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Rapid Responses: Rapid Responses published:
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Millions of people CAN be wrong - but they may benefit from it
- Edwin P Kirk (20 May 2005)
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Complex reasons for increased acupuncture use
- Ellen C G Grant (20 May 2005)
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The problem is the sham control, not the RCT principle
- Richard A Cookson (20 May 2005)
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Mixed up terminology and poor suggestions
- Anton JM de Craen (21 May 2005)
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Dynamic Interactions between different treatment components occur in precribing too
- Matthew Anselm Johnson (22 May 2005)
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Some questions?
- Alan J Young (22 May 2005)
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Re: Some questions?
- John P. Heptonstall (23 May 2005)
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The molecular mechanism of acupuncture: heresy or axiomatic?
- Paul K Wright, John A Wright (23 May 2005)
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Further thoughts re placebo effect in a busy NHS acupuncture clinic??
- Jonathan Freedman (23 May 2005)
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Against Double Standards in Medicine.
- Edzard Ernst (23 May 2005)
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Why use the needles at all?
- Matt J Hodgkinson (23 May 2005)
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Re: Further thoughts re placebo effect in a busy NHS acupuncture clinic??
- Anthony Campbell (23 May 2005)
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Cochrane was there first.
- Graham H Curtis Jenkins (23 May 2005)
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Rethink your therapeutic model, not the use of a controlled trial
- Paul C Fletcher (23 May 2005)
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Controlled experiments are not the preserve of drug trials
- Leslie B Rose (23 May 2005)
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Complex interventions can be evaluated in randomised controlled trials
- Shaun Treweek (23 May 2005)
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RCTs may be vaild for evaluating acupuncture
- Richard Bartley (23 May 2005)
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Do me a favour!
- Amer I Sheikh (23 May 2005)
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Re: Further thoughts re placebo effect in a busy NHS acupuncture clinic??
- John P. Heptonstall (24 May 2005)
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Re: Millions of people CAN be wrong - but they may benefit from it
- Nabeel Sunni (24 May 2005)
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Acupuncture is rational medicine
- Adrian R White, John Campbell (24 May 2005)
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Sighs of Relief in Complementary & Alternative Medicine
- Robert T. Mathie (26 May 2005)
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Assay Sensitivity Issues with Pragmatic Trials
- Ronald J. Feise (26 May 2005)
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Re: Acupuncture is rational medicine
- Peter Morrell (26 May 2005)
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A better class of placebo?
- Morris Fraser (27 May 2005)
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Acupuncture is a rational medicine: a second response
- Richard Bartley (27 May 2005)
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Re: Re: Acupuncture is rational medicine - a matter of paradigm shifts
- Peter KK Au-Yeung (27 May 2005)
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Re: Re: Acupuncture is rational medicine
- Dr. Herbert H. Nehrlich (27 May 2005)
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Scrutinize the scientific literature, not the chakras.
- Paul, K Wright (27 May 2005)
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Inclusion of a Temporal Axis in Random Controlled Trial solves the dilemma?
- Paul G Champion (28 May 2005)
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Re: Scrutinize the scientific literature, not the chakras.
- Peter KK Au-Yeung (28 May 2005)
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Re: alleged decline of Galenic medicine
- Peter Morrell (31 May 2005)
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Re: Cochrane was there first.
- Tony Jewell (31 May 2005)
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Placebo-controlled trials are still needed for complex interventions such as acupuncture. Comment on Paterson and Dieppe (BMJ 2005;330:1202-05)
- Luciana AC Machado, Chris G. Maher (1 June 2005)
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Re: Re: alleged decline of Galenic medicine
- Stevie M Gamble (2 June 2005)
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Homeopathy has the same problem with placebo RCTs
- Trevor Thompson (6 June 2005)
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Effects of Acupuncture
- George T Lewith (6 June 2005)
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The importance of complementary therapies.
- Aswinkumar Vasireddy (7 June 2005)
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Re: Why use the needles at all?
- John P Heptonstall (7 June 2005)
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Re: Homeopathy has the same problem with placebo RCTs
- Anthony Campbell (8 June 2005)
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There may be science behind the needles!
- Velayutham sankar (11 June 2005)
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Re: There may be science behind the needles!
- John P Heptonstall (12 June 2005)
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Edwin P Kirk, Staff Specialist Dept of Medical Genetics, Sydney Children's Hospital, High St, Randwick NSW 2031
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It is interesting that both Fiona Godlee in her editorial, and Paterson and Dieppe in this article, say that it is paradoxical that acupuncture has a long history and widespread use but has not been shown to be effective in controlled trials. The fact that something has been around for a long time and is widely believed in has no bearing at all on its validity. Consider the enduring popularity of astrology and the world's many religions (they can't all be right!) There is no doubt that the placebo effect is real and that people can benefit from it. It seems likely that acupuncture, including all the components described by Paterson and Dieppe (not just the needles), is a particularly good placebo. Probably we ought not to be so squeamish in mainstream medicine about the deliberate use of placebos. But if we are going to use them we should do so consciously, and we should not waste resources on unnecessarily complex forms of placebo. Perhaps a new avenue of research could be the refinement of placebos. What are the minimum requirements for delivery of a really effective and safe placebo? What is the best way to train an expert placebo-ologist? Competing interests: None declared |
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Ellen C G Grant, physician and medical gynaecologist Kingston-upon-Thames, KT2 7JU, UK
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Paterson and Dieppe write that the specific effects of non- pharmaceutical treatments are not always divisible from placebo effects and may be missed in randomised trials.1 The main problem with any type of epidemiological study, whether of the effects of drugs or other treatments, is the difficulty in clarifying the multiple causes of patients’ complaints and therefore of obtaining meaningful and matching controls. I have not encountered placebo effects in my management of migraine patients because instead of giving drugs, I have concentrated on advising removal of the major precipitating factors in each individual. These are exogenous hormone use, smoking, alcohol use, regular medications, nutritional deficiencies and adverse reactions to common foods and chemicals.2,3 Clearly any type of randomised double-blind placebo controlled trial, whether pharmacological or not, which fails to take these major illness precipitating factors into account can fail to obtain a clear beneficial effect or, conversely, can grossly underestimate adverse effects of therapy, as has been happening with HRT.4 There have been no randomised double-blind placebo controlled trials of the total adverse effects of similar or identical progesterone-dominant contraceptive hormones. However, in the 1960s studies before, during and after medication showed a large accumulation of adverse effects which varied with different doses and balances of progestogens and oestrogens.5 The almost universal use of immuno-suppressive progesterones by young and middle-aged women, at some time or other, along with the desire to stop smoking, has resulted in increased use of “alternative medicine”, including endorphin-releasing acupuncture. 1 Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202- 1205 (21 May), doi:10.1136/bmj.330.7501.1202 2 Grant ECG. Food allergies and migraine. Lancet 1979;1:966-69 3 Grant ECG .Food allergy and migraine Lancet 1979;2:358-59 4 Grant ECG. Epidemiologists’ long-term underestimation of harm from hormones http://bmj.com/cgi/eletters/329/7456/2#65645, 3 Jul 2004 5 Anon. Changing oral contraceptives. BMJ 1969;4:789-91 & Today's Drugs Competing interests: None declared |
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Richard A Cookson, Senior Lecturer, Health Economics School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ
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Paterson and Dieppe raise an important problem with standard RCTs of acupuncture that use a sham control group (i.e. what we might call "acupuncture without needles"). They point out that there is more to acupuncture than just the needles - other essential features of acupuncture include the "emergent nature of Chinese diagnoses" and "discussion of central concepts of Chinese medicine". However, this is not a problem with the RCT principle - as implied in the BMJ's headline reporting of this paper and in parts of the paper itself - but with the sham control. The solution, surely, is to perform an RCT with a more appropriate control - whether this be some other common therapy, or "watchful waiting", or even (in a more pragmatic vein) "treatment as usual". There are of course plenty of problems with RCT designs and plenty of good reasons to use non-RCT designs in many contexts. But this isn't one of them. Richard Cookson Competing interests: None declared |
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Anton JM de Craen, senior epidemiologist Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden
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Paterson and Dieppe report on the distinction of characteristic and incidental (placebo) effects in complex interventions such as acupuncture. They state that many of the elements of the healthcare encounter that are categorised as incidental in drug trials (e.g talking and listening to patients) are an integral part of complex non-pharmaceutical interventions. The conclude that sham controlled trials will not detect the whole characteristic effect which may lead to false negative results. The article by Paterson and Dieppe and the accompanying editorial by Godlee mix up the two methodological tools frequently employed in studying intended effects of medical interventions: randomisation and adequate control intervention which enables blinding. Paterson and Dieppe clearly want to discuss the type of control within a clinical trial while Godlee states that "Paterson and Dieppe convincingly explain why randomised controlled trials (RCTs) are no good at evaluating complex interventions, such as acupuncture and psychotherapy". The BMJ website makes it even worse by stating on the home page "RCT's can't properly assess treatments like acupuncture" which directly links to the article of Paterson and Dieppe. Moreover, Paterson and Dieppe themselves also mix up the methodological tools. The first sentence of the third section called "Underlying assumptions of placebo controlled design" actually reads "Three assumptions underlie the design of randomised controlled trials". It is clear that the issue is not in the randomisation, which is only there to ensure comparability of prognosis between treatment groups. The issue is in the type of control. In stead of suggesting an innovative approach for the control group, the authors advocate randomised studies with a pragmatic or cluster design. These designs will yield results with low internal validity and will therefore not be accepted as proof of effectiveness of the intervention. This is especially important for studies where the outcome parameter is subjective, e.g. pain. The authors give some examples of characteristic factors within a complex intervention such as acupuncture that possibly contribute to the whole treatment effect: adjusting the needling procedure during treatment, aspects of the diagnostic process, and talking and listing to patients. These factors can easily be "switched off" in the control group and deliberately employed in the intervention group. The control intervention would then include the sham acupuncture, not adjusting the needling procedure during treatment, a conventional diagnostic process, hardly talking or listening to patients. In stead of moving towards non-blinded trials, it should be a challenge to define the active ingredients of the complex intervention and to find adequate controls for them. Competing interests: None declared |
