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Örebro University
Medical Education
Master thesis, 30 HP
January 2021
Arguments for and against acceptance of Qigong in Swedish Healthcare
Version 3
Author: Victoria Hogrell, Bachelor of Medicine
Supervisor: Rolf Ahlzén, General practitioner, Associate Professor of Medical
Humanities at Karlstad University
Word count abstract: 343
Word count manuscript: 7330
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Abstract:
Introduction
Traditional Chinese Medicine (TCM) is an ancient medical practice, performed since
approximately 2000 B.C. Qigong constitutes one of five main pillars in TCM and is a method of meditation, exercise as well as self-medication. Basic tenets of TCM is the body existing in balance with Qi (life-energy) and its emphasis on holistic dynamic processes over material structure. A lot of research has been done on the positive health effects of Qigong, although it is unclear whether the evidence situation is judged to be sufficient to prove Qigong effective. Objective
To investigate the arguments for and against acceptance of Qigong in Swedish Healthcare Methods
This is a qualitative study that followed the hermeneutical method, as well as the normative ethical theory, of study-design and data analysis. Searches of grey literature and electronic databases (Pubmed, Cochrane) were performed, serving the purpose to collect different perspectives. The selection of sources was based on relevance to the aim. Data emerged was analysed in order to investigate the most relevant ethical arguments for and against
integration of Qigong in the Swedish healthcare. Results
Main arguments against acceptance of Qigong were: “Traditional Chinese Medicine’s underlying philosophy stand in opposition to scientific worldview”, “Lack of strong evidence”, “Complementary and Alternative Medicine lead people away from Evidence Based Medicine”, and “Economical incentive and bias in Complementary and Alternative Medicine and Qigong”.
Main arguments for acceptance of Qigong were: “Extensive proven experience”, “Further acceptance and integration may increase patient safety and promote research”, and “Qigong is risk-free and highly available at low cost”
Conclusion
A strong argument against acceptance of Qigong is “lack of strong evidence”. Strong arguments for acceptance of Qigong are “further acceptance and integration may promote research” and “Qigong is risk-free and highly available at low cost”. Thus, strong arguments are found for, as well as against, integration of Qigong in Swedish established healthcare. The balance between these strong arguments, however, will have to be discussed further, as there is no obvious right answer.
Key words: Complementary and Alternative Medicine, Integrative Medicine, Traditional Chinese Medicine, Qigong, Ethics
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Abbreviations
TCM – Traditional Chinese Medicine
CAM – Complementary and Alternative Medicine EBM – Evidence Based Medicine
SOU – The Swedish governments official investigations
KAM – Committee for Complementary and Alternative Medicine of Sweden IVO – The Health and Social Care Inspectorate of Sweden
KI – The Karolinska Institute
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Index
Abstract: ... 1
1 Introduction... 3
1.1 Concepts & Definitions ... 3
1.2 Qigong History & Philosophy ... 4
1.2.1 Qigong History... 5
1.2.2 Traditional Chinese Medicine’s fundamental philosophy ... 5
1.2.3 Types of Qigong ... 6
1.2.4 The medical effects of Qigong ... 6
1.3 Complementary and Alternative Medicine in the Swedish Healthcare system ... 7
1.3.1 Legislation... 7
1.3.2 Research ... 8
1.3.3 Research Investigations ... 9
1.3.4 SOU 2019:28 Asplunds Complementary and Alternative Medicine Investigation ... 9
1.3.5 Prevalence in Sweden ... 9 1.3.6 Professional Organizations ... 10 2 Aim ... 11 3 Method ... 11 3.1 Study design... 11 3.2 Selection of sources ... 12 3.3 Delimitation ... 13
4 Relevant ethical principles ... 13
4.1 Autonomy Principle ... 13
4.2 Do-Good Principle ... 14
4.3 No-Harm Principle ... 14
4.4 Integrity Principle ... 14
4.5 Justice Principle ... 14
5 Result and discussion ... 15
5.1 Arguments against acceptance of Qigong ... 15
5.1.1 Traditional Chinese Medicine’s underlying philosophy stands in opposition to scientific worldview ... 15
5.1.2 Lack of strong evidence ... 17
5.1.3 Complementary and Alternative Medicine lead people away from Evidence Based Medicine ... 18
5.1.4 Economical incentive and bias in Complementary/Alternative Medicine and Qigong ... 20
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5.2.1 Extensive proven experience ... 21
5.2.2 Further acceptance and integration may increase patient safety ... 22
5.2.3 Further acceptance and integration may promote research... 24
5.2.4 Qigong is risk-free and highly available at low cost... 25
5.3 Limitations and weakness of the study ... 27
6 Conclusion ... 27
7 Acknowledgement ... 28
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Introduction
Qigong is a method of meditation, physical activity as well as self-healing that has been passed down from generation to generation in ancient China since approximately 2000 B.C. Today much research is executed on the medical effect of Qigong, indicating a positive effect especially in chronic disorders such as hypertension, arthritis, chronic fatigue syndrome, neck problems, headaches and prevention of cardiovascular disease (1)(2)(3). However, the quality of the studies is unknown, as only few are translated into English (4). The scope of research published on Pubmed and Cochrane is limited and further trials of high methodological quality with greater sample size and follow-up are needed.
The most important aspect of Qigong is its positive health effect, but Qigong is also considered important in study/sports-contexts and for relaxation purposes (1)(2). In recent years Qigong has spread beyond China's borders and is now practiced worldwide (1)(3).
1.1 Concepts & Definitions
It is not apparent what is defined as Complementary and Alternative Medicine (CAM) and what is defined as Evidence Based Medicine (EBM). Synonymous terms for EBM are e.g., "scientific medicine", "school medicine", "conventional medicine", "western medicine" as well as "traditional medicine" (5).
REGION: COMPLEMENTARY AND ALTERNATIVE MEDICINE
IS DESIGNATED:
SCANDINAVIA “Complementary and Alternative Medicine” in the future increasingly “Integrative Medicine”
THE UK "Complementary Medicine" EU CONTEXT "Unconventional Medicine" FRANCE "Soft or Parallel Medicine" ENGLAND "Supplementary medicine" INTERNATIONALLY “Traditional Medicine”
4 The term "integrative medicine" reflects the aim of integrating complementary methods in the official healthcare under certain conditions. This study uses the term CAM as it is established internationally as well as in Sweden (6). Those working with CAM are referred to as “CAM practitioners” and the care given “CAM-care”.
