Advance Access Publication 31 July 2006 eCAM 2006;3(4)397–409
Immunology and Homeopathy. 4. Clinical Studies—Part 2
Paolo Bellavite1, Riccardo Ortolani2, Francesco Pontarollo1, Valeria Piasere1,
Giovanni Benato2and Anita Conforti3
1Department of Scienze Morfologico-Biomediche,2Association for Integrative Medicine ‘Giovanni Scolaro’ and
3Department of Medicina e Sanita ` Pubblica, University of Verona, Piazza L.A. Scuro, 37134 Verona, Italy
The clinical studies on the effectiveness of homeopathy in respiratory allergy (18 randomized trials
and 9 observational studies) are described. The literature of common immunologic disorders including
also upper respiratory tract infections (URTI) and otorhinolaryngology (reported in part 1), is evaluated
and discussed. Most of initial evidence-based research was addressed to the question of whether
homeopathic high dilutions are placebos or possess specific effects, but this question has been often
equivocal and is still a matter of debate. The evidence demonstrates that in some conditions homeopathy
shows significant promise, e.g. Galphimia glauca (low dilutions/potencies) in allergic oculorhinitis,
classical individualized homeopathy in otitis and possibly in asthma and allergic complaints, and a few
low-potency homeopathic complexes in sinusitis and rhinoconjunctivitis. A general weakness of
evidence derives from lack of independent confirmation of reported trials and from presence of
conflicting results, as in case of homeopathic immunotherapy and of classical homeopathy for URTI.
The suitable methods to evaluate homeopathy effectiveness, without altering the setting of cure, are also
Keywords: allergy – asthma – evidence-based homeopathy – homeopathic immunotherapy –
homeopathic medications – homeopathy – immunology – isopathy – rhinoconjunctivitis
In the first part of this review (1) the evidence-based research
on homeopathy in common upper respiratory tract infections
(URTI) or in otorhinolaryngologic complaints has been
described. We shall here describe studies performed in the
field of allergology and, more specifically, in oculorhinitis
(hayfever) and allergic asthma. The methods of analysis and
the criteria of classification are the same as described in the
first part of the review.
Finally, the global body of evidence regarding the effect-
iveness of the different therapeutic approaches, in the condi-
tions considered in this review, is presented in the Discussion.
Here, the classification of the therapeutic approaches is
made according to a grade of evidence in six levels, which
was developed by Natural Standard, an international research
collaboration that aggregates and synthesizes data on
naturalstandard.com/index.asp). A summary of these criteria
is reported in Table 1.
Allergies are the most common immunological diseases
among general population, and increasing evidence suggests
that incidence of allergic disorders is rising dramatically.
The results of several studies indicated that patients before
seeking homeopathic care for their allergic symptoms were
unsatisfied within conventional health care system and that
their choice was mostly motivated by assumption of few side-
effects or by a wish to ‘try everything’ (2–7). Approximately
50% of asthma patients in the UK have used some form of
complementary therapy for their asthma at some stage, and
most of these patients have indicated that they derived at
least some benefit (8).
For reprints and all correspondence: Paolo Bellavite, University of Verona,
37134 Verona, Italy. Tel: þ39-045-8202978; Fax: þ39-045-8202978;
? 2006 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/
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Several studies using homeopathy have reported beneficial
effects from treating allergy-related conditions, other studies
have not found benefits over placebo. A summary of these
papers in chronological order is given in Table 2, here in the
text they will be grouped according to different modalities of
therapy that have been investigated.
Classic Individualized Homeopathy
According to this approach each patient received his/her single
medicine (‘simillimum’). In many reports using classic indivi-
dualized prescription, there is an indication of most frequently
In starting this brief analysis of results obtained in allergo-
logy, we cite a retrospective study, reported at a homeopathic
conference (13), which included children treated with
individualized homeopathy. The results appeared to be
encouraging, since 44.2% of patients had a ‘satisfactory
reaction’, 36.7% a ‘manifest improvement’, 18.3% a ‘relative
improvement’ and 0.8% showing ‘no reaction’. The remedies
prescribed most frequently were Lycopodium clavatum,
sulphur, Pulsatilla and Silicea.
Castellsagu (16), retrospectively evaluated a series of
children who had suffered from allergic bronchial asthma,
and who were treated with a single drug in accordance with
classical homeopathic method. Twenty-two different drugs
were prescribed (the most used were sulphur, Calcarea
carbonica, Lycopodium and Pulsatilla), at different potencies.
After 3 years of treatment, the results showed a complete cure
in 58% of cases, improvements in 23% and failures in 19%.
In brief, the results obtained in such a serious chronic disease
are encouraging, but the open and uncontrolled nature of the
trial makes it impossible to draw definite conclusions.
