placebo: art or science?

3
Complementary Therapies in Clinical Practice (2008) 14, 149151 EDITORIAL Placebo: Art or science? I am delighted to report a huge increase in on-line access to the Complementary Therapies in Clinical Practice (CTCP) web-site and in the number of publications downloaded from the site. CTCP papers are published electronically in advance of hard copy publication. As soon as they can be regarded as formally publishedan advan- tage for author and reader alike. On-line publication speeds up the availability of knowledge ensuring information is current. Prior to this, some journals could take up to 2 years before becoming available in the public domain; thus denying readers access of current information and research results that could develop our knowledge about a topic or enhance patient care. Even today, not all journals are able to offer electronic access to newly published papers. However, from the thousands of international readers accessing CTCP each month, there is clearly a demand for this service. An example of the value of on-line publication occurred in the previous issue of CTCP (vol. 14, no. 2). Entitled, The Antibacterial use of Honey against Community-Associated Methicillin Resistant Staph- lococcus Aureus (CA-MRASA), 1 this research study formed the focus of a recent news item on a British Broadcasting Corporation (BBC) television chan- nel, 2 thus not only readers of CTCP but also the general public were informed of the study findings. By taking a fresh look at existing products such as honey, it is possible to offer new insights into clinical practice. Frequently, papers published in this journal consider a broad range of integrated medical approaches for use in health care. Nearly all of them offer additional knowledge about treatment modalities. However, we are also keen to ensure that studies published in CTCP, broaden readers perspectives by describing differing cultural approaches to medi- cine. Learning about sociological and anthropolo- gical aspects of medical practice promotes a greater consciousness about differing social values and world views. In turn, this facilitates academic enquiry, an understanding of world cultures, medical practice and social behaviour. In many respects, our understanding of what it means to be healthy or what constitutes medical care is directly influenced by social, geographical and cultural interpretations of what it is to be healthy. Case studies and medical opinion offer valuable insights into therapeutic efficacy. Although gener- alisations cannot be drawn from such publications, case studies nevertheless form the foundations of both orthodox and integrated medical practice; they are the bedrock upon which clinical observa- tions are made. In turn this stimulates the forma- tion of research questions and eventually research. Common methodological challenges in research are not the sole domain of complementary thera- pies or integrated medicine but encompass all areas of research. However, there is a tendency by critical opponents of integrated medical ap- proaches to imply that certain clinical practices are without substantive foundation, because the randomised controlled trial (RCT) approach has failed to offer substantive evidence of efficacy. Randomised controlled trials usually include a placebo arm against which an experimental arm or arms are compared. This implies that the placebo is constant and inert. However, Miller and Kaptchuck suggest that the term placebo, is surrounded by ‘conceptual confusion and misleading terminol- ogy’ 3 (p. 222). They argue that far from being regarded as an inert state, the placebo may well be an active state commonly overlooked by general medical research and should be renamed ‘contex- tual healing’. Miller and Kaptchuck note that from 1977 to 2006, the number of citations listed on PubMed for ‘the placebo effect’ increased from 214 to 1675. 3 Indeed, as early as 1984, Katz, 4 noted that the ARTICLE IN PRESS www.elsevierhealth.com/journals/ctnm 1744-3881/$ - see front matter & 2008 Published by Elsevier Ltd. doi:10.1016/j.ctcp.2008.05.004

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Page 1: Placebo: Art or science?

ARTICLE IN PRESS

Complementary Therapies in Clinical Practice (2008) 14, 149–151

1744-3881/$ - sdoi:10.1016/j.c

www.elsevierhealth.com/journals/ctnm

EDITORIAL

Placebo: Art or science?

I am delighted to report a huge increase in on-lineaccess to the Complementary Therapies in ClinicalPractice (CTCP) web-site and in the number ofpublications downloaded from the site.

CTCP papers are published electronically inadvance of hard copy publication. As soon as theycan be regarded as formally published—an advan-tage for author and reader alike.

On-line publication speeds up the availability ofknowledge ensuring information is current. Prior tothis, some journals could take up to 2 years beforebecoming available in the public domain; thusdenying readers access of current information andresearch results that could develop our knowledgeabout a topic or enhance patient care. Even today,not all journals are able to offer electronic accessto newly published papers. However, from thethousands of international readers accessing CTCPeach month, there is clearly a demand for thisservice.

An example of the value of on-line publicationoccurred in the previous issue of CTCP (vol. 14, no.2). Entitled, The Antibacterial use of Honey againstCommunity-Associated Methicillin Resistant Staph-lococcus Aureus (CA-MRASA),1 this research studyformed the focus of a recent news item on a BritishBroadcasting Corporation (BBC) television chan-nel,2 thus not only readers of CTCP but also thegeneral public were informed of the study findings.By taking a fresh look at existing products such ashoney, it is possible to offer new insights intoclinical practice.

