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      Principles to guide integrative oncology and the development of an evidence base

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          Abstract

          Background

          Integrative oncology uses both conventional and complementary medicine to meet the needs of individual patients and to focus on the whole person. The core principles of integrative oncology include individualization, holism, dynamism, synergism, and collaboration, but the nature of the evidence to guide the development of integrative oncology has been given little attention.

          Objectives

          • To discuss the need for evidence to support the integration of complementary therapies for integrative oncology care.

          • To emphasize that the evidence base must be valid and respect the underlying principles of individual complementary therapies and integrative oncology practice.

          • To suggest ways to begin developing the evidence base.

          Review and Discussion

          Although the evidence for safety and efficacy seems paramount for supporting the integration of an individual complementary therapy into mainstream cancer care, the need for evidence to support the overall practice of integrative oncology has to be considered as well.

          We argue that developing an evidence base for integrative oncology requires a contextual and comprehensive research approach that assesses a range of outcomes over a suitable period of time that the patient and the patient’s family, in addition to the health care providers, deem important.

          Conclusion

          A whole-systems framework to the development of the evidence base for integrative oncology can guide the development of evidence that respects the complex nature of many complementary and integrative practices and their underlying principles of care delivery.

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          Most cited references29

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          Use of complementary and alternative medicine in cancer patients: a European survey.

          The aim of this study was to explore the use of complementary and alternative medicine (CAM) in cancer patients across a number of European countries. A descriptive survey design was developed. Fourteen countries participated in the study and data was collected through a descriptive questionnaire from 956 patients. Data suggest that CAM is popular among cancer patients with 35.9% using some form of CAM (range among countries 14.8% to 73.1%). A heterogeneous group of 58 therapies were identified as being used. Herbal medicines and remedies were the most commonly used CAM therapies, together with homeopathy, vitamins/minerals, medicinal teas, spiritual therapies and relaxation techniques. Herbal medicine use tripled from use before diagnosis to use since diagnosis with cancer. Multivariate analysis suggested that the profile of the CAM user was that of younger people, female and with higher educational level. The source of information was mainly from friends/family and the media, while physicians and nurses played a small part in providing CAM-related information. The majority used CAM to increase the body's ability to fight cancer or improve physical and emotional well-being, and many seemed to have benefited from using CAM (even though the benefits were not necessarily related to the initial reason for using CAM). Some 4.4% of patients, however, reported side-effects, mostly transient. It is imperative that health professionals explore the use of CAM with their cancer patients, educate them about potentially beneficial therapies in light of the limited available evidence of effectiveness, and work towards an integrated model of health-care provision.
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            Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT.

            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.
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              Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding.

              Evidence of effectiveness is increasingly used to determine which health technologies are incorporated into public health provision. Acupuncture is a popular therapy that has been shown to be superior to placebo in the treatment of nausea and dental pain, and promising for migraine and osteoarthritis of the knee. For many other conditions, such as chronic pain, in which acupuncture is often used, the evidence is either insufficient or negative. Misleading results may occur for a number of reasons. False negative results may arise from inadequate treatment schedules and inappropriate control interventions. This consensus document considers these issues with the aim of improving the design of efficacy trials of acupuncture in order that they are more likely to be conclusive and more meaningfully interpreted. Clinical trials of acupuncture must use an optimal form of treatment; this can be defined by examining standard texts, by surveying and consulting experts. There are a great many variables in treatment (such as point selection, form of stimulation) all of which need to be addressed in designing and reporting clinical trials. The control procedure is determined by the precise research question that is being addressed. For efficacy studies, in which the question is whether acupuncture has specific effects (i.e. is superior to placebo), sham forms of acupuncture appear the most appropriate method of controlling for needle penetration. A recent development of blunted, telescopic needles may represent a major advance. Such procedures may produce a therapeutic response so should preferably be recorded as 'sham' procedures rather than true 'placebo' controls. Blinding in clinical trials is an accepted means of reducing bias. Patient blinding in acupuncture studies can be achieved by sham procedures and its success should be measured. While practitioner blinding is difficult, though not impossible, blinding of the observer and the analyst should be considered as the ideal for all studies. A number of recommendations are made which aim to improve the quality of sham-controlled acupuncture studies.
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                Author and article information

                Journal
                Curr Oncol
                CO
                Current Oncology
                Multimed Inc. (66 Martin St. Milton, ON, Canada L9T 2R2 )
                1198-0052
                August 2008
                : 15
                : s2
                : s83-s87
                Affiliations
                [* ]Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, SK.
                []Department of Community Health Sciences, University of Calgary, Calgary, AB.
                Author notes
                Correspondence to: Anne Leis, Department of Community Health and Epidemiology, 107 Wiggins Road, Saskatoon, Saskatchewan S7N 5E5. E-mail: anne.leis@ 123456usask.ca
                Article
                co15_s2ps083
                2528554
                18769572
                7d4ddcd5-8b5e-4704-a5e0-36519e0bd8c1
                2008 Multimed Inc.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Integrative Oncology

                Oncology & Radiotherapy
                randomized controlled trials,evidence-based medicine,integrative oncology,whole-systems research

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