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Focus on Alternative and

Complementary Therapies
Volume 17(1) March 2012 e3–e8
© 2011 The Authors
FACT © 2011
Royal Pharmaceutical Society
ISSN 1465-3573

䊏 Lewith GT, Jonas WB, Walach H (Eds). Clinical includes the suggestion that sometimes ‘. . . modern
Research in Complementary Therapies: Principles, findings discredit received wisdoms and these should
Problems and Solutions (2nd edn) be adjusted or discarded’ (p. 167), but it does not
identify any particular botanical product that should
Edinburgh: Churchill Livingstone, 2011. 426 pages. be discarded as medicine. The book gives clinical
£37.99 (paperback). researchers little reason or guidance to ever stop
ISBN 9780443069567 declaring that more research is needed for methods
Reviewed by WM London, California State University, Los represented as ‘CAM’. A not-so implicit theme of
Angeles, USA CRCT is that ‘CAM’ methods are too complex, intri-
cate, safe and/or popular to discard.
The foreword to the second edition of Clinical Never mind that many surveys of public interest in
Research in Complementary Therapies (CRCT) was these areas (cited in CRCT) have had results conflated
written by Harold C Sox. As editor of Annals of Inter- and inflated by the inclusion of exercise, meditation
nal Medicine between 2001 and 2009, Dr Sox fre- and other personal lifestyle practices labelled as CAM
quently published papers promoting CAM as if it was or unconventional.1 Never mind that it is likely that
a meaningful category of medical practice; also sug- much of the public’s interest in these areas is attrib-
gesting that it was an important focus area for utable to marketing efforts of people and companies
medical education. But in his foreword to CRCT, Dr offering nostrums promoted as CAM, and to favour-
Sox predicts that the application of the same high able publicity given to optimistic researchers who
standards of research to all kinds of treatments will investigate hypothesised causal connections that
lead to the extinction of the term CAM, and to have a small probability of being real. Media atten-
the replacement of the CAM–conventional medicine tion given to efforts to clinically evaluate so-called
dichotomy with the ‘more universal distinction CAM methods that sensible people recognise as non-
between proven and unproven therapies’ (p. xi). Dr sense gives ‘CAM’ a veneer of respectability. And
Sox must not have noticed that CRCT is a book that: never mind that the scientific community appropri-
(1) enthusiastically promotes the use of the term and ately disregards treatments with farfetched ration-
concept of ‘CAM’; (2) emphasises the supposedly ales, especially when clinical research findings are
special nature of ‘complementary’ modalities; and frequently inconclusive and favourable reports pre-
(3) suggests special considerations to address in dominantly come from proponents.
studying these modalities. The authors of the chapter The apparent raison d’etre of CRCT may best be
on laboratory research and biomarkers take a very summarised in this statement, remarkably placed in a
different view from Dr Sox, stating that ‘although it is chapter titled ‘Toward standards of evidence for CAM
easy to recommend that CAM be held to the same research and practice’:
standards as conventional basic science, the com-
plexity and intricacies of CAM, as reported in the ‘Finally, when exploring theories and data that do
White House Commission on CAM Policy, remain not fit into current assumptions about causality (e.g.
understated’ (p. 90). energy healing or homeopathy), a carefully thought-
Some authors of CRCT acknowledge that various out basic science strategy is needed. Given the public
‘complementary’ therapies are unsupported by clini- interest and the implications for science of these
cal research (i.e. unproven or non-validated) for areas, it is irresponsible for the scientific community
various intended purposes. However, these authors to ignore them completely.’ (p. 29)
avoid declaring treatments as disproved (i.e. invali-
dated) for any intended purpose, no matter how But apparently the message is that it is responsible
implausible the rationale might be for the treatment. to dismiss the laws of chemistry and physics as
The chapter in CRCT on research in herbal medicine merely current assumptions about causality.

e4 Focus on Alternative and Complementary Therapies March 2012 17(1)

