Observations about controlled clinical trials expressed by Max Haidvogl
in the book Ultra High Dilution (1994) have been appraised from a perspective two
decades later. The present commentary briefly examines changes in homeopathy
research evidence since 1994 as regards: the published number of randomised controlled
trials (RCTs), the use of individualised homeopathic intervention, the ‘proven efficacy of
homeopathy’, and the quality of the evidence.
American College of physicians ACP high value care recommendations in rheumat...
Controlled clinical studies of homeopathy
1. ORIGINAL PAPER
Controlled clinical studies of homeopathy
Robert T Mathie
British Homeopathic Association, Luton, United Kingdom
Introduction: Observations about controlled clinical trials expressed by Max Haidvogl
in the book Ultra High Dilution (1994) have been appraised from a perspective two
decades later. The present commentary briefly examines changes in homeopathy
research evidence since 1994 as regards: the published number of randomised controlled
trials (RCTs), the use of individualised homeopathic intervention, the ‘proven efficacy of
homeopathy’, and the quality of the evidence.
Methods: The commentary reflects the details of RCTs that are available in a
recently published literature review and by scrutiny of systematic reviews of RCTs in
homeopathy.
Results: The homeopathy RCT literature grew by 309 records in the 18 years that imme-
diately followed Haidvogl’s article, with more than a doubling of the proportion that
investigated individualised homeopathy. Discounting one prior publication, the entire
systematic review literature on homeopathy RCTs post-dates 1994. A total of 36
condition-specific systematic reviews have been identified in the peer-reviewed litera-
ture: 16 of them reported positive, or tentatively positive, conclusions about homeopa-
thy’s clinical effectiveness; the other 20 were negative or non-conclusive. Reviews
typically have been restricted in the strength of their conclusions by the low quality of
the original RCT evidence. Three comprehensive systematic reviews concluded,
cautiously, that homeopathy may differ from placebo; a fourth such review reached
negative conclusions. A recent high-quality meta-analysis concluded that medicines pre-
scribed in individualised homeopathic treatment may have small, specific, effects.
Conclusions: Despite important growth in research activity since 1994, concerns about
study quality limit the interpretation of available RCT data. The question whether
homeopathic intervention differs from placebo awaits decisive answer. Homeopathy
(2015) 104, 328e332.
Key words: Clinical research evidence; Haidvogl; Homeopathy; Meta-analysis;
Randomised controlled trial; Systematic review
Introduction
In his contribution to the book Ultra High Dilution, pub-
lished in 1994, Max Haidvogl summarised his chapter on
clinical studies of homeopathy as follows: “Numerous
controlled clinical studies have proved the efficacy of ho-
moeopathic remedies, but most of them could not meet suf-
ficient methodological quality. However, specially (sic)
homoeopathic studies have to show a maximum in scientific
standard because they have to withstand much more criti-
cism than pharmacological studies relating to the common
paradigmas (sic) of clinical medicine. Clinical studies on
homoeopathy should be planned in co-operation between
homoeopathic practitioners and university clinics, because
this allows for a maximum methodological standard and
also for the possibility of publication in distinguished jour-
nals with a high impact factor, which usually are not avail-
able for homoeopathic practitioners. Controlled clinical
human studies in the field of homoeopathy are only useful
if they take into account the characteristics of homoeo-
pathic drug prescription, i.e. the person-specific, individ-
ual choice of the remedy.”1
Haidvogl based these observations importantly on the
contemporary comprehensive review of randomised
controlled trials (RCTs) of homeopathy by Kleijnen and
colleagues (who, from today’s perspective, misleadingly
E-mail: rmathie@britishhomeopathic.org
Received 27 February 2015; revised 12 May 2015; accepted 20
May 2015
Homeopathy (2015) 104, 328e332
Ó 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.homp.2015.05.003, available online at http://www.sciencedirect.com
2. termed their study a ‘meta-analysis’).2
Of the 105 trials
with interpretable data, 81 indicated positive results, which
included RCTs that received high-quality ratings for ran-
domisation, blinding, sample size, and other methodolog-
ical criteria. Kleijnen came to the conclusions: ‘Based on
this evidence we would be ready to accept that homoeopa-
thy can be efficacious, if only the mechanism of action
were more plausible’; ‘the evidence presented in this re-
view would probably be sufficient for establishing ho-
moeopathy as a regular treatment for certain indications’.
It is apparent, therefore, that Haidvogl provided a reason-
able summary of the clinical research evidence that existed
at the time.
The present paper briefly addresses the following:
Since 1994, what has happened to the RCTevidence as re-
gards: the number of published studies; the use of individ-
ualised homeopathic intervention; the ‘proof of efficacy’
(including systematic review and meta-analysis data);
the quality of evidence, including the peer-reviewed status
of the publications?
