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Fundamentals: Evidence-Based Practice in Complementary and Alternative Medicine—Perspectives, Protocols, Problems, and Potentials

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Evidence-Based Practice in Complementary and Alternative Medicine

Abstract

As an introduction to this remarkable compilation of erudite chapters on the cutting-edge nature of CAM in general, with special focus on Ayurvedic medicine, we present here a brief overview and discussion of the current status of the fundamentals of EBDM for health care. The thesis of this chapter is that CAM is enriched by the systematic approach of comparative effectiveness and efficacy research and analysis for practice (CEERAP). We discuss the implications and applications of EBDM in CAM, the systematic nature of the CEERAP process toward EBDM, and the pitfalls and limitations of this approach as it pertains specifically to Ayurvedic medicine.

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Notes

  1. 1.

    The term “power” is intended here from the perspective of statistical significance and clinical relevance.

  2. 2.

    Of course, assuming that the fundamental tenets of ethical behavior are verified and enforced.

  3. 3.

    It is interesting to note that Ancient Rome, which signifies the foundations of the cultural traditions in the West, already recognized the need to consider the health of the mind and the health of the body (cf. mens sana in corpore sano, a healthy mind in a healthy body). Of course, the medicine of Rome (e.g., Galen, 129 AD–ca. 210 AD) rested upon the medicine of ancient Greece (e.g., Hippocrates 460 BCE–ca. 370 BCE) and was sustained throughout the Middle Ages and the Renaissance in Europe. It was perhaps not before the Swiss scientist Paracelsus (1493–1541) that a movement against this tradition began to be clearly articulated in the West, despite the fact that his hermetical views were that sickness and health in the body relied on the harmony of man (microcosm) and Nature (macrocosm). While, Paracelsus is considered by many as one of the “fathers” of Western medicine, his views that because everything in the universe is interrelated, beneficial medical substances are to be found in herbs, minerals, and various alchemical combinations thereof that will be benefit in preventive disease, and in regaining health. We are part of, Paracelsus argued, the universe, one coherent organism that permeates with one uniting life-giving spirit, and our health derives from and depends upon our interrelationship with its entirety. Within the span of a hundred years, Western thought underwent a remarkable transformation, leading to the work of Malpighi, Tissot, Jenner, Koch, Pacini, and many others that paved the way to today. The point to note, however, is that the drive to reductionism, which appears to be predilected in the West at present, is not the only valid perspective upon the health sciences, and in fact was not the Western approach to health care a few hundred years ago, when indeed it was considerably more affine to the modes of health care we today label as “alternative.”

  4. 4.

    The primary cause.

  5. 5.

    The distinction between the “effectiveness” and the “efficacy” of a clinical intervention is critical at this juncture. The US Federal Coordinating Council for Comparative Effectiveness Research Report to the President and the Congress, dated June 30, 2009, stated that “…because it (comparative effectiveness research) …[applies]… to real-world needs and decisions faced by patients, clinicians, and other decision makers [generally including assessment of risks, costs vs. benefits]…”. By contrast, in “…efficacy research, …the question is typically whether the treatment is efficacious [i.e., works clinically] under ideal, rather than real-world, settings …[and]….[t]he results … are … not necessarily generalizable to any given patient….” Simply stated, whereas the former pertains to risk, benefits and cost assessment, the efficacy pertains to whether or not a given clinical intervention works clinically, and brings about the clinical outcome sought.

  6. 6.

    This approach to sampling is in no way different than what is done in a clinical trial, where the investigator determines and establishes before hand what is the accessible and what is the target sample of the study.

  7. 7.

    The following section “resources” list a few search engines specific to complementary and alternative medicine.

  8. 8.

    The bibliome is the body of pertinent research literature available for any given systematic review (SR): the term systematic review indicates the report produced from a research synthesis.

  9. 9.

    NIH in fact categorizes several types of clinical trials, including Prevention trials: prevent a disease, prevent a disease from returning; Screening trials: better detect certain diseases or conditions; Diagnostic trials: find better tests or procedures for diagnosing a particular disease or condition; Treatment trials: test experimental treatments, new drugs, surgery, or radiation therapy; Quality of life trials: improve comfort and quality of life for individuals with a chronic illness (i.e., Supportive Care trials); Compassionate trials: (Expanded Access trials): provide partially tested, unapproved therapeutics to patients with no other options.

  10. 10.

