Effectiveness of Homeopathy in Immunology and Inflammation ...

The Homoeopathic Heritage International 2008 ◆ 35

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Introduction

Homeopathic experience and litera-ture have often been relegated to aself-contained, self-sufficient worldwhich at the same time proves diffi-cult to judge according to the cate-gories of modern medicine. This situ-ation today is slowly but steadilychanging. Homeopathic clinicalresearch has developed over the lasttwenty years with the increasinglygreater use of modern medical meth-ods (clinical trials, observationalstudies, statistic evaluations, com-puterized storage programs andinstrumental or laboratory testing).Over two hundred clinical trialsdesigned to verify the efficacy home-opathic treatments have been pub-lished, many (but not all) of whichhave led to positive results. Theauthors of a meta-analysis of thehomeopathic clinical trials publishedup to 1991(1) wrote that the evidencewas sufficient to make homeopathy a

treatment worthy of consideration inparticular cases, although they alsorecommended further – and betterquality studies – before drawing anydefinite conclusions. The results ofanother meta-analysis(2) also con-firmed that homeopathic therapy hassignificant effects. However, it mustbe stressed that, although suchanalyses make it possible to excludea generalized “placebo effect” as theonly explanation of the resultsobtained by means of homeopathy,they are not sufficient to show thathomeopathic treatment is surely effi-cacious(3-5).

As in other medical disciplines,statistically significant result in favorof homeopathy could be reached bypooling all of the methodologicallyreliable studies in a given area, butthis occurred very rarely, because fewseries have been conducted for singleconditions and because the experi-mental approaches or the medicines

used are too heterogeneous to be ableto conclude that any one protocol isefficacious. Some of these series doc-ument clinically useful effects anddifferences against placebo(2,6-9) andsome series do not(10), or their evi-dence is “promising” but insufficientfor drawing conclusions(11). In sum-mary, the data are not strong enoughto make a general recommendation touse homeopathy for first-line treat-ment of these conditions.

Recent controversies on the ques-tion of whether homeopathy is aplacebo response(12-16) have shownthat an approved answer of thisdilemma is at present not possible,because the evaluation of the evi-dence and the inclusion or exclusionof papers from meta-analyses varyaccording to pre-selected criteria,that differ in different reviews, a sortof “bias” of the observer(17,18).Moreover, there is a noteworthy con-fusion of what type of “homeopathy”

Effectiveness of Homeopathy in Immunology and Inflammation Disorders. A Literature

Overview of Clinical StudiesDr. Paolo Bellavite, Dr. Salvatore Chirumbolo, Dr. Paolo Magnani,

Dr. Riccardo Ortolani, Dr. Anita Conforti, (Italy)

Abstract: Here we summarize the clinical research carried out in the past three decades to evaluate the effectiveness ofhomeopathy in conditions characterized by respiratory allergy, common upper respiratory tract infections, otorhinolaryn-gologic complaints, and rheumatic diseases. Most of initial evidence-based research, especially in allergy, was addressedto the question of whether homeopathic medicines used in high dilutions are placebos or possess specific effects, but thisquestion has been often equivocated and is still a matter of debate. Collectively the evidence demonstrates that in someconditions homeopathy shows significant promise, e.g. Galphimia glauca (low dilutions/potencies) in allergic oculorhinitis,classical individualized homeopathy in otitis, in fibromyalgia and possibly in upper respiratory tract infecions and allergiccomplaints. A general weakness of the evidence derives from the scarcity of independent confirmation of reported trialsand from the presence of conflicting results, as in case of homeopathic immunotherapy of allergy and for asthma. In ouropinion, since the homeopathic medicines are safe and under the light of few clinical and pre-clinical findings, their usecould be regarded as a possible option in infections of upper airways, otitis, allergic rhinitis and asthma, provided that thehomeopathic methodology of prescription is correct and not progressive. The suitable methods to evaluate homeopathyeffectiveness, without altering the setting of the cure, are also discussed.

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is evaluated (e.g. use of low or highpotencies) and when the homeopa-thy is accused for its lack of “plausi-bility”(1,12,19), the different modalitiesare not suitably distinguished.

The aim of this lecture series is toprovide an overview of the best ofavailable homeopathic literature inthe fields of immunoallergology andcommon inflammatory diseases. Inthis field, there is a body of pre-clini-cal research suggesting that homeo-pathic remedies may regulate theimmune system at cellular and/orsystemic levels(23,24). There are alsopreliminary ex-vivo observations ofsignificant changes of immune cells(CD4 lymphocytes) in people treatedwith high potencies of homeopathicmedicines(25).

Patients with diseases of theimmune system like allergies andasthma, or with enhanced suscepti-bility to recurrent infections, or withchronic inflammatory diseases of themusculoskeletal system often haverecourse to homeopathy as “alterna-tive” medicine(26-34), hoping to solvediseases that are not cured with con-ventional drugs, or as a “comple-mentary” cure hoping to reduce theconsumption of NSAIDS or othersteroids that may have adverseeffects, to relief some symptoms andto improve quality of life.Unfortunately, there is paucity of evi-dence-based recommendations of theuse of homeopathic remedies inthese conditions.

Evidence-based medicine willhave increasing impact also in thefield of complementary and alterna-tive medicine, but the systematicevaluation of the research evidencein homeopathy is an expectation thatrequires suitable methods of evalua-tion(35,36). In this new and controversialfield, the stringency of the tools uti-lized to systematically evaluate thescientific literature should be alwaysaccompanied by a consensus on the

clinical protocols that better reflectthe modality of cure, the type of fol-low-up and the relevance of out-comes, which can be different fromthose of conventional medicine.Otherwise the results, instead ofhelping the judicious use of evidencein making clinical decisions, becomeonly the source of new controversy,especially when disseminated by themedia, as was in the Lancet’s meta-analysis that was inappropriatelyboosted by the editorial title “The endof homeopathy”(37).

Clinical research on homeopathyhas been initially focusing on thequestion of placebo. The first rele-vant RCT published by top medicaljournals came out in 1986 with thetitle “Is homeopathy a placeboresponse?”(38) and twenty years later ameta-analysis published in this fieldmeaningfully had the title “Are theclinical effects of homeopathy placeboeffects?”(12). This clearly indicates thatwe haven’t still an accepted answer,but possibly also because the ques-tion is not correct, and this is the casefor those medicines that contain lowdilutions, i.e. ponderal doses, ofactive principles. The latter medi-cines by definition can’t be consid-ered as inert placebos, but the dis-tinction was ignored by the famedLancet’s meta-analysis(12) and its relat-ed editorial(37).

Here, we have distinguished thepublications in three major groups,each one of which holds a rationalefor the employ of homeopathic reme-dies. A first group includes patholo-gies consisting in due to anomaloussusceptibility to infections that maybe, at least in part, due to inadequacyof efficiency of the immune system inthe rejection of the extraneousaggressor. The second groupincludes pathologies due to hyper-sensitivity of the immune system, themost widespread of which is imme-diate hypersensitivity, or allergy, and

its major manifestations at the levelof respiratory system. This hypersen-sitivity results typically from anoverproduction of IgE and degranu-lation of mast cells when specificantigens combine with the antibodyat the local site. The third groupincludes the chronic conditions dueto rheumatic diseases or auto-immune pathologies in which oneobserves an immune response direct-ed against auto-antigens, causingself-maintained lesions inside inter-nal organs, skin, muscles and joints.

For each group of pathologies,the different homeopathic methodsutilized, namely a) classical individu-alized homeopathy, b) isotherapy aredealt with in separate sub-chapters.

MethodsThis review reports all the literatureon human subjects available to us inthe considered fields from 1978 to2006. Principal information sourceswere current reading of major CAMjournals during the past fifteen years,screening of the monthly publicationof complementary medicine index(British Library), of the databases of Central Council forresearch in Homeopathy (CCRH,www.ccrhindia.org/) and of Hom-inform Information Service (BritishHomeopathic Library, http://homin-form.soutron.com/), literature search-ing using Medline, CAM on PubMed(www. nlm.nih.gov/nccam/camon-pubmed.html), Cochrane Database ofSystematic Reviews and CAMbase,cross-referencing between publishedpapers. We directly received severalpapers from Authors. We have alsochecked the existing systematicreviews and meta-analyses that covertrials of immunoallergology. Theanalysis includes controlled clinicaltrials (with and without randomiza-tion), observational studies and caseseries. All forms of homeopathic inter-vention are included.



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When complementary and com-plex interventions such as acupunc-ture or homeopathy are considered,there is no consensus on the qualitycriteria used to classify the clinicaldata according to the importance oftreatment outcomes, the scientificstrength and the reliability(14,39,40). As wewill discuss later, the problems ariseespecially as regards the role of blind-ing and concealment, of follow-upindexes particularly in chronic cases,of healing markers, of primary andsecondary outcomes, and in general ofthe validity of experimental vs. obser-vational studies. Therefore, to allow asemi-quantitative ranking of homeo-pathic treatment studies, we haveadopted the following three criteria.

First, we have classified the pub-lications according to the type ofstudy, using, with slight modifica-tions, the classification system thathas been developed by the NationalCancer Institute for human studies ofcomplementary and alternativemedicine in cancer studies(http://www.cancer.gov/cancertopic-spdq/levels-evidence-cam/ HealthProfessional/page2). According tothis classification, the score indescending order of strength isreported in Table 1. The main modi-fication with respect to the NCI clas-sification is that we have includedthe randomized (non-blinded) equiv-alence studies, comparing twomodalities of therapy, in level 1b andthe non-randomized equivalencestudies in level 2. Those types ofstudies have increasing importancein homeopathic literature.

