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Acupuncture versus Placebo for the Treatment of Chronic Mechanical Neck Pain: A Randomized, Controlled Trial

Peter White, PhD, BSc; George Lewith, DM, FRCP; Phil Prescott, PhD, DIC, ARCS, BSc; and Joy Conway, PhD
[+] Article and Author Information

From University of Southampton, Southampton, United Kingdom.


Acknowledgments: The authors thank Professor C. Cooper (Medical Research Council) and Dr. R. Ellis (Southampton General Hospital) for support with this project.

Grant Support: The study protocol was developed in 1997 and was funded by the Henry Smiths Charity and the Hospital Savings Association in 1998. Recruitment began in 1999 and was completed in 2001. Dr. Lewith's post was supported by the Laing Foundation.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Peter White, PhD, BSc, MCSP, Complementary Medicine Research Unit, Mail Primary Medical Care, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST, United Kingdom; e-mail, pjw1@soton.ac.uk.

Current Author Addresses: Drs. White and Lewith: Complementary Medicine Research Unit, Mail Primary Medical Care, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST, United Kingdom.

Dr. Prescott: School of Mathematics, University of Southampton, Highfield, Southampton SO17 1BJ, United Kingdom.

Dr. Conway: School of Health Professions, University of Southampton, Highfield, Southampton SO17 1BJ, United Kingdom.

Author Contributions: Conception and design: P. White, G. Lewith, J. Conway.

Analysis and interpretation of the data: P. White, G. Lewith, P. Prescott, J. Conway.

Drafting of the article: P. White, G. Lewith, P. Prescott.

Critical revision of the article for important intellectual content: P. White, G. Lewith.

Final approval of the article: P. White, G. Lewith.

Statistical expertise: G. Lewith, P. Prescott.

Obtaining of funding: G. Lewith.

Administrative, technical, or logistic support: G. Lewith, J. Conway.

Collection and assembly of data: P. Prescott.


Ann Intern Med. 2004;141(12):911-919. doi:10.7326/0003-4819-141-12-200412210-00007
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Compared with baseline, acupuncture reduced pain by a mean of 58.9% at 1 week after treatment and by a mean of 65.1% at 8 weeks after treatment. This improvement was maintained in the longer term, with a decrease from baseline of 61.3% and 57.8% at 6 and 12 months after treatment, respectively. The longitudinal analysis of our primary outcome showed a significant difference between study groups at both 5 weeks (P = 0.011) and 12 weeks (P = 0.005) after randomization. The magnitude of the difference in pain between groups was 6 mm on the VAS, representing a between-group difference of 12% (CI, 3% to 21%) from baseline. This falls outside our definition of a clinically effective difference. Clinicians and researchers have varied, diverse, and somewhat arbitrary opinions about what constitutes a clinically significant effect in treatment of chronic pain. We based our power calculation on work by Lewith and Machin (17) and on pilot work by Petrie and Hazleman (21) and based our definition of a significant clinical outcome (30% between-group difference) on work by Melzack (39).

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Figures

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Figure 1.
Study flow with outcome assessments.

NDI = Neck Disability Index; SF-36 = Short Form-36; VAS = visual analogue scale.

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Figure 2.
Mean pain scores on the visual analogue scale from baseline to week 12.

Treatment took place from week 1 to week 4.

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Tables

References

Letters

NOTE:
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Comments

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No Title
Posted on January 6, 2005
Edzard Ernst
Peninsula Medical School, Universities of Exeter & Plymouth, UK
Conflict of Interest: None Declared

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

In Response
Posted on February 10, 2005
Peter J White
University of Southampton
Conflict of Interest: None Declared

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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Summary for Patients

Acupuncture for Treatment of Chronic Neck Pain

The summary below is from the full report titled “Acupuncture versus Placebo for the Treatment of Chronic Mechanical Neck Pain. A Randomized, Controlled Trial.” It is in the 21 December 2004 issue of Annals of Internal Medicine (volume 141, pages 911-919). The authors are P. White, G. Lewith, P. Prescott, and J. Conway.

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