A further retrospective study evaluated patients suffering
from bronchial asthma (both children and adults) and under
individualized homeopathic treatment for more than 3 years
(22). A statistically significant decrease in frequency and
severity of attacks before and after treatment was reported.
There was also a marked decrease in the use of conventional
medication. The most frequently prescribed remedies were
Arsenicum album, Nux vomica, sulphur, Pulsatilla and Silica.
A communication in a conference of International Homeo-
pathic Liga reported a trial on the effectiveness of classical
individualized treatment of asthmatic people who were
allergic to dermatophagoides (23). Symptoms and immunolo-
gic parameters were evaluated before and after an 8 months
treatment. Significant decrease in number of exacerbations, of
spirometric tests and immunologic markers was observed in
active homeopathic group. A full report would permit a
detailed evaluation of the trial.
A trial on individualized homeopathic therapy in asthma
was published in a Mexican homeopathic journal (25). The
study was double blind and controlled with placebo but
the randomization was not specified. The main result was a
reduction of asthma attacks after 4 months of therapy, with a
significant difference in favor of homeopathy.
A pharmacoeconomic study (not reported in Table 2
because it does not concern effectiveness) assessed the
homeopathic treatment in allergic diseases in a health
maintenance organization (4). The computerized medication
charts of each patient were evaluated for conventional
medication consumption 3 months before and 3 months after
homeopathic intervention, with each patient serving as his
or her own control. The results showed that 56% of patients
reduced their use of conventional medication following
homeopathic intervention. The most significant reduction
was in anti-histamine use, followed by decreases in bron-
chodilator use and steroids, with an average saving of $24
per patient in the 3 month period following homeopathic
Negative Trial, Questionable Method
The effects of individualized homeopathic remedies as an
adjunct to conventional treatment were compared with placebo
medication in children with mild to moderate asthma (33).
There were no clinically relevant or statistically significant
changes in active quality-of-life score. Scores of severity of
Table 1. Synthesis of the levels of evidence of therapeutic efficacy
Level of evidenceCriteria
A (strong scientific evidence) Statistically significant evidence of benefit from >2 properly randomized trials (RCTs), OR evidence from one
properly conducted RCT AND one properly conducted meta-analysis AND with supporting evidence in basic
science, animal studies or theory
B (good scientific evidence)Statistically significant evidence of benefit from 1–2 properly randomized trials, OR evidence of benefit from
?1properlyconductedmeta-analysis OR evidenceofbenefitfrom >1cohort/case–control/non-randomizedtrials
AND with supporting evidence in basic science, animal studies or theory
C (unclear or conflicting scientific evidence)Evidence of benefit from ?1 small RCT(s) without adequate size, power, statistical significance or quality of
design by objective criteria, OR conflicting evidence from multiple RCTs without a clear majority of the properly
conducted trials showing evidence of benefit or ineffectiveness
D (fair negative scientific evidence)Statistically significant negative evidence (i.e. lack of evidence of benefit) from cohort/case–control/
E (strong negative scientific evidence) Statistically significant negative evidence (i.e. lack of evidence of benefit) from ?1 properly randomized
adequately powered trial(s) of high-quality design by objective criteria
Lack of adequate evidence Unable to evaluate efficacy due to lack of adequate available data. This is not equivalent to negative evidence
Homeopathy and immunology. Clinical studies
Table 2. Homeopathic clinical studies of allergy and asthma
Reference and year
Hardy (1984) (9)
(HIT) made with house
HIT better than placebo
Gaus (1985) (10)
6· dynamized versus placebo
and Galphimia glauca
Eye and nose symptoms
Trend to positive, not
less symptoms in patientstaking dynamized verum
medicine than other groups
Reilly et al. (1986) (11)
Pollen 30c (HIT) versus
HIT better than placebo
Ludtke (1987) (12)
Galphimia 2c versus placebo
Eye and nose symptoms
Significantly less eye
symptoms in verum group
Mosquera (1990) (13)
Improvement in most cases
Campbell et al. (1990);
Reilly et al. (1994) (14,15)
Allopathy þ allergen
30c (HIT) versus
allopathy þ placebo
Symptoms (VAS) and
Less symptoms in verum
group than placebo, no difference in tests
Castellsagu (1992) (16)
Improvement in most
Nolleveaux (1992) (17)
Pollen 30c, Apis 15c,
Lung histamine 15c
Improvement in most
Ludtke (1995) (18)
Galphimia 4D versus placebo
Eye and nose symptoms
Significant relief in verum
1996, 1997 (19–21)
Engystol-N versus placebo
only in verum group
Eizayaga 1996 (22)
Significant decrease of
symptoms after therapy
et al. (1997) (23)
Individualized versus placebo
Verum better than placebo,
significant changes of
Micciche ´ et al. (1998) (24)
Homeopathic protocol based
on three low-dilution drugs versus conventional therapy
Trend to better improvement
in the homeopathic group
et al. (1998) (25)
Individualized versus placebo
and attack intensity
Higher reduction of asthma
attacks in verum group
Table 2. Continued
Reference and year
Hardy (1984) (9)
(HIT) made with house
HIT better than placebo
Matusiewicz et al.