The term EBM refers to the care provided by professionals subjected to inspection by The Health and Social Care Inspectorate of Sweden (IVO) and furthermore based on scientific evidence and proven experience (7). By law, healthcare professionals are obliged to comply with the Patient Safety Act (2010:659), which reads under Chapter 6 "Obligations for healthcare professionals, etc.", subheading "General obligations”:
“1§ Healthcare professionals must conduct their work in accordance with science and proven experience” (7).
This study will use the term EBM as well as EBM-care, referring to the established healthcare.
1.2 Qigong History & Philosophy
Qi means energy/vitality, derived from the ancient Chinese word for “rice steam”. Gong, on the other hand, means training/work. The word Qigong is thus translated into "training with vitality" (1,2,4,8). Qi is described as life-energy that moves through the body “like steam”, related to the breathing, consciousness and soul. The center of Qi is called Dantian, located below the umbilicus. Qi flows between the various organs via channels in the body, called Meridians, and along the meridians are the acupuncture points that affect the flow of Qi. Health and illness occur in the flow of Qi. Qigong can be performed regardless of age and physique. No tools are required and no more space than one step in each direction (1,2,8,8– 10)
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1.2.1 Qigong History
Qigong’s positive effects have been described by philosophers and "wise men" for centuries. It is known that humans about 2000 B.C. in middle China (along the Yellow River) danced to expel "moisture/poison”, keep warm and heal diseases e.g. arthritis. The Yellow Emperor’s Classic of Medicine (original title Huangdi Neijing) is one of the world's oldest medical dissertations, estimated authored 3000 B.C. It describes breathing techniques and stretches said to cure common symptoms such as fatigue and depression (1)(3).
Lao Zi, a famous philosopher from 500 B.C., highlighted the importance of relaxing the chest, tightening the abdominal muscles and focusing on Dantian. During the Three
Kingdoms period (280-220 B.C.) a famous Chinese doctor Hua Tou created the spectacle Five Animals, aiming to help people regain ability to strengthen the body and cure disease by
mimicking wild animals’ natural movements, which people considered to have lost due to modern society. The exercises were named after wild animals, for an invigorating effect (1,2,8).
”Moving like a bear and a bird results in a long life” (1).
During the 20th-century modern medicine developed explosively with new chemical drugs
and surgical methods, while in the East TCM (Traditional Chinese Medicine) continued to be highly valued. China’s empire ended in a revolution in 1911 and in 1949 communism took hold. The people's great appreciation for Qigong was not dampened despite political opposition, on the contrary, the first Qigong-clinic was established in 1955 in the Heibei Province. In 1959 the Ministry of Public Health held the first national meeting aiming at exchanging experience in Qigong (1)(2).
1.2.2 Traditional Chinese Medicine’s fundamental philosophy
In TCM pain/illness signify friction in the Qi-flow along the meridians. Stimulation of the acupuncture points can release the friction, adding “good” energy from the outside and "bad" energy can be released. Each meridian belongs to an organ (1,2,4,9,11,12)
TCM consists of five basic methods: Qigong, acupuncture, massage, herbs and Moxa burning (dried leaves from Artemisia Moxa that are kept close to the skin). The latter four require an
6 outsider to treat, while Qigong is self-healing to combat diseases (2)(4)(5). It is said that illness cannot return if you have recovered in this way - you have built up immunity (1).
All TCM-methods are based on the same philosophy: Balance in the universe - Yin and Yang, restoring non-friction (9,10–12). The concept of Yin and Yang originates from one of the oldest and most influential works of Chinese literature: The Book of Changes (Yi Jing) about 3000 B.C. The message is that everything in the universe has two sides and that these sides must exist in balance. If there is only one side, it becomes too strong or weak and thus everything would disappear, as fire would burn up the earth without water (2).
Yin and Yang together with the "center" form “the five elements”: wood, fire, water, metal and earth. These elements are associated with the "five major organs": the liver, lungs, heart, kidneys and spleen. The yin-organs form pairs, are compact and are considered most
important. Yang-organs are hollow and cooperate with Yin (1)(2)(3).
Fundamental is the Chinese philosophy Dao, "the right way", meaning that everything from a rock to a piece of paper and a human must be balanced, in its own natural way (1)(3).
1.2.3 Types of Qigong
There are five major types of Qigong: the Daoist, Buddhist, Confucian, Medical and Martial arts, all types descended from Daoism or Buddhism. Medical Qigong is described more theoretically than practically, focusing on the acupuncture points and meridians (1,2,11).
Qigong is further divided into active and passive Qigong. Active Qigong (Donggong) involves movements while passive Qigong (Jinggong) involves meditation (standing, sitting or lying down) aimed at building and storing Qi (1)(2).
1.2.4 The medical effects of Qigong
Much research is executed in China on the medical effect of Qigong. The quality however is unknown, as only few are translated into English (4). A Cochrane Library search was
7 regarding Qigong and its role in the following patient groups: Neck pain, general cancer patients, prevention of cardiovascular disease, chronic obstructive pulmonary disease and cardiac rehabilitation with atrial fibrillation (12–17).
Altogether they conclude very limited evidence for the effectiveness of Qigong, most of the trials are at high risk of bias, hence a low confidence in the validity of the results.
One systematic review suggests beneficial effects of Qigong for chronic mechanical neck pain, while stretching or endurance exercises had a minimal effect (13). One systematic review indicate clear beneficial effects of Qigong in cardiovascular prevention, although with small sample size (12).
Problematic is that trials show great variation in participants recruited, duration of Qigong and follow-up, as well as uncertainty whether Qigong was practiced during the whole trial period (12)(14–16)(17). The importance of adequate descriptions of the attributes of the exercise e.g. intensity, frequency and duration has been underlined, as well as that professionals with a comprehensive understanding of physiology deliver the training (14,15,17).
1.3 Complementary and Alternative Medicine in the Swedish Healthcare system
1.3.1 Legislation
Complementary and Alternative Medicine (CAM) is defined as “Measures aimed at medically preventing, investigating or treating diseases and injuries that have not been accepted in healthcare” (18).
