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Scientific framework of homeopathy: Evidence-based Homeopathy

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  • Scientific Society for Homeopathy

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Paper aims at considering all important aspects of the scientific framework of homeopathic practice, looking at the levels of scientific evidence of each aspect in an objective way, through an extensive review of literature. Levels of evidence considered are: I) existence of meta-analyses and/or systematic positive reviews of literature; IIa) multiple positive randomized controlled trials (RCTs); IIb) some positive RCTs; IIIa) positive multiple cohorts studies; IIIb) positive studies with some cohorts; IV) opinion of experts (clinical and daily practice cases). Conclusions are clear: homeopathy must stay within the framework of medical practice, and it is even a necessity for public health.
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E.C.H. European Committee for Homeopathy
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LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
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E.C.H. European Committee for Homeopathy
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www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
SCIENTIFIC FRAMEWORK
OF HOMEOPATHY
Evidence Based Homeopathy 2013
Revised edition aer 67
th
LMHI Congress, September 2012 (Nara, Japan)
Editor: LMHI Secretary for Research Dr Michel Van Wassenhoven
E.C.H. European Committee for Homeopathy
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SUMMARY
This booklet is aimed at considering all important aspects of the scientific
framework of homeopathic practice including ethical questions and
evaluation of daily practice, looking at the level of scientific evidence of
each of these aspects. The conclusions are that homeopathy has to stay
in the framework of medical practice and it is even a necessity for public
health. Of course, more research is always necessary.
This booklet is a joint production of the Liga Medicorum Homoeopathica
Internationalis and of the European Committee for Homeopathy.
E.C.H. European Committee for Homeopathy
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www.homeopathyeurope.org
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EvidEncE BasEd HomEopatHy 2013
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CONTENTS
Chapter I: Introduction ......................................................................................................... page 4
Chapter II: General framework and ethical aspects …..…………...……................................ page 5
Chapter III: Framework of the practice ……………………………………....................................... page 22
Chapter IV: Meta-analyses – Systematic “Reviews”…………………...................................... page 27
Chapter V: The results of ‘ECHO’ …..…………………………………............................................ page 33
Chapter VI: Internal evidence – Heuristic ………………………….............................................. page 38
Chapter VII: The homeopathic medicine has a specific activity …………............................ page 44
Physics of homeopathic medicines / Mechanism of action …................... page 47
Chapter VIII: Veterinary homeopathy …………………………………….......................................... page 51
Chapter IX: Questioning homeopathic medicines ……………………….................................. page 53
Chapter X: Homeopathy and epidemic diseases …………………………................................ page 57
General conclusions: …..………..………………………………………….............................................................. page 62
Denitions …..………..………………………………………….............................................................. page 63
References …..………..………………………………………….............................................................. page 65
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CHAPTER I
INTRODUCTION
The aim of this booklet is the study of the current frame-
work of the practice of homeopathy in the world. The
scientific adequacy will be considered regarding the
level of positive evidence currently available for each
considered aspect.
The comparable Oxford university scale is divided
into five levels instead of four.
Level of evidence :
I = the existence of meta-analyses and/or
systematic positive « reviews » of the literature.
IIa = controlled multiplied experiments,
randomised, positive results.
IIb = some controlled experiments, randomised,
positive results.
IIIa = study with multiple cohorts, positive results.
IIIb = study with some cohorts, positive results.
IV = opinion of experts (clinical and daily cases)
The use of homeopathic medicines is widely spread
throughout the world population.
In Europe and some other countries in the world, these
medicines are submitted to a registration procedure (1)
that guarantees an optimal pharmaceutical quality and
safety for users.
A potential risk may exist when these medicines are
used without having already made a medical diagnosis.
To minimize this risk it is essential to keep homeopathy
within the framework of medical practice.
In several countries, a law on patients’ rights has come
into force. This means that the patients have the right to
choose or to refuse a proposed treatment. Medical doc-
tors cannot inform the patient correctly if they do not
know all possible medical approaches. As such, an ethical
dilemma is created when the use of homeopathic medi-
cines would warrant consideration and Medical Doctors
are not aware of the possible efficiency of homeopathic
treatments.
It is essential for public health to formulate concrete
answers to all of these questions. This booklet is also
aimed to help in the formulation of pragmatic solutions
to these problems.
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CHAPTER II
GENERAL FRAMEWORK AND ETHICAL POINT OF VIEW (2)
A. The place of the non-conventional
medicine in our public health system
The World Health Organisation (WHO) concludes, in a
report of May 2005, concerning the politics surrounding
traditional medicine in different countries (3), that tra-
ditional medicine (TM), all over the world, maintains its
popularity. In addition, during the last ten years the use
of CAM (Complementary and Alternative Medicine) has
increased in several countries. The safety of the use of
these products and their quality control and evaluation in
term of efficacy are priorities for the political authorities
as well as for the population.
The WHO questioned their 191 members. Of those 141
countries (74 %) responded.
Of these countries who responded, 32 % have developed
a policy of health including TM/CAM and 56 % stated that
a policy concerning TM/CAM is in “construction”.
Only 5 countries developed this regularization prior to
1990.
Of those responders, 28 % have an adapted national
program specific to TM/CAM and 58 % have put in place
a national committee responsible for TM/CAM. In most
cases this committee is part of the Health Department.
Of these responding countries 43 % have established a
committee of experts for TM/CAM.
A problem of harmonization exists among the different
countries. This may be attributed to major difficulties such
as the absence of a standardized educational program for
TM/CAM and a lack of experts on this matter. Countries
are asking the support and advice of the WHO to develop a
national policy concerning the regularization of TM/CAM.
First part of chapter II
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Beijing Declaration
Adopted by the WHO Congress on Traditional Medicine, Beijing, China, 8 November 2008
Participants at the World Health Organization Congress
on Traditional Medicine, meeting in Beijing this eighth day
of November in the year two thousand and eight:
• Recalling the International Conference on Primary
Health Care at Alma Ata thirty years ago and noting that
people have the right and duty to participate individually
and collectively in the planning and implementation of
their health care, which may include access to tradi-
tional medicine;
• RecallingWorldHealthAssemblyresolutionspromoting
traditional medicine, including WHA56.31 on Traditional
Medicine of May 2003;
• Noting that the term "traditional medicine" covers
a wide variety of therapies and practices which may
vary greatly from country to country and from region
to region, and that traditional medicine may also be
referred to as alternative or complementary medicine;
• Recognizingtraditionalmedicineasoneoftheresourc-
es of primary health care services to increase availability
and affordability and to contribute to improve health
outcomes including those mentioned in the Millennium
Development Goals;
• RecognizingthatMemberStateshavedifferentdomes-
tic legislation, approaches, regulatory responsibilities
and delivery models;
• Notingthatprogressintheeldoftraditionalmedicine
has been obtained in a number of Member States
through implementation of the WHO Traditional Medi-
cine Strategy 2002-2005;
• Expressingtheneedforactionandcooperationbythe
international community, governments, and health
professionals and workers, to ensure proper use of
traditional medicine as an important component con-
tributing to the health of all people, in accordance with
national capacity, priorities and relevant legislation;
In accordance with national capacities, priorities, relevant
legislation and circumstances hereby make the following
Declaration:
I. The knowledge of traditional medicine, treatments and practices should be respected, preserved, promoted
and communicated widely and appropriately based on the circumstances in each country.
II. Governments have a responsibility for the health of their people and should formulate national policies, regula-
tions and standards, as part of comprehensive national health systems to ensure appropriate, safe and effective
use of traditional medicine.
III. Recognizing the progress of many governments to date in integrating traditional medicine into their national
health systems, we call on those who have not yet done so to take action.
IV. Traditionalmedicineshouldbefurtherdevelopedbasedonresearchandinnovationinlinewiththe"Global
strategyandplanofactiononpublichealth,innovationandintellectualproperty"adoptedattheSixty-rst
World Health Assembly in resolution WHA61.21 in 2008. Governments, international organizations and other
stakeholders should collaborate in implementing the global strategy and plan of action.
V. Governments should establish systems for the qualification, accreditation or licensing of traditional medicine
practitioners. Traditional medicine practitioners should upgrade their knowledge and skills based on national
requirements.
VI. The communication between conventional and traditional medicine providers should be strengthened and ap-
propriate training programs be established for health professionals, medical students and relevant researchers.
