Randomised trial of acupuncture compared with conventional massage and “sham” laser acupuncture for treatment of chronic neck painCommentary: Controls for acupuncture—can we finally see the light?

Sir,

We have read with interest the discussion of the recent paper by
Irnich et al 1 and their thoughtful reply. Dr Irnich suggests that some of
the criticisms are due to detail omitted from the paper because of space
restrictions, and we agree that this is an important issue. We are not
sure, however, if this argument can also be used for the ‘electronic’
version of the BMJ, as clearly much more detail is given here. Perhaps the
BMJ editor or the paper's authors could clarify this for us?

Even though Irnich et al's paper is far from perfect, we believe it
is an important study. We have no doubt that it will score highly on the
Jadad scale, but this is simply a measure of bias and not a reflection of
the quality of a trial per se. Scientific progress is generally a slow
process which is partially dependent on peer review, and it is vital that
we are able to learn from each other's constructive criticisms. We must
assure Dr Irnich that our comments were made in an attempt to further the
process of constructive scientific discussion after thoughtful
consideration.

With regard to Dr Irnich's comments on placebo, in particular the
needle developed by Streitberger 2 which Irnich felt was not a real
placebo because it could not be applied double blind. The definition of a
placebo is that it is inactive, harmless and given "to please the patient"
3 i.e. that it has no specific therapeutic effect 4. The fact that the
practitioner cannot be blinded during its use is an issue relating to
bias, not whether the Streitberger needle is a placebo. A single blind,
placebo controlled trial would conventionally require that the patient is
unable to detect the difference between verum and placebo. We feel,
therefore, that Dr Irnich may be a little premature in his castigation of
this needle, particularly in the light of Streitberger’s early results.
Whether the Streitberger needle is truly physiologically inert requires
further investigation. We feel, however, that the use of this needle is
not very far removed from the reality of acupuncture practice, and
probably represents one of the better options that we have at this present
time, although its use may be limited by the fact that it cannot be
applied to all acupuncture points. In our trials thus far, we have found
the technique can be performed easily and convincingly.

With regard to the outcomes used, we have not suggested that visual
analogue scales (VAS) are not valid in their own right. Our concern is
centred around the issue of how this was conducted. Combining VAS with
range of movement in this way, creates a new, previously unvalidated,
process of outcome measurement. We feel that it is scientifically
legitimate to question the validity of the outcome process for the reasons
stated in our original letter. Whilst Dr Irnich has answered some of the
questions we have raised in this regard, there was not a sufficient
description of this in the published methodology or the subsequent
correspondence. Questioning the validity of the primary outcome does not
in any way preclude us from commenting on the overall results of the study
as presented by the authors. The results clearly suggest that acupuncture
treatment was not superior to the ‘placebo’ control, and we therefore feel
justified in concluding that this trial was negative for acupuncture,
given those results.
We feel that details of the intervention should be clear in the study
methodology and that it is unacceptable to bury this within the reference
section. Reproducibility must be a prerequisite for any controlled trial.
The quality of scientific reporting within the field of acupuncture has
improved significantly over the last 20 years, both in our own and other
studies. Our quoted research relates to the process of outcome
measurement, not our inadequate reporting of treatment protocols over 15
years ago. We also fail to see why it might be ethically acceptable to
use a placebo treatment for five sessions but not for six or eight.
Surely an intervention is either ethically acceptable or it is not.

Lastly, with regard to the sham laser, we do accept Dr Irnich’s
statement that “there is always a first time”, although it is perhaps a
shame that such a large and important study has utilised a previously
unevaluated control. We would have expected some appropriate and
published pilot work prior to such a large scale study.

In conclusion we feel that this study would be difficult, if not
impossible, to reproduce from the information that we currently have
available to us. We are also unsure of the robustness of the outcome
measures and the placebo employed, and are therefore unclear how much
value we should place on the study's conclusions.

Reference List

1. Irnich D, Behrens N, Molzen H, Konig A, Gleditsch K, Krauss M et
al. Randomised trial of acupuncture compared with conventional massage and
sham laser acupuncture for treatment of chronic neck pain. British Medical
Journal 2001;322:1574-7.

2. Streitberger K,.Kleinhenz J. Introducing a placebo needle into
acupuncture research. Lancet 1998; 352:364-5.

3. Webster's Dictionary. The new international Websters dictionary
of the English language. Florida: Trident Press International, 1995.

4. Lynoe N. Is the Effect of Alternative Medical Treatment Only a
Placebo Effect. Scand J.Soc.Med. 1999;18:149-53.