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The Dutch complementary and alternative medicine (CAM) protocol

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Background: Complementary and alternative medicine (CAM) is subject to heated debates and prejudices. Studies show that CAM is widely used by psychiatric patients, usually without the guidance of a therapist and without the use of a solid working method, leading to potential health risks. Aim: The purpose of this study is to facilitate the judicious use of CAM alongside conventional psychiatry in an outpatient psychiatric clinic. Methods: A search was made through scientific and legal articles and discussion in focus groups. Results: In the Centre for Integrative Psychiatry (CIP) of Lentis in the Netherlands, some carefully selected CAM are offered under strict conditions, alongside conventional treatments. Because of the controversy and the potential health risks, Lentis designed a protocol that is presented. Conclusions: The CIP hopes, by using this protocol, to better serve and respect the individual needs and preferences of the diversity of psychiatric patients in our Dutch multicultural society, and better protect them from harm.
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Paradigms
The Dutch Complementary and Alternative
Medicine (CAM) Protocol:
To Ensure the Safe and Effective Use
of Complementary and Alternative Medicine Within
Dutch Mental Health Care
H.J. Rogier Hoenders, MD,
1
Martin T. Appelo, PhD,
2
Erik H. van den Brink, MD,
1
Bregje M.A. Hartogs, MSc,
1
and Joop T.V.M de Jong, PhD, MPH
3
Abstract
Background: Complementary and alternative medicine (CAM) is subject to heated debates and prejudices.
Studies show that CAM is widely used by psychiatric patients, usually without the guidance of a therapist and
without the use of a solid working method, leading to potential health risks.
Aim: The purpose of this study is to facilitate the judicious use of CAM alongside conventional psychiatry in an
outpatient psychiatric clinic.
Methods: A search was made through scientific and legal articles and discussion in focus groups.
Results: In the Centre for Integrative Psychiatry (CIP) of Lentis in the Netherlands, some carefully selected CAM
are offered under strict conditions, alongside conventional treatments. Because of the controversy and the
potential health risks, Lentis designed a protocol that is presented.
Conclusions: The CIP hopes, by using this protocol, to better serve and respect the individual needs and
preferences of the diversity of psychiatric patients in our Dutch multicultural society, and better protect them
from harm.
Introduction
In2002, Silvia Millecam, a famous Dutch actress, died of
breast cancer after refusing conventional medical treatment
while trusting herself to practitioners treating her with com-
plementary and alternative medicine (CAM). The Dutch
Healthcare Inspection did an extensive inquiry into the mat-
ter. Three doctors were put on trial for malpractice and were
convicted by the Medical Disciplinary Tribunal. Two of them
lost their medical license. In the years that followed, there
were heated debates on the use of alternative medicine in the
Netherlands.
Supporters of CAM claim that conventional treatments
have too many side-effects, lack effectiveness and room for
patients’ wishes and needs. On the other hand, opponents
state that CAM is quackery and that the effects are based on
placebo and ‘‘ridiculous principles.’’
1
This reaction reminds
us of earlier resistance to change in medicine; for instance, in
1911 Herrick was almost laughed out of medicine for stating
that atherosclerosis causes myocardial infarction.
2
Previous and current bias against new developments is
undesirable because both patients and doctors are uncertain
about safety and effectiveness of CAM. This is all the more
important because about half of the population in a variety
of Western countries
3
and almost half of Dutch psychiatric
outpatients use CAM annually.
4
A majority of patients get information on CAM via the
Internet, friends, or family. The quality of this information
varies greatly, leading to potentially harmful and dangerous
situations.
5
In the Netherlands, many doctors do not inform their
patients about CAM and they certainly avoid prescribing or
referring to CAM. Recently the Dutch Minister of Health has
announced more severe punishment for practitioners who
harm their patients either by applying unsafe therapies or by
delaying the start of conventional treatment.
6
Therefore, in
1
The Centre for Integrative Psychiatry, Lentis, Groningen, The Netherlands.
2
The Psycho-oncology Therapy Centre ‘‘Het Behouden Huys,’’ Haren, The Netherlands.
3
The Open University of Amsterdam, Amsterdam, The Netherlands.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 17, Number 12, 2011, pp. 1–5
ªMary Ann Liebert, Inc.
