Research in IM is challenging for many reasons. Major challenges include concerns with fitting IM into existing models of scientific research, difficulty obtaining consistent funding, and challenges finding respectable publishing outlets. Despite these challenges, some fabulous research has emerged in the last 10-20 years, not only proving the effectiveness of IM, but also demonstrating the cultural and personal value of IM in the U.S. Many of these studies, moreover, have successfully shown the limitations inherent in currently available research models, and have played a huge role in the major reevaluation of research methodology for the study of medicine in the U.S.
In this Article:
II. Methodological Challenges of Research in IM
III. Funding Challenges of Research in IM
IV. Publishing Challenges for IM Research
V. Overcoming the Challenges
This article examines some of the challenges of doing research in IM, including methodological challenges, funding challenges, and publishing challenges. It further explores some examples of research projects that have overcome these hurdles using innovative approaches.
Research in the growing field of Integrative Medicine comes with a set of unique challenges. The first, most obvious challenge has to do with the core differences between biomedicine and the various forms of CAM (Complementary/Alternative Medicine) that are integrated into conventional medical practice in IM. Often such disparities range from philosophical differences about how the body works to differences in diagnostic practice and treatment approach. For example, in Chinese medicine the body is understood as an interconnected network of mental, physical, and spiritual processes, each of which is constantly affected by the other. Health is understood as an intricate and ongoing balance of these multiple processes, and disease is understood to be a manifestation of imbalance at many “levels” of the self [1-2]. This view of the person derives from many different strands of traditional Chinese philosophy, including Daoism, Confucianism, and Buddhism .
Diagnosis in Chinese medicine derives from this philosophical approach, and involves the assessment of a patient by an adept practitioner who is able to diagnose imbalance in a specific individual at a specific time from the pulse, the tongue, and other subtle cues that rarely lend themselves to mechanical measures like blood pressure cuffs and thermometers. Treatment is addressed to the individual in a similar sense, and often involves a range of modalities, including acupuncture, herbal medicine, massage, and self-care. Effectiveness is assessed regularly—often on a weekly basis—throughout the course of treatment. Treatment protocol is then adjusted according to changes in the patient’s pattern . Even when integrated with conventional biomedical diagnostic and treatment approaches, Chinese medicine always maintains a focus on the individual as a whole . This differs from biomedicine, where the focus is more generally on the disease as an entity separate from the individual that must be eradicated.
Differences like these can make it difficult to research CAM and IM with current medical research models, including especially the gold standard clinical trial design or the RCT (Randomized Clinical Trial). Such models depend on the construction of studies that attempt to research one variable—for example, a specific drug or procedure—on another variable—such as a score on an objective scale measuring distress, or a biological marker such as cortisol levels.
For CAM and IM researchers, the RCT is problematic due to differences in diagnosis (an IM practitioner will likely only begin with the biomedical disease name), treatment (treatment with IM may vary depending on the day or the individual) and assessment (IM often considers changes in wellbeing or behavioral modifications to be more important than biological markers). For all of these reasons and more, the core differences between CAM/IM and biomedicine generate a complex set of challenges for conducting good medical research on IM modalities.
The second major set of challenges in both CAM and IM research has to do with getting financial support from government and private funding organizations. In the U.S., there has only been government support for any type of Integrative or Alternative medicine since the early 1990s, when the Office of Alternative Medicine (OAM) was formed as a part of the National Institutes of Health (NIH). In 1999, with support from Congress, the OAM expanded to become the currently recognized National Center for Complementary and Alternative Medicine (NCCAM), the organization that currently funds the most research in IM. With over $127 million dollars in NCCAM funds available for CAM and IM research, and private organizations such as the Bravewell Collaborative also increasingly supporting research projects in CAM and IM, there is a lot more support than there ever has been in the past. For many of the reasons outlined above, however, researchers seeking to investigate the effectives of CAM and IM therapies have been challenged to create studies that fit in with the existing demands of medical researchers, where CAM and IM techniques are often approached as if they were new drugs or procedures rather than centuries-old approaches to holistic healthcare .