Devoting clinical research resources to investigat- medications” but in themselves complex whole
ing energy healing and homeopathy makes about as systems of diagnosis and treatment.’ (Editors’ preface,
much sense as supporting research and development p. xiii) ‘. . . CAM research also requires evaluation of
for perpetual-motion machines. Recruiting human “model validity”, which assess the likelihood that the
beings as research participants so that the efficacy of research has adequately addressed the unique theory
dubious treatments can be investigated, especially and therapeutic context of the CAM system being
when government funds are allocated for such evaluated’ (p. 23).
purposes, has been challenged on ethical grounds.2
However, the book makes no attempt to ethically Comment
justify research to test on human beings treatments The claimed importance of whole systems and model
of implausible value. Unlike other recent clinical validity is contradicted in the chapter on mind-body
research textbooks, CRCT lacks even one chapter on medicine, which emphasises the relaxation response
clinical research ethics. (RR) as the key common element among diverse
Three sentences on one page are devoted to the approaches and points out that ‘. . . it is not neces-
ethical consideration of informed consent. No expla- sary to adopt a specific theoretical approach or a
nation is given on how to ensure informed consent particular religious orientation to achieve the RR’ (p.
in properly disclosing the benefits that research 282). Why should research be conducted to validate
participants or others can reasonably expect from whole systems composed of traditions that developed
homeopathic or energy healing treatment. Neverthe- from pre-scientific or non-scientific thinking? Such
less, CRCT encourages outcome research on such traditions were supposedly started by people who
interventions. were oblivious to the need for careful precautions
In the entire book of more than 400 pages of text, against self-deception, misperception and supersti-
ethics is mentioned on one page discussing the use of tion. Traditional systems for healing that get recogn-
placebo controls in RCTs and in two pages of a ised as CAM are often based upon folklore and
chapter focused on promoting research on prayer and cultism. Traditionalism means resistance to change
distant healing. The latter chapter illustrates that it is and adherence to conventional thinking, relying on
difficult to imagine an intervention labelled as a type custom rather than standards that reflect scientific
of CAM that is too absurd for proponents to recom- evidence.
mend as worthy of clinical testing. The authors of the The CAM–conventional dichotomy discussed by Dr
chapter cite the US NIH Panel Report on CAM Sox should be recognised as a false dichotomy, since
Research Methodology, stating it has the following one connotation of conventional is reliance on what
underlying assumptions: ‘research is always feasible – is customary, rather than what is evidence-based. The
and essential, regardless of the therapy under consid- adherence to convention in whole systems labelled as
eration’ and ‘research rarely provides unequivocal CAM reflects orthodoxy and resistance to the icono-
answers.’In other words, research is usually pointless clasm of scientific progress. We have no more reason
but we need to do more of it. Before the publication to continue with research on homeopathy as a whole
of the first edition of CRCT, the chapter’s lead author, system than we have for conducting research based
the late Elisabeth Targ, coauthored a paper on a upon phlogiston, spontaneous generation, miasma
double-blind study of prayer, which had been pub- and other obsolete theories.
lished without first revealing to reviewers that allo- For the most complex systems of healing mentioned
cation concealment had been compromised and that in CRCT, it is reasonable to doubt that diverse practi-
endpoints had been selected post-hoc.3 Unfortunately, tioners of each supposed system are able to apply the
CRCT neglects to emphasise the need to avoid such systems consistently. It is not clear that ‘model integ-
unethical researcher conduct. Conspicuously absent rity’ is preserved in practice or that ensuring ‘model
is any mention of Daniel Wirth, who apparently integrity’ in clinical research is both feasible and likely
fabricated evidence in his prominently publicised to be fruitful. The book fails to question whether all
distant-healing research.4 facets of multifaceted ‘CAM’ interventions are needed
to optimise outcomes. This includes a lack of
expressed interest by the authors concerning whether
Recurring points traditionalist practitioners, such as herbalists, who
Some key points, recurring in different CRCT chap- individualise treatments really know what they are
ters, were as follows (each summarised and followed doing when they concoct novel mixtures uniquely
by comments): tailored for each individual patient.