A second criterion that may helpin “weighing” each paper is the pub-lication type, which we scoredaccording to a classification wherethe top papers are those published inmainstream medical literature andthe last level is provided by publica-tions in books or conference proceed-ings (Table 2). Communications

reporting single cases or expert opin-ions were excluded. Although thisorder may be questionable for anumber of reasons (especially as con-cerns the difference between main-stream and complementary/alterna-tive medicine journals), we believethat it may facilitate the reader injudging the grade of evidence pro-vided by each study.

Finally, the global body of evi-dence regarding the effectiveness ofthe different therapeutic approaches,in the conditions considered in thisreview, has been presented in theDiscussion. Here the classification ofthe therapeutic approaches is madeaccording to a grade of evidence in 6 levels that was developed byNatural Standard, an internationalresearch collaboration that aggre-gates and synthesizes data on com-plementary and alternative therapies(http://www.naturalstandard.com/index.asp). A summary of these criteriais reported in Table 3.

Research with Fixed prescriptionof low potencies and complex formu-lations have not been included in thispaper but the treated group hadshown significant improvement.Certain interesting things found dur-ing these research works: It has beenreported that some plant componentsof, e.g. Euphorbium and Pulsatilla, havea direct anti-viral (respiratory syncy-tial virus and herpes simplex virustype 1) effect in vitro(79). No seriousadverse effects were reported.

Infections of upper airways and otorhino-laryngologic diseases

Homeopathic research in the otorhi-nolaryngologic field includes studiesof acute and chronic rhinitis, otitismedia, sinusitis, tonsillitis. Here thediseases of infectious origin are con-sidered, while the allergic diseasesare considered in the next section.

Various groups of homeopathicresearchers have worked on thesediseases, which are very frequent inthe general population, with often(but not always) positive results. Theunnecessary use of antibiotics in theinitial treatment of acute otitis mediaand URI is currently being ques-tioned. Homeopathy has been usedhistorically to treat this illness, and itis interesting to see if there aremethodologically rigorous trials todetermine whether there is a positivetreatment effect.

We also report a relevant study onpost-chemotherapy stomatitis, whichis caused both by direct mucosal dam-age and by infections due toimmunecompromission. We haveomitted the trials on influenza bothbecause the limited space of this lec-ture and the existence of systematicreviews covering the topic(21,41). A sum-mary of these studies in chronologicalorder is reported in (Table 4) and abrief outline of each protocol with themain results of the different homeo-pathic strategies is given as follows.

Classic IndividualizedHomeopathyThe first report of classical homeopa-thy dates in 1997 when Friese et al.(43)

reported an open study comparingthe results obtained in otitis media inchildren, treated using two differentmedical approaches. They comparedclassical unitary homeopathic reme-dies (Aconitum, Apis mel., Belladonna,Lachesis, Pulsatilla, Silicea, Lycopodium,Chamomilla and Capsicum) prescribedafter an individual homeopathic caseanalysis (repertorisation), with con-ventional therapy based on antibi-otics, mucolytics and antipyretics in agroup of children. The duration ofpain was two days in the homeopath-ic group and three days in the con-ventional therapy group (n.s.) and theduration of therapy was four and tendays respectively. The latter difference

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was statistically significant (p<0.01),but it should be noted that the dura-tion of antibiotic therapy for theseconditions can’t be shorter than aweek, so this comparison may notreflect the clinical outcomes. Relapseswere experienced by respectively29.3% and 43.5% of the subjects, witha mean number of relapses of 0.41 vs.0.70 (p=0.39). In brief, this pragmaticstudy comparing homeopathic withconventional therapy showed that theresults were similar, but with a trendin favor of the former.

In an open, prospective, multi-centre study, Kruse(44) evaluated agroup of children with otitis mediafor six weeks, controlling the resultsagainst conventional therapy. Thehomeopathy group was treated withsingle remedies like Aconitum 30X,1

Apis 6X, Belladonna 30X, Capsicum 6X,Chamomilla 3X, Lachesis 12X andother remedies; the reference groupwas treated with antibiotics (amoxi-cillin, erythromycin, etc.), secretolyt-ics (ambroxol, acetylcisteine),antipyretics (paracetamol, etc.) andsympathomimetics such as nasalsprays. In the homeopathic group,70.7% of the children who completedthe study did not experience anyrecurrence; in the allopathic group,64% of the children completing thestudy remained relapse free (n.s.).The average duration of pain in thetwo groups was respectively threedays and four days (n.s.). Therefore,also this study suggested a similareffectiveness of the homeopathic andconventional treatments, with a posi-tive trend in favor of the former.

De Lange et al.(45) carried out adouble-blind, randomized studywhich they evaluated the frequency,duration and severity of rhinitis,pharyngitis and tonsillitis in a groupof children. The homeopathic pre-scription included “constitutional”remedies for preventive purposesand remedies for the treatment ofacute phases. The year-long therapywas continuously adjusted on anindividual basis, and the data werecollected by means of diaries kept bythe parents and attending physi-cians. The results showed that thehomeopathic therapy was slightlybut not significantly better thanplacebo: the mean number of infec-tive episodes was 7.9/year in thetreated group and 8.4/year in thecontrol group. The children in theactive group experienced episodesthat were generally shorter and lesssevere, and were disease-free for 53%of the days (as against 49% in theplacebo group); the percentage ofchildren not requiring antibioticswas 62% vs. 49% in homeopathy andconventional therapy respectively.Adenoidectomy was performed in16% of the treated subjects vs. 21% ofthe controls. The results of a ques-tionnaire concerning the children’sglobal well-being showed a slightpreference for the homeopathic treat-ment (4.81 vs. 4.17 points). Theauthors concluded that the differ-ences between the two treatmentswere interesting but small; the mainreason for the lack of statistical sig-nificance was that a considerableimprovement in both groups was

observed during the year of observa-tion, something that may havemasked a small specific effect of thehomeopathic treatment. The paperwas criticized by homeopathic expertclinicians(53) and methodologists(18)

maintaining that in that study home-opathy had to prove benefit addi-tional to conventional therapy. Ifhomeopathy was effective, controlchildren would need more antibioticsand tonsillectomy, and this was thecase; such surplus of conventionaltherapies could have created falsenegative results.

The purpose of the observationalstudy of Frei and Thurneysen(47) wasto find out how many children withacute otitis media are relieved of painwith individualized homeopathictreatment. A group of children withthis condition received a first individ-ualized homeopathic medicine in thepediatric office. If pain-reduction wasnot sufficient after 6 h, a second (dif-ferent) homeopathic medicine wasgiven. After a further 6 h, childrenwho had not reached pain controlwere started on antibiotics. Pain con-trol was achieved in 39% of thepatients after 6 h, another 33% after12 h. Compared with literature’s data,the authors stated that the resolutionrate is 2.4 times faster than in untreat-ed cases. The six more frequently pre-scribed remedies were Pulsatilla,Belladonna, Sulphur, Phosphorus,Calcium carbonicum, Lycopodium.

An interesting multicentre,prospective, observational study in areal world medical setting comparedthe effectiveness of homeopathy withconventional medicine(48). Thirtyinvestigators with conventional med-ical licenses at six clinical sites in fourcountries enrolled a series of patientswith at least one of the followingthree complaints: upper respiratorytract complaints including allergies;lower respiratory tract complaintsincluding allergies; or ear com-

1Homeopathic remedies are solutions of substances diluted and succussed(“dynamized” or “potentized” according to traditional terminology) in 1:100 serial dilu-tions (centesimal, c) or 1:10 serial dilutions (decimal, x), or in other types of serial dilu-tions like Korsakovian (K), 1/50,000 (LM), continuous flux, etc. According to theAvogadro's law and as an approximate reference value, assuming a 1 Mole/l concentra-tion of pharmacologically active principles in the starting solution (mother tincture),dilutions lower than 12c or 24x (here referred as “low potencies”) should contain a con-sistent number of molecules of the active principle. This means that the allegation ofbeing “placebos” can not be always based on the purported absence of drug moleculesas it is often done.



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plaints. Four hundred and fifty-sixpatient visits were compared: 281received homeopathy, 175 receivedconventional medicine. The responseto treatment (healing or a majorimprovement after 14 days of treat-ment) was 82.6% among the patientsreceiving homeopathy and 68%among those receiving conventionalmedicine. The adverse events in theconventional therapy group were22.3% vs. 7.8% in the homeopathygroup. Seventy-nine percent of thepatients treated with homeopathywere very satisfied as against 65.1%of those receiving conventional treat-ment. Since the trial was not random-ized, no statistical comparisonbetween groups could be done. Inany case, homeopathy appeared tobe at least as effective as convention-al medical care in the treatment ofpatients with these three conditions.

A randomized double-blindplacebo control pilot study was con-ducted(49) in children with otitis media.Subjects having middle ear effusionand ear pain and/or fever for no morethan 36 h entered into the study. Theyreceived either an individualizedhomeopathic medicine or a placeboadministered orally three times dailyfor 5 days, or until symptoms sub-sided. Outcome measures includedthe number of treatment failures after5 days, 2 weeks and 6 weeks. Diarysymptom scores during the first 3days and middle ear effusion at 2 and6 weeks after treatment were also eval-uated. There were fewer treatmentfailures in the group receiving home-opathy after 5 days, 2 weeks and 6weeks, with differences of 11.4%,18.4% and 19.9%, respectively, butthese differences were not statisticallysignificant. Diary scores showed a sig-nificant decrease in symptoms at 24and 64 h after treatment in favor ofhomeopathy (P < 0.05).

