Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Acupuncture is not a placebo intervention.
- Edwin H Klimek (16 March 2004)
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Yes It's True
- Ned Hoke (18 March 2004)
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Acupuncture and clinical outcome
- Edzard Ernst (19 March 2004)
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Re: Acupuncture and clinical outcome
- John P Heptonstall (19 March 2004)
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A lowering of standards
- David W. Ramey (19 March 2004)
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Disapointment at lack of genuine control limb
- Nicholas Charles Mansfield (24 March 2004)
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The salubrious effect of needle sticks.
- Robert A. Da Prato, M.D. (24 March 2004)
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Re: The salubrious effect of needle sticks.
- John P Heptonstall (25 March 2004)
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Reducing the cost of headaches
- Ellen CG Grant (26 March 2004)
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Acupuncture for headache: Questionable conclusions
- Alan H. Morris (26 March 2004)
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NNTs matter
- Carlos Cuello (26 March 2004)
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Re: Reducing the cost of headaches
- John P Heptonstall (27 March 2004)
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Pleasure and headache
- Tom Hughes-Davies (28 March 2004)
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Acupunture but Design Studies....
- Felipe C. Cepeda, Ella J. Ariza eariza@javeriana.edu.co (29 March 2004)
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Placebo ethics
- David Brookman (29 March 2004)
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Acupuncture for chronic headache in primary care: patients' attitude towards acupuncture must not be forgotten
- Ulrich Ronellenfitsch (29 March 2004)
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Re: Placebo ethics
- John P Heptonstall (30 March 2004)
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not scientifically convincing at all
- Daniel K Ng, Chung-hong Chan (30 March 2004)
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not scientifically convincing at all: updated
- Dainel K Ng, Danny Chan, CH Chan (30 March 2004)
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High Type 1 error of a pragmatic trial
- Jongbae Park (31 March 2004)
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Re: not scientifically convincing at all: updated
- John P Heptonstall (1 April 2004)
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Would this trial design be acceptable for a medicine?
- Malccolm J VandenBurg (4 April 2004)
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Re: Would this trial design be acceptable for a medicine?
- John P Heptonstall (4 April 2004)
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Weekly Visits for 3 months help patients with chronic headache?
- Victor Patterson, Raeburn Forbes (7 April 2004)
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Re: Weekly Visits for 3 months help patients with chronic headache?
- John P Heptonstall (9 April 2004)
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Acupuncture as prophylactic treatment for 'chronic headache'
- Guus G Schoonman, Natalie J. Wiendels, Peter J. Goadsby, Michel D. Ferrari (13 April 2004)
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Re: Acupuncture as prophylactic treatment for 'chronic headache'
- John P Heptonstall (20 April 2004)
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What was trialed?
- John Parkinson (5 May 2004)
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Correction
- David W. Ramey (19 May 2004)
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Response from the authors
- Andrew J Vickers, Rebecca W Rees, Catherine E Zollman, Rob McCarney, Claire M Smith, Nadia Ellis, Peter Fisher, Robbert Van Haselen, David Wonderling, Richard Grieve (19 May 2004)
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Banjo lessons, and other interventions
- David W. Ramey (20 May 2004)
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Accurate Accupuncture Study
- Donald Hall (4 January 2005)
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Edwin H Klimek, none St. Catharines Ontario Canada
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Acupuncture is not a placebo intervention. It is subcutaneous and often intramuscular insertion of a fine needle at any of 2,000 (or more) sites. It is a mechanically induced trauma with puported distantly projected benefits rationalized by an oriental philosophy of care that predates both our understanding of "western" medicine and the scientific method. In this study treatment accords with teaching of current day acupunture advocates and was "individualised to each patient and were at the discretion of the acupuncturist". "Acupuncturists in the study had completed a minimum of 250 hours of postgraduate training in acupuncture, which included theory and practice of traditional Chinese medicine". This BMJ trial indicates that the measurable outcome of those receiving subcutaneous needle insertion, compared to those not receiving the needling, does not affect the number of visits to health care practioners (General practitioner, Specialist, Complementary therapist) or the number of days off sick, by a difference accountable for by chance ranging from a P value of 0.1 - 0.8. Despite this lack of statistical significance the article states "Table 4 shows data on use of resources. Patients in the acupuncture group made fewer visits to general practitioners and complementary practitioners than those not receiving acupuncture and took fewer days off sick." This is misleading. Pain related scores benefited from needle insertion. In fact, "The effects of acupuncture seem to be long lasting; although few patients continued to receive acupuncture after the initial three month treatment period (25, 10, and 6 patientsreceived treatment after 3, 6, and 9, months, respectively), headache scores were lower at 12 months than at the follow up after treatment." This is puzzling, but may be in part explained by a survivor effect. Although there were equal numbers of patients lost from the acupuncture arm of the trial (54) compared to the non acupuncture group (56), withdrawals from acupuncture because the treatment was either, ineffective, adverse or inconvenient in the acupuncture group (12) compared to zero in the regular care group. Note that nonresponders remained in the other group. This bias was not addressed. Given the modest improvement demonstrated, this trial demonstrates the relative safety of the intervention, not the benefits. As in many studies of an intervention purporting benefit there is no true control group receiving "sham" intervention, in this case acupuncture. It is also not stated if additional traditional chinese therapies were used. The patient population is striking for being overwhelmingly female (83 - 86%) with two decade history of headache. How this might be generalizeable to other groups is not addressed other than indicating acupuncture should be considered as part of NHS. Among the other concerns one might raise in this specific study is the minimal data on the groups. Data for weight, BP, or activity/exercise intervention is not presented. The lack of description of intercurrent treatment other than the statement "Use of medication use fell by 23% in controls but by 37% in the acupuncture group (adjusted difference between groups 15%; 95% confidence interval 3%, 27%; P = 0.01)." may further confound the outcome. E. Klimek MD
Competing interests: None declared |
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Ned Hoke, ecological medicine/private USA
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We acupuncturists know the actuality of this finding and this, among others, gives us great satisfaction in our work. Often working with individuals who've undergone various and sometimes extensive other forms of intervention acupuncture provides dependable therapy in many cases. If, besides acupuncture, we examine energetic etiology, look carefully at behaviors and undesirable responses to food, enviromental toxins, hypertonic states of unrelenting natures, we often can give logic for a clients personal re-creation of their living ways such that the headaches no longer are fed their necessary "food". This becomes delightful indeed as people once reduced and limited with chronic headaches literally become free. It is gratifying to see Andrew Vickers et. al. find the outcomes they have. <end> Competing interests: None declared |
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Edzard Ernst, Laing Chair in Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter EX2 4NT UK
