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Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial seriesCommentary: Larger trials are needed

BMJ 2000; 321 doi: (Published 19 August 2000) Cite this as: BMJ 2000;321:471

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Sir - The medical community has an increasing concern about the
quality1 and fairness2 of reporting of clinical research, and experience
as well as repeated stories suggest that, whatever their source,
overstatements regarding the benefits or risks of therapeutic options may
have serious
consequences in terms of cost, safety or community health. In this
context, one may be surprised by the BMJ commenting the work by Taylor et
al3 as "evidence" favouring homoeopathy over placebo (p. 518) and, more
by the presentation of this paper as a significant one.

Actually, the
first "evidence" is that the study in question was a negative one as its
results were clearly comparable for homoeopathy and placebo regarding the
primary efficacy parameter. Additional evidence includes a relative
weakness in experimental design, since the use of concomitant drugs was
left to the patient's discretion : greater use in vasoconstrictors and
antihistamine is all the more likely to account for the reported
improvement in nasal inspiratory peak flow that initial aggravation of
rhinitis symptoms in the homoeopathy group is likely to have worsened the
baseline imbalance regarding the use of these agents (see the authors'
Table 1). Concerning the experimental design on the other hand, one may
remark that in an indication
such as perennial rhinitis, the usual efficacy parameters are generally
the consumption of anti-allergic drugs and symptoms scores4, and not
visual analogue scales (VAS); likewise, one may wonder whether a total
duration of 4
weeks might have the slightest clinical relevance in such a chronic

Finally, this is an elementary notion of the meta-analytic methodology
that pooling data from some clinical trials (i.e. without any systematic
method of selection) can never be seen as "evidence" of anything -
especially when this
pooling includes heterogeneous diseases, some of them acute (hay fever)
and some chronic (asthma, perennial rhinitis); incidentally, it is
uncertain whether VAS is robust parameter to assess efficacy in a disease
such as

It may be of interest to note that similar questions on selection biases
as well as clinical relevance were raised about a previous review
published in the Journal and also presented as suggesting an efficacy of
In contrast to physics, chemistry or biology, most of clinical research
cannot be reproduced (due to obvious problems of recruitment, duration of
treatment, organisation, cost, etc.) and this is why we have a
professional obsession of fraud, misleading reports or misstatements:
this is one of the greatest challenge and responsibility for experts to
develop, as a sixth
sense, their ability to detect every indirect sign of fallacy. In the
present case, the issue is by no means any suspicion of fraud or
misconduct: but when published evidence itself does not support the
authors' discussion, it is not expected that Editors will amplify
overstatement by inappropriate comments.

We need far more solid results prior to rejecting "the hypothesis that
homoeopathy in a placebo response" i.e. before challenging our current
understanding of physical world: for the time being, "evidence" from
clinical research is still that homoeopathy results from an anachronistic
persistence of outdated medical misconceptions.


Consultant in drug monitoring and pharmacoepidemiology

1 boulevard de la République 78000 Versailles (France)

Competing interest : none

1. Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison
TC. Randomised controlled trial of homoeopathy versus placebo in perennial
allergic rhinitis with overview of four trial series. BMJ 2000; 321: 471-

2. Altman DG. Better reporting of randomised controlled trials: the
CONSORT statement. BMJ 1996; 313: 570-1

3. Rennie D. Fari conduct and fair reporting of clinical trials.
JAMA 1999; 282: 1766-9

4. Malling HJ. Immunotherapy as an effective tool in allergy
treatment. Allergy 1998; 53: 461-472

5. Girard M. Trials of homoeopathy. BMJ 1991; 302: 727

Competing interests: No competing interests

08 September 2000
Marc Girard