An equivalence trial was per-formed by Steinsbekk et al(50), who

investigated whether individualizedtreatment by homeopaths is effectivein preventing childhood URTI.Children recruited by post from agroup previously diagnosed withURTI, were randomly assigned toreceive either homeopathic care for 12weeks or to conventional health care.There was a significant difference inmedian total symptom score in favorof homeopathic care (24 points) com-pared to the control group (44 points)(p = 0.026). The days with symptomswere 8 and 13 in the homeopathicgroup and the reference group respec-tively (p = 0.006). On the other hand,negative results were obtained by thesame group(51) in a double-blind place-bo controlled randomized trial.

A study to compare effectivenessand costs of two treatment strategies(‘homeopathic strategy’ vs. ‘antibiot-ic strategy’) used in routine medicalpractice by allopathic and homeo-pathic GPs in the treatment of recur-rent acute rhinopharyngitis in chil-dren was published(52). Data from alarge series of patients, clinicallyobserved for 6 months, were ana-lyzed and grouped according to typeof drug prescribed and the episodesof acute rhinopharyngitis, complica-tions, and adverse effects. Directmedical costs (medical consultations,drug prescriptions, further tests) andindirect medical costs (sick-leave)were also evaluated. The resultsshowed that the ‘homeopathic strate-gy’ yielded significantly betterresults than the ‘antibiotic strategy’in terms of number of episodes ofrhinopharyngitis (2.71 vs. 3.97,P<0.001), number of complications(1.25 vs. 1.95, P<0.001), and quality oflife (global score: 21.38 vs. 30.43,P<0.001), with lower direct medicalcosts in favor of homeopathy (€88 vs.€99, P<0.05). The authors suggestedthat homeopathy may be a cost-effec-tive alternative to antibiotics in thetreatment of recurrent infantile

rhinopharyngitis. Of course, theseconclusions should be confirmed orproven to be wrong with random-ized studies on homogeneous groupsof patients.

Systematic ReviewsNo systematic reviews on the effec-tiveness of homeopathy in these con-ditions have been published. Areview on all the complementary andalternative medicines for URTI inchildren just mentioned homeopathy,as a modality of prevention andtreatment that is not adequately sup-ported by clinical trials(55).

Allergic ConditionsAllergies are the most commonimmunological diseases among thegeneral population, and increasing evi-dence suggests that the incidence ofallergic disorders is rising dramatical-ly. The results of several studies indi-cated that patients before seekinghomeopathic care for their allergicsymptoms were unsatisfied within theconventional health care system andthat their choice was mostly motivatedby the assumption of few side-effectsor by a wish to “try everything” (27,29,34,56-

58). Approximately 50% of asthmapatients in the UK have used someform of complementary therapy fortheir asthma at some stage, and mostof these patients have indicated thatthey derived at least some benefit (59).

We shall here describe the stud-ies that have been carried out in thefield of allergology and, more specif-ically, oculorhinitis (hayfever) andallergic asthma. Several studies usinghomeopathy have reported benefi-cial effects from treating allergy-related conditions, other studies havenot found benefits over placebo. Asummary of these papers in chrono-logical order is given in (Table 5),here in the text they will be groupedaccording the different modalities oftherapy that have been investigated.



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Classic IndividualizedHomeopathyIn starting this brief analysis of theresults obtained in the field of aller-gology, we cite a retrospective studyby M. Mosquera Pardo, reported at ahomeopathic conference(63). Thestudy included children who weretreated with individualized homeop-athy. The results appeared to beencouraging, since 44.2% of patientshad a “satisfactory reaction”, 36.7% a“manifest improvement”, 18.3% a“relative improvement” and 0.8%showing “no reaction”. The remediesprescribed most frequently wereLycopodium clavatum, Sulphur,Pulsatilla and Silicea.

Castellsagu(65) retrospectively eval-uated a series of children who hadsuffered from allergic bronchial asth-ma for between 18 months and 11years, and who were treated with asingle drug in accordance with theclassical homeopathic method.Twenty-two different drugs were pre-scribed (the most used were Sulphur,Calcarea carbonica, Lycopodium andPulsatilla), at different potencies(mainly 200 K). After three years oftreatment, the results showed a com-plete cure in 58% of cases, improve-ments in 23% and failures in 19%. Ofthe cured cases, 53% needed only onehomeopathic drug, 27% required 2-4remedies, and 20% required 5-9 dif-ferent drugs. The time to cure was 2-6months in 33.3% of cases, one year in33.3%, 1-3 years in 20% and more thanthree years in 13.3%. In brief, theresults obtained in such a seriouschronic disease are encouraging, butthe open and uncontrolled nature ofthe trial makes it impossible to drawdefinite conclusions.

A further retrospective studyevaluated patients suffering frombronchial asthma (both children andadults) and under individualizedhomeopathic treatment for morethan three years(66). A statistically sig-

nificant decrease in the frequencyand severity of attacks before andafter the treatment was reported.There was also a marked decrease ofthe use of conventional medication.The most frequently prescribedremedies were Arsenicum album, Nuxvomica, Sulphur, Pulsatilla, and Silica.

In 1997 a communication in aconference of InternationalHomeopathic Liga (LMHI) reporteda double-blind, randomized, placebocontrolled trial the effectiveness ofclassical individualized treatment ofasthmatic people who were allergicto dermatophagoides(67). Symptomsand immunologic parameters wereevaluated before and after 8-monthstreatment. Significant decrease in thenumber of exacerbation and of spiro-metric tests was observed in theactive homeopathic group.Asthmatic patients showed at base-line higher levels of interleukin-4produced by non-stimulatedPeripheral Blood Mononuclear Cells(PBMC) cultures, as compared tocontrols. After treatment, there was adecrease in the spontaneous produc-tion of interleukin-4 by PBMC on theactive homeopathic group that wasnot observed in the placebo group.Complex differential changes ofother variables (IL-5, Interferon-Gamma, and soluble CD23) werealso reported. These results suggestthat homeopathic treatment waseffective and had concomitantimmune regulatory effects in thepatients with active vs. placebo treat-ment. Unfortunately this interestingand promising communication wasnot followed, to the best of ourknowledge, by a full report thatwould permit a detailed evaluationof the trial.

A trial on individualized homeo-pathic therapy in asthma was pub-lished in a Mexican homeopathicjournal(68). The study was doubleblind and controlled with placebo

but the randomization was not speci-fied. The main result was a reductionof asthma attacks after 4 months oftherapy, with a difference in favor ofhomeopathy vs. placebo (p<0.05).

A pharmacoeconomic study (notreported in (Table 4) because it doesnot report data of effectiveness)assessed the effect of integrativehomeopathic treatment in allergicdiseases on conventional medicationconsumption in a health mainte-nance organization(57). Forty-eightpatients were treated for allergic dis-eases with homeopathic and conven-tional medications. The computer-ized medication charts of eachpatient were evaluated for conven-tional medication consumption threemonths before and three monthsafter the homeopathic intervention,with each patient serving as his orher own control. The results showedthat 56% of the patients reduced theiruse of conventional medication fol-lowing the homeopathic interven-tion. The most significant reductionwas in antihistamine use (a 70%reduction), followed by decreases inbronchodilator use (55%) andsteroids (50%). The patients whoused also conventional medicationsfor their allergic disorders reducedtheir medication expenses by anaverage of 60%, with an average sav-ing of $24 per patient in the 3-monthperiod following the homeopathicintervention.

In a randomised, double blind,placebo controlled trial the effects ofindividualized homeopathic reme-dies as an adjunct to conventionaltreatment were compared with place-bo medication in children with mildto moderate asthma(73). The main out-come measure was the active qualityof living subscale of the ChildhoodAsthma Questionnaire administeredat baseline and follow up at 12months. There were no clinically rel-evant or statistically significant



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changes in the active quality of lifescore. Scores of severity of symptomsindicated relative improvements butthe sizes of the effects were small.There were no differences betweenthe groups for other measures. Theauthors concluded that adjunctivehomeopathic remedies are not supe-rior to placebo in improving thequality of life of children with mildto moderate asthma. This is a studythat raised high media coverage as aproof of the inefficacy of homeopa-thy, but various authors have raiseddoubts that the parameters usedwere sensitive enough to differenti-ate between children who have noasthma and those who have onlymild asthma(77-79). In fact, includedpatients had very mild or lackingsymptoms, which hardly could beameliorated and expected peak flowvalue in the treatment group wasalready over 100% at the beginningof the study. Therefore, this studyshould be interpreted with cautionand will not permit a definitive judg-ment about the role of adjunctivehomeopathic treatment in asthma.

An observational study where theoutcome and costs of homeopathictherapy were compared with those ofconventional treatment in routine carehas been published(76). Since all thechildren included in this study wereaffected by allergic diseases (homeo-pathic therapy: 54 atopic dermatitis, 20allergic rhinitis, 17 asthma; conven-tional therapy: 64 atopic dermatitis, 11allergic rhinitis, 12 asthma), the resultsof this subset of patients may be ofinterest for this review. Allergic chil-dren were treated either with classichomeopathic approach or with con-ventional therapies provided by doc-tors selected from an address list ofgeneral practitioners. The two groupswere not randomized but their diseasegrade at baseline was similar. Briefly,the results after 12 months of cureindicated that the symptom severity

scores (assessed both by patients andby physicians) decreased more signifi-cantly in homeopathic group than inconventional group. There was also atrend to a better improvement of qual-ity of life in the homeopathic group,but not statistically significant afterdiagnosis-specific adjustment. Overallcosts were higher in homeopathic carethan conventional care (€1049 vs.€366), but the difference betweengroups was not statistically significant.