In Sweden the term for CAM was “Quackery” in legal contexts until 1999, when the Quackery Act from 1960 was worked into a new law (together with the Competence, Disciplinary Sanctions, Supervision and Duties Act): The Patient Safety Act (1998:531), aiming at strengthening the patient's position in care and creating a better overview (5)(19)(7).
8 The law prohibits CAM practitioners to treat a range of conditions: notifiable infectious diseases, cancer, diabetes, epilepsy and diseases related to pregnancy/childbirth. It is forbidden to use general anesthesia or hypnosis, provide written advice or treatment
instructions without personal examination. Children under the age of 8 may not be examined.
Healthcare professionals are under the supervision of The Health and Social Care
Inspectorate of Sweden (IVO) and must carry out their work in accordance with "science and proven experience" (see 1.1). CAM methods cannot be used without renouncing professional certification (5). The term "proven experience" is not defined in legal text, generating
discussions regarding gray areas (19).
CAM-care is subject to 25% value-added tax difference from Evidence Based Medicine (EBM) -care, and since CAM methods rarely are region subsidized they are usually
expensive. Exceptions are in some regions where agreements have been made with specific physiotherapists, chiropractors and naprapaths. Most countries have more liberal legislations, as licensed professionals under own responsibility can work with CAM (5).
1.3.2 Research
A bibliometric analysis of scientific papers and textbook chapters shows that at least 5000 CAM related articles and book chapters are published annually worldwide, representing 0.5-0.6% of all medicine/health publications. Swedish researchers produce about 70 CAM articles annually, of which 20% are clinical trials. Swedish CAM research teams are generally small. Collaboration with EBM researchers as well as interdisciplinary CAM research is scarce (19).
Reviews of the international literature indicate that research on acupuncture and Mind-Body Therapies (health interventions working on physical and mental level e.g. yoga and Qigong) dominate, however with scattered results and methodological problems (19).
Leading funders of Swedish CAM research are the Swedish Research Council, The Karolinska Institute (KI) and the Ekhaga Foundation (5). In an interview study of the Asplund’s investigation basically all research funders rejected the idea of earmarking funds
9 for CAM research. Most CAM representatives state that the greatest problem with CAM research is insufficient funding (19).
1.3.3 Research Investigations
CAM research has been investigated on several occasions last four-five decades. The Swedish governments official investigations (SOU) -1989:60 aimed to extensively examine the CAM situation (18). Other major government CAM investigations are the Kjell Asplund's CAM Investigation (2017-2019) (19).
SOU-1989 stated that CAM research is very limited, often narrow, carried out by few researchers. The lack of interdisciplinary research was highlighted in SOU-1989 and Asplund's report SOU-2019 (5)(19). Swedish CAM studies are published in scientific journals with low impact and are relatively low-cited (19).
Investigations have suggested refrainment from controlled clinical trials in psychologically-oriented methods. Considered important, however, are e.g. empirical effect-assessment of the most common CAM methods, comparative studies regarding care of patients, analyses of the treatment process itself and studies of expectation-effects (19). The importance of
collaboration in order to build research competence has been highlighted in various government investigations (5)(19).
1.3.4 SOU 2019:28 Asplunds Complementary and Alternative Medicine Investigation
The Swedish government appointed a study with the aim of reviewing CAM in Sweden, resulting in SOU 2019:28 Asplunds Investigation 2017. The first partial report presented 2019 proposed various changes in order to increase patients’ ability to obtain adequate information on CAM methods (among other things) (19).
1.3.5 Prevalence in Sweden
The most common CAM methods in Sweden are chiropractic and naprapathy, followed by massage, acupuncture, "CAM herbal remedies" and relaxation-exercises e.g. meditation, yoga
10 and Qigong (6)(19). A government appointed investigation revealed that more than 200 CAM therapies were present in Sweden in 1999, of which 13 originating from TCM (Traditional Chinese Medicine) or Japanese traditional medicine (5). In Stockholm and Halland regions Qigong specialized physiotherapists are integrated in public healthcare (20–22).
Asplund's investigation SOU 2019:28 performed a metanalysis of 20 studies and opinion-polls published in 1987–2018 that examined CAM use and attitudes in the Swedish
population. The studies with the highest response rate indicated altogether that 17–39% of the population used CAM in the last two weeks or during the last year, while other studies report up to 70%. Use in patients with diagnoses were approximately 29-58% (differs between studies). The investigation furthermore illuminated that a higher level of education is associated with higher CAM use (19).
Stockholm region decided in 1999 to establish a CAM research center, aiming at initiating CAM studies and training CAM practitioners in research. Osher Centrum of Integrative Medicine was established at KI in 2005 after a donation of 43million SEK, from the private company Osher Foundation. The center has no clinical activity but is said to work with local health units. More Osher Centers are established in the United States (23). In Sweden's healthcare programs CAM education is seldom included. KI medical education offer optional CAM courses (24).
1.3.6 Professional Organizations
Asplund's investigation highlights the lack of official Swedish CAM company or practitioner statistics (19). About 30 CAM professional organizations have been identified with about 8000 members, although far from all CAM practitioners are registered anywhere. These organizations pursue issues of interest e.g. raising awareness of CAM, quality/patient safety issues and research development. Most have ethical guidelines, requirements for
liability/patient injury insurance and educational requirements including mandatory base-medicine (see 5.2.2). CAM courses are generally conducted privately, without government transparency (19).
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Aim
To investigate the arguments for and against acceptance of Qigong in Swedish Healthcare.
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Method
3.1 Study design
This is a qualitative study that followed the hermeneutical method, as well as the normative ethical theory, of study-design and data analysis. The medical humanities have other
methodological conditions than biomedical science and the basic approach is qualitative. The hermeneutical method implies seeking meaning, intention and context, through linguistic interpretation based on analysis of concepts, descriptions, arguments and opinions (25).
The normative ethical theory of data-analysis means that the content of arguments are evaluated in the light of general ethical principles. Valued conflicts are illuminated and the strength of the arguments are weighed against each other. The selection of sources was based on relevance to the question. The principles used have a wide-spread acceptance in the medical ethical discourse (26).