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19/03/04 Dear Sir The interesting study by Vickers et al (1) was aimed at determining “the effects of a policy of ‘use acupuncture’”. For this purpose, the trial design was adequate and innovative. The conclusion “acupuncture leads to persisting, clinically relevant benefits” is, however, misleading. It implies that a causal relationship between acupuncture and clinical outcome has been proven. An alternative explanation of results would be that patients’ expectations caused the changes in outcome and not the acupuncture itself. This differentiation between specific and non-specific effects is not trivial. If the result is expectation dependent, it might change once the public image of acupuncture changes. If tomorrow’s papers report that acupuncture has caused the death of a film star, for instance, the public’s love affair with this therapy might end abruptly. Replication of this trial would then generate a much less encouraging result. My general point is that pragmatic trials like that by Vickers et al 1 are informative but rarely conclusive and certainly don’t constitute a basis for policy decisions. If we want to know whether acupuncture or any other treatment directly causes clinical benefit, we need other types of data. E Ernst, Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth Reference List 1. Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith C, Ellis N et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ, doi:10.1136/bmj.38029.421863.EB (published 15 March 2004). BMJ 2004;1-6. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic Leeds LS27 8EG
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Sir Edzard Ernst's response sounds more like sour grapes than science - I note that he has written disparaging articles about acupuncture and acupuncturists before and suspect that he found it difficult to offer any scientific criticism of this well designed study.(1) However, if his untested hypothesis is correct we ought to experience a massive decline in support for Western Medicine as public expectation is affected by realisation that Western Medicine is now the 3rd or 4th biggest killer and maimer of humanity after cancer and heart disease; and I hope that Prof. Ernst wastes no time informing the medical establishment of his hypothesis to offset what could become a cascade of patients refusing medical treatments adding to the problems of health services said to be in decline. Fortunately, with 60% of all consultations in the USA and 40% of all European consultations taking place with Alternative Medicine practitioners, there is hope for public health. Regards John H. Reference 1. BMJ 2000;320:523 (19 February) and Rapid Responses, especially Adrian White 2nd Aug 2000 and John P Heptonstall 4th Aug 2000. Competing interests: I practice Traditional Chinese Medicine - specialising in Acupuncture & Moxibustion |
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David W. Ramey, Veterinary surgeon, Private Practice Calabasas, CA USA
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The paper by Vickers, et al, sets disturbing precedents for publication of scientific papers by medical journals. The paper is purposely uncontrolled i.e. it does not compare acupuncture to sham acupuncture or any comparable intervention. Nevertheless, the authors claim their study is valid because it is similar to a study that DID use controls, and thus it can be used in lieu of doing it themselves. Without controls, the study has not shown acupuncture to be superior to ANY intervention. Nor has it shown acupuncture to be "cost effective." Acupuncture essentially doubled the cost of care. Of course, cost effectiveness should be considered in light of the "compared to what?" standard - other, cheaper, less invasive interventions (non-invasive electroacupuncture(?), massage (?), banjo lessons (?)) might be just as effective. There are traces of statistical sleight-of-hand, as well. In their "regression analysis" of pain scores, the authors don't post the regression coefficient (perhaps no line could fit that scattered data series well). The authors also fail to discuss why, at 28 weeks, the "control" group seems to have more "headache free days" than the acupuncture group. Perhaps there's some data mining going on. Trials such as this essentially test to see how good a placebo doctors can invent. As such, they are fraught with enormous ethical and intellectual difficulties. However, as noted in the repeated comments that "the NHS should consider further funding of acupuncture," it seems that the study goal was to pursue funding, and everything else was developed around it. No longer does it matter if an intervention really does any good, as long as patients like it and doctors can get government to pay for it. David Ramey, DVM Competing interests: None declared |
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Nicholas Charles Mansfield, GP principal West Walk Surgery,Yate,Bristol BS37 4AX
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Sirs As an NHS General Practitioner using acunpucture regularily in my surgeries I read this trial with eagerness. I have been impressed by the usefulness of this tool in my daily practice but am concerned by the paucity of objective evidence for its efficacy. The conclusion of the Cochrane review quoted in this paper clearly shows that the efficacy of acupuncture per se has not been demonstrated clearly. It is therefore not sufficent to refer back to previous studies as justification for not having a sham acupuncture limb. Without an appropriate control limb we simply do not know whether the acupuncture itself contributed to improving the patients' symptoms. As such I am very disappointed that a golden opportunity has been lost both to support me in my decision to devote time to the practice of acupuncture and to support a case for funding of acupuncture as an enhanced service. Nick Mansfield Competing interests: None declared |
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Robert A. Da Prato, M.D., Medical Officer Military Entrance Processing Station, 7545 NE Ambassador Place, Portland OR 97220
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Many years ago an elderly retired physician told me that the best non -specific therapy he had used during his entire career was an injection of a "tiny" amount of epinephrine, when his patients did not respond to more directed therapies. He said it cured a wide array of complaints, including allergy, headache, chronic aches and pains, etc. Of course I dismissed this as so absurd, it wasn't worth testing, not to mention the potential risks. Later, in my allergy career, I noted rapid relief of a variety of symptoms after intradermal and subcutaneous needle punctures. Nothing consistent, but sometimes remarkable in degree of symptom reduction, and I was always more surprised than the patient when it occurred. It is certainly possible that the benefits of acupuncture as claimed may be due simply to non-specific effects of multiple mini pains, rather than to a highly ritualized method of needle placement specific to symptoms and signs. A more realistic procedure for studies such as these would be to have a researcher armed with no knowledge of acupuncture but with an equal number of needles (and a few basic rules such as don't stick one in the patient's eye,place them with confidence,and wear a white coat)"treat" the control group. I am tempted to predict no difference in outcomes, based on my experiences using (according to acupuncturists, I am sure) very haphazard needle placement. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic Leeds LS27 8EG
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Sir If Dr Da Prato had kept abreast of international medical advancements he would know that parenteral therapy has been long and widely used in China to treat and cure many diseases. Both chemical and herbal ingredients have been injected into acupoints to good effect. I remember a study in South China, when I lived over there a couple of decades ago, I was told about by a teacher of mine who was an MD from Canton, that proved parenteral therapy better than electroacupuncture, massage and Cimetidine treatments for Stomach ulcer; The results were something like Electroacupuncture took 2 months to completely heal ulcer Chinese massage took 6 months to completely heal ulcer Parenteral therapy (injections of B6 I believe, but may have been Chinese herb) took one month to completely heal ulcer Cimetidine took two months to produce scar-healing, and did not result in complete healing of the ulcer. Ironically, the latter was one of (if not the) the World's best selling drugs at the time; obviously Dr Da Prato was not the only one unaware of the salubrious effect of needling - in this case to cure ulcers - as compared to Cimetidine at that time.... If sticking needles anywhere produced the desired effects would the Chinese have meticulously developed the system that exists now - a Nation with more pragmatists you are unlikely to find. If Dr da Prato would like to formalise research to test his hypothesis I'd be happy to advise but think he's best advised to read a few Chinese research papers first - rather than make assumptions based on the opinion of a physician who performed procedures he hardly understood - before embarking on work that flies in the face of the scientific acumen, excellent research and experience of millions of Oriental pragmatists. Regards John H. Competing interests: A practising Traditional Chinese Medicine - acupuncture & moxibustion specialist |
