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Updated 2010-01-12 Søren Ventegodt, MD, MMedSci, EU-MSc-CAM Direktør for Forskningscenter for Livskvalitet Leder af forskningsprojektet ”Klinik for holistisk medicin, psykologi og sexologi” Director Quality of Life Research Center Research Clinic for Holistic Medicine and Sexology Nordic School of Holistic Medicine Nordic Campus, Interuniversity College Postadresse/postal address: Frederiksberg Alle 13A, 2tv DK-1820 Copenhagen V Denmark Direct +45 33 14 11 13 Mobile +45 20 66 67 66 ventegodt@livskvalitet.org www.livskvalitet.org Member of Danish Medical Association Member of International Society of Holistic Health |
Søren
Ventegodt, MD, MMedSci, EU-MSc-CAM1,2,3,4,5, 1Quality of 2Research Clinic for Holistic Medicine 4Scandinavian Foundation for Holistic
Medicine, 6Faculty of Social Sciences, Department of Behavioral Sciences, Ariel University Center of Samaria, Ariel, Israel; 7National 8Office of the Medical Director, Division for Mental Retardation, Ministry of Social Affairs, Jerusalem, Israel; 9Kentucky Children’s Hospital, AbstractWe have developed the concept of Open Source Research Protocols to allow every patient, physician, researcher and medical authority full and current insight into our international research team’s research and development in clinical holistic medicine (CHM). Only by openness and a free dialog with all interested parties will we be able to avoid bias and secure a high quality and speed in the development of CHM. Holistic mind-body medicine is today developed by researchers all over the world, and the ongoing publication of all aspects of the protocol enable us to guarantee that all aspects have been peer-reviewed and holding up to international standard. A standard both with regard to the quality of the research, the documentation of treatment efficacy and safety and all ethical, philosophical and methodological aspects. We encourage all medical researchers to shift to the Open Source Research Protocol format to minimize bias and accelerate medical research for the benefit of all patients. We encourage all public and private, national and international research organs, foundations and institutions to support the development of the scientific, holistic medicine and its institutions, financially and politically. Holistic medicine is consciousness-based medicine that uses conversational therapy and bodywork instead or as supplement to drugs and surgery. The experts in holistic medine, especially its physicians, therapists and researchers, needs protection, special attention and support as they might be up against strong commercial interests. Keywords: Holistic health and medicine, IntroductionResearch in holistic medicine needs to have the same quality as biomedical research protocols. The lack of research expertise and national organs to regulate this kind of research and assure its quality has lead us to develop the concept “Open Source Research Protocol”, where all important procedures, treatment techniques, ethical considerations, documentation standards, systems for quality assurance, including instruments for measurement of effect like questionnaires that have been published in peer-reviewed scientific journals (see table 1). The publication of all aspects of the protocol and the research that resulted has made it possible to have an excellent standard of research. We also believe that by publishing all part of the protocol and receiving critique from internationally recognised scientific journals have avoided much of the bias that all research obviously contain. Table 1. The peer-reviewed journals that have published the research
protocols and scientific papers on quality of life research and clinical
holistic medicine •
Arch Sex Behaviour (sexology)
(Medline/PubMed) •
BMJ
(medicine) (Medline/PubMed) •
Child Care Health Dev (pediatrics)
(Medline/PubMed) •
Eur J Surg (surgery) (Medline/PubMed) •
Int J Adolesc. Med Health (adolescent
medicine, pediatrics) (Medline/PubMed) •
Int J Child Health Human Dev
(pediatrics, human development) (PsycINFO, PubMedCentral) •
Int J Disabil Hum Dev (disability,
human development) (PsycINFO) •
Ital J Pediatr (pediatrics, adolescent
medicine) •
J Altern Med Res (alternative medicine) •
J Coll Physicians Surg Pak (Medicine)
(Medline/PubMed) •
J
Compl Integr Medicine (alternative medicine)
(Medline/PubMed) •
J Pediatric Adolesc Gynecol
(gynecology, pediatrics) (Medline/PubMed) •
J Pain Management (medicine)
(PsycINFO, PubMedCentral) •
Med Sci Monit (medicine) (MedLine/PubMed) •
Oral Health Prev Dent (dentistry)
(Medline/PubMed) •
South
Med J (medicine) (Medline/PubMed) •
Social Indicators Research
(sociology) (PsycINFO) •
ScientificWorldJournal (medicine)
(Medline/PubMed) •
Ugeskrift
for Læger (medicine) (Medline/PubMed) The research papers have been arranged according to several systematic categories according to the headlines and topics listed in table 2. The general title of the papers is mentioned in the title of the paper to make it easy to identify all papers of a series. Table 2. The most important series of papers that constitute the research protocol in clinical holistic medicine •
QOL methodology describes
the method used to measure quality of life used with the Quality of Life Survey
Study at the •
QOL philosophy describes
the philosophy behind our work with quality of life presented in the books
“Quality of life. To seize the meaning of life and get well again” (1995),
“Life philosophy that heals. Quality of life as medicine” (1999),
“Consciousness-based medicine” (2003) and “Principles of Holistic Medicine.