Methods
This commentary has been informed by an analysis of
the RCT records detailed in the text and the appendices
of a recent major literature review3
and by close scrutiny
of the systematic review literature.4,5
Results
Number of RCTs and individualisation
Up to and including 2011, there had been a total of 489
published records of RCTs in the peer-reviewed and non-
peer-reviewed literature; 95 of them were repeat publica-
tions.3
From an analysis of these RCT records, it is
apparent that 180 (37%) of the 489 would have been poten-
tially available to Haidvogl (i.e. published up to the end of
1993); the RCT literature therefore grew by 309 records in
the interim period. It is also apparent that, up to and
including 1993, only 26/180 (14%) RCTs had studied indi-
vidualised homeopathy; for the years since then, the figure
increased to 114/309 (37%). Before 1994, the large major-
ity (87%) of RCTs were placebo-controlled; during the
intervening years to 2011, the corresponding figure was lit-
tle changed (83%).3
In 1994, homeopathy was rightly described as a ‘new
field’ of clinical research investigation; indeed, the 15
years from 1997 witnessed a sharp increase in research ac-
tivity to an average of 10e12 RCT papers per annum,
compared to 2e6 per annum in the 15-year period up to
1991.3
The marked increase in RCT research on individu-
alised prescribing might reflect the homeopathy research
community’s response to Haidvogl’s encouragement to
investigate that key facet. The lack of change in the propor-
tion of placebo-controlled trials, however, suggests that
conventional study design has prevailed over Haidvogl’s
expressed concerns about appropriateness and ethics of
double-blinding.
Systematic reviews and quality of evidence
Haidvogl’s recognition that poor-quality studies domi-
nated the research literature contrasts with his associated
summary conclusion about ‘proven efficacy’. Neverthe-
less, the main text of his article clarifies that low methodo-
logical quality does seriously undermine the reliability of
evidence. Focus on reliable evidence as a critical arbiter
of efficacy or clinical effectiveness has not been considered
sufficiently in reviews during the years since 1994, though
this matter is being rectified in a new series of systematic
reviews of homeopathy RCTs.6,7
The latter programme
of research is also reflecting evidence solely from peer-
reviewed journals, whose relative contribution to the total
RCT literature in homeopathy increased strikingly from
1997 onwards.3
Every systematic review or meta-analysis of homeopa-
thy for a specific medical condition, or for a group of diag-
noses, has been published since Haidvogl’s article in 1994.
At the time of writing the present article, the peer-review
literature comprised 36 such systematic review papers,
16 of which reported clearly or tentatively positive conclu-
sions on homeopathy’s effectiveness; 11 reviews reported
clearly or tentatively negative conclusions; nine were
non-conclusive either way. All 36 references, together
with those that reported a more comprehensive review of
homeopathy RCTs, are listed in Table 1.
Detailed consideration of RCT quality is intrinsic to all
systematic reviews in the Cochrane Library, and seven re-
views on homeopathy have been published there; four of
the seven included meta-analysis, an approach that has
seldom been applied for disease-specific reviews outside
the Cochrane context. None of those seven reviews reached
a clearly positive conclusion about homeopathy’s effec-
tiveness (Table 1).8e14
Two of the reviews highlighted
some positive meta-analysis findings, but which were
undermined by the low quality of the available evidence.
Mathie et al. (2012) reported that, 48 h after the start of
treatment for influenza, the homeopathic medicine Oscil-
lococcinumÒ
produced a statistically significant absolute
risk reduction of 7.7% in the frequency of symptom relief
compared with that of placebo (mean risk ratio = 1.86).13
In
meta-analysis of two RCTs of participants with irritable
bowel syndrome, Peckham et al. (2013) found a statisti-
cally significant difference in global improvement between
Asa foetida treatment and placebo at two-week follow-up:
73% of patients in the homeopathy group improved,
compared to 45% in the placebo group (mean risk ra-
tio = 1.61).14
Following Kleijnen,2
there have been four further
comprehensive systematic reviews of RCTs in homeopa-
thy; each of them included meta-analysis data. Three of
those systematic reviews of RCTs reached the cautious
conclusion that homeopathy differs from placebo.15e17
Boissel et al. undertook meta-analysis on the primary out-
comes of 15 strictly selected trials, and obtained a pooled
significance value of P = 0.0002; they concluded ’there is
evidence that homeopathic medicine is more effective
than placebo’, but ‘the strength of this evidence is low
Randomised clinical trials
RT Mathie
329
Homeopathy
3. Table 1 Interpretation of original authors’ conclusions from systematic reviews of homeopathy RCTs*
Review type Positive Tentatively positive Non-conclusive Tentatively negative Negative
Comprehensive (all homeopathy) Boissel 1996 [15] Shang 2005 [18] z
Cucherat 2000 [17]
Kleijnen 1991 [2]
Linde 1997 [16] y
Comprehensive (individualised homeopathy) Linde & Melchart 1998 [20]
Mathie 2014 [7]
By group of diagnoses Bellavite 2006a [27] Kassab 2009 [12] Altunc¸ 2007 [44] Ernst & Pittler 1998 [47]
Bellavite 2006b [28] L€udtke & Hacke 2005 [38] Milazzo 2006 [45]
Bornh€oft 2006 [29] Simonart 2011 [46]
Davidson 2011 [30]
Iannitti 2014 [31]
Jonas 2000 [32]
By single medical condition Jacobs 2003 [24] Barnes 1997 [33] Long & Ernst 2001 [39] Smith 2003 [9] Cooper & Relton 2010 [48]
Schneider 2005 [25] Ernst 2011a [34] McCarney 2003 [8] Coulter & Dean 2007 [11]
Taylor 2000 [26] Boehm 2014 [35] McCarney 2004 [10] Ernst 1999 [49]
Mathie 2012 [13] Owen & Green 2004 [40] Ernst 2011b [50]
Peckham 2013 [14] Pilkington 2005 [41] Ernst 2012 [51]
Perry 2010 [36] Pilkington 2006 [42] Ernst & Barnes 1998 [52]
Wiesenauer & L€udtke 1996 [37] Saha 2013 [43]
Entries arranged alphabetically, by first author name, per section.