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Ellen CG Grant, physician and medical gynaecologist 20 Coombe Ridings, Kingston-upon-Thames, Surrey, KT2 7JU, UK
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Am I alone in finding Andrew Vickers and colleagues’ paper about treating migraine with acupuncture somewhat unintelligible?1 Surely the goal should be to prevent regular migraine attacks? If this is achieved the cost of treatment becomes negligible. Monthly headaches mostly occur in women of reproductive ages. Women are more susceptible to migraine attacks than non-smoking men probably because of vascular changes, premenstrually, in early pregnancy and when they take hormones or ergot. Most frequent and severe attacks occur in patients taking ergot medications, progesterones and oestrogens (OCs or HRT) or smoking. In each of three groups of 30 patients, monthly migraine attacks were reduced tenfold when these major precipitants were discontinued. Stopping taking hormones reduced migraine attacks from 424 to 34, stopping ergotamine from 530 to 52 and stopping smoking from 169 to 16. Advising patients to avoid cheese, chocolate, citrus food and alcohol reduced migraine attacks from 127 to 67 in the non-user control group.2 60 patients with residual headaches followed individually tailored low- allergy, high-protein diets.3 Wheat was the commonest “hidden allergen” to be unmasked after exclusion dieting. All had fewer headaches and 85% became headache free. 15 out of the 60 patients had hypertension and they became normotensive. Patients took an average of 115 tablets per month before the exclusion diets but 0.5 tablets afterwards.3 Migraine is not due to deficiency of the many drugs commonly used for treatment. Migraine attacks signal disturbed biochemistry and zinc and/or magnesium deficiencies are common. Enzyme co-factor deficiencies appear to increase adverse reactions to common foods and chemicals.4 Pregnancy and exogenous progestagens and oestrogens lower zinc and magnesium concentrations and increase copper concentrations. Zinc deficiency can be diagnosed by assessments of concentrations in sweat and white blood cells. Magnesium deficiency can be diagnosed by assessments of concentrations in sweat and red blood cells. Copper deficiency is common among past hormone users and can usually be diagnosed by a blood superoxide dismutase function test. Correcting deficiencies helps to ensure normal cell membrane transport, efficient immune function and balanced cytokine production.5 Tolerance to foods improves when nutritional deficiencies have been repleted. The costs of numerous headache medications and time off work are huge world wide. Preventing severe recurrent headaches is clearly the most cost effective treatment. However, I am in sympathy with the use of acupuncture to treat an acute headache. In the name of migraine research in the 1970s, I visited a well-known Harley Street acupuncturist. By the time I drove through London, in a car without the benefit of air conditioning, I had a headache. “Don’t worry”, said the expert “I’ll soon fix that.” A point between my big and second toe was chosen and my headache immediately improved. With a second twirl of the needle the headache was gone. He said headaches had become more difficult to treat than they use to be because so many women were taking hormones. Ellen C G Grant 20 Coombe Ridings, Kingston-upon-Thames, Surrey KT2 7JU, UK 1 Vickers AJ, Rees RW, Zollman CE, McCarney R, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ 2004:328:744, doi:10.1136/bmj.38029.421863. 2 Grant ECG. Oral contraceptives, smoking, migraine, and food allergy. Lancet 1978; 2:581-582. 3 Grant ECG .Food allergy and migraine. Lancet 1979; 2: 358-59. 4 Grant ECG. The pill, hormone replacement therapy, vascular and mood over- reactivity, and mineral imbalance. J Nutr Environ Med 1998; 8: 105-116. 5 Sherman AR. Immune dysfunction in iron, copper, and zinc deficiencies. In: Bodgen JD, Klevay LM, eds. Clinical Nutrition of the Essential Trace Elements and Minerals: The Guide for Health Professionals. Totawa, NJ: Humana Press Inc., 2000: 309-331. Competing interests: None declared |
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Alan H. Morris, Professor of Medicine, Adjunct Prof. of Medical Informatics, U of Utah Pulmonary Division, LDS Hospital, Salt Lake City, Utah ,84143, USA
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I applaud the efforts of Vickers et al. (and those of Wonderling et al.) dealing with the evaluation of acupuncture for headache. The authors may be correct about the effectiveness of acupuncture, but I believe their methods are deficient and do not lead to highly credible conclusions for the following reasons: 1-The acupuncture intervention actually included referral and transportation to a specialist, the touching of skin with needles, and the penetration of the acupuncture needles (plus associated unspecified encounters in the specialists office). Note that the control group did not experience any of these intervention components. 2- The effect they observed (the difference between 34% and 16% responses) is small compared to well know non-specific effects like the placebo effect. 3- The signal to noise ratio for response is small and required powerful mathematical manipulation (see their figure for distribution of responses). 4- The methods do not include enough detail to allow adequate scrutiny. The authors conducted an effectiveness trial before evidence from an efficacy trial indicated the intervention to be efficacious. The authors took the risk that an effectiveness trial (pragmatic trial) would encounter a signal to noise ratio large enough to make the results and conclusions obvious. Unfortunately this is not the case with their study of headache. Their study does, to their credit, raise important questions. Is the small effect of their intervention due to referral to specialists, to touching the skin with needles, to penetration of the skin with the acupuncture needle, or to due to other unrecorded exposures (confounders) at the acupuncturists site? These questions should be answered before serious consideration of policy change is engaged. Competing interests: None declared |
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Carlos Cuello, ITESM Av. Morones Prieto 3000 pte 64710 Monterrey, Mexico
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I read with interest the article of Vickers et. al. I have always been reluctant to use alternative medicine because I was waiting for some more evidence to recommend this treatment option. However, the numbers are showed clearly, the reduction in frequency of "clinically relevant" symptoms at 3 months is 10% (95% CI 2,19) and at 12 months is 15% (95%CI 6,25) which results in a number needed to treat of 7 at 12 months (obviously, with a 95%CI of 4 to 16). This study shows a good methodology, with some flaws already stated by the authors. Is in our hands to recommend or not this treatment to patients asking for other options, and we now have the evidence to tell them that for every 7 or 16 patients in acupunture, one good result will be obtained (at the twelth month)... the table is open for disussion. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre LS27 8EG
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Sir How refreshing it is to read Ellen CG Grant's response on the subject - at last a physician who recognises the importance of diet, lifestyle and enviorment in illness - not least migraine - and is willing to reproduce that advice on the eBMJ. I inform all migraine patients (and patients with various disorders that respond remarkably to such alterations) they could expect dietary and environment changes that I suggest to provide perhaps 70 to 80% of the curative effect. The 'acupuncture' serves to correct physiological, and other, imbalances that represented the illness and allowed for greater sensitivity to exogenous effects. With acupuncture & moxibustion, and attention to dietary and lifestle advice, patients recover much more rapidly than with either alone. Although Trad. Chinese Medicine (TCM) recognises that certain types of foods (and lifestyles) affect certain types of disorder, it also requires that every patient is unique and therefore every piece of treatment and advice must be individualised to that patient to ensure complete recovery. Regards John H. Competing interests: None declared |
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Tom Hughes-Davies, Retired paediatrician Breamore Marsh SP6 2EJ
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Patients whose treatment was unchanged improved when they kept diaries. That a greater, though statistically borderline, improvement followed 8 or so half hour sessions of encouragement and needling is not surprising. The paper demonstrates the effect of a change of interest on headache sufferers. That this is peculiar to acupuncture is not shown. Learning to use a computer or buying (or getting rid of) a cat might well be as effective. Competing interests: None declared |
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Felipe C. Cepeda, General Practitioner Bogota, Colombia, Ella J. Ariza eariza@javeriana.edu.co