An inductive approach was used, thus the information collected with the aim of developing new theories, without a definite hypothesis in advance. The interpretation is inevitably
subjective and the author must clarify the starting point, the pre-understanding, of the issue to be analysed. It is impossible in this kind of study to completely free oneself from the
subjective element (25). Thus; I had done no previous research on Qigong, Traditional Chinese Medicine (TCM) or Complementary and Alternative Medicine (CAM) and my prior knowledge of the matter was only awareness of TCM-integration in China’s Evidence Based Medicine (EBM) -care.
The qualitative methodology implicates that data collection and analysis were started simultaneously, meaning that the questions at issue grew and developed when unexpected findings or patterns were discovered (25). Prior to the start of data collection the aim was to investigate "TCM's role in Swedish healthcare", without any limitation within TCM. This
12 developed into “Advantages and disadvantages of accepting Qigong as an example of TCM in Swedish healthcare”, which in turn amounted to the current aim.
It is not meaningful to attempt to separate the result and discussion in an ethical study of this sort, because the result actually is a discussion. The whole aim of the study is to analyse, evaluate and problematize. Hence, result and discussion was presented under the same heading.
3.2 Selection of sources
A broad search of information was conducted, in order to serve the aim of this study – to explore the width of perspectives regarding CAM and TCM in society. Thus, searches of grey literature (e.g., published books, textbooks, e-books, government appointed studies,
university thesis, online medical newspaper articles, general articles and health websites) as well as published articles (Pubmed, Cochrane) ware performed.
The selection of information in this study was entirely based on relevance, serving the purpose to investigate the aim of this study, aiming at mapping out the essence of the subject and simultaneously discovering different perspectives and arguments.
Firstly the electronic library database of Värmland region “Karlstad City Library” was explored see figure 2, containing all available literature in all of Värmland region’s city libraries, thus differ from other regions library content. The keywords were searched in English and Swedish translation. In total 12 titles were included and 325 excluded because: Qigong, TCM or CAM not main subject, duplicates of titles, not rich in content or not available.
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Figure 2. Literature search of the Värmland region’s electronic library database.
The article search was conducted by the electronic article databases (Pubmed, Cochrane) with the purpose of briefly exploring the breadth of research in Qigong. The selection of studies was based on relevance to the question, as stated above. The Pubmed article search was done with the following MeSH terms: "Complementary Therapies/ethics" OR "Integrative
Medicine/ethics" OR “Qigong” OR “Qigong/ethics”. A more limited Cochrane article search was done with the term “Qigong” and 6 out of 7 systematic reviews were briefly investigated, one excluded because Qigong was not actually included in the trial.
3.3 Delimitation
As this study followed the hermeneutical method of data analysis the selection of sources was entirely based on relevance and guided by the aim, investigating the main arguments for and against integration of Qigong in Swedish healthcare. The exclusion/inclusion criteria were determined during the course of the study (25).
This study was tightly defined because of the limitations of a master thesis. Greater scope of sources and more systematic article searches could be included in a more extensive study.
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Relevant ethical principles
14 Autonomy means the individual's right to understand the implications, risks and potential consequences of treatment prior to choice making, and not undergo forced treatments. Important is the “informed-consent” healthcare praxis, which must precede medical procedures. Access to information of consequences of different treatment alternatives is fundamental for informed-consent (27,28).
One should be able to exercise self-determination and take moral responsibility for one's actions (27,28), and not be in a position of dependence or subjected to constraint, as the informed-consent then becomes an illusion. The precondition for autonomy is decision making competency (27).
4.2 Do-Good Principle
Do-good principle means striving to meet the patient's needs, medically as well as humanely, to the greatest possible extent based on the situation (28).
4.3 No-Harm Principle
No-harm principle means choosing the alternative causing the least harm/suffering, in relation to the amount of good done. Unjustified risk-taking should be avoided (28).
4.4 Integrity Principle
Integrity Principle refers to each person's intrinsic value as a person, physically and mentally. Physical integrity imply e.g. consent for physical examination. Mental integrity includes e.g. individual values and beliefs, which cannot be subject to intrusion or manipulation.
Individual opinions and values cannot be violated (27,28).
4.5 Justice Principle
Justice Principle meaning striving for greatest possible justice based on need (28) - a
15 means. Human value is tied to each individual person, regardless of performance or
personality (27).
All are equal and should be treated equally according to individual need, unless ethically relevant differences exist (27,28).
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Result and discussion
5.1 Arguments against acceptance of Qigong
5.1.1 Traditional Chinese Medicine’s underlying philosophy stands in opposition to scientific worldview
Each medical system is based on an ideology and philosophy. The basis of Evidence Based Medicine’s (EBM) scientific theoretical approach is philosophical orientations such as materialism, arising from the theories, ideas and values from the 18th century’s
Enlightenment. The western scientific worldview can thus be regarded as a specific philosophical theory, rather than an objective truth – a product of our scientific history (2)(4)(24).
The western philosophy, however, is considered to be more truthful, and full relativism thus not justified. In modern western healthcare (such as Sweden’s) an accurate system has been developed for quality-assurance. Healthcare workers follow strict rules, regulations and specific principles. Exam certificates issued by authorities are required to obtain titles. At employment individual tests and control of load registers are performed. Prescribed drugs are proven effective according to medical research, and the methods of therapy cannot be in conflict with accepted science e.g. biophysics, biochemistry or physiology according to the so-called "reasonableness criterion” (4).
EBM-care stands in contrast to Complementary and Alternative Medicine (CAM) -care regarding education, government controls and view of evidence. Traditional Chinese Medicine (TCM) is based on proven experience without "scientific evidence", while EBM requires reproducible research findings for acceptance (4). EBM's general purpose is to
16 influence cell processes for disease control, while TCM aims to attain balance in "Qi” (1)(4). Swedish medical training focus mainly on pathogenesis, not salutogenesis (factors that support human health and well-being). TCM, however, aims at achieving a general balance (2)(24).
Quotes illustrating the contrast in fundamental understanding of health, science and research are "Small has no inside, large no outside" and "From nothing becomes something", Yi Jing ca 3000 B.C (1).