Philosophy behind quality of life” (2005). These are publications describing
the philosophy on which the entire project is based. •
QOL theory covers
the related life and human points of view described theoretically. •
QOL questionnaires are the
questionnaires used in the Quality of Life Survey Study and later studies. •
QOL results are results
from the Quality of Life Survey Study. •
Theories of existence are new theories on quality of life and the human
nature described coherently and concisely. •
Holistic medicine describes
our research program for the holistic-medical project ― a new research
paradigm for researching alternative and holistic medicine and a theory for
process of holistic healing. •
QOL as medicine describes
results from the treatment of patients suffering from various chronic diseases,
like chronic pains, alcoholism and Whiplash Associated Disorders. •
Clinical holistic medicine
describes how to deal with the variety of problems presented by the patients in
the medical clinic using holistic medicine. •
Human development is
a series of papers to address a number of unsolved problems in biology today.
First of all, the unsolved enigma concerning how the differentiation from a
single zygote to an adult individual happens has been object for severe
research through decades. By uncovering a new holistic biological paradigm that
introduces an energetic-informational interpretation of reality as a new way to
experience biology, these papers try to solve the problems connected with the
events of biological ontogenesis from a single cell involvement in the fractal
hierarchy, to the function of the human brain and “adult human metamorphosis”. •
Quality of working life research is a series of paper that addresses
the fundamental needs for happiness and efficiency the working situation. This
applies to physicians and therapists as well as other occupations. The series
of paper analyses how we can develop in our job, and continue to learn and
grow, and avoid the routine and boredom that in the end forces us to compromise
with quality and patience. Research in clinical holistic medicineMillennia ago, around the year 300
BCE, at the island of Cos in old Greece, the students of the famous physician
Hippocrates (460-377 BCE) (1) worked to help their patients to step into
character, get direction in life, and use their human talents for the benefit
of their surrounding world. For all we know this approach was efficient
medicine that helped the patients to recover health, quality of life, and
ability for which Hippocrates gained great fame. For more than 2,000 years this
was what medicine was about in most of On other continents similar medical systems were developed. The medicine wheel of the native Americans, the African Sangoma culture, the Samic Shamans of northern Europe, the healers of the Australian Aboriginals, the ayurvedic doctors of India, the acupuncturists of China, and the herbal doctors of Tibet all seems to be fundamentally character medicine (2-8). All the theories and the medical understanding from these pre-modern cultures are now being integrated into what has been called integrative or transcultural medicine. Many of the old medical systems are reappearing in modern time as alternative, complementary and psychosocial medicine. This huge body of theory is now being offered as a European Union Master of Science degree (2-8). Interestingly, two huge movements of the last century have put this old knowledge into use: psychoanalysis (9) and psychodynamic therapy (10,11) (most importantly STPP or short term psychodynamic psychotherapy) (12,13) going though the mind on the one hand and through the body on the other. Bodywork developed through most importantly Reich (14), Lowen (15) and Rosen (16) with sexual therapy along the tantric tradition (17). A third road, but much less common path has been directly though the spiritual reconnection with the world (18,19). Our international research collaboration became interested in existential healing from the data that originated from the epidemiological research at the Copenhagen University Hospital (Rigshospitalet) starting in 1958-61 at the Research Unit for Prospective Pediatrics and the Copenhagen Perinatal Birth Cohort 1959-61. Almost 20 years ago we were conducting epidemiological research on quality of life, closely examining the connection between global quality of life and health for more than 11.000 people in a series of huge surveys (see 20 for a review of these studies) using large and extensive questionnaires, some of them with over 3,000 questions. We found (quite surprisingly) from this huge data base that quality of life, mental and physical health, and ability of social, sexual and working ability seemed to be caused primarily by the consciousness and philosophy of life of the person in question. Objective data were only to a small extent involved, like being adopted, coming from a family with only one breadwinner, mother being mentally ill, or the person in question financially poor or poorly educated (which are obviously very much socially inherited) (20). Clinical holistic medicine is holistic mind-body medicine, which is also clinical medicine, i.e. medicine based on patient self-exploration and self-insight for obtaining existential healing. It is also called holistic body psychotherapy, mindful mind-body medicine, and similar names. The open source research protocolWe have always revealed the sources of funding and support in the papers
constituting the Open Source Research Protocol (20-244), as we do in the
present paper. Today we are in the strange situation that very few controlled
clinic studies have been made, sine most of the research has been conducted by
using the patients as their own control. The
rationale for this is that almost all patients that seek complementary medical
treatment of the holistic, existential type, has tried biomedical treatment
first, and after this often several complementary and alternative types of
treatment, before they came to the Copenhagen Research Clinic and entered our
research protocol. In one study, the patients had their problems and suffering
for 8.9 years (mean) (115). As nothing had helped these patients before the
came to our clinic, we find it justified to use them as their own controls.