Frequently, papers published in this journalconsider a broad range of integrated medicalapproaches for use in health care. Nearly all ofthem offer additional knowledge about treatmentmodalities.

However, we are also keen to ensure that studiespublished in CTCP, broaden readers perspectives bydescribing differing cultural approaches to medi-cine. Learning about sociological and anthropolo-

ee front matter & 2008 Published by Elsevier Ltd.tcp.2008.05.004

gical aspects of medical practice promotes agreater consciousness about differing social valuesand world views. In turn, this facilitates academicenquiry, an understanding of world cultures,medical practice and social behaviour. In manyrespects, our understanding of what it means to behealthy or what constitutes medical care is directlyinfluenced by social, geographical and culturalinterpretations of what it is to be healthy.

Case studies and medical opinion offer valuableinsights into therapeutic efficacy. Although gener-alisations cannot be drawn from such publications,case studies nevertheless form the foundations ofboth orthodox and integrated medical practice;they are the bedrock upon which clinical observa-tions are made. In turn this stimulates the forma-tion of research questions and eventually research.

Common methodological challenges in researchare not the sole domain of complementary thera-pies or integrated medicine but encompass allareas of research. However, there is a tendency bycritical opponents of integrated medical ap-proaches to imply that certain clinical practicesare without substantive foundation, because therandomised controlled trial (RCT) approach hasfailed to offer substantive evidence of efficacy.

Randomised controlled trials usually include aplacebo arm against which an experimental arm orarms are compared. This implies that the placebo isconstant and inert. However, Miller and Kaptchucksuggest that the term placebo, is surrounded by‘conceptual confusion and misleading terminol-ogy’3 (p. 222). They argue that far from beingregarded as an inert state, the placebo may well bean active state commonly overlooked by generalmedical research and should be renamed ‘contex-tual healing’.

Miller and Kaptchuck note that from 1977 to2006, the number of citations listed on PubMed for‘the placebo effect’ increased from 214 to 1675.3

Indeed, as early as 1984, Katz,4 noted that the

Page 2: Placebo: Art or science?

ARTICLE IN PRESS

EDITORIAL150

placebo effect appeared to be an integral compo-nent of the ‘art’ of medicine, with argumentspresenting the ‘science’ of medicine. Miller et al.reason that the art of medicine may reside in thetherapeutic encounter—an area that has beenconsistently underrated in the desire to promotescientific objectivity and technological medicaldevelopments.3,4

Despite increasing focus upon the placebo effect,it would seem that we still have no greaterunderstanding about the mechanisms underlyingthis phenomenon.3 If we do not understand themechanism of action for placebos then how can thisbe used effectively as a base line arm for RCTswhere placebo is assumed to be a neutrallyaffective state—a biological stasis upon which toevaluate the measurable effect of a drug ortherapy?3

Two interpretations of the placebo are suggestedby Miller and Kaptchuk3: firstly, a perception thatthis constitutes an inert intervention and secondly,emphasis upon placebo as part of double blindresearch methodology has resulted in it ‘being thepreferred means of rigorously determining treat-ment efficacy.3 They note that in both cases theplacebo effect has been undervalued or evendismissed as having no therapeutic efficacy of itsown.

This presents a paradox for complementarymedicine (and possibly research in general). In-sufficient RCTs substantiating particular therapiesare met with accusations that practitioners do notknow nor can scientifically demonstrate what theunderlying mechanisms of a therapy are. Never-theless, proponents of the RCT approach exhortresearchers to perform research using a control armthat has been insufficiently studied in its own right.

In this respect, the tendency to dismiss studieswhere placebo or therapy response is not suffi-ciently different is throwing the baby out with thebath water. Is it acceptable to argue that placeboand the RCT are the best research tools availablewhen it is known that changes can occur due to‘placebo’ effects?5–7

In 1995, Ernst commented that just as responsesfollowing drug treatment do not necessarily in-dicate true drug effects, so responses to placebo donot necessarily constitute placebo effects.8 This isinteresting given his most recent publication Trickor Treatment, Alternative Medicine on Trial9 wherenot only a differing view is proffered but theauthors appear to elevate themselves to be bothjudge and jury in determining efficacy of a range oftherapeutic approaches.