Asthma H Inj. Plfugerplex
Use of allopathic drugs,
Slight decrease of
conventional medicationand infections; no change
in spirometric tests
Weiser et al. (1999) (27)
complex formulation Luffa
complex versus chromolyn
Equivalence of homeopathy
Reilly (2000) (28)
30c versus placebo (HIT)
and nasal air flux tests
Slightly better tests in
Aabel et al. (2000) (29)
Homeopathic birch pollen
Betula 30c versus placebo
Slightly less symptoms
during 10 days. Aggravation
after taking verum
Aabel (2000) (30)
Homeopathic birch pollen
Betula 30c versus placebo
Verum worse than placebo
Aabel (2001) (31)
Homeopathic birch pollen
Betula 30c versus placebo
Similar improvement in
verum and placebo
Lewith et al. (2002) (32)
Allergen (dust mite) 30c
versus placebo (HIT)
Symptoms (VAS) and
expiration flux (FEV)
No final therapeutic effect,
Hermoni (2002) (4)
Allergic asthma and
Homeopathic care (various)
The homeopathic intervention
led to reduction in the use of
White et al.(2003) (33)
Asthma (mild to moderate)
Individualized versus placebo
symptoms and tests
No changes of QOL, small
not significant improvementof symptoms in verum group
Li et al. (2003) (34)
HIT prepared from individual
allergens versus placebo
No improvement after
Kim et al. (2005) (35)
HIT prepared from common
allergens versus placebo
Better clinical changes in
verum group as compared
Witt et al. (2005) (36)
Allergic diseases including
rhinitis and asthma
Classic homeopathy versus
Better outcomes in
Colin (2006) (37)
Ear, nose and throat allergies,
Success rate of 87.6%
Study type and publication classification are according to Tables 1 and 2 of part 1 (1).
Homeopathy and immunology. Clinical studies
symptoms indicated relative improvements but the sizes of
effects were small. The authors concluded that adjunctive
homeopathic remedies are not superior to placebo in improv-
ing the quality of life of children with mild to moderate
asthma. This is a study that raised high media coverage as a
proof of inefficacy of homeopathy, but various authors have
raised doubts that the parameters used were sensitive enough
to differentiate between children who have no asthma and
those who have only mild asthma (38–40). In fact, included
patients had very mild or lacking symptoms, which
hardly could be ameliorated. Therefore, this study should be
interpreted with caution.
Effectiveness in ‘Real World’
An observational study where outcome and costs of homeo-
pathic therapy were compared with those of conventional
treatment in routine care has been published (36). Since all
children included in this study were affected by allergic
diseases (homeopathic therapy: 54 atopic dermatitis, 20
allergic rhinitis, 17 asthma; conventional therapy: 64 atopic
dermatitis, 11 allergic rhinitis, 12 asthma), the results of this
subset of patients may be of interest for this review. Allergic
children were treated either with classic homeopathic
approach or with conventional therapies provided by doctors
selected from an address list of general practitioners. The two
groups were not randomized but their disease grade at base-
line was similar. After 12 months of cure, symptom severity
scores decreasedmore significantly in homeopathic group than
in conventional group. There was also a trend to a better
improvement of quality of life in the homeopathic group, but
not statistically significant after diagnosis-specific adjustment.
A series of cases of respiratory allergy treated with
individualized and constitutional homeopathy in a private
homeopathic practice was recently reported (37). The author
estimated an overall success rate of 87.6% for homeopathic
treatment in these conditions. Only two cases of ear, nose and
throat allergies out of a total of 105 showed no improvement,
no patients deteriorated. Two cases with worsening and three
without improvement were noted out of 42 cases of pulmonary
One of the most extensive lines of research in homeopathy was
the attempt to utilize high dilutions of substances, known to
cause allergy, to prevent or cure the same allergies. This is an
application of the ancient isopathic principle (41) that has been
also termed ‘homeopathic immunotherapy (HIT)’ (11,14,42).
The chosen model, use of pollen in hay fever, actually comes
from the work of a homeopath—Dr Charles Blackley—who,
in the 1870s, first identified pollen as the cause of respiratory
seasonal allergies (42).
To start the description of these results, it is worth citing
a first report in a non-indexed journal by Hardy in 1984 (9).
