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Rapid Responses: Rapid Responses published:
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Self-deception in healing processes; is it ethical?
- Paul Vaucher (12 April 2008)
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There is a far way to go.
- Yun Hyung Koog, Byung-Il Min. (14 April 2008)
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Let us call it Curabo effect
- Bertrand Graz, John-Paul Vader (15 April 2008)
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Placebo-effect or social desirability?
- Edzard Ernst (15 April 2008)
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Basic skills of CBT
- Dirk Van Duppen (16 April 2008)
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Placebo
- John M.S. PEARCE (2 May 2008)
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Physicians are placebo !
- Josef Panasoff (4 May 2008)
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Helping patients feel better
- T Everett Julyan (6 May 2008)
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Placebo or nocebo?
- W Grant Thompson, Kenneth W. Heaton (13 May 2008)
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Doctor-patient interaction is not an element of the placebo effect
- Simon J Heyland, Jim Moorey (14 May 2008)
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The Limits of Positivism
- Pat Bracken (29 May 2008)
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Authors Response
- Ted J Kaptchuk (4 June 2008)
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Placebo needle
- Nobuari Takakura, Hiroyoshi Yajima (5 June 2008)
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Which are the placebo effects - comment on Kaptchuk et als IBS placebo study
- Stephen Birch, Mark Bovey (30 June 2008)
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Paul Vaucher, osteopath Centre Ostéopathique, 2015 Switzerland
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Kaptchuk and al’s [1] randomised clinical trial opens new insights to therapeutic possibilities in functional disorders. Their results suggest improving the patient-practitioner relationship brings as much benefit as the use of drugs in patients with irritable bowel syndrome. This study also supports new theories suggesting positive effect from acupuncture or osteopathic manipulative therapy could arise from the complex interactions between patient and practitioner alone rather than the intervention itself. These theories have emerged from results of three armed randomised clinical trials which suggested complex interventions mainly had an effect from other components than the manipulation itself [2]. From then, research has become interested in improving these effects [3]. Qualitative studies on the subject have revealed similar factors than those used by Kaptchuk and al to improve patient-practitioner relationship [4-6]. It has therefore become reasonable to consider acupuncture or manual therapy as a mean for practitioners to make patients understand themselves better, become confident and improve their chances of recovery. However, using deception to achieve this does not appear ethical and can also be confusing for patients [7]. Should we make patients believe the intervention itself is effective when in reality it is more the changes in their own conception of their symptoms which are making them better? Should we also maintain the practitioner in their self-deception? Can we develop positive expectation and confidence speaking of the patient’s ability to recover instead of falsely making them believe the effect is from a “therapeutic ritual”? Trust in the patient-practitioner relationship makes it important for both patient and practitioner to be truthful to one and another. I therefore hope further studies will be planned to explore the maintained benefit of improved patient-practitioner relationship without the use of deception. 1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. Bmj 2008. 2. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. Bmj 2005;330(7501):1202-5. 3. Williams NH. Optimising the psychological benefits of osteopathy. International Journal of Osteopathic Medicine 2007;Vol. 10(2):36-41. 4. Vincent C, Furnham A, Willsmore M. The perceived efficacy of complementary and orthodox medicine in complementary and general practice patients. Health Educ Res 1995;10(4):395-405. 5. Underwood MR, Harding G, Klaber Moffett J. Patient perceptions of physical therapy within a trial for back pain treatments (UK BEAM) [ISRCTN32683578]. Rheumatology (Oxford) 2006;45(6):751-6. 6. Westmoreland JL, Williams NH, Wilkinson C, Wood F, Westmoreland A. Should your GP be an osteopath? Patients' views of an osteopathy clinic based in primary care. Complement Ther Med 2007;15(2):121-7. 7. Lee-Treweek G. I'm not ill, it's just this back: Osteopathic Treatment, Responsability and Back Problems. Health 2001;vol. 5(No. 1):31- 49. Competing interests: None declared |
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Yun Hyung Koog, KMD Department of East-West Medicine, Graduate School, Kyung-Hee University, Seoul, 130-701 South Korea, Byung-Il Min.
