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Immunology and Homeopathy-4 Part-2 2006

Immunology and Homeopathy-4 Part-2 2006

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Published by Dr. Nancy Malik
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Advance Access Publication 31 July 2006
eCAM 2006;3(4)397–409
doi:10.1093/ecam/nel046
Lecture Series
Immunology and Homeopathy. 4. Clinical Studies—Part 2
Paolo Bellavite
1
, Riccardo Ortolani
2
, Francesco Pontarollo
1
, Valeria Piasere
1
,Giovanni Benato
2
and Anita Conforti
3
1
Department of Scienze Morfologico-Biomediche,
2
Association for Integrative Medicine ‘Giovanni Scolaro’ and
3
Department 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 trialsand 9 observational studies) are described. The literature of common immunologic disorders includingalso upper respiratory tract infections (URTI) and otorhinolaryngology (reported in part 1), is evaluatedand discussed. Most of initial evidence-based research was addressed to the question of whetherhomeopathic high dilutions are placebos or possess specific effects, but this question has been oftenequivocal and is still a matter of debate. The evidence demonstrates that in some conditions homeopathyshows 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 fewlow-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 alsoanalyzed.
Keywords:
allergy – asthma – evidence-based homeopathy – homeopathic immunotherapy –homeopathic medications – homeopathy – immunology – isopathy – rhinoconjunctivitis
Introduction
In the first part of this review (1) the evidence-based researchon homeopathy in common upper respiratory tract infections(URTI) or in otorhinolaryngologic complaints has beendescribed. We shall here describe studies performed in thefield of allergology and, more specifically, in oculorhinitis(hayfever) and allergic asthma. The methods of analysis andthe criteria of classification are the same as described in thefirst 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 ismade according to a grade of evidence in six levels, whichwas developed by Natural Standard, an international researchcollaboration that aggregates and synthesizes data oncomplementary and alternative therapies (http://www.naturalstandard.com/index.asp). A summary of these criteriais reported in Table 1.
Allergic Conditions
Allergies are the most common immunological diseasesamong general population, and increasing evidence suggeststhat incidence of allergic disorders is rising dramatically.The results of several studies indicated that patients beforeseeking homeopathic care for their allergic symptoms wereunsatisfied within conventional health care system and thattheir choice was mostly motivated by assumption of few side-effects or by a wish to ‘try everything’ (2–7). Approximately50% of asthma patients in the UK have used some form of complementary therapy for their asthma at some stage, andmost of these patients have indicated that they derived atleast some benefit (8).
For reprints and all correspondence: Paolo Bellavite, University of Verona,37134 Verona, Italy. Tel:
þ
39-045-8202978; Fax:
þ
39-045-8202978;E-mail: paolo.bellavite@univr.it
Ó
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/ by-nc/2.5/) which permits unrestricted non-commerical use, distribution, and reproduction in any medium, provided the original work is properly cited.
 
Several studies using homeopathy have reported beneficialeffects from treating allergy-related conditions, other studieshave not found benefits over placebo. A summary of thesepapers in chronological order is given in Table 2, here in thetext 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 singlemedicine (‘simillimum’). In many reports using classic indivi-dualized prescription, there is an indication of most frequentlyused medicines.In starting this brief analysis of results obtained in allergo-logy, we cite a retrospective study, reported at a homeopathicconference (13), which included children treated withindividualized homeopathy. The results appeared to beencouraging, since 44.2% of patients had a ‘satisfactoryreaction’, 36.7% a ‘manifest improvement’, 18.3% a ‘relativeimprovement’ and 0.8% showing ‘no reaction’. The remediesprescribed 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 withclassical homeopathic method. Twenty-two different drugswere prescribed (the most used were
sulphur, Calcareacarbonica, Lycopodium
and
Pulsatilla
), at different potencies.After 3 years of treatment, the results showed a complete curein 58% of cases, improvements in 23% and failures in 19%.In brief, the results obtained in such a serious chronic diseaseare encouraging, but the open and uncontrolled nature of thetrial makes it impossible to draw definite conclusions.A further retrospective study evaluated patients sufferingfrom bronchial asthma (both children and adults) and underindividualized homeopathic treatment for more than 3 years(22). A statistically significant decrease in frequency andseverity of attacks before and after treatment was reported.There was also a marked decrease in the use of conventionalmedication. 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 classicalindividualized treatment of asthmatic people who wereallergic to dermatophagoides (23). Symptoms and immunolo-gic parameters were evaluated before and after an 8 monthstreatment. Significant decrease in number of exacerbations, of spirometric tests and immunologic markers was observed inactive homeopathic group. A full report would permit adetailed evaluation of the trial.A trial on individualized homeopathic therapy in asthmawas published in a Mexican homeopathic journal (25). Thestudy was double blind and controlled with placebo butthe randomization was not specified. The main result was areduction of asthma attacks after 4 months of therapy, with asignificant difference in favor of homeopathy.A pharmacoeconomic study (not reported in Table 2because it does not concern effectiveness) assessed thehomeopathic treatment in allergic diseases in a healthmaintenance organization (4). The computerized medicationcharts of each patient were evaluated for conventionalmedication consumption 3 months before and 3 months afterhomeopathic intervention, with each patient serving as hisor her own control. The results showed that 56% of patientsreduced their use of conventional medication followinghomeopathic intervention. The most significant reductionwas in anti-histamine use, followed by decreases in bron-chodilator use and steroids, with an average saving of $24per patient in the 3 month period following homeopathicintervention.