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At the sixty-second World Health Assembly of
22 May 2009 (WHA62.13 – Agenda item 12.4 about
Traditional medicine) the WHO concluded as follow:
Having considered the report on primary health care, in-
cluding health system strengthening (Document A62/8);
Recalling resolutions WHA22.54, WHA29.72, WHA30.49,
WHA31.33, WHA40.33, WHA41.19, WHA42.43, WHA54.11,
WHA56.31 and WHA61.21; Recalling the Declaration
on Alma-Alta which states, inter alia, that “The people
have the right and duty to participate individually and
collectively in the planning and implementation of their
health care” and “Primary health care relies, at local and
referral levels, on health workers, including physicians,
nurses, midwives, auxiliaries and community workers as
applicable, as well as traditional practitioners as needed,
suitably trained socially and technically to work as a health
team and to respond to the expressed health needs of
the community”;
Noting that the term “traditional medicine” covers a wide
variety of therapies and practices which may vary from
country to country and from region to region;
Recognizing “traditional medicine” as one of the resources
of primary health care services that could contribute to
improved health outcomes, including those in the Millen-
nium Development Goals;
Recognizing that Member States have different domestic
legislation, approaches, regulatory responsibilities and
delivery models related to primary health care;
Noting the progress that many governments have made
to include “traditional medicine” into their national health
care;
Noting that progress in the field of “traditional medicine”
has been achieved by a number of Member States through
implementation of the WHO traditional medicine strategy
2002-2005 (Document WHO/EDM/TRM/2002);
Expressing the need for action and cooperation by the
international community, governments and health profes-
sionals and workers, to ensure proper use of “traditional
medicine” as an important component contributing to the
health of all people, in accordance with national capacity,
priorities and relevant legislation;
Noting that the WHO Congress on “Traditional Medicine”
took place from 7 to 9 November 2008, in Beijing, China,
and adopted the Beijing Declaration on “Traditional Medi-
cine”;
Noting that African Traditional Medicine Day is commem-
orated annually on 31 August in order to raise awareness
and the profile of “traditional medicine” in the African
region, as well as to promote its integration into national
health systems,
1. URGES Member States, in accordance with national
capacities, priorities, relevant legislation and circum-
stance:
(1) to consider adopting and implementing the Beijing
Declaration on Traditional Medicine in accordance with
national capacities, priorities, relevant legislation and
circumstances;
(2) to respect, preserve and widely communicate, as
appropriate, the knowledge of traditional medicine,
treatments and practices, appropriately based on the
circumstances in each country, and on evidence of
safety, efficacy and quality;
(3) to formulate national policies, regulations and
standards, as part of comprehensive national health
systems, to promote appropriate, safe and effective
use of traditional medicine;
(4) to consider, where appropriate, including traditional
medicine into their national health systems based on
national capacities, priorities, relevant legislation and
circumstances, and on evidence of safety, efficacy and
quality;
(5) to further develop traditional medicine based on
research and innovation, giving due consideration to
the specific actions related to traditional medicine in
the implementation of the Global strategy and plan
of action on public health, innovation and intellectual
property;
(6) to consider, where appropriate, establishing sys-
tems for the qualification, accreditation or licensing
of traditional medicine practitioners and to assist
traditional medicine practitioners to upgrade their
knowledge and skill in collaboration with relevant health
providers, on the basis of traditions and customs of
indigenous peoples and communities;
(7) to consider strengthening communication between
conventional and traditional medicine providers and,
where appropriate, establishing appropriate train-
ing programmes with content related to traditional
medicine for health professionals, medical students
and relevant researchers;
(8) to cooperate with other in sharing knowledge and
practices of traditional medicine and exchanging train-
ing programmes on traditional medicine, consistent
with national legislation and relevant international
obligations;
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2. REQUESTS the Director-General:
(1) to provide support to Member States, as appropriate
and upon request, in implementing the Beijing Declara-
tion on Traditional Medicine;
(2) to update the WHO traditional medicine strategy
2002-2005, based on countries’ progress and current
challenges in the field of traditional medicine;
(3) to give due consideration to the specific actions
related to traditional medicine in the implementation
of the Global strategy and plan of action on public
health, innovation and intellectual property and the
WHO global strategy for prevention and control of non
communicable diseases;
(4) to continue providing policy guidance to countries
on how to integrate traditional medicine into health
systems, especially to promote, where appropriate,
the use of traditional/indigenous medicine for primary
health care, including disease prevention and health
promotion, in line with evidence of safety, efficacy and
quality taking into account the traditions and customs
of indigenous peoples and communities;
(5) to continue providing technical guidance to support
countries in ensuring the safety, efficacy and quality of
traditional medicine; considering the participation of
peoples and communities and taking into account their
traditions and customs;
(6) to strengthen cooperation with WHO collaborating
centres, research institutions and non governmental
organizations in order to share evidence-based infor-
mation taking into account the traditions and customs
of indigenous peoples and communities; and to support
training programmes for national capacity building in
the field of traditional medicine.
Eighth plenary meeting, 22 May 2009
A62/VR/8
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WHO Safety Issues in the Preparation
of Homeopathic Medicines 2010
This official WHO booklet is considering the challenges
of quality control and regulation of homeopathic medi-
cines in the world. It can be requested at bookorder@
who.int under ISBN number 978 92 4 159884 2 (NLM
classification: WB 930). It may be downloaded at www.
who.int/medicines/areas/traditional/prephomeopathic/
en/index.html.
It defines homeopathy as one of the most commonly used
form of herbal medicines
(even if plants are not the only
stocks used in homeopathy)
. There is a large market for
homeopathic products around the world. For example, in
2008, Australia spent 7.3 million US dollars on homeo-
pathic medicines, France spent more than 408 million,
Germany 346 million and the United Kingdom more than
62 million US dollars. In the United States, adults spent
2.9 billion US dollars on homeopathic products in 2007.
The use of homeopathic medicines has spread more and
more, and now it is widespread, not only in the European
region, but also in south Asian countries and North and
South American countries. With the worldwide increase
in the use of homeopathic medicines and the rapid ex-
pansion of the global market, the safety and the quality
of homeopathic medicines has become a major concern
for health authorities, pharmaceutical industries and con-
sumers. The safety of the homeopathic medicines largely
depends on their quality. Requirements and methods for
the quality control of finished homeopathic medicines
are far more complex than for chemical drugs, particu-
larly for the combined or mixed homeopathic medicines.
Furthermore, the quality of the homeopathic medicines
is influenced both by the quality of the procedure used
during their production and the quality of the raw material.
Products that meet high quality standards are needed to
allow the patient to make safe use of the homeopathic
medicines. Now, this is more and more important be-
cause, as a consequence of market globalization, many of
the raw materials and medicines used in the homeopathic
systems come from different countries.
Adverse events occurring during homeopathic treatment
are rarely attributed to the homeopathic medicine itself.
However, safety assessment should also consider pos-
sible impurities of the source material or contamination
in production and failures of good manufacturing practice.
Furthermore, because many homeopathic medicines can
be purchased as non-prescription medicines in commu-
nity pharmacies and health stores, without consultation
with a healthcare provider, it has become increasingly
important to provide sufficient and accessible informa-
tion regarding such medicines. Although homeopathic
medicines are generally assumed to be benign, the level
of authorization, appropriate labelling and quality assur-
ance should take into consideration their extensive use,
including that within vulnerable populations such as the
elderly, pregnant women and children.
In Europe the report Concerted Action for Complemen-
tary and Alternative Medicine (CAM) Assessment in the
Cancer Field” (4) observed the same tendency concerning
an increase in the use of CAM. This evolution goes on in
different countries within different scientific frameworks.
CAM would be understood as Non Conventional Medicine
meaning that it is not yet part of a Convention in Medicine.
This situation could evolve in the future.
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In 19 of the 29 European countries (Central and South
Europe) only the statutorily regulated individuals have the
legal authorization to treat patients. In the ten remaining
countries (Northern Europe) non-statutorily regulated
individuals can offer care. In these countries several
responsibilities remain in hands of medical doctors. The
authorities control CAM practices by a “permit to prac-
tice”, a licence, a protected title or voluntary registration.
A supervising commission is installed in these countries.
This commission determines which type of CAM can be
considered as “sound professional practice” when deliv-
ered by statutorily regulated individuals. The practice by
statutorily regulated individuals is strictly limited in some
countries whereas in other countries these statutorily
regulated individuals can have a free, unlimited practice.
Regulation systems in Europe
« fully controlled systems » n=19 « partial controlled systems » n=10
Countries Austria, Belgium, Cyprus, Czech Denmark, Finland, Iceland, Liechtenstein,
Republic, Estonia, France, Germany, Irland, Malta, The Netherlands, Norway,
Greece, Hungary, Latvia, Lithuania, Sweden, UK
Luxembourg, Italy, Poland, Portugal
Spain, Slovenia, Slovakia, Switzerland,
Who is allowed to treat? Statutorily regulated individuals. Statutorily regulated individuals. Everybody
Authorized •“risky”medicalprocedures •“risky”medicalprocedures
Medical •treatingseriousdiseases •treatingseriousdiseases 
Activities: •safemedicalprocedures •safemedicalprocedures •safemedicalprocedures
•preventive/prophylaxis •preventive/prophylaxis •preventive/prophylaxis
Diagram 1: Regulation in European countries (CAM-CANCER report).
“Plants” and homeopathic medicines authorized on the
market are controlled by specific European directives and
these directives are implemented in national legislation.
How can we protect patients from treatment inadequacy?
The best way would be the recognition of CAM treatments
in an adequate and legal way, but questions remain: is
it better to limit the practice of CAM to accredited per-
sons (Central and South Europe) versus non-accredited
persons (Northern Europe)? Is the efficacy and quality
of the CAM sufficiently verified in order to consider its
introduction in the healthcare systems?
Regulation system
All-regulated system
Semi-regulated system
Not included
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Table 2: regulated CAM in different European countries.
X: year of legalisation unknown.
Y: new law in preparations.
Countries Regulating CAM providers by law License CAM
Register
No Yes
Chiro- Osteo- Napra- Homeo- Acu- Naturo Phyto-
practics pathy pathy Pathy puncture -pathy therapy
Austria no
Belgium 1999 1999 1999 1999 2013 2013
Bulgaria 2005
Cyprus X y y
Czech Republic 2002
Estonia no
France no
Denmark 1992 2004
Finland 1994 1993 1994
France 2002
Germany 1939
Greece 2010
Hungary 1997
Iceland 1990 2005 2005
Ireland no y
Italy y 2015 y y 2015 2015
Latvia (physicians) x x
Liechtenstein 1985
Lithuania (physicians) x
Luxembourg no
Malta x x x
The Netherlands no
Norway 1988 2004
Poland no
Portugal 2003 2003 2003 2003 2003 x
Spain 2009
Slovakia no
Slovenia 2007 2007 2007 y
Sweden 1989 1994 y
Switzerland x x x
UK 1994 1993 1950 y y x
Number 11 13 8 2 7 4 1 1 3 4
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B. Teaching of homeopathy and use in
hospitals in 22 European countries (5)
Austria :
Officially recognized diploma as an additional qualification
(medical doctor / veterinary doctor qualified in home-
opathy). Postgraduate education. Optional introductory
course on CAM during basic education at the universities
of Vienna, Innsbruck and Graz.
In 11 hospitals homeopathic care is possible on consul-
tation.
Belgium:
Post-graduate diploma delivered by private schools. A
National diploma exists delivered by the Homeopathic
Faculty, grouping the different schools.
A compulsory optional introductory course at the Uni-
versity of Leuven (U.C.L.)
No official possibility for homeopathic care in hospitals but
patient’s rights include homeopathy as a possible patient
choice in collaboration with the family medical doctor.
Bulgaria:
Postgraduate diploma in private schools recognized by
the medical association.
No possibility of homeopathic care in hospitals.
Czech Republic:
Postgraduate diploma in private schools.
No possibility of homeopathic care in hospitals.
Denmark:
Education in private schools open for everybody (no
formal medical education required)
No possibility of homeopathic care in hospitals.
