t h e s u r g e o n x x x ( 2 0 1 7 ) 1 e7 Available online at www.sciencedirect.com ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net Matter for Debate Integrative medicine or infiltrative pseudoscience? Ben Li*, Thomas L. Forbes, John Byrne Division of Vascular Surgery, Department of Surgery, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada article info abstract Article history: Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific Received 19 October 2017 approach to the practice of medicine. Recently, the non-evidence-based practice of com- Accepted 5 December 2017 plementary and alternative medicine (CAM) has been increasing in the United States and Available online xxx around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions Keywords: with evidence-based medications or if patients choose to forego evidence-based care. CAM Complementary may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Alternative Despite these drawbacks, patients continue to use CAM due to media promotion of CAM Integrative therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Medicine Given the increasing demand for CAM, many medical institutions now offer CAM services. Institution Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti- vaccination views. These controversies demonstrate the non-evidence-based philoso- phies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries. © 2017 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. decisions about the care of individual patients”.1 Prior to this, Introduction treatment decisions were based on clinical expertise and experience with little consideration of scientific evidence, In 1992, Dr. Gordon Guyatt introduced the concept of leading to significant variations in decision making.2 Health evidence-based medicine, defined as the “conscientious, care professionals began to realize the merits of consistently explicit, and judicious use of current best evidence in making incorporating evidence into clinical decision making and * Corresponding author. Division of Vascular Surgery, 6EN-214, Toronto General Hospital, 200 Elizabeth St., Toronto, Ontario, Canada M5G 2C4. E-mail addresses: [email protected] (B. Li), [email protected] (T.L. Forbes), [email protected] (J. Byrne). https://doi.org/10.1016/j.surge.2017.12.002 1479-666X/© 2017 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. Please cite this article in press as: Li B, et al., Integrative medicine or infiltrative pseudoscience?, The Surgeon (2017), https://doi.org/ 10.1016/j.surge.2017.12.002 2 t h e s u r g e o n x x x ( 2 0 1 7 ) 1 e7 became increasingly appreciative of the concept.2 Today, discipline, CAM has evolved into a successful business evidence-based medicine offers a clear, systematic, and sci- throughout the world.19 entific approach to the practice of medicine.3 It is taught to health care professionals at every level of training and is the gold standard for how we provide care to patients today.4 Reasons for increased CAM use by the public The reasons for CAM use are complex and include the costs of Non-evidence-based medicine evidence-based therapies, dissatisfaction with conventional medicine, and a desire for a more holistic approach to treat- Complementary and alternative medicine (CAM) describes ment.19 In developing countries, people rely on CAM to treat health care approaches developed outside of evidence-based most of their diseases because evidence-based therapies are medicine.5 Alternative medicine is used in place of limited and expensive.20 In developed countries, CAM is more evidence-based medicine, whereas complementary medicine commonly used for disease prevention and health mainte- is used in conjunction with evidence-based medicine.5 Most nance.17 People suffering from chronic diseases such as back people use CAM along with conventional medicine, but some pain, headaches, arthritis, and cancer tend to use CAM to choose to forego evidence-based care.6 Terms such as inte- alleviate their symptoms because they do not find enough grative and functional medicine are increasingly used to de- symptom relief from conventional therapies.21,22 National pict a “holistic” approach to medicine, but they are similar to surveys suggest that approximately half of U.S. residents use CAM and are not supported by scientific evidence.5,7 These CAM to treat symptoms, particularly chronic pain.8 practices include visits to naturopathic, homeopathic, and Patients may also get side effects from evidence-based chiropractic clinicians, herbal remedies, acupuncture, medi- treatments such as pain and nausea.23 These side effects tation, yoga, and tai chi.5 Data from the 2007 National Health may lead patients to seek out CAM therapies that they believe Interview Survey showed that 40% of U.S. residents use 1 or have fewer side effects.23 This perception is fueled by an more CAM health practices,8 spending about $34 billion per increasing public distrust of pharmaceutical companies and year out of pocket.9 drug safety, leading people to pursue CAM therapies that they believe to be more “natural” than conventional medications.24 Patients may also believe that CAM provides more holistic Harms of CAM care than conventional medicine.25 CAM supporters argue that evidence-based