/j.eujim.2009.08.156
The WHO perspective on integration of traditional medicine into health system
X. Zhang WHO, Traditional Medicine Programme of WHO, Geneva, Switzerland The reality of health care systems is that there is a strong demand for traditional medicine (TM), as shown in the WHA 56.31 resolution on traditional medicine in 2003 the
171
popular use of TM demonstrates that it is widely accessible, affordable, and culturally accepted in large parts of developing countries, especially in Africa, Asia and Latin America, where TM is often deeply rooted in the local culture. In Europe and North America, people are increasingly using TM as complementary to or as an alternative for western medicine (WM) treatments. TM has a distinct appeal to broad populations of people. TM systems often have specific theories, diagnoses and treatments which may be different than the methods and treatments of WM. Recognizing these differences, it is essential to understand that both systems of TM and WM have their advantages and weakness. The advantage of TM may be found in their utilization for chronic diseases, improving quality of life and health maintenance, as well as for some health conditions that could not be treated well with WM. There are significant challenges facing this integration. There is lack of appropriate standards and measures to control the quality of TM, especially herbal medicines. There is also a lack of appropriate accepted research methodology to evaluate TM based on TM characteristics. Therefore, the cooperation and collaboration between the experts of both TM and WM is necessary. WHO encourages countries to integrate TM into health systems so that patients will obtain the health benefits from both TM and WM. In support of integrating TM into their existing health systems, WHA 62.13 resolution on TM adopted in May 2009 urges the Member States to respect, preserve and communicate, as appropriate, the knowledge of traditional medicine, treatments and practices, appropriately based on the circumstances in each country, and on evidence of safety, efficacy and quality; to consider, where appropriate, including traditional medicine into their national health systems based on national capacities, priorities, relevant legislation and circumstances, and on evidence of safety, efficacy and quality; to further develop traditional medicine based on research and innovation, giving due consideration to the specific actions related to traditional medicine in the implementation of the Global strategy and plan of action on public health, innovation and intellectual property resolution which was adopted in 2008. This abstract can be surmised by a statement made by Dr. Margaret Chan, Director-General of WHO, during the WHO Congress on Traditional Medicine in 2008. ‘‘The two systems of traditional and western medicine need not clash. Within the context of primary health care, they can blend together in a beneficial harmony, using the best features of each system, and compensating for certain weaknesses in each.’’ 10.1016/j.eujim.2009.08.157