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EDITOR-Kaptchuk et al's study1 is a creative and outstanding work. Many articles about acupuncture have approached to detect the effect difference between real acupuncture and sham or no acupuncture. Their work is different from previous acupuncture series. However, their article may be explained differently according to the underlying premises. First premise is that acupuncture points were same in group 2 and
acupuncture points were selected, according to the individual type, in
group 3. Then, each effect can be obtained as follows:
Second premise is that acupuncture points were selected, according to the
individual type, in group 2 and group 3. Acupuncture points can be based
on questionnaire in group 2 and on listening, talking, touching and seeing
in group 3. Then, each effect can be obtained as follows:
As you can see, two premises have a weakness. The weak point of first premise is that exact practitioner-patient interaction cannot be sought from their article, because needling effect on correct acupuncture points is uncertain. The weak point of second premise is that acupuncture points in group 2and group 3 are not likely to be same. If same, individual characteristics do not exist. Thus, it violates the traditional oriental acupuncture system.2 Therefore, there is a far way to go. From Kaptchuk et al's article, first premise was considered. So we propose for experimenters to provide fourth arm that can exclude needling effect on correct acupuncture points. 1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008 Apr 3. 2. Walji R, Boon H. Redefining the randomized controlled trial in the context of acupuncture research. Complement Ther Clin Pract. 2006;12(2):91 -6. Competing interests: None declared |
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Bertrand Graz, research fellow University Institute for Social and Preventive Medicine, Bugnon 17, 1005 Lausanne, Switzerland, John-Paul Vader
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In their study on components of placebo effects (1), Kaptchuk et al. found that the most robust component of placebo is the patient-physician relationship. Not any patient-physician relationship, of course, but a relationship with definite qualities: Warmth, empathy, duration of interaction and communication of positive expectation. Positive expectations, whether communicated to the patient or not, seem to have an independent effect (2,3) and might be especially potent when they are rooted in the doctors confidence in the prescribed treatment (4). The correlation between doctors positive expectation and patient progress might indeed be significant enough to deserve a name of its own: The I-will-cure-this-patient attitude or, closer to the linguistic rationale of the word placebo: the curabo effect (curabo means I will cure in latin, while placebo means I will please). In research conditions, when treatment is given with doubts that it might be only a placebo, the curabo effect may be non-operative and non -apparent because it is evenly distributed in the study groups. On the contrary, in the real world practice, when the prescriber is honestly convinced of giving a verum treatment with specific effectiveness, the curabo effect can develop its full potential. References: (1) Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; doi: 10.1136/bmj.39524.439618.25 (2) Priebe S, Gruyters T. The importance of the first three days: predictors of treatment outcome in depressed in-patients. Br J Clin Psychol 1995;34(pt 2):229 36. (3) Clarkin JF, Hurt SW, Crilly JL. Therapeutic alliance and hospital treatment outcome. Hosp Community Psychiatry 1987;38:8715. (4) Graz B, Wietlisbach V, Porchet F, Vader JP: Prognosis or Curabo Effect? Physician Prediction and Patient Outcome of Surgery for Low Back Pain and Sciatica. Spine 2005;30 (12):14481452. Competing interests: None declared |
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Edzard Ernst, Director, Complementary Medicine Peninsula Medical School, Universities of Exeter & Plymouth, 25 Victoria Park Road, Exeter, EX2 4NT
