WS-CAM Information
Abstracts from Previous Papers on Whole Systems of CAM Research
(from http://www.ncbi.nlm.nih.gov/pubmed/):
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J Altern Complement Med. 2008 Jun;14(5):475-87.
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A pilot whole systems clinical trial of traditional chinese medicine and naturopathic medicine for the treatment of temporomandibular disorders.
Department of Family and Community Medicine, The University of Arizona, Tucson, AZ 85719, USA. ritenbau@email.arizona.edu
OBJECTIVES: To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. DESIGN: A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). SETTING/LOCATION: Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. SUBJECTS: One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic. INTERVENTIONS: Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. OUTCOME MEASURES: TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst). RESULTS: Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference. CONCLUSIONS: These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.
PMID: 18564953 [PubMed - indexed for MEDLINE]
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J Altern Complement Med. 2007 Jul-Aug;13(6):659-68.
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The process of whole person healing: “unstuckness” and beyond.
Department of Medicine (Program in Integrative Medicine), The University of Arizona, Arizona Health Sciences Center, Tucson, AZ, USA. mkoithan@nursing.arizona.edu
OBJECTIVE: The purpose of the present study was to fully explore the descriptions of patients’ experiences of change after receipt of whole systems of complementary and alternative medicine (CAM) treatment. The aim was to develop an understanding of “unstuckness,” including characterization of states, processes, and modifying factors. DESIGN: This was a secondary descriptive qualitative analysis, using techniques borrowed from phenomenology and grounded theory. SETTING/LOCATION: Three existent datasets collected at two different universities in the United States and Canada were used in the secondary analysis. PARTICIPANTS: Patients with chronic illnesses (including cancer and multiple nonmalignant conditions) who were treated with different packages of care were interviewed for the primary three studies (n = 76 with over 150 interview sessions). Complete data sets from these participants were used in this secondary analysis. OUTCOME MEASURES/DATA COLLECTION TECHNIQUES: Original transcripts were coded asking specific research questions about the experience of change subsequent to whole systems treatments. RESULTS: Data clearly indicated experiential differences between stuckness, unsticking, and unstuckness. Descriptors and characteristics of each state were identified, as was an initial grounded theory of change or transformation that occurs as an outcome of whole medical systems of CAM. CONCLUSIONS: The results provide preliminary conceptualizations and descriptions of the impact that CAM whole systems interventions may have on the individual’ s life courses. This constitutes a first step in the identification, measurement, and evaluation of whole systems outcomes in a clinical setting. The emerging conceptualization of the process from stuckness to transformation may also provide a link between clinical research and systems science theory.
PMID: 17718649 [PubMed - indexed for MEDLINE]
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BMC Med Res Methodol. 2007 Feb 11;7:7.
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Researching complementary and alternative treatments–the gatekeepers are not at home.
National Research Center in Complementary and Alternative Medicine, Faculty of Medicine, University of Tromsø, N-9037 TROMSØ, Norway. Vinjar.Fonnebo@fagmed.uit.no
BACKGROUND: To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities. DISCUSSION: There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This “gap” might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited. Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic “agents” before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated ‘whole system’ of care, without careful consideration of the safety issue. We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise: 1. Context, paradigms, philosophical understanding and utilization 2. Safety status 3. Comparative effectiveness. 4. Component efficacy 5. Biological mechanisms. SUMMARY: Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.
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J Altern Complement Med. 2006 Nov;12(9):843-50.
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Methodological challenges in whole systems research.
Kaiser Permanente Center for Health Research, Portland, OR, USA.
PMID: 17109574 [PubMed - indexed for MEDLINE]
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Integr Cancer Ther. 2006 Dec;5(4):293-307.
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Models for the study of whole systems.
Department of Family, Program in Integrative Medicine, University of Arizona College of Medicine, Tucson, AZ 85719, USA. ibell@u.arizona.edu
This article summarizes a network and complex systems science model for research on whole systems of complementary and alternative medicine (CAM) such as homeopathy and traditional Chinese medicine. The holistic concepts of networks and nonlinear dynamical complex systems are well matched to the global and interactive perspectives of whole systems of CAM, whereas the reductionistic science model is well matched to the isolated local organ, cell, and molecular mechanistic perspectives of pharmaceutically based biomedicine. Whole systems of CAM are not drugs with specific actions. The diagnostic and therapeutic approaches of whole systems of CAM produce effects that involve global and patterned shifts across multiple subsystems of the person as a whole. For homeopathy, several characteristics of complex systems, including the probabilistic nature of attractor patterns, variable sensitivity of complex systems to initial conditions, and emergent behaviors in the evolution of a system in its full environmental context over time, could help account for the mixed basic science and controlled clinical trial research findings, in contrast with the consistently positive outcomes of observational studies in the literature. Application of theories and methods from complex systems and network science can open a new era of advances in understanding factors that lead to good versus poor individual global outcome patterns and to rational triage of patients to one type of care over another. The growing reliance on complex systems thinking and systems biology for cancer research affords a unique opportunity to bridge between the CAM and conventional medical worlds with some common language and conceptual models.