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In the article Vickers et al give their conclusion as clinical improvement of the patients who receive acupuncture as treatment but the value of the p was statistically relevant only for the role functioning physical and levels of energy but for Physical functioning, Role functioning emotional, Emotional well being, Social functioning, Pain and General health do not show a statistically meaningfully change which do not represent since our point of view a real progress in Health change. In other way they mentioned a persisting benefits but the follow up was for one year that we consider is not a real persisting benefit in patient with a Chronic Headache. One more point refers to the methodology because patients were randomised to a policy of "use acupuncture" or "avoid acupuncture.", will be useful to know if they had in mind the Hawthorne effect and a possible halo effect as the cause of the bias for the results since the patients who receive the acupuncture may unconsciously be hoping for a better result since they were receiving an extra treatment . This may be avoided becoming the non acupuncture group in an acupuncture group who receive needle treatment for example for other indications. There is not clear if in the acupuncture treatment the Chinese diagnostic was made and the oriental medicine protocols were used in the differential diagnosis and management for these patients. For more information this are some recommended lectures: 1. Performing systematic reviews of clinical trials of acupuncture: problems and solutions. White, A., Trinh, K., and Hammerschlag, R.; Clin Acupunct Orient Med 2002, Vol. 3(1) p.26-31 2. http://www.psy.gla.ac.uk/~steve/hawth.html Competing interests: None declared |
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David Brookman, senior lecturer Australia 2308
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There is some disquiet raised by your publication of this article. The first is the assumption that a placebo effect is a patient benefit - this may be true in a system where there is no primary cost to the consumer but if an unproven remedy is marketed then the selling of the remedy is fraudulent. Your article will be used to justify the use of acupuncture to induce placbo efects in patients in much of the world for money. Secondly providing a placebo remedy requires convincing the patient that the remedy is beneficial, if there is no evidence to support benefit (and your unblinded study does not prove any benefit merely belief) then this offends one of the principles of medical ethics that of patient autonomy. I would be most interested in seeing this study repeated with sham acupunture, or with participant consent being obtained by a non believer in acupuncture. Competing interests: None declared |
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Ulrich Ronellenfitsch, PhD student in epidemiology University of Heidelberg, Dpt. of Tropical Hygiene and Public Health, 69120 Heidelberg, Germany
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Sir, in a randomised control trial, Vickers et al. find that migraine patients receiving acupuncture in addition to "usual" care have a lower headache score than those receiving usual care alone.(1) They recommend an expansion of NHS acupuncture services and, in the same issue, Wonderling et al. consider it a cost-effective intervention.(2) By recruiting patients from GP practices, the study overcomes the limitation of numerous previous studies which included only attendants of specialised institutions such as headache clinics.(3) Nevertheless, the patients recruited here might still not be an unbiased sample of all migraine patients in the study region. The will to enrol in a clinical trial where acupuncture is one of the offered treatments might depend to a large extent on one's general attitude towards acupuncture. Someone who a priori doesn't believe in this "alternative" treatment might not want to participate in such a trial but opt exclusively for "standard" treatment. Consequently, patients believing in acupuncture might enrol more frequently than those who don't do so. This, however, would distort the results considerably. Those receiving acupuncture might experience a much stronger effect of treatment since it is their preferred method whereas the therapeutic effect in the control group might diminish because the patients are not given their favourite treatment. This would lead to an overestimation of the difference in headache scores. To account for that bias, Vickers et al. should have asked participants as well as those who declined participation for their attitudes towards acupuncture and examined possible differences. I do not doubt that acupuncture can be an effective treatment for migraine patients believing in that method but its recommendation as a cost-effective intervention for every migraine patient lacks sound evidence. (1) Vickers AJ, Rees RW, Zollman CE, McCarney R, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ 2004;328:744-7 (2) Wonderling D, Vickers AJ, Grieve R, McCarney R. Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care. BMJ 2004;328:747 (3) Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial. J Intern Med. 2003;253(2):181-8 Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre LS27 8EG
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Sir An interesting response from Dr Brookman as he tries to corrupt public perception by mixing concepts of placebo, patient benefit and proof for acupuncture, with fraud utilising this study and stating as evidence that... "an unproven remedy is marketed then the selling of the remedy is fraudulent" and deciding that "Your article will be used to justify the use of acupuncture to induce placbo efects in patients in much of the world for money". He conveniently (or naively) ignores the fact that fraud cannot be alleged as his government, our government, the US government and those of China, Japan and Korea have acknowledged (on behalf of their peoples) that acupuncture is valuable for health - as did the World Health Organisation which, after analysing the data, in 1981 recommended acupuncture for the treatment of over 40 diseases from ENT, through musculoskeletal, to autoimmune. Furthermore, it is acknowledged by billions of people worldwide that 'acupuncture' works for headaches and migraine. Their acceptance of the technique is testament to its worldwide acceptance and intrinsic value - marketing its use in accordance with this study cannot defraud those persons. Acupuncture has performed far better than placebo in hundreds of well documented studies in China proving that acupuncture works for migraine and headaches. This study takes a different slant - it asks if acupuncture is worthwhile when provided by certain people working from certain centres. The Traditional Chinese Medicine doctrine that underpins usage of the technique informs how and why acupuncture works for migraine and headaches. Vickers et al are not teaching us anything we do not know about acupuncture per se, they are informing the public that one can improve migraine and headache by visiting certain centres like those used in the study, and can save valuable taxpayers money as well. There is nothing fraudulent about this study, or what it conveys to the public, and therefore the publication of the study cannot serve to defraud the public; it tells it as it was found, with no intention to defraud. Fraud necessarily involves criminal deception, that one acts in a deceitful way. There is no evidence that either Vickers et al or the BMJ seeks to support public deception, nor seeks to support defrauding the public, and the study has much in common with the findings of the recent published study from Freiburg, Germany (BMC Public Health 2004, 4:6). Perhaps Dr Brookman could elaborate on the evidence he has which supports his allegation of Vickers etal, or the BMJ, supporting fraud? Such accusations by Dr Brookman are misplaced, and one must wonder what he stands to gain from making such allegations - insinuations about health fraud, and that acupuncture is a fraudulent unproven practice, resonates with the mentality of the Quackpot fraternity ( see http://www.ncahf.org/pp/definitions.html) - is Dr Brookman a Quackpot supporter, if so perhaps he could look very closely at the definitions they adhere to and recent findings against senior members in the US courts? Sham acupuncture does not exist, and 'non-believers' are irrelevant - acupuncture has long been shown to work with or without belief - in humans and other animals. Regards John H. Competing interests: I am a practising Traditional Chinese Medicine - acupuncture & moxibustion specialist |
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Daniel K Ng, Consultant Paediatrician Kwong Wah Hospital, Hong Kong, 852, Chung-hong Chan
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Dear Editors,
We are writing in response to the article “Acupuncture for chronic headache in primary care; large, pragmatic, randomized trial” by Vickers et al1. Cochrane review of the randomized trials of acupuncture for headache concluded the quality and amount of evidence are not fully convincing.2 However, we believe that this conclusion will remain status quo even after this large study by Vickers because Vickers’ study is not scientifically convincing at all.
