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Understanding the
   Placebo Effect
                in
 Complementary
        Medicine
  Theory, Practice and Research
                                                _
The placebo elicits more passionate debate, scepticism     Cont.t.s
and personal belief than almost any other aspect of        (e(il Helman
medicine. As yet, there are no concrete answers - but      Edzard Ernst
many challenging observations and powerful effects         Gunver Kienle
occur daily in health care.                                Helmut Kiene
                                                           Angela dow
This book will stimulate and inform every reader - from
                                                           James Hawkins
the experienced practitioner to the new student - who
                                                           David Reilly
has ever asked, 'What is the placebo really, and why
                                                           Robert Withers
should it matter to me?' Written in an accessible and
                                                           Janet Rkhardsan
engaging style, with contributions from leading figures
                                                           Phil Latey
in health care, the book in particular tackles issues of
                                                           Stephen G Wright
the placebo effect in complementary medicine.
                                                           Jean Sayre-Adams
                                                           Anton J M de (raen
David Peters, MB, ChB, DRCOG, MFHom, MRO, is               Angela JEM Lampe-xhoenmae(kers
Clinical Director, The Centre for Community Care and       Jos Kleiinen
Primary Health, University of Westminster, London, UK      John Heron
                                                           Peter Fenwi(k
  /�\
.L.A        CHURCHill
            LIVINGSTONE
 UL
A Harcourt Health Sciences Company
      Harcourt                                                   ISBN 0-44 3-06031-2
                                                                  II
      Health Sciences
Visit our website for
additional outstanding products
www.harcourt-international.com                                9 7804             3 11
See inside for more information
Understanding the Placebo Effect in
Complementary Medicine
For Churchill Livingstone:
Publishing Manager: lnta Ozols
Project Development Manager: Katrina Mather
Project Manager: Derek Robertson
Desigl1 Direction: George Ajayi
Understanding the Placebo
Effect in Complementary
Medicine
Theory, Practice and Research
Edited by
David Peters        MB ChB DRCOG MFHom MRO
Clinical Director, The Centre for Community Care and Primary Health,
University of Westminster, London, UK
  /�\
.I�         CHURCHILL
            LIVINGSTONE
 :u
EDINBURGH LONDON NEW YORK PHILADELPHIA ST LOUIS SYDNEY TORONTO 2001
CHURCHILL LIVINGSTONE
An imprint of Harcourt Publishers limited
© Harcourt Publishers Limited 2001
b     is a registered trademark of Harcourt Publishers Limited
The right of David Peters to be identified as editor of this work has
been asserted by him in accordance with the Copyright, Designs and
Patents Ac11988
All rights reserved. No pari of this publication may be reproduced,
stored in a retrieval system, or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording or otherwise.
without either the prior permission of the publishers (Harcourt
Publishers Limited, 32 Jamestown Road, London NWl 7DY), or a
licence permitting restricted copying in the United Kingdom issued by
the Copyright Licensing Agency, 90 Tottenham Court Road, London
W1POLP.
First published 2001
ISB    0443060312
British library Cataloguing in Publication D ata
A catalogue record for this book is available from the British Library
library of Congress Cataloging in Publication Data
A catalog record for this book is available from the Librnry of
Congress
Note
Medical knowledge is constnntly changing. As new information
becomes available. changes in treMment, procedures, equipment and
the use of drugs become necessary. The editor, contributors and the
publishers have taken care to ensure that the information given in this
text is accurate and up to date. However, readers arc strongly advised
to confirm that the information, especially with regard to drug lIsage,
complies with the latest legislation and standards of practice.
                                                                                   Tho
                                                                                -.