A third major challenge facing IM researchers consists of finding publishing opportunities within mainstream medical research journals once they have completed their studies. There are several respected, peer-reviewed journals dedicated to the publication of CAM and IM research, including The Journal of Complementary and Alternative Medicine, Evidence-Based Complementary and Alternative Medicine (eCAM), Complementary Therapies in Medicine, and Alternative Therapies in Health and Medicine. When IM researchers want to speak to a broader audience of more mainstream biomedical physicians, however, they are consistently challenged to adjust their research reports to conform to the underlying assumptions and expectations—including especially the supremacy of the RCT—of more mainstream journals.
Despite all of these challenges, there have been many research teams at major universities in the U.S. and beyond who have made significant inroads into delineating the science of IM using traditional RCT style designs. For example, UCLA researchers in East-West Medicine have demonstrated Tai Chi’s effectiveness in treating headache . This study took 47 adults suffering from tension headaches and separated them into a Tai Chi treatment group and a control group. For the patients who did Tai Chi for 15 weeks, significant improvements were found not only in their tension headaches, but also in their energy levels and overall emotional well-being.
Other studies have expanded upon the RCT design and have created innovative strategies for investigating CAM and IM. Many researchers in Chinese medicine, for example, have devised research designs ensuring that subjects are treated according to their genuine Chinese medical diagnosis rather than just put in groups based on their biomedical diagnosis.
Other innovative strategies for RCT design draw upon the notion of “Whole Systems Research” or WSR. Whole Systems studies attempt to measure the effectiveness of whole medical systems such as Ayurveda or Chinese medicine [6, 7]. WSR studies are specifically designed to evaluate CAM and IM practices as part of a complex package of care for real patients suffering from real conditions such as back pain or headaches [8, 9]. The treatment group in such studies thus receives the whole package of care associated with whole systems of healing in addition to standard biomedical treatment. The control group, on the other hand, receives only biomedical treatment. Other examples of WSR include “n of 1” studies that study a single case over time .
Finally, yet other studies of CAM and IM have gone around the RCT altogether, incorporating research models derived from the Social Sciences as well as from Health Services Research (HSR) to demonstrate the validity of alternative forms of research in CAM/IM. Social science researchers, for example, use diverse research methodologies such as participant observation, focus group interviews, video-recording, and ongoing semi-structured interviewing. Such techniques, as Claire Cassidy points out, are “time and cost effective for finding out generally what people think is going on” . These methods are ideal for the outset of a detailed research study when researchers need to first assess the major social, cultural, economic, and personal themes influencing the process under observation.
As such, social science methods demonstrate what actually happens in an IM setting–including the way healing spaces are organized, the kinds of explanations offered to patients, the way evidence is interpreted in CAM/IM, and the way students learn the language of CAM/IM—as opposed to simply showing efficacy narrowly defined. These types of studies include examinations of the ways doctors communicate notions of risk in a contemporary integrative medical center , the way that physicians in Chinese integrative hospitals negotiate diagnosis and treatment , or the ways in which contemporary students of Chinese medicine participate in the Chinese-English translation of concepts .
Health services researchers use a mixed methods approach to examining CAM and IM. Observational and descriptive studies in HSR, for example, have shed light on the way CAM and IM modalities are “actually done” . Studies looking at CAM and IM’s effectiveness for changing patients’ health-related quality of life (HRQOL) have also become increasingly popular in HSR . HSR researchers similarly draw upon many of the WSR and social science techniques described above.
Many of the studies described in this article have come a long way towards demonstrating the effectiveness of CAM and IM techniques in treating a range of conditions, especially chronic illnesses and pain. These studies have also been successful in pushing the boundaries of conventional research protocols, and have shown that there are multiple legitimate ways to understand the ways in which a treatment or set of treatments effect suffering individuals.
by Sonya Pritzker, Ph.D., L.Ac.