The authors showed a relief of oculorhinitis symptoms in
patients allergic to house dust by homeopathic potencies of
house dust. The same approach characterized long-lasting and
deep investigations by a group led by D. Reilly. A double-
blind study, published as preliminary report in 1985 (43) and
as a full paper in 1986 (11), compared the effects of placebo
and of a 30c homeopathic preparation designed as Pollen
because it contained a mixture of 12 pollens. The results were
positive insofar as patients receiving the homeopathic treat-
ment had significantly fewer symptoms and used half of
anti-histamine rescue treatment than controls.
The same group published the results of a study on patients
with severe atopic asthma requiring daily administrations of
bronchodilators, most of whom were being treated with
steroids (14). Patients received a placebo for 4 weeks and
were then randomly divided into two groups, one of which
continued the placebo, whereas the other was treated with a
30c homeopathic preparation of the main allergen to which
each patient was sensitive. The patients revealed a statistic-
ally significant difference in favor of the active treatment.
These studies, enriched by further statistical analyses and a
meta-analysis of all of patients, were published in 1994 (15)
and showed an extremely high probability (P ¼ 0.0004) that
the homeopathic effect was not due to a placebo effect. The
time-course of symptoms improvement of this trial series is
reported in Fig. 1. A clear difference can be seen between HIT
and placebo, but the effect may be considered quite small for
A trial of the homeopathic medication Lung histamine 5c
used prophylactically in children with asthma also reported
promising results in reducing the frequency of attacks (44), but
the design of study did not allow persuasive evidence (42). An
uncontrolled study conducted in Belgium observed the effect
of Pollen 30c (prepared from a mixture of 12 grass pollens)
combined with Apis mellifica 15c and Lung histamine 15c,
in allergic oculorhinitis (17). The regimen was one tablet per
day and progress was monitored for 6 months by registering
nasal and ocular symptoms as well as by doctor’s assessment.
From 69 to 86% of patients—according to the parameter
evaluated—showed clinical improvements.
Further Multicenter Studies
Reilly’s group has subsequently organized a multicenter study
on patients affected by allergic rhinitis (28). The study
involved administration of a 30c potency of the main allergen
or (in control group) an indistinguishable placebo. The results
demonstrated a significant improvement in nasal air flow in
treated patients in comparison with those receiving placebo
(P ¼ 0.0001). Subjective symptoms improved but not in a
statistically significant manner. It is interesting to note that
the group treated with homeopathic preparations of allergen
more frequently reported an initial worsening, that is well
known in homeopathy. This study offered further proof that
high homeopathic dilutions cannot be assimilated to a simple
placebo. However, as underlined by the authors themselves,
this does not mean that their proposed HIT is an efficacious
homeopathic therapy for chronic rhinitis (also because classic
homeopathy requires individualized treatment).
A study of HIT, with essentially negative results, was
published in 2002 by an independent group led by G. Lewith
(32). Patients with asthma and positive skin prick tests for
house dust mite entered the trial. After a 4 week baseline
assessment, participants were randomized to receive oral HIT,
made with their specific allergen, or placebo, and then assessed
over 16 weeks by means of three visits and diary assessments
every other week. There was no difference in most final
outcomes between placebo and HIT, but there was a different
pattern of change during the trial in diary assessments
concerning morning peak expiratory flow, visual analogue
scale and mood. In brief, the homeopathic medicine caused
a slight but statistically significant worsening during the
early phases of treatment than placebo, while at the end
of experimental period the effectiveness of HIT was not
significantly different from placebo. This study sparked a
considerable discussion in the same Journal (45). In a
subsequent paper, some of the authors of the past negative
trial of HIT have discussed their data of the same trial using
complexity theory (46). This is an evidence for a different
oscillation in outcome (both physiological and subjective) of
verum treatment with respect to placebo (see Fig. 2). The
authors suggest that such time dynamics are consistent with a
complexity theory interpretation of how the body functions as
a whole and speculate that these oscillatory phenomena require
a different trial methodology from that currently employed.
A series of double-blind, randomized, placebo-controlled
trials on preventive and therapeutic effectiveness of pollen
of Betula (HIT) were conducted by a Norwegian group. In the
first study (29), the effect of the homeopathic remedy Betula
30c versus placebo for adult patients with birch pollen allergy
was tested. No statistically significant difference between
groups was found, except for a brief period when those
receiving verum having fewer and less serious symptoms. For
some days these differences were statistically significant.
Surprisingly, the verum group also reported some aggravation
after medication, more than did placebo group, a result in
agreement with that of previously mentioned trials (28,32).
The second study (30) involved children and gave uncertain
results, according to the authors possibly because the pollen
count was very low during treatment period and only 3 days
were high enough to provoke allergic symptoms. This time the
verum-treated patients fared worse than placebo group; they
used more rescue medication and had higher symptom scores
during these 3 days. The authors suggested that the findings
may document a putative ‘aggravation response’, but certainly
do not support the usefulness of the tested homeopathic
prophylaxis for this condition. The third paper (31) with
similar protocol with addition of a crossover of treatments
showed a consistent response in both verum and placebo
groups, with no consistent clinical advantage of HIT.