Finland:
Education in private schools, open for everybody (no
foregoing medical education required)
No possibility of homeopathic care in hospitals.
France:
Officially recognized diploma as an additional qualifica-
tion (medical doctor /veterinary doctor qualified in ho-
meopathy). Post-graduate education at the universities
in Aix-Marseille, Besançon, Lille, Paris-Bobigny, Bordeaux
II, Limoges, Poitiers and Lyon. Private schools also exist.
Optional introductory course of CAM during the basis
education at some universities
In 2 hospitals patients can come for a homeopathic
consultation: Hôpital St. Jacques en Hôpital St. Luc Paris.
Germany:
Officially recognized diploma as an additional qualifica-
tion (medical doctor /veterinary doctor qualified in ho-
meopathy). Post-graduate education at the universities
of Berlin, Düsseldorf, Hannover, Heidelberg and Freiburg.
Private schools also exist
Compulsory optional introductory course of CAM during
the basic education at some universities
In 1 hospital patients can come for a homeopathic con-
sultation: ‘Charité’ hospital in Berlin.
Greece:
Postgraduate diploma in private schools and some
universities.
No possibility of homeopathic care in hospitals.
Hungary:
Postgraduate diploma in private schools recognized by
the medical chamber.
No possibility for homeopathic care in hospitals.
Ireland:
Postgraduate diploma in private schools, open for every-
body (no foregoing medical education required).
No possibility for homeopathic care in hospitals.
Italy:
Officially recognized diploma as an additional qualifica-
tion (medical doctor /veterinary doctor qualified in ho-
meopathy). Post-graduate courses for medical doctors
in Bologna, Roma, Siena (also dentists and pharmacists)
Universities.
Postgraduate diploma in private schools for medical doc-
tors, dentists, veterinarians, pharmacists. Postgraduate
diploma organized by the Provincial Medical College in
Reggio Calabria.
No possibility for homeopathic care in hospitals at this
moment but announced.
Luxembourg:
Postgraduate diploma in private schools.
No possibility for homeopathic care in hospitals.
Netherlands:
Postgraduate diploma in private schools.
Optional introductory course of CAM during the basis
education at some universities
No possibility for homeopathic care in hospitals.
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Norway:
Education in private schools, open to everybody (no
foregoing medical education required).
No possibility for homeopathic care in hospitals.
Poland:
Officially recognized diploma as an additional qualifi-
cation (medical doctor /veterinary doctor qualified in
homeopathy). Post-graduate education at 8 universities.
No possibility for homeopathic care in hospitals.
Portugal:
Postgraduate diploma in private schools.
No possibility for homeopathic care in hospitals.
Romania:
Officially recognized diploma as an additional qualifi-
cation (medical doctor/veterinary doctor qualified in
homeopathy). Post-graduate education at 8 universities.
Optional introductory course of CAM during the basis
education at some private universities
No possibility for homeopathic care in hospitals.
Slovenia:
Postgraduate education at the private school of the Slo-
venian Homeopathic Society accreditated by ECH.
No possibility for homeopathic care in hospitals.
Spain:
Officially recognized diploma as an additional qualifica-
tion (medical doctor/veterinary doctor qualified in ho-
meopathy). Post-graduate education at the universities
of Sevilla, Murcia and Barcelona.
Optional introductory course of CAM during the basis
education at some universities
No possibility for homeopathic care in hospitals.
Sweden:
Education in private schools open for everybody (no
foregoing medical education required).
No possibility for homeopathic care in hospitals.
Switzerland:
Postgraduate diploma in private schools. At the univer-
sity of Bern education in CAM is available.
Homeopathic care only in private hospitals.
Great-Britain:
Officially recognized diploma as an additional qualifica-
tion (medical doctor/veterinary doctor qualified in home-
opathy). The official recognized “Faculty of Homeopathy”
delivers the diplomas. Postgraduate education in private
schools, open for everybody.
Optional introductory course of CAM during the basis
education at some universities
In 4 hospitals homeopathic consultations are possible:
London, Liverpool, Bristol and Glasgow.
Homeopathy in intensive care and emergency
services:
Recent publications show the benefit of homeopathy in
hospitals but also in emergency services for patients in
critical state (6, 7, 8, 9, 10, 11). The authors suggest the
development of algorithms including homeopathy al-
lowing quick and adequate responses for these patients.
The place of Homeopathy in India:
Homeopathy is available for patients in 230 hospitals
(10.851 beds) and 5.836 dispensaries. Officially registered
practitioners number 217,850. Two hundred sixteen col-
leges are teaching homeopathy. All of these activities are
coordinated by the ministry (health-education-scientific
research), as follows: more and more pathogenetic tri-
als, clinical verification, efficiency and efficacy research
including cost evaluation and even laboratory research in
an organized and a systematic way. India is emerging as
one of the strengthened infrastructures in homeopathy.
On 1 January 2013, the Government of India, Depart-
ment of AYUSH/Ministry of Health and Family Welfare,
published a booklet “HOMEOPATHY - Science of gentle
healing” (ISBN:978-93-81458-05-1 New Delhi 2013, www.
ccrhindia.org/Dossier/index.html)
This booklet is a complete overview of the situation of
homeopathy in India including principles, research and
development, drug regulation, education and practice.
The integration of the homeopathic approach into the
Indian Health system is not only supported by many evi-
dences in daily practice but also from large scale research
including basic research.
The place of CAM in the U.S.A.:
The Consortium of the Academic Health Centres (12)
integrate CAM in 30 university medical centres. As in
Great Britain, the concept of “integrated” medicine pre-
dominates. All possible treatments must be offered to the
patient. This attitude is based on the results of intensive
scientific research on CAM. Thus far the results are very
hopeful for homeopathy.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
14
SUMMARY OF FIRST PART:
In the world, the use of homeopathy has increased in many countries. In Europe, homeopathy, as other
CAM, is already partly regulated. Homeopathy is integrated in 6 of the 22 countries. Medical students
get familiar with CAM by an introduction course in 9 of the 22 countries. A postgraduate diploma in
homeopathy is recognized in 18 of the 22 countries. Despite the interest there are still some queries
outstanding before considering full integration in all countries. Part 2 will study the reasons for this
reservation.
The place of Homeopathy in South America:
Homeopathy is relatively popular in South America, with
higher popularity in Brazil and Argentina. The Brazilian
government recognizes formally homeopathy, and there
is more than a dozen training programs for physicians.
There are 15,000 doctors specialized in homeopathy in
Brazil, making it the 16th among the 61 medical special-
ties. A research conducted in 2005 among medicine
students found out that 85 % of them were of the opinion
that Homeopathy should be part of the curriculum (19 %
think it should be mandatory and 72 % optional).
In Brazil, since 1979 Homeopathy started figuring in the
Council of Medical Specialties of the Brazilian Medical
Association
, and since 1980 it is considered a specialty
of the Federal Medicine Council, not being considered
alternative medicine anymore, but instead part of what is
called
integrative medicine
nowadays. The UHS – Unified
Health System, includes it in the attending routine and it
is established as government policy. In the country, there
are also vet doctors, dentists and pharmaceutics that
officially work with homeopathy.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
15
Second part of chapter II
Arguments in relation to the reservations about CAM, in general, and homeopathy, in particular.
We know that in some European countries integration
of homeopathy in the health services, even at University
hospitals, is already accomplished. Nevertheless, some
people resist this integration.
The conventional pharmaceutical industry, with its enor-
mous financial power, does not like the development of
“other” medical systems of medicine that could be an
alternative to their market. This resistance is not really
structured but competition is always a problem and if
there is some opportunity to limit the action field of the
“others” they will not hesitate to use it.
The “rationalists” are not so numerous but very well orga-
nized and very influential on the mass media. One single
argument is sufficient to condemn everything that they do
not accept:
“it is simply impossible that something would
exist out of their rational way of thinking”.
Scientific doubt is rejected. Scientific facts that do not
find an explanation within their paradigm are
a priori
false.
Somewhere there must be an error”.
This “rational
world” is based on, and limited to, the molecular paradigm
that is part of molecular biology. Outside of this scientific
paradigm nothing can exist. However, other intercellular
communication means do exist: biophotons (13), biopho-
nons (14) and electromagnetic waves (15) have been
identified; they are activated by the communications
between cells and molecules. There is also the molecular
print in a solvent (16). These facts are not explicable by
the molecular biology. Even effects of hormones cannot
be explained only by the molecular theory because the
number of molecules is insufficient to explain the amount
of activated cells receptors; therefore the so-called “am-
plification” phenomenon must be developed.
As such, the major reason for rejection of scientific
research in the field of homeopathy is a theoretical reti-
cence. Research would not be necessary because the ob-
served effects cannot fully match the molecular paradigm
and its investigations’ methods. Therefore, possible cures
with homeopathy must all be due to the placebo effect
associated with psychological influences (believing) and
even spontaneous healing. Of course, this position forgets
the results achieved on animals and in children and that a
great majority of the delivered medicines are on a “molec-
ular level”. As an example of this position, we can consider
a publication in
The Lancet
(17), in fact a scientific fraud
(18, 19), but such publication based on manipulation of
facts would be sufficient to justify the placebo theory and
rejection of further research into homeopathy. By redo-
ing this statistical exercise, it was possible to confirm the
fraud and to deduce that the conclusions of this publica-
tion must have been written before looking at the facts.
The authors used a new mathematic model for literature
analysis that could confirm these conclusions. Unfortu-
nately, the strict application of this new method came to
a conclusion they did not desire, namely homeopathy is
efficient in certain areas. The authors preferred to avoid
these results and to quote only some negative results in
accordance with the a priori desired conclusions. The
redaction committee of
The Lancet
were very interested
in the negative conclusions and the impact such publica-
tion could have in the mass media and did not scrutinize
enough the content of this paper.
The Royal Academy of Medicine in Belgium recognized
in 2009 that the conclusion of
The Lancet
editorial (“Ho-
meopathy is a placebo”) cannot be sustained from this
publication (see further).
In fact, this is a war between two different paradigms.