DOI: 10.1089/acm.2010.0762
1
the Netherlands patients and doctors are informed about
what cannot be done concerning CAM, while it remains un-
clear what could or should be done. Despite calls from the
World Health Organization (WHO)
7
and the European
parliament,
8
until now the Dutch government did not for-
mulate a policy on this matter.
In an effort to fill this gap and inspired by the North
American consortium of 44 academic health centers for in-
tegrative medicine (CAHCIM)
9
, Lentis (a community mental
health facility in the North of the Netherlands) founded a
Centre for Integrative Psychiatry (CIP) in 2006. It consists of
an outpatient clinic, a research department, an educational
department, and organizes an annual conference (with ap-
proximately 1000 attendees).
10
Its main purpose is to provide
safe and effective integrative mental health care.
What Is Integrative Psychiatry?
Integrative psychiatry is based on the principles of ‘‘inte-
grative medicine’’: reaffirming the importance of the rela-
tionship between practitioner and patient; focusing on the
whole person; using all therapeutic approaches (conven-
tional and CAM) based on the principles of evidence-based
medicine (EBM); and achieving optimal health and healing.
The debate in the Netherlands focuses mainly on the
principle of EBM (i.e., the use of CAM within conventional
treatment centers, and the correct definition of EBM). In this
regard, it is noteworthy that Sackett et al.
11
defined EBM as
(1) the best available evidence for effective and safe treat-
ment options, (2) the preferences and needs of the patient,
and (3) the clinical expertise of the professional. These three
together should be decisive in making treatment choices.
This definition is in contrast with the present-day more re-
ductionist explanation of EBM in which the first and third
principles are emphasized without paying much attention to
the patient’s preference.
12
The original definition therefore
accommodates therapies that still lack (sufficient) evidence-
Table 1. Prejudices Against Complementary and Alternative Medicine (CAM)
Prejudice Refutation
1. Only few people use CAM 1. 30%–70% of the population uses CAM
3
and 43% of Dutch psychiatric
outpatients
4
2. My patients do not use CAM because
they never ask or tell me about it
2. 60%–75% of patients using CAM do not tell their doctor out of fear
of a negative response
a
3. CAM users are less educated and
easily influenced
3. CAM users are typically female, highly educated, high income
with chronic disease
b,c
4. They use CAM instead of conventional
medicine
4. 80%–95% combines
b
5. They use CAM because of negative
reasons (against conventional medicine)
5. Besides disappointment about side effects and limited results, also
positive reasons play a part: good relationship with therapist and a
shared belief about health and disease (holism)
d
6. CAM effects are due to placebo 6. Several CAM are more effective then placebo
e,f,19
7. CAM and EBM are incompatible 7. CAM can be offered based on the principles of EBM
g,16
8. CAM are not endorsed by influential
institutions
8. The CAHCIM,
9
the WHO,
7
and the EP
8
endorse the integration
of effective CAM in conventional clinics
a
Van de Creek L, Rogers E, Lester J. Use of alternative therapies among breast cancer outpatients compared with the general population.
Altern Ther Health Med 1999;5:71–76.
b
Astin JA. Why patients use alternative medicine. JAMA 1998;279:1548–1553.
c
Eisenberg DM, Davis RB, Ettner SL. Trends in alternative medicine use in the United States, 1990–1997. JAMA 1998;280:1569–1575.
d
Furnham A. Why do people choose and use complementary therapies? In: Ernst E, ed. Complementary Medicine: An Objective Appraisal.
Oxford: Butterworth Heinemann, 1996.
e
Ernst E, ed. The Desktop Guide to Complementary and Alternative Medicine: An Evidence Based Approach. Edinburgh: Mosby,
Hartcourt Publishers Limited, 2006.
f
Lake JH, Spiegel D, ed. Complementary and Alternative Treatments in Mental Health Care. Washington, DC, London: American
Psychiatric Publishing, 2006.
g
Wilson K, Mills EJ. Introducing evidence-based complementary and alternative medicine: Answering the challenge. J Complement Altern
Med 2002;8:103–105.
EBM, evidence-based medicine; CAHCIM, academic health centers for integrative medicine; WHO, World Health Organization; EP,
European Parliament.