The study design of Vickers’s trial was seriously faulted as the acupuncture sites used were highly individualized among patients. To make the situation even worse, the acupuncture sites selected, the depth and duration of needling, size of needle used for each patient were not recorded at all. Inadequately elaborated protocols of acupuncture in Vickers’s manuscript hindered other researchers to reproduce their results. Irreproducible results are invalid scientifically. Prescriptions of acupuncture by different methods give significantly different outcomes. Grouping acupuncture to different sites as one type of treatment is simply unacceptable as acupuncture sites in different location are seen to correspond to different physiological and anatomical features.3 Previous publications by the same authors concluded that the high proportion of positive results of Medline-indexed controlled trials in acupuncture conducted in East Asia and Eastern Europe was related to different level of methodologic rigor.4 In our opinion, the recent study by Vickers et al1 serve as a superb example of positive results attributed to lack of methodologic rigor.
Daniel K. Ng* M Med Sc, FRCP Consultant Pediatrician Chung-hong Chan BSc Research Fellow Department of Paediatrics, Kwong Wah Hospital Waterloo Road, Hong Kong SAR, China References: 1. Vickers AJ, Rees RW, Zollman CE et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ. 2004; 328: 444-0 2. Melchart D, Linde K, Fischer P, Berman B, White A, Vickers A, Allais G. Acupuncture for idiopathic headache (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd. 3. Vickers A, Zollman C. ABC of complementary medicine: Acupuncture. BMJ 1999;319:973-976 4. Vickers A, Goyal N, Harland R, Rees R. Do Certain Countries Produce Only Positive Results? A systematic Review of Controlled Trials. Controlled Clin Trials. 1998;19:159-166 Competing interests: None declared |
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Dainel K Ng, Consultant Paediatrician Kwong Wah Hospital, Hong Kong (852), Danny Chan, CH Chan
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Dear Editors,
We are writing in response to the article "Acupuncture for chronic headache in primary care; large, pragmatic, randomized trial" by Vickers et al.1 Cochrane review of the randomized trials of acupuncture for headache concluded the quality and amount of evidence are not fully convincing.2 However, we believe that this conclusion will remain status quo even after this large study by Vickers because Vickers’ study is not scientifically convincing at all.
Daniel K. Ng*
Danny Chan
Chung-hong Chan
Department of Paediatrics,
1. Vickers AJ, Rees RW, Zollman CE et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ. 2004; 328: 444-0
Competing interests: None declared |
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Jongbae Park, ILMAEK Korea Research Fellow Complementary Medicine, Peninsula Medical School, 25 Victoria Park Rd, Exeter, EX2 4NT
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I read Vickers et al. and applaud their painstaking efforts to determine the effects of a policy of “use acupuncture” on headache in comparison with that of “avoid acupuncture”. [1] The authors’ research questions and the methods opened my vision to a new research arena, i.e. societal perspectives of acupuncture practice beyond medical science. While appreciating several justifiable merits of the methods, I am concerned about the solidity of their conclusions as discussed below. The strongest argument could be that the study is not blinded. The headache score and SF-36 as the primary and a secondary outcome measures, respectively are both self assessments. Therefore, all potential confounding factors that joining in a trial and receiving acupuncture treatments may create in real life might well have influenced the outcomes. These include the extra attention, time spent with the patient, physical touching, and the patient’s expectation corresponding to the above as well as actual acupuncture. Although the nature of a pragmatic trial has difficulties in excluding confounding factors and this may always be true in the real world, but using an objective outcome measure could have yielded cleaner data than this study. In addition, the patients allocated in the control group who were not included in the active acupuncture cohort, despite their original motivation to take part in an acupuncture trial, may have felt left out and the effect of disappointment might have influenced the outcomes. With regard to the effect of the patients’ expectations, with appreciation of the advantage of a pragmatic trial, one can design a 6-arm trial to determine the effect of both expectation and the actual receiving of acupuncture. At interview, patients can be divided into 3 groups in respect of their positive, negative, or neutral expectations. They are further allocated into either acupuncture or standard care through randomisation. Comparison between each group can identify the differences that are generated by their differing expectations. [Figure] As the pragmatic trial design does not test the effects of a therapy but those of a policy or service, the claims based on such a study should not be separately made for the therapy applied by itself, nor used to promote the therapy in different service settings. However, I am anxious that this study can be seen as an evidence of proving the effects of the physiological action of needle insertion as the authors foresee. In conclusion, this applaudable study may have a high Type 1 error (false positive), but opened wide discussion regarding the use of pragmatic trial design in acupuncture research, and highlights the extra caution required in the interpretation and utilization of the results. 1. Vickers AJ, Rees RW, Zollman CE, McCarney R, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ 2004:328:744, doi:10.1136/bmj.38029.421863. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre LS27 8EG
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Sir I think Daniel and Danny are mistaken saying that 'Vicker's study is not scientifically convincing at all' - some of my reasons for disagreeing with the pair are given in Jongbae Park's enlightened response of the same date - basically this 'pragmatic' study was not designed to test the kind af acupuncture used but to compare 'use acupuncture' with 'avoid acupuncture'. One cannot say there was a 'serious fault' because points were individualisation per patient. That is how acupuncture is performed socially and traditionally. Records of needle insertion, depth, duration are not essential for publication but, I agree with Daniel and Danny, they would add to the overall flavour and provide useful information for those interested. 'Reproduction of the results' through further trials would be valuable, more pragnmatic trials ought to be encouraged. Traditionally, interventions are individualised by all the different types and styles of acupuncture/acupuncturist involved, who use different methodologies, and whose practices originated from different working models (eg Japanese, Korean, TCM, western medical, auricular etc.) so ideally that is how they should be represented scientifically. One should also hold trials which investigate point selection methods, diagnoses and prescriptions, various protocols, so it is possible to elucidate what acupuncture is, does and how it works (in a Western sense as well as in every sense it is modelled) - this was not such a trial. As Daniel and Danny say 'prescriptions of acupuncture by different methods' can 'give different outcomes'. That is not unlike different prescription drugs given for similar diagnoses depending on physician eg. anti-convulsants or anti-depressants can result in different outcomes - that's the nature of medical interevntion and is why pragmatic trials are valuable using practitioners from different 'schools of thought'. For myself, what Vickers et al have done is set up a scenario analogous to two streets, one sporting GPs and the other physio- acupuncturists - the former 'avoid acupuncture' and the latter 'use acupuncture'. Randomised