The cover to this book mimics a Victorian poster,presumably with the intention of conveying a clear

message to the general public that if there is littleevidence to support a therapy, then it must be atrick rather than treatment. This is a surprisingstance to adopt and I look forward to the samecritical evaluation being afforded by the authorsshould they decide to focus upon Western medicaltreatment

The first sentence on the flier for this bookstates:

NHS doctors wouldn’t dream of writing out aprescription for a drug that hadn’t been thor-oughly tested, was unproven and where sideeffects were unknown

—O yes they would—it happens all the time. Ifwe question the placebo response then we mustalso question how accurate the ‘thorough testing’was. Indeed if testing was as thorough as Singhet al. argue, there would be no treatment recallsfor unanticipated side-effects once medical treat-ments were in the public domain. Furthermore,there would be no exploratory or emergencyinvestigative treatments—argued in the name ofsaving lives.

In the introduction to their book Singh and Ernst9

comment:

The contents of this book are guided entirely bya single pithy sentence, written over 2000 yearsago by Hippocrates of Cos. Recognised as thefather of medicine, he stated: ‘There are, in facttwo things science and opinion; the formerbegets knowledge, the latter ignorance’ Weshould use science to decide whether or not itworks, rather than relying upon somebody’sopinion9 (p. 1).

And yet surely we commonly visit the doctorprecisely for an opinion that doctors often suggest a‘second opinion’ might be appropriate. In thisinstance it would seem that ‘science’ overlooksboth medical opinion and the process of thetherapeutic encounter.

Hippocrates also said:

A physician without knowledge of astrology hasno right to call himself a physician.10

It would seem that quotes can be a sign of theirtimes. Exactly how Hippocrates squared these twoquotes up remains unknown. Interpretation andgeneralisation to some extent depend upon what isselected out of the whole to focus upon.

The art of medicine, as part of the therapeuticencounter has been marginalised by medicaltechnology; technological healing has eclipsedhealing through the clinician–patient relationship.3

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EDITORIAL 151

Evaluating therapies and developing methodsthat other people can replicate is important—butobservation is central to effective medical practiceand in the initial stages of any research process.

Interpreting placebo as ‘contextual healing’ensures that greater emphasis is placed upon theclinical encounter restoring the balance of what iscommonly referred to as ‘the art and science ofmedicine’. There is a need to look carefully at whatwe mean by placebo and the impact placebo hasupon health and well being. Far from being an inertbaseline measurement, placebo offers therapeuticefficacy—what this is and how it occurs should becarefully considered rather than overlooked.

In complementary and integrated medicine, thetherapeutic encounter and individualised patientcare form the fulcrum of care. Systematic observationis pivotal during consultations. Perhaps we shouldattempt to observe both the therapeutic encounterand its impact upon treatment efficacy rather thancontinually attempting to control outcome.

There is a need for safety but not at the cost ofthe art of medicine—of remembering ‘what personhas a disease rather than what disease a personhas’ (Hippocrates’ also said this!).10

Nevertheless, no matter what the results show,there will always be a cohort of people who willcontinue to dismiss particular therapies who ‘fail’the RCTapproach. Clearly individuals have the rightto choose to do this, but it is unfortunate whendiffering value judgements are afforded to emer-ging fields of medicine for no other reason thandeeply held bias.

CTCP aims to offer subscribers diverse opinionsabout the art and science of health care. It is onlyby debate, reflection, observation and analysis that

we learn—but we must also be open to thepossibility that we might be looking in inappropri-ate places for answers to certain questions. The artis to explore with tolerance, humility and an openmind:

Cure sometimes, treat often, comfort always(Hippocrates).

References

1. Maeda Y, Loughrey A, Philip Earle JA, Cherie Millar B, Rao J,Kearns A, et al. Antibacterial activity of honey againstcommunity-associated methicillin-resistant Staphlyococcusaureus (CA-MRASA). Complement Ther Clin Pract (CTCP)2008;14(2):77–82.

2. /http://news.bbc.co.uk/go/em/fr/-/1/hi/northern_ireland/7376300.stmS /www.lisarconti.comS.

3. Miller FG, Kaptchuk TJ. The Power of context: reconcep-tualizing the placebo effect. J R Soc Med 2008;101(5):222–5.

4. Katz J. The silent world of doctor and patient. New York:The Free Press; 1984.

5. Fisher S, Greenberg R, editors. From Placebo to Panacea:putting psychiatric drugs to the test. London: Wiley; 1997.

6. Beecher H. The powerful placebo. JAMA 1955;159(311):551–3.

7. Greenberg RP. Stalking the pesky placebo; musings on howexpectations shape experience (Ed. Book review). J NervMent Dis 2000;188(60):321–3.

8. Ernst E, Resche KL. Concept of true and perceived placeboeffects. BMJ 1995;311:551–3.

9. Singh, Ernst E. Trick or treatment: alternative medicine oftrial. London: Bantam; 2008.

10. Hippocrates Circa 460BC-370 BC.

Denise Rankin-BoxE-mail address: [email protected]