 Negative Trial, Questionable Method 
The effects of individualized homeopathic remedies as anadjunct to conventional treatment were compared with placebomedication in children with mild to moderate asthma (33).There were no clinically relevant or statistically significantchanges in active quality-of-life score. Scores of severity of 
Table 1.
Synthesis of the levels of evidence of therapeutic efficacyLevel of evidence Criteria
A
(strong scientific evidence) Statistically significant evidence of benefit from
>
2 properly randomized trials (RCTs), OR evidence from oneproperly conducted RCT AND one properly conducted meta-analysis AND with supporting evidence in basicscience, 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-randomizedtrialsAND 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 properlyconducted 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/ non-randomized trials
E
(strong negative scientific evidence) Statistically significant negative evidence (i.e. lack of evidence of benefit) from
!
1 properly randomizedadequately powered trial(s) of high-quality design by objective criteriaLack of adequate evidence Unable to evaluate efficacy due to lack of adequate available data. This is not equivalent to negative evidence
 398
Homeopathy and immunology. Clinical studies
 
      T    a      b      l    e      2  .
    H   o   m   e   o   p   a    t    h    i   c   c    l    i   n    i   c   a    l   s    t   u    d    i   e   s   o    f   a    l    l   e   r   g   y   a   n    d   a   s    t    h   m   a    R   e    f   e   r   e   n   c   e   a   n    d   y   e   a   r    C   o   n    d    i    t    i   o   n    (    d    i   a   g   n   o   s    i   s    )    S    t   u    d   y    t   y   p   e    P   u    b    l    i   c   a    t    i   o   n   c    l   a   s   s    i    f    i   c   a    t    i   o   n    S    t   u    d   y   g   r   o   u   p    T   r   e   a    t   m   e   n    t    (   s    )    O   u    t   c   o   m   e   s    K   e   y   r   e   s   u    l    t   s    H   a   r    d   y    (    1    9    8    4    )    (    9    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    (    h   o   u   s   e    d   u   s    t    )    1   a    2    7    0    H   o   m   e   o   p   a    t    h    i   c    i   m   m   u   n   o    t    h   e   r   a   p   y    (    H    I    T    )   m   a    d   e   w    i    t    h    h   o   u   s   e    d   u   s    t   p   o    t   e   n   c    i   e   s    S   y   m   p    t   o   m   s    H    I    T    b   e    t    t   e   r    t    h   a   n   p    l   a   c   e    b   o    W    i   e   s   e   n   a   u   e   r   a   n    d    G   a   u   s    (    1    9    8    5    )    (    1    0    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    1   a    1    b    1    6    4
    G   a    l   p    h    i   m    i   a   g    l   a   u   c   a
    6
      ·
    d   y   n   a   m    i   z   e    d   v   e   r   s   u   s   p    l   a   c   e    b   o   a   n    d
    G   a    l   p    h    i   m    i   a   g    l   a   u   c   a
    6
      ·
   n   o   n  -    d   y   n   a   m    i   z   e    d    E   y   e   a   n    d   n   o   s   e   s   y   m   p    t   o   m   s    T   r   e   n    d    t   o   p   o   s    i    t    i   v   e ,   n   o    t   s    t   a    t    i   s    t    i   c   a    l    l   y   s    i   g   n    i    f    i   c   a   n    t   :    l   e   s   s   s   y   m   p    t   o   m   s    i   n   p   a    t    i   e   n    t   s    t   a    k    i   n   g    d   y   n   a   m    i   z   e    d   v   e   r   u   m   m   e    d    i   c    i   n   e    t    h   a   n   o    t    h   e   r   g   r   o   u   p   s    R   e    i    l    l   y
   e    t   a    l .