                                                                              policy IS 10 1M
                                                                           paper mlnulactured
                                                                          from lustalnable lor""
Printed in China                                                                     I
        Contents
    Contributors         ix
    Preface        xi
    Section 1       Theory     1
        1. Placebos and nocebos: the cultural construction of belief          3
           Cecil G. Helman
        2. Towards a scientific understanding of placebo effects        17
           Edzard Ernst
        3. A critical reanalysis of the concept, magnitude and existence of placebo
           effects    31
           Gunver S. Kienle and Helmut Kiene
        4.   Behavioural conditioning of the immune system        51
             Angela Clow
    Section 2       Practice    67
        5. How can we optimize non-specific effects?        69
           James Hawkins
    , 6. Some reflections on creating therapeutic consultations          89
         David Reilly
    •   7. Psychoanalysis, complementary medicine and the placebo                 111
           Robert Withers
        8. Intersubjectivity and the therapeutic relationship     131
           Janet Richardson
    • 9. Placebo responses in bodywork           147
         Phil Latey
•   10. Healing and T herapeutic Touch: is it all in the mind?          165
        Stephen G. Wright and Jean Sayre-Adams
    Section 3       Research       177
    11.      Non-specific factors in randomized clinical trials: some methodological
             considerations    179
             Anton f. M. de Craen, AngeLa J. E. M. Lampe-Schoenmaeckers and Jos KLeijnen
                                                                                        vii
     viii   CONTENTS
u   12. The placebo effect and a participatory world view   189
        John Heron
    Epilogue         213
    13. Psychoneuroimmunology: the mind-brain connection          215
        Peter Fenwick
    Index      227
Contributors
Angela Clow PhD
Senior Lecturer, Department of Psychology,
University of Westminster, London, UK
Anton J M de Craen PhD
Clinical Epidemiologist, Department of Clinical Epidemiology,
Leiden University Medical Centre, The Netherlands
Edzard Ernst MD PhD
Director, Department of Complementary Medicine,
University of Exeter, Exeter, UK
Peter Fenwick MB BChir (Cantab) DPM FRCPsych
Consultant Neuropsychiatrist Emeritus, Maudsley Hospital, London, UK
James Hawkins MB BChir (Cantab)
Independent Specialist, Edinburgh, UK
Cecil G Helman MB ChB MRCGP DipSocAnthrop
Associate Professor, Department of Human Sciences,
BruneI University, Uxbridge, UK;
Senior Lecturer, Department of Primary Care and Population Sciences,
Royal Free and University College Medical School, London, UK
John Heron BA
Director, South Pacific Centre for Human Inquiry,
Auckland, New Zealand
Dr med Helmut Keine
Institut fur angewandte Erkenntnistheorie and medizinische
Methodologie, Bad Krozingen, Germany
Dr med Gunver S Kienle
Institut fur angewandte Erkenntnistheorie and medizinische
Methodologie, Bad Krozingen, Germany
                                                                       ix
 x   CONTRIBUTORS
Jos Kleijen MD PhD
Professor and Director, NHS Centre for Reviews and Dissemination,
University of York, York, UK
Phil Latey DO
Private Practitioner and Lecturer, Sydney, Australia
Angela J E M Lampe-Schoenmaeckers     MD
Anesthesiologist, Department of Anesthesiology, Academic Medical
Centre, University of Amsterdam, Amsterdam, The Netherlands
David Reilly FRCP MRCGP FFHom
Consultant Physician, Glasgow Homoeopathic Hospital, Glasgow, UK;
Honorary Senior Lecturer in Medicine, University of Glasgow,
Glasgow, UK
Janet Richardson   PhD BSc RN DipDN PGCE RNT
Director of Integrated Health Development, School of Health Care,
Oxford Brookes University, Oxford, UK
Jean Sayre-Adams RN    MA RPTT
Director, The Sacred Space Foundation, Cumbria, UK
Robert Withers   MPhil BAc RSHom
Private Practitioner; Senior Lecturer, University of Westminster,
London, UK
Stephen G Wright MSc RN RNT DipN DANS RPTT FRCN MBE
Associate Professor, Faculty of Health, St Martin's College, Lancaster, UK;
Chairman, The Scared Space Foundation, Cumbria, UK;
Preface
Complementary practitioners promote the idea that their methods some
how 'switch on' self-organising processes. One of complementary and
alternative medicine's most intriguing implications for mainstream health
care is that doctors should re-integrate this aspect of the healing task; that
we must not only confront established pathology but also learn how better
to catalyse the process of healing. As practitioners we prefer to think we are
effective: why else would we be practitioners? But therein lie several poten
tial problems: firstly, because we might be less effective than we like to
think; and secondly, that therefore it will be difficult to reflect honestly on
our effectiveness. In the search to become more effective some practitioners
aim for ever more technical expertise, but to what extent is our therapeutic
effectiveness determined by our humanity and presence rather than tech
nical knowledge and our skill as a therapist? How much of a treatment's
effect is due the patients own response and resilience? Would it be demean
ing if we as practitioners had to accept that a great deal of recovery
depends on responses we trigger and, that as practitioners we have to
persuade, rather than force recovery?