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Matthew Anselm Johnson, GP Principal Fitzrovia Medical Centre W1T6EU
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There are a number of "biomedical" interventions where the same problems as described by the authors may occur. One such area is in the treatment of drug addictions, where the patient is seen regularly and adjustments made to doses of substitute medications with a view to a range of social, psychological, and medical factors. The ongoing discussion between practitioner and patient about dose, efficacy, and progress, is a part and parcel of the actual prescribing process itself. Methadone programmes are actually very variable in terms of their outcomes, for precisely these sorts of reason. Some are run "mechanically" without regard to the importance of psychosocial processes to the prescribing events themselves, whilst psychologial treatments are regarded as entirely different and detachable parts of treatment. Much the same could be said for the treatment of depression and other common psychological disorders, and probably a number of psychosomatic conditions as well. I therefore think the article has important ramifications well beyond acupuncture and physiotherapy. Competing interests: None declared |
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Alan J Young, GP BA1 7NP
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Although I am hampered in having no familiarity with the research cited in this article I find a number of questions rising in my mind
• The distinction between “characteristic” and “incidental” effects could be seen quite differently. In a study looking at a different problem is it not quite possible for factors currently listed as “incidental” (such as the therapeutic setting) to be the focus of the study and therefore “characteristic”? • If “diagnosis” is such a fluid concept (I ask myself if it might be an alien concept) in acupuncture is it correct to use the word? We may be using the word to mean very different things. Could it mean that different Chinese acupuncturists can never be compared? • The comments on Chinese medicine being holistic seems harsh on those in the western medical traditions who do seek to treat the whole patient. Surely it is not a qualitative difference between Chinese and western medicine (although I concede they may well do it much better than us) but rather a difference between research and clinical settings? That is why much “good” research is difficult to apply in primary care. • Regarding the statement in the article “Our findings may also prove useful in understanding some of the many paradoxes within the literature on the placebo effect. For example, they explain two recurring paradoxes in relation to sham acupuncture trials. Firstly, the discrepancy between acupuncture’s long history and widespread use and its lack of proved clinical effectiveness in randomised controlled trials and secondly, the fact that generally both sham and real acupuncture have good treatment effects” I find myself asking whether the most obvious assumption in response to this statement in the article is that acupuncture itself might be ineffective and it is within the so-called “incidental” factors that the therapeutic effect should be sought. • In the paragraph describing physiotherapy interventions the approach described exactly parallels clinical practice in other disciplines. One draws on science but in the therapeutic setting there are so many variables. A GP cannot slavishly follow research findings. This paragraph seems to reflect once more a confusion between clinical and research settings. • I confess to being very influenced by two articles in the BMJ in the late 80s “Doctors and witchdoctors - which doctors are which?” It introduced a busy clinician (in the hills of Nepal at the time) to Karl Popper and the principle that, as I recall, good research should seek to prove one’s favoured hypothesis incorrect rather that seek for confirmation. One gets the feeling, maybe erroneously, that the hypothesis here is that acupuncture works and that research is geared to confirm that hypothesis. Could there be a hidden danger here? • Finally, if indeed acupuncture is effective, we need to employ it for patients’ benefit. If every acupuncturist/patient interaction is as individual as described then marshalling all the data to either prove or disprove is like “herding cats”. Competing interests: None declared |
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John P. Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre. Practitioner of TCM -acu LS27 8EG
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I think Dr Young's admirable response is indicative of many GPs who wish to understand what 'acupuncture' really is about. His final paragraph is perhaps the most profound "Finally, if indeed acupuncture is effective, we need to employ it for patients’ benefit. If every acupuncturist/patient interaction is as individual as described then marshalling all the data to either prove or disprove is like “herding cats” ". in that he (inadvertently?) provides an excellent opinion as to the desirability and accuracy of certain types of research intervention into 'acupuncture' interventions in general. The essence of any intervention, be it acupuncture or pharmacy, involves an individual patient/practitioner relationship - at the very least - which is seen as a most important aspect of any intervention to those versed in TCM philosphy and science. It may be analogous to what is described as 'placebo' in Western medicine, but unlike WM which tends to separate placebo and medicinal effect I believe it adds an extra dimension to any intervention/medicinal effect. "Herding cats" may therefore be an accurate, if not unfortunate, analogy for any attempt to marshall sufficient data to prove/disprove the effects of patient/practitioner interaction. It has no bearing on proving/disproving whether acupuncture has effect (that has been done) or what particular effects it is capable of (that has been done) but one needs to "herd cats" if one wishes to understand 'placebo effects' of any intervention, including acupuncture that add to the proven effects identified by scientific means in China and abroad. Western medicine tends to ignore, may be ignorant of, that aspect of placebo which may be one reason why so many potentially excellent medical interventions fail or damage the patient - the physician fails to activate his/her innate healing potential (that some healers refer to as a prerequisite for successful healing - unconditional love for the patient) and merely distribute the latest pharmaceutical fad. Regards John H. Competing interests: Practitioner of TCM acupuncture & moxibustion |
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Paul K Wright, Clinical Fellow in Breast Surgery Northern Institute of Cancer Research, University of Newcastle upon Tyne, NE2 4HH., John A Wright
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Authors: Paul K Wright, John A Wright. Paul K Wright, clinical fellow in breast surgery. Northern Institute of Cancer Research, Paul O’Gorman Building, Medical School, University of Newcastle upon Tyne, Framlington Place, Newcastle upon Tyne, NE2 4HH. John A Wright, general practitioner. West Wirral Group Practice, Heswall Surgery, “Winterdyne”, Rocky Lane, Heswall, Wirral, CH60 OBY. Paterson and Dieppe raise some important points that must be considered in the planning and appraisal of any acupuncture study (1). In particular, acupuncture has complex multifaceted elements involved, including the diagnostic process and the relationship that exists between the practitioner and the patient. Chinese medicine has not traditionally been on the syllabus at medical schools in the Western world. However, physicians should not dismiss acupuncture as an heretical art with the placebo effect being its only conceivable mode of action. There is considerable evidence that acupuncture has an underlying molecular mechanism with physiological consequences. A salient reiterated theme in the biomedical literature is that of a physiological effect mediated via opioid receptors for manual acupuncture, electroacupuncture and acupressure (2). Rodent, lapine and human studies have demonstrated that these effects are antagonized by naloxone (2-5). Beyond analgesia, studies have shown that acupuncture can affect glycaemic control, gastric motility, gastric acid secretion, blood pressure homeostasis, ocular hydrodynamics and immune responses (2-5). Although acupuncture is in many ways enigmatic, it clearly has neurohumoral and immunoregulatory effects. Therefore the molecular mechanisms of acupuncture warrant further investigation and consideration. Cognizance of this is important for physicians and objective acupuncture research. We look forward to the results of future studies that contribute to our understanding of acupuncture at the molecular level and identify any relevant clinical utility. References 1)Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ. 2005; 330: 1202 -1205. 2)Chen XH, Geller EB, Adler MW. Electric stimulation at traditional acupuncture sites in periphery produces brain opioid-receptor-mediated antinociception in rats. J Pharmacol Exp Ther. 1996; 27(2): 654-660. 3)Lin JG, Chen WC, Hsieh CL, Tsai CC, Cheng YW, Cheng JT, Chang SL. Multiple sources of endogenous opioid peptide involved in the hypoglycemic response to 15Hz electroacupuncture at the Zhongwan acupoint in rats. Neurosci Lett. 2004; 366(1): 39-42. 4)Chao DM, Shen LL, Tjen-A-Looi S, Pitsillides KF, Longhurst JC. Naloxone reverses inhibitory effect of electroacupuncture on sympathetic cardiovascular reflex responses. Am J Physiol. 1999; 276(6): H2127-2134. 5)Fujiwara R, Tong ZG, Matsuoka H, Shibata H, Iwamoto M, Yokoyama MM. Effects of acupuncture on immune response in mice. Int J Neurosci. 1991. 57(1-2): 141-150. Competing interests: None declared |
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Jonathan Freedman, General practitioner St Albans
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I have been providing an NHS acupuncture service for more than 10 years. I operate this is such a manner that I can see up to 25 patients in a two hour clinic (by carrying out initial assessments outside the clinic and using up to three rooms). I try and be supportive as I am with all other patients but there simply isn't time for me spend more than 5 mins with the patient and sometimes the "interaction" is even less than this - i.e. the time taken to put the needles in (and hopefully remember to remove them!). I treat a huge range of condtions (not only musculoskeletal) and consistently get success rates around 70% (oft quoted for acupuncture but as the article correctly points out the evidence from RCTs is still thin). I think it is a misconception that all acupuncturists spend ages with their patients (I wish I had time to but NHS general practice doesn't work like that). So, from my own experience I do not over-rate the placebo element, (certainly not the 'therapist' component of it) but feel that the trials need to be really rigorous in their design and pragmatic. It has been exciting and encouraging to see the evidence emerging from such trials and published in this journal over the past 12-18/12. Competing interests: None declared |
