Research

http://hpathy.com/scientific-research/an-update-on-research-in-homeopathy/

 

Vergleich: Siehe: Group Analysis Evaluation + Research Anhang (Bellavite, Salvatore Chirumbolo and Marta Marzotto) + Scientific study of homeopatic treatment

[H. Frei (Kinderarzt Laupen Schweiz) and A. Thurneysen]

 

https://www.researchgate.net/publication/7471540_Research_on_Homeopathy_State_of_the_Art

[Harald Walach, Ph.D. /Wayne B. Jonas, M.D., Ph.D./John Ives, Ph.D./Roel van Wijk, Ph.D./Otto Weingärtner, Dr.Phil.Nat.]

In this paper, we review research on homeopathy from four perspectives, focusing on reviews and some landmark studies. These perspectives are laboratory studies, clinical trials, observational studies, and theoretical work. In laboratory models, numerous effects and anomalies have been reported. However, no single model has been sufficiently widely replicated. Instead, researchers have focused on ever-new models and experiments, leaving the picture of scattered anomalies without coherence. Basic research, trying to elucidate a purported difference between homeopathic remedies and control solutions has also produced some encouraging results, but again, series of independent replications are missing. While there are nearly 200 reports on clinical trials, few series have been conducted for single conditions. Some of these series document clinically useful effects and differences against placebo and some series do not. Observational research into uncontrolled homeopathic practice documents consistently strong therapeutic effects and sustained satisfaction in patients. We suggest that this scattered picture has to do with the fourth line of research: lack of a good theory. Some of the extant

theoretical models are reviewed, including placebo, water structure, silica contamination, energy models, and entanglement models. It emerges that local models, suggesting some change in structure in the solvent, are far from convincing. The nonlocal models proposed would predict that it is impossible to nail down homeopathic effects with

direct experimental testing and this places homeopathy in a scientific dilemma. We close with some suggestions for potentially fruitful research.

INTRODUCTION

The Myth of Telephos is the first clear trace of it in the West: Telephos was the king of the Mysians, who the Greeks attacked accidentally when they were on their way

to raid Troy. Telephos was wounded by the spear of Achilles. And, when the wound did not heal and festered, he asked the Pythia, the prophetess of Delphi, for advice.

She gave him the cryptic answer: “Ho trosas kai iasetai”—“He who has slain the wound will cure it again.” He then visited Achilles, who brought some of the spear’s rust

into the wound, which subsequently healed. This first echo of the therapeutic simile principle in the West shows that it is an ancient therapeutic idea. It was taken up by Hippocratic medicine, by Galen and Celsus. It can be found in Paracelsus’ work.

It

University College Northampton, UK.

University Hospital Freiburg, Germany.

Samueli Institute, Alexandria, VA.

International Institute of Biophysics, Neuss, Germany.

Dr. Reckeweg & Co. GmbH, Bensheim, Germany.

seems likely that Hahnemann knew of this tradition.

But it was his idea to test remedies in healthy volunteers and to note the symptoms as a way to put the simile principle into concrete practice.

These symptoms he then used as indications of remedies in sick people. While the principle of testing remedies was new in Hahnemann’s time, other researchers, such as

the Swiss physician and researcher von Haller, had already advocated this. It was Hahnemann’s insight to combine the simile principle with testing of medications and to use this information for therapy.

Today, the simile principle is also used in other branches of therapy.

Allergology makes use of it in desensitization. Psychotherapy, in some forms, uses the activation of similar situations or constellations of symptoms that produced trouble to cure it.

Hahnemann’s unique insight was what he called dynamization or potentization. Although a case can be made that this is an idea that, in principle, has been around at least

since Paracelsus, who also spoke of letting the “spirit of substances” free, the practical application by Hahnemann was unique. When he adminstered his remedies to his volunteers, initially his family and students, he soon discovered that crude substances needed dilution because of toxic sideeffects. So he started a process of stepwise dilution and succussion. When diluting a substance, after 24 steps in a dilution ratio of 1:10 or after 12 steps in a ratio of 1:100, a dilution of one mole of starting substance would,

by calculation, not have any molecules of the initial substance left.

This corresponds to a Hahnemannian dilution of C12 or 24

Beyond this boundary, statistically speaking, none of the starting material remains in a homeopathic remedy.

Avogadro’s number refers to the number of molecules in one mole (i.e., 6.023*1023). This fact was not known to Hahnemann. Although Hahnemann did not know for sure,

he guessed that his dilutions would have very little or none of the starting substance and, therefore, he called his remedies dynamizations or potencies, referring to the paradoxical experience that, with his stepwise process of dilution and succussion, he observed stronger therapeutic effects than with original substances. It is precisely homeopathy’s emphasis on so-called high potencies (i.e., remedies succussed and diluted beyond Avogadro’s number) that creates tension with modern science because no accepted rational theory exists that could explain increased therapeutic effect with decreasing amounts of the active agent, even to the point of there being no molecules of

the initial agent present at all.