   In everyday speech, a placebo is a fake treatment, something given to
please the patient. How strange then that placebo effects should be so
strong; so consistent that experimental studies must be intricately designed
to avoid them, so great is their influence on treatment outcomes. Modern
clinical trials aim to bracket off all human variables and bias by using
randomisation and blinding, for only when they achieve this, can small
differences in outcome between experimental group and control group be
attributed to the treatment alone. Yet the fact that around 60% of contrgl
groups tend to improve forces us to ask what the personal and inter
personal factors that so profoundly affect outcomes might be; and how we
should make better use of them. There are important issues here: why are
'fake' treatments so effective and so hard to distinguish from 'real' ones;
what ought we to make of the insidious implication that personal and
inter-personal elements are not part of proper practice? Since they include
resilience, natural remission and the effect of a good practitioner-client rela
tionship - all desirable aspects of good medicine - these 'human factors'
                                                                              xi
 xii   PREFACE
ought surely to be understood and maximised rather than excluded. In
reality, of course, these elements are an inseparable part of practice, for we
do not work in a vacuum and the art of communication has its proper place
in all professional life. Over-reliance on technique and an inability to
engage humanly is arguably a sign of practitioner boredom, burn-out and
depression.
   The placebo response focuses our mind on health care as a skilled
human activity, so it is of particular interest to those of us whose clinical
work involves skilled use of hands, heart or language. In fact, complemen
tary therapies and psychotherapies have proven very hard to fit into the
framework of randomised controlled trials; so has family medicine. I
believe the insinuation that they are therefore unscientific and that hard
science alone should be a basis for proper practice has harmed health care
by diminishing the 'art of medicine'. The over-emphasis on technical effec
tiveness has also sidelined medicine's interest in our innate capacity for
natural recovery and made us all less curious about how to support them.
Lately, however, because medical technology has met with only limited
success in treating epidemic chronic degenerative diseases, the question of
how to catalyse resilience has come to the fore.
   In the 1970s, when George Engel made his famous challenge to biomed
icine and set out a framework for a bio-psycho-social model, these
bio-psychological pathways were still ill-defined. Nowadays psycho
physiology has better maps and it is widely acknowledged that
psycho-social pressures are met by physiological and potentially patho
physiological changes; we can cite clear examples of beneficial psycho
somatic effects. Obviously then human factors do have a powerful
influence on health, health care and all treatments. So, to dismiss this as
mere placebo response and at best the result of pious fraud is no longer
satisfactory. Any practitioner who thinks about her work will rightly feel
some uncertainty about how her presence and personality as well as the
treatments she gives, affects her patients. But by mixing up and confusing
these and other influences, the concept of placebo effect may well have
undermined our confidence in humane practice and quite possibly made it
more difficult.