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Edzard Ernst, Head of Complementary Medicine Peninsula Medical School, Universities of Exeter & Plymouth
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Dear Sir, Patterson and Dieppe (BMJ 2005;330:1202-5) eloquently argue that, unlike drug therapy, acupuncture treatment includes characteristic factors such as “the diagnostic process and aspects of talking and listening”. Therefore, they deduce “placebo”-controlled trials of acupuncture are unfair and prone to false negative results. Yet they grossly exaggerate the differences between acupuncture and drug therapy. Patterson and Dieppe seem to assume that “biomedical doctors” (what a term!) are all uncaring robots and that “incidental factors” are unrelated to “biomedical” theory. Where ever good medicine is practiced, there will also be an abundance of “the diagnostic process and aspects of talking and listening”. These and other “incidental elements” are characteristic of any type of good medical practice and sound medical theory. Complementary medicine does not have a monopoly on holism. There obviously is a huge difference between an optimal acupuncture session and a consultation with a poor doctor, and unfortunately there are many of those around. But, in this context, little difference exists between good doctoring and good acupuncturing. It therefore does not seem unreasonable to test the tools of doctors (often drugs) in a similar way as the needles of acupuncturists. “Placebo”- controlled acupuncture trials are not misguided – only their sometimes overstretched conclusions are. And the introduction of double-standards into medical research can only backfire. Competing interests: None declared |
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Matt J Hodgkinson, Senior Assistant Editor BioMed Central, London, W1T 4LB
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Randomized controlled trials often show that sham acupuncture and genuine acupuncture both have the same positive benefit, but are indistinguishable from each other. It is plain that there is an effect upon patients which needs investigating, but if you were to conclude that the RCT was invalid as a test of acupuncture from this result, you would be mistaken, even if you were the editor of the BMJ! If sham acupuncture and genuine acupuncture give the same result, this clearly shows that the actual needling element of acupuncture has no effect. The fact that sham procedures give the same positive benefit indicates that it is something else in the experience of receiving acupuncture which helps patients, possibly a version of the placebo effect, or the way in which acupuncturists otherwise care for or listen to their patients. Why then use the needles at all? Competing interests: BioMed Central has published trials and other articles concerning acupuncture. I am a member of the Green Party of England and Wales, which supports the increased use of complementary and alternative medicines. This comment states my own opinion, and is not the policy of either BioMed Central or the Green Party. |
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Anthony Campbell, Former consultant physician, Royal London Homeopathic Hospital Retired
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I'd like to endorse Dr Freedman's comment about the effectiveness of medical (non-traditional) acupuncture in a busy NHS setting. In over 20 years' experience of acupuncture done in this way for a wide range of disorders I also found its success rate to be about 70%, and in some perhaps surprising conditions, such as ulcerative colitis, the response rate was rather higher. This was using a minimalist approach without reference to "meridians", "points", or other esoteric ideas and certainly without relying on verbal suggestion. The best results were often found in patients who initially expressed frank disbelief, while those who arrived with strong expectations of success were sometimes disapointed. However, I think it may be a mistake to focus too strongly on the role of verbal suggestion as the main placebo element in physical treatments such as acupuncture. Acupuncture is a hands-on procedure and in this respect it resembles physiotherapy, osteopathy, chiropractic, and even massage. Modern acupuncturists frequently make use of trigger points and the examination for these is essentially manual. Among primates, we are the only species that does not routinely perform physical grooming. The manual therapies provide one of the few occasions when it is socially acceptable for comparative strangers to touch another's body in a manner that approximates to primate grooming. It seems likely to me that part of the success of the manual therapies depends on this, and differences in success rates among therapists are probably related to differences in how they apply touch. The mechanism of touch as therapy is no doubt complex but is likely to involve the limbic system (cingulate gyrus) and release of oxytocin. I am not suggesting that this is the whole basis for the acupuncture effect, but I think it plays a part and is certainly more important than the verbal scene-setting. It is therefore true to say that it is more than just the needles, but perhaps not quite in the way that Patterson and Dieppe imply. References: Dylan Evans, The Placebo Effect. HarperCollins, 2003. Campbell A. Acupuncture and the placebo response. Complementary Therapies in Medicin;2008(1):43-46. Campbell A. The limbic system and emotion in relation to acupuncture. Acupuncture in medicine 1999;17:124-130. Nathan B, Touch and emotion in manual therapy. Churchill Livingstone 1999. Competing interests: None declared |
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Graham H Curtis Jenkins, Retired 38 Richmond Road Staines UK TW18 2AB
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Dear Sir, It is refreshing to read the conclusions of the authors of this paper. However they are not new but certainly demand reiterating in the current evidence based health environment which relies on RCT evidence to justify new ways of delivering health care. Cochrane himself warned that RCT methodolgy should only be used in "cure" conditions not "care" ones.Unfortunately many researchers either disregard this wise advice or can only get funding for RCTs and are forced to apply the RCT research methodology quite inappropriately to measure the efficacy in what can only be called care conditions such as acupuncture and psychological therapy where the number of variables that need to be controlled for quite outways the ingenuity and funding of the researchers to complete successfully and honestly. For this reason RCTs purporting to demonstrate the efficacy and efficiency of interventions like cognitive behaviour therapy in care conditions such as depression,anxiety,PTSD,Eating disorders should be treated with the greatest caution. Graham Curtis Jenkins Competing interests: ex Director Counselling In Primary Care Trust |
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Paul C Fletcher, Wellcome Trust Senior Research Fellow Addenbrooke's Hospital CB2 2QQ
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I read Paterson and Dieppe’s article with interest but growing bafflement. They advance the idea that placebo-controlled trials of certain interventions are inappropriate because the features of placebo administration that are considered incidental to certain treatments are actually characteristic of others. It seems to me that their argument should be unpacked. Taking their chosen example, suppose that I attempt a controlled evaluation of the effects of acupuncture, using sham acupuncture as a control condition. If I find no difference, in terms of my chosen measure of therapeutic efficacy, between the two interventions, this tells me something very important: that the features distinguishing real acupuncture from its control have no addition benefits under these circumstances. Paterson and Dieppe very sensibly raise the possibility that this is because there are certain features of the process (human contact, support, etc.) that are common to the two conditions. Yet they would then have us believe that this renders the placebo condition invalid. On the contrary, it gives me two important pieces if information. First, I must address sincerely the possibility that my model of what makes acupuncture effective is wrong. I must re-evaluate my model and design further controlled studies to test my modified hypotheses. Second, it means that, if confronted with a patient, I would now be able to offer them two equally effective treatments and explain to them that the additional measures taken in one of them (over and above empathy, support, etc.) have not shown a measurable additional benefit. Let the potential recipient of treatment make their own decision on this basis. The arguments that Paterson and Dieppe put forward could be applied equally well to pharmaceutical research. But when placed into this context, their flaws become more obvious. If my drug fails to show benefits over and above placebo, would I be justified in saying that, in fact, the therapeutic process driven by this drug actually required the empathy, support etc. that were provided in the placebo condition? Possibly. Would I be able to persuade my colleagues and patients that, given this moving of the goalposts, they should be willing to accept my drug? I hope not. I was especially befuddled by the consideration of the fact that the many effects of a treatment are not necessarily distinct or additive. One would hope that any experimenter would consider the possibility of individual factors interacting. However, if the benefits of a treatment are not purely additive, but arise from its interaction with background factors (present in the placebo intervention) then this would actually lead to potential false positives rather than false negatives. That is, the experimenter assuming pure additivity might attribute the entire benefits to the treatment rather than to its interaction with factors considered incidental. Ultimately, if I wish to offer a treatment, governed by a therapeutic theory, then it rests with me, whether that theory is biochemical or not, to establish that my theory is viable and that the components of the treatment that are central to this theory can be shown to be useful. If they cannot, then it is my theory, and not controlled experimentation, which requires a rethink. Competing interests: None declared |
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Leslie B Rose, Director Pharmavision Consulting Ltd, Salisbury, SP2 8NJ, UK
