Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial seriesCommentary: Larger trials are needed
Before taking this study´s results as an opportunity to dive deeply
in speculations how homoeopathy might work, we should first take a more
careful look at the study and state that
the trial was negative,
the meta-analysis was (or may be) flawed,
there was no homoeopathy at all.
All three preceding trials used the change in VAS as the sole main
endpoint - with significant results. In this trial the calculation of
sample size was also done for one main endpoint only - the change in VAS,
consistent with the others. The p-value is 0.82 which obviously means that
the trial was by no means able to reproduce the positive results of the
others.
The discrepancy with additional "objective" data is interesting but not
positive for homoeopathy: What is to be the interpretation of this
discrepancy in the light of the preceding trial where the discrepancy was
just the other way round?
The meta-analysis is founded on 4 trials with different indications,
different treatments, flaws in design and analysis and a significant
heterogeneity in treatment effects. The latter is almost spectacular in a
series of only 4 relatively small trials considering the low power of
these statistical tests. Obviously, there were large differences between
the trials. In such heterogeneous situations, researchers are advised to
refrain from doing meta-analyses because these can lead to grossly
misleading results.
The patients in this study underwent allergic testing according to
standards of orthodox medicine. The allergens were chosen on the basis of
standards of orthodox medicine. There was no homoeopathy at all. The only
part reminding the reader of homoeopathy is the dilution procedure. This
whole scenario has nothing to do with the usual practice of homoeopathy –
which, if the trial were perceived to be negative, would be the unanimous
justification by homoeopaths.
Do we learn anything from this publication which is convincingly in
favour of homoeopathy? My answer is: No.
Competing interests:
No competing interests
25 August 2000
Jürgen Windeler
Head of Dep. Evidence Based Medicine
Medical Advisory Service of Social Sickness Funds (MDS), Essen, Germany
Rapid Response:
In fact: It isn´t positive
Before taking this study´s results as an opportunity to dive deeply
in speculations how homoeopathy might work, we should first take a more
careful look at the study and state that
the trial was negative,
the meta-analysis was (or may be) flawed,
there was no homoeopathy at all.
All three preceding trials used the change in VAS as the sole main
endpoint - with significant results. In this trial the calculation of
sample size was also done for one main endpoint only - the change in VAS,
consistent with the others. The p-value is 0.82 which obviously means that
the trial was by no means able to reproduce the positive results of the
others.
The discrepancy with additional "objective" data is interesting but not
positive for homoeopathy: What is to be the interpretation of this
discrepancy in the light of the preceding trial where the discrepancy was
just the other way round?
The meta-analysis is founded on 4 trials with different indications,
different treatments, flaws in design and analysis and a significant
heterogeneity in treatment effects. The latter is almost spectacular in a
series of only 4 relatively small trials considering the low power of
these statistical tests. Obviously, there were large differences between
the trials. In such heterogeneous situations, researchers are advised to
refrain from doing meta-analyses because these can lead to grossly
misleading results.
The patients in this study underwent allergic testing according to
standards of orthodox medicine. The allergens were chosen on the basis of
standards of orthodox medicine. There was no homoeopathy at all. The only
part reminding the reader of homoeopathy is the dilution procedure. This
whole scenario has nothing to do with the usual practice of homoeopathy –
which, if the trial were perceived to be negative, would be the unanimous
justification by homoeopaths.
Do we learn anything from this publication which is convincingly in
favour of homoeopathy? My answer is: No.
Competing interests: No competing interests