The dominant paradigm must explain everything and if
something cannot be totally explained by this dominant
paradigm, it will be considered as artefact. However, new
paradigms exist and could explain other facts. As example,
the paradigm of information
does not “eliminate” the
molecular paradigm
, it is an additional paradigm that
can explain some facts that the molecular paradigm does
not explain at all.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
16
We shall not minimize the importance of the unspecific
effects in each medical approach. A placebo has been
denedas"asubstanceorprocedure...thatisobjectively
withoutspecicactivityfortheconditionbeingtreated".
Under this definition, a wide variety of things can be
placebos and exhibit placebo effects. Pharmacological
substances administered through any means can act as
placebos, including pills, creams, inhalants, and injections.
Medical devices such as ultrasound can act as placebos.
Sham surgery, sham electrodes implanted in the brain and
sham acupuncture, either with sham needles or on fake
acupuncture points, have all exhibited placebo effects.
The physician has even been called a placebo; a study
found that patient recovery can be increased by words
that suggest the patient “would be better in a few days”,
and if the patient is given treatment, that “the treatment
would certainly make him better” rather than negative
wordssuch as "I am not surethat the treatment I am
goingtogiveyouwillhaveaneffect."Theplaceboeffect
may be a component of pharmacological therapies: pain
killing and anxiety reducing drugs that are infused secretly
without an individual’s knowledge are less effective than
when a patient knows that he is receiving them. Likewise,
the effects of stimulation from implanted electrodes in
the brains of those with advanced Parkinson’s disease
are greater when they are aware that they are receiving
this stimulation.
The placebo effect has been controversial throughout
history. Notable medical organizations have endorsed
it, but, in 1903, Richard Cabot concluded that it should
be avoided because it is deceptive. Newman points out
the "placebo paradox", it may be unethical to use a
placebo, but also unethical
"not tousesomethingthat
heals."
He suggests to solve this dilemma by appropriat-
ing the meaning response in medicine, that is make use
oftheplaceboeffect,aslongasthe"oneadministering
... is honest, open, and believes in its potential healing
power."DavidH.Newman.
Hippocrates' Shadow.
Scribner
(2008). p. 134-159.
ISBN 1-4165-5153-0.
Professor Dr Claudia M. Witt (MBA. Institute for Social
Medicine, Epidemiology and Health Economics/ Charité
University Medical Center Berlin/ www.charite.de/cam)
presented at the 63rd LMHI Congress (2008), a com-
munication on research in homeopathy. This research is
aimed at isolating the specific effects of the homeopathic
medicines from the other effects of the medical approach
with a patient.
The hypothesis that “the placebo effects, during placebo-
controlled clinical trials of individualized homeopathy are
higher than in conventional medicine” was scrutinized in
a systematic literature analysis in 2010 (20). The results
were that in 13 matched sets the placebo effect in homeo-
pathic trials was larger than the average placebo effect of
the conventional trials; in 12 matched sets it was lower.
Additionally, no subgroup analysis yielded any signifi-
cant difference. As such placebo effects in Randomized
Controlled Trials on classical homeopathy did not appear
larger than placebo effect in conventional medicine.
Usually common medical doctors, especially special-
ists, are not interested in other medical approaches and
researches. They know very well what they are doing
every day; they are satisfied with the results obtained in a
majority of their patients and do not need something else.
They are only interested in more research, information
and improvement of their actual practice. If some patients
are not ameliorated by, or do not tolerate the proposed
treatment, they are classified as “difficult, “untreatable”
patients. The therapy will not be questioned and research
on other approaches will not be considered. They are not
“against” homeopathy but why would they encourage
better studies on a medical approach they do not know?
The benefit
Benefit
for the
patient
Specific effect
Setting
(e.g. doctor patient interaction)
Patient factors
(e.g. expectation)
Physician factors
(e.g. expectation)
Natural cours of disease
Regression to the mean
Placebo
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
17
Plausibility and evidence: the case of homeopathy.
In April 2012, a paper of Lex Rutten, Robert T. Mathie,
Peter Fisher, Mara Goossens & Michel Van Wassenhoven
was accepted for publication in the European Journal of
Medicine, Health Care and Philosophy.
They stated that Homeopathy is controversial and
hotly debated. The conclusions of systematic reviews of
randomized controlled trials of homeopathy vary from
‘comparable to conventional medicine’ to ‘no evidence
of effects beyond placebo’. It is claimed that homeopathy
conflicts with scientific laws and that homoeopaths reject
the naturalistic outlook, but no evidence has been cited.
We are homeopathic physicians and researchers who do
not reject the scientific outlook; we believe that examina-
tion of the prior beliefs underlying this enduring stand-off
can advance the debate. We show that interpretations
of the same set of evidence for homeopathy and for
conventional medicine can diverge. Prior disbelief in ho-
meopathy is rooted in the perceived implausibility of any
conceivable mechanism of action. Using the ‘crossword
analogy’, we demonstrate that plausibility bias impedes
assessment of the clinical evidence. Sweeping state-
ments about the scientific impossibility of homeopathy
are themselves unscientific: scientific statements must
be precise and testable. There is growing evidence that
homeopathic preparations can exert biological effects;
due consideration of such research would reduce the
influence of prior beliefs on the assessment of systematic
review evidence.
They concluded that the disagreement around the in-
terpretation of systematic reviews and meta-analyses is
partly a function of plausibility bias. They showed that it
is an important factor in the interpretation of the results
of RCTs of homeopathy and the source of much of the
disagreement concerning the interpretation of systematic
reviews and meta-analyses of such research.
Plausibility bias is necessary and probably unavoidable:
in making decisions about our beliefs or courses of action
we must take account of existing intellectual frameworks.
However, plausibility bias can have a damaging effect on
scientific progress and this is the case for homeopathy. To
be admissible in scientific discourse, plausibility bias must
itself be scientific. This means that it must be testable,
which in turn requires that it must be explicit and precise.
Sweeping generalizations about homeopathy ‘wrecking
whole edifices’ or standing in opposition to conventional
science etc. are unscientific: they are incapable of being
tested. It is remarkable that their authors do not specify
precisely why they believe that homeopathy has such
apocalyptic implications for science. We are unaware
of any contribution to the debate that has mentioned
a single specific scientific law that is threatened by ho-
meopathy.
Hansen and Kappel’s assertion that the homeopathic
community rejects the naturalistic outlook is not evi-
dence based. Plausibility bias has introduced more heat
than light into the debate around homeopathy: it has
fired the debate without illuminating its information
content. We do not deny that homeopathy raises major
scientific issues, but we remain convinced that these
will eventually be resolved by application of authentic
scientific method, especially in the context of further in
vitro experiments. (21)
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
18
ird part of chapter II
Ethical aspects
The Position of Ethics
Two fundamental rights must be taken into account:
the
therapeutic freedom for therapists and the freedom of
choice of therapy for the patient.
1. The bio-ethic of the 21th Century and sources:
It is good to mention some existing important ethical lines
and their applications in the field of alternative medicine.
If we consider the actual medical ethic, one can observe
that there is a tendency to go further than the oath of
Hippocrates, just because the ethic is taking into account
technical and human complexity. So medical ethics is in
permanent mutation and permanently questioned.
a. Appearance of the medical techno-science
In the context of the medical technology, especially in the
fields of research connected with human life, the bio-ethic
is concerned. Science cannot remain morally neutral.
b. The role of the concept “scientism” in the actual
way of thinking:
3 important steps are distinguished by A. Comte in the
evolution of a human being.
1. The theological step: humans cannot explain under-
standable phenomenon by religion.
2. The metaphysical step: the appearance of abstract
entities.
3. The step of the positivism.
• Phenomena are connected to laws
(Constant relation among phenomena).
In the positivist attitude, science becomes the foundation
of the individual and social life. The moral conscience is
obliged to evolve as quickly as the evolution of the science
as a consequence of this positivist attitude. The result is
an ethical revolution. Trying to define the actual concept
“moral, a possible approach can be in connection with
his hereditary nature: the moral conscience is the result
of the heritage of the human feelings (example: compas-
sion, devotion). Thus the “moral” is the result of the so-
ciobiological evolution we transmit. This approach of the
terminology “moral” can be confirmed by the inability of
the human being to make a final law about human rights.
It is necessary to consider an evolving bio-ethic, based on
the evolution of the nature of the human being.
• WherewouldweplacehomeopathyandCAM
in this context?
Using the positivist attitude, homeopathy is based on the
fact that it is a fully experimental science. But homeopathy
exceeds this positivist attitude, keeping a “metaphysical”
aspect. The homeopathic phenomena are only linked to
the natural right.
c. Positivism.
Conventional medicine is based on scientism. It is impor-
tant to underline that the representatives of this conven-
tional science determine laws, allocations of budgets and
the composition of the ethical committees. The National
Ethical Committee is composed and directed by research-
ers who are at the same time judge and jury! Therefore
we can understand that political action is based on ethi-
cal orientations submitted to the rules of the dominant
science paradigm. Orientations are decided not only by
a compromise among individuals but also by a social
consensus. The actual ethic is indeed accepted by the
majority of the people but it is not based on the individual
rights of every human being. In this way it is immediately
submitted to legislative power.
The actual ethic is based on 2 principles:
1) Difference between
the ethic of conviction and the
ethic of responsibility
(Theory of Weber)
2) Discussions as empirical tool to come to a consen-
sus.
The ethic of conviction is based on the principles of the
metaphysics and of religion.
On the other hand, the ethic of responsibility disregards
these principles. The ethic of responsibility is more
adapted to a rational approach of the problems caused by
the progress of the medical research. When formulating a
law, a consensus can be reached by discussion. Society
confirms the accepted laws. These laws are the result of
a dialogue based on the expression of all opinions above
all convictions. References to “truths” or to the “absolute”
must be avoided because interaction would not be pos-
sible anymore. It may become clear that the moralistic
philosophy and the positive right have different subjects
and methods. The positive right covers the practice, pro-
tects persons and punishes infringements; at this level a
minimal consensus will be sufficient.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
19
d. Access to the metaphysical dimension of the hu-
man being
This allows the describing of the limits of positivism.
Therefore it is necessary to look at the relation between
the positive and the metaphysical sciences. Agnosticism
and Progress ideology (amelioration of mankind and well-
being) dominate our actual society.
• Ahumanbeingisuniqueandsensitive;
• Adualityinsciencecouldexist:sciencecanexplainthe
universe but who explains science?