Quite remarkably we have been able to help every second of the patients
independent of the type of problem they have presented, and independent of the
seriousness of the problem (126-133). In our recent protocols we have only
included patients, who experienced their problem as “bad” or “very bad” on a
five point Likert scale (126-133). We have
used a new research paradigm called the “square curve paradigm” (78), that
documents the lasting effect of an immediate significant improvement, that
comes simultaneously with the process of existential healing of the patient –
the process that we call Antonovsky-salutogenesis. One of the great concerns in
our project has been to cover also the philosophical (21-40), methodological
(54-61) and interdisciplinary aspects (41-53,77-70,134-139) of the research,
which has lead to many series of papers. We have also found it extremely
important to find the dimensions we need to intervene on to help the patients
in many different research designs to avoid the bias from one specific research
strategy. Therefore the prospective cohort design has been extremely important
in our research. The
international collaboration has constantly been expanded and today about 30
different researchers have participated in the scientific work that constitutes
the Open Source Research Protocol. Most importantly we have developed a unique
concept of recording the case, including measuring before and after the
treatment with validated quality of life and health questionnaire, which has
allowed us to monitor every side effect and unexpected event during the
treatment (see table 3). We are
happy to notice that clinical holistic medicine seems to be an extremely
efficient type of treatment that causes no harm without side effects
(126-133,170,227-230). We also know that this kind of therapy can prevent
suicide (227-230), and even side effects from biomedical, pharmaceutical treatments
(170). Table 3. Yearly itemized account of side effects and serious complications or events for the treatment with clinical holistic medicine Itemized account 31/12 1991: No side
effects or serious complications or events Itemized account 31/12 1992: No side
effects or serious complications or events Itemized account 31/12 1993: No side
effects or serious complications or events Itemized account 31/12 1994: No side
effects or serious complications or events Itemized account 31/12 1995: No side
effects or serious complications or events Itemized account 31/12 1996: No side
effects or serious complications or events Itemized account 31/12 1997: No side
effects or serious complications or events Itemized account 31/12 1998: No side
effects or serious complications or events Itemized account 31/12 1999: No side
effects or serious complications or events Itemized account 31/12 2000: No side
effects or serious complications or events Itemized account 31/12 2001: No side
effects or serious complications or events Itemized account 31/12 2002: No side
effects or serious complications or events Itemized account 31/12 2003: No side
effects or serious complications or events Itemized account 31/12 2004: No side
effects or serious complications or events Itemized account 31/12 2005: No side
effects or serious complications or events Itemized account 31/12 2006: No side
effects or serious complications or events Itemized account 31/12 2007: No side
effects or serious complications or events Itemized account 31/12 2008: No side
effects or serious complications or events Quality assurance
The strategy for data collection and quality assurance in the clinic for
CAM (complementary and alternative medicine) and holistic medicine has been
developed in the Research Clinic for Holistic Medicine, where it has been used
since 2004 (168). We are using a questionnaire (QOL10) measuring global quality
of life (QOL1, QOL5) (58,59,63), self-rated mental and physical health,
self-rated social, sexual and working ability, self-rated I-strength, self-rated
self esteem (relation to self) and relation to partner and friends. We measure
before treatment, after treatment (three month) and again one year after the
treatment has been completed (127). The
complete lack of side or adverse effects from ethical and professionally
conducted consciousness-based medicine has been documented through a systematic
review of the literature (170). This is an
extremely lucky situation, meaning that the physician, who is working with
holistic medicine does not need a clinical assurance. In Denmark the Scientific
Ethical Committee (Helsinki) accepted from the very beginning that our research
in “quality of life as medicine” (holistic medicine) was not covered by their
domain (Copenhagen
Scientific Ethical Committee under the numbers (KF)V. 100.1762-90, (KF)V.
