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Rapid Responses to:
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Electronic letters published:
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In Response
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Peter J White, Ph.D. University of Southampton, G Lewith
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P.J.White{at}Soton.ac.uk Peter J White, et al.
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The Editor Annals of Internal Medicine Dear Sir, We would like to reply both to the editorial and to the fast response regarding our paper on the use of acupuncture for the treatment of chronic mechanical neck pain(1). We agree, as pointed out in our paper, that a weakness of this study was the fact that only one practitioner provided treatment and this might have implications with respect to its generalisability. However, both Professor Ernst in his letter (on line fast response page) and the editorial comments make the same error in interpreting our results and conclusions, i.e. that of confusing effectiveness and efficacy. We believe that this is an important distinction. From the results it can be clearly seen that acupuncture did indeed have a large effect. It is an effective treatment. Patients, on average, experienced in the region of a 60% reduction in pain from baseline scores in both treatment arms. A clinical improvement of this magnitude is significant and certainly shows a large ‘effect’, which, if this were a drug trial, would probably be a much sought after improvement. Such an improvement would also imply that, not only was the treatment protocol sound, but also that it was delivered in a competent manner with both the acupuncture and control appearing to be delivered credibly and with conviction. Indeed the fact that the practitioner was able to elicit similar responses to acupuncture from a placebo treatment would tend to suggest that, contrary to Professor Ernst’s comments, the acupuncturist was probably quite skilled as a practitioner. The acupuncture treatment protocol employed in this study would be very similar to that found in many physical therapy departments throughout the UK and is therefore generalisable within that context. In statistical terms, the trial also showed efficacy i.e. the real acupuncture was statistically significantly better than the placebo treatment. However in terms of our protocol definition of ‘clinical’ improvement over and above placebo, efficacy was not proven. We would stress however that many clinicians may feel that our own definition of clinical efficacy (not effect) might be rather ambitious (a 30% difference between acupuncture and control treatments) and may judge that the statistically significant improvement we have demonstrated in this trial is of clinical significance. We would be the first to admit that what constitutes a ‘clinically significant improvement in pain’ is a rather arbitrary decision and as such may vary from clinician to clinician. However we are bound to report our protocol definition of effective treatment as our primary analysis. It would be logical to assume that previous expectation might blunt the apparent benefit of acupuncture as stated in the editorial (2) and the editors may have assumed that patients in the trial might have felt that the control treatment would be ineffective. There is no evidence to support this view, rather that the reverse was true. The data from the credibility ratings implies that patients probably had a high expectation of a positive result in both treatment groups. This in turn might suggest that such an attitude predisposed patients to achieving a large treatment effect. Our previous research however(3;4) suggests that belief in CAM is not a predictor of outcome. Finally, we agree with Professor Ernst that it is important to monitor and report adverse effects. It was for this reason that such effects were indeed monitored and are clearly presented in table 5 of our paper. P.White & G.Lewith, University of Southampton, UK. P.J.White@soton.ac.uk Reference List (1) White, P, Lewith, G., Prescott, P, and Conway, J. Acupuncture versus Placebo for the Treatment of Chronic Mechanical Neck Pain. Ann Intern Med 141, 911-919. 2004. (2) Editorial. Treatments for Back Pain: Can we get past trivial effects? Ann Intern Med. 2004;141:957-58. (3) Lewith G, Hyland M, Shaw S. Do attitudes and beliefs about complementary medicine affect treatment outcome? American Journal of Public Health. 2002;92:1604-6. (4) White P. Attitude and outcome: is there a link in Complementary Medicine? American Journal of Public Health. 2003;93:1038. Conflict of Interest:None declared |
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Edzard Ernst, MD PhD FRCP FRCPEd Peninsula Medical School, Universities of Exeter & Plymouth, UK
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Edzard.Ernst{at}pms.ac.uk Edzard Ernst
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The Editor Annals of Internal Medicine 06/01/05 Sir The trial by White et al demonstrates that, compared to placebo, acupuncture does not generate clinically relevant improvement for patients suffering from chronic neck pain 1. It has at least two major flaws. There was only one acupuncturist. Thus two dramatically different conclusions can be drawn from its findings: i) the particular form of acupuncture used in the study was not better than placebo, or ii) the therapist was in some way inadequate. In any case, the generalisability of the result seems close to zero. There is no mention of adverse effect monitoring. This is surprising since both the medication 2 and the needling 3 have a potential for serious adverse events. Reporting of adverse events is an essential requirement for any clinical study 4, and any trial design which predictably leads to more than one conclusion is less than rigorous. E Ernst, Director Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth References 1. White P, Lewith G, Prescott P, Conway J. Acupuncture versus placebo for the treatment of chronic mechanical neck pain. Ann Intern Med 2004;141:911-9. 2. Dukes MNG, Aronson JK. Meyler's side effects of drugs. 14th Edition. Elsevier; Amsterdam. 2000. 3. Ernst E, White A. Life-threatening adverse reactions after acupuncture? A systematic review. Pain 1997;71:123-6. 4. Ioannidis JPA, Evans SJW, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8. Conflict of Interest:None declared |
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