• Certainlythereisarelationbetweenscienceandspirit.
Positive sciences should only be an instrument. A human
being uses this instrument, but should not be enslaved to
it. Natural sciences show us how deeply we are anchored
to the very depths of nature. These sciences teach us to
know our impact and our responsibility to nature; a hu-
man being creates science but goes beyond this science
by his spirit.
This last approach may be considered as individualistic
and keeps no account with the social responsibility that
is, as we have already seen, totally different. Must we
accept to go on with the split between the social and
individual ethic?
Because of the evolution of quantum physics, we know
that homeopathy and the other CAM are not considered
science in the way that the other sciences are. In this
connection we have an ethical problem. The individual
approach dominates in homeopathy but the social re-
sponsibility of the medical doctor homeopath is the same
as of every other medical doctor.
2. The bio-ethic and its most important currents
The most common definition of the bio-ethic could be
formulated as following
“science of morals.
This defini-
tion is confusing because the reason for the existence of
ethics is not scientific. All bio-ethical problems such as re-
search on embryos and euthanasia divide our conscience.
These problems also penetrate the field of contemporary
homeopathy.
Let us reflect on the origin of the word “ethic, originating
from the Greek word “ethos” (
“safe home”
). Referring
to this source, one finds that ethics is neither a matter
of arguments, nor of concepts. Ethics is more a state of
mind, a way of being in the presence of the pain appearing
on the face of another. Emmanuel Levinas defines pain as
“the impossibility of finding a safe home”
. So, it should be
logical to consider ethical all actions done with the ex-
pectation to make the world more liveable. Homeopathic
medicine and CAM, like the whole humanistic world, is
par excellence a medicine of hospitality, listening to the
patient with the purpose of enlightenment of the pain by
offering him a new “safe home”.
It is interesting, in accordance with the discussions going
on at this moment at the international level about the fac-
tor “health”, to explain two dominant ethical sensitivities:
• Therstoneisthe
"utilitarianethic"
predominant in the
Anglo- Saxon world.
• Thesecondoneisthe
deontological”
inspired more
from the continental way of thinking.
We will place homeopathy and other CAM therapies in
relation to the problems encountered concerning the
national diversity of the concept of philosophy.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
20
A. The utilitarian Ethic
The emphasis is put on the “utility” of each action for
“the highest happiness for the most possible number of
people. The utilitarian concept evaluates the moral value
of an action to its consequences (not the intentions, but
the consequences count). The founder (Bentham) of the
utilitarian ethic said:
“good is what is good for me without
harming the other”.
The utilitarian ethic is also called
“naturalistic”
: namely, acting according to good is acting
respectful of the gifts of nature to us.
It is a philosophy proclaiming the “doctrine of enjoyment”
and, as such, including the free transactions between
persons under the form of a contract. The problem of a
woman carrying a child for another woman or of the selling
of cosmetics is illustrative: why forbid when everybody
enjoys it?
B. The Ethic of the Deontology
The deontological ethic (“Deon”= Greek = what is neces-
sary to do) is not based on the right of enjoyment but on
the duty to be respectful of the other person. Here one
could say that it is a
“person-bound”
ethic. Kant is the
symbolic person for this movement. Not only are the
consequences of an action important but also the inten-
tions preceding our behaviour.
Act in a way you should
treat humanity as well as you would yourself and the other;
always and at the same time as an aim and never only as
a tool.
We cannot accept a world where people consider
their body as a business.
C. Applications to Homeopathy
Homeopathy was the object of so much scepticism in the
20th century. This is mainly because of the fact that it is
integrating science and “non scientific” knowledge. They
seem to leave the framework of the positivist medicine. To
integrate homeopathy in our health service, they have to
be in harmony on the ethical level. Ethical questions, typi-
cal for complementary and alternative medicine must be
considered. What is needed to integrate them safely into
the existing health system, offering patients and medical
doctors a free choice of therapy?
a. Developing at European Union level, and in the
world, legislation allowing the integration of CAM
in the health services.
The integration of the practice of CAM and homeopathy
in free medical practice and in the structures of hospitals
is necessary. It is a matter of social and ethical good
sense. For medical doctors, the social and collective
responsibility is also linked to their deontological re-
sponsibility. By integration, it will be ethically possible
to offer patients more medical approaches respecting
freedom of choice even when s/he moves from one
country to another.
b. CAM therapies have their own fields of action
and indications and are not allowed to replace the
conventional medicine with its specific indications.
It is necessary to define the indications for CAM; home-
opathy and some CAM therapies are curative in certain
clinical situations. In some pathology, scientific studies
showed positive results. On the other hand, their appli-
cation may not be indicated in other specific situations
and modern technology would be preferred in order to
help the patient.
c. Problems related to life.
A medical doctor will be consulted regularly for problems
related to “life”. The medical doctor, having at his/her dis-
posal complementary and alternative therapies, is more
able to advise the patient about a medicine respecting
natural rights. His advice can be an element for discus-
sion in regard to a heavy technical intervention. On the
other hand there must be a deontological ethic to this
advice evaluating also what may be the consequence of
this decision for the well being of the patient.
d. The freedom of choice for the patient as well for
the physician.
This is a fundamental right, based on clear and unbiased
information that a medical doctor can give to a patient.
At this level, the education of a medical doctor in conven-
tional as well as in alternative medicine is necessary. After
a medical diagnosis it will be possible, for this medical
doctor, to offer his patient different possible available
treatments. The patient can make his/her choice when
s/he is well informed. When the physician has to make
this choice, he has to consider all ethical aspects as well
as the methods he considers using for treatment.
e. Homeopathic medicines.
Homeopathic medicines have very precise indications.
Their action is proved by research and validated clinical
trials (see further). Homeopathy is an experimental
science, based on clinical research and verification. On
the other hand, research gets only little support at the
national level as well as the European or intercontinental
authorities. CAM and especially homeopathy ask for vali-
dation and financial support by the authorised authori-
ties so that from an ethical point of view the user of these
products can get guarantees about safety and efficacy.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
21
IN CONCLUSION:
Looking towards a more humanistic medicine, in contrast
with a very technically and over specialized medicine, the
reconciliation between scientific progress and respect for
the human person must be a priority.
Therapies such as homeopathy have several indications in
the field of chronic as well as in the field of acute diseases;
even within very extreme situations (comatose patients).
We may see in intensive care units that homeopathy can
help patients.
For the wellbeing of everybody, the development of re-
search within homeopathy is necessary; funding it, in a
correct way, is needed as is a good education in Medicine
and in homeopathy for the physicians using homeopathy.
The patient becomes impatient.
When everything is regulated, a free choice for the patient
and the medical doctor will be possible. Efficient results
and the amelioration of a patient’s health and welfare will
be guaranteed.
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
LMHI Liga Medicorum Homoeopathica Internationalis
research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
22
CHAPTER III
Framework of the practice: Belgium (Europe) as an example.
Survey IPSOS, May 2011, on a representative sample
of the Belgian population above 18 years old (1000 =
100 %); 21.7 % do not know homeopathy at all; 78.3 % are
aware of the existence of homeopathy in Belgium; from
them 38.8 % never use homeopathy but 11.8 % are open
for this use if needed; 39.5 % are (or were 5.1 %) using
homeopathy. In the users group, 55 % are users for more
than 5 years, 17 % between 3 and 5 years, 7 % between 1
and 2 years, 4 % for some months and 17 % do not know.
Motivations for using homeopathy: better for health 57 %;
avoiding “chemicals” 41 %, efficacy 39 %, medical doctor
prescription 32 %, advice of a friend 28 %, advice of the
pharmacist 23 %.
Motivations for non-users: 43 % do not know homeopathy
well, not proposed by my medical doctor 40 %, not proven
30 %, slowness of action 30 %, I am not ill 28 %, I do not
know an homeopathic doctor 25 %.
The most important channels for the use of homeopathy
are the family doctor (84 %) and the pharmacist (66 %).
Information about homeopathy is expected from the
medical doctor (58 %); from the pharmacist (39 %);
from the internet (36 %); from the media (29 %) and
from books (15 %).
More than 22 % of the family doctors prescribe homeo-
pathic medication more or less on a regular basis. Three
percent of them prescribe homeopathy as a first choice.
The profile of the medical doctor homeopaths, members
of a Union shows that a majority (87 %) are first line Medi-
cal Doctors. There is also a broad use of homeopathy by
veterinarians and dentists. Pharmacists are more and
more longing for knowledge on homeopathic preparation
and how to offer advice about homeopathy.
The reasons why patients ask for a homeopathic treat-
ment are various and are certainly not limited to “easy to
cure” indications.
From an earlier publication (22): Inquiry of 6000 persons,
representative of the Belgium population, homeopathy is
used for grave and chronic illness (17 %), 17 % for specific
diseases like allergic conditions, 7 % due to inefficacy of
conventional treatments and 3 % because intolerance to
some conventional drugs.
Although all ages are represented, from pediatrics to
adults, 75+, but the group above 55+ years old is con-
sidered to be the most expensive for the budget of the
National Health Service.
Recent problems Use of
in the family homeopathy
Winter events
(coryza, cough,
otitis, influenza, etc.) 20 % ++++
Pain in joints 16 % ++
Allergy 10 % +++
Stress 8 % ++
Injuries 7 % +++
Hypertension 7 %
Bowel problems 6 % ++
Prevention
(Influenza, allergy,etc.) 4 % ++
Skin symptoms
(Eczema,etc.) 3 % +
Diabetes 3 %
Heat flushes 3 % +
Urinary infection 2 %
Teething problems (child) 1 % +
None of these 10 %
Together 100 % Users 40 %
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
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research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
23
The demand and supply of the medication in the phar-
macy was also scrutinized in the same inquiry. Self-
medication covers 15 % of the demand; the physicians
(prescriptions) are responsible for 44 % and the phar-
macists’ advice covers 30 %.
One may conclude that the use of homeopathic medica-
tion is widespread (even more than expected including
self medication and pharmacists’ advice).
Within the framework of the complementary insurance,
reimbursement of prescribed homeopathic medicinal
products is possible from 25 % to 50 % of the price.
Several inquiries on medical doctor homeopaths show
that most of them prescribe homeopathy within the
framework of first line medicine.