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Dear Sir/Madam, The brilliant study by Ted Kaptchuk et al 1 gives us extremely useful insights in the components of the placebo effect. This research is important, not least because it pertains to most areas of clinical medicine. But it is also hugely complicated and confusing. One could, for instance, argue that the results reveal not the impact of the placebo but that of social desirability, a much neglected factor in this type of investigation. Put simply, social desirability describes the phenomenon that patients who are treated with kindness and empathy may state that their symptoms have improved when, in fact, they have not. This is dramatically different from a placebo-effect, because it is not actually associated with clinical improvement: the patient does not feel better but only pretends to. But the results of clinical trials can nevertheless be affected by the phenomenon 2. In the study by Kaptchuk et al, the impressive difference in outcome between the limited and the augmented group might be due to social desirability. It is conceivable, I think, that patients receiving extra warmth and attention returned that kindness to their therapist by pretending they had improved while, in fact, they had not. There is no easy way to control for social desirability in such studies. One option would be to focus on objective endpoints - but this, I am sure, would introduce other problems. Prof. Ernst, MD, PhD, FRCP, FRCPEd
Reference List (1) Kaptchuck TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; doi:10.1136/bmj.39524.439618.25:1-8. (2) Ernst E. Dissecting the therapeutic response. Swiss Med Wkly 2008; 138:23-24. Competing interests: None declared |
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Dirk Van Duppen, GP Grouppractice doctors for the peopele. B-2100 Antwerp
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Kaptchuk et al. found that the most robust component of what they consider as a placebo effect is the patient-physician relationship. (1) Although this augmented patient-physician relationship as applied in this study presupposes some basic skills of cognitive behavioural therapy (CBT). Questions like how irritable bowel syndrome is related to relationships and lifestyle , how the patient understood the "cause" and "meaning" of his or her condition, as well as active listening, empathy or communication of confidence and positive expectation as response to patients anxiety, negative perceptions of symptoms or catastrophically way of thinking are basic techniques and primary steps of CBT. This study proves that these basic interventions, feasible in physicians daily consultations, can be effective for IBS and most probably for other functional somatic symptoms and syndromes. Training of physicians in applying these ICE (questioning ideas, concerns and expectations of the patient) techniques in their communication with patients can be very useful. Because of the continuity in his relationship with the patient and the holistic approach the GP has strong opportunities for a positive patient- practitioner relationship. Therefore it would be useful that this kind of research would be done in family practice. 1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008 Apr 3. Competing interests: None declared |
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John M.S. PEARCE, Emeritus Consultant Neurologist Hull, UK Hu107bg
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Kaptchuk et al. are surely correct in asserting the important contribution of warmth, attention,empathy and confidence to the placebo effect they demonstrate. But the converse must also be true: witholding these items is likely to have negative or deleterious effects on symptoms. Unfortunately this negative element was introduced into group 2 patients who were told: "practitioners introduced themselves and stated they had reviewed the patients questionnaire and "knew what to do." They then explained that this was "a scientific study" for which they had been "instructed not to converse with patients." This is likely to have falsely exaggerated the benefits of group 3 patients . Their results are therefore difficult to interpret. It is worth emphasizing that the commonly held view that a placebo response is determined by psychological genesis is false. The placebo effect is highly complex, but evidence suggests it is effected via organic, possibly neuro- humoral mechanisms. The great error is to regard responders as sham, or fake, or to interpret symptoms that do respond as being psychogenic or non-organic. Competing interests: None declared |
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Josef Panasoff, Senior staff member Allergy Dept,Lin Clinic,Clalit Health services, Haifa,35152 'Israel
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This article just confirms one of the earliest teachings I got as a young first year medical students in the Buenos Aires faculty of Medicine : the physician is the first (and most important) part of the treatment that the patient recieves.Empathy,understanding and showing our patients that we really care for them as human beings and not as a "disease" help improve the chances of success. Competing interests: None declared |
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T Everett Julyan, SpR in Liaison Psychiatry Stirling Royal Infirmary, Stirling FK8 2AU