100.2123/91, (KF)V. 01-502/93, (KF)V. 01-026/97, (KF)V. 01-162/97, (KF)V.
01-198/97) A simple
way to judge the therapeutic value of a treatment is to compare the likelihood
for the patient benefiting for the cure with the likelihood for the patient
being harmed; this can simply be expressed as the “Number Needed to treat to
Harm” (NNtH or simply NNH) over “Number Needed to treat to Benefit” (NNtB or
simply NNT). The therapeutic value (TV) can thus be defined as NNH/NNT and if
TV is 1 or below 1, the treatment harms more patient that it benefits. This is of
course not a fair estimate, if the benefits qualitatively are of more value
than the harms – compare surviving from appendicitis vs. the post surgical pain
(TV<1 as not every patient survives, but every patients will have the pain). To solve
this problem the QALY (Quality-Adjusted Life-Years) concept has been developed, and if one
converts the benefits and harms into the same global quality of life scale,
they can be compared fairly (171,237,241). Ethical aspectsThe rationale for treating with clinical holistic medicine is naturally
its high efficacy (see table 4) (126-133 see also 227-233,238) compared with
the complete lack of adverse/side effects (126-133,170,227-230,233).
Hippocrates’ ethics “primum non nocera”, “first do no harm”, is fully respected
in clinical holistic medicine, but not always adapted or possible in
biomedicine (172,173,239-241). Scientific holistic medicine has had its highly
developed ethics already from its first days, when it was created as a science
by Hippocrates and his students (1,225,231). We have carefully considered all
ethical aspects relevant for today’s practice of holistic medicine and holistic
sexology and have participated in the development of the ethical rules of the
International Society of Holistic Health that organise holistic medical
practitioners worldwide (125) (see also the society’s homepage on
www.internationalsocietyforholistichealth.com). Specific ethical discussions are to be found
in the papers presenting the specific holistic medical (82,109) and holistic
sexological tools (84,114,115,118,120,122,124,225). Table 4. Treatment success rate when all treatment failures (non-responders), drop-outs of the survey, and dropouts of treatment are taken as non-responders. Patient’s own experience as measured self-rated with the questionnaire QOL10, and the patient is taken as cured if the state of the measured factor was bad or very bad before treatment and not bad after treatment (and one year after treatment, statistically, using the square curve paradigm). The data comes from clinical studies covering the holistic treatment of 600 patients. (CHM: Clinical holistic medicine. HMS: Holistic manual sexology. HMS-D: Holistic manual sexology – Dodson’s method for treating chronic anorgasmia) Physical
illness (CHM) 39%(p=0.05) (126,128) Mental
illness (CHM) 57% (p=0.05) (129) Low
quality of life (CHM) 56% (p=0.05) (131) Low
self-esteem (CHM) 61% (p=0.05) (132) Low
working ability (CHM) 52% (p=0.05) (133) Sexual
dysfunction(CHM) 42% (p=0.05)
(130) Sexual
dysfunction (HMS) 56% (p=0.05)
(115) Sexual
dysfunction (HMS-D) 93% (p=0.05) (169) Informed consentThe most important aspect of ethical conduct is full information to the
patient and the openness of the protocol with public and scientific
publications that will give every patient the possibility to see exactly what
the principles, procedures, results, and side effects of the treatment are. An
important aspect of communication and decision making by the patients is the
selection of material for reading by the patient and also verbally explained to
the patient, before initiating the treatment and making the therapeutic
contract. The patient filling in the questionnaire and the other papers
related to the treatment is legally taken as a written consent. As not every
patient is able to read scientific papers, we have also published easy-to-read
books on quality of life philosophy, clinical holistic medicine and the results
from the research, which have been included as a part of the research protocol
(209-217). In the Research Clinic for Holistic Medicine in Before
treatment in holistic medicine the patient should be informed about the course
of the treatment in general terms and it is recommended to also receive a
written contract for the treatment signed by the patient. InsuranceOne ting that makes the practice of medicine very difficult and expensive
is the need for medical insurance. This need comes from practicing medicine
with a risk of harming the patient. From the very beginning the Scientific
Ethical Committee accepted that holistic, consciousness-based medicine was so
risk-free that we did not need insurance. This is a strong indicator of
clinical holistic medicine being harmless, in spite of its efficacy. Today we
know five different types of formal errors that can be made in clinical
holistic medicine, but none of them are causing harm to the patients (232).