In this paper, we wish to point out a few findings from homeopathic research that appear to be robust, delineate areas of contention, and outline potentially fruitful avenues

for research. We do not consider the practical or therapeutic applications and the wide variety thereof. We have organized this brief review in four sections:

1. Experimental research to study the efficacy of homeopathic remedies in vitro, in cell systems, or in vivo

2. Basic research that tries to elucidate the nature of  homeopathic remedies

3. Clinical research that tries to find proof of clinical efficacy and experimental research in humans (so called “provings” or pathogenetic trials)

4. Some theoretical models.

Since, in most fields, reviews have been presented and are discussed and referenced elsewhere, we restrict ourselves to the most outstanding findings and to areas of hot

debate.

EXPERIMENTAL RESEARCH

Historically, homeopaths were among the first to introduce double-blinded experiments in human subjects.

Arguably, among the first experimental models in homeopathy was the one presented by Kolisko who studied the influence of high potencies of silver nitrate (Argentum ni-

tricum) on the growth of plant seedlings, mostly wheat, and

found cyclical changes.

16–18

Some potencies, even beyond

Avogadro’s number, produced an increase in growth length

of seedlings, while other potencies produced a decrease. This

experiment has recently been reproduced in blinded fashion,

with similar results.

19

Our own joint attempts, however,

were equivocal (data not yet published).

Many plant and animal models have been studied

18

but

only few have been replicated independently, and the qual-

ity of the studies is often poor. A review of detoxification

paradigms brings them into context.

20

In this type of ex-

periment, a biologic system—plant or animal—is intoxi-

cated with a substance, and is either pretreated with a home-

opathically succussed and diluted substance, or is treated

therapeutically after the fact. One hundred and five (105)

such experiments were reviewed. The vast majority were of

suboptimal quality. Among the high-quality experiments,

positive results were reported twice as frequently as nega-

tive ones, with an overall positive effect in 4 of 5 experi-

ments and a protection index of roughly 20%. The authors

of the review noted that many models exist but only a

few replications have been achieved. A more specialized re-

cent review presented studies on agents used in warfare and

tolerance-induction via diluted substances and concluded

that these models documented some effects of such diluted

substances.

21

A full database of all experiments has been

compiled by Albrecht and van Wijk and will shortly be

available as the HomBRex-Data Base (see www.carstens-

stiftung.de).

22

WALACH ET AL.

814

*

Hahnemannian” here refers to the method of using a fresh vial

for every step; frequently, the same glass vial is used for Kor-

sakovian potencies, mainly beyond C200. When using that method,

molecules remain longer, through adhesive forces.

One seemingly promising model was developed by

French homeopaths.

23–26

The basic idea is the following:

Basophil cells are extracted from the blood of donors. These

cells are then stimulated by an antigen, causing them to de-

granulate. The antigen is diluted and then presented, testing

whether the diluted antigen is also active. As a variant

model, one can try to prevent degranulation by using an-

other potentized substance (such as potentized histamine)

that may inhibit degranulation. In the most recent set of ex-

periments, potentized histamine has been used. A series of

experiments was conducted by Benveniste and his labora-

tory groups, culminating in a final publication postulating

the replicability of the effect across laboratories.

27

This pub-

lication was heavily criticized, resulting in independent in-

vestigations of the paradigm with no clear-cut reproducible

effect,

28,29

although other experiments, again, yielded posi-

tive results.

30,31

Apparently, even before that, some of the

participating laboratories had withdrawn because the effect

was not consistent across laboratories. This and similar mod-

els were continued by Benveniste later as so-called “digital

biology” because he believed that a kind of electromagnetic

information was responsible for the effect. He claimed that

one could save this information in digital media and play it

to a biologic system, with the same effect.

32,33

Rigorous re-

cent independent replications of this effect with the cooper-

ation of Benveniste’s team revealed that the effect is not re-

producible but is likely to be the result of a very subtle

experimenter effect.

34

A similar model was presented recently by a multina-

tional group, using roughly the same procedure and report-

ing an overall significant summary statistic, claiming a re-

duction of basophil degranulation caused by the application

of histamine potentized up to 30, which is beyond Avo-

gadro’s number.

35–37

An independent group, using the same

model but even better methods of identifying the cells, repli-

cated the result.

38

A careful analysis of the studies, how-

ever, shows a common pattern in this research.