Homeopathic ImmunotherapyOne of the most extensive lines ofresearch in homeopathy was theattempt to utilize high dilutions ofsubstances known to cause the aller-gy (antigens) to prevent or cure thesame allergies. This is a applicationof the ancient isopathic principle(22),that has been also termed “homeo-pathic immunotherapy (HIT)”(38,64,80).Isopathy does not match the fullexpression of Hahnemann’s rules,according to which the treatment isadapted to the whole characteristic ofthe patients. Nevertheless, the studyof HIT offered a simple model ofcomparing the action of ultra-dilutedand dynamized substances with thatof placebo on the immune system.

To start the description of theseresults, it is worth citing a first reportin a non-indexed journal by Hardy in1984(60). The authors were able toshow a relief of oculorhinitis symp-toms of in patients allergic to housedust by homeopathic potencies. Thesame approach characterized thelong-lasting and deep investigationsof isopathic treatment of respiratoryallergies by the Glasgow group led byD. Reilly. A double-blind study, pub-lished as preliminary report by theBritish Homeopathic Journal in 1985(81)

and as a full paper by The Lancet in1986(38), compared the effects of place-bo and of a 30c homeopathic prepara-tion designed as Pollen because itcontained a mixture of 12 pollens.

The results were positive insofar asthe patients receiving the homeo-pathic treatment had significantlyfewer symptoms and used half of theanti-histamine rescue treatment thanthe controls. This study, given thegood methodology, the novelty of theapproach and the prestige of the jour-nal in which it was published, wasfollowed by literature reverberationsand by a series of predictable criti-cisms. By the way, it is noteworthythat the chosen model, the use ofpollen in hay fever, actually comesfrom the work of a homeopath —Dr.Charles Blackley - who, in the 1870s,first identified pollen as the cause ofrespiratory seasonal allergies(80).

The same group published theresults of a study on patients withsevere atopic asthma requiring dailyadministrations of bronchodilators,most of who were being treated withsteroids(64). Without any change intheir basic therapy, the patientsreceived a placebo for four weeksand were then randomly dividedinto two groups, one of which con-tinued the placebo, whereas the otherwas treated with a 30c homeopathicpreparation of the main allergen towhich each patient was sensitive. Thepatients recorded the intensity ofsymptoms every day using a visualanalogue scale for the following fourweeks. Analysis of the end-of-studyjudgments of the patients revealed astatistically significant difference infavor of the active treatment. Thesestudies of Reilly’s group, enriched byfurther statistical analyses and ameta-analysis of all of the patients,were published in 1994(20). An analy-sis of symptom intensity during thecourse of treatment revealed that thehomeopathic immunotherapy wassuperior to placebo (p=0.003). Thetreated group showed a similar trendtowards an improvement in respira-tory function and the results ofbronchial reactivity tests, but this



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was not statistically significant. Themeta-analysis of all three previousstudies as a whole showed anextremely high probability(p=0.0004) that the homeopathiceffect was not due to a placebo effect.

Reilly’s group has subsequentlypublished a multicentre, randomizedand double-blind study on patientsattending hospital otorhinolaryngo-logic department for their chronicallergic rhinitis(8). The study involvedthe administration of a 30c potencyof the main allergen or (in the controlgroup) an indistinguishable placebo.The results demonstrated a signifi-cant improvement in nasal air flow inthe treated patients in comparisonwith those receiving placebo(p=0.0001). Subjective symptomsimproved but not in a statisticallysignificant manner. It is interesting tonote that the group treated withhomeopathic preparations of theallergen more frequently reportedthe initial worsening, that is wellknown in homeopathy. This studyoffers further proof that high homeo-pathic dilutions cannot be assimilat-ed to a simple placebo.

A replication study of HIT, withessentially negative results, waspublished in 2002 by an independ-ent group led by G. Lewith(72).Patients with asthma and positiveskin prick tests for house dust miteentered the trial. After a 4-weekbaseline assessment, the partici-pants were randomized to receiveoral HIT, made with their specificallergen, or placebo, and thenassessed over 16 weeks by means ofthree visits and diary assessmentsevery other week. There was no dif-ference in most final outcomesbetween placebo and homeopathicimmunotherapy, but there was a dif-ferent pattern of change during thetrial in three of the diary assess-ments: morning peak expiratoryflow (P=0.025), visual analogue scale

(P=0.017) and mood (P=0.035). Byweek three, there was a significantdeterioration in the visual analoguescale (P=0.047) and mood (P=0.013)in the homeopathic immunotherapygroup. In brief, the homeopathicmedicine caused a slight but statisti-cally significant worsening duringthe early phases of treatment thanplacebo, while at the end of experi-mental period the effectiveness ofHIT was not significantly differentfrom placebo. This study sparked aconsiderable discussion in the sameJournal (Brit. Med. J.). The reply ofReilly, the author of previous (posi-tive) studies on homeopathicimmunotherapy, stated that theLewith’s study was not actually areply of their work, because thepatient population, the drug admin-istration, and the outcome measureswere different(82). In any case, the dif-ferent patterns of change betweenHIT and placebo during the courseof the study are unexplained, butseem to confirm a statistically signif-icant “homeopathic aggravation”and symptoms oscillations that,being obtained using high allergendilutions/dynamisations, are consis-tent with an immunologic effect ofthe medicine that is different fromthat of placebo.

In a subsequent paper, some ofthe Authors of the last negative trialof homeopathic immunotherapyhave discussed their data of the sametrial using complexity theory(83). Thisis an evidence for a different oscilla-tion in outcome (both physiologicaland subjective) of verum treatmentwith respect to placebo. The authorssuggest that such time dynamics areconsistent with a complexity theoryinterpretation of how the body func-tions as a whole and speculate thatthese oscillatory phenomena requirea different trial methodology fromthat currently employed.

A series of double-blind, ran-

domized, placebo-controlled trials onthe preventive and therapeutic effec-tiveness of pollen of Betula (HIT),were conducted by a Norwegiangroup. In the first study(69), the effectof the homeopathic remedy Betula30c vs. placebo for adult patientswith birch pollen allergy was tested.No statistically significant differencebetween the groups was found,except for a brief period when thosereceiving verum having fewer andless serious symptoms. For somedays these differences were statisti-cally significant. Surprisingly, theverum group also reported someaggravation after the medication,more than did the placebo group, aresult in agreement with that of pre-viously mentioned trials(8,72). The sec-ond study(70) involved children andgave uncertain results, according tothe authors possibly because thepollen count was very low duringtreatment period and only three dayswere high enough to provoke allergicsymptoms. This time the verumtreated patients fared worse than theplacebo group; they used more res-cue medication and had highersymptom scores during these threedays. The authors suggested that thefindings may document a putative“aggravation response”, but certain-ly do not support the usefulness ofthe tested homeopathic prophylaxisfor this condition. The third paper(71)

with similar protocol with additionof a cross-over of treatments showeda consistent response in both verumand placebo groups, with no consis-tent clinical advantage of HIT.

A double-blind trial showed pos-itive effects of homeopathicimmunotherapy of seasonal allergicrhinitis(75). The drug was preparedfrom common allergens (tree, grass,weed species) specific to theSouthwest region of the US, whichwas compared with placebo. Studyoutcomes included allergy-specific



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symptoms using the rhinoconjunc-tivitis quality-of-life questionnaires.The outcomes were positive (p < 0.05)and subjects reported no adverseeffects during the 4-weeks interven-tion period.

Systematic ReviewsA meta-analysis of 7 randomizedclinical trials to assess the efficacy ofhomeopathic preparations ofGalphimia glauca in the treatment ofallergic rhinitis was published byLudtke and Wiesenauer(6). The data areconsistently in favor of a statisticallysignificant effect of the low-dosehomeopathic medicine over placebo,particularly in the relief of eye symp-toms. Verum estimate of success isreported of about 80%. The validityof these experimental studies wasconfirmed also by independentmeta-analyses(2,4).

The review of Kleijnen et al.(1) andthe meta-analysis of Reilly of his ownstudies(8) suggested that HIT waseffective in the treatment of rhinitis.

There have been a few reviews ofrandomized, controlled trials pub-lished regarding the use of homeopa-thy for asthma treatment. In 1991 anoverview of all the complementaryand alternative therapies used forasthma(84) including homeopathyconcluded that this modality must beregarded as unproven despite thefact that is widely used; in 1996 asimilar study(85) concluded that thepreliminary evidence suggests thathomeopathy may be of help in asth-ma, associating HIT and classicalhomeopathy, but that larger con-trolled studies are needed. A specificmeta-analysis on asthma was pub-lished in 2000 and regarded three tri-als(86). The authors found that two ofthe three studies were positive,although two were thought to be ofsuboptimal quality. Six trials wereincluded in a review(10,87). These trialswere found to be of variable quality

and the results of the studies are con-flicting in terms of effects on lungfunction. The authors underlinedthat standardized treatments in thesetrials are unlikely to represent com-mon homeopathic practice wheretreatment tends to be individualized.

A review on all the complemen-tary therapies in the management ofasthma(79) included a brief considera-tion of homeopathic trials and con-firmed that there is insufficient evi-dence to reliably assess the possiblerole of homeopathy in treatment forthis condition. More and larger trialsare therefore urgently needed toassess properly the role of homeopa-thy in the management of asthma,but experts(2,10,86,87) suggested that aswell as randomised trials, there is aneed for observational data to docu-ment the different methods of home-opathic prescribing and how patientsrespond. Further studies could assesswhether individuals respond to a“package of care” (i.e. the effect ofthe medication as well as the consul-tation, which is considered a vitalpart of individualized homeopathicpractice) rather than the homeopath-ic medicine against placebo alone.