Key point two

Key point one Viable alternatives to the hierarchical understanding
‘. . . the range of complementary and alternative of evidence in evidence-based practice are available
medicines (CAM) on offer are not simply “alternative and necessary for evaluating ‘CAM’ interventions.
Book Reviews e5

Comment example, RCTs for primary and secondary prevention

The modern evidence-based practice movement have shown that recommendations based upon
emphasises a hierarchical view of clinical study types, observational study findings for consumers to take
ranging from the least rigorous (e.g. anecdotal antioxidant vitamin supplements (often described as
reports) to the most rigorous (e.g. RCTs); topped off CAM) are misguided.5
with systematic reviews and meta-analyses. The The real problem with the hierarchy of clinical
authors of the text concede that RCTs are appropriate evidence is that it gives no consideration to the bio-
for establishing internal validity, which refers to posi- logical plausibility of claimed intervention effects.
tive findings in a trial being attributable to the test It is extraordinary to claim that interventions of
intervention. However, the authors suggest that RCTs implausible value can have important therapeutic
lack external validity (generalisability) and do not effects. The evidence to support an extraordinary
adequately answer the questions that clinicians and claim should be extraordinarily persuasive. When
patients have about ‘CAM’ interventions. there is a high Bayesian (prior) probability of an inter-
Thus, CRCT offers several alternative (non- vention being clinically effective, the supportive evi-
hierarchical) models to demonstrate how a variety of dence need not be so extraordinary. Thus, when Dr
study types could be useful in aiding decision- Sox calls for the same standards of evidence for
making. For example, so-called pragmatic studies ‘CAM’ as for other health care, he lets preposterous
with flexible inclusion and exclusion criteria, which methods promoted as CAM off easy.
may involve comparing standard treatment with and
without ‘CAM’ treatment, are encouraged even Key point three
though CRCT authors acknowledge that such a ‘Outcomes that are objective and easy to measure, or
design does not establish the superiority of ‘CAM’ well known, are often selected instead of more diffi-
treatment to placebo. The supposed advantage of cult patient-oriented, subjective outcomes, though
pragmatic studies is their superior external validity. the latter may be more relevant.’ (p. 31)
The authors do not make it clear how findings of
studies that suffer from lack of control for confound- Comment
ing can be informative to practitioners who follow Thus, the first chapter in CRCT on research method-
the research literature and who are concerned about ology focuses on qualitative methods, which the
a patient population not included in the research. It chapter explains:
is already well known that providing additional
attention to patients is likely to produce favourable ‘are based on a constructivist . . . paradigm which is
subjective outcomes. It is not at all clear that, in order closely aligned with the ontological assumption of
to produce desirable non-specific effects, artful care relativism. Those who adopt this paradigm generally
needs to be rooted in the kind of ‘CAM’-style mysti- reject the idea that there is an intrinsic reality that
cism that has been the focus of pragmatic studies. one can “find” or “know” ’ (pp. 44–5).
When a treatment has been shown to be beneficial
for an intended purpose under the ideal conditions The authors of that chapter also suggest that quali-
that can be established in an RCT, it is said to be tative methods are ‘the most appropriate approach
‘efficacious’. In contrast, treatment that works well in to understanding . . . why and how complex CAM
real-world healthcare settings is said to be ‘effective’. interventions work’ (p. 44). It might seem that under-
The problem is that, outside of a clinical trial, condi- lying this view is some presumption that ‘CAM’
tions are typically less conducive to producing methods work, at least in producing favourable sub-
favourable results, not more conducive. Thus, treat- jective outcomes, if not favourable objective out-
ments that have been shown to be efficacious in the comes. But if the suggestion is that there is no intrinsic
nearly ideal conditions of an RCT may not be effec- reality, such a presumption may be an illusion.
tive in the real world. None of the chapters presents If subjective outcomes really are the key for ‘CAM’,
a persuasive case that CAM treatments are unique in perhaps the discussions of appropriate research meth-
that they can be more optimally delivered in real- odology throughout the book are beside the point.
world settings than in more tightly controlled set- Charlton has suggested that ‘Alternative medicine
tings of RCTs. will survive and grow most effectively by dropping
In an otherwise instructive chapter on systematic its scientific pretensions and becoming candidly
reviews and meta-analyses, Klaus Linde and Ian D mythic, poetic, fictive, symbolic, metaphorical and
Coulter express support for high quality observa- fantasy-based.’6 But the problem with this suggestion
tional studies and note that some studies have found is that real people in the real world have real, objec-
similar results for treatments in both RCTs and obser- tively recognisable health problems that some prac-
vational studies. But they do not offer examples of titioners really do treat with fantasy-based ‘CAM’
interventions recommended on the basis of observa- methods that supposedly produce objective out-
tional studies that later fared poorly in RCTs. For comes that are favourable – and real.
e6 Focus on Alternative and Complementary Therapies March 2012 17(1)