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The thought-provoking article by Paterson and Dieppe (BMJ 2005;330:1202-5) begins with a fundamental misunderstanding. The authors have assumed that the placebo-controlled clinical trial was conceived from the outset in response to the need to test orthodox drugs. The truth is that this design is simply a subset of the inactive-controlled experiment which is the basis of science as a whole. Even disciplines such as astronomy, which might be considered by the layman to be predominantly a cataloguing exercise, rely heavily on controlled experiments to verify observations. Therefore Paterson and Dieppe are embarking on a more dangerous course than they have probably imagined, by challenging the overall scientific method. Having started in this wrong direction, the paper continues similarly. The argument that the diagnostic process in acupuncture is a continuum, in contrast to Western orthodoxy, would be interesting if there were any credibility for the former. But I am aware of no reliable evidence that any group of traditional Chinese medicine (TCM) practitioners can come up with a consistent diagnosis for a single patient. This begs the question that the TCM practitioner may be obliged to modify the diagnosis continually in the hope of getting it right. Are they making up the rules as they go along? Having successfully differentiated TCM from `biomedicine', Paterson and Dieppe then move even further from rationality, by highlighting the TCM concept of `balance'. Is this separation from evidence-based science deliberate? The underlying philosophy of TCM is by any reasonable standards fictitious. Nobody has ever demonstrated the anatomical or humoral entities said to underlie the effects of acupuncture. The inclusion of reflexology and naturopathy in the discussion serves only to dispel whatever shreds of reason may remain. However some very good points are made about the value of `talking and listening'. Would that the NHS could afford more of this. But in their oft-cited 2000 report on complementary and alternative medicine (CAM), the House of Lords Select Committee found that a CAM consultation typically occupies from two to four hours. One only has to speculate on the effect that would have on waiting lists, were it to be scaled up as the government seems to want to do. The accompanying editorial by Godlee (BMJ 2005;330 (21 May), doi:10.1136/bmj.330.7501.0-g) is astonishingly categorical in its condemnation of randomised controlled trials. Even Paterson and Dieppe stop short of declaring them to be `no good' in this context. There are not many absolutes in medicine, and nailing one's colours to that particular mast might be risky. In summary, if TCM practitioners claim that sticking needles into people has benefits, what is wrong with asking whether that is true? If they are however saying that, well no actually it's the `talking and listening' that do the trick, then are they not guilty of fraud? Leslie B Rose BSc CBiol MIBiol MICR lesrose@ntlworld.com Competing interests: None declared |
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Shaun Treweek, Researcher Tayside Centre for General Practice, University of Dundee, DD2 4BF, UK
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Paterson and Dieppe[1] and, it appears, the editor of the BMJ are confusing poor conduct of a randomised trial with a failure of the method itself. Randomisation done well looks after bias due to confounders, both known and unknown. If the trial designers introduce their own bias by choosing a poor control then that is hardly the fault of randomisation. If the aim is to see whether acupuncture is more effective than current practice one can easily and uncontroversially make the assumption that needling, talking and listening all form part of the complex intervention that is acupuncture and then compare the whole package to current practice. The issue of what bit of the package does what is then irrelevant. Indeed, it is likely that current practice is as complex in its own way as the authors (rightly) say acupuncture is. Talking and listening, for example, are an important part of acupuncture (Paterson and Dieppe seem to suggest that talking and listening are more important than needling, although they describe this as a paradox) but talking and listening are also likely to be part of current practice. It may be the case that different bits of a complex package address different elements of the patient population much like, to quote an example I recently heard from Dave Sackett, the plastic toy and the nutritional information on breakfast cereal packets address different sectors of the market. To try and separate the two might not make sense, or be possible, but you'd still like to know that together they sell cereal. To show that in healthcare you need a randomised controlled trial. 1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202 -5. Competing interests: None declared |
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Richard Bartley, Chartered Physiotherapist Denbigh, Wales, UK
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Basic science research into any potential physiological mechanisms related to acupuncture often requires the use of blinded RCTs using sham procedures, whether these are used on rodents or people. On the other hand, pragmatic clinical research requires a recognition of non-needling therapeutic factors that are part of an acupuncture treatment session. In this respect, the authors are correct to question the relevance of RCTs in testing the efficacy of acupuncture as a total therapeutic approach. I would argue however that verbal interaction with patients is not an incidental factor (placebo), but a charecteristic element in itself, that is simply combined with the needling process. RCTs using sham controls where the objective is to test for clinically useful physiological events might enable us to decide whether acupuncture is a useful adjunct to patient education. Competing interests: None declared |
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Amer I Sheikh, Consultant in Family Medicine King Faisal Specialist Hospital & Research Center, Riyadh. KSA
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Paterson and Dieppe have concluded that complex interventions such as acupuncture have characteristic features, which in drug trials are said to be placebo, and it is these placebo effects that play an integral role in these interventions. I agree. However, these placebo effects are not only present in so called “complex” interventions? I am a British-trained General Practitioner, and like my colleagues, have been trained in communication and consultation skills. In addition, I have been taught to make a diagnosis in physical, psychological and social terms so that I can take a holistic approach with my patients. I make frequent use of the “drug doctor” (Balint, 1957) and even my straightforward prescribing consultations are pretty “complex”. Fiona Godlee, in her editorial, infers that acupuncture and psychotherapy achieve their effect mainly from the therapeutic relationship, and that is the reason for their failure to show efficacy in RCT’s because the therapeutic relationship is used in both arms of the studies. This is misguided. I practice both acupuncture and psychoanalysis and maintain the same therapeutic relationship and use of the “drug doctor” as I do when I am prescribing a drug. This is characteristic of my consultations. However, even my charming personality and bedside manner are not enough to alleviate chronic pain or to solve psychological problems! If they were, I would not have needed to spend precious time and money in learning other therapies. Balint M. The doctor, the patient and his illness. London: Pitman; 1957 Competing interests: None declared |
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John P. Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre. Practitioner of TCM -acu LS27 8EG
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An independent "rating" of my success given by a GP with patients he referred to me over several years was 95% success rate; I believe that is more in keeping with expectations of success rates evidenced by over 2 decades of Chinese research papers I have studied. I typically found such studies to produce about 25-35% cure rate, 30-40% much improved rate, 15- 25% improved rate, 5-10% no improvement, and 1-5% adverse reaction rate. Regards John H Competing interests: None declared |
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Nabeel Sunni, SHO A&E Diana Princess of Wales Hospital, Grimsby DN33 2BA
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I think that the main problem with such alternative therapies is the subjectivity of the practice and therefore the inability to reproduce the results constantly. Saying that I do find a logical eplanation to most of these therapies. Therefore it is impossible to have a unanimous agreement on whether or not these treatments have any real effect; especially if we consider the fact that most practicing doctors differ in their beliefs regarding the effectiveness of many traditional mainstream medical treatments. Therefore the fact that we don't have proof as to how they work and their effectiveness doesn't mean that they don't. As far as placebo treatment is concerned I do agree that it does work in many cases and is actually quite effective. We must not forget that the only way a placebo will work is if the patient has full belief that this is an effective treatment. Competing interests: None declared |
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Adrian R White, Clinical Research Fellow, Peninsula Medical School N32 ITTC Building, Tamar Science Park, Plymouth PL6 8BX, John Campbell
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Paterson and Dieppe1 summarise the results of clinical trials of acupuncture: acupuncture to genuine points on meridians has large effect sizes compared with no treatment, but sham acupuncture to ‘inappropriate’ points off meridians is almost as good. The authors call this a ‘paradox’ and argue that it has arisen because the RCTs have not tested the ‘holistic’ effects of acupuncture. Their own qualitative research has demonstrated an effect which could be described as psychotherapeutic.2 This effect seems to arise from two sources: firstly, from a sound therapeutic relationship that is an essential feature of good medicine of any sort, and of course warrants further research; and secondly, from the characteristic (or specific) features of traditional Chinese medicine particularly what they call ‘the emergent and contingent diagnosis’. This needs more careful scrutiny. Traditional Chinese medicine includes a number of concepts that are contrary to the current prevailing understanding of anatomy and physiology. One is the whole idea of ‘meridians’. Another is the very basis of diagnosis and treatment: that a particular set of points can be chosen to treat ‘Liver fire rising’, and a different set of points chosen to treat ‘Dampness in the Spleen’. This belief system requires the suspension of disbelief by many Western practitioners and patients, and raises questions about the use of belief in medicine, credulity, and patient autonomy. Traditional Chinese acupuncturists themselves show ‘reticence in challenging the status quo’ of their received health beliefs. Indeed, the whole thrust of the RCT evidence already referred to – that treatment effects do not depend on needling the precise appropriate points – calls these beliefs into question. There is an alternative theoretical model that provides a solution to the ‘paradox’ of RCT results in acupuncture: that the needles stimulate nerves, not meridians and points. Therefore, for many conditions, the needle can be inserted almost anywhere within the relevant spinal segment: it is the skin or muscle penetration that is sufficient. So needling ‘inappropriate’ points, the usual procedure adopted in the past as a ‘control’ in RCTs, is a physiologically active treatment. There is no such thing as a nearby point that is ‘inappropriate’ and there is no paradox after all: the results of previous RCTs are exactly what you would expect. Recently, a credible sham procedure was developed that does not involve skin penetration, and some early results have shown that it is less effective than needling.3;4 The apparent paradox considered by Paterson and Dieppe may not be a paradox and alternative models need considered. There may be, after all, an important future for a biomedical approach to the evaluation of acupuncture, investigating the effect of the very thing that makes the therapy instantly recognisable – needle insertion. Adrian White
Reference List 1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005;330:1202-5. 2. Paterson C, Britten N. Acupuncture as a complex intervention: a holistic model. J Alt Complement Med 2004;10:791-801. 3. Kleinhenz J, Streitberger K, Windeler J, bacher A, Mavridis G, Martin E. Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis. Pain 1999;83:235-41. 4. Guerra de Hoyos JA, Martin MC, Leon EB, Lopez MV, Lopez TM, Morilla FA et al. Randomised trial of long term effect of acupuncture for shoulder pain. Pain 2004;112:289-98. Competing interests: Adrian White is editor of Acupuncture in Medicine, the journal of the British Medical Acupuncture Society |
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Robert T. Mathie, Research Development Adviser British Homeopathic Association, Luton, LU1 3BE