Table 2. Prejudices for Complementary
and Alternative Medicine (CAM)
Prejudice Refutation
1. If it does not work,
at least it will not harm
1. Some supplements or herbs
can cause severe side-effect
or interactions
a
2. Natural substances are
more healthy then
chemicals
2. Nature contains severe
toxins, besides natural
medicines
3. CAM does not need to
be researched; I know
it works from experience
3. Experience is not enough;
research is needed to
distinguish from placebo
and bias
11
4. CAM are not suitable
for research because of
their specific nature
4. Science can be applied to
all phenomena; it is essential
to choose the right design
b
a
Ernst E. Serious psychiatric and neurological adverse effects of
herbal medicines: A systematic review. Acta Psychiatr Scand
2003;108:83–91.
b
Walach H, Falkenberg T, Fonnobo F, et al. Circular instead of
hierarchical: Methodological principles for the evaluation of complex
interventions. BMC Med Res Methodol 2006;6:29.
2 HOENDERS ET AL.
based proof. It is also important to realize that according to
some researchers, only about one third of culturally and
professionally accepted interventions in Western medicine
are proven effective by randomized controlled trials.
13,14
Prejudices
Some reasons why opponents feel doctors should not use
CAM seem to be based on prejudices. Table 1 compares the
most common prejudices against CAM with information
from scientific studies.
Similarly, those in favor of CAM also seem to have
prejudices. Those are mentioned in Table 2. We therefore
argue that CAM needs serious attention, both within
conventional treatment centers and in the alternative field
(Table 2).
The CAM Protocol
One of the primary tasks of our center was to formulate a
scientific model based on the requirements that it would (1)
answer patients’ needs and wishes; (2) respect their freedom
FIG. 1. Complementary and alternative medicine (CAM) protocol for the Center for Integrative Psychiatry (CIP). CBT,
cognitive behavioral therapy; EBAM, evidence-based alternative medicine; ROA, routine outcome assessment.
DUTCH CAM PROTOCOL 3
of choice; (3) would offer Western medicine and CAM that
are safe and effective; (4) would protect against quackery
and abuse; (5) should be based on Dutch law, the jurispru-
dence of the Medical Disciplinary Tribunal, and the rules of
the Dutch Association of Medical Practitioners; and (6) be
based on scientific evidence.
The authors reviewed documents, the scientific literature,
and collected information with the help of focus groups.
15
This resulted in the CAM protocol.
16
In this protocol, we
distinguish (between) complementary and alternative medi-
cine. The first is defined as ‘‘approaches based on main-
stream biomedical theory and supported by research
evidence but not part of mainstream practice because of so-
cial, political or ideological reasons.’’ Examples are St. John’s
wort and massage. Alternative medicine is defined as ‘‘ap-
proaches that are based on concepts that are outside main-
stream Western medicine.’’ Examples include homeopathy
and healing.
17
Based on an analysis of the results, we pro-
duced the algorithm shown in Figure 1.
This is the working method of the CIP. The first step of the
algorithm clarifies that CAM can only be used after an ex-
tensive and precise stepwise process. CAM can only be
started if conventional treatments have been applied before
or at least advised as suggested by guidelines and protocols.
In addition, CAM is considered if there is no danger when a
patient refused treatment (for instance: a patient with mania
or psychosis with severe symptoms will be strongly advised
first to accept conventional medication even when asking for
CAM).
After deciding to start CAM, the second step is based on
the principles of EBM (i.e., alternative treatments with a
lower level of evidence can be provided on a patient’s re-
quest when there is no contraindication). However, these
treatments will not be offered within the CIP. Patients will be
referred to an external network that provides these treat-
ments in conjunction with proven treatments provided by
CIP and not instead of them. In addition, there are the fol-
lowing required conditions:
The therapists are members of a (para)professional or-
ganization with a formal procedure for complaints and
malpractice.
The therapists base their treatments and way of working
on the professional guidelines of the organization.
The therapists conform themselves to legal demands
concerning patient files.
The clinic or office where patients are being treated meet
privacy and hygiene demands, as common in conven-
tional medicine.
The therapists have malpractice insurance.
There has to be at least monthly contact between the CIP
and the alternative practitioner.
After finishing the alternative treatment, there will be at
least one contact with the CIP to evaluate.
The alternative therapists agree to be included in sci-
entific evaluation by routine outcome measurement
(ROM) of the effect of the treatments and agrees with
publication, regardless the results.