sufferers walk along one or other street and enter for treatment (I would have preferred one street to have used only acupuncture, not 'acupuncture plus standard treatment', but that is another protocol). In this case I would also have liked to see a third street 'confuse acupuncture' where different kinds of acupuncture were available (Japanese, Korean, auricular, Western medical, TCM, etc.) as that is the more common scenario a member of the public would find when looking to 'use acupuncture'. Who the practitioners are, what their preferences are, how they worked, what diagnoses and prescriptions were used, though recorded, why particular persons benefitted or not need not be published in this case. The outcomes have been recorded as a subsection of society who 'used' or 'avoided' acupuncture. The various outcome measures gave a strong indication that to 'use' acupuncture one gained certain benefits beyond those who 'avoid' acupuncture - subjective outcome (improvements in symptoms, energy etc) and objective outcome (days off sick, physician visits, reduction in medication etc.) - being what patients actually experience in the real world. Researchers tend to forget that the 'research trial world' (where one can almost endlessly select protocols to control, blind or confound for almost anything) is not necessarily the best representation of the real world. The GlaxoSK Chairman recently announced (despite all the RCTs and their statistical validity of trialling drugs) that most drugs work for only about 20% of real people. Clearly we need to see more pragmatic trialling of drugs and, as alternative medicines are already a majority public choice, drug treatments ought to be regularly pragmatically trialled against alternative medicines. Daniel and Danny suggest it would have been 'more clinically relevant' to use GB20 and TE21 for RCT purposes - I could suggest another dozen acupoints that may be as relevant not least LIV3, LIV2, Sp6, GB21, GV20, TE5, UB23, S36 etc. with equally good reasoning but the point is that TCM practitioners do not work in that way, and Vickers et al used 'physios trained in TCM'. All persons who use acupuncture should study the doctrine and principles of TCM, and apply these in practice then 'acupuncture clinical research' could concentrate on using acupuncture as it was intended and not as a means to provide a few limited (in value and scope) acupoints to 'impact on daily clinical practice'. All such practice is doing is 'single point acupuncture' which is not good acupuncture according to TCM. Short cut acupuncture serves the physician not the patient in my opinion. It is little different from giving every patient with a sore throat any antibiotic that in trials has been shown to 'work for some sore throats'. One would hope that a physician would perform an indiviualised diagnosis using appropriate diagnostic tools before deciding which, if any, antibiotic is most likely to serve the patient well. Patients deserve the same value from acupuncture intervention. I would like to end by saying that I had the pleasure of working at Kwong Wah Hospital in Kowloon on several occasions with one of my TCM teachers, who I used to help on her rounds visiting private practice patients there, almost 20 years ago now. It has a very good reputation and I was impressed by the acceptance of traditional practices alongside western medical practices (one rarely saw at QE or QM hospitals) so many years ago. I also understand the trend towards 'single point' acupuncture, driven more by political/medical scientific expediency than good scientific scrutiny of the traditions, it also encroaches into daily practice in the west through 'western medical acupuncture'. More pragmatism, and less politics, in science would greatly help all of us and our patients. Regards John H. Competing interests: None declared |
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Malccolm J VandenBurg, Pharmaceutical Physician 114Harley StreetW1G 7JJ
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I am sure this research project entailed an enormous ammount of hard work in planning, co-ordination and analysis. It ticks presumably all the right boxes for ethical approval. informed consent and statistical analysis. It concludes that accupuncture leads to persisting clinically relevant benefits, by randomising patients to standard care or this plus twelve additional accupuncture sessions. Those in the accupuncture group received far more proffessional contact from caring people. Throughout the history of clinical trials such contact has been shown to improve outcomes. Patients love to be cared for and respond appropiately. The authors in their section on "Limitations" mention there is no "sham accupunture" group and dismiss possibilities of bias and the relevance of a placebo effect. Indeed they say "in everyday practice patients benefit from placebo", as if to justify the possibility that this may have contributed to the effect. In the "what is already known section" of the article it says that "The methodoligical quality of previous studies has been questioned". Surely the same must be said of this study. If a pharmaceutical medicine had been studied in this way there would be an outburst of indignation in relation to the conclusions. I am not sure why we have these double standards. I have no doubt accupuncture is beneficial for pain, and use it for myself and my patients. I am however not sure that this article takes the scientific rationale for its use any further forward. Competing interests: I am a pharmaceutical physician whom has received an income from the pharmaceutical industry in the past and continue to consult for the industry |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre Leeds LS27 8EG
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Sir I think the design creates an excellent concept for trialling drugs 'in the market place' after the round of various trial phases is complete - toxicology, RCT etc. and have found a drug safe and effective. Unlike all modern drugs, acupuncture has been shown to be safe and effective over millennia so drugs require different protocols at first to ensure safety - bearing in mind that they are largely resposnible for modern medicines position as the 3rd or 4th biggest killer and maimer of mankind - so great caution must be taken before unleashing any into the public arena. Once they become accepted for public consumption, the various drugs could be trialled for efficacy and effectiveness against acupuncture, and other modalities, as per the Vickers et al concept - pragmatically. Trialling drugs as acupuncture was trialled in this study -where the prescription was left to the style, experience and discretion of the practitioner - we should soon begin to see the realty of primary care prescribing; it could also reveal trends in prescribing, costs, patient satsifaction, and many other outcomes and variables in drug prescribing etc. the like of which we rarely, if ever, realise from current drugs research methodology. I'm not sure how popular this would be with pharmaceutical companies but I think it would be in the public interest. Regards John H. Competing interests: None declared |
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Victor Patterson, Consultant Neurologist Royal Victoria Hospital, Belfast, UK, Raeburn Forbes
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You claim in This week in the BMJ (27/03/04) that the paper by Vickers et al shows that acupunture is beneficial for chronic headache disorders. We would take issue with that claim because the design of the study does not make it clear what was causing the modest effect which the authors noted. The treated arm of the study received 3 treatments which were not received by the control arm: these were, first, input from another human being for a mean of 11 sessions, second, insertion of needles, and third, insertion of needles in accordance with acupuncture prescriptions. Both the BMJ and the authors may attribute the effect to the third treatment and as pragmatic neurologists (who see large numbers of these patients) we may attribute it to the first, but sadly both these conclusions are equally speculative because the design of the trial does not separate them. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre LS27 8EG