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Charlotte Paterson and Paul Dieppe have provided an important, evidence-based, illustration of some of the problems associated with placebo-controlled trials of complex therapeutic interventions. The world of complementary & alternative medicine (CAM) should breathe a collective sigh of relief, not because its researchers wish to accept ‘double standards’ but because this study design may be incapable of clearly answering questions of clinical effectiveness in highly individualised therapies. Many in CAM research have been worrying at this issue for some time, and we now have additional grounds on which to make the case for accepting a more appropriate trial method for this question. The answer, of course, is randomised trials that compare a CAM therapy with standard care, for example, with outcome measures relevant to both. That type of trial does have reduced internal validity, but its validity in the ‘real world’ can be strong. Testing the efficacy of a non-individualised CAM intervention for a specified medical condition or symptom is a quite different matter. Such therapeutic situations do exist, even in the usually individualised world of homeopathic treatment for instance. Here, it seems much more reasonable to answer the question with placebo-controlled design. It is notable that, of the 50 or so published trials in homeopathy that have positive findings, the vast majority have tested non-individualised rather than individualised remedies. As we learn more about the real world of therapeutic effectiveness in CAM, we can perhaps apply placebo-controlled design more often and more relevantly. As this week’s editorial rightly suggests, let’s be sensible and ask one (simple) question at a time. Competing interests: None declared |
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Ronald J. Feise, Clinical Research Institute of Evidence-Based Chiropractic, 6252 Rookery Road, Fort Collins, CO 80528, USA
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Paterson’s paper presents some interesting comments about assessment of the clinical benefit of acupuncture (1). The authors suggest the use of a pragmatic trial, but this may be problematic. In trials studying pain using two active controls (e.g., acupuncture and manipulation) where authors find "no important clinical differences," a conclusion that both interventions are ineffective (if little to no change occured) or effective (if a large change occured) may be misleading. The absence of a difference could mean that the study lacks sensitivity (due to design flaws) to demonstrate an effect (2). Those performimg pragmatic trials might want to consider an internal control group (e.g., modified active control, no treatment control) to demonstate a study’s ability to show a difference, if one exists, over the range of interest. Ronald J. Feise rjf@chiroevidence.com References: 1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330: 1202- 1205 (21 May), doi:10.1136/bmj.330.7501.1202 2. Max MB, Laska EM. Single-dose analgesic comparisons. In: Max MB, Portenoy RK, Laska EM, eds. The Design of Analgesic Clinical Trials. New York: Raven Press, 1991:55-95. Competing interests: None declared |
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Peter Morrell, Hon Research Associate, History of Medicine Staffordshire University, UK
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Adrian White's use of the term rational [1] needs some qualification. In contradistinction to empirical medicine that merely works for no apparent reason, rational medicine is medicine that conforms to a theory of disease and the organism. While acupuncture does conform to a theory, it is not a theory of the organism or of disease that most scientists would recognise. The theory of acupuncture that needles stimulate the flow of Qi energy in the 12 meridians is OK so far as it goes, except to say that these meridians have never been observed and the mysterious and imputed Qi energy is pretty elusive too. Therefore, it is hard to stretch the strict label of rational sufficient to encompass it. In this regard, it is much clearer that acupuncture, like homeopathy, reflexology and crystal therapy, etc may well be an empirical medicine that works after a fashion, but to call it rational is inappropriate and highly misleading, because the theories that these systems operate under, if any, have not been confirmed through observation and experiment and therefore must be regarded - at best - as provisional paradigms rather than scientifically proven value systems. They are non-standard forms of rationality. Indeed, in many cases the rationale behind these medical systems is largely at variance with accepted scientific knowledge, which is why globally so many scientists regard them as species of pseudoscience and castigate them as unacceptable breeds of medical deception or quackery. This is not to say that the complementary therapies are bogus, harmful or ineffective, but merely that it is incorrect to call them rational, for the reasons given above. [1] Adrian R White, Acupuncture is rational medicine, BMJ rapid response, 24 May 2005 http://bmj.bmjjournals.com/cgi/eletters?lookup=by_date&days=2#107779 Competing interests: None declared |
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Morris Fraser, Psychiatrist 8660 De Panne, Belgium
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Paterson and Dieppe would appear to have an incomplete understanding of the structure of randomised controlled trials. In the first place, their perception that diagnosis and treatment are fixed throughout the trial period is simply wrong. In trials of hypoglycaemic agents, for example, dosage is regularly adjusted in response to change in such factors as glycaemic control and tolerance. The other arguments depend in some degree on the shared conviction of alternative practitioners that it is only they - as distinct from ‘biomedical’ practioners - who take the trouble to listen to patients and empathise with them. This is largely an in-group article of faith; in reality it is another deeply flawed perception. It is very possible, however, that acupuncture is a better class of placebo than most. Competing interests: None declared |
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Richard Bartley, Chartered Physiotherapist Wales, UK
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Adrian White alluded to an alternative biomedical explanation for acupuncture needling that might form a basis for rational medicine. He made it quite clear that there was no scientific basis for meridian theories, of which Chinese acupuncture is based on. I am a little confused therefore as to why Peter Morrell seems to thing that Adrian White was espousing the virtues of meridian practice and the art of Qi. It seemed to me that White was arguing just the opposite. Competing interests: None declared |
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Peter KK Au-Yeung, Specialist Anaesthetist Hong Kong
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Like many older systems of "scientific" theory, the Qi and meridians theory belongs to the metaphysical paradigm, another prime example of which is the Western medicine theory of four humours, organs and elements of around 500 years ago. This has many parallels with the five elements and organs of Traditional Chinese Medicine. That theory also gave rise to the Great Venesection Debate, which Vesalius was a party to, in the mid sixteenth century. When Newton, Galileo et al found that the physical world could be described and predicted using polynomial (and with Newton's invention, differential) mathematics, science embraced the physical paradigm. Medicine did not sit quite comfortably with this as the human creature was and is still too complex to be described by such mathematical modelling, except in certain limited spheres (eg pharmacokinetics). Physicists around 100 years ago found that a statistical approach could make better predictions for sub-atomic events than the polynomial models and quantum mechanics was born. Despite Einstein's unease with the statistical approach, his seminal work on the photo-electric effect of 1905 managed to unite the conventional polynomial approach of wave theory with the statistical methods of quantum mechanics, and earned him the 1922 Nobel Prize in Physics. Epidemiology is the medical equivalent of quantum mechanics. Perhaps we need an alternative Einstein to reconcile the metaphysical with the physical and statistical paradigms which we use to great effect at the moment. After all, it is not a great stretch of the imagination to find the basis for say, electro-acupuncture of the ear in reducing brochospasm in asthma. The lung area is actually covered by the sensory branch of the vagus which innervates the external auditory meatus. Stimulation of the area can result in the afferent signals synapsing in the nucleus of the tractus solitarius in the medulla oblongata with the efferents being the bronchial branches of the same wandering vagus nerve. Apparently, great caution is required in needle placement for this type of treament, as the stimulation of the neighbouring cardiac area can give severe bradycardia, a reflex giving rise to excessive vagal input to the heart, perhaps? Competing interests: None declared |
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Dr. Herbert H. Nehrlich, Private Practice Bribie Island, Australia 4507
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I wholeheartedly agree with Peter Morrell . His writing has a strange effect on me, something one could not call rational as it cannot be explained easily. However, it is repeatable. Perhaps it is his eloquent English, coupled with such convincing logic. As far as acupuncture or any other "alternative" methods of "healing" being called rational, why bother? Call it empirical, scientific, intuitive or whatever may please you or the patient, it still is (like orthodox medicine) the application of one or the other of an armamentarium of mostly bungled therapeutic interventional methods upon an unsuspecting and/or end-of-rope human being. Patient, rational observation will reveal that the date of death appears to be pretty much pre-ordained - there is even a website that offers a specific day of death for you and me (you go first, please). So, let us face it, we really are mostly entertaining ourselves and our hapless victims when we do rounds at the hospital and drape the stethoscope around the neck in the surgery. Who was it that said "gambling doesn't pay" ? Competing interests: While I agree that gambling can indeed pay, I have never said "crime" does. |
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Paul, K Wright, Clinical Fellow in Breast Surgery Northern Institute of Cancer Research, University of Newcastle upon Tyne, NE2 4HH
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I would like to emphasize the message of Peter Au-Yeung, that much of our problem with dealing with complementary medicine is the fact that the underlying proposed mechanism of action does not fit into our Western world view. World views always change over history and although many elements are correct, time allows identification of flaws in each world view. Peter Morrell appears to be more concerned with the semantic origins and use of the word rational rather than any logical appraisal of acupuncture. One's world view should not cloud the ability to consider subjects that traditionally fall outside this perception. There may be no subtle energy that flows around the body in energy channels called meridiens. However, dissenters should consider that animal studies with naloxone acting as an antagonist to acupuncture are rational and suggest a molecular signalling mechanism for acupuncture. One does not have to completely understand the molecular action of something to know that it has a physiological effect. No molecular pathways are completely understood. There will always be an element of incomplete knowledge. Time always shows that there are many levels of complexity to be revealed in scientific discovery. Readers should forget chakras and energy channels, and start by considering the abundant animal studies in the scientific literature. Excessive criticizm of an ancient world view is not scientific or rational. Competing interests: None declared |
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Paul G Champion, n/a Southall UB2 4UP
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Zang-Hee Cho et al had similar results when using functional magnetic resonance imaging (fMRI) to visualise and objectively measure the effect on 12 subjects. [1]
BUT this study found that less stimulation was required to achieve analgesia with meridian needling than sham needling.