   With these questions in mind a conference was held at the University of
Westminster in collaboration with the Scientific and Medical Network in
September 1997. This book builds on some leading thoughts presented
there. The conference brought practitioners and researchers together
around the theme of self-healing responses and the keynote address was
given by Professor Herbert Benson, whose Timeless healing: the power and
biology of belief (Benson & Stark 1996), had been published just before the
conference. Our own book is one ripple in the wave of renewed interest
Benson's book heralded. Important contributions to our understanding
made since include books by Harrington (1997) and by Dixon and Sweeney
                                                              PREFACE   xiii
(2000) The Harrington book arose out of a fascinating Harvard Conference
in 1994 and it updates in important ways the key work on placebo
response, the ground-breaking book Placebo-theory research and mechanisms
(White et al 1985). Dixon and Sweeney's book (2000) has set out to rehabil
itate and re-value human and contextual factors, warning against the
dangers of losing them from clinical practice. We hope our collection of
accounts from practice will complement these works.
   This book is for practitioners who want to think about the balance
between technique and relationship in their own work. Our authors offer
theoretical frameworks from psychology, psycho-immunology and anthro
pology, but there can be no single explanation or final word written on this
topic. For, given the great array of influences on treatment outcomes, a
single general theory of health and healing would be impossible to achieve.
Nor would it be desirable. Alongside various theoretical perspectives you
will find here chapters by practitioners with diverse clinical perspectives
who have thought about how non-technical factors (being with, rather than
doing to patients) influence their own practice. These are highly experi
enced voices: at times highly subjective, idiosyncratic and convinced. Any
authority they carry depends on their authenticity, and these accounts are
presented here as reflective work-in-progress. They are an attempt to share
the maps and imaginations practitioners use to make sense of their experi
ence of what happens in the space between themselves and their clients. As
such they are about belief and being, rather than fact. We expect them to be
wondered about, questioned and criticised by colleagues, with the aim of
reaching beyond out current understanding of the inter-subjective world
and how it might influence healing outcomes.
   The human self-healing response is a realm where the boundaries
between subjective mind and objective body blur and fade. How could we
learn to use it wisely and well? Our authors offer some ideas about this.
How might we, as practitioners and scientists, reflect on this elusive capac
ity for self-healing and our role in it as therapists? Two very different
approaches to research are discussed: one experimental and searching for
objectivity, the other qualitative and searching for a rigorous subjectivity.
No doubt both these approaches and more too, will be needed as we unfold
a new science of health.
   Lydia Temoshok (1986) has compared the term 'placebo' to a theory
used by 18th century chemists, who, before oxidation was understood,
postulated a burning substance loses 'phlogiston'. Because the notion
appeared to fit some of the facts, it delayed the discovery of oxygen and the
acceptance of the true explanation - oxidation. Similarly, the placebo
concept hides our ignorance and perpetuates partial truths about clinical
work and outcomes while at the same time obscuring a better understand
ing. Is the placebo response our phlogiston? Will it disappear from our
language once we have a real grasp of the therapeutic relationship and
 xiv     PREFACE
mind-body interactions? We hope this book casts some light on these
questions and inspires practitioners to reflect on their own and their clients'
humanity and the extra-ordinary human capacity for self-healing.
London, 2001                                                                  David Peters
REFERENCES
Benson H, Stark M   1996 Timeless healing: the power and biology of belief. Scribner, New
  York
Dixon M, Sweeney K     2000 The human effect in medicine: theory, research and practice.
  Radcliffe Medical Press, Oxford
Harrington A (ed)   1997 The placebo effect: an interdisciplinary exploration. Harvard
  University Press, Cambridge, MA
Temoshok  L 1986 Review of Placebo - theory, research and mechanisms. Advances in
  Mind-Body Medicine   3(1): 71-73
White L, Tursky B, Schwartz G (eds) 1985 Placebo - theory, research and mechanisms.