Arthro-RheumaticDiseasesDespite a growing interest in uncov-ering the basic mechanisms of arthri-tis, medical treatment remains symp-tomatic. Current medical treatmentsdo not consistently halt the long-term progression of these diseases,and surgery may still be needed torestore mechanical function in largejoints. Patients with rheumatic syn-dromes often seek alternative thera-pies, with homeopathy being one ofthe most frequent, together withacupuncture(33,88,89). On patients’ self-perceived efficacy homeopathyachieved higher scores in osteoarthri-tis, while satisfaction was lower withrheumatoid arthritis and connective

tissue diseases(39). The literature inthis area is summarized in (Table 6).

Classical IndividualizedHomeopathyRetrospective studies and case histo-ries suggested that recovery or clini-cal improvement may be achieved byhomeopathic care in conditions likeosteoarthritis, ankylosing spondylitisand rheumatoid arthritis(98).Literature of clinical trials in this fieldbegan in 1978 when a Scottish groupled by Gibson published a study onthe homeopathic treatment ofrheumatoid arthritis conducted atthe Glasgow HomeopathicHospital(90). In this pilot study, agroup of patients with rheumatoidarthritis were treated with classichomeopathy; a group was treatedwith high doses of salicylate. Bothgroups were compared with a thirdgroup of patients who receivedplacebo. The patients who receivedhomeopathy did better than thosewho received salicylate. The designof the trial was not randomized nordouble blind, so that it was not possi-ble to distinguish between the effectsdue to the physicians and the effectsdue to the drugs. In a subsequentstudy, the same group evaluatedindividualized homeopathic therapyagainst placebo(91) in double-blindconditions. Each patient of the verumgroup received his or her own pre-scribed remedy, while the otherswere treated with placebo. Theresults after three months of therapyshowed an improvement in thesymptoms (mainly spontaneouspain, stiffness in the joint, prensilestrength) of 83% of the treatedpatients, as against only 22% of thosereceiving placebo. On the other hand,no differences between verum andplacebo groups were observed withregard to laboratory variables.

A trial characterized by thor-oughly negative results was conduct-



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ed in patients with osteoarthritis(92)

who were divided into three groups:one received Rhus toxicodendron 6x,second fenoprofen, and the thirdplacebo. The results showed thatonly the group treated with fenopro-fen showed a significant improve-ment in symptoms in comparisonwith placebo.

The negative result of the lastmentioned trial suggests that thetested medicine can’t be effectivewhen prescribed on the basis of thedisease diagnosis and in the absenceof individualization of the prescrip-tion. These methodological issueshave been addressed in subsequenttrials carried out in Great Britain. Forexample, in a double-blind trialinvolving patients suffering fromfibrositis (primary fibromyalgia)(93),the doctor had a choice between thethree homeopathic drugs likely to beactive in this condition: Arnica mon-tana, Rhus toxicodendron and Bryoniaalba: no difference was foundbetween the groups treated with theremedies and those treated withplacebo. A similar trial involvingpatients with fibromyalgia was car-ried out in the Department ofRheumatology of St. Bartholomew’sHospital, London(94). The diagnosiswas reached on the basis of the con-ventional diagnostic criteria definedby Yunus, and the patients then hadtheir homeopathic history taken:only those for whom the remedyRhus toxicodendron 6C (poison ivy)was indicated were included in thetrial. This was a double-blind, place-bo-controlled, cross-over study. Theresults were positive in favor of thehomeopathic treatment, which led toa reduction in pain symptoms andimprovement in general conditions.This experience indicates that theproblem of disconnection between“conventional” diagnosis and home-opathic prescribing that should beindividualized can be solved by

including in the trial a sub-group ofpatients who, according to classicalhomeopathic guidelines, are suscep-tible to a single medicine.

Another approach is to includeall the patients, irrespective of theremedy prescribed, and to evaluatethe homeopathic cure itself, not theeffectiveness of single remedies. Insuch a double-blind randomizedtrial, carried out on patients withactive rheumatoid arthritis(95), theapproach was similar to that ofGibson’s group(91) with the differencethat here patients were allowed toreduce the dosage of analgesic andprednisone if they improved.Patients were treated for six months;all patients were monthly inter-viewed by an expert homeopathicphysician and the selected homeo-pathic medicine was maintained orchanged according to the patient’sresponse. Patients were assessedevery month by a blinded evaluator.In patients treated with homeopathy,there was a significant intragroupimprovement, comparing trial outsetand end of treatment, in 3 of 5observed variables, namely 15-meterwalking time, articular index andfunctional class. With placebo, onlyone variable improved significantly,that was articular index. Both groupsshowed a significant decrease of thedaily dose requirement of pred-nisone. The overall assessment byphysicians confirmed an improve-ment in both groups (59% and 44% ofpatients in verum and placeborespectively), but there was no statis-tically significant difference. Adverseeffects were scarcely and comparablyreported in both groups.

A negative study of the effective-ness of homeopathy (individualizedprescriptions) in rheumatoid arthritishas been published(96). This was a 6-month randomized, cross-over,double-blind, placebo-controlled,single-centre study set in a teaching

hospital rheumatology out-patientclinic. The participants of the studyhad definite or classical rheumatoidarthritis and were receiving non-steroidal anti-inflammatory drugs. Inaddition to the conventional treat-ment, patients received either indi-vidualized homeopathic treatment inpotencies of 6c and/or 30c, or identi-cal matching placebos. The main out-come measures were visual analoguescale pain scores, objective indexes ofstiffness and laboratory erythrocytesedimentation rate (ESR). There weremany drop-outs from the trial.Placebo and active homeopathy haddifferent effects on pain scores; meanpain scores were significantly lowerafter 3 months’ placebo therapy than3 months’ active therapy (P=0.032 byWilcoxon rank sum test). Articularindex, ESR and morning stiffnesswere similar with active and placebohomeopathy. In conclusion, this trialfound no evidence that active home-opathy improves the symptoms ofRA, in patients attending a routineclinic who are stabilized on conven-tional anti-inflammatory treatment.

A double-blind, randomized trialto assess the effectiveness of individu-alized classical homeopathy in thetreatment of fibromyalgia was carriedout in Arizona(97). Patients (mean age49 yr, 94% women) received eitherhomeopathic remedy in 1LM(1/50,000) potency or placebo.Participants on active treatmentshowed significantly greater improve-ments in tender point count and ten-der point pain, quality of life, globalhealth and a trend toward less depres-sion compared with those on placebo.This trial was paralleled by a series ofinteresting analyses aimed at charac-terizing some factors that may be cor-related with the therapeutic outcome:1. Homeopaths rated each patient’s

vital force in a five-point scale,with 1 = very weak to 5 = verystrong and this parameter wascorrelated better with perceived



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mental function, energy, and pos-itive dimensions of the individ-ual, beyond absence of disease(99).

2. The possibility of changing thegroup for an optional cross-overtrial was offered and the analysisof responses allowed distin-guishing subgroups of differentresponders. Individual differ-ence factors predicted better andpoorer responders withfibromyalgia to specific and non-specific effects of homeopathicand placebo treatments(100).

3. Fibromyalgia patients showedevidence of sensitizability inpain pathways and electroen-cephalographic (EEG) alterationsand the homeopathic treatmentgroup significantly increased inglobal alpha-1 and alpha-2 dur-ing a test based on laboratoryelicitation by temporolimbicolfactory stimulation or sniffing,while the placebo groupdecreased(101).

4. Baseline and 3-month differencescores for initial prefrontal elec-troencephalographic alpha fre-quency cordance (a correlate offunctional brain activity) showedthat people who better respond-ed to therapy exhibited signifi-cantly more negative initial dif-ference scores at prefrontalsites(102).These findings suggestthat EEG changes of specificareas of brain may be a biomark-ers of the individualized homeo-pathic medicines.

Systematic ReviewsA review of research have concludedthat there is a body of evidence tosuggest that homeopathic medicines,either individually prescribed orused in a homeopathic formula, canprovide relief for people with rheu-matic disease(89). A systematic reviewof the clinical evidence for andagainst the effectiveness of homeo-pathic medicines in the treatment ofpatients with osteoarthritis has beenpublished(11) in which the authors

conclude that, although the smallnumber of randomized clinical trialsconducted so far favor homeopathictreatment, they do not allow any firmconclusion as to the effectiveness ofhomeopathic remedies in the treat-ment of osteoarthritis patients.

Fibromyalgia has been the object oftwo reviews of complementary andalternative treatments(146,147), whose con-clusions were that the evidence of effi-cacy of homeopathy was limited due tothe existence of only one quite old, nonreplicated, RCT(94), but at that time thecareful trial of Bell and coworkers wasnot published yet(97). A general reviewof the state of the art of homeopathicresearch(5) summarized six existing ran-domized clinical trials and found thatfour of them had high quality and pos-itive outcomes. According to theseauthors the clinical evidence, particu-larly in osteoarthritis and fibromyalgia,is “promising”, and more research inthis area is warranted.

DiscussionWhile complementary medicine andhomeopathy are becoming anincreasingly prominent part of thehealth care practices, there is paucityof controlled studies concerning theireffectiveness. While traditionalknowledge has been accumulatingfor over 200 years, only in the pastfew decades modern research meth-ods such as randomized clinical tri-als, rigorous observational studies,and equivalence studies comparinghomeopathy with conventional stan-dard therapies have been applied. Itis therefore not true that there are noserious controlled trials on homeo-pathic medicine, though it must beadmitted that such trials are too fewto allow any very firm conclusions tobe drawn.

Few well-designed studies havebeen reproduced by independentresearch teams for two main reasons:the lack of sufficient funding and the

lack of a sufficient number of well-trained homeopaths who are quali-fied and interested in research. As amatter of facts, the debate on the effi-cacy of homeopathy is still very hot,as shown by a series of reviews(2-5) andchiefly by the controversial meta-analysis published by The Lancet(12,37)

and by the significant expert reactionsto the latter(103-105).