medicine does not put enough emphasis Currently, there is insufficient evidence to support the use of on health promotion and focuses solely on “sick care”.26 They CAM therapies as they lack efficacy.10 There are also harmful claim that CAM focuses more on preventive care than interactions between some CAM therapies and evidence- evidence-based medicine.26 based medications.11,12 According to the National Center for The media compounds all of these factors by increasingly Complementary and Alternative Medicine, there is rarely a reporting on CAM therapies with inaccurate or incomplete consensus among CAM experts on the optimal product, dose, information.27 People may believe the media without con- or intended users.13 CAM can also cause harm to patients who firming the accuracy of the information through scientific choose to forego evidence-based treatment.14 For example, a studies.27 recent study demonstrated that patients using alternative medicine as the sole treatment for cancer were 2.5 times more likely to die than patients receiving conventional therapy.15 Public misconceptions about CAM Beyond the negative impact on health, CAM use can put a significant financial burden on patients and may reduce their Many of the factors that are driving CAM use are mis- ability to pay for evidence-based care.16 In the majority of conceptions held by the public. For example, preventive countries, CAM is not covered by health insurance and pa- medicine, which focuses on factors such as diet, lifestyle, and tients pay the majority of costs out-of-pocket.17 Expenditures stress management are all encompassed in evidence-based for CAM services increased by 45.2% between 1990 and 1997 in medicine.28 Health care professionals who practice the U.S. and was estimated to be $21.2 billion in 1997, with evidence-based medicine regularly provide preventive medi- $12.2 billion paid out of pocket.17 This amount exceeded the cine to patients as first-line therapy based on recommenda- 1997 out-of-pocket expenditures for all hospitalizations in the tions by clinical practice guidelines.28 The CAM community U.S.17 These expenditures have continued to increase over the often misappropriates preventive medicine as their own and past two decades, with U.S. citizens spending $30.2 billion out- presents conventional medicine as solely focused on pre- of-pocket on CAM approaches in 2012.18 scribing drugs.26 This message polarizes health care into Despite the fact that CAM is not evidence-based and puts conventional pharmaceutical medicine versus preventative financial strain on patients, its use continues to increase in the CAM therapy, misinforming the public and skewing their United States and around the world. Frass et al. (2012) per- perception about evidence-based medicine. formed a systematic review of trends in CAM use in Canada, Furthermore, CAM therapies have not been shown to be the United States, Austria, Switzerland, Germany, Denmark, more effective than evidence-based therapies at alleviating Australia, Italy, South Korea, and Britain, and found a signif- symptoms such as chronic pain.29 Evidence-based medica- icant increase in CAM use in all these countries between 1990 tions also do not cause more side effects than CAM thera- and 2006.19 Although few scientific data exist for much of the pies.30 Patients tend to believe that treatments that sound Please cite this article in press as: Li B, et al., Integrative medicine or infiltrative pseudoscience?, The Surgeon (2017), https://doi.org/ 10.1016/j.surge.2017.12.002 t h e s u r g e o n x x x ( 2 0 1 7 ) 1 e7 3 “natural” are better for them than those that do not, such as members, up from 8 in 1999.37 These centres include the drugs, which are often associated with “non-natural, chemi- Cleveland Clinic and Mayo Clinic, which actively support the cal-based” compounds.31 This naturalistic fallacy is provision of CAM services, as well as research and education dangerous because CAM therapies, such as herbal remedies, in CAM.38,39 The Cleveland Clinic's Centre for Integrative & can cause significant harm to patients, while evidence-based Lifestyle Medicine sees more than 5000 patients a year and medications have been thoroughly tested to ensure an provides services including acupuncture, herbal medicine acceptable safety profile.31 consultations, and chiropractic therapy.38 The Mayo Clinic Underlying these misconceptions is a lack of understand- has an Integrative Medicine and Health team that provides ing from the public about CAM and the fact that it is not evi- massage therapy, acupuncture, and animal-assisted ther- dence-based.31 Although the public believes that scientific apy.39 Although there are financial incentives for these in- evidence in medicine is important, it is often difficult for them stitutions to offer CAM services due to increasing demand, to discern evidence-based practices from non-evidence based their support of CAM legitimizes non-evidence-based and practices due to the significant amount of circulated ineffective therapies. misinformation.32 Although these misconceptions exist, it is important to recognize that factors such as increasing public distrust of Case study: CAM at the Cleveland Clinic pharmaceutical companies and a desire