Other authors communicated, in a letter (34), to have
obtained negative findings in an open study in which they
assessed the effects of HIT in children with stable asthma. This
could be because of the small sample size (n ¼ 12) or because
the lack of efficacy of remedy.
New Positive Findings
A recent double-blind trial showed significantly positive
effects of HIT of seasonal allergic rhinitis (35). The drug was
prepared from common allergens (tree, grass, weed species)
specific to Southwest region of US, which was compared with
placebo. Study outcomes included allergy-specific symptoms
using the rhinoconjunctivitis quality-of-life questionnaires.
Figure 1. Effect of homoeopathic immunotherapy (HIT) on visual analogue scale (VAS) scores averaged over four trials. On average, there was a mean reduction
of the visual analogue scale score of 10.9 mm in the homoeopathy group compared with 1.1 mm in the placebo group (P < 0.001). Reproduced with permission
from Taylor et al, reference 28.
Homeopathy and immunology. Clinical studies
The subjects reported no adverse effects during the 4 weeks
Fixed Prescription of Low-Potencies
The treatment of allergic patients using low potencies
(4· or 6·) extract from the plant G. glauca has been investi-
gated for many years by Wiesenauer’s group (10,18,47). In a
double-blind, randomized study of patients with seasonal
allergic rhinitis, Wiesenauer and Gaus (10) used G. glauca 6·
without individual homeopathic prescriptions. After 1 month
of treatment, an improvement in eye symptoms was observed
in 80% of patients in the homeopathic group, in 65% of
patients in the placebo group and in 66% of patients in the
group receiving the dilution alone, without dynamization. The
data were promising but there was not clear cut statistical
Two years later, Wiesenauer and Ludtke (12) published
the results of another double-blind, randomized, placebo-
controlled study of the effects of G. glauca in allergic rhinitis.
After 1 month of treatment, there were clear improvements
in the experimental group in terms of eye symptoms and
nasal symptoms. As in the 1985 study, the authors confirmed
the efficacy of Galphimia in seasonal allergic rhinitis, and
suggested that it should be used only after homeopathic
identification of sensitive individuals in order to minimize the
number of non-responders. Wiesenauer subsequently contin-
ued the experiments and his group has published a number of
papers concerning the efficacy of G. glauca, the most effective
potency being the 4· (18,48,49).
A group of investigators tested the effectiveness of two
homeopathic complexes in bronchial asthma. In the first
clinical trial the complex Engystol-N (tablets) was studied
(19–21). Patients were randomly assigned to verum or placebo
groups, under blind conditions. During observation period,
those treated with homeopathic complex showed greater
improvement of respiratory function. In another paper (26),
they described a double-blind, randomized, placebo-controlled
study of patients with allergic bronchial asthma already being
treated with steroids, bronchodilators and other drugs. One
vial of complex Asthma H Inj. Plfugerplex (a mixture of
low dilutions of many homeopathic plants and minerals) was
administered subcutaneously every week for 9 months. The
administration of Triamcinolone decreased in treated group
and increased in placebo group. The treated group also showed
a significant reduction in contracted infections and in cationic
protein levels, a marker of local inflammation. There was no
change in spirometric parameters (FEV and FVC), possibly
because patients were advised to take the lowest cortisone dose
compatible with the absence of cough and resting dyspnea.
Micciche ´ et al. (24) carried out an open study of children
with allergic oculorhinitis comparing conventional anti-
histaminic and cortisone treatment with a homeopathic
protocol based on three drugs (Dolisosbios No. 15, an
organotherapeutic, Mn-Cu Oligodrop and Histaminum 4c)
initiated after the start of pollen season in order to evaluate
their acute phase efficacy. After 2 months of treatment, 30 out
of 35 children in homeopathic group were cured, 2 received
only a slight benefit and 3 were switched to conventional
treatment because of relapses. In conventional treatment
group, 21 out of 35 children were cured, 7 showed a slight
improvement and 7 had to discontinue treatment because of
toxic effects. As in other reports from ‘equivalence’ studies,
the effectiveness of homeopathy is clearly demonstrated when
it is compared with conventional therapies. However, the
validity of results is limited by the fact that this was not a
Weiser et al. (27) have reported a study of seasonal allergic
rhinitis, using a complex product (Luffa compositum) in nasal
spray formulation. The homeopathic remedy consisted of a
Figure 2. Oscillatory effects in a homeopathic clinical trial. Although the
study failed to show a clinical improvement at the end of the trial period, there
wasneverthelessa significantdifferencebetweenactive treatmentcomparedto
placebo: the pattern of data indicate that verum, compared to placebo,
approximates to an oscillation. PEF, peak of expiratory flow; VAS, visual
analogue scale. Reproduced with permission from Hyland and Lewith,
fixed combination made up of Luffa operculata and G. glauca
(in 4·, 12·, 30· potencies), plus histamine and sulfur (in 12·,
30·, 200· potencies). There was a reference group of patients
without homeopathic therapy who were treated only with
standard intranasal therapy based on chromolyn sodium. The
results of the study demonstrate a quick and lasting effect of
the treatment, which produced a nearly complete remission of
hay fever symptoms. Adverse systemic effects did not
occur. Local adverse events appeared in 3 patients among a
total of 146. In conclusion, the authors suggested that, for
the treatment of hay fever, the homeopathic nasal spray is
as efficient and well tolerable as conventional therapy with
Systematic Reviews of Allergy and Asthma
A meta-analysis of seven randomized clinical trials (RCT) to
assess the efficacy of homeopathic preparations of G. glauca
in treatment of allergic rhinitis was published by Ludtke
and Wiesenauer (50). The data are consistently in favor of a
statistically significant effect of the low-dose homeopathic
medicine over placebo, particularly in relief of eye symptoms.