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Editor On the basis of their study on the placebo response in irritable bowel syndrome, Kaptchuk et al. conclude that "the patient-practitioner relationship is the most robust component" of the placebo effect [1]. Despite some significant limitations, including extremely brief follow-up and potential bias in patient recruitment, their findings fit with previous observations that the therapeutic relationship is correlated to beneficial outcomes [2]. However, the inclusion of another comparison group would have shed light on an important issue they do not disuss - how would patients respond to the augmented patient-practitioner relationship in the absence of sham acupuncture (or any other intervention)? It is possible that the "doctor as drug" effect alone may be stronger than the study indicates [3]. Doctors often feel under pressure to "do something", when much of the time our patients may benefit most when we are free to just "be someone" - the one who helps them feel better. 1. Kaptchuk T.J., Kelley, J.M., Conboy, L.A., Davis, R.B., Kerr, C.E., Jacobson, E.E., et al. (2008) Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ, 336, 999-1003. 2. Martin, D.J., Garske, J.P., & Davis, M.K. (2000) Relation of the therapeutic alliance with outcome and other variables: A meta-analytic review. Journal of Consulting and Clinical Psychology, 68(3), 438-450. 3. Balint, M. (2000) The Doctor, His Patient and The Illness. Churchill Livingstone, 2nd Edition. Competing interests: None declared |
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W Grant Thompson, Emeritus professor of medicine, University of Ottawa 7 Nesbitt Street, Nepean, Ontario, K2H 8C4, Canada, Kenneth W. Heaton
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We congratulate Kaptchuck et al [1] on their important paper. We agree that a therapeutic relationship which engenders a strong placebo effect is the practitioner's most important tool in managing patients whose chronic symptoms have no apparent cause. In primary care, Thomas [2] found that the effectiveness of a doctor visit increased from 39 to 64%, when it included a diagnosis and a positive attitude, with or without a placebo pill. In another study [3], patients with non-cardiac chest pain who obtained reassurance from negative lab tests (though of no diagnostic value) were back to work faster, were more satisfied with care, and sought less help than controls. In irritable bowel syndrome, we [4] have advocated a firm diagnosis accompanied by explanation and truly effective reassurance, such that lingering fears of serious disease are allayed. Psychosocial circumstances may impair a patient's ability to cope with symptoms, for exmple, an over- busy cell phone-dominated lifestyle can compete with basic biological activities such as eating, sleeping, defecation and even sex. Therapists greatest gift to such patients can be time spent exploring with them the implications of their lifestyle on their well-being empathy in action. If, in a clinical trial, therapeutic benefit = therapeutic gain from a treatment + disorder's natural history + placebo effect [5]; then, another possibility is: therapeutic loss = therapeutic gain from a treatment + disorder's natural history - nocebo effect. In the former case, a harmful treatment (such as bloodletting) may achieve a net benefit if it is accompanied by a large placebo effect from the personality and reputation of the practitioner and the mystique of the procedure. In the latter case, a useful treatment such as dietary advice may be undermined by poor doctor/patient interaction. Healthcare systems that assign more value to technological procedures than to consultations and which provide inducements for rapid patient turnover are nocebos in this group of patients. Doctors need face-to-face time to bring to bear their personality, reputation, authority, and reassuring compassion. There is no need for dummy pills; the placebo is the doctor [5]. 1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; doi: 10.1136/bmj.39524.439618.25 2. Thomas KB, General practice consultations: is there any point in being positive? BMJ 1987; 294:1200-2 3. Sox HCJr, Margulies I, Sox CH. Psychologically mediated effects of diagnostic tests Ann Int Med 1981; 95:680-5 4. Thompson WG, Heaton KW. Irritable Bowel Syndrome, 2nd edn. Health Press, Abingdon, 2003 5. Thompson WG The Placebo Effect in Health and Disease: Combining Science and Compassionate Care. Prometheus Press, Amherst NY, 2006 Competing interests: None declared |
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Simon J Heyland, specialist registrar in psychotherapy Gaskell House Psychotherapy Centre, Swinton Grove, Manchester M13 0EU, Jim Moorey