for more holistic care are real perceptions that influence the behavior of patients. The Cleveland Clinic, ranked the 2nd best hospital in the We need to better understand why patients feel this way so United States by U.S. News and World Report in 2017,40 runs that we can improve their trust in evidence-based medicine. multiple CAM centres, including the Wellness Institute, Improving the transparency of pharmaceutical companies33 Centre for Integrative Medicine, Centre for Personalized and better educating students and health care professionals Healthcare, Centre for Functional Medicine, and a Chinese about the importance of providing evidence-based holistic herbal therapy clinic.41 Some of its CAM centres have received care34 may improve patient satisfaction with conventional significant criticism over the years for having leaders that hold health care. non-evidence-based beliefs that can cause harm to patients. Whether or not the factors leading to increased CAM use The Centre for Functional Medicine (CFM) was created are reasonable, it is indisputable that the demand for CAM through the Cleveland Clinic's partnership with the Institute services is increasing in the United States and around the for Functional Medicine.41 The U.S. Federal Trade Commission world.19 This has prompted a greater number of states to li- found that the Institute for Functional Medicine's founder, cense CAM practices, leading to a corresponding increase in Jeffrey Bland, created several corporations that made false CAM practitioners.8 and exaggerated claims about their health services, leading to a $45,000 civil penalty.42 Furthermore, the founder of the CFM, Dr. Mark Hyman, co-authored an anti-vaccination book.43 Use of CAM at medical institutions Despite being founded by leaders with beliefs that can cause harm to patients, the CFM saw nearly 5300 appointments and Over the past few decades, there has been an increase in the had a waiting list of over 1100 individuals since its opening in number of clinical centres providing CAM services, the num- 2014.44 In 2016, the Cleveland Clinic stated that the CFM will ber of medical schools teaching CAM strategies, the number of receive funding to double in size.44 As a result of the strong researchers studying CAM interventions, and the number of media promotion of CFM,45 patients are unaware of the po- patients seeking CAM care.35 A survey of U.S. hospitals found tential harms and lack of therapeutic effectiveness that come that 27% offered CAM in 2005, up from 8% in 1998.13 All 18 with receiving care from a centre that holds strong non- hospitals on the U.S. News and World Report's 2008 list of evidence-based beliefs about medicine. “America's Best Hospitals” provide CAM of some type.13 The Additionally, the Director of the Cleveland Clinic Wellness majority (63%) of CAM patients are self-referred, but 38% of Institute, Dr. Daniel Neides, wrote an anti-vaccination column centres receive more than half of their CAM patients from in a local news outlet in January 2017.46 He was forced to referrals by health care professionals within their own in- retract the article and faced disciplinary action from the stitutions.35 This is because an increasing number of health Cleveland Clinic.47 The Cleveland Clinic tried to distance care professionals are beginning to support CAM.36 A survey of themselves from Dr. Neides by stating that those were his 233 physicians at the Mayo Clinic in 2006 showed that 44% personal views and do not reflect those of the Wellness would refer a patient to CAM therapy if a CAM practitioner Centre.47 However, as the Director of the Wellness Centre, Dr. was available at their institution.36 More than half of the re- Neides' attitude toward evidence-based medicine influences spondents (57%) thought that incorporating CAM therapies the underlying philosophy of the Wellness Centre, the care would have a positive effect on patient satisfaction and 48% that patients at the Centre receive, and what students learn at believed that offering CAM would attract more patients.36 The the Centre. strong affiliations to hospitals and growing referrals from Following the retracted column, the CEO of the Cleveland conventional care providers demonstrate that CAM has Clinic, Dr. Toby Cosgrove, reaffirmed the Cleveland Clinic's insinuated itself into the U.S. health care system.35 commitment to CAM by stating that “some approaches may Many well-established academic medical institutions now be considered unconventional, but most e acupuncture, yoga, offer CAM services. The national Academic Consortium for Chinese herbal medicine, guided imagery and relaxation Integrative Medicine now has 70 academic medical centres as techniques e have scientific backing.”48 This is a misguided Please cite this article in press as: Li B, et al., Integrative medicine or infiltrative pseudoscience?, The Surgeon (2017), https://doi.org/ 10.1016/j.surge.2017.12.002 4 t h e s u r g e o n x x x ( 2 0 1 7 ) 1 e7 statement because although some single studies have Countries should look towards Australia and England as demonstrated positive results with these CAM therapies, models for restricting non-evidence-based practices in systematic reviews of the evidence have demonstrated that