Verum estimate of success is reported of ?80%. The validity
of these experimental studies was confirmed also by inde-
pendent meta-analyses (51,52).
The review of Kleijnen et al. (53) and the meta-analysis of
Reilly of his own studies (28) suggested that HIT was effective
in the treatment of rhinitis. There have been a few reviews of
randomized, controlled trials published regarding the use of
homeopathy for asthma treatment. Six trials were included in
a recent review (54,55). These trials were of variable quality
and the results of the studies are conflicting in terms of effects
on lung function. The authors underlined that standardized
treatments in these trials are unlikely to represent common
homeopathic practice where treatment tends to be individual-
ized. More and larger trials are therefore urgently needed
to assess properly the role of homeopathy in management
of asthma, but experts (51,56,57) suggested that as well as
randomized trials, there is a need for observational data to
document the different methods of homeopathic prescribing
and how patients respond. Further studies could assess whether
individuals respond to a ‘package of care’ (i.e. the effects of
medication as well as consultation, which is considered a vital
part of individualized homeopathic practice) rather than the
homeopathic medicine against placebo alone.
While complementary medicine and homeopathy are becom-
ing an increasingly prominent part of health care practices,
there is paucity of controlled studies concerning their
effectiveness. Traditional knowledge has been accumulating
for over 200 years, but only in past few decades modern
research methods such as RCT, rigorous observational studies
and equivalence studies comparing homeopathy with con-
ventional standard therapies have been applied.
Few well-designed studies have been reproduced by inde-
pendent research teams for two main reasons: lack of sufficient
funding and lack of a sufficient number of well-trained
homeopaths who are qualified and interested in research. As
a matter of fact, the debate on efficacy of homeopathy is still
very hot, as shown by a series of reviews (51,52,58,59) and
chiefly by the controversial meta-analysis published by the
Lancet (60,61) and by the significant expert reactions to the
Even though the number of papers published in peer-
reviewed journals is increasing, the results of many clinical
studies on effectiveness of homeopathy are characterized by
low standards of methodology (52,53,65). The major problems
in most trials were the description of allocation concealment,
imprecise outcomes and the reporting of drop-outs and
withdrawals. Other concerns are publication bias (tendency
to publish more positive than negative trials, a problem that is
also present in conventional medicine) and lack of independent
replications of most conducted studies.
This review summarizes the trial data for or against homeo-
pathy as a treatment for a series of diseases due to disorders of
immune system and/or dysregulation of local inflammatory
processes. We are confident that the reported studies represent
a large majority of available literature in this field, although
some omission cannot be excluded. Clearly, the few dozens
of papers reported are highly heterogeneous in terms of disease
conditions, drug used and experimental designs.
There was great heterogeneity in the nature of the
homeopathic intervention applied: mostly fixed combinations
or complexes, several individualized homeopathy with single
remedies, some isotherapy studies in allergy. In Table 3 the
studies concerning the disorders of immune system considered
in this review are grouped according to clinical condition and
type of homeopathic treatment; the clinical evidence of the
major groups of treatments was classified according to criteria
that have been reported in Table 1.
The best evidences of effectiveness appearing in the top two
rows of Table 3 and are G. glauca (low potencies) in allergic
oculorhinitis, classical individualized homeopathy for otitis,
Euphorbium compositum for rhinitis–sinusitis, Traumeel in
post-chemotherapy stomatitis. The use of homeopathy in those
conditions is indirectly supported also by evidence in basic
science, animal studies or theory [(89,90) and P. Bellavite,
R. Ortolani, F. Pontarollo, G. Pitari, A. Conforti, unpublished
data]. In grade C (unclear or conflicting evidence) there are
many studies, because positive results reported by some
authors were not replicated by others. The classical individu-
alized therapy of allergy and asthma was shown to be effective
in a number of studies and not effective only in one trial, but
several positive trials were of lower quality and published in
non-indexed journals; so, as a caution, we considered the
scientific evidence as still unclear according to the criteria of
Table 1. The number of homogeneous trials is too small to
attempt pooling and meta-analysis.