UCLA Center for East-West Medicine
ExploreIM’s research column is dedicated to hosting stories not only about specific research studies, but also about the research process. We welcome feature length stories about getting and keeping funding, stories about designing research and carrying it out, and stories about the triumphs and tribulations of publishing IM research. We also encourage stories about particularly provocative research findings.
We hope for ExploreIM’s research column to be a place for the public to learn about what kinds of issues plague researchers in IM, as well as it is a forum for IM researchers to come together to share stories about the research process that will hopefully help us create better studies that contribute to the positive transformation of healthcare and research.
- Wiseman N, Ellis A. Fundamentals of Chinese medicine. Brookline: Paradigm Publications, 1996.
- Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-west medicine. Integr Cancer Ther. 2006 Mar; 5(1):56-62
- Unschuld PU. Medicine in China: A history of ideas. Berkeley: University of California
- Ruggie M. Marginal to mainstream: Alternative medicine in America. Cambridge: Cambridge University Press, 2004.
- Kaptchuk TJ. Powerful placebo: the dark side of the randomised controlled trial. The Lancet. 1998 June; 351(9117): 1722-1725.
- Lao, L. et al. Assessing clinical efficacy of acupuncture: considerations for designing future trials. In Stux. G. & Hammerschlag, R. (Eds.), Clinical Acupuncture: Scientific basis. Berlin: Springer, 2001. Pp. 187-209.
- Ritenbaugh C, Aikin M, Bradley R, Caspi O, Grimsgaard S, Musial F. Whole systems research becomes real: New results and next steps. J Alt Comp Med 2010; 16(1): 131-137.
- Abbott RB, Hui KK, Hays RD, Li MD, Pan T. A randomized controlled trial of Tai Chi for tension headaches. eCAM 2007;4(1)107–113. doi:10.1093/ecam/nel050
- Allen B Schnyer RN, Hitt S. The efficacy of acupuncture in the treatment of major depression in women. Psychological Science 1998; 5: 397-401.
- Verhoef MJ, Lewith G, Ritenbaugh C, Boon H, Fleishman S, Leis A. Complementary and alternative medicine whole systems research: Beyond identification of inadequacies of the RCT. Comp Ther Med 2005; 13(3), 206-212.
- MacPherson H. Pragmatic clinical trials. Comp Ther Med 2004; 12: 136-140.
- Thomas KJ, Fitter M, Brazier J, MacPherson H, Campbell M, Nicholl JP, et al. Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain assessed as suitable for primary care management. Comp Ther Med 1999; 7(2): 91-100.
- Vickers A, Rees R, Zollman C, Ellis N. Acupuncture for migraine and headache in primary care: a protocol for a pragmatic, randomised trial. Comp Ther Med 1998; 7: 3-18.
- Cassidy CM. Beyond numbers: Qualitative research methods for Oriental medicine. In G Stux & R Hammerschlag (eds.) Clinical acupuncture: Scientific basis. Berlin, Springer; 2001. Pp. 151-169.
- Creswell JW, Klassen AC, Plano VL, Smith KC. Best practices for mixed methods research in the health sciences. Office of Behavioral and Social Sciences Research. Available: http://obssr.od.nih.gov/scientific_areas/methodology/mixed_methods_research/index.aspx
- Salkeld EJ. Holistic physicians’ clinical discourse on risk: An ethnographic study. Medical Anthropology 2005; 24: 325-347.
- Karchmer E. Chinese medicine in action: On the postcoloniality of medical practice in China. Medical Anthropology 2010; 29(3): 226-252.
- Pritzker SE. The part of me that wants to grab: Embodied experience and living
translation in U.S. Chinese medical education. Ethos 2011; 39(3): 395-413.
- Coulter ID, Khorsan R. Is health services research the holy grail of complementary and alternative medicine research? Alt Ther Jul/Aug 2008; 14(4): 40-45.
-  Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK . Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71.