Even though the number ofpapers published in peer-reviewedpapers in increasing, the results ofmany clinical studies on the effec-tiveness of homeopathy are charac-terized by low standards of method-ology(1,4,106). The major problems inmost trials were the description ofallocation concealment, impreciseoutcomes and the reporting of drop-outs and withdrawals. Other con-cerns are the publication bias (thetendency to publish more positivethan negative trials, a problem that isalso present in conventional medi-cine) and the lack of independentreplications of most conducted stud-ies. As a matter of facts, even if thesame criticisms are applicable to con-ventional medicine(12), the positivefindings of most studies have notbeen unequivocally and generallyaccepted as valid.

This review summarizes the trialdata for or against homeopathy as atreatment for a series of diseases dueto disorders of immune system and/ordysregulation of local inflammatoryprocesses. We are confident that thereported studies represent the largemajority of the available literature inthis field, although some omission cannot be excluded. Clearly, the fewdozens of papers reported are highlyheterogeneous in terms of the diseaseconditions, of the drugs used, and ofexperimental designs.

We have collected a total of 64studies, 35 of which were double-blind randomized clinical trials (type1a of 1), 7 randomized non-blinded



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equivalence studies (type 1b), 9 nonrandomized equivalence studies, 8observational prospective studies, 5retrospective studies of case-seriesbut only 41 studies are consideredhere and reported in Tables 4-6. InTable 7 these studies are groupedaccording to the clinical conditionand the type of homeopathic treat-ment; the clinical evidence of themajor groups of treatments was clas-sified according to the criteria thathave been reported in Table 3. Therewas great heterogeneity in the natureof the homeopathic interventionapplied: mostly fixed combinationsor complexes, several individualizedhomeopathy with single remedies,some isotherapy studies in allergy.

The best evidences of effective-ness appear in the top two rows ofTable 7 and are Galphimia glauca (lowpotencies) in allergic oculorhinitis,classical individualized homeopathyfor otitis and for fibromyalgia. Ingrade C (unclear or conflicting evi-dence) we found most of studies,because promising results reportedby some authors were not replicatedby others. The number of homoge-neous trials is too small to attemptpooling and meta-analysis.

It would also be appropriate tocompare the efficiency of differentforms of homeopathy for the samecondition, but the small sizes of thestudied populations and the differ-ences between them still prevent anyreliable quantitative evaluation.

In synthesis, there are manypromising studies supporting theclinically demonstrable activity ofhomeopathic medicines, but thedatabase of high-quality homeopath-ic research in various fields is verysmall, the “hard” proofs of efficacy,particularly in the high-dilutionrealm, are still fragmentary and theirmethodological quality is often poor.Quite surprisingly, it has been shownin a comparative study(12) that the

mean quality of a representative ran-dom sample of allopathic medicineclinical trials is lower that the globalquality of homeopathic trials! In anycase and in the final analysis, theproofs so far collected are insufficientto allow a claim that highly dilutedhomeopathic medicines are moreefficacious than placebos in treatinghighly prevalent inflammatory orimmune diseases.

Placebo and Effectiveness,Different QuestionsMost studies here reviewed suggestthat homeopathic medicines in highdilutions, prescribed by trained pro-fessionals, are safe and are unlikelyto provoke severe adverse reactions,in agreement with previousreports(108-110). Thus, homeopathyseems to be safe, but there is noaccepted theory for the action of med-icines diluted beyond the Avogadrolimit (111).

On evaluating the evidence infavor and against clinical effective-ness of a therapy, it should be point-ed out that the placebo question isexceedingly important but is notequivalent to the question of whetherthe therapeutic approach is clinicallyeffective. The evidence of specificactivity of a drug over placebo is usu-ally achieved in experimentalresearch where the active substance(verum) is blindly tested against anidentical placebo in two homoge-neous groups of patients (random-ized clinical trial, RCT). This “artifi-cial” setting may have high internalvalidity but often fails to reproducethe “real life” application of themethod. Patients and physiciansneed also an answer to the empiricalquestion of whether and how muchthe homeopathic therapy, consideredas a whole system of cure, may helpto decrease symptoms, improvequality of life and may substituteother, often more toxic, forms of ther-

apy. The need of more pragmaticstudies aimed to “improving”instead of “proving” homeopathyhave been suggested(2,82,112).

The uncertainty regarding theefficacy and mechanisms of homeop-athy may be due also to the publica-tion bias, according to which theavailable literature may not reflect thenumber of trials done, since clinicaltrials are more likely to be publishedwhen they are positive than whenthey are negative. This is true both ofhomeopathic and allopathic thera-pies, but the situation is complicatedby the fact that probably a “negative”publication bias against homeopathyexists in mainstream journals of con-ventional medicine. For example, astudy(113) showed that among 46 ran-domized trials published in a total of23 different journals (26 in CAM jour-nals and 20 in conventional journals),69% of those in conventional journals(n=20), reported negative findingscompared to only 30% of those inCAM journals (n=26).

It has been suggested that inhomeopathic studies of chronic ill-ness, it might better to comparepatients receiving homeopathy tothose receiving standard convention-al therapy(114). Subject would be ran-domized to one of two groups (toeliminate bias in treatment selection)and followed for a period of time.This study design does not answerthe question of whether or not home-opathic medicines are placebo, butmay give important pragmatic indi-cations: if the system as a whole canbe shown more effective than conven-tional treatment or equally effectiveat lower side effects, this would besufficient to make homeopathic treat-ment worthwhile to many people.

To Blind or not to BlindRelated to this problem is the blind-ing procedure that often is utilized inclinical research. This procedure has



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been so widely employed in the evi-dence-based research on convention-al drugs that there is the tendency toconsider it as the gold standard forany clinical research. However, it hasbeen shown that randomized trialshave important limitations in inter-ventions that require particularskills(115) and finding the correcthomeopathic simillimum depends onin-depth anamnesis and atmosphereof trust, which is disrupted by ran-domization(18). In homeopathy, theparameters of evaluation follow spe-cific rules, that imply the considera-tion of the totality of a patient’ssymptoms which includes the dis-ease’s symptoms and a continuousfollow-up that often requires carefulevaluation of the response by the cli-nician, and often change of the medi-cine, particularly in chronic cases. Tosuccessfully discriminate betweenthe complex responses to a homeo-pathic treatment it is important toknow the characteristics of the sub-stance given to the patient and thehealing steps of this modality(14).

There is mounting evidence thatthe placebo effect is related to theexpectation of clinical benefit, andseveral lines of evidence - includingthe activation of the limbic circuitry,the activation of opioid and sero-tonin pathways, and the release ofdopamine - indicates a link betweenthe placebo effect and reward mecha-nisms(116,117). Therefore, if we considerthese putative mechanisms, we seethat the placebo “effect” is definitelynot due to the “activity” of the - bythe definition - inert substance butmainly to the intrinsic healing capac-ities and response of the treated sub-ject. This response is also the one thatis expected to be triggered by thehomeopathic remedy, either actingthrough the neuroendocrine path-ways or through an immunologicalmechanism that is connected withthe central response to stress system.

We have to consider the greatimportance that is given by classichomeopathy to the interactions suchas those between patient-doctor-medicine and environment-body-mind. It has been suggested thataccording to the theory of “entangle-ment” the remedy would act in thecontext of a tripartite relationshipwith the patient and the practitioner(118-121). What may be the physical basisof such an entanglement is still amatter of speculation, but this pointforces us to take into account the“context” of cure (e.g.: patient-physi-cian interactions) and therefore toseriously question the double blind-ing for testing homeopathy: thismethod by definition would disruptthose interactions(122).

It is essential to raise the rightquestions and to utilize the rightmethods. In homeopathy, the tradi-tional double-blind RCT is the goldstandard to investigate the mecha-nism of action of a remedy, i.e. to dis-tinguish its specific effects from otherunspecific factors, in rigorous experi-mental settings (high internal validi-ty). This may be done assuming thatthe blinding procedure does notaffect the therapeutic setting, aswould be the case of short-lastingconditions where the goal is cure oneor few common symptoms of the dis-ease ( a sort of “allopathized” home-opathy). When the difference ofeffects between a homeopathic poten-cy and placebo has been assessed bydouble-blind RCTs, e.g. for dilutionsof pollen in allergy or for many com-plex remedies, the large majority oftrials give positive results in favor ofa real, direct (but admittedly small)effect. We have also seen that, in awell conducted isopathic trial(72,83), thefinal outcome was clinically insignifi-cant, but the kinetics of response tohomeopathic medicine were marked-ly and significantly different fromthose of placebo.

In this scenery, a way to accumu-late evidence in favor or against theclinical usefulness of homeopathy isthat of controlled equivalence stud-ies, comparing homeopathy (or spe-cific homeopathic medicines and for-mulations) with conventional treat-ment. Finding that the two approach-es are equieffective is particularlyimportant in those fields that havebeen considered in the presentreview, where a definite and satisfy-ing therapy is often lacking. Forexample, it is still under discussionwhether antiinflammatory drugs andantibiotics are effective in the treat-ment of URTI, also because they areknown to have considerable side-effects. In contrast, homeopathy isreported to have little side-effectsand, according many reports, a com-parable efficiency.

Observational ResearchObservational research into uncon-trolled homeopathic practice docu-ments consistently strong therapeu-tic effects and sustained satisfactionin patients(5). An observational studyshowed that a substantial proportion(70.7%) of patients attending a home-opathic hospital outpatient unitrecorded positive changes in a widerange of chronic diseases(123).Superimposable to this finding is thereport showing that seven out of tenpatients visiting a Norwegian home-opath reported a meaningfulimprovement in their main com-plaint six months after the initial con-sultation(124). Similar or even higherpercentages of patients declaringtheir satisfaction with homeopathiccure were reported by others(125-129).Interestingly, a study was undertak-en to investigate the preferences ofpatients with asthma for varioustreatment modalities showed that theextent to which the doctor treated thepatient as a whole person was also astatistically significant attribute for



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the choice of homeopathic therapyvs. conventional therapy, even if theclinical results are perceived asequivalent(59).