In synthesis, there are many promising studies supporting
clinically demonstrable activity of homeopathic medicines
Homeopathy and immunology. Clinical studies
in immunoallergology but the database of high-quality
homeopathic research in various fields is very small. Most
studies here reviewed suggest that homeopathic medicines in
high dilutions, prescribed by trained professionals, are safe and
are unlikely to provoke severe adverse reactions, in agreement
with previous reports (91–93).
Placebo and Effectiveness, Different Questions
Clinical research on homeopathy has been initially focusing
on the question of placebo. The first relevant RCT published
by top medical journals came out in 1986 with the title ‘Is
homeopathy a placebo response?’(11) and 20 years later a
meta-analysis published in this field meaningfully had the title
‘Are the clinical effects of homeopathy placebo effects?’ (61)
(Fig. 3). This clearly indicates that we still do not have a
consensus, but possibly also because the question is not
correct, and this is the case for those medicines that contain
low dilutions, i.e. ponderal doses, of active principles. The
latter medicines by definition cannot be considered as inert
placebos, but the distinction was ignored by the famed
Lancet’s meta-analysis (61) and its related editorial (60).
On evaluating the evidence in favor and against clinical
effectiveness of a therapy, it should be pointed out that the
placebo question is exceedingly important but is not equivalent
to the question of whether a therapeutic approach is clinic-
ally effective. The evidence of specific activity of a drug
over placebo is usually achieved in double-blind RCT.
Epidemiologists agree that this ‘artificial’ setting may have
high internal validity but often fails to reproduce the ‘real life’
application of the method. Patients and physicians need also
an answer to the empirical question of whether and how
much the homeopathic therapy, considered as a whole system
of cure, may help to decrease symptoms, improve quality of
life and may substitute other, often more toxic, forms of
therapy. More pragmatic studies aimed at ‘improving’ instead
of ‘proving’ homeopathy have been suggested (45,51,94).
To Blind or Not to Blind
The blinding procedure that is often related to the problem is
utilized in clinical research. This procedure has been so widely
employed in evidence-based research on conventional drugs
that there is the tendency to consider it as the gold standard
for any clinical research. However, randomized trials have
important limitations in interventions that require particular
skills (95) and finding the correct homeopathic simillimum
depends on in-depth anamnesis and atmosphere of trust, which
is disrupted by randomization (96). In homeopathy, the
parameters of evaluation follow specific rules that imply
consideration of the totality of a patient’s symptoms which
includes the disease’s symptoms and a continuous follow-up
that often requires careful evaluation of response by the
clinician, and often change of medicine, particularly in chronic
Table 3. Summary of the levels of evidence of clinical homeopathic studies in immunoallergology
Level of evidence Infections of upper airways and
Allergy and asthma
A (strong scientific evidence)– Galphimia glauca (low potencies)
IN ALLERGIC OCULORHINITIS
(10), (12), (18), (49), (50), (51)
B (good scientific evidence)CLASSICAL INDIVIDUALIZED
HOMEOPATHY IN OTITIS (66), (67), (68), (69), (70)
Euphorbium compositum IN
RHINITIS–SINUSITIS (71), (72), (73), (74)
Traumeel-S IN POST-CHEMOTHERAPY
C (unclear or conflicting
CLASSICAL INDIVIDUALIZED HOMEOPATHY
!Effective: (69), (76);
!Not effective: (77), (78), (79).
HOMEOPATHIC COMPLEX FORMULATIONS:
Grippheel (83), (84)
HOMEOPATHIC IMMUNOTHERAPY (ISOTHERAPY):
!Effective: (9), (11), (17), (15), (28), (29), (35);
!Not effective: (31), (30), (46), (32), (34)
CLASSICAL INDIVIDUALIZED HOMEOPATHY:
!Effective: (8), (13), (16), (22), (23), (25), (36), (37);
!Not effective: (33). HOMEOPATHIC
Luffa compositum (27);
Asthma H Inj. Plfugerplex (26);
Engystol-N (20), (19), (21).
D (fair negative scientific evidence) Engystol-N injection (85)
Luffa þ Cinnabaris þ Kalium bichromicum (86)
E (strong negative scientific evidence)–
Lack of adequate evidence Lymphomyosot (87), Phytolacca americana þ
Guajacum officinale þ Capsicum annuum,
Sinusitis PMD (88)
Homeopathic protocol based on Dolisosbios No. 15,
Mn-Cu Oligodrop and Histaminum (24)
The characters of reference numbers indicate the type of study and of publication: boldface indicates randomized controlled trial or meta-analysis covering the
topic; italics indicate non-randomized controlled trial; normal case indicates uncontrolled, observational and retrospective studies; underlines indicate PubMed
cases. To successfully discriminate between complex respon-
ses to a homeopathic treatment it is important to know the
characteristics of the substance given to the patient and the
healing steps of this modality.