Center for Integrative Psychiatry
In the CIP of Lentis, only conventional and complemen-
tary medicines that have been proven effective and safe are
being practiced. That means that they have to be based on
(reviews of ) several well-designed scientific studies. Ex-
amples are St. John’s wort for depression,
18
valerian for in-
somnia,
19
relaxation for anxiety,
20
mindfulness-based stress
reduction
21,22
and mindfulness-based cognitive therapy for
depression,
23
massage for stress, anxiety, and depression,
24
exercise for depression, anxiety, and sleep disorders,
25
heart
rate variability training for anxiety and stress-related and
depressive symptoms,
26,27
single vitamins as a supplement
to medication for depression (such as folic acid),
28
food
supplements like such as S-adenosyl-l-methionine 1,4-buta-
nedisulfonate for depression,
29
melatonin for sleep disor-
ders,
30
inositol for depression, panic, and obsessive–
compulsive disorder,
31
and dietary changes for depression.
32
These treatments, integrated with conventional psychia-
try, have been offered for 3 years to psychiatric outpatients in
the CIP.
Alternative medicine such as homeopathy, Reiki, or heal-
ing are not being offered. However, patients can be referred
to these treatments under strict conditions, which are ex-
plained above. All treatments are evaluated by ROM. In
addition, we study the outcome of innovative treatments
with individual outcome measurements (IOM) such as ‘‘Nof
1 design,’’ ‘‘single-subject experimental design,’’ and ‘‘time
serial analysis.’’ ROM consists of six questionnaires: psy-
chopathology, quality of life, resiliency, costs, satisfaction,
and one self-report personalized outcome indicator, chosen
by the patient. Patients fill out these forms before treatment
starts, every half year, at the end of treatment, and half a year
after their discharge. Patients with IOM fill out diaries con-
cerning items that are most relevant to their treatment and
symptoms to assess subjective improvement on core symp-
toms and complaints.
Conclusions
Because of the increasing demand of patients for alterna-
tive medicine and integrative treatments and because of so-
cial, political, scientific, and ethical reasons, and inspired by
the CAHCIM, Lentis has founded a CIP. Here it offers se-
lected complementary treatments alongside conventional
ones under strict conditions. By doing so, the CIP responds
to a call from the WHO and European Parliament, even
though the Dutch government still has not made a policy on
this subject. Because of the controversy surrounding CAM,
because of the lack of clear information, and because we
need not only an open attitude but also a critical one, the CIP
has formulated the CAM protocol. It believes that in this way
CAM can be offered in a safe and effective way within
conventional treatment centers. The CIP hopes in this way to
better serve and respect the individual needs and preferences
of the diversity of patients who need mental health care in
our Dutch multicultural society. It believes the protocol also
protects against quackery, abuse, and false hope.
Acknowledgments
The authors thank E.C. Waarsenburg for valuable sug-
gestions, S.D.E. Broekema for designing Figure 1, and K.M.
van der Ploeg for general assistance.
Disclosure Statement
No competing financial interests exist.
4 HOENDERS ET AL.
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Address correspondence to:
H.J. Rogier Hoenders, MD
The Centre for Integrative Psychiatry, Lentis
P.O. Box 86
AB Groningen 9700
The Netherlands
E-mail: hjr.hoenders@lentis.nl
DUTCH CAM PROTOCOL 5
... Treatment At the CIP, patients are treated with conventional therapies (medication, cognitive behavioural therapy, EMDR, and counselling by specialized nurses), lifestyle training (diet, exercise, relaxation, communication, and heart rate variability training), MBCT, and a selection of evidence-based complementary medicines such as Saint John's Wort, omega-3 fatty acids, s-adenosyl methionine (SAMe) and methylfolate. The CIP follows the principle of stepped care and uses a protocol with an algorithm to guide clinical decision making (Hoenders et al. 2011). Reaffirming the importance of the therapeutic relationship (including shared decision making and emphasis on patient preference ) is one of its main features (CAHCIM 2004). ...
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There is considerable debate about routine outcome monitoring (ROM) for scientific or benchmarking purposes. We discuss pitfalls associated with the assessment, analysis, and interpretation of ROM data, using data of 376 patients. 206 patients (55 %) completed one or more follow-up measurements. Mixed-model analysis showed significant improvement in symptomatology, quality of life, and autonomy, and differential improvement for different subgroups. Effect sizes were small to large, depending on the outcome measure and subgroup. Subtle variations in analytic strategies influenced effect sizes substantially. We illustrate how problems inherent to design and analysis of ROM data prevent drawing conclusions about (comparative) treatment effectiveness.