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Kaptchuk et al[1] make a stimulating contribution to our thinking about the effective elements of medical treatment in their study of patient response to three so-called placebo conditions waiting list observation, sham acupuncture, and sham acupuncture plus practitioner interaction for irritable bowel syndrome (IBS). We were not surprised to see that patients in the third arm of their study (those receiving augmented interaction) showed clinically significant improvements in several IBS-related domains. Why were we not surprised? First, because this placebo condition permitted many of the non-specific factors of psychotherapy that are widely understood to be efficacious[2]. A closely related concept - the therapeutic alliance - has been consistently shown to be positively associated with clinical outcome, even for pharmacotherapy studies[3]. Second, although the authors attempted to control for psychotherapeutic factors by not allowing specific cognitive and behavioural interventions that might be beneficial for irritable bowel syndrome in the augmented interaction condition, they unfortunately made no reference to another form of evidence-based psychotherapy for IBS. Two substantial randomised controlled trials[4,5] have shown the effectiveness of psychodynamic-interpersonal (PI) therapy for IBS. This is a significant omission from the paper by Kaptchuk et al, as it means that PI interventions were not controlled for in the present study. In fact the permitted clinician behaviours in the augmented interaction group seem at face value to map closely onto interventions expected in PI therapy (eg exploring the patients causal attribution of their IBS, making links between IBS and relationships). It seems the authors were offering some of their subjects PI therapy without knowing it. On a more general note, we would argue strongly that it is incorrect to label patient-practitioner interaction as an element of the placebo effect at all. The term placebo means that the treatment is inert, that it contains no active ingredient. Any resulting treatment effect is therefore due to expectancy on the part of the patient. This expectancy effect is what should be labelled placebo. Therefore to lump the patient- practitioner interaction in with expectancy effects and call them both placebo is wrong. In fact patient-practitioner interaction is the primary active ingredient of most if not all psychological treatment, whether for IBS or any other disorder, with or without a therapeutic ritual, as practised by general physician or specialist psychotherapist. The quality of this relationship has been shown to account for 30% of outcome variance, compared to just 15% for expectancy/placebo[6]. Simon Heyland, Specialist Registrar in Psychotherapy
Competing interests: JM trains and supervises clinicians practising psychodynamic-interpersonal therapy. 1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome, BMJ 2008; 336: 999-1003. 2. Frank JD & Frank JB. Persuasion & Healing: a comparative study of psychotherapy. Baltimore: John Hopkins University Press, 1991. 3. Elkin I, Shea MT, Watkins JT, Imber SD, Sotsky SM, Collins JF et al NIMH Treatment of Depression Collaborative Research Program: general effectiveness of treatments. Arch Gen Psych 1989;46:971-82. 4. Creed FH, Fernandez L, Guthrie E, Palmer S, Ratcliffe J, Read N, et al. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. Gastroenterology 2003;124:303-17. 5. Guthrie E, Creed, Dawson D and Tomenson B. A controlled trial of psychological treatment for the irritable bowel syndrome. Gastroenterology 1991;100:450-57. 6. Lambert MJ. Psychotherapy outcome research: implications for integrative and eclectic therapists in Norcross JC and Goldfried MR (eds) Handbook of Psychotherapy Integration. New York: Basic Books, 1992. Competing interests: JM trains and supervises clinicians practising psychodynamic-interpersonal therapy. |
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Pat Bracken, Professor of Philosophy, Diversity and Mental Health University of central Lancashire, PR1 2HE
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While the study by Kaptchuk et al demonstrates very clearly the power of non-specific aspects of treatments for conditions such as Irritable Bowel Syndrome, it is questionable whether they are really justified in drawing the conclusions that they do. Their main hypothesis is that the non-specific aspects of treatment can be theoretically and practically separated into three distinct components: the patients response to observation and assessment, their response to the application of a therapeutic ritual (the placebo) and their response to the quality of the professionals interaction with them. They wish to be specific about the non-specifics. They interpret their results as confirming their hypothesis. Their fundamental assumption is that by putting the randomised patients through the three different pathways they