medicine. there is insufficient evidence to demonstrate clinically rele- vant benefit for acupuncture49 and Chinese herbal medi- cine.50,51 Yoga carries with it the benefits of exercise,52 while Discussion guided imagery and relaxation techniques improve stress management.53 These effects are shown by the evidence and The use of CAM is increasing significantly in the United States these techniques are routinely recommended to patients by and around the world, particularly at medical institutions health care professionals for specific indications.54,55 Howev- known for providing rigorous evidence-based care. Given the er, the CAM community often misappropriates these tech- increasing demand for CAM, medical institutions have niques as their own and make claims about their effectiveness financial incentives to provide CAM services. However, this that go beyond the evidence.31 encourages patients to spend a significant amount of money on therapies that have no proven benefit. Academic medical institutions are supposed to show the highest level of A need for greater regulation of CAM commitment to evidence-based medicine. When they support CAM, it sends the message that practices without a proven In the U.S., CAM products are often classified as dietary sup- therapeutic or safety profile have a place in modern medicine. plements and are not regulated as strictly as conventional Indeed, the presentation of proven ineffective therapies drugs with respect to their safety, efficacy, and marketing alongside high quality, evidence-based medicine in academic claims.56e58 Furthermore, there is no standardized system for medical centres inadvertently legitimizes their usage and is licensing CAM practitioners in the U.S. and there are signifi- confusing for the public. This is dangerous for patients and cant variations between states in the regulation of services damages the reputation of medicine as an evidence-based that CAM practitioners can provide.59 As a result of this lack of discipline. More detrimentally, the public may be misguided standardized regulation, the American Chiropractic Associa- into thinking that CAM is evidence-based. tion is lobbying legislative assemblies to provide chiropractors Improving health care requires an increasing focus on with legal recognition as primary health care providers in 7 medicine that has been scientifically tested to be safe and states.60 Passage of bills that extend the privileges of chiro- effective. Reducing the rigour of evidence in medicine will not practors, such as allow them to prescribe drugs, would lead to improve the health of our population. Health care pro- a significant infiltration of non-evidence-based medicine into fessionals must understand how deep CAM runs in their in- the modern health care system, potentially posing a signifi- stitutions and ensure that they not only continue to provide cant health risk to the public.61 There have been numerous the best, evidence-based care for their patients, but also to proposals to improve the U.S. government's regulation of CAM advocate against the practice of non-evidence-based medi- products, services, and practitioners to ensure the safety of cine. Practitioners and institutions should respond to the the public.56 However, these proposals have largely been public demand for more holistic care, but do so in a way that is ineffective in changing government policy.56 evidence-based. Governments also need to improve regula- Other countries, such as Australia and England, have tion of CAM products and services, following the examples of demonstrated success in improving governmental regulation successful policy changes in Australia and England. CAM of CAM products.62e64 In 2014, the Department of Health in should follow the same efficacy and safety regulatory stan- Australia published a report recommending that the Thera- dards as conventional medicine. peutic Goods Administration increase random testing of CAM products due to high levels of non-compliance.62 They found that 61% of reviewed products were in breach of regulatory Declaration requirements.62 As a result, they recommended that regula- tors continue random testing and enforce penalties for The authors declare that they have no potential conflicts of breaches of regulation, while being more stringent in pre- interest nor any financial declarations. venting CAM producers from making unsubstantiated claims about their products.62 The Australian government accepted these recommendations and has moved towards stricter Sources of financial support regulation of CAM products.63 In 2017, the National Health Service (NHS) in England announced that homeopathic rem- This research did not receive any specific grant from funding edies and 17 other CAM products will no longer be publicly agencies in the public, commercial, or not-for-profit sectors. funded.64 The decision was made based on recommendations by the British Medical Association and the House of Commons' Science and Technology Committee stating that homeopathic references medications have not been shown to be more effective than placebo.64 NHS England noted that homeopathic medications were a “misuse of NHS funds,” costing the organization 1. 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