The western evidence based healthcare system with clear regulations conceivably strengthens the do-good and no-harm principle. EBM-care’s standardized treatments for
symptoms/illness may furthermore strengthen the Justice principle “All are equal and should be treated equally” (unless ethically relevant differences exist), unlike TCM aimed at
achieving unique individual balances.
EBM views disease processes as a result of external "aggression" and/or genetics, which are combated via opposites e.g. antihypertensive medicine against hypertension. Health problems are often considered to come from outside and thus also the solution – The responsibility lies largely with the healthcare system, hence the word patient (4). From TCM’s perspective this can be regarded as discharge of responsibility, and can be considered to compromise the Autonomy Principle which states the importance of self-determination and moral
responsibility.
TCM contrarily state that health is achieved through harmonizing opposites and the key to health lies in ourselves (4). Nevertheless, it can be argued that emphasis is placed on personal responsibility within EBM-care as well, e.g. “motivating conversation” in primary care.
What is the difference between combating and harmonizing opposites? Do the two worlds meet somewhere? In fact there are EBM-treatments aiming at achieving general health and “balance” e.g. Prescription Physical Activity (as well as combating the metabolic syndrome). Prescription Physical Activity is relatively newly introduced in EBM-care, and official healthcare seems to be moving towards a more holistic health perspective, in line with TCM.
17 An interesting question is whether the scientific worldview really proves the foundation of TCM incorrect? If Qi's non-existence cannot be proven, can it be claimed that the two “worlds” do not co-exist? TCM's underlying philosophy and foundation cannot stand in true opposition to the scientific worldview if there is room for both philosophies to exist
simultaneously. This is a large and long-running discussion in philosophical science theory.
In summary, "TCM's philosophy in opposition to scientific worldview" is considered to be a relatively strong counter argument given TCM and EBM’s contrasting view on pathogenesis. However, various parallels can be drawn between the philosophical basis of EBM and TCM, e.g. Qi as a metaphor for adenosine triphosphate, the energy-carrying molecule that drives cell processes.
5.1.2 Lack of strong evidence
Qigong has been partly integrated in Swedish healthcare despite doubtful evidence, e.g. Stockholm and Halland regions. In the textbook Alternative Medicine: Complementary
Therapy Methods (5) this is explained by arguing that Qigong has been "proven effective"
against a number of illnesses, and therefore accepted. On Uppsala University Hospital’s website Qigong is recommended as physical activity (29). Altogether it is unclear whether the evidence behind Qigong is judged to be sufficient or not, and so the credibility of the above counter argument.
The no-harm and do-good principles are relevant to discuss. Logically, healthcare should recommend treatment methods with strong evidence in order to achieve most effective and safe results possible. The above principles speak against integration if Qigong lacks strong evidence.
The question is how much emphasis should be placed on evidence-degree regarding
treatment methods with no side effects, such as Qigong (see 5.2.4). The purpose of medical trials is to ensure that benefits of treatment outweigh the risks, as well as that useless methods are not applied. How important is strong evidence in the absence of side effects? The do-good principle imply striving to meet the patient's needs, medically as well as humanely, to
greatest possible extent (see 4.2). It can be argued to be humane to support the use of
18 Furthermore, it is interesting to consider how well adapted western research tradition is to the evaluation of CAM methods. The Swedish governments official investigations
(SOU-investigations) highlight that study methods with high evidence, e.g. double-blinded randomized trials, are not well applicable in the evaluation of CAM methods. Do such research methods work when evaluating Qigong?
Government investigations and CAM advocates have proposed appropriate research methods for evaluating CAM methods such as Qigong (see 1.3.3) e.g. well-documented long-term case studies, observational studies, patient stories and other types of qualitative research. A "significant deviation" from clinically-controlled trials is recommended regarding primarily psychologically-oriented methods (e.g. Qigong). In development of research methods that do CAM methods justice, CAM practitioners have highlighted the importance of being involved in research, as knowledge of the traditional medical system is fundamental (19)(24).
In summary, it remains unclear whether the evidence behind Qigong is judged to be sufficient or not, as Qigong is partly integrated in Swedish healthcare on the basis of current evidence. However, the need for greater studies with suitable choice of research methods in order to evaluate the evidence for Mind-Body therapies (e.g. Qigong) has clearly been stated in SOU-investigations and the counter argument is thus judged to be strong.
5.1.3 Complementary and Alternative Medicine lead people away from Evidence Based Medicine
Concern seems to exist regarding CAM leading people away from EBM, that an acceptance of CAM's underlying philosophies implies a distrust of Western science and undermines the credibility of established healthcare.
It seems reasonable to "protect" people from this, in line with the no-harm principle, as CAM practitioners generally lack the educational background to make correct diagnosis or react to symptoms of serious illnesses. Furthermore, information about different treatment options and their implication is fundamental for the autonomy principle. This will likely not be the case if patients primarily seek CAM (considering educational background) compromising autonomy and most importantly no-harm principle.
19 The above concern is based on the idea that patients choose between EBM-care and CAM-care. Is this the reality? SOU-investigation indicates that 29-58% of patients with disease diagnoses used CAM the last two weeks/year, and a higher level of education (hence average income) correlates with higher CAM use (see 1.3.5).
Considering the statistics CAM is most likely used as a complement to EBM. Indeed, a study by The Karolinska Institute (KI) indicates that 75% of all patients used CAM in the past year, but few mention it to their doctor, presumably due to stigma (24). This poses a significant patient safety risk, via EBM-CAM treatment-interactions (see 5.2.3). In line with the no-harm principle healthcare should work against this stigmatization, e.g. via basic CAM education for healthcare professionals, fundamental for dialogue between patient and caregiver.
Other studies indicate that patients in Sweden (like other high income countries) turn to CAM due to dissatisfaction/lack of help or "lack of values" in the established care, rather than as a first choice (19,30), suggesting that EBM-care lead people away from itself rather than the other way around (although it can be assumed that the healthcare professionals in EBM-care most often tries all possible treatments, and not all conditions can be helped).
Swedish healthcare's major problems with continuity and waiting time are established. Patients with high incomes have the opportunity to compensate for these "missing values" in EBM-care via CAM-care (for certain health problems). People without the financial security are, however, completely dependent on region funded care.