    According to Pocock [12], at least five different degrees or levels of clinical trials can be identified, the first two of which, certainly, fit in the descriptive narrative of experimental mechanistic-type research, and thus consistently fall short a ranking above observational studies in the pyramidal representation of the “level of evidence”: Phase 0—human microdosing studies, designed to test whether or not the drug or agent behaves in human subjects as was expected from preclinical studies; Phase I—first stage of testing in a small sample of human healthy volunteer subjects (n  <  100) to verify the treatment’s safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics; Phase II—larger, but still limited, study (n  <  300) with volunteer normal subjects and patients to test how the efficacy of the treatment (IIA studies test dose requirements; IIB verifies efficacy at the prescribed dose[s]); Phase III—large multicenter studies (n  >  3,000) aimed at being the definitive assessment of efficacy and effectiveness, usually in comparison with current “gold standard” treatment; Phase IV—“post marketing surveillance” trial, aimed at detecting rare or long-term adverse effects over a much larger patient population and longer time period than possible in a Phase III trial.

  11. 11.

    The Institute of Ayurveda and Integrative Medicine (I-AIM) collaborated with the South Asian Cochrane Network to organize a workshop to develop standards for reporting Ayurveda clinical trials (cf. South Asian CONSORT meeting, Christian Medical College, Vellore, India, January 12, 2010; Professor Darshan Shankar, Hon. Adviser for Indian Systems of Medicine to the Member (Health), Planning Commission of India, Chair). STRACT was proposed as the possible name for the CONSORT-like checklist of standards for reporting Ayurveda clinical trials.

  12. 12.

    prisma.org

  13. 13.

    In cumulative meta-analysis studies are added one at a time in a specified order (e.g., according to date of publication or quality) and the results are summarized as each new study is added. In a graph of a cumulative meta-analysis each horizontal line represents the summary of the results as each study is added, rather than the results of a single study. That is to say, a cumulative meta-analysis is actually a series of meta-analyses, where each analysis in the sequence incorporates one additional study. While cumulative meta-analysis is most often used to track evidence over time, it is also be used to show how the evidence shifts and changes in time.

  14. 14.

    In the case of repeated t test, this bias lends the analysis increasingly less powerful, by “chipping away” from the level of significance, α as follows: p(Type I error)  =  1  −  (1  −  α)c, thus when c  =  1 (one comparison) then p  =  1  −  (1  −  0.05)1  =  1  −  (0.95)1  =  0.05; but if we were to perform 3 “cumulative” t tests, then c  =  3 and p  =  1  −  (0.95)3  =  0.14. It is probable that the level of significance of a cumulative meta-analysis would be biased in a similar manner, based on probability distributions.

  15. 15.

    Chiappelli et al. [5]; Phi et al. [45].

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Author information

Authors and Affiliations

  1. Division of Oral Biology and Medicine, UCLA School of Dentistry, Los Angeles, CA, USA

    Francesco Chiappelli

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  1. Francesco Chiappelli
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Correspondence to Francesco Chiappelli .

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Editors and Affiliations

  1. , PG Department of Kaya Chikitsa, State Ayurvedic College, Tulsi Das Marg, Lucknow, 226003, India

    Sanjeev Rastogi

Appendix

Appendix

Evidence-Based Complementary and Alternative Medicine Online Resources Prepared by Linda Murphy and Jennifer Hoock for W8 at STFM 2007 (available from www.fmdrl.org/index.cfm?event=c.getAttachment&riid=1487)

1.1 Free Online Full-Text and/or Bibliographic Databases on CAM

  • AGRICOLA (Agricultural Online Access) AGRICOLA is created by the US National Agricultural Library. It includes citations about herbs and medicinal plants and includes references from the Herb Research Foundations’ HerbalGram. Production of electronic records began in 1970, but the database covers materials in all formats, including print works from the fifteenth century. Some records are linked to online full-text documents. URL: http://agricola.nal.usda.gov/

  • CAM on PubMedCAM on PubMed was developed jointly by NLM & NCCAM. CAM on PubMed provides journal citations related to complementary and alternative medicine (CAM). It is a subset of all citations found on the NLM’s PubMed. The subset contains over 220,000 citations from mid-1950 to the ­present. The ­subset restricts retrieval to specific CAM topics. Individual citation displays holding ­information, and some of which provide direct access to free full-text of articles. URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&itool=toolbar