    (    1    9    8    6    )    (    1    1    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    (    h   a   y    f   e   v   e   r    )    1   a    1   a    1    4    4
    P   o    l    l   e   n
    3    0   c    (    H    I    T    )   v   e   r   s   u   s   p    l   a   c   e    b   o    S   y   m   p    t   o   m   s    (    V    A    S    )    H    I    T    b   e    t    t   e   r    t    h   a   n   p    l   a   c   e    b   o    W    i   e   s   e   n   a   u   e   r   a   n    d    L   u    d    t    k   e    (    1    9    8    7    )    (    1    2    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    1   a    3    1    3    2
    G   a    l   p    h    i   m    i   a
    2   c   v   e   r   s   u   s   p    l   a   c   e    b   o    E   y   e   a   n    d   n   o   s   e   s   y   m   p    t   o   m   s    S    i   g   n    i    f    i   c   a   n    t    l   y    l   e   s   s   e   y   e   s   y   m   p    t   o   m   s    i   n   v   e   r   u   m   g   r   o   u   p    M   o   s   q   u   e   r   a    (    1    9    9    0    )    (    1    3    )    A   s    t    h   m   a    4    3    1    2    0   c    h    i    l    d   r   e   n    I   n    d    i   v    i    d   u   a    l    i   z   e    d    h   o   m   o   e   o   p   a    t    h   y    b   r   o   n   c    h    i   a    l   a   s    t    h   m   a    G   e   n   e   r   a    l   a   s   s   e   s   s   m   e   n    t    I   m   p   r   o   v   e   m   e   n    t    i   n   m   o   s    t   c   a   s   e   s    (   u   n   c   o   n    t   r   o    l    l   e    d    )    C   a   m   p    b   e    l    l
   e    t   a    l .
    (    1    9    9    0    )   ;    R   e    i    l    l   y
   e    t   a    l .
    (    1    9    9    4    )    (    1    4 ,    1    5    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    1   a    1   a    2    8    A    l    l   o   p   a    t    h   y
     þ
   a    l    l   e   r   g   e   n    3    0   c    (    H    I    T    )   v   e   r   s   u   s   a    l    l   o   p   a    t    h   y
     þ
   p    l   a   c   e    b   o    S   y   m   p    t   o   m   s    (    V    A    S    )   a   n    d   r   e   s   p    i   r   a    t   o   r   y    t   e   s    t   s    L   e   s   s   s   y   m   p    t   o   m   s    i   n   v   e   r   u   m   g   r   o   u   p    t    h   a   n   p    l   a   c   e    b   o ,   n   o    d    i    f    f   e   r   e   n   c   e    i   n    t   e   s    t   s    C   a   s    t   e    l    l   s   a   g   u    (    1    9    9    2    )    (    1    6    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    4    1    b    2    6   c    h    i    l    d   r   e   n    I   n    d    i   v    i    d   u   a    l    i   z   e    d    G    l   o    b   a    l   e   v   a    l   u   a    t    i   o   n    I   m   p   r   o   v   e   m   e   n    t    i   n   m   o   s    t   p   a    t    i   e   n    t   s    (   u   n   c   o   n    t   r   o    l    l   e    d    )    N   o    l    l   e   v   e   a   u   x    (    1    9    9    2    )    (    1    7    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    3    3    1    0    8
    P   o    l    l   e   n
    3    0   c ,
    A   p    i   s
    1    5   c ,
    L   u   n   g    h    i   s    t   a   m    i   n   e
    1    5   c    S   y   m   p    t   o   m   s    I   m   p   r   o   v   e   m   e   n    t    i   n   m   o   s    t   p   a    t    i   e   n    t   s    (   u   n   c   o   n    t   r   o    l    l   e    d    )    W    i   e   s   e   n   a   u   e   r   a   n    d    L   u    d    t    k   e    (    1    9    9    5    )    (    1    8    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    1   a    2    1    1    5
    G   a    l   p    h    i   m    i   a