PMID: 17101758 [PubMed - indexed for MEDLINE]
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Complement Ther Med. 2005 Sep;13(3):206-12.
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Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT.
Department of Community Health Sciences, University of Calgary, Faculty of Medicine, Canada. mverhoef@ucalgary.ca
Complementary and alternative medicine (CAM) often consists of whole systems of care (such as naturopathic medicine or traditional Chinese medicine (TCM)) that combine a wide range of modalities to provide individualised treatment. The complexity of these interventions and their potential synergistic effect requires innovative evaluative approaches. Model validity, which encompasses the need for research to adequately address the unique healing theory and therapeutic context of the intervention, is central to whole systems research (WSR). Classical randomised controlled trials (RCTs) are limited in their ability to address this need. Therefore, we propose a mixed methods approach that includes a range of relevant and holistic outcome measures. As the individual components of most whole systems are inseparable, complementary and synergistic, WSR must not focus only on the “active” ingredients of a system. An emerging WSR framework must be non-hierarchical, cyclical, flexible and adaptive, as knowledge creation is continuous, evolutionary and necessitates a continuous interplay between research methods and “phases” of knowledge. Finally, WSR must hold qualitative and quantitative research methods in equal esteem to realize their unique research contribution. Whole systems are complex and therefore no one method can adequately capture the meaning, process and outcomes of these interventions.
PMID: 16150375 [PubMed - indexed for MEDLINE]
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Altern Ther Health Med. 2003 Jul-Aug;9(4):32-6.
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Whole systems research: a discipline for studying complementary and alternative medicine.
Kaiser Permanente Center for Health Research, Portland, Ore., USA.
The new discipline of whole systems research (WSR) targets the study of complex CAM therapies as system-level phenomena, as opposed to single-agent or uni-dimensional effects. This article describes the pre-defined goals, issues that were developed, and opportunities that were revealed in a workshop held in Vancouver BC, in which scientists, practitioners, and policy makers met to lay the foundations of WSR. Important issues were identified, such as treatment individualization, problems of diagnosis, patient-practitioner interaction, varying therapeutic contexts, and patient-determined outcome values. Research design issues that were addressed included a variety of challenges to the study of intact systems, in relation to both synergy and emergent behaviors, and the opportunities to innovate the conventional RCT. As the network of CAM scientists and practitioners engaged in WSR expands, a common nomenclature and body of techniques will help us to a better understanding of the ways in which whole systems affect healing.
PMID: 12868250 [PubMed - indexed for MEDLINE]
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Chronic Illn. 2008 Dec;4(4):264-77.
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The patient’s experience of holistic care: insights from acupuncture research.
Institute of Health Services Research, Peninsula Medical School, University of Exeter, Exeter EX1 2LU, UK. charlotte.paterson@pms.ac.uk.
OBJECTIVES: To characterize the diverse nature of peoples’ experiences of acupuncture treatment for chronic health problems. Specifically, the paper addresses how this analysis deepens our understanding of holism and its relation to the therapeutic theory base. METHODS: A secondary analysis of five longitudinal interview studies using a constant comparative method. Patients experienced different types of acupuncture - traditional (based on Chinese medicine) and Western-style (based on biomedicine) in a variety of settings in the UK and Australia. RESULTS: The markedly different experiences of acupuncture treatment were best characterized in relation to the concept of holism. Being treated ;as a whole person’ was associated with traditional acupuncture in both private and NHS practice, but not within a research trial setting. In the trial, both patients and practitioners ;played their part’ in a scientific experiment. Holism was especially important to people with several health problems. DISCUSSION: The findings suggests that the experience of holistic care, in the sense of ;being treated as a whole person’ is dependent on four factors: (a) the therapeutic theory that underpins the treatment; (b) structural factors such as time and setting; (c) the intention of the practitioner; and (d) the intention and needs of the patient.
PMID: 19091935 [PubMed - in process]
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Integr Cancer Ther. 2004 Sep;3(3):230-7.