Key point four Special issues in establishing CAM research quality,

The non-specific effects of treatment with ‘CAM’ and III Applying research standards in CAM. None of
interventions are not easily separated from specific the chapters focuses on research methods or findings
effects, and they do not need to be when caring for regarding the many bizarre methods of disease
patients. screening and diagnosis promoted in the health mar-
ketplace as types of ‘CAM’. Including an honest
appraisal of relevant studies of screening and diag-
Comment nostic methods would not have reflected well on the
This is part of the rationale offered in CRCT in ‘CAM’ movement.8 Prognostic issues and primary
support of pragmatic real-world investigations. Thus, prevention are also largely neglected.
the argument is that even if a ‘CAM’ method fares The most useful chapters for aspiring researchers
poorly in an RCT (and the suggestion is that this may are in the first and third section. With minor editing,
occur because of the complexity of whole-system care several of these chapters could be enlightening com-
offered in ‘CAM’ methods), it might still be of benefit ponents of any textbook on clinical research and not
because ‘CAM’ acts as a good placebo: just one with a focus on ‘CAM’. For example, the
chapter on ‘Questionnaires – development, valida-
‘Instead of considering the placebo effect as of sec- tion, usage’ by Walach, Kohls and Guthlin is a clear,
ondary importance, it might be more apt to consider concise and useful introduction to relevant concep-
the placebo effect as contextual healing, an aspect tual foundations, practical solutions and practical
of healing that has been produced, activated, or issues. The chapter is mostly free of undefined tech-
enhanced by the context of the clinical encounter nical terminology, with the exception of the four-
that maximizes contextual healing, including the page section on factor analysis. The chapter on
environment of the clinical setting, cognitive and ‘Randomized controlled trials’ by Witt and Lewith is
affective communication of practitioners and the readable, substantive, and promotes scientific rigor –
ritual of administering the treatment.’ (p. 66) with the exception of its short section on pragmatic
A chapter on the placebo effect defines the effect in The chapter on ‘Inspiration and perspiration’ by
terms of ‘the meaning of a therapeutic intervention Vickers is a gem. Vickers explains important details to
for a particular patient and context’ (p. 314). The address in carrying out a study properly, including:
chapter is predominantly about eliciting outcomes research question, protocol, research team, study
that rely on self-report such as analgesia. It does not manual, management, data and patients. He shows
establish that the placebo effect is strong, consis- how difficult it is to carry out a study properly.
tently evoked and relevant to objective outcomes. Anyone who is interested in a career in clinical
Although possible physiological mechanisms mediat- research would do well to read the chapter.
ing placebo effects are discussed, social and psycho- Since a study can easily go wrong in many ways, we
logical processes that lead people to make favourable have good reason to be skeptical about extraordinary
statements in specific contexts are neglected. The research findings, especially when researchers have
authors of the chapter claim that ‘. . . there is strong strong ideological commitments. Vickers offers the
evidence against the notion that placebo effects are most important message in the book: ‘Research has to
nothing but response bias’ (p. 321), but they do not be done properly, or not at all’ (p. 311).
attempt to examine how important response bias is,
how social and psychological factors influence a
patient’s self-report, and how difficult it is to distin- References
guish apparent physiologically-mediated placebo 1 London WM. Statement to the White House Commission
effects from distorted reporting. Vulnerabilities of on Complementary and Alternative Medicine Policy. [online
patients to errors in memory, misperception and self- document] Washington, DC: Academy of Educational
deception are well established.7 People who submit Development, May 15 2001 (revised September 8,
to farfetched medical treatments, especially when 2001) <>
offered by a charismatic provider or at significant accessed May 2011.
opportunity cost, may be inclined to talk themselves 2 Atwood K. The ongoing problem with the National
into believing that the treatment works and report Center for Complementary and Alternative Medicine.
that they have been helped, but this is not considered Skeptical Inquirer 2003; 27: 23–9.
in CRCT. 3 Bronson P. A prayer before dying. Wired [online]
2002; 10. <
prayer.html> accessed April 2011.
Concluding remarks 4 Solfvin J, Leskowitz E, Benor DJ. Questions concerning
The 20 chapters of the book are organised into three the work of Daniel P. Wirth. J Altern Complement Med
sections: I Standards of quality in CAM research; II 2005; 11: 949–50.
Book Reviews e7