39

One lab-

oratory found a reduction of degranulation, while another

laboratory saw an increase, and still another laboratory noted

no effect. It remains to be seen whether the model will be

reproducible and stable in the hands of independent re-

searchers. What we see in these studies has been a recurrent

pattern in homeopathy research, with equally intensive at-

tempts at finding stable in vitro models.

40–44

This pattern is

that there are dramatic results, often in the first experimen-

tal tests, which are not compatible with random fluctuations

only. These results are often also replicable to a certain de-

gree. But rarely are they stable to the degree demanded by

mainstream research to accept such phenomena beyond

doubt and without a comprehensive theoretical framework.

Another experimental model that has achieved some rep-

utation for replicability is the thyroxin-dependent stimula-

tion of metamorphosis in tadpoles.

45–48

In that model, tad-

pole metamorphosis is accelerated by adding thyroxin in a

high potency (usually 30). Thyroxin stimulates growth and

quickens the metamorphosis from the two-legged stage into

the four-legged stage. Potentized thyroxin can produce this

effect also and, if potentized thyroxin is administered before

a stimulating dose, it can also reverse the effect. This model

has been mainly used by one group of researchers but has

been partially replicated in several laboratories. However,

one completely independent replication failed

49

and one was

positive.

50

In addition, in one large study, the effect was sig-

nificant mainly because, in one laboratory, there were very

strong effects.

A number of groups, mainly in France, have studied the

effects of potentized dilutions beyond Avogadro’s number.

While a number of interesting single results have been re-

ported,

51,52

which have been reviewed in a report soon to

be presented to the World Health Organization,

53

there has

been no consistent attempt at isolating one replicable

model.

18

Thus, there are some hints from experimental research

that homeopathic substances diluted and succussed beyond

Avogadro’s number are biologically active but there are no

consistent effects from independently reproducible models.

One noticeable advancement has been made: van Wijk

and colleagues demonstrated in a series of studies how the

similia principle can be captured biologically.

†,‡

Although

these studies were mainly carried out with low doses of sub-

stances with some potential molecular action, these investi-

gations are interesting nevertheless because they elucidate

what potential avenues the effect can take. Cell cultures were

treated with low levels of toxic substances. The cell cultures

then expressed different patterns of heat shock or stress pro-

teins, dependent on the substance used, as a sign of the stress

the cells suffered. Patterns can be considered as remedy pic-

tures, and chemical compounds can be defined by their de-

gree of similarity regarding these patterns. The following

question can then be addressed: Is stimulation of vitality of

diseased cells related to the degree of similarity between the

symptom pattern of diseased cells and the remedy picture?

Cells’ survival was recorded for their vitality. Experiments

were carried out with a disease induced by physical means:

heat shock. These cells were then treated with chemical com-

pounds that were applied in low doses. The chemical com-

pounds were defined by their degree of similarity regarding

the heat-shock symptom pattern. Experimental data showed

that stimulation of survival capacity was positively corre-

lated with the degree of similarity; the correlation was highly

significant. For instance, when heat-shocked cells were

treated with low doses of arsenite this resulted in less cell

HOMEOPATHY RESEARCH

815

van Wijk R, Wiegant FAC. Cultured Mammalian Cells in Ho-

moeopathy Research: The Similia Principle in Self-Recovery.

Utrecht, Germany: Faculteit Biologie, Universiteit Utrecht, 1994.

van Wijk R, Wiegant FAC. The Similia Principle in Surviving

Stress: Mammalian Cells in Homoeopathy Research. Utrecht, Ger-

many: Department of Molecular Cell Biology, Utrecht University,

1997.

death than without treatment. The patterns of arsenite and

heat shock show a high degree of similarity. In contrast, a

treatment with copper does not decrease cell death; the pat-

terns of heat shock and copper show a low degree of simi-

larity. These data suggest that we can, quite exclusively, rely

upon symptomatic (molecular) expression for indicating a

treatment. It means that stimulation of the (disease) pattern

by another irritation that has a similar pattern is able to ex-

tinguish the diseased state in cells and increases the number

of surviving cells.

54,55

Subsequently, research by Jonas and colleagues demon-

strated that specific protective proteins and their mRNA pre-

cursors are stimulated by specific dilutions of toxins.

56

This

finding bridges the gap somewhat between the simile prin-

ciple and potential biologic mechanisms but does not ad-

dress the question of ultra-high dilutions.

Using an in vitro model, Schmidt, Süß, and Nieber eval-

uated the inhibitory effects of liquid belladonna in high po-

tencies on the acetylcholine-induced contraction of the rat

ileum.

57

This result, of course, also waits for replication.