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Supporting the transformative process: experiences of cancer patients receiving integrative care.
Tzu Chi Research Group, Vancouver, British Columbia, Canada.
PURPOSE: The purpose of this study is to describe the essential features of the transformative experience among people living with cancer who are seeking integrative care and to identify factors supporting this process. It is hoped that after establishing the nature and meaning of this change or shift, one will better understand what is most meaningful in terms of providing appropriate care and support to patients seeking integrative care. STUDY DESIGN: An interpretational, qualitative approach guided sampling, data collection, and analysis with 11 individuals. A purposeful sample was drawn from selected integrative care facilities according to sociodemographics and type of cancer. Due to the complexity of this subject, second interviews were conducted with 5 participants to enhance the richness and validity of the data. RESULTS: The experience of transformation is a dynamic 4-stage process in which participants learned about themselves and became more aware of who they are and how they relate to the world. Participants found that 4 dimensions of integrative medicine played a fundamental role in supporting this process. These dimensions include (1) having access to a range of appropriate therapies to support individual journeys, (2) care that focuses on one’s overall well-being, (3) control over cancer management, and (4) developing healing relationships with care providers. CONCLUSION: Although practitioners may not be able to create transformative experiences for patients, they may be able to establish and maintain conditions that support this process.
PMID: 15312264 [PubMed - indexed for MEDLINE]
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J Altern Complement Med. 2004 Oct;10(5):879-89.
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- J Altern Complement Med. 2005 Apr;11(2):221-5.
A biostatistical approach to ayurveda: quantifying the tridosha.
School of Biosciences and Bioengineering, Indian Institute of Technology Bombay, Powai, Mumbai 400 076, India. rrj@math.iitb.ac.in
OBJECTIVE: To compute quantitative estimates of the tridosha–the qualitative characterization that constitutes the core of diagnosis and treatment in Ayurveda–to provide a basis for biostatistical analysis of this ancient Indian science, which is a promising field of alternative medicine. SUBJECTS: The data sources were 280 persons from among the residents and visitors/training students at the Brahmvarchas Research Centre and Shantikuj, Hardwar, India. DESIGN/METHODOLOGY: A quantitative measure of the tridosha level (for vata, pitta, and kapha) is obtained by applying an algorithmic heuristic approach to the exhaustive list of qualitative features/factors that are commonly used by Ayurvedic doctors. A knowledge-based concept of worth coefficients and fuzzy multiattribute decision functions are used here for regression modeling. VALIDATION AND APPLICATIONS: Statistical validation on a large sample shows the accuracy of this study’s estimates with statistical confidence level above 90%. The estimates are also suited for diagnostic and prognostic applications and systematic drug-response analysis of Ayurvedic (herbal and rasayanam) medicines. An application with regard to the former is elucidated, extensions of which might also be of use in investigating the role of nadis in Ayurvedic healing vis-a-vis acupuncture and acupressure techniques. The importance and scope of this novel approach are discussed. CONCLUSIONS: This pioneering study shows that the concept of tridosha has a sound empirical basis that could be used for the scientific establishment of Ayurveda in a new light.
PMID: 15650478 [PubMed - indexed for MEDLINE]
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J Altern Complement Med. 2003 Feb;9(1):39-50.
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Homeopathic practitioner views of changes in patients undergoing constitutional treatment for chronic disease.
Program in Integrative Medicine, University of Arizona, Tucson, AZ 85724-5153, USA. ibell@u.arizona.edu
OBJECTIVES: To identify areas that classical homeopathic practitioners would want to see evaluated in a patient self-report questionnaire sensitive to change during constitutional treatment. DESIGN: Open-ended, written practitioner questionnaire, analyzed using inductive content analysis. SETTINGS/LOCATION: Two classical homeopathic meetings held in the western United States. SUBJECTS: Homeopathic practitioners attending the above professional meetings and volunteering to complete the questionnaire in response to announcements prior to sessions. DATA COLLECTION METHODS: Practitioners completed a demographic questionnaire and answered an open-ended question inquiring for changes about which to ask people undergoing classical homeopathic constitutional treatment. RESULTS: The categories that the 38 homeopaths identified included changes in: (1) emotions; (2) mentation; (3) specific physical functioning; (4) general physical changes; (5) perception of self; (6) relationships; (7) spirituality; (8) lifestyle; (9) energy; (10) dream content and tone; (11) well-being; (12) perceptions by others; (13) life relationships; (14) a sense of freedom or feeling less “stuck”; (15) sleep; (16) coping; (17) ability to adapt; (18) creativity; and (19) recall of past experiences. Sixteen percent (16%) of participants added more in-depth description of the nature of changes across categories (i.e., a rhythmical process of innovation and flux). CONCLUSIONS: The findings are consistent with the systemic orientation of classical homeopathic philosophy to evaluate and treat the patient as a whole. Taken together, the results support the need for development of new, multidimensional outcome measures for clinical research in homeopathy beyond the disease-specific and health-related quality-of-life scales available from conventional medical research.