According to the justice principle and human value all should be treated equally, regardless of performance or personality. Meanwhile, access to CAM therapies depends on income or place of residence. It can be argued reasonable to extend CAM integration for equality between regions, and an expanded integration of Qigong via physiotherapists can be considered realistic and feasible, as it can be attained at low-cost for the government (see 5.2.4).
In summary the counter argument “CAM lead people away from EBM” is considered insubstantial, as patients rather seem to use CAM as a complement when EBM-care is not "sufficient".
20
5.1.4 Economical incentive and bias in Complementary/Alternative Medicine and Qigong
CAM companies are (usually) not integrated in the established healthcare, but run entirely by private funds. The economy is thus completely dependent on care-seekers. The more care that is sought, the greater the financial income. This may create inappropriate incentives, aiming at generating greater earnings rather than following ethical principles. Authors of literature regarding CAM methods often run private CAM companies, thus bias can also be assumed in literature.
Altogether this could compromise the no-harm, do-good and furthermore autonomy principle, patient's right to information about implications and consequences of different treatment options, and furthermore not be in dependency meaning that the informed-choice becomes an illusion, e.g. if CAM practitioners assure patients that their treatment methods are the solution to all diseases/symptoms. Presumably CAM practitioners and authors most often provide patients with best information possible, but this cannot be assumed.
However, the above patient safety situation could be viewed as an argument for further integration of promising CAM methods, as patients then are referred to CAM practitioners via e.g. primary care, treatment options presented by licensed healthcare professionals and the financial interest of CAM practitioners becomes solely their own salary. Literature bias could be minimized through development of a government-run CAM information platform (see 5.2.2).
Yet, there are reasons to judge economical incentives in Qigong treatment as insignificant, regardless of integration, as Qigong is a risk-free method of self-treatment and in literature encouraged to be performed daily at home (although group training exist).
In summary, The counter argument is judged to be strong and highly relevant in discussion of general CAM methods, but insubstantial regarding Qigong, considering the insignificant economical incentive.
21 5.2 Arguments for acceptance of Qigong
5.2.1 Extensive proven experience
The positive effects of Qigong have been described since thousands of years ago, e.g. in one of the world's oldest medical thesis Huangdi Neijing ca 3000 B.C. (see 1.2.1). In 1949 traditional Chinese culture, the philosophical basis of Qigong, was banned due to entrance of Communism in China. Despite this Qigong survived, and today practiced all over the world (1). According to government investigations, relaxation-exercises (e.g. Qigong and yoga) are the most common CAM treatments in Sweden after chiropractic and naprapathy (see 1.3.5).
A positive effect of Qigong could be assumed given the history, regardless of the questionable evidence situation. According to the do-good principle the patient's needs should be met as far as possible, medically as well as humanely. Thus it can be argued that Qigong should be encouraged, at least humanely, despite the underlying effects not being proven.
Could it be that the efficiency depends on something not yet measured in lab or not yet connected to the context? CAM advocates support the EBM-care’s quality-assurance system, but question whether everything must be proven with "strong evidence"? Perhaps the effect of Qigong is achieved on longer term than ordinary clinical trials (4) (see 5.1.2)?
According to the Patient Safety Act (2010:659) healthcare professionals must work according to “science and proven experience”. However, one could question whether this really is attained in practice. E.g. when introducing new drugs, surgical methods or vaccines, does not healthcare rather work according to science or proven experience, new methods introduced on the basis of “science” only?
Legal texts lack definition of the term “proven experience” (see 1.3.1), amounting to controversial gray areas. A government investigation by the Swedish Agency for Health Technology Assessment highlights that even descriptions for interpretation are missing(31). The National Board of Health refers to a bill (1993/94:14) in SOU-1989:60 (18), which in
22 turn refers to an answer given by the National Board of Health to an individual doctor in 1976 (32).
According to Lars-Åke Jonsson, expert in the Ministry of Social Affairs, judge and former chairman of the Swedish Health and Medical Care Responsibility Committee, there are no clear limits to what licensed health professionals may or may not do. E.g. treatment tradition, common sense and clinical perspective does not fit in the concept of "science" and is thus explained by "proven experience” (31).
Qigong is an approximately 3000-4000 year old method that, without side-effects, evidently brings a positive effect given the history. One can argue for the reasonableness of accepting Qigong on the basis of "proven experience", in line with the do-good as well as no-harm principle. Of course, a method’s long history does not constitute guarantee of safety and reason, regard tobacco smoking as an example (4).
In summary, the argument “extensive proven experience” is considered to be insubstantial considering the current wording of the Patient Safety Act (2010: 659), regardless of how questioned the law’s formulation is.
5.2.2 Further acceptance and integration may increase patient safety
The contrast between EBM-and CAM-care regarding patient safety is evident (see 5.1.1). In EBM care treatment is determined after careful diagnosis by well-trained healthcare
professionals. CAM practitioners, contrastingly, generally do not have the medical knowledge to diagnose diseases, physical injuries or symptoms, or understand the
consequences of delayed care. This in combination with financial incentives (see 5.1.4) can amount to CAM practitioners promising too much relief, or even cure, potentially resulting in consequences such as delayed diagnosis (and treatment) of serious illnesses (4).
Several government investigations have highlighted deficient CAM legislation and government-efforts to ensure patient safety. Legislative changes were proposed in SOU-1989(18), the Competence Committee 1996 (33), the Patient Safety Inquiry 2008 (34) and the Competence and Responsibility Inquiry 2010 (35), regarding prohibition of e.g:
23 - Treating serious mental illnesses
- Use of misleading job-titles (19).
No change in legislation has taken place and few proposals have resulted in concrete changes. Other unrealized proposals are regarding introduction of mandatory basic medical education for CAM practitioners, an official government-run CAM information portal, special CAM research financial funds and official CAM practitioners registry (19)(24).
Due to the obvious patient safety problems in CAM care Committee for Complementary and Alternative Medicine of Sweden (KAM) was founded in 1984, an umbrella-organization of CAM professional unions. KAM organizes authorization of CAM practitioners by education level, e.g. "Authorized Body Therapist" corresponds to basic medical education of minimum 20 higher education credits plus training of specific therapy field. Furthermore, KAM has established ethical rules (e.g. professional secrecy), ethical advice (patient complaint
handling) and annual quality-controls (e.g. union membership, liability insurance, compliance with the ethical rules) (5)(19).