  Guilford Press, New York
                                                     SECTION 1
                                                     Theory
SECTION CONTENTS
1. Placebos and nocebos: the cultural
   construction of belief 3
   Cecil G. Helman
2. Towards a scientific understanding of placebo
   effects 17
   Edzard Ernst
3. A critical reanalysis of the concept, magnitude
   and existence of placebo effects 31
   Gunver S. Kienle and Helmut Kiene
4. Behavioural conditioning of the immune
  system 51
  Angela Clow
THIS PAGE INTENTIONALLY
       LEFT BLANK
Placebos and nocebos: the cultural
construction of belief
Cecil G. Helman
 The role of context in placebo and        Cultural differences
   nocebo phenomenona                      The psychoanalyst
                                           Anton Mesmer
 The 'total drug effect'
                                         The macrocontext of Western medicine
 The context of ritual healing
                                         The cultural construction of belief
 Contexts of ritual healing: some
   examples                              The nocebo effect
   Traditional healers
   Western medicine                      Conclusion
Editor's note
Cecil Helman's book 'Culture, health and illness' made me aware that
our 'obvious' ways of doing medicine actually depend on a hidden
world view, a framework of unexamined assumptions that holds our
thinking in place. When looked at through the anthropologist's eye,
many deeply rooted certainties (including mind-body dualism and a
bias towards reductionism) can be seen for what they are: beliefs. I
wanted Heilman's anthropological gaze to liberate us from the notion
of real and unreal elements in treatment. One wrong assumption we
make is that placebos are 'things' that fool us into feeling better. In this
chapter he persuades us that the greater part of any treatment
outcome has to do with factors that are anything but biological. Even
apparently unequivocal clinical facts actually depend on culture and
custom; in fact, even within the practice of conventional medicine in
Europe, diagnoses, treatments and symptom patterns vary from nation
to nation. He helps us see that the way we think about health and
healthcare is culture bound-making it obvious for instance that, at a
time when beliefs and social relationships are changing, people will
seek out new ways of putting together their healing encounters, and
making it seem less strange that effectiveness and beliefs should be so
intricately bound together. Hellman not only gives us a framework for
asking how and why complementary therapies have taken such a hord,
but also calls into question whether treatment, relationships and
outcomes can ever be fully understood if plucked out of their cultural
landscape.
                                                                                3
 4   THEORY
There are many different ways of understanding the placebo effect: this
chapter deals with some of the perspectives of social anthropology.
Anthropology is the study, and comparison, of different human groups,
societies and cultures-particularly of their social organization, beliefs and
behaviours. An editorial in the British Medical Journal (Editorial 1980) has
called it 'the most scientific of the humanities and the most humane of the
sciences'. One recent branch of social anthropology, medical anthropology, is
the study of how people in different cultural and social groups explain the
causes of ill health, the types of treatment they believe in and the people
and institutions to whom they turn if they do get ill. It is also concerned
with how these health-related beliefs and behaviours relate to physical,
psychological and social changes in the human organism, in both health
and disease (Helman 2000).
THE ROLE OF CONTEXT IN PLACEBO AND NOCEBO
PHENOMENONA
The concepts of medical anthropology are particularly relevant to under
standing the role of context in the placebo and nocebo phenomena-that is,
the extent to which both are influenced by the social, cultural, economic
and physical environment in which they appear. Of key importance are
the mechanisms by which certain human groups-whether societies or
cultural groups-create, reinforce and maintain the belief system that
underlies these phenomena.
   To the anthropologist, placebos and nocebos are always, to some extent,
culture bound, for they do not exist in a vacuum. Their effects always
depend, to some degree, on the wider context of cultural beliefs, values,
expectations, assumptions and norms as well as on certain social and
economic realities in which they occur. All of these help to create belief
in the placebo in the first place: validating both its healing power and that
of the person who actually administers it. This implies, therefore, that
placebos that work in one cultural group may not necessarily have the
same effect in another.
THE 'TOTAL DRUG EFFECT'
One model developed by Claridge (1970) in psychopharmacology provides
a useful way of conceptualizing some aspects of the placebo effect. He
suggested the concept of the 'total drug effect' whereby the overall effect of
a drug on an individual usually depends on a number of different factors
in addition to (or separate from) its pharmacological action. These are
the attributes of: (1) the drug itself (such as its colour, shape, form, brand
name and price), (2) the prescriber (such as attitude, beliefs, self-confidence,
air of authority and clothing), (3) the recipient (such as psychological state,
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IV
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Sommer simulacrum
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