  • Cochrane Collaboration Complementary Medicine Field Funding was awarded in 1996 to the University of Maryland Program of Complementary Medicine to establish the Cochrane Collaboration Complementary Medicine Field. Their main function is to construct a database of all the known RCTs (published or unpublished, in all language) that pertain to CAM. Approximately 5,800 CAM RCTs and over 230 systematic reviews have been identified. URL: http://www.campain.umm.edu/ris/risweb.isa

  • HerbMed The public site of HerbMed is a free, searchable database produced by the Alternative Medicine Foundation, Inc. It is updated only two times a year. The new herbs and updates of existing herbs are only available on the professional version, HerbMedPro, and it is available for licensing or subscription (http://www.herbmed.org/licensing.asp). HerbMed aims to provide access to the scientific data underlying the use of herbs for health. Information is provided for each herb on evidence for activity, warnings (including contraindications, adverse effects, and interactions), preparations, mixtures, mechanisms of action, and other information. URL: http://www.herbmed.org/

  • ICL (Index to Chiropractic Literature) This is a free web-based database funded by the Association of Chiropractic Colleges. Librarians from 13 different chiropractic colleges contributed to its indexing. This database indexes 41 chiropractic journals using terms from MeSH and CHIROSH from 1985 to the present. URL: http://www.chiroindex.org/#results

  • Memorial Sloan-Kettering Cancer Center This information resource, presented by our Integrative Medicine Service, provides evidence-based information on herbs, botanicals, and other products. URL: http://www.mskcc.org/mskcc/html/11570.cfm

  • NIH The Office of Dietary Supplements (ODS) The ODS provides a web-­searchable database of funded research and scientific papers on dietary supplements. It contains two databases called CARDS and IBIDS. The International Bibliographic Information on Dietary Supplements (IBIDS) database provides access to bibliographic citations and abstracts from published, international, scientific literature on dietary supplements. Computer Access to Research on Dietary Supplements (CARDS) is a database of federally funded research projects pertaining to dietary supplements. URL: http://dietary-supplements.info.nih.gov/index.aspx

  • OSTMED: The Osteopathic Literature Database A bibliographic index to the osteopathic medicine literature. Sponsored by the American Osteopathic Association and the American Association of Colleges of Osteopathic Medicine, OSTMED is produced by the Gibson D. Lewis Health Science Library of the University of North Texas Health Science Center at Fort Worth and the A.T. Still Memorial Library of the Kirksville College of Osteopathic Medicine. OSTMED® contains selected journal and book citations from the 1800s through 2003. Unfortunately, since financial support ceased January 31, 2004, citations are no longer being added to the database. URL: http://ostmed.hsc.unt.edu/ostmed/index.html

  • The Trip Database: “It is produced by TRIP Database Ltd.” The TRIP database searches sources of medical information, including publications on evidence-based medicine, query-answering services, guidelines, E-textbooks, medical images, patient information leaflets, and peer-reviewed journals in PubMed. URL: http://www.tripdatabase.com/index.html

1.2 Systematic Reviews

  • Bandolier Complementary and Alternative Therapies Bandolier Complementary and Alternative Therapies provides EBM health-care-related issues to medical professionals and consumers. Health topics include the nature of evidence, herbal medicine and supplements, acupuncture, homeopathy, massage, and safety concerns. The site provides abstracts of systematic reviews, meta-analyses, or other studies about CAM. The content is “tertiary” publishing, distilling the information from secondary reviews of primary. Currently it contains over 100 summaries on the effectiveness of CAM. URL: http://www.jr2.ox.ac.uk/bandolier/booth/booths/altmed.html

  • The Cochrane Library Developed by the Cochrane Collaboration, the Cochrane Library supplies high-quality evidence to inform people providing and receiving care, and those responsible for research, teaching, funding, and administration at all levels. The database is updated quarterly on the Internet. The Library consists of Systematic Reviews, Abstracts of Reviews of Effectiveness, Register of Controlled Trials, the Methodology Reviews, and the Cochrane Methodology Register. The Library contains over 5,700 reports of RCTs and over 80 systematic reviews in CAM. URL: http://www3.interscience.wiley.com/cgibin/mrwhome/106568753/HOME