A review comprising more than two authors is designated by its first author only. Cochrane reviews highlighted in bold.
* Summary description of a review’s RCT evidence in homeopathy as ‘positive’, ‘non-conclusive’ or ‘negative’ is based on subjective interpretation of the original review authors’ main conclusions, and
reflecting key caveats that may have caused their conclusions to be expressed tentatively.
y
Positive re placebo comparison; non-conclusive re specific medical conditions.
z
Tentatively negative re specific effect of homeopathic medicines.
Randomisedclinicaltrials
RTMathie
330
Homeopathy
4. because of the low methodological quality of the trials’.15
Linde and co-authors identified 89 RCTs that had adequate
data for analysis; they described the results of their meta-
analysis as ‘not compatible with the hypothesis that the
clinical effects of homeopathy are completely due to pla-
cebo’.16
In a subsequent analysis of the same data set,
Linde and colleagues subsequently investigated the influ-
ence of methodological quality on study outcome and
found that studies with higher quality tended to yield less
positive results than those with lower quality.18
After dis-
carding most of the lower-quality trials, homeopathy re-
mained more effective than placebo e but less strikingly
so than in their initial analysis. In both of Linde’s reviews,
homeopathy was not clearly ‘efficacious’ for any specific
medical condition. Cucherat’s group synthesised the evi-
dence by combining the P values for the primary outcomes
from the individual trials. The combined value for 17 com-
parisons was highly significant (P < 0.001); however,
sensitivity analysis showed that P tended towards a non-
significant value (P = 0.08) as trials were excluded in a
stepwise manner based on their level of quality.17
The fourth comprehensive systematic review, based
ultimately on eight ‘large trials of higher quality’ of
homeopathy compared to six corresponding trials of
conventional medicine, concluded there was ‘weak
evidence for a specific effect of homoeopathic remedies’,19
a finding the authors regarded as ‘compatible with the
notion that the clinical effects of homoeopathy are placebo
effects’.
In 1998, a meta-analysis of RCTs of individualised
homeopathy reported a significant overall effect that
marginally was not sustained for the best-quality trials.20
A recent high-quality meta-analysis of such RCTs, howev-
er, reported a significant overall effect that was sustained
for the best-quality trials: it concluded, with caveats con-
cerning the low overall quality of the evidence, that medi-
cines prescribed in individualised homeopathy may have
small, specific, treatment effects.7
This cautiously positive
conclusion about effectiveness of an individualised homeo-
pathic prescription reflected a broad spectrum of medical
conditions: it therefore transcends evidence in homeopathy
for any one specified health condition.
Conclusions
In the years following Haidvogl’s published article, there
was an increase from 14% to 37% in the proportion of
RCTs that investigated individualised homeopathy. Apart
from the paper by Kleijnen in 1991,2
the entire systematic
review literature on homeopathy RCTs post-dates 1994.
While evidence in homeopathy for any single named con-
dition is currently deficient,21
there is some RCT evidence
overall that individualised homeopathic medicines are
modestly, but detectably, more effective than placebos.22
Concerns about trial quality continue to limit the interpre-
tation of available data: the overarching question, germane
to Haidvogl’s key focus, whether or not individualised
homeopathy is distinguishable from placebos, therefore
awaits decisive answer.7
Use of high or low dilution of
homeopathic medicines in RCTs has seldom been consid-
ered in formal review, though it is included importantly in
the most recent programme of research.6
In many respects, Haidvogl was ahead of his time in the
sharp focus of the issues he raised in the 1994 article. Over
twenty years on, the wisdom and importance of his publi-
cation can be considered in the subsequent improvement
in the number, if not necessarily the quality, of original
RCT papers and systematic reviews. With ongoing im-
provements in relevance and quality, and with increasing
collaborative research worldwide,23
there is likely to be
an improvement in the decisiveness of RCT evidence in
homeopathy that is published during the next two decades.
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