The National Board of Health has officially taken a positive stance to KAM’s quality-assurance system (5), but is it sufficient? Much problematic is that only few CAM
practitioners are KAM members. Furthermore, no official information bank exist for CAM methods, CAM regulations, insurance or complaints instance (19).
Government investigations such as Asplund’s have proposed mandatory CAM education equivalent to 1-2 higher education credits during medical and nursing programs, similar to Harvard Medical School (24), entailing several patient safety dimensions, in line with no-harm and autonomy principle, such as:
- Ensuring that healthcare professionals have a basic understanding of the most common CAM-methods, prerequisite for patient discussions and choice-making
- Reducing the risk of interactions between EBM-and CAM-treatment - Reducing the risk of patient terminating EBM-treatment (4)(19)(24).
Asplunds Investigation has furthermore proposed government collected CAM information at www.1177.se, for patients as well as healthcare staff, and moreover a cooperation with Norway and Denmark in usage of already existing information portals (19).
24 Further proposals for increased patient safety are: national CAM quality-registry, clarification of The Health and Social Care Inspectorate of Sweden’s (IVO) role regarding CAM
complaint handling, assignments to the Swedish Consumer Agency to present CAM consumer guidance-information and lastly development of a CAM integration condition-policy (19).
In summary, the current CAM patient safety situation clearly compromises the no-harm and autonomy principle (right to an informed choice) regarding CAM use generally. An increased acceptance and integration (e.g. proposed measures) could dramatically improve patient safety. Noteworthy is that Qigong itself is risk-free and thus some mentioned efforts to improve patient safety are less relevant. Yet, an integration of Qigong implies that patients are referred via EBM-care and diagnosed by healthcare professionals. Thus this pro-acceptance argument is judged to be moderate-strong.
5.2.3 Further acceptance and integration may promote research
See 1.2.4, 1.3.3, 1.3.4. for summary of CAM and Qigong research situation. Government investigations, literature and CAM advocates highlight the strong connection between
acceptance-level of treatment methods and research opportunities. The more accepted/already practiced in EBM care, the easier to achieve funding to investigate the treatment method’s effects (4)(5)(19). Insufficient funding constitutes the main problem in CAM research (see 1.3.2).
There is a significant difference in incentives behind EBM and CAM research. EBM research is mainly driven by large pharmaceutical companies, with financial interests in introducing new products to the market. CAM research funding, however, comes mainly from altruistic funders (4). Regarding Qigong, the research incentive is undeniably low given absence of sales opportunities e.g. medicines, tools or (necessarily) CAM instructor.
More and more people are using CAM methods with questionable evidence, but this has not resulted in further research funding for investigation (4). In the absence of apparent research results, patients seek CAM practitioners for answers, who often lack basic medical education
25 and understanding of pathophysiology. This poses a patient safety problem, with delayed correct diagnostics at stake, compromising the no-harm and autonomy principle.
Government investigations have highlighted the importance of interdisciplinary CAM
research for development of research-competence among CAM practitioners (see 1.3.3). Low research-competence means lower probability of valid study results, which in turn reduces the chance of receiving research grants, leading to continued difficulties in developing research-competence – Leading to a vicious circle with patient safety at stake. Asplund’s investigation has furthermore highlighted the importance of investigating EBM-CAM treatment interactions by increased CAM research funding (19).
In Asplunds investigation, previously considered CAM methods (now partially integrated into Swedish EBM-care) were examined and an absence of a common-pattern in integration was identified (see 5.2.2). The EBM-care system, however, have models for introducing new EBM methods. The same policies are proposed to be applied to CAM methods – thus no discrimination of philosophical treatment background.
Important questions that remain are which CAM methods the government should invest in? How much evidence is needed for the method before investment? Asplund’s investigation proposed a government-assignment for the Swedish National Agency for Medical and Social Evaluation to evaluate relevant CAM methods (19).
In summary, further Qigong trials could provide clarity which patient groups are most helped by Qigong and under what conditions. Given the lack of incentives for this research field, government funds are fundamental, for clarity in the questionable evidence situation, with future health benefits (at low cost for the individual as well as society) at stake. The argument is thus assessed as strong.
5.2.4 Qigong is risk-free and highly available at low cost
Qigong can be performed by all people regardless of age, physique, economy or access to tools/space. The only possible risk is muscle stretching, but even this is considered to be very low considering that all movements are performed in a slow and controlled manner. Qigong can be performed in group training contexts, but this is not necessary. Qigong specialized
26 physiotherapists are integrated in Stockholm’s and Halland’s EBM-care, patients thus
instructed under high-cost protection (see 1.3.5).
In the literature there are descriptions of all movements and one is encouraged to perform Qigong every day. Qigong literature can be borrowed from city libraries, thus the entire Swedish population has free-access to Qigong. In China, people gather spontaneously in the parks in the morning (especially the elderly) to practice Qigong together.
With an aging population the number of fragile patients in Swedish healthcare is steadily increasing, many patients unable to cope with daily-living activities, much less physical activity such as strength training or even walking. Qigong constitutes an option for the most fragile patients, given that several Qigong movements do not even require lifting one foot off the ground.
Passive Qigong is meditation, standing, sitting or lying down (see 1.2.3), and can thus be performed by all people regardless of functionality (requiring only consciousness) - uniquely accessible and strongly in alignment with the no-harm principle.
Psychoneuroimmunology research has discovered that patients can experience placebo effect via impressions of positive health effects (e.g. pain-relief) in people nearby, i.e. group
pressure enhances the placebo effect. Parallels have been drawn to religion as the placebo effect consequently becomes stronger in “healing-context” (4).
Hence, Qigong could be even more effective in group context, via e.g. physiotherapists, and more patients could benefit from this potential positive health effect if the integration of Qigong was expanded, in line with the do-good principle.
According to the UN Declaration of Human Rights the "highest attainable standard of physical and mental health" is a human right, first articulated in the 1946 constitution of the World Health Organization, WHO (36). According to WHO, 20% of the world's population uses 80% of the world's healthcare resources (24), and globally about 80% of the world's population is treated with CAM, most commonly herbal remedies (4). WHO has officially encouraged CAM integration in its member countries’ EBM-care, because of the low-cost and availability (24).