  • PEDro: an initiative of the Centre for Evidence-Based Physiotherapy (CEBP) PEDro is the Physiotherapy Evidence Database. It has been developed to give rapid access to bibliographic details and abstracts of randomized controlled trials and systematic reviews in physiotherapy. Most trials on the database have been rated for quality to help users quickly discriminate between trials that are likely to be valid and interpretable and those which are not. Reliability of the PEDro scale for rating quality of randomized controlled trials has been published in Physical Therapy 83(8):713–721, 2003 August. Abstract can be viewed at http://www.ptjournal.org/info/pt_abs.cfm. PEDro also contains evidence-based clinical practice guidelines. URL: http://www.pedro.fhs.usyd.edu.au/index.html

1.3 Fee-Based EBCAM Online Resources

  • The Natural Medicines Comprehensive Database A comprehensive database that provides evidence-based, clinical information on natural products. It is designed for medical professions and updated daily. Product Search is available at the top of every page. It can be browsed or find general data on a selected product. It can also be searched by scientific name, common name, brand name, or by ingredient. URL: http://www.naturaldatabase.com

  • Natural Standard (electronic resource): the authority on integrative medicine The database provides evidence-based information about complementary and alternative therapies. It contains three subdatabases: herbs and supplements, condition center, and alternative modalities. For each therapy covered by Natural Standard, a research team gathers scientific data and expert opinions. Validated rating scales are used to evaluate the quality of available evidence. Information is incorporated into comprehensive monographs designed to facilitate clinical decision-making. All monographs undergo blinded editorial and peer review prior to inclusion. URL: http://www.naturalstandard.com/

1.4 CAM Curriculum Resources

  • EDCAM: Educational Development for Complementary and Alternative Medicine Provided CAM curriculum resources that were developed and reviewed by the EDCAM grant team and advisory panel along with expert consultants in the field of CAM and medical education. URL: http://www.amsa.org/humed/CAM/index.cfm

  • Stress reduction, relaxation, and wellness: “This module describes a workshop that would provide medical students with healthy coping skills and introduce lifelong self-care techniques for stress reduction, relaxation, and wellness. Both didactic and experiential learning are emphasized, particularly in the area of mind-body medicine.” URL: http://www.amsa.org/humed/CAM/A.doc

  • Introduction to Evidence-Based Complementary and Alternative Medicine: “This module provides guidelines and resources for basic introduction to the various medicines practiced around the world, collectively referred to as complementary and alternative medicines (CAM). Epidemiology, usage, and terminology are emphasized.” URL: http://www.amsa.org/humed/CAM/B.doc

  • The Core Curriculum CAM Integration in ten categories: “The curriculum resource materials were developed and reviewed by the AMSA Foundation’s EDCAM Grant Team and Advisory Panel along with expert consultants in the field of CAM and medical education.” URL: http://www.amsa.org/humed/CAM/resources.cfm

  • Nutrition and Lifestyle: “This module provides guidelines and resources for education to medical students about the medical aspects of nutrition and lifestyle and their effects on health.” URL: http://www.amsa.org/humed/CAM/C1.doc

  • Mind–Body Medicines: “This module provides guidelines and resources for education to medical students about mind-body medicines and the scientific and clinical basis for their usage.” URL: http://www.amsa.org/humed/CAM/C2.doc

  • Alternative Systems of Medical Thought: Traditional Chinese Medicine, Kampo, Tibetan Medicine, and Acupuncture: “This module provides guidelines and resources for education to medical students about alternative medical paradigms evolving in Asia and the clinical practice of traditional Chinese medicine (TCM), kampo, Tibetan medicine, and acupuncture.” URL: http://www.amsa.org/humed/CAM/C3.doc

  • Alternative Systems of Medical Thought: Yoga, Ayurveda, Native American, and Yoruba-Based Medicines: “This module provides guidelines and resources for education and background on alternative systems of medicine including Yoga and Ayurveda, and also introduces other systems that emphasize attunement with the environment such as Native American medicines and Yoruba medicine.” URL: http://www.amsa.org/humed/CAM/C4.doc

  • Alternative Systems of Medical Thought: Homeopathy and Flower Essences (updated 5/03): “This module provides guidelines and resources for education to medical students about homeopathy and provides a brief introduction to flower essence therapy.” URL: http://www.amsa.org/humed/CAM/C5.doc

  • Bioenergetic Medicines: “This module provides guidelines and resources for education to medical students about medical therapies using low-level energetic fields known commonly as energy medicine.” URL: http://www.amsa.org/humed/CAM/C6.doc

  • Pharmacologic/Biologically Based: Herbal Medicines: “This module provides guidelines and resources for education to medical students about plants used as medical therapies in herbal medicine, and introduces basic principles of naturopathy and aromatherapy.” URL: http://www.amsa.org/humed/CAM/C7.doc