Recent reviews and metaanalysis of holistic mind-body medicine and non-drug Political and financial
aspects
The political and financial aspects of medical research are well known
and one of the aspects that we just recently have started to explore is how to
get holistic medicine accepted as valid, medical treatment in countries, where
biomedicine is seen as the only medicine. We know today that many different
types of pharmaceutical products are almost without therapeutic value and
compared with the above-mentioned efficacy much less attractive, but strong
commercial interests work against the holistic
medicine and even sometimes against the researchers that develop it. We
encourage everybody to analyse and discriminate carefully the facts and the
fictions about the holistic physicians and researchers in holistic medicine,
when stories about misconduct and abuse by such people hit the media and public
authorities, as these stories might be false, fabricated, and planted by
biomedical colleagues in close collaboration with the pharmaceutical industry
(236). In recent
years the whole network of researchers in holistic medicine have been bothered
by a diversity of hostile actions against their clinical and research
practices. Rumours have often started in the media by biomedical colleges
working closely together with the pharmaceutical industry, most often
psychiatrists who are completely dependent on the use of psychopharmacological
drugs with false accusations of sexual abuse of patients in the media. These
tactics have been common and patients have been manipulated to tell they were
abused even when the physician had not touched them at all (this happened to
the first author in 2005) or child pornography downloaded on computers, while the
researchers were on holiday and followed by “anonymous tips” to the police.
Often the researchers have been in severe shock for a long time and even ill
for extended periods of time. Recently, in the Nordic countries and Fortunately
national authorities as well as international experts have recently started to
recognize the clinical, holistic medicine as scientific and efficient. Recently
the ConclusionsThe Open Source Research Protocol give all interested parties –
patients, physicians, therapists, researchers and politicians direct admission
to all important parts of the protocol, allowing for peer review and critique
of all part of it. The publication allows other researchers to be inspired and
use part for their own research and practice. This is important, because the
trend of chronic illness/disability in our societies has been on the increase. We
recommend that the pharmaceutical companies also start using the concept of
Open Source Research Protocol; obviously if you want to keep what you are doing
secret this is now attractive, but many of the aspects of the protocol could
easily be published, and this would give confidence in the industry and its
products. We
encourage all public and private, national and international research organs,
foundations and institutions to support the development of scientific, holistic
medicine and its institutions financially and politically. The experts in the
holistic medical field, especially the holistic physicians and researchers in
holistic medicine, needs protection as they are often attacked by people
connected to biomedicine. This presumably, because the development of holistic
medicine (that in principle works though the patients consciousness and not
pharmaceutical drugs), is a serious threat to strong commercial interests. We
encourage the police and other public authorities to investigate all attacks
from biomedicine carefully and the media not to publish stories of violent and
sexual abuse of patients by the holistic physicians, therapists and researchers
until these stories, that might have been fabricated and false, have been
investigated by the police and found to be true. AcknowledgmentsThe Danish Quality of Life Survey,
Quality of Life Research Center and the Research Clinic for Holistic Medicine,
Copenhagen, was from 1987 till today supported by grants from the 1991 Pharmacy
Foundation, the Goodwill-fonden, the JL-Foundation, E Danielsen and Wife's
Foundation, Emmerick Meyer's Trust, the Frimodt-Heineken Foundation, the Hede
Nielsen Family Foundation, Petrus Andersens Fond, Wholesaler CP Frederiksens
Study Trust, Else and Mogens Wedell-Wedellsborg's Foundation and IMK Almene
Fond. The research in quality of life and scientific complementary and holistic
medicine was approved by the Copenhagen Scientific Ethical Committee under the
numbers (KF)V. 100.1762-90, (KF)V. 100.2123/91, (KF)V. 01-502/93, (KF)V.
01-026/97, (KF)V. 01-162/97, (KF)V. 01-198/97, and further correspondence. We declare no conflicts of interest. References1.
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