... This implies that in choosing an intervention, one should take into account the highest level of available scientific evidence about the different treatment options; the values, preferences and frame of reference of the patient; and the professsionalism and experience of the therapist (Sackett, Straus, Scott Richardson, Rosenberg, & Haynes, 2000). The number of options in integrated medicine is larger than in regular health care (Hoenders, Appelo, Van den Brink, Hartogs, & De Jong, 2011; Lake, 2007; Lake & Spiegel, 2006), since CAM treatments are not excluded beforehand. The European Parliament (1997) and the World Health Organization (2003) plead in favour of promoting integrative medicine (Chung, Hillier, Lau, Wong, Yeoh, & Griffiths, 2011). ...
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• Integrative mental health (IMH) aims to use the best available evidence to provide holistic solutions for the management and prevention of mental-health problems • St John's wort, kava, omega-3 fatty acids have the strongest evidence to support their use • The patient is included as a central, active participant in the IMH team • For patients refusing standard psychiatric treatment, IMH offers alternate options • A holistic approach to management should include the patient's spirituality • IMH practitioners have honed their clinical skills generally take a heuristic and commonsense approach to treatment • Psychiatry, with its inherent complexities and comorbidities, lends itself to IMH • Issues of patient confidentiality, consent and practitioner lack of training in mental illness are specific to IMH.
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Heart rate variability for the treatment of major depression is a novel, alternative approach that can offer symptom reduction with minimal-to-no noxious side effects. The following material will illustrate some of the work being conducted at our laboratory to demonstrate the efficacy of heart rate variability. Namely, results will be presented regarding our published work on an initial open-label study and subsequent results of a small, unfinished randomized controlled trial. Autonomic nervous system (ANS) dysfunction is thought to play a significant role in depression. Prior research indicates that individuals suffering from depression often show decreased vagal tone, increased heart rate, fatigue, sleep disturbance, and sympathetic arousal. Heart rate variability (HRV) biofeedback involves training subjects to adjust their breathing rate to a resonant frequency (RF), a breathing rate (usually slower than normal breathing) at which respiratory sinus arrhythmia (RSA) is maximized. Why HRV biofeedback for depression? Colleagues from our laboratory already have demonstrated that in healthy individuals, HRV biofeedback produces a significant increase in baroreflex gain (change in heart rate for each mm Hg change in blood pressure), presumably leading to improved homeostatic control over blood pressure and other processes associated with it (Lehrer et al., 2003; Vaschillo, Lehrer, Rishe, & Konstantinov, 2002). It also appears to produce an increase in vagus nerve activity. Indirectly, through anatomical projections from the baroreceptors to the hypothalamus and limbic system and increased parasympathetic activity, this method also would be expected to increase modulation of emotionally and autonomically mediated reflexes throughout the body, resulting in reduction of depressive symptoms.
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The effect of exercise on negative affect has been examined in hundreds of studies. However, the effect of exercise on diagnosed clinical depression has received far less attention. Furthermore, poor methodological techniques predominate and results have been conflicting. A meta-analysis was conducted to investigate the effect of exercise on clinical depression and depression resulting from mental illness. The 37 chosen studies (since 1996) examined the effect of a chronic exercise paradigm (independent variable) on depression (dependent variable). Each study's variables were coded: design, subjects, exercise, and dependent measure characteristics that could moderate the effect of exercise on depression. Moderator variables were analyzed using ANOVA. Results showed an overall mean effect of –.72. Therefore, individuals who exercised were –.72 of a standard deviation less depressed than individuals who did not exercise. (PsycINFO Database Record (c) 2012 APA, all rights reserved)
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Interventions based on training in mindfulness skills are becoming increasingly popular. Mindfulness involves intentionally bringing one's attention to the internal and external experiences occurring in the present moment, and is often taught through a variety of meditation exercises. This review summarizes conceptual approaches to mind-fulness and empirical research on the utility of mindfulness-based interventions. Meta-analytic techniques were incorporated to facilitate quantification of findings and comparison across studies. Although the current empirical literature includes many methodological flaws, findings suggest that mindfulness-based interventions may be helpful in the treatment of several disorders. Methodologically sound investigations are recommended in order to clarify the utility of these interventions.