describe, they are effectively observing the differential impact of these different elements. However, their study does not control for the question of intensity of involvement with the healer. As well as involving the successive addition of the three postulated elements of the non-specific clinical interaction, the three arms of the study also involve different levels of time spent engaging with the practitioner. An alternative interpretation of their results would be that non-specifics factors are important and the more that happens in treatment situations, the better. Perhaps, the greater the level of involvement with the practitioner, the greater is the degree of trust, confidence and expectation generated. But there is a deeper assumption at work in this research: that the non-specific aspects of treatment response can be investigated with the same positivist tools that are applied in research on the specific (technical) aspects. The researchers are attempting to break the non- specific dimension of treatment into separate variables that can be controlled in empirical studies such as this. This is questionable. Moerman (2002) argues that we should move from talking about the placebo effect and instead speak of the meaning response. What we are dealing with when we study the non-specific aspects of healing are the ways in which medical encounters always involve negotiations around meanings: the meaning of pain, sickness, healing and sometimes death. What we are dealing with is really the art of healing (Gadamer, 1996). Understanding a piece of art is always primarily an act of interpretation and only secondarily something that involves empirical investigation. Appreciating Picassos Guernica involves looking at it as a whole and understanding the context (political, cultural and personal) in which it was produced. We can only understand the various elements of the painting by first grasping how it works as a whole. If the non-specific aspects of medical treatments are indeed something approaching an art, it is questionable how far empirical studies underscored by a logic of positivism will get us. Gadamer HG. The Enigma of Health. Stanford: Stanford University Press, 1996. Moreman D. Meaning, Medicine and the Placebo Effect. Cambridge: Cambridge University Press, 2002. Pat.Bracken@hse.ie Competing interests: None declared |
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Ted J Kaptchuk, Associate Professor Harvard Medical School, Boston, MA 02215
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Our team is appreciative of all the thoughtful discussion this study has generated. We can offer a few remarks. Dr. Ernsts raises the issue of social desirability as a possible contributor to a placebo response. Indeed, we believe that this could a factor in the placebo response. Dr. Bracken argues that our augmented medical encounter is closest to an art form and involves interpretations of meaning not reducible to empirical study. We disagree and believe that it is essential to be specific about non- specifics. In terms of both of these points, we performed a nested series of in-depth interviews with an additional 27 patients which we expect will provide data to address Dr. Ernsts question on how patients bonded with researcher and with Dr. Brakens concern with non-reducible questions of meanings. Dr. Heyland points out that our augmented arm may represent a form of psychodynamic-interpersonal therapy. To the extent it does represent this (or as Dr. van Duppen suggests a form of cognitive behavioral therapy), we would say that such a therapeutic relationship might be a valuable component of any positive healing encounter. Actually, we are not sure if it is right or not to consider the patient-physician relationship a part of the placebo effect (endless debates have not resolved this), but it is certainly a non-specific component of medical care. Our study suggests that such a supportive relationship can significantly modify the placebo response and contribute towards enhanced clinical outcomes. We agree with Dr. Pearce that our limited arm was unreal and may have exaggerated the benefits of the augmented arm. But randomized trials often need to create somewhat unrealistic conditions (e.g., patient populations without co-morbidity) to demonstrate an effect. Also, it should be noted that our study was not designed to compare limited with augmented but rather determine whether three different non-specific effects could produce outcomes analogous to dose-dependent. Both Dr. Thompsons comments that a positive therapeutic relationship can engender a strong placebo effect and that physician need more face-to-face time with patients and Dr. Panasoffs remarks that physicians are placebo and are helpful in the context of this entire discussion on whether our