5 Bjelakovic G, Nikolova D, Gluud LL et al. Mortality in On the whole, the new strategic plan looks reason-
randomized trials of antioxidant supplements for able. I am slightly concerned that safety aspects do
primary and secondary prevention: systematic review not feature more prominently. In my view, the risks
and meta-analysis. J Am Med Assoc 2007; 297: 842–57. of CAM remain under-researched and are the most
6 Charlton B. Healing but not curing: Alternative medical important aspect for future CAM research. Any strat-
therapies as valid new age spiritual practices. In: Ernst E egy that fails to realise this could be biased or flawed.
(Ed). Healing, Hype, or Harm? A Critical Analysis of One also has to be clear that the proof of the pudding
Complementary or Alternative Medicine. Exeter: Societas is in the eating; thus, we will have to see how the
Imprint Academic, 2008. pp. 68–77. plan is translated into action. On paper, the plan
7 Tavris C, Aronson E. Mistakes Were Made (but Not by Me): appears to be reasonable, so let us hope that the next
Why We Justify Foolish Beliefs, Bad Decisions, and Hurtful
few years will show that the plan has led to wise
Acts. Orlando, FL: Harcourt, 2007.
8 Barrett S, London W, Baratz R, Kroger M. Consumer
Health: A Guide to Intelligent Decisions, 8th edn. New References
York: McGraw-Hill, 2007. 1 Ernst E, Posadzki P. An independent review of NCCAM-
funded studies of chiropractic. Clin Rheumatol 2011; 30:
䊏 National Center for Complementary and Alterna- 2 Ernst E, Hung SK, Clement YN. NCCAM-funded RCTs of
tive Medicine. Exploring the Science of Comple- herbal medicines: an important critical assessment. Per-
mentary and Alternative Medicine: Third Strategic fusion 2011; 24: 89–102.
Plan, 2011–2015
Bethesda, MA: National Institutes of Health, National
Center for Complementary and Alternative Medi- 䊏 Kolasinski SL (Ed). Complimentary and Alternative
cine, 2011. 60 pages. NIH Publication no. 11–7643 Medicine in Rheumatology.

Reviewed by E Ernst, Exeter, UK Philadelphia: Saunders/Elsevier, 2011. 152 pages.