Their paper shows fMRI images of the twelve subjects averaged out. The images between pain-specific acupoints and sham are quite clearly discernible so the paper is I think worth looking at.
Therefore, this suggests that temporal variables should be thoughtfully designed in and recorded in future trials -(just the cost of having someone in a 'white doughnut' should help to focus the mind on the importance of the passage of time).
Also, it suggest that if a RCT is well designed then it is suitable for studying acupuncture and other empirical based treatments.
Trying to go by Occam's razor - maybe the acupoints came about simply from time economy and the more patients a acupuncturist can treat, the more he will learn (and earn) and more students will seek him out and so on. As for the meridians, perhaps they were conceptualised because the mind instinctively wants to join up dots in to patterns in order to remember them and in this case it happens to suit placing them [the acupoints] along meridians. Since Ötzi the Iceman [2] had tattoos, some of which coincide with known acupuncture points then perhaps tattooists became archyacupuncturists through observations of serendipity.
1] Medical Acupuncture A Journal For Physicians By Physicians Volume 14 / Number 1 "Aurum Nostrum Non Est Aurum Vulgi" fMRI Neurophysiological Evidence Of Acupuncture Mechanisms Zang-Hee Cho, PhD; Young-Don Son, MSc; Jae-Yong Han, MSc; Edward K. Wong, MD; Chang-Ki Kang, MSc; Kyung-Yo Kim, PhD; Hyung-Kyoon Kim, PhD; Byung-Yeol Lee, PhD; Yoon-Kyung Yim, PhD; Ki-Hyon Kim, PhD Http://www.medicalacupuncture.org/aama_marf/journal/vol14_1/article1.html
2] Http://en.wikipedia.org/wiki/%D6tzi_the_Iceman
Competing interests: None declared |
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Peter KK Au-Yeung, Specialist Anaesthetist Hong Kong
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Paul Wright wrote: "World views always change over history and although many elements are correct, time allows identification of flaws in each world view." This is not confined to Complementary Medicine versus mainstream Western Medicine. There are enough instances even in mainstream science that differing views on a certain phenomenom were offered, each supported by their own set of experimental results. Take pain theory from my own specialty of anaesthesia. Descartes' specificity theory was supported by the anatomy of pain pathways as well as the various sensory organs in the skin, but could not explain say failure to feel pain "in the heat of battle". Pattern theories could adequately explain those but was faced with the problem of what to do with the skin's sensory organs, well demonstrated to respond differently to different types of painful stimuli. Only when psychologist Ronald Melzack teamed up with anatomist Patrick Wall did the collaboration produce the seminal "Gate Control Theory" (Science, 1965), later refined and published in Brain in 1978. Sometimes the evidence for one theory is so overwhelming that the alternative theory is discredited, throwing out the truth therein contained as the proverbial baby with the bathwater. Newton's suggestion of light particles ("corpuscles" which he thought were emitted from the eyes) was consigned to history when the diffraction pattern obtained from Young's slits "confirmed" Huygen's wave theory of light. It took Bohr's quantum theory and Einstein's paper on photoelectric effect to recognize the particulate nature of light and link the two theories together. (I would like to point out the error in my previous rapid response - Einstein was awarded the 1921 (not 1922) Nobel Prize in Physics for this work.) An open mind to the "truths" contained in an alternative world view is a useful character for a scientist too. Competing interests: None declared |
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Peter Morrell, Hon Research Associate, History of Medicine Staffordshire University, UK
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Peter Au-Yeung gives a slightly misleading impression of the durability of Galenic medicine when he calls it "another prime example...the Western medicine theory of four humours, organs and elements of around 500 years ago." [1] Galenic medicine persisted for much longer than that. For example, the medicine taught by Hermann Boerhaave [1668-1738] in Leiden in the 1720s, which became the official medicine of Europe until the middle of the 19th century, was an only slightly modified form of Galenism... a mere 150 years ago, which might seem uncomfortably close for some to our own modern era. And distinct vestiges of the Galenic 'purge and bleed' approach were still in evidence in 1960s medicine with the use of such humour-expelling measures as expectorants like Ammonium Carbonate and Squill [also a diuretic], diaphoretics like Spirits of Nitrous Ether, Peppermint, Capsicum and Elder Flower Composition, such 'drawing remedies' as Kaolin poultice, Magnesium Sulphate paste, and laxatives like Licorice, Senna and Tincture of Rhubarb. The theory behind the use of all these remedies was broadly Galenic: to expel bad humours through sweat, phlegm, urine, etc. Therefore, it is not true that Galenic medicine had "become invisible and mute," [2] as early as the 1600s...on the contrary, it was still very much in evidence only 40 years ago. Tempting though it is to think these Galenic remedies endured for so long because they worked, that is healed the sick, yet that remains an open question. As Peter Au-Yeung implied, even if they did, the medical theory has been considerably modified since, and superseded by physiology. By comparison, in the case of acupuncture, the theory, and the methods based upon it, have barely changed in at least two millenia. Sources [1] Peter KK Au-Yeung, Re: Re: Acupuncture is rational medicine - a matter of paradigm shifts 27 May 2005 [2] Mary Webb, Precious Bane, Foreword, 1924 Competing interests: None declared |
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Tony Jewell, Director of Public Health NSC Strategic Health Authority
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I think we should be cautious in following Patterson and Dieppes concerns about the scientific analysis of complex therapies. Curtis Jenkins supports them but his reference to Cochrane is misplaced as the Cochrane Collaboration has many reviews on acupuncture. For example one on the use of P6 point in preventing postoperative nausea and vomiting cites RCT evidence and the fact that the evidence points to a favourable Odds ratio (1). There is much scientific work needed to examine why acupuncture has been used continuously in China for over 2500 years (2)Hiding behind a holistic therapeutic approach won't help. 1. Lee A, Done ML "Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting" The Cochrane database/Systematic Reviews 2005. Issue 2 2. Hillier S, Jewell T. "Healthcare and Traditional Medicine in China" Routledge 2005 Competing interests: None declared |
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Luciana AC Machado, MAppSc student Back Pain Research Group, School of Physiotherapy, University of Sydney PO Box 170 Lidcombe NSW 1825, Chris G. Maher
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In their paper “Characteristic and incidental (placebo) effects in complex interventions such as acupuncture”, Paterson and Dieppe discuss the problems in using placebo-controlled trials for testing non- pharmaceutical treatments such as acupuncture and physiotherapy.1 The authors argue that differentiating specific and placebo effects is sometimes meaningless because elements considered incidental in drug trials may be specific components for complex interventions. Therefore, they argue, placebo-controlled trial designs are not appropriate for testing the effects of complex interventions. Different interventions do not share the same specific or incidental effects. This is clear when comparing pharmacological treatment and psychotherapy but may not be as clear when the intervention under investigation consists of biological as well as psychological elements such as acupuncture. According to Paterson and Dieppe, the characteristic or specific effects of acupuncture include needling, the diagnostic process and aspects of talking and listening; therefore, a trial in which the placebo group differs from the active group only with regards to needling may underestimate effects of acupuncture. However, one important point missed by Paterson and Dieppe is that there is nothing wrong with the design described above; the only problem is in the research question. When the placebo group receives the same treatment as the active group except the needles are not inserted, the trial assesses the effect of needling, not acupuncture. In addition, if the placebo group differs only in the location of the inserted needle what is being assessed is the effect of needle location.2 The same logic applies to investigation of chiropractic or manipulative treatment. If the placebo group receives the same intervention as the active group but not the thrust,3 the trial attempts to measure the effect of the thrust, not the effect of chiropractic treatment. There are trials that have configured the active and placebo treatments so that they differ only in terms of the vertebral level treated4 or the manipulative technique used5; these trials attempt to measure the effect of vertebral level and technique not manipulative treatment. A critical issue is that there is not a single placebo treatment that should be applied in all trials. Instead researchers need to configure the active and placebo interventions so that the difference between the two interventions will answer the specific research question they are interested in. When describing their results researchers should avoid conclusions such as acupuncture was more effective than placebo and instead explicitly describe how the two treatment arms differed e.g. acupuncture at verum points was no more effective than acupuncture delivered to adjacent sites. This approach acknowledges the complexity of treatments such as acupuncture and physiotherapy yet still permits use of the most powerful tool we have to judge treatment effects: the randomised controlled trial. The randomised, placebo-controlled trial is still the gold-standard design for clinical testing and the problems in using this design in acupuncture or physiotherapy trials are not in the design itself, but in the research question and the ingenuity of researchers to develop a placebo to answer that question. Researchers should be aware that there is not an ideal placebo for each intervention, but there is a placebo that is ideal for each research question. 1. Paterson C and Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005;330:1202- 05. 2. Leibing E, Leonhardt U, Goerlitz A, Rosendeldt J, Hilgers R and Ramadori G. Acupuncture treatment of chronic low-back pain – a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain 2002;96:189 -96. 3. Hawk C, Azad A, Phongphua C and Long C. Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. JMPT 1999;22:436-43. 4. Chiradejnant A, Latimer J, Maher CG and Stepkovitch N. Does the choice of spinal level treated during posteroanterior (PA) mobilisation affect treatment outcome? Physiotherapy Theory and Practice 2002;18:165- 74. 5. Chiradejnant A, Maher CG, Latimer J and Stepkovitch N. Efficacy of therapist-selected versus randomly selected mobilisation techniques for the treatment of low back pain: a randomised controlled trial. AJP 2003;49:233-41. Competing interests: None declared |