PMID: 12676034 [PubMed - indexed for MEDLINE]
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J Altern Complement Med. 2003 Oct;9(5):671-81.
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Acupuncture for people with chronic illness: combining qualitative and quantitative outcome assessment.
MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol, UK. c.paterson@bristol.ac.uk
OBJECTIVES: Many people with chronic disease seek acupuncture treatment, despite it being largely excluded from Western state-funded health care systems. What benefits and problems do such people perceive and experience as important? To what extent do three subjective health questionnaires encompass and measure these treatment effects? DESIGN AND OUTCOME MEASURES: A longitudinal qualitative study, using a constant comparative method, informed by grounded theory. Each person was interviewed three times over 6 months and before each interview participants completed three health status questionnaires, EuroQol, COOP-WONCA charts, and MYMOP2. Semistructured interviews used open-ended questions to explore peoples’ experiences of illness and treatment, and then used the cognitive interview technique to discuss their questionnaire responses. SUBJECTS AND SETTINGS: Eight professional acupuncturists in seven different settings publicized the study to their patients. We interviewed a maximum variation sample of 23 people with chronic illness, who were having acupuncture for the first time. RESULTS: In addition to changes in their presenting symptoms people experienced whole-person effects that were characterized by changes in strength and energy, and changes in personal and social identity. These effects were distinct but not divisible because of their interdependence and their complex and individual development over time. The health status questionnaires varied in their ability to reflect and measure these changes, and the whole person effects were often missed. After 6 months some people had changed their treatment goals and some individuals were still seeing health improvement. One person found that acupuncture exacerbated her symptoms. CONCLUSIONS: Knowledge of the range, individuality, and varied temporal patterns of treatment outcomes can guide potential patients, clinicians, health care providers, and researchers. Qualitative methods have highlighted the strengths and weaknesses of different outcome questionnaires, and the importance of long-term follow-up. We plan to do further work on appropriate outcome questionnaire selection and development.
PMID: 14629845 [PubMed - indexed for MEDLINE]
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J Altern Complement Med. 2001 Jun;7(3):261-8.
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Patient perspectives on outcomes after treatment with acupuncture.
Northern College of Acupuncture, York, United Kingdom. clinic@chinese-medicine.co.uk
OBJECTIVES: To determine patients’ experience of outcomes after acupuncture treatment. DESIGN: A patient questionnaire followed by semistructured interviews. SETTING: Acupuncture practices in York, England. SUBJECTS: Questionnaires were distributed by 4 acupuncturists to all 132 of their patients over a 2-week period, 72 (55%) of whom responded. Of these, 11 patients were interviewed. INTERVENTIONS: Patients received normal care from their acupuncturists, all of whom were members of the British Acupuncture Council. OUTCOME MEASURES: Patients reported on physical symptoms, emotional/mental symptoms, lifestyle changes, major life changes and inner life changes affecting outlook and attitudes to health. Patients also reported on the extent they attributed change to acupuncture and what they valued about attending for treatment. RESULTS: Primary reasons for attending were categorized by patients as physical symptoms (90%), mental and emotional problems (9%) and general health and well-being (1%). For physical symptoms, 75% of patients reported definite change; for emotional and mental symptoms, 67%; lifestyle changes, 40%, major life changes, 27%; and for inner life changes, 54%. Over time, many of the patients (42%) changed their primary reason for attending from their initial physical concerns, half of whom describing their new focus as related to general health and well-being. Some emotional changes were experienced by 83% of patients, irrespective of the initial reason for attending. For all these changes, 58% of patients reported that they “substantially” attributed the changes to acupuncture, and 25% “totally”. The interviews provided additional data on the depth of the changes particularly for the longer term patients and on what they valued about treatment. CONCLUSIONS: Treatment with acupuncture results in a broad range of outcomes from physical and emotional change through to wider benefits involving the patients’ lifestyle, outlook, and attitude toward their health. Existing outcome measures are not adequate to assess these wider benefits. The results suggest that patients experienced holistic benefits from acupuncture, an outcome that could be described as holism-in-action.
PMID: 11439847 [PubMed - indexed for MEDLINE]