Every MD receives, yearly, his individual profile of prescrip-
tions of medical imaging and clinical biology from the
National Institute of Health. This profile allows us to make
a comparison between the profile of MD homeopaths and
all other physicians.
Fifty-two percent of the accredited GP homeopaths sent
their profile, the values of the consecutive years were put
together and a yearly average calculated.
The year average of patient contacts was 2.415. Thirty-
four percent of the Belgium physicians have fewer con-
sultations; 66 % have more consultations.
If we consider the average amount paid back by the in-
surance for each individual patient contact concerning
medical imaging, the value for this group is 2.6 mean-
ing that only 26 % of the Belgian physicians cost less.
Seventy-four percent of the physicians cost more than
the group of homeopathic physicians.
If we consider the total amount of yearly prescriptions
of clinical biology, of MD homeopaths the worth is 2.9
meaning that 29 % of the Belgian physicians prescribe
less; 71 % prescribe more. The average number of re-
quested analyses for each prescription is higher under
the MD homeopaths in comparison to the average of
Belgian physicians (worth 3.7). MD homeopaths are
prescribing more complete biological evaluation than
the non-homeopaths MDs but in a lower frequency. This
means that concerning the total amount of demanded
medical analyses, 37 % of the physicians prescribe less
than the MD homeopaths, 63 % more.
If we consider the average amount paid back by the
insurance on each individual patient contact (if we
should have the same number of yearly consultations)
concerning clinical biology the value by patient contact
is 4.8 meaning that 48 % of the Belgium physicians cost
less; 52 %, more.
This confirms that the specific medical act of the ho-
meopathic physicians creates no particular problems
for social insurance. If the costs of the clinical biology
are added to the costs of the consultations the total
amount for the homeopathic group situates itself at
the value of 3.3 meaning that 33 % of the Belgian
physicians cost less; 67 % cost more to the national
insurance service.
More information would be needed about the profile of the
patients consulting a homeopathic physician in compari-
son with the profile of patients consulting conventional
physicians. If the practice of a homeopathic physician
100 %
80 %
60 %
40 %
20 %
0 %
Under 2
years
2 to 4
years
5 to 9
years
10 to 19
years
20 to 39
years
40 to 59
years
60 to 74
years
75 years
and over
N/R
2,2 %
4,3 %
7,3 %
6,5 %
25,3 %
31,2 %
14,3 %
3,3 %
5,5 %
3.1.2 Age group overall
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
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research@lmhint.net
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EvidEncE BasEd HomEopatHy 2013
24
were completely different from the conventional one, an
extrapolation could indeed have been biased. The same
problem exists if the patients consult also, on a regular
basis, conventional physicians for supplementary analy-
sis. In fact, we are already sure that that is not the case;
50 % of patients are asking for a Global Medical File
(inscription) by an MD homeopath.
CONCLUSIONS:
• Thepracticeofhomeopathicdoctorsispartofthe
framework of medical practice. Clinical biology and
medical imaging are used when necessary.
• Noabnormalitiesarefoundconcerninginsufcient
or exaggerated prescription profiles. The profiles of
MD homeopaths are similar in comparison with the
conventional colleagues.
• No signicant difference in the prescriptions of
clinical biology and medical imaging prescribed by
MD homeopaths in comparison with the conventional
colleagues.
• Thebiological analyses of the homeopathic physician
are more complete and extensive.
Comparison of the prescription of
medicines costs at each consultation.
For GPs the cost of the prescription at each consultation
is about 27 €.
GP homeopaths prescribe, at each consultation, conven-
tional medication for about 12 €.
The number of patient contacts of MD homeopaths is
based on the reimbursed consultations by the National
Institute of Insurance Service (INAMI). A lot of patients
are insured through private insurance companies and as
such are not counted as patient contact, but the supply
of medicines is counted. Therefore, the real number for
consultations is higher and the real cost for each consul-
tation must be corrected to 9.85 € per patient contact.
Some could say that this difference exists because the
homeopathic medical doctor treats less severe ailments,
but, we saw before that a homeopathic doctor treats
chronic and severe diseases. This fact can be confirmed
by studying the volume of prescriptions at each consul-
tation. In this case, we can see that this volume is 50 %
lower for the homeopathic M.D. compared to conventional
doctors.
Comparison between medicinal
products.
The two following tables show clearly that the homeo-
pathic physicians prescribe relatively more conventional
remedies linked to blood and cardio-vascular problems
in comparison with all medical GP’s.
On the other hand, MD homeopaths prescribe less in other
sectors, such as NSAID and antibiotics. Here a difference
of 50 % is remarkable.
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www.homeopathyeurope.org
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research@lmhint.net
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EvidEncE BasEd HomEopatHy 2013
25
Group: all general practioners
Group: general practioners homeopaths
A) Stomach-Bowel and metabolism
B) Blood and related system
C) Cardiovascular system
D) Skin Preparations
G) Uro-genital system including sexual hormones
H) Hormones except sexual hormones
J) Antitiotics- antiinfectious general
L) Cycstotatics immunomodulation agent
M) Bone and muscular system
N) Central nervous system
P) Antiparasit
R) Respiratory system
S) Sense organes
V) Diverse
A) Stomach-Bowel and metabolism 2,821,927,586
B) Blood and related system 658,112,663
C) Cardiovascular system 8,255,730,375
D) Skin Preparations 425,834.184
G) Uro-genital system including sexual hormones
931,036,645
H) Hormones except sexual hormones 657,816,135
J) Antitiotics- antiinfectious general 4,267,869,391
L) Cycstotatics immunomodulation agent 688,306,116
M) Bone and muscular system 1,571,803,524
N) Central nervous system 3,063,849,422
P) Antiparasit 6,906,430
R) Respiratory system 2,200,219,686
S) Sense organes 142,806,140
V) Diverse 27,417,668
3 % (B)
11 % (A)
31 % (C)
2 % (D)
16 % (J)
4 %
(G)
3 % (L)
6 % (M)
11 % (N)
0 % (P)
0 %
(V)
3 %
(H)
9 % (R)
1 %
(S)
3 % (B)
11 % (A)
40 % (C)
1 % (D)
9 % (J)
4 %
(G)
4 % (L)
5 % (M)
11 % (N)
0 % (P)
0 %
(V)
3 % (H)
8 % (R)
1 %
(S)
A homeopathic doctor sees more patients with respira-
tory tract problems than do conventional colleagues.
% of prescriptions homeopaths MDs versus non-homeopaths MDs.
40
20
0
-20
-40
-60
-80
-65
-50
-50
-35
-30
-26
30
40
-75
Antibiotics Divers Hemato Muscle-Bone Nervous
System
Cancer/
Immuno
Digestion Respiratory Heart-
Circul.
-6
Total
This is not the case for cardio-vascular problems where
no homeopathic alternative exists.
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www.homeopathyeurope.org
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EvidEncE BasEd HomEopatHy 2013
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Conclusion of these surveys:
• ThemedicalactivityoftheGPhomeopathisdonewithin
the framework of medicine. The Royal Academy of
Medicine in Belgium concluded that only when applied in
this context, by qualified Medical Doctors, is homeopathy
acceptable (see further).
• Prescriptions of conventional remedies occur when
necessary.
• Thenumber of patient contacts is 24 % lower for MD
homeopaths in comparison with all GPs.
• Thecost of each prescription of GP homeopaths for
conventional remedies is 50 % lower (more or less 15 €)
• Forhormonaltreatments,uro-genitalandcardio-vascu-
lar pathologies, homeopathy may be not an alternative
for the conventional treatment.
• Ontheotherhand,thereis a spectacular decrease in
percentage of prescriptions of NSAIDs and antibi-
otics. This is very important for health care in general
because it reduces the risk of resistance against antibiot-
ics and subsequent iatrogenic disease through NSAIDs
(stomach ulcers).
• All together, knowledge and use of homeopathy can
generate a considerable decrease of the volume and
of the cost of the prescriptions at each patient contact
(especially for antibiotics and NSAIDs)
Of course this survey does not allow evaluation of the cost
of homeopathic medicine because these data are not taken
into account by the National Institute of Insurance Service
(INAMI). It would be interesting to analyse the number of
contacts, by a single patient, with a conventional GP in ad-
dition to the contacts with a MD homeopath when it exists.
The average amount of contacts for each patient is 5 per
year to a GP homeopath.
The strategy of a treatment (only conventional
or only homeopathy or both) depends on the
diagnosis. Homeopathic therapy is only possible
within the framework of medical practice taking
into account the freedom of therapy for the medi-
cal doctor.
All these results are published (20) and some more facts
are of interest, as follows:
The treatment by a homeopathic physician causes an
important reduction in the consultations with another GP
or a specialist (2/3 less). The patients in the worst physi-
cal condition at the start of the treatment derive the most
benefit from homeopathic treatment. The average length
of a homeopathic consultation is 37 minutes.
As a result of a homeopathic treatment, 52 % of the pa-
tients are able to stop one or more conventional medicines.
Particularly medicines for the central nervous system can
be consequently reduced (21 %), along with medicines
concerning the respiratory tract (16 %), and antibiotics
(16 %). The homeopathic physician prescribes only 1/3
of the total amount of medicines prescribed by a conven-
tional physician. For antibiotics, this is even only 1/5. If we
extrapolate this to all patients, this would give a reduction
of 2/3 on the budget of medicines.
Through all these surveys we showed that home-
opathy has a place and has to stay or be imple-
mented at least within the general practice of first
line medicine. There is no evidence of any medical
deviant conduct by the homeopathic physician.
At the 63rd LMHI Congress (May 2008) comparable results
were presented for France, Italy and USA:
• Chaufferin G. L’homéopathie est-elle coût-efcace ?
Homeopathic medicines represent 6 % of distributed
medicines but only 1 % of the costs in medicines for the
patients.
• RoccoV,HuckS,RodriguezAA.Measuringprivateho-
moeopathic practice in Italy. An important factor in the
decision to come to homeopathy is MDs competence,
education and experience.
• FryeJ.Comparinguseofhomeopathywithapractitioner
and use as self-care in the U.S. 2002 National Health
interview survey.