So, we are in the situation that ifwe adopt the strict criteria of evi-dence-based medicine, that were ini-tially developed for chemical drugs,the analysis of published literature onhomeopathy finds insufficient evi-dence to support clinical effectivenessof homeopathic therapy in most con-ditions of care. If we accept observa-tional studies and equivalence stud-ies as valuable tool of investigation,we find many proofs of the effective-ness of homeopathic drugs. Ofcourse, in the case of equivalencestudies it is difficult to judge whetherthe result is positive in favor of home-opathy or uncertain, because thisdepends on the conventional arm ofthe trial. In any case this is valuableinformation on a pragmatic stand-point because enables the decisionbased on other factors like patient’spersonal preference, adverse effects,availability, and costs.

There are many reasons why thedevelopment of clinical homeopathicresearch must proceed with a re-eval-uation of observational studies asvaluable tools to yield data of clinicaleffectiveness and medical knowledge.The integration of randomized clinicaltrials, observational prospective stud-ies and pharmacoeconomic studies isthe future of the research in this field.

Conclusions and ProspectsIn summary, there is anefficacy/effectiveness paradox (simi-lar to that found in several otherareas of complementary medicineresearch) with a weak evidence infavor of homeopathy when studiesare done in randomized and double-blind conditions, but yet there is doc-umented effectiveness in equivalencestudies comparing homeopathy andconventional medicine and docu-

mented usefulness in general prac-tice(5): the therapy is useful whenapplied in open practice and pro-duces substantial effects, even inpatients with chronic diseases (130,131).But, considering only double-blindand randomized studies of highestmethodological quality (the latterevaluated using the most rigorouscriteria of evidence-based medicinethat were developed for traditionaldrugs), it is hard to convince skepticsthat homeopathy is significantly dif-ferent from placebo (3,4,12).

This paradox leads to two con-clusions: 1) additional clinicalresearch, both experimental andobservational, including studiesusing different designs, is necessaryfor further research development inhomeopathy, and 2) it is conceivablethat the discrepancies are due to thelack of a consistent theory of theaction mechanism of homeopathy(5),so that additional basic research andinnovative approaches to this prob-lem are urgently warranted.

Given their current spread, morescientific research into non-conven-tional therapies is in the interests ofmedicine as a whole (and not justhomeopathy or allopathy). However,it is not possible to ignore the diffi-culties that this emerging sector ofbiomedical research has to face: a) themethodological difficulties, above allrelated to classical homeopathy, thatrepresent a great challenge for clinicalepidemiology; b) the fact that home-opathy is still practiced only in pri-vate clinics, and there is a lack oflarge-scale clinics at university level;and c) the fact that classical homeo-pathic products (unitary remedies)cannot be patented because they aresimply dilutions of natural sub-stances. These are all unlikely toencourage industry to invest the largeamounts of money necessary tofinance clinical studies involving suf-ficiently large patient populations.

Nevertheless, the growing publicinterest in homeopathy (probably duemore to a “liking” for the therapeuticsystem as a whole and the use ofsmall doses rather than to any scien-tific certainty concerning its effective-ness) allows us to hope that also thissector of medicine will receive greaterattention from the competent authori-ties and the scientific world. It will benecessary to adapt research method-ologies to the homeopathic field inorder to respect the complexity of itsdiagnostic procedure, but it is equallynecessary to ensure that the protocolsinclude objective measurements ofclinical and laboratory parameters, aswell as adequate control groups ofuntreated subjects or subjects treatedwith conventional therapies.

Even in the absence of any undis-putable demonstration of the clinicaleffectiveness of the homeopathicmethod in allergies, what has beendiscussed above makes it plausible(at least as a working hypothesis)that a careful analysis of clinical signsand symptoms in accordance withthe traditional procedure ofHahnemann can help physicians toimplement a therapy aimed at thecomplex and subtle pathophysiologi-cal disorders caused by a disease byexploiting the principle of similarsthat can be re-evaluated as the princi-ple of the inversion of effects, or“paradoxical pharmacology”. Thisconcept will be the target of a furtherlecture of this series.

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Level of evidence

1a

1b

2

3

4

Study design

Double-blind randomized clinical trials

Non-blinded randomized clinical trials, including those

comparing homeopathy with conventional therapy as

control (equivalence studies)

Non-randomized controlled clinical trials, including those

comparing homeopathy with conventional therapy

(equivalence studies)

Prospective observational studies, without control group

Retrospective studies of case-series

Table 1. Classification of clinical studies in homeopathy

Class

1a

1b

2

3

Publication type

Mainstream medicine indexed , peer-reviewed, journal

Complementary/alternative medicine indexed, peer-

reviewed, journal

Non-indexed journal

Book or book chapter, conference proceedings

Table 2. Classification of publications according the type

Level of Evidence

A (Strong Scientific Evidence)

B (Good Scientific Evidence)

C (Unclear or conflicting scientific evi-

dence)

D (Fair Negative Scientific Evidence)

F (Strong Negative Scientific Evidence)

Lack of Evidence

Criteria

Statistically significant evidence of benefit from >2 properly randomized trials (RCTs), OR

evidence from one properly conducted RCT AND one properly conducted meta-analysis.

Statistically significant evidence of benefit from 1-2 properly randomized trials, OR evidence

of benefit from >1 properly conducted meta-analysis OR evidence of benefit from >1

cohort/case-control/non-randomized trials.

Evidence of benefit from >1 small RCT(s) without adequate size, power, statistical signifi-

cance, 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 inef-

fectiveness.

Statistically significant negative evidence (i.e., lack of evidence of benefit) from cohort/case-

control/non-randomized trials.

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.

Unable to evaluate efficacy due to lack of adequate available data. This is not equivalent to

negative evidence.

Table 3. Levels of evidence of therapeutic efficacy according to Natural Standard (see Methods)


TABLE 4. Homeopathic clinical studies of infections of upper airways and ear-nose-throat diseases

Reference

and year

Gassinger

1981 (42)

Bordes

1986

Connert

991(55)

Weiser

1994 (56)

Friese

1997 (43)

Kruse

1998 (44)

Wiesenauer

1998 (60)

De Lange

1999 (45)

Frei 2001

(47)

Riley 2001

(48)

Condition

(diagnosis)

Acute rhinitis

Cough

Rhinitis and

nose obstruction

Chronic sinusitis

Otitis media

Otitis media in

children

Acute tonsillitis

Pharingitis,

tonsillitis

Acute otitis

media

Respiratory

tract complaints

or ear com-

plaints

Study

type

1b

1a

3

1a

2

2

3

1a

3

2

Publ.

classif.

1b

2

2

2

1a

3

1b

1a

1b

1b

Study

group

53

60

26

155

131

children

126

107

170

children

230

children

456

Treatment(s)

Eupatorium perfolia-tum 2x vs. aspirin

Low-dilution (3c)

homeopathic com-

plex in syrup

(Drosera) vs. placebo

Euphorbium com-positum

Euphorbium com-positum vs. placebo

Individualized vs.

allopathy

Individualized vs.

allopathy

Low-dilution homeo-

pathic complex of

Phytolacca ameri-cana, Guajacumofficinale, Capsicumannuum

Individualized vs.

placebo

Individualized

Individualized home-

opathy vs. allopathy

Outcomes

Symptom severity

score

Symptoms

Symptoms, rhino-

manometry

Subjective symptoms

and functional tests

Duration of pain and

therapy

Duration of pain and

therapy

Subjective and

objective symptoms

Frequency, duration

and severity of rhini-

tis, pharyngitis

episodes

Pain

Healing or a major

improvement after 14

days of treatment,

adverse effects

Key results

Equivalence between

homeopathy and

allopathy

Decrease of symp-

toms 20/30 treated

patients, as against

only 8/30 in the

placebo group

Decrease of symp-

toms in most patients

(uncontrolled)

21.1% improvement

in the verum group,

14.4% in the placebo

group. No change in

tests.

Homeopathy slightly

better than conven-

tional therapy

Equivalent efficacy

Decrease of symp-

toms in most patients

(uncontrolled)

Little, non significant,

effect in favor of

homeopathy vs.

placebo

Improvement in 39%

of patients after 6h,

another 33% after

12h (uncontrolled)

Improvement in

82.6% of homeo-

pathic patients, 68%

of allopathic


FACE JOURNAL



FACE JOURNAL

TABLE 4. (Contd.) Homeopathic clinical studies of infections of upper airways and ear-nose-throat diseases

Reference

and year

Jacob 2001

(49)

Steinsbekk

2005A (50)

Steinsbekk

2005B

(51)

Trichard

2005 (52)

Condition

(diagnosis)

Acute otitis

media

Upper respirato-

ry tract infec-

tions

Upper respirato-

ry tract infec-

tions

Acute

rhinopharyngitis

Study

type

1a

1b

1a

4

Publ.

classif.

1a

1b

1a

1b

Study

group

75

children

169

children

251

children

499

children

Treatment(s)

Individualized vs.

placebo

Individualized vs.

untreated

Individualized, par-

ents-selected, vs.

placebo

Homeopathic strate-

gy vs. allopathic

strategy (e.g. antibi-

otics).