patient-practitioner relationship should or should not be considered a placebo effect. Whether our outcomes represent classical conditioning (Pearce) or expectancy (Heyland and Graz) or some combination of both is still unclear to many of our team and needs further study. We appreciate Dr. Yuns remarks on acupuncture. But from our perspective, our study has nothing to do with acupuncture. In order to study placebo effects, we used non-penetrating sham needles that scratched randomly selected non-acupuncture points. To our knowledge, mild scratching the skin for six or twelve sessions is unlikely to have any specific effects on digestion. However, the results of our sub-study comparing acupuncture to sham acupuncture will be reported elsewhere. We agree with Dr. Julyans remarks that another arm of just patient-practitioner relationship would have been helpful. His remarks remind us that much work is required before we have a full and comprehensive understanding of placebo effects. Sincerely, Ted Kaptchuk
Competing interests: None declared |
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Nobuari Takakura, Research Manager Hanada College, 20-1 Sakuragaoka-machi Shibuya-ku Tokyo 150-0031, Hiroyoshi Yajima
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We congratulate Kaptchuk et al. (1) on their outstanding report, which was written with considerable ingenuity. Using single-blind placebo acupuncture needles, Kaptchuk et al. assessed three components of placebo effects: assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship. The conclusion that the patient-practitioner relationship is the strongest component is very insightful for evaluating the benefit of complementary and alternative medicine. They treated patients with irritable bowel syndrome, who were allotted to the following treatment groups: waiting list, placebo acupuncture alone (limited) and placebo acupuncture with a defined positive patient-practitioner relationship (augmented). In this report, the patients were well masked, i.e. 76%-84% and 56%-84% of the patients believed that they received genuine acupuncture at 3 and 6 weeks of treatment, respectively. This implies that a large proportion of the patients perceived specific sensations associated with skin pressure during blunt tip needle application, making them believe that the treatment received was genuine. We believe that the sensations elicited by the placebo or real needle had significant psycho-physiological impact on the patients in terms of therapy. Since the practitioners were well trained to adhere to the protocol throughout the experiment, there might be no significant difference in the sensations during placebo application between limited and augmented treatments. However, if this is not the case, the role of psycho-physiological impact by placebo application cannot be excluded in bringing about a greater improvement in the augmented group compared to the limited group. For the single-blind needle used in this study, the amount of skin pressure by the blunt tip could not be controlled mechanically or automatically and was dependent on the unmasked practitioner's discretion, which might have led to a possible bias. We believe that the skin pressure should be kept equal throughout the experiment, and if the patient-practitioner masking placebo needle is used (2), the practitioner bias is no longer a cause for concern. (1) Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; doi:10.1136/bmj.39524.439618.25:1E. (2) Takakura N, Yajima H. A double-blind placebo needle for acupuncture research. BMC Complement Altern Med 2007;7:31. Competing interests: None declared |
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Stephen Birch, Acupuncture practice, education and research Amsterdam, 1054SG, Mark Bovey
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A placebo can only be assumed to be inert according to current knowledge [1]. The sham procedure used in Kaptchuk et als IBS placebo study [2] is already known not to be inert. One cannot touch the body without biological effects. Some of these effects may in theory be attributable to placebo, others are normal reactions to touch and can have many dimensions to them [3, 4]. Therefore the sham acupuncture which necessarily involves touch and pressure is not an inert placebo (something admitted by its proponents [5]) and cannot have effects solely attributable to the ritual of therapy [6] as the authors claim [7]. Thus placebo effects in both the sham treatment arms are necessarily overstated. Additionally some aspects of the effects of touch are probably specific to the acupuncture therapy [8], a possibility acknowledged by the lead author in recent discussions about the role of touch in taiji chuan [9, 10]. In these articles about taiji chuan the lead author also demonstrates knowledge