For more general information see Bornhöft G, Matthiessen
P. “Homeopathy in Healthcare: Effectiveness, Appropri-
ateness, Safety, Costs. Berlin: Springer, 2011
www.springer.com/medicine/complementary+%26+alte
rnative+medicine/book/978-3-642-20637-5
E.C.H. European Committee for Homeopathy
info@homeopathyeurope.org
www.homeopathyeurope.org
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research@lmhint.net
www.lmhi.net
EvidEncE BasEd HomEopatHy 2013
27
CHAPTER IV
META ANALYSES – SYSTEMATIC REVIEW
The “gold standard“, accepted by everybody to evaluate
the efficacy of a remedy is a meta-analysis or a system-
atic audit of RCTs. Since 1991, six comprehensive reviews
concerning homeopathy were published.
The conclusion of most comprehensive systematic
reviews has been that homeopathy has a positive and
specific effect greater than placebo alone. Several ran-
domized and controlled studies (RCT) showed a statisti-
cal significance difference between homeopathy and
placebo. More research is justified.
Report about all comprehensive systematic reviews on homeopathic trials
• Kleijnen&al.1991(23)
British Medical Journal
.
105 studies with interpretable results. Meta-analysis
based on validated criteria.
77 % of the studies show positive result for home-
opathy.
The results are mostly favourable for homeopathy
regarding the quality of trials.
“There is a legal argument for further evaluation of
homeopathy”.
• Boissel&al.1996(24)
Report for the European
commission.
15 studies. Inclusion of only very rigor-
ous studies (highest quality).
Combined p-values for the 15 studies is significant.
(p = 0.0002).
“It is evident that homeopathy is more efficient
than placebo”.
Little evidence for non-published negative results.
Further research is justified.
• Linde&al.1997(25)
The Lancet.
89 studies.
“Odds ratio” combined 2.45 (95 % CI, 2.05-2.93) in
favour of homeopathy.
“Odds ratio” for the best 26 studies was 1.66.
It is not possible that the clinical effects of home-
opathy are due completely to placebo.
• Linde and Melchart 1998 (26)
Journal of Alterna-
tive and Complementary Medicine.
32 studies,
inclusion of studies on invidualised homeopathy only
(24).
Individualised homeopathy is more efficient than a
placebo: the value of the combined coefficient was
1.62 (95 % CI, 1.17-2.23).
Further pragmatic research is justified.
• Cucherat&al.2000(27)
European Journal of
Clinical Pharmacology.
16 trials representing
17 comparisons with placebo (based on data from the
Boissel 1996 study).
Several studies have positive results. More trials
have a positive result than would be expected to
chance alone.
Publication bias is unlikely.
More clinical trials are needed.
• Shang&al.2005(28)
Lancet.
110 trials included,
but the final conclusion is based on a selection of 8
trials.
Final conclusion (8 heterogeneous trials) : weak
evidence for a specific effect of homeopathic
remedies, but strong evidence for specific effects of
conventional interventions
Presented as comparison of homeopathy and care-
fully matched conventional trials, but data about
conclusive trials were missing
Quality of homeopathy trials is better: 21 (19 %)
good quality trials for homeopathy, 9 (8 %) for
conventional medicine.
Homeopathy is effective for acute upper respira-
torytractinfections(oddsratio0•36[95%CI
0•26–0•50]),basedon8trialswithoutindications
for bias.
• Bornhöft G., Matthiesen P. 2011. Report for the Swiss
Federal Office of Public Heath. This report used the
health technology assessment (HTA) method examin-
ing not only the efficacy of a particular intervention but
also its “real world effectiveness”, its appropiateness,
safety and costs. This report is fully in line with the prin-
ciples of EBM, unlike assessments based only on RCTs.
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In this assessment papers were selected also looking
at the respect of the homeopathic fundamental rules
such as similarity and individualisation of treatments.
This report contains a systematic review for upper re-
Comments on meta-analyses
Randomized Controlled Trials (RCTs) for homeopathy
were originally meant to prove that homeopathy as a
method is not a placebo effect, despite the questioned
mechanism of action. For this purpose meta-analyses
combined trials for different indications in one analysis.
Despite heterogeneity that arises from such combina-
tions, some positive evidence could be demonstrated in
a number of meta-analysis. We would like to stress that
these analyses disregard the surplus value of homeopa-
thy. Homeopathy is predominantly used by patients with
chronic and recurrent complaints and is valued for the
fact that it appears to have systemic effects, exceeding
single indications as is common in conventional medi-
cine.
Selecting subgroups in a limited number of trials readily
leads to false negative results.
The Cochrane Handbook
for Systematic Reviews
states “Reliable conclusions can
only be drawn from analyses that are truly pre-specified
before inspecting the trials’ results” (31).
The Cochrane
Handbook
further recommends, “Meta-analysis should
only be considered when a group of trials is sufficiently
homogeneous in terms of participants, interventions and
outcomes to provide a meaningful summary”. Pooling of
results of studies on different conditions is also question-
able if homeopathy works for some conditions and not
for others (32). Because of the questioned mechanism
of action the evidence for homeopathy was scrutinized
in a way that is not required for conventional therapies.
Linde et al (1997) showed that the positive outcome for
homeopathy cannot be explained by publication bias (25).
Shang et al (2005) showed that quality of homeopathy
trials is better compared to conventional trials matched
on indication (28).
The analysis by Shang,
et al.
, (2005). This analysis
did not comply with the QUOROM guidelines that suf-
ficient information should be given to reconstruct the
conclusions. The authors did not reveal which trials (8 for
homeopathy, 6 for conventional medicine) led to the final
conclusion. Neither the summary nor the introduction
clearly specified the aim of the study. The meta-analysis
does not compare studies of homeopathy versus stud-
ies of conventional medicine, but rather specific effects
of these two methods in separate analyses (33, 34, 35,
spiratory tract infections and allergies and concluded
that a positive effect is not only apparent in placebo
controlled studies, but especially also in the comparison
with conventional treatments. (29)
36). Therefore, a direct comparison must not be made
from this study. Post-publication data revealed that the
conclusion was not based on a comparison with matched
conventional trials, as suggested by the authors (37). The
conclusion was based on 8 studies for 8 different indica-
tions; the inefficacy of one of these indications, muscle
soreness in marathon runners, was already proven (38).
The conclusive subset of 8 trials was based on a
post
hoc
definition for 'larger trials', n=98 for homeopathy
and 146 for conventional medicine. If 'larger' would have
been defined as 'above median sample size', including 14
homeopathy trials, the outcome would be significantly
positive. Excluding the indication 'muscle soreness in
marathon runners' homeopathy is efficacious in most
subsets of larger good quality studies.
Shang,
et al.
, stated that the asymmetry of the funnel plot
indicated inefficacy when compared with conventional
medicine. This comparison was not rectified because of
difference in quality, especially in smaller trials. For trials
with sample size <100 homeopathy had 14 good quality
trials and conventional medicine 2 (p=0.003). Stronger
effect in smaller good quality trials is caused by better se-
lection of patients and then asymmetry of the funnel plot
is no indication for bias. Funnel plots are thought to detect
publication bias, and heterogeneity to detect fundamental
differences among studies. New evidence suggests that
both of these common beliefs are badly flawed. Using
198 published meta-analyses, Tang and Liu demonstrate
that the shape of a funnel plot is largely determined by
the arbitrary choice of the method to construct the plot
(39). When a different definition of precision and/or effect
measure was used, the conclusion about the shape of the
plot was altered in 37 (86 %) of the 43 meta-analyses with
an asymmetrical plot suggesting selection bias.
As stated before, Shang, et al., were not clear about the
aim of their analysis. The methodology of comparing ho-
meopathy with conventional trials matched on indication
was suited for comparison of quality. Comparing of effects
of subgroups was not allowed because the matching was
lost in forming subgroups.
The only valid conclusion of
this analysis is that quality of homeopathy trials is better
than of conventional trials, for all trials (p=0.03), but also
for smaller trials with n<100 (p=0.003).
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Another interesting finding from Shang,
et al.
, data was:
"Theeighttrialsofhomoeopathicremediesinacutein-
fections of the upper respiratory tract that were included
in our sample, the pooled effect indicated a substantial
benecialeffect(oddsratio0•36[95%CI0•26–0•50])
and there was neither convincing evidence of funnel-plot
asymmetry nor evidence that the effect differed between
the trial classified as of higher reported quality and the
remainingtrials".In1997,Lindestatedthat,"homeopathy
functionednotbetterthanplaceboinaspecicdisease".
Thus the original hypothesis that homeopathy as a meth-
od is a placebo effect was reformulated towards specific
indications. This hypothesis corresponds with systematic
conventional research. The advantage is less heteroge-
neity in the set of analyzed trials, but it disregards the
surplus value of homeopathy, see above (30). Compare
this surplus value with psychotherapy and Post Traumatic
Stress Disorder (PTSD) with symptoms like palpitations,
flashbacks, headache and insomnia. Psychotherapy gets
closer to the source of the disease than a combination of
beta-blockers, painkillers and tranquillizers. It would make
no sense to require RCT evidence that psychotherapy
works better than beta-blockers. Likewise the same ho-
meopathic medicine could cure headache, eczema and
herpes lips in the same patient. The real problem with
homeopathy was the implausibility. It makes no sense
to prove that homeopathy is plausible for one indication,
but not for another.
Nevertheless, there are a number of medical conditions
with proof for homeopathy: this is a solution to the prob-
lem of heterogeneity of medical conditions. Seventeen
systematic reviews or meta-analyses focused on RCTs of
homeopathy in 15 specific areas were performed: anxi-
ety, childhood diarrhea, chronic asthma, delayed-onset,
muscle soreness, dementia, depression, headache and
migraine, HIV/AIDS, induction of labor, influenza treat-
ment and prevention, osteoarthritis, post-operative ileus,
seasonal allergic rhinitis (hay fever) and vertigo.
This critical approach has been explained by Jonas,
Kaptchuk and Linde in 2003 (32). The level I of evi-
dence is reached for childhood diarrhea and seasonal
allergic rhinitis. Other meta-analysis showed this same
level for allergic rhinitis (40), post-operative ileus (41),
rheumatoid arthritis (42) and the protection from toxic
substances (43).