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Sir I would be most grateful for research references from Dr Patterson that support his contention that any person who "visits another human being for input for a mean 11 visits" will invariably see an improvement to migraine/chronic headaches that exceeds the results expected from visits, as made in Vickers et al study, to GPs for standard care. I could then refer to these to justify telling chronic migraine/headache sufferers (that I usually benefit with as many acupuncture & moxibustion treatments as it takes - supported with dietary and lifestyle advice) who have run the gauntlet of GPs and neurologists for decades to no avail that another alternative is to seek "another human being who will provide input for a mean 11 visits" to attain the elusive improvement. If that intervention works, as Dr Patterson and other "pragmatic neurologists" suggest, why do neurologists and GPs insist on prescribing drug regimes for so long without benefit when 11 visits to a human being may suffice; and why have I never heard from a patient that they were advised by their physician to try the "11 visit to a human being" approach? Regards John H. Competing interests: None declared |
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Guus G Schoonman, Research fellow Department of Neurology, Leiden University Medical Centre (2333 ZA, Leiden, the Netherlands), Natalie J. Wiendels, Peter J. Goadsby, Michel D. Ferrari
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Dear editors, Vickers et al conclude that "acupuncture leads to persisting and clinically relevant benefits for patients with chronic headache"(1). We compliment the authors for their laudable attempt in conducting such a complicated pragmatic trial but we are inclined to arrive at opposite conclusions. We feel that the observed differences versus control were clinically irrelevant, and that the control group was "doing much worse" than to be expected rather than the acupuncture group "doing better" . The primary efficacy score (weekly headache score) is unusual, not recommended by accepted guidelines(2), and not validated with respect to reliability, reproducibility and clinical relevance. Its calculation is not explained unambiguously. As we understand it, headache severity was assessed four times daily on a 0-5 score. Thus, the maximum weekly headache score is 7 x 4 x 5 = 140. The weekly headache score improved after one year from 24.6 to 16.2 in the acupuncture group and from 26.7 to 22.3 in the usual care group. This is a difference of 4.6 on a total scale of 140 (3.3 %). We are uncertain as to the clinical relevance of this statistically significant difference. The average baseline weekly headache scores were 24.6 and 26.7 and the (calculated) average weekly number of days with headache is around 4. From this we would calculate that the maximum average headache severity per day was 26.7 / 4 days / 4 assessment points = 1.7. This is less than grade 2, which was defined as "mild headache that can be ignored at times". Such a low severity is extremely unlikely for migraine headaches(3) The lack of a clinically relevant improvement is also reflected in the minute or even statistically barely significant improvements for the secondary outcome measures. For example, after one year the difference in reduction of number of headache days per month is 1.8 days with an average headache severity of less than grade 2. Is this a clinically relevant gain? Similarly, out of 9 SF-36 health status scales, only one showed a statistically significantly improvement. We are also unsure as to whether the one year primary endpoint assessment was based on patients continuing to assess their headaches scores 4 times daily for 12 months, or on a one week assessment at the end of the year. The first would be highly unlikely, the second is statistically unsatisfactory. Another major problem seems to be the lack of a sham procedure in the control group and the unblinded design with "open randomisation". The authors describe that suitable patients were actively invited to participate in this study, but then 50% were randomised to no treatment other than usual care. In contrast to blinded controlled studies where patients do not know that they have been assigned to "no treatment", here patients were fully aware and may have been greatly disappointed, potentially resulting in a negative placebo effect. This could explain the remarkably low response in the control group of only 15% at three and 12 months for both the weekly headaches score and the proportion of patients with at least a 50% reduction in days with headache. This compares unfavourably with the usual placebo effects of 20-40%(2) found in migraine prophylaxis studies. The acupuncture responder rate of 30% is also much lower than is usually seen for active treatments in migraine prophylactic trials and more in line of what is seen for placebo rates(2). Finally, we are concerned that 6% of the study patients did not have migraine, but instead tension-type headache. Because of the fundamentally different pathophysiological basis of both disorders, this doesn't seem to help to understand why acupuncture would work in the first place. Why not excluding these patients from the analysis? The new work places complementary therapies squarely on the agenda for research, but can in no way be taken as proof for the effect of acupuncture in the treatment of migraine. Moreover, it certainly should not be a basis for funding widespread uncontrolled application of this approach. Guus G. Schoonman, Research fellow Department of Neurology Leiden University Medical Centre, Leiden, The Netherlands Natalie J. Wiendels, Research fellow Department of Neurology Leiden University Medical Centre, Leiden, The Netherlands Peter J. Goadsby, Professor of Neurology Institute of Neurology The National Hospital for Neurology and Neurosurgery, Queen Square London UK Michel D. Ferrari, Professor of Neurology Department of Neurology Leiden University Medical Centre, Leiden, The Netherlands References 1. Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith CM, Ellis N et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ 2004;328:744. 2. Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000;20:765-86. 3. Goadsby PJ, Lipton RB, Ferrari MD. Migraine- current understanding and treatment. N.Engl.J.Med. 2002; 346:257-70. Competing interests: None declared |
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John P Heptonstall, Director of The Morley Acupuncture Clinic and Complementary Therapy Centre Leeds LS27 8EG
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Sir I think it only fair, and in the public interest, that any respondents to this paper who have/have had a professional and/or financial interest in remedies for headaches and migraine that 'compete with' acupuncture should declare those interests. I have read that Prof. Ferrari may have received funding from various pharmaceutical companies including Glaxo Wellcome (1), and Prof. Goadsby has held the position of Wellcome Senior Research Fellow (2), therefore pharmaceutical companies that are involved in the production of headache and migraine remedies. Regards John H. References (1)http://www.kopzorgen.nl/nieuws/nieuws24.html (2) http://www.ion.ucl.ac.uk/~headache/staff.html Competing interests: I am a practitioner of Traditional Chinese Medicine acupuncture & moxibustion |
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John Parkinson, Dept. Community Health Sciences University of Dundee DD1 9SY