Outcomes

Treatment failures

and symptoms

scores

Symptoms score

Prevention of new

episodes

Number of episodes,

quality of life, costs

Key results

Less failures in

verum group, not sig-

nificant; little and sig-

nificant decrease of

symptoms in verum

group

Decrease of days

with symptoms in

homeopathic group

No effectiveness of

homeopathy over

placebo

Various indexes sig-

nificantly in favor of

homeopathic strate-

gy, lower medical

costs (uncontrolled)

TABLE 5. Homeopathic clinical studies of allergy and asthma

Reference

and year

Hardy 1984

(60)

Wiesenauer

1985 (61)

Mosquera

1990 (63)

Castellsagu

1992 (65)

Eizayaga

1996 (66)

Condition

(diagnosis)

Allergic ocu-

lorhinitis

(house dust)

Allergic ocu-

lorhinitis

Asthma

Allergic asthma

Allergic asthma

Study

type

1a

1a

4

4

4

Publ.

classif.

2

1b

3

1b

1b

Study

group

70

164

120

children

26

children

62

Treatment(s)

Homeopathic

immunotherapy

(H.I.T.) made with

house dust potencies

Galphimia glauca 6x

dynamized vs. place-

bo and Galphimia

glauca 6x non-

dynamized

Individualized

homoeopathy

bronchial asthma.

Individualized

Individualized

Outcomes

Symptoms

Eye and nose symp-

toms

General assessment

Global evaluation

Smptoms scores

Key results

H.I.T. better than

placebo

Trend to positive, not

statistically signifi-

cant: less symptoms

in patients taking

dynamized verum

medicine than other

groups

Improvement in most

cases (uncontrolled)

Improvement in most

patients (uncon-

trolled)

Significant decrease

of symptoms after

therapy (uncon-

trolled)



FACE JOURNAL

TABLE 5. (Contd.) Homeopathic clinical studies of allergy and asthma

Reference

and year

Lara-Marquez

1997 (67)

Micciché

1998 (98)

Riveron-

Garrote 1998

(68)

Taylor-Reilly

2000 (8)

Aabel 2000

(69)

Aabel 2000

(70)

Aabel 2001

(71)

Lewith 2002

(72)

White 2003

(73)

Li 2003

(74)

Kim

2005 (75)

Witt 2005

(76)

Condition

(diagnosis)

Allergic asthma

Allergic ocu-

lorhinitis

Allergic asthma

Allergic rhinitis

Allergic rhinitis

Allergic rhinitis

Allergic rhinitis

Allergic asthma

Asthma (mild to

moderate)

Allergic asthma

Allergic rhinitis

Allergic dis-

eases including

rhinitis and

asthma

Study

type

1a

2

1a

1a

1a

1a

1a

1a

1a

3

1a

2

Publ.

classif.

4

2

2

1a

1b

1b

1b

1a

1a

1a

1a

1b

Study

group

19

70

children

80

50

66

73

51

242

96

children

12

children

40

178

Treatment(s)

Individualized vs.

placebo

Homeopathic proto-

col based on three

low-dilution drugs vs.

conventional therapy

Individualized vs.

placebo.

Individual allergen

30c vs. placebo

(H.I.T.)

Homeopathic birch

pollen Betula 30c vs.

placebo

Homeopathic birch


placebo

Homeopathic birch


placebo

Allergen (dust mite)

30c vs. placebo

(H.I.T.)

Individualized vs.

placebo

H.I.T. prepared from

individual allergens

vs. placebo

H.I.T. prepared from

common allergens

vs. placebo

Classic homeopathy

vs. conventional care

Outcomes

Symptoms, spirome-

try parameters and

immunological mark-

ers

Global evaluation

General symptoms

and attack intensity

Symptoms (VAS) nd

nasal air flux tests

Symptoms score

Symptoms (VAS)

Symptoms (VAS)

Symptoms (VAS) and

expiration flux (FEV)

Quality of life, symp-

toms and tests

Spirometric tests

Symptoms,quality-of-

life questionnaires

Symptoms,quality-of-

life questionnaires,

costs

Key results

Verum better than

placebo, significant

changes of laborato-

ry markers

Trend to better

improvement in the

homeopathic group

Higher reduction of

asthma attacks in

verum group

Slightly better tests

in verum group

Slightly less symp-

toms during 10 days.

Aggravation after tak-

ing verum

Verum worse than

placebo

Similar improvement

in verum and placebo

No final therapeutic

effect, initial aggrava-

tion

No changes of QOL,

small not significant

improvement of

symptoms in verum

group

No improvement after

treatment (uncon-

trolled)

Better clinical

changes in verum

group as compared

with placebo

Better outcomes in

homeopathic group



FACE JOURNAL

TABLE 6. Homeopathic clinical studies of arthrorheumatic diseases

Reference

and year

Gibson 1978

(90)

Gibson 1980

(91)

Shipley 1983

(92)

Fisher

1986 (93)

Fisher 1989

(94)

Andrade

1991 (95)

Van Haselen

2000 (136).

Fisher 2001

(96)

Bell 2004

(97)

Condition

(diagnosis)

Rheumatoid

arthritis

Rheumatoid

arthritis

Osteoarthritis of

hip and knee

Fibrositis

(fibromyalgia)

Fibrositis

(fibromyalgia)

Rheumatoid

arthritis

Osteoarthritis of

the knee

Rheumatoid

arthritis

Primary

fibromyalgia

Study

type

2

1a

1a

1a

1a

1a

1b

1a

1a

Publ.

classif.

1a

1a

1a

1b

1a

1a

1a

1a

1a

Study

group

195

46

36

24

30

44

172

112

62

Treatment(s)

Individualized pre-

scription vs. saly-

cilates and placebo,

12 months

Individualized pre-

scription vs. placebo,

3 months

Rhus toxicodendron6x vs. Placebo and

fenoprofen

Arnica, Rhus tox,Bryonia 6c vs. place-

bo

Rhus tox (individual-

ized) vs. placebo

Individualized vs.

Placebo, 6 months

Local application of a

homeopathic gel vs.

piroxicam gel

NSAIDS +

Individualized pre-

scription vs. NSAIDS

+ placebo

Individualized pre-

scription vs. placebo

Outcomes

Physician evaluation

Pain and articular

indexes

Symptoms

Pain symptoms

Pain symptoms

Clinical measure-

ments and global

evaluation by physi-

cian

Pain and arthritic

indexes

Pain and articular

indexes

Pain symptomsQOL

Key results

Better relief in home-

opathic group than

allopathic and place-

bo. High drop outs.

Better relief in home-

opathic group than

placebo

No effect of homeop-

athy over placebo,

fenoprofen superior

to both

Trend to positive in

favor of homeopathy,

but not significant dif-

ferences

Slightly positive: ther-

apeutic success in

more patients taking

verum vs. placebo

Small but not signifi-

cant differences in

favor of verum over

placebo

Equivalence of

homeopathic and

allopathic gels

No effect of homeop-

athy over placebo

Homeopathy signifi-

cantly better than

placebo in all out-

comes



FACE JOURNAL

Infections of upper airways and

ear-nose-throat diseases

Classical individualized homeopathy

for otitis (43),(44), (47), (48), (49)

Classical individualized homeopathy

for URTI: In favor: (48), (50);

against: (45), (51), (52).

Allergy and asthma

Galphimia glauca (low potencies)

in allergic oculorhinitis: (61), (62),

(92), (7), (6), (2)

Homeopathic immunotherapy

(isotherapy): In favor: (60), (38),

(20) (8), (69), (75); In against: (71),

(70), (72), (74).

Classical individualized homeopa-

thy: In favor: (63), (65), (66), (67),

(68), (76); against: (73).

Arthrorheumatic diseases

Classical individualized home-

opathy in fibromyalgia: (94),

(97)

Classical individualized home-

opathy for rheumatoid arthritis:

In favor: (90), (91), against:

(95), (107)

Arnica, Rhus tox, Bryonia 6c for

fibromyalgia (93)

Rhus toxicodendron 6x for

osteoarthritis (92)

Level of Evidence

A (Strong Scientific

Evidence)

B (Good Scientific

Evidence)

C (Unclear or conflicting

scientific evidence)

D (Fair Negative

Scientific Evidence)

F (Strong Negative

Scientific Evidence)

Table 7. Summary of the levels of evidence of clinical homeopathic studies. The characters of references numbers indicate the type of

study and of publication: bold= randomized controlled trial or meta-analysis covering the topic; italics=non randomized controlled trial; normal case= uncontrolled, observational and retrospective studies; underlined=indexed journals.

Warning Against Use of Streptomycin

We cite below a warning on use of Streptomycin by the World Health Organisation. We are accustomed to many suchwarnings against many of their favourite preparations which bask in the sunshine of their patronage but only for ashort while. Certain drugs were acclaimed as panaceas for all the evils to which human flesh is subject to be told a bitlater on, that the drugs so acclaimed have been found out to be worse than the evils they were said to remove.

The WHO has issued a warning against unrestricted distribution and indiscriminate use of streptomycin, in a moveto avoid the emergence of streptomycin-resistant strains of tubercle bacilli.

Reasons given in the warning against abuse of streptomycin are that in spite of reduced toxicity of new forms of thisdrug, it must still be considered as having danger; and that precise knowledge as to its clinical indications, especial-ly in pulmonary tuberculosis, is still lacking.

Despirte the great success which streptomycin has had in reducing the mortality from tuberculous meningitis andmiliary tuberculosis from 100% to between 50%-60%, there are indications that in many types of tuberculosis nowbeing treated with streptomycin, the bacilli which cause the disease speedily become resistant to the drug.

It is in cases of pulmonary tuberculosis in particular that this resistance to streptomycin is most frequently found. Thereal danger lies in the fact that if children are infected by the resistant types of bacilli then treatment with strepto-mycin is of no avail. Recently this is the case with erythromycin.


Effectiveness of Homeopathy in Immunology and Inflammation ...

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