of complex interventions and the difficulties of doing research on them. Among other things, the evidence he cites comes from acupuncture related studies showing how many aspects of patient-practitioner psycho- social-verbal interactions are specific aspects of acupuncture treatment [11]. This and other supporting studies have demonstrated the complex nature of acupuncture as an intervention [8, 12]. Unfortunately in the third arm of the IBS placebo study since sham acupuncture was used to investigate placebo effects, not only is there a problem with the sham not being inert, but the study will have attributed to placebo some effects due to these non-placebo related specific components of acupuncture intervention. There is no discussion of this and no attempt to tease apart placebo related treatment components from these acupuncture specific non- placebo related patient-practitioner interactional components [12]. Thus the study will necessarily have further overestimated placebo effects in this third arm, due to this mislabeling of treatment components. This placebo study chose to use sham acupuncture as its placebo treatment. This was an unfortunate choice. No sham acupuncture treatment has ever been demonstrated to be inert, raising questions about bias in acupuncture studies [1] and thus the suitability of sham acupuncture in trials of acupuncture [13]. Recently experts have raised the issue of whether there should be a moratorium on sham acupuncture studies due in part to these difficulties [14]. The authors of this study have chosen to ignore the same evidence and arguments about complex interventions and the inherent difficulty of separating their placebo effects that they have used and cited elsewhere [8, 9, 10], raising other questions about this placebo study. It would have been much more interesting and relevant to answer the questions about placebo that this study attempted to investigate if they had chosen a sham (placebo) standard pharmaceutical intervention administered in normal GP practice where the doctor usually does not have time to talk much with the patient, and use as a third arm an extended discussion treatment arm added to the placebo medication. References 1. De Craen AJM, Tijssen JGM, Kleijnen J. Is there a need to control the placebo in placebo controlled trials? Heart. 1997;77:9596. 2. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schnyer RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomized controlled trial in patients with irritable bowel syndrome. BMJ, 2008:336(7651):999-1003. 3. Fields T. Touch Therapy. London, Churchill Livingstone. 2000. 4. Leder D, Krucoff MW. The touch that heals: the uses and meanings of touch in the clinical encounter. J Alt Complem Med. 2008:14(3):321-327. 5. White AR. Acupuncture research methodology. In Lewith G, Jonas WB, Walach H, eds. Clinical Research in Complementary Therapies. Edinburgh: Churchill Livingstone, 2002:307323. 6. Birch S. Comment on 'sham device v inert pill: randomised controlled trial of two placebo treatments. February 9, 2006 & Yes lets get real: what placebo isnt. March 10, 2006. http://www.bmj.com/cgi/eletters/332/7538/391#129658 7. Kaptchuk TJ, Stason WB, Davis RB, Legedza ART, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomized controlled trial of two placebo treatments. BMJ 2006; 332:391- 397. 8. Schnyer R, Birch S, MacPherson H. Acupuncture practice as the foundation for clinical evaluation. In MacPherson H, Hammerschlag.R, Lewith G, Schnyer R (eds). Acupuncture Research: Strategies for Building an Evidence Base. London, Elsevier, 2007:153-179. 9. Wayne PM, Kaptchuk TJ. Challenges inherent in Tai Chi research: Part I - tai chi as a complex multicomponent intervention. J Alt Complem Med. 2008:14(1):95-102. 10. Wayne PM, Kaptchuk TJ. Challenges inherent in Tai Chi research: Part II - defining the intervention and optimal study design. J Alt Complem Med. 2008:14(2):191-197. 11. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ, 2005:330:1202- 1205. 12. MacPherson H., Thorpe L, Thomas K. Beyond needling - therapeutic processes in acupuncture care: a qualitative study nested within a low back pain trial. J Alt Complem Med, 2006:12(9):883-880. 13. Birch S. A review and analysis of placebo treatments, placebo effects and placebo controls in trials of medical procedures when sham is not inert. J Alt Complem Med, 2006: 12(3):303-310. 14. Paterson C. The colonization of the lifeworld of acupuncture: The SAR conference. J Alt Complem Med. 2008:14(2):105-106. Stephen Birch Foundation (Stichting) for the Study of Traditional East Asian Medicine (STEAM), Amsterdam, the Netherlands Mark Bovey Coordinator, Acupuncture Research Resource Centre, Thames Valley University, London, UK Competing interests: None declared |
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