£70.99 (hardback).
The mission of the US National Center for Comple- ISBN 978-1455705023
mentary and Alternative Medicine (NCCAM) is ‘to
define, through rigorous scientific investigation, the Reviewed by E Ernst, Exeter, UK
usefulness and safety’ of CAM. This sounds reason- Many survey data show that patients try complemen-
able, but is it? Why use words like ‘define’ and ‘use- tary and alternative medicine (CAM) for rheumatic
fulness’? Why not use standard terminology, such as diseases more frequently than for any other condi-
‘test the efficacy and safety . . .’? Such seemingly tion. This fact clearly justifies the attempt to look at
minor or trivial deviations from the norm have long CAM from a rheumatic perspective. This is what this
attracted criticism. Many US scientists now feel that special issue is all about. It is written by multiple
after spending more than US$100 million annually (mostly US) authors; hence, the text suffers from a
for more than a decade, NCCAM has demonstrated degree of heterogeneity. Most of the articles are
that it is not up to the task. We have recently shown authoritative and informative. Noteworthy articles
that much of the research sponsored by NCCAM is are on tai chi, yoga, meditation, fish oil, herbal medi-
seriously flawed.1,2 In the light of such arguments, a cine, glucosamine/chondroitin and diet. Apart from
new ‘Strategic Plan’, as provided in this document, is the embarrassing spelling mistake in the title of the
probably necessary. issue (‘complimentary medicine’), this is a good issue,
The new plan of the NCCAM outlines five ‘strategic which will serve all those clinicians well who regu-
objectives’: larly consult patients suffering from rheumatic
• Advance research on mind/body treatments.
• Advance research on natural products.
• Increase understanding of ‘real-word’ patterns of 䊏 Smith JC. The Medical War Against Chiropractors:
CAM-use and integration. The Untold Story from Persecution to Vindication
• Improve research capacity.
• Develop and disseminate reliable information. Charleston, SC: CreateSpace, 2011. 264 pages.
US$24.95 (paperback).
After a closer look at these objectives, one cannot ISBN 978-1453744871
fail to notice that there has been a shift towards Reviewed by E Ernst, Exeter, UK
mainstream issues, subjects and methodologies.
Many former critics might be pleased with this This book is focused on the unfortunate legal battle
change in attitude. between the American Medical Association (AMA)
e8 Focus on Alternative and Complementary Therapies March 2012 17(1)

and the US chiropractic profession. It could be an rich source for rampantly paranoid ideas that sadly
interesting historical exposé but, unfortunately, JC still exist in the chiropractic profession.
Smith spoils it thoroughly by his entirely one-sided,
biased view and inflammatory language. Smith goes
not one but several steps too far and thus loses all
credibility. For instance, he repeatedly compares the 䊏 Upton R, Graff A, Huntstone-Joliffe G (Eds).
‘medical lynch mob’ to Nazis and extreme racists: American Herbal Pharmacopoeia: Botanical
‘Just as the Nazis used the Big Lie to undermine the Pharmacognosy – Microscopic Characterization of
image of Jews, so did the AMA use its own version of Botanical Medicines
the Big Lie to defame the chiropractors’ (p. 132).
Elsewhere, Smith states that the actions of some Boca Raton, FL: CRC Press, 2011. 800 pages. £108.00
medical professionals in Florida were ‘clearly reminis- (hardback).
cent of the days of racial desegregation in the South’ ISBN 9781420073263
(p. 179). Reviewed by E Ernst, Exeter, UK
This is a great shame, not least because the tensions
between the two professions would deserve a schol- This is an authoritative and weighty book on the
arly evaluation. I suspect that a sober analysis would microscopic characterisation and identification of
have put the clinical evidence in the centre; an aspect herbal medicines. The book includes detailed micro-
that Smith avoids almost entirely. The tensions, I scopic descriptions of about 140 species using high
fear, are not between two groups fighting over the quality photographs and line drawings. It was com-
same patients, but between one group believing in piled by some of the leading experts in this field. In
science and evidence and the other having very little my view, this book will soon become a standard,
more than aggressive promotion. As it turns out, this universally accepted test in the area of pharmacog-
book is not an analysis of a 130-year-old conflict but nosy. Hence, this book should be on the shelves of
provides a wealth of misguided concepts; it is also a every researcher of herbal medicine.