27 Health is a very economic issue, which is reflected in the correlation between CAM use and educational level (and generally income, see 1.3.5) (24). According to the justice principle all people are equal, regardless of performance or personality. Despite this, everyone is not offered the same healthcare between Sweden's regions.
It can be argued unrealistic to offer the entire population exactly the same healthcare, due to society's limited resources, notwithstanding the justice principle. Physiotherapist-led Qigong could, however, be integrated at low-cost for the government since the method can be performed in huge groups – A very small risk of negative distribution of resources (2) in comparison with Sweden's most common CAM treatments; chiropractic and naprapathy, in which massage often is included (see 1.3.5). Thus, the pro-argument “high availability, risk-free and low-cost” is judged to be strong.
5.3 Limitations and weakness of the study
This study was limited in many ways. The depth of the discussion had to be weighed against the width of the discussion, and this study prioritized width in order to serve the purpose to explore many different perspectives. For the same purpose the literature search is entirely based on relevance to the aim of this study, which stands in contrast to a systematic review that is reproduceable. The researcher has an inevitable personal impact on data collection as well as the interpretation phase, typical for qualitative research. One can assume bias in the literature concerning the history of Qigong, although comparisons have been made between different sources of knowledge and patterns have been noted.
6
Conclusion
A strong argument against acceptance of Qigong is “lack of strong evidence”. “Traditional Chinese Medicine’s underlying philosophy stand in opposition to scientific worldview” is judged to be moderate-strong. Strong arguments for acceptance of Qigong are “further acceptance and integration may promote research” and “Qigong is risk-free and highly
28 available at low cost”. “Further acceptance and integration may increase patient safety” is assessed as moderate-strong.
Evident is the need of further Qigong studies of high methodological quality with sufficient sample size, follow-up and research method adapted to the questions at issue. The current Complementary and Alternative Medicine (CAM) research situation results in a downward spiral and the fact that Qigong is risk-free and highly available at low-cost should be weighed against the lack of strong evidence.
7
Acknowledgement
This thesis would not have been possible without the exemplary guidance of my supervisor Rolf Ahlzén, thank you for your unwavering support.
29
8
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32
Integration av Qigong i svensk sjukvård – Etiska dilemma?
Victoria Hogrell
Traditionell kinesisk medicin är uråldriga medicinska behandlingsmetoder, använda sedan ca 2000 år f.kr. Qigong utgör en av fem grundpelare och är en metod för avslappning, träning såväl som själv-behandling. Fundamentalt inom traditionell kinesisk medicin är att kroppen existerar i balans med Qi (=livsenergi) samt fokus på holistiska dynamiska processer över materiell struktur.
I den här studien har vi utforskad den historiska och filosofiska bakgrunden till Qigong, vilken roll komplementär- och alternativmedicin spelar i Sverige (med särskild tonvikt på behandlingsmetoder från traditionell kinesisk medicin) och slutligen potentiella etiska dilemma med att integrera Qigong i svensk sjukvård.
Ett starkt argumentet emot integration av Qigong är enligt vårt studieresultat bristen på stark evidens. Starka argument för acceptans av Qigong är, å andra sidan, att en utökad acceptans och integration kan främja vidare forskning, samt att Qigong som behandlingsmetod är riskfri och mycket tillgängligt på låg bekostnad för individen såväl som samhället.
Det här studien påvisar ett behov av ytterligare Qigong-studier av hög metodologisk kvalitet med tillräcklig provstorlek, uppföljning och forskningsmetod anpassad till de aktuella
forskningsfrågorna, samt att den nuvarande forskningssituationen resulterar i en nedåtgående spiral för fortsatt Qigong-forskning. Vidare konkluderas att det faktum att Qigong är riskfritt bör vägas emot bristen på starka bevis.
D-uppsats i Medicin, 30hp, HT 2020 Läkarprogrammet, Örebro Universitet Handledare: Rolf Ahlzén
33 Örebro, Sweden, 2020-12-30 Dear Editor of the Journal of Medical Ethics,
Enclosed you will find our manuscript entitled “Ethical Considerations concerning the Introduction of Qigong in Swedish Healthcare”. We have investigated the ethical
considerations concerning the introduction of Qigong in Swedish Healthcare, the historical and philosophical background of Qigong as well as what role Complementary and
Alternative Medicine serve in Swedish health care, with particular emphasis on treatment methods from Traditional Chinese Medicine.
We conclude that a strong argument against acceptance of Qigong is “lack of strong evidence” and strong arguments for acceptance of Qigong are “further acceptance and integration may promote research” as well as “Qigong is risk-free and highly available at low cost”. Evident is the need of further Qigong studies of high methodological quality with sufficient sample size, follow-up and research method adapted to the questions at issue. The current research situation results in a downward spiral and the fact that Qigong is risk-free and highly available at low-cost should be weighed against the lack of strong evidence. The author and supervisor have approved of the final version of the manuscript as well as publication in your journal. It has not been published elsewhere, and is not under
consideration as your journal constitutes our very first choice. Yours sincerely,
Victoria Hogrell, Bachelor of Medicine Örebro University
34
Ethical considerations
This is a qualitative study with the purpose to seek meaning, intention and context through linguistic interpretation, based on analysis of concepts, descriptions, arguments and opinions.
Thus, thus study does not deal with patients, animals, sample tissues, patient files or other confidential information.
Included sources are grey literature (e.g., published books, textbooks, e-books, government appointed studies, university thesis, online medical newspaper articles, general articles and health websites) as well as articles (Pubmed, Cochrane) which all are published and available
for anybody to read. Thus, no need to gather informed-consent.
There is a risk that the topic of the study is controversial, as it discusses complementary and alternative medicine. However, the very goal of the study is to explore the width of perspectives in society, not to state personal opinions. Yet, the interpretation is inevitably subjective and therefore the author’s starting point, the pre-understanding of the issue to be
analysed, is therefore clarified in the method.
Because this study investigates different religions, cultures and beliefs, the content may stand in opposition the reader’s belief. It should be noted that the purpose is to explore different
perspectives in order to achieve the aim of the study, without adding any value to the respective religions, cultures and beliefs themselves.