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Stevie M Gamble, retired HMIT EC2Y 8BL
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I must concur with Peter Morrell's observation that Galenic Medicine was still going strong a mere forty years ago; indeed, one could argue that vestiges remain. For example, I devote a hefty chunk of my day to physiotherapy designed to expel phlegm, and have done so since I was a small child. The same routine applies to anyone diagnosed as bronchiectatic, whether their condition stems from cystic fibrosis, measles, mercury or the time- honoured 'haven't got a clue' causation familiar to most doctors. Of course, the people whose bronchiectasis is mercury-induced do have a genuine grudge against Galenic medicine; mercury was used as a purgative, hence its inclusion in teething powders. Broncho-pneumonia was one of the leading causes of death in Pink Disease, and bronchiectasis was the result of the broncho-pneumonia in babies and children who survived. No mercury, no bronchiectasis… Stevie Gamble Competing interests: None declared |
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Trevor Thompson, Clinical Lecturer Academic Unit of Primary Care, University of Bristol, Cotham House, Bristol BS6 6JL
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<>PConsent asked 29.5.05 JS
In their article, Paul and Charlotte focus on the problems of using placebo designs in the assessment of acupuncture. The same trouble arises in RCTs of individualised homeopathy. On the basis of our narrative analysis of eighteen “packages of care” (one new and four follow-up consultations) at Bristol Homeopathic Hospital, we discovered that the processes the practitioners used to diagnose the particular homeopathic remedy, were in themselves the very same processes that induced in the patients the greatest sense of being heard. One young woman for instance disclosed for the first time, in her homeopathic consultation, a sense of guilt that she had held for over ten years in relation to the untimely death of her father. This disclosure was highly therapeutic but also the result of skilled questioning aimed at the selection of a homeopathic remedy. Somewhere in the scrum of it all her severe eczema cleared up. Lets imagine it is the specific homeopathic approach to the consultation that did the trick. Now imagine there are a hundred such patients and they have these consultations and are randomised to verum or placebo. They all get better and so, according to the “non-specific model”, homeopathy is deemed to be ineffective. However in fact it was a specific aspect of homeopathy, the specifically homeopathic approach to case taking, that made the difference. This would then constitute a false negative. I would defy a well-meaning (non-specific) chat to have the same therapeutic power as an in-depth homeopathic consultation in which an individualised remedy is selected and prescribed. As with some of the other rapid-responders on acupuncture, I don’t feel that consultational effects are the whole story with homeopathy, but they are important and their denial leads to underestimation of the benefits of the intervention. We publish our findings later this year. Meantime we welcome this recent contribution to the debate. Competing interests: None declared |
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George T Lewith, Reader in Complementary Medicine Primary Medical Care, Aldermoor Health Centre, Southampton SO16 5ST
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EDITOR - Traditionally, complementary and alternative medical (CAM) treatments have been thought of as having specific effects. These concepts are an inherent part of practitioner training, practitioner belief and patient perception. However, there is often little objective evidence to sustain claims of efficacy. For instance, we usually consider the specific effect of acupuncture to be related to an individualised point prescription and therefore central to that specific effect is acupuncture point location and penetrating needling. Similarly, homeopathy is thought to “carry” its specific effect through a potentised remedy. It has also been suggested that the non-specific effect of a complementary medical intervention may be system specific1. For instance, a clinical response to homeopathy may be predicted by covariates that relate both to the individuals receiving homeopathic treatment and the specific nature of the homeopathic consultation process2. Similarly, the therapy specific intervention of acupuncture may be related to the capacity of concepts within traditional Chinese medicine to provide therapeutic benefit through an explanatory model of illness for the individual patient, as well as the “act” of needling3. This would suggest that there may be many potential confounders within randomised controlled trials of CAM which are different to those encompassing the non-specific effects involved in other consultation environments such as primary care. The suggestion that “simply being kind and understanding” within a conventional medical consultation is the same as the time spent with patients within a CAM consultation may therefore be incorrect. The specific nature of each individual whole system underpins the consultation process and may be a vital and effective part of treatment1. Consequently, at the heart of current clinical trial methodology within CAM, may be an assumption based on tradition and myth. For instance, the efficacy of acupuncture may not only be dependent on the point specific effect of needling, but on the context, environment and “traditional Chinese consultation” through which the process of acupuncture is defined. These suggestions are entirely consistent with those of Patterson and Diepe4 and furthermore provide us with a series of hypotheses that we are currently evaluating using a mixture of qualitative and quantitative methods in both homeopathy and acupuncture within our research group at Southampton. George Lewith, Reader in Complementary Medicine Director of the Complementary Medicine Research Group Primary Medical Care, University of Southampton, Southampton, SO16 5ST Gl3@soton.ac.uk Reference List 1. Verhoef MJ, Lewith GT, Ritenbaugh C, Thomas K, Boon H, Fonnebo V. Whole Systems Research: moving forward. FACT 2004;9:87-90. 2. Bell IR, Lewis DA, Brooks AJ, Schwartz GE, Lewis SE, Walsh BT et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology 2004;43:577-82. 3. Cox H, Henderson L, Wood R, Cagliarini G. Learning to take charge: women's experiences of living with endometriosis. Complementary Therapies in Nursing and Midwifery 2003;9:62-8. 4. Paterson C,.Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005;330:1202-5. Competing interests: None declared |
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Aswinkumar Vasireddy, SHO A&E Basildon University Hospital (SS16 5NL)
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The recent paper in the BMJ regarding the variables involved in complex interventions highlights the importance of non-pharmaceutical interventions1. Osteopathy is a very popular form of alternative therapy used particularly in the chronic back pain sufferer. The origins lie in the folk traditions of “bone setting”. Practitioners commonly use their hand for both diagnosing and treating musculoskeletal complaints. A typical session lasts 15 to 30 minutes & involves history taking, palpation for changes in muscle tension & skin circulation with a variety of techniques being used. Interestingly, osteopathy is sometimes used to treat infectious diseases & blindness as well as neck pain, sports injuries and arthritis. A number of reviews have commented on randomised controlled trials that have shown a benefit in spinal manipulation. A large UK trial involving 741 patients with low back pain randomised to manipulation or outpatient care stated “worthwhile, long term benefit”. However, a number of methodological weaknesses in this study need to be taken into account, e.g. the use of subjective outcome measures. Safety is also a concern in any physical manipulation with worse case scenarios being stroke & spinal cord injury. Commonly, patients tend to have mild pain or discomfort. Contraindications include infection, ligament rupture, acute # or dislocation. Osteopaths generally tend to work in the community or private sector. However, PCTs and local health authorities are contracting an increasing number of practitioners. Osteopathy is one of only two complementary therapies that are regulated by statute with the GOC (General Osteopathic Council) having a similar statement as the GMC. The article by Paterson & Dieppe (2005)1 reinforces the need for new novel trial designs if further accurate research is to undertaken into such complex interventions. References: 1. Paterson C & Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 2005; 330; 1202- 5 (21 May) 2. Meade TW, Dyer S, Browne W & Frank AO. Randomised comparison of chiropractic and hospital outpatient management for low back pain: results from extended follow up. BMJ 1995; 311; 349-51 (5 August) Competing interests: None declared |
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John P Heptonstall, Director of the Morley Acupuncture Clinic Leeds LS27 8EG