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Properly conducted high quality trials of any healthcare intervention are a must and properly conducted trials of therapies such as acupuncture should be funded and conducted more often than is the current norm. However, in this study it is difficult to assess what about acupuncture was actually on trial. Clearly, acupuncture needles, gauge unknown, number unknown, were inserted somewhere, to some depth, for some time, using some acupuncture technique, for some number of treatments by 12 Physiotherapists in the patients allocated to receive acupuncture. We also know that those physiotherapists had some training in Traditional Chinese Medicine (TCM). What we do not know is, whether the way the acupuncture was given at each treatment was based upon the western diagnosis or a TCM diagnosis. The paper does state that treatment was individualised to each patient but does not report on how such was decided. The study would therefore seem to be the equivalent of a trial reporting "Any drug for chronic headache" versus some other form of care! Would such a trial ever get ethical approval unless powered in such a way that sub-group analysis of, at minimum, each class of drug could be undertaken. It would therefore seem that this trial missed a real opportunity to make fundamental progress in our understanding about acupuncture. It should have been powered to allow for at least some level of sub-group analysis based upon protocoled "needle insertion plans" and or TCM diagnosis. Acupuncture in the UK is given by 4 groups of people- 1) those with a recognised TCM qualification 2) GPs who have undertaken some training in acupuncture but do not use TCM diagnosis 3) Physiotherapists without advanced training who do not use TCM diagnosis 4) Physiotherapists with advanced training who may or may not use a TCM diagnosis. What does each of these groups learn from this study? I am not sure. Competing interests: 5 years ago I undertook some consultancy for the British Acupuncture Council |
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David W. Ramey, Private veterinary surgeon Calabasas, CA USA 91311
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In my critique of Dr. Vickers' paper, I incorrectly read Figure 2. I apologize for the erroneous comments drawn from that misreading. Rather than comparing treatment effects at 28 days, the graph appears to show a mild benefit of acupuncture in a subset of patients, with other patients, those with very few or very many headaches (28 days per month), appearing to show no benefit from acupuncture. I also note that my comments about statistical sleight-of hand might have been taken as offensive. They were not intended as such. Other responses amply demonstrate the problems with both the study and the statistical interpretations therein, comments with which I wholeheartedly agree. David Ramey, DVM Competing interests: None declared |
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Andrew J Vickers, Assistant Attending Research Methodologist Memorial Sloan-Kettering Cancer Center, NY, NY 10021, Rebecca W Rees, Catherine E Zollman, Rob McCarney, Claire M Smith, Nadia Ellis, Peter Fisher, Robbert Van Haselen, David Wonderling, Richard Grieve
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Our trial has clearly raised a great deal of comment. We will try to address the issues raised by each respondent. A number of correspondents seem to have misunderstood the question we were seeking to answer in this trial. This was a pragmatic rather than explanatory trial. The research question was ‘Does acupuncture make a worthwhile difference to primary care patients with headache?’, not ‘Is acupuncture better than a placebo?’ The intervention was one which could easily be applied in the NHS, and used a group of acupuncturists with common professional background and training, while allowing them judgment in precisely what intervention they applied. We believe that we have shown that this intervention is effective and that the conclusions are directly generalisable to NHS primary care. Dr Klimek complains that we claimed lower resource use (e.g. GP visits) in the acupuncture group despite lack of statistical significance. Whilst this point is well taken, our statement is correct as written. Moreover, we think that statistical significance has a questionable role as regards resource use. Our analytic strategy was to A) determine whether acupuncture has clinical effects such as reduced headache; B) if so, estimate the resource implications of acupuncture. Statistical significance is an important part of A, but not B, because your decision is a clinical one. Now you might find out that the resource implications of a clinical decision might make you change that decision, for example, if a treatment worked, but was far too expensive. But you don't start by looking at cost, otherwise you would use ineffective drugs just because they were cheap. Klimek also argues that no patients dropped out of the control group because treatment was ineffective. This is simply because these patients did not receive on-study treatment and we did not offer them this as an option when asking about reasons for withdrawal. It is not true that "this bias was not addressed" as we undertook careful sensitivity analysis as described on bmj.com. Note that 96% of patients provided post- randomization data. We can also recommend Klimek consults table 2 to answer questions about concurrent medication. We agree with Professor Ernst that pragmatic trials do not stand alone and require other types of data. Were our study to be the only trial ever conducted on acupuncture for headache we agree that it would not form a basis for policy decisions. However, our trial can be put in the context of a Cochrane review. This review included a total of 11 trials comparing acupuncture to placebo acupuncture in patients with migraine. Two found no effects over sham acupuncture, three showed trends in favor of acupuncture and five trials reported that patients in the acupuncture group did significantly better than those in the sham acupuncture group. The final trial reported a positive trend but was judged to be uninterpretable due to the high drop-out rate. We would like to assure Dr Ramey that comparison of clinically reasonable alternatives such as standard care versus standard care plus new therapy are routine in the medical literature. Ramey claims that acupuncture is not "cost effective" on the grounds that it "doubled the cost of care". This is despite our careful analysis of whether acupuncture was worth the additional costs using standard techniques and varying the threshold of willingness to pay. Ramey argues that acupuncture might be less effective than other interventions, and gives banjo lessons as an example. We completely agree. This is, of course, an argument against any trial. For example, one could look at the recent topiramate trial and claim "okay, topiramate was better than placebo. But was it better than banjo playing?" We repudiate Ramey's suggestion that we engaged in statistical sleight-of-hand. Ramey misreads figure 2: he questions the results of the control group "at 28 weeks", when the X axis is "headache days at baseline", thus turning his own mistake into a deliberate attempt to mislead on behalf of the authors. Ramey engages in further ad hominem argument when claiming that we repeatedly state: "the NHS should consider further funding of acupuncture" (which we never do) because our goal was to obtain funding for a therapy. This reduces scientific debate to accusations about motives, a datum, of course, to which we have no access. Numerous respondents, including De Prato, Mansfield, Patterson, Brookan and Brinkman ask, in short, could acupuncture have been a placebo? Morris puts it well when he points out that "the acupuncture intervention actually included referral and transportation to a specialist, the touching of skin with needles, and the penetration of the acupuncture needles". We agree that, taken alone, our results do not address the extent to which the effects of acupuncture are due to "penetration of the acupuncture needles". This is because our trial did not set out to answer this question. Nonetheless, our trial, like all clinical trials, needs to be put in the context of other research, such as the Cochrane review cited above. We do accept the criticism that our choice of words was not always optimal. We randomised patients to policies of either "use acupunctur | |||