Level IIa of evidence is obtained for asthma (44), fi-
brositis (45), influenza (46), muscular pain (47), otitis
media (48), several pain sensations (49), side effects of
radiotherapy (50), strains (51) and infections of the ear,
nose and throat (52).
Level IIb of evidence is obtained in the treatment of
anxiety (53), hyperactivity disorders (54, 55), irritable
bowel (56), migraine (57), osteoarthritis of the knee
(58), premenstrual syndrome (59), pain associated with
unwanted post partum lactation (60), prevention of nau-
sea and vomiting during chemotherapy (61), septicemia
(62), post-tonsillectomy analgesia (63) and aphthous
ulcers (64).
The practical choice of a treatment for a specific patient is
only little helped by the RCT results; they are obtained in
“an ideal artificial situation” far from the personal context
of the patient. The homeopathic diagnosis is more than a
search to a disease; it is an approach including the whole
person, with the aim of an individualized and global treat-
ment. The method of evaluation has to be adapted to this
reality; today Bayes’ statistics authorize such research
(see further).
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New method for future systematic reviews of homeopathic publication (2012).
The above described Swiss Report was the first one that
tried to consider not only the scientific quality of a publica-
tion but considered also the respect of the homeopathic
medical approach. To allow this assessment in a sys-
tematic way, a group of researchers (ISCHI) elaborated
and tested a new method for appraising model validity of
randomized controlled trials of homeopathic treatment:
multi-rater concordance study. This method has been ac-
cepted for publication in 2012 in BioMedCentral Medical
Research and Methodology.
This paper describes a method for assessing the model
validity of RCTs of homeopathy. To date, only conventional
standards for assessing intrinsic bias (internal validity)
of trials have been invoked, with little recognition of the
special characteristics of homeopathy. They aimed to
identify relevant judgmental domains to use in assessing
the model validity of homeopathic treatment (MVHT).
We define MVHT as the extent to which a homeopathic
intervention and the main measure of its outcome, as
implemented in a randomized controlled trial (RCT),
reflect ‘state-of-the-art’ homeopathic practice.
To reach this goal they used an iterative process, within
an international group of experts. They developed a set
of six judgmental domains, with associated descriptive
criteria. The domains address: (I) the rationale for the
choice of the particular homeopathic intervention; (II)
the homeopathic principles reflected in the intervention;
(III) the extent of homeopathic practitioner input; (IV) the
nature of the main outcome measure; (V) the capability
of the main outcome measure to detect change; (VI)
the length of follow-up to the endpoint of the study. Six
papers reporting RCTs of homeopathy of varying design
were randomly selected from the literature. A standard
form was used to record each assessor’s independent
response per domain, using the optional verdicts ‘Yes’,
‘Unclear’, ‘No’. Concordance among the eight verdicts
per domain, across all six papers, was evaluated using
an appropriated statistical method. (65)
The six judgmental domains enabled MVHT to be as-
sessed with ‘fair’ to ‘almost perfect’ concordance in each
case. For the six RCTs examined, the method allowed
MVHT to be classified overall as ‘acceptable’ in three,
‘unclear’ in two, and ‘inadequate’ in one.
They concluded that future systematic reviews of RCTs
in homeopathy should adopt the MVHT method as part
of a complete appraisal of trial validity. This work is ongo-
ing now.
In the Journal Homeopathy (2013);102:3-24, Mathie, R.T.
& all published the next step. Looking at randomised con-
trolled trials of homeopathy in humans and characterising
the research journal literature available for systematic
review, they concluded that from the 489 available re-
cords, 226 needs to be rejected as non-journal, minor
or repeat publications, or lacking randomisation and/or
controls and/or a ‘homeopathic’ intervention. The 263
accepted journal papers will be the basis for a forthcom-
ing programme of systematic reviews.
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Advice of the Belgian Royal Academy of Medicine concerning conclusions
of “The Lancet” publication of Shang-Egger (66)
The best and most detailed critic of the Shang, et al.,
publication is a sensitivity analysis of obtained results and
conclusions from the selected clinical trials in the final
evaluation (67). If we consider the 21 trials of good quality,
OR became 0.76 with IC 95 % of 0.59-0.99 and p=0.039,
argument for a homeopathic efficacy significantly higher
than the placebo effect. Looking at the sensitivity of this
analysis, it appears that OR is significantly different of 1
for all combinations between 14 trials (n = threshold 69)
and the whole 21 trials (exception: the combination of 17
trials with n = threshold 50). However, in most of these
analyses, the funnel plot reveals a moderate (but non
significant) asymmetry (68). The results of predicted OR
values using the technique of meta-regression (normally
preferred in case of significant asymmetry) show values
near one, indicating a possible absence of significant dif-
ference between homeopathy and placebo. In addition,
this complementary analysis of the Shang publication
reveals an important heterogeneity between the clinical
trials (higher than 50 %, criteria making a meta-analyze
null and void). In this case it is recommended to use the
technique of meta-regression, see above, instead of a
meta-analysis for traditional random purpose (69). This
heterogeneity can have multiple reasons. One of these is
probably the kind of considered diseases or conditions.
A justified reproach can be done to Shang in the fact that
he retained in his analysis trials where homeopathy has
no demonstrated effect as “muscle soreness”, particularly
when one of the trial finally retained by Shang contribute
to increase considerably the heterogeneity of the sample.
If this “muscle soreness” trial is omitted in the analysis,
OR calculated on 7 trials (instead of 8) goes to 0.88/0.80
(even if this is still not significant: IC 0.61-1.05). However,
in a sensitive analysis, the difference became significant if
we consider 8 trials (rejecting muscle soreness, incorpo-
rating another trial on 80 people (0R = 0.75 IC O.58-0.96
p=0.025) or 6 trials with inclusion criteria of 100 people
(OR = 0.73 IC 0.59-0.91 p=0.005) instead of the 8 trials
selected by Shang (inclusion criteria 98 people). Con-
versely, the positive results with the 21 trials are mostly
related to the presence of two large trials on influenza. If
one of these two trials would be rejected, OR is no more
significantly different of one. Another consequence of this
important heterogeneity is the interpretation that can be
done to the funnel plot aimed to exclude small sized trials
(68). Indeed, rather than considering small sized trials as
more bias sensitive (and as such eliminated for the final
analysis), one alternative could be to consider these small
sized trials as more effective because they are performed
in condition where the effect of homeopathy is particularly
clear and as such an important cohort of people is not
needed to demonstrate this effect (67). If this is the case
(and this situation cannot be excluded
a priori
), it is clear
that the exclusion of small sized trials as Shang decided, is
a major bias in the final conclusion. The sensitive analysis
demonstrates clearly that the significance of the observed
superiority effect of homeopathy compared to placebo
depends, in a crucial way, on the number of trials taken
into account in the analysis.
All published meta-analyses of controlled clinical trials in
homeopathy are, more or less, subjects for critics and are
controversial (70). Admittedly the Shang, et al., analysis,
published in the Lancet is very critical and cannot, as
such, and, with it only, support the proposed final
conclusion:
“This finding is compatible with the notion
that the clinical effects of homeopathy are placebo ef-
fects. (
71). Nevertheless, the sensitive analysis of Lüdtke
et al., (67) is clear enough by concluding:
“Our results do
neither prove that homeopathic medicines are superior
to placebo nor do they prove the opposite”.
***
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But there is more, if we compare the matched conven-
tional and homeopathic RCT’s proposed by Shang (26)
and considering only the most common reason for using
For homeopathy, 9 out of 21 publications showed statis-
tically significant positive results, 2 negative, 4 were of
high quality.
Source: www.ispm.ch/fileadmin/doc_download/1431.Study_characteris-
tics_of_homeopathy_studies_corrected.pdf
For the conventional approaches, 11 out of 21 showed
statistically significant positive results, 3 negative, 3 were
of high quality.
Source: www.ispm.ch/fileadmin/doc_download/1431.Study_characteris-
tics_of_allopathy_studies_corrected.pdf
homeopathy (see Chapter III: the upper respiratory tract
infections) we can see that the efficacy of homeopathy
is at least equal to the conventional treatments’ efficacy.
Coming to the point, it is relevant to quote the conclu-
sions of R.T. Mathie published in the journal
Homeopathy
(Vol 92, Issue 2, April 2003, Pages 84-91) after a review
of the available literature he concluded:
“The available
research evidence emphasizes the need for much more
and better-directed research in homeopathy. A fresh
agenda of enquiry should consider beyond (but include)
the placebo-controlled trial. Each study should adopt
research methods and outcome measurements linked
to a question addressing the clinical significance of ho-
meopathy's effects.
Prospective comparison surveys between medical ap-
proaches would be promoted (non-inferiority trials) in
specific areas described further in this booklet. Random-
ized placebo-controlled trials are of course a reference
for “the best evidence” but respect of the individualized
homeopathic treatment and daily practice must always
be considered (a very difficult point considering the indi-
vidual approach in homeopathy).
Conclusion:
As such, we could conclude that more research is cer-
tainly needed considering the coherent beam of available
results in specific areas described further in this booklet.
All levels of evidence are needed.
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CHAPTER V
THE RESULTS OF THE ‘ECHO’-STUDIES
‘ECHO refers to surveys looking at Economic, Clinical and
Humanistic Outcomes.
In the literature more than 22 publications, using validated
scores concerning quality of live (QoL), are found to
evaluate the efficacy of homeopathic medicines. Twenty
eigth thousand five hundred and sixty four patients are
included in the different studies. A level IIIa of evidence
is obtained for all ECHO-studies (all diagnoses merged).
A first group of studies compares the QoL score before
and after the treatment. The control group is the group
itself before treatment. The improvements are statisti-
cally and clinically significant, for all merged diagnoses.
Some diagnoses were considered separately: asthma in
children, headache, cancer patients, anxiety and depres-
sion after stopping the estrogenic hormonal treatment
because of breast cancer, allergies, general problems,
intestinal disorders, anxiety disorder, depression and skin
problems. These are also the most common diagnoses
in general practice.
A second group uses an external control group treated
with conventional medicine. The results of these studies
show that the homeopathic treatment is just as efficient
as conventional medicine in general practice. Respiratory
problems, diabetic polyneuropathy, chronic problems in
the ear, nose and throat ar