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As far as I can see, there is no such thing as "sham acupuncture" that creates the same effects as genuine acupuncture. I would welcome any input that Matt J Hodgkinson can provide which informs exactly which points or techniques can be used that may be defined as "sham acupuncture" and exactly how these created the same effects as genuine acupuncture. Further, Leslie B Rose says "I am aware of no reliable evidence that any group of traditional Chinese medicine (TCM) practitioners can come up with a consistent diagnosis for a single patient". Perhaps Leslie could provide evidence for his 'awareness', for example references please? Is Leslie Rose aware of any reliable evidence that any group of TCM practitioners cannot come up with a consistent diagnosis for a single patient? I know such evidence exists for biomedical practitioners, for example psychiatrists, but know of no reliable study that would so inform Leslie about TCM practitioners. Regards John H. Competing interests: Practitioner of TCM acupuncture & moxibustion |
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Anthony Campbell, Former consultant physician, Royal London Homeopathic Hospital Retired
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Dr Thompson is surely right to say that the effects of non-specific chatting are different from those of a homeopathic consultation. This is because the homeopathic consultation is not conducted at random but has a particular scope and direction and follows a prescribed formula. A homeopathic consultation affords the patient an opportunity to talk at length about his or her problems in a structured environment and this in itself can be therapeutic. Psychotherapy has been defined as "the talking cure"; judged on that basis, homeopathy is a form of psychotherapy. The late Anthony Storr was sceptical about much psychoanalytic theory but nevertheless thought that psychoanalysis could have beneficial effects on patients. I think much the same is true of homeopathy, whether or not there is an additional specific effect from the remedies themselves. It is doubtless significant that all the different forms of homeopathy appear to have about the same success rates. Reference: Lancet 1997 Sep 20;350(9081):834-843 Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Competing interests: None declared |
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Velayutham sankar, Doctor Royal Bolton Hospital, Minerva Road, Farnworth,Bolton, BL4 OJR
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Dear sirs, It is interesting to read the article by Charlotte Paterson and Paul Dieppe(1) about Characteristic and incidental (Placebo) effects in complex interventions such as acupuncture. They have based their article on interviews. It appears to be a qualitative study. Is the study based on purely asking targeted and preformed questions or is it based on action research? If grounded theory approach is used, whether any other themes have emerged? What package is used for analysing the data? These questions need to be answered clearly. Few centuries before B.C, along with the advent of philosophies like Taoism and Confucianism, acupuncture began to evolve in China. It’s emerged from the regions of Eastern China and its practice is wide spread. Acupuncture is based on Yin-Yang and interconnection between this opposites based on Qi. Qi is an abstract concept and does not have western scientific evidence. While western medicine is based on symptoms and signs the acupuncturist diagnosis is qualitative(2). This is where the sharp divide comes between the two different systems. Western science strongly rejects metaphysical explanation in treatment however believers in eastern system feel otherwise. The acupuncture has been modified in different countries over many centuries in some form or other though the concept of meridians still largely unchanged. According to traditional Chinese medicine about 10 sessions would be more appropriate for acupuncture(7). However, in practice it is difficult to achieve such lengthy sessions in the west across the different health service delivery systems. Acupuncture-induced analgesia is mediated by inhibition of pain transmission at a spinal level and activation of central pain-modulating centers by release of opioids and other peptides that can be prevented by opioid antagonists (naloxone)(5). Modern neuroimaging methods (functional MRI) confirmed the activation of subcortical and cortical centers, while transcranial Doppler sonography and SPECT showed an increase of cerebral blood flow and cerebral oxygen supply in normal subjects. There are animal studies shows the CSF from acupuncturised rabbits induces similar changes in the rabbits not subjected to treatment(4). The role of Complementary and alternative medicine is being tested in a western scientific manner to study their effectiveness. Previous research done on acupuncture is of poor quality with limited sample size and faults with the study design. Some acupuncture trials have shown good results persistently for symptoms like the control of vomiting. However, regarding the pain control there are conflicting views(3). Each year about £16 million is spent by the British Public for seeking complementary and alternative therapy(6). Agencies like the Royal Society of Medicine want to promote research into the effectiveness of complementary and alternative therapy. Similarly the use of acupuncture appears to be spreading in the United states(2). The number of acupuncturists also on the rise in United States and across the Globe. Henceforth, there is a strong case for encouraging properly designed trials in the grey areas about pain control from acupuncture .These can include traditional acupuncturists also in carrying out the needling process! References 1. Paterson C, Dieppe P- Characteristic and incidental (Placebo) effects in complex interventions such as acupuncture; BMJ May 2005; 330:1202-1205. 2. Ted j Kaptchuk- Acupuncture: Theory, efficacy and practice; Annals of Internal medicine 273:136:374-383. 3. Rosted P.The use of acupuncture in dentistry: a review of the scientific validity of published papers. Oral Diseases; Jun 1998; 4(2):100-4. 4. Han js. Physiology of Acupuncture; review the 30 years of research: Journal of alternative and complementary medicine -1997 Supplement 1:s 101-108. 5. Jellinger KA.Principles and application of acupuncture in neurology. Wiener Medizinische Wochenschrift. 2000;150 (14):278-85. 6. The Times 20/05/05. London edition. 7. Cheng Xinnong, ed. Chinese acupuncture and moxibustion. Beiijing: Foreign Languages Press, 1987. Competing interests: None declared |
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John P Heptonstall, Director of the Morley Acupuncture Clinic Leeds LS27 8EG
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Although I agree with much of Dr. Velayutham sankar's points, I would take issue with his statement that "Acupuncture is based on Yin-Yang and interconnection between this opposites based on Qi. Qi is an abstract concept and does not have western scientific evidence. While western medicine is based on symptoms and signs the acupuncturist diagnosis is qualitative". Acupuncture is 'based on' sticking needles in acupoints, it is not 'based on yin or yang'; it is the yin aspect of a modality called acupuncture & moxibustion, the latter being the yang aspect of that modality. The doctrine that underpins the development and usage of the technique called acupuncture, Traditional Chinese Medicine, describes a fundamental principle of nature - that the universe can be described in terms of Yin and Yang, the duality of nature. Treatments which may be given using acupuncture are designed to restore that duality, Yin/Yang, to healthy oscillating equilibrium. Qi is no more 'abstract' a concept than any concept of energy, eg electrical or magnetic, or other quantum phenomena. Just like electricity or magnetism, one can quantify and to some extent qualify certain characteristics of Qi such as movement whilst, like electricity and magnetism, one is unable to define exactly what Qi is. Like electricity, magnetism, weak and strong forces of nature the movement and quality of Qi can be modulated - by modalities such as acupuncture & moxibustion - and the principles that govern the manipulation of Qi; just as electricity and magnetism by physics, the effects of modulation and demodulation of Qi are easily described by TCM. Western scientific evidence that describes what Qi is and does includes for example skin impedance measurements, velocity measurements of Qi movement along meridians, infra red and infra sound, electric and magnetic components of Qi. Traditional Chinese Medicine diagnosis, just as Western medical diagnosis, does include analysis of signs and symptoms. There are differences in how and why these may be interpreted differently, not least because treatments are deployed through different modalities, but perhaps 70-80% of an investigation involves the gathering and interpretation of signs and symptoms little different from the average GP intervew other than the TCM interview will be far more in-depth as one is not prescribing a pill whose mode of action is hardly understood by the prescribing physician but was designed and is understood by biochemists not present; a TCM practitioner is providing a comprehensive invasive bodily treatment that is well understood by that practitioner, analogous to the understanding an electronics engineer displays when invasively correctly circuit malfunctions, and which requires adherence to principles and practices of TCM developed and handed down over recent millennia. The physician might benefit from high tech diagnostic and treatment interventions (in China these are available to TCM practitioners but much less so in the UK) whereas the TCM practitioner has a more extensive grasp of often extremely revealing visual and palpable characteristics for example of pulses, tongue, ear, foot, face, and other diagnostic interpretative tools unavailable to the western medic. As the two paradigms gain ever closer relations, patients should be able to access the best of both worlds. Regards John H. Competing interests: Practising TCM acupuncture & moxibustion specialist |
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