We consider the great importance that is given by classic
homeopathy to the interactions such as those between patient–
doctor–medicine and environment–body–mind (97,98). It has
been suggested that, according to the theory of ‘entanglement’
(99–102), the remedy would act in the context of a tripartite
relationship with the patient and the practitioner. What may be
the physical basis of such an entanglement is still a matter of
speculation, but this point forces us to take into account the
‘context’ of cure (e.g. patient–physician interactions) and
therefore to seriously question the double blinding for testing
homeopathy: this method by definition would disrupt those
According to these premises, one can assume that in
homeopathic cure a complex interaction of these mechanisms
occurs: (i) a small physical action of extremely low-dose
remedy, (ii) the activation of centers responding to ‘placebo
effect’ due to beliefs, expectations of the patient and (iii) the
endogenous healing mechanisms (99,100,104–108). If this is
the case, the therapeutic effect is due not to the sum of these
factors but to their product and any procedure decreasing
or shuting down one of them (as blinding undoubtedly does)
may markedly affect homeopathic cure, much more than
allopathic drug effect. As a consequence of the interference
with everyday routine homeopathic practice, more false
negative findings are expected in homeopathic double-blind
studies than in allopathic ones (109).
Observational research of uncontrolled homeopathic practice
documents consistently strong therapeutic effects and sus-
tained satisfaction in patients (59). An observational study
showed that over 70% of patients attending a homeopathic
hospital out-patient unit recorded positive changes in a wide
range of chronic diseases (110). Superimposable to this find-
ing is the report showing that 7 out of 10 patients visiting a
Norwegian homeopath reported a meaningful improvement in
their main complaint 6 months after the initial consultation
(111). Similar or even higher percentages of patients declar-
ing their satisfaction with homeopathic cure were reported by
others (112–116). Interestingly, a study was undertaken to
investigate the preferences of patients with asthma for various
treatment modalities showed that the extent to which the
doctor treated the patient as a whole person was also a
statistically significant attribute for the choice of homeopathic
therapy versus conventional therapy, even if clinical results are
perceived as equivalent (8).
So, we are in the situation that if we adopt the strict criteria
of evidence-based medicine, which were initially developed
for chemical drugs, the analysis of published literature on
homeopathy finds little evidence of superiority of homeo-
pathic medicines over placebo. If we accept observational
Figure 3. Titles of Lancet’s two publications on homeopathic trials. Reproduced with permission from Lancet 1986;2:881–6 (A) and from Lancet
Homeopathy and immunology. Clinical studies
studies and equivalence studies as valuable tools of invest-
igation, we find many proofs of effectiveness of homeopathy.
In any case this is valuable information from a pragmatic
standpoint because it enables the decision based on other
factors like patient’s personal preference, adverse effects,
availability and costs. The integration of RCT, observational
prospective studies and pharmacoeconomic analyses are the
future of research in this field.
Conclusions and Prospects
In summary, there is an efficacy/effectiveness paradox (similar
to that found in several other areas of complementary medicine
research) with a weak evidence in favor of homeopathy when
studies are done in randomized and double-blind conditions,
but yet there is documented effectiveness in equivalence
studies comparing homeopathy and conventional medicine
and documented usefulness in general practice (59): the
therapy is useful when applied in open practice and produces
substantial effects, even in patients with chronic diseases
(117,118). This paradox leads to two conclusions: (i) addi-
tional clinical research, both experimental and observational,
including studies using different designs, is necessary for
further research development in homeopathy and (ii) it is
conceivable that the discrepancies are due to lack of a
consistent theory concerning the action mechanism of homeo-
pathy (59), so that additional basic research and innovative
approaches to this problem are urgently warranted.
Nevertheless, the growing public interest in homeopathy
(probablydue more toa ‘liking’ forthis therapeutic system as a
whole and the use of small doses rather than to any scientific
certainty concerning its effectiveness) allows us to hope that
also this section of medicine will also receive greater attention
from the competent authorities and the scientific world.
Rigorous clinical studies examining effectiveness of homeo-
pathy like other complementary and alternative medicines are
needed (119). It will be necessary to adapt research methodo-
logies to the homeopathic field in order to respect the
complexity of its diagnostic procedure, but it is equally
necessary to ensure that protocols include objective measure-
ments of clinical and laboratory parameters, as well as
adequate control groups of untreated subjects or subjects
treated with conventional therapies.
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Received March 6, 2006; accepted June 9, 2006