    4    D   v   e   r   s   u   s   p    l   a   c   e    b   o    E   y   e   a   n    d   n   o   s   e   s   y   m   p    t   o   m   s    S    i   g   n    i    f    i   c   a   n    t   r   e    l    i   e    f    i   n   v   e   r   u   m   g   r   o   u   p    M   a    t   u   s    i   e   w    i   c   z    1    9    9    5 ,    1    9    9    6 ,    1    9    9    7    (    1    9  –    2    1    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    1   a    2    4    0    H   o   m   e   o   p   a    t    h    i   c   c   o   m   p    l   e   x
    E   n   g   y   s    t   o    l  -    N
   v   e   r   s   u   s   p    l   a   c   e    b   o    R   e   s   p    i   r   a    t   o   r   y    t   e   s    t   s    C    l    i   n    i   c   a    l    i   m   p   r   o   v   e   m   e   n    t   o   n    l   y    i   n   v   e   r   u   m   g   r   o   u   p    E    i   z   a   y   a   g   a    1    9    9    6    (    2    2    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    4    1    b    6    2    I   n    d    i   v    i    d   u   a    l    i   z   e    d    S   y   m   p    t   o   m   s   s   c   o   r   e   s    S    i   g   n    i    f    i   c   a   n    t    d   e   c   r   e   a   s   e   o    f   s   y   m   p    t   o   m   s   a    f    t   e   r    t    h   e   r   a   p   y    (   u   n   c   o   n    t   r   o    l    l   e    d    )    L   a   r   a  -    M   a   r   q   u   e   z
   e    t   a    l .
    (    1    9    9    7    )    (    2    3    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    1   a    3    1    9    I   n    d    i   v    i    d   u   a    l    i   z   e    d   v   e   r   s   u   s   p    l   a   c   e    b   o    S   y   m   p    t   o   m   s ,   s   p    i   r   o   m   e    t   r   y   p   a   r   a   m   e    t   e   r   s   a   n    d    i   m   m   u   n   o    l   o   g    i   c   a    l   m   a   r    k   e   r   s    V   e   r   u   m    b   e    t    t   e   r    t    h   a   n   p    l   a   c   e    b   o ,   s    i   g   n    i    f    i   c   a   n    t   c    h   a   n   g   e   s   o    f    l   a    b   o   r   a    t   o   r   y   m   a   r    k   e   r   s    M    i   c   c    i   c    h   e    ´
   e    t   a    l .
    (    1    9    9    8    )    (    2    4    )    A    l    l   e   r   g    i   c   o   c   u    l   o   r    h    i   n    i    t    i   s    2    2    7    0   c    h    i    l    d   r   e   n    H   o   m   e   o   p   a    t    h    i   c   p   r   o    t   o   c   o    l    b   a   s   e    d   o   n    t    h   r   e   e    l   o   w  -    d    i    l   u    t    i   o   n    d   r   u   g   s   v   e   r   s   u   s   c   o   n   v   e   n    t    i   o   n   a    l    t    h   e   r   a   p   y    G    l   o    b   a    l   e   v   a    l   u   a    t    i   o   n    T   r   e   n    d    t   o    b   e    t    t   e   r    i   m   p   r   o   v   e   m   e   n    t    i   n    t    h   e    h   o   m   e   o   p   a    t    h    i   c   g   r   o   u   p    R    i   v   e   r   o   n  -    G   a   r   r   o    t   e
   e    t   a    l .
    (    1    9    9    8    )    (    2    5    )    A    l    l   e   r   g    i   c   a   s    t    h   m   a    1   a    2    8    0    I   n    d    i   v    i    d   u   a    l    i   z   e    d   v   e   r   s   u   s   p    l   a   c   e    b   o    G   e   n   e   r   a    l   s   y   m   p    t   o   m   s   a   n    d   a    t    t   a   c    k    i   n    t   e   n   s    i    t   y    H    i   g    h   e   r   r   e    d   u   c    t    i   o   n   o    f   a   s    t    h   m   a   a    t    t   a   c    k   s    i   n   v   e   r   u   m   g   r   o   u   p
eCAM 2006;3(4)
399

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