  • Pharmacologic/Biologically Based: Nutrition, Dietary Supplements and Vitamins: “This module provides guidelines and resources for education to medical students about nutrition from a biochemical aspect. It includes background on dietary supplements, vitamins, and minerals.” URL: http://www.amsa.org/humed/CAM/C8.doc

  • Manipulative Therapies: Chiropractic and Osteopathy: “This module provides guidelines and resources for education to medical students about osteopathy and chiropractic, practices employing manipulative therapy.” URL: http://www.amsa.org/humed/CAM/C9.doc

  • Manipulative Therapies: Therapeutic Massage: “This module provides guidelines and resources for education to medical students about manual therapies including touch therapy, massage, and other medicinal approaches using hands, touch, and/or body awareness. It includes background on other movement and/or educational approaches such as Feldenkrais, Trager, Alexander Technique, deep fascial realignment like Rolfing, and massage therapies used in other systems such as Ayurveda and traditional Chinese medicine.” URL: http://www.amsa.org/humed/CAM/C10.doc

  • CAM Clinical Interviewing: “This outline describes suggested activities for ­students to learn how to incorporate holistic principles into their clinical skills of interacting with patients. Divided into four main categories, the CAM clinical interviewing components of the curriculum should emphasize CAM history ­taking, holistic interviewing, patient-centered care, and cultural competency. An additional introduction to alternative medical methods of clinical diagnosis is also provided.” URL: http://www.amsa.org/humed/CAM/D.doc

  • Integrative Medicine Field Study: “This module provides suggested activities and resources for students interested in moving beyond didactic and experiential work in CAM. As part of the integrative medicine field study course, AMSA suggests four independent and self-directed exercises to complement the existing curricula: CAM research, literature searches, community service, and mentorship.” URL: http://www.amsa.org/humed/CAM/E.doc

  • The Consortium of Academic Health Centers for Integrative Medicine (CAHCIM): The Center is supported by a grant from the Philanthropic Collaborative for Integrative Medicine. Their membership currently includes 36 highly esteemed academic medical centers http://www.imconsortium.org/cahcim/members/home.html. Their mission is “to help transform medicine and health care through rigorous scientific studies, new models of clinical care, and innovative educational programs that integrate biomedicine, the complexity of human beings, the intrinsic nature of healing, and the rich diversity of therapeutic systems.” URL: http://www.imconsortium.org/

  • Core competencies in integrative medicine for medical school curricula: a proposal. Acad Med. 2004 Jun;79(6):521–531. Review.PMID: 15165971 [PubMed—indexed for MEDLINE]

  • Curriculum in Integrative Medicine: A Guide for Medical Educators. May 2004 “The Consortium of Academic Health Centers for Integrative Medicine Education Working Group developed a set of competencies for undergraduate medical ­education (medical school level) that was published in the June 2004 issue of Academic Medicine: Core Competencies in Integrative Medicine for Medical School Curricula: A Proposal URL: http://www.imconsortium.org/img/assets/20862/AcademicMedicine1.pdf As a follow-up, the EWG project leaders developed and disseminated a curriculum guide that provided specific examples and illustrations from Consortium institutions regarding how medical schools can approach the implementation of the recommended competencies. The Guide for Medical Educators is no longer available in print, but all materials may be downloaded. The EWG is presently writing a follow-up article to this guide that will highlight these innovative curricula and provide additional examples from newer Consortium member schools.” URL: http://www.imconsortium.org/img/assets/20825/CURRICULUM_final.pdf

  • Northwest AHEC Online Professional Curriculum on Herbs and Dietary Supplements These online courses specifically designed for Physicians, ­physician assistants, nurses, advanced practice nurses, pharmacists, dietitians, nutritionists, other interested health-care professionals and health professions students-in-training (including residents, fellows, and postdoctoral students). The goal is to improve knowledge, confidence, and communication with the use of herbs and dietary supplements. The curriculum has been approved for a maximum of 14 h of continuing education credit. URL: https://northwestahec.wfubmc.edu/learn/herbs_ce/index.cfm

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Chiappelli, F. (2012). Fundamentals: Evidence-Based Practice in Complementary and Alternative Medicine—Perspectives, Protocols, Problems, and Potentials. In: Rastogi, S. (eds) Evidence-Based Practice in Complementary and Alternative Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-24565-7_1

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