BASIC RESEARCH

In order to truly understand the mechanism, one would

have to find a plausible theory and experimental backing

to clarify how a highly diluted substance can affect a bio-

logic system. Since it is unlikely that a sufficient number

of molecules of the initial active agent are present in high

dilutions of homeopathic remedies, a researcher would have

to explain how a biologic effect can be brought about in

the first place. One of the earliest attempts at theoretically

explaining potential effects hypothesized that an “imprint”

of homeopathic “information” from the molecules dis-

solved in the remedy is produced by the potentization

process, conserved, multiplied by further potentization, and

then communicated to the body and taken up as a biologic

signal.

58–60

Different attempts have been made to substantiate the

claim that homeopathic dilutions are different from control

solutions. A thorough review of existing studies showed that

the studies presented so far were methodologically deficient

in several respects.

61

Modern attempts at measuring differ-

ences were either negative or produced small effects. How-

ever, during the potentization process, ions are dissolved out

of the glass vials. Thus, homeopathic potencies always con-

tain many different substances apart from the purported re-

medial one

62,63

and, therefore, only studies conducted with

succussed controls and in blinded measurements can be in-

formative. Only a few such studies have been performed. A

series of studies using nuclear magnetic resonance imaging

were able to document differences.

64,65

However, very thor-

ough predecessor studies, conducted in a triple-blinded

setup, were unable to confirm clear-cut and replicable dif-

ferences,

66

and other independent studies yielded sometimes

positive,

67

sometimes negative results.

68

A recent study us-

ing thermoluminescence found significant differences be-

tween a homeopathic test substance and succussed con-

trols,

69

a result that awaits replication. Another recent study

using a high-frequency electromagnetic probing device

demonstrated some differences,

61

while another purported

black-box measurement device did not produce replicable

results.

70

A recent thorough attempt to identify a specific set

of water clusters in homeopathic preparations that looked

promising was subsequently found to be unworkable be-

cause the preparations had subtle contaminants. This study

clearly showed the complex interdisciplinary expertise re-

quired to conduct high-quality research in homeopathy.

71

A

review of all extant literature on physical studies trying to

identify a materially active component and methodologi-

cally rating the studies concluded that most studies were

rather weak from a methodological point of view

72

(see

Table 1 for an overview). Together, this very weak litera-

ture shows that no viable evidence for stable water clusters

(required for so called “water memory”) currently exists.

We have developed a model system for testing homoeo-

pathically prepared solutions using the reaction between en-

zymes and their substrates as the test bed. With this system,

we measure the amount of product produced in an enzyme-

substrate reaction per unit time in a water environment. We

have observed that homeopathically prepared solutions sta-

bilize these reactions in water (manuscript in preparation).

Under normal circumstances, enzymes denature in water.

However, when in the presence of C30 potencies of a vari-

ety of compounds, this denaturation does not occur. Water

diluted and succussed to C30 does not provide a significant

level of stabilization. Furthermore, the starting compound

influences the degree of enzyme stabilization observed. We

have done a careful chemical analysis of the various prepa-

rations and have discovered that silica is the principal con-

stituent that varies among the solutions (4–40 micromolar

amounts). Succussed water also has dissolved silica in it but

at lower concentrations and perhaps in different forms and

molecular structures. As silica may occur in a variety of con-

figurations and in various molecular forms with other ele-

ments from the glass vials, this could explain the differences

among the various solutions. It is reasonable to assume that

the nature of the starting material affects the amount and na-

ture of the silica dissolved from the glass. In addition, var-

ious forms of silica are known to interact with proteins and

have been shown to interact with cells of the immune sys-

tem.

73

It is, therefore, possible that this contamination from

the walls of the glass in which homeopathic remedies are

made is an underlying explanation for some of the effects

reported with homeopathic remedies. According to this hy-

pothesis, the mechanism of action is fairly nonspecific and

most of the specificity is imparted from the patient’s im-

mune system. This could explain the variability observed in

a number of published trials and experiments.

WALACH ET AL.

816

CLINICAL RESEARCH

Pathogenetic trials

Hahnemann’s observation that substances ingested by

volunteers, even when diluted, produce symptoms was the

background for the first blinded experimental study in home-

opathy, probably even in the history of pharmacology. It was

a trial conducted by homeopaths in Nuremberg in 1835.

74

Volunteers were to take either Natrum muriaticum C30 or

a control substance from coded bottles and report back af-

ter some days. Of the 55 volunteers, 50 produced reports.

Eight (8) volunteers had symptoms, 5 with Nat. mur, 3 with

water. Thus, this first test ended inconclusively. Homeopaths

have conducted many so-called “proving” trials, an inade-

quate translation of the original German word Prüfung,

which means “testing.” More recently, these tests have been

called pathogenetic trials (PTs).

75

Normally, provings have

not been conducted blindly or in double-blinded fashion and

have not been usually evaluated with qualitative methods.

The homeopathic epistemology here is circular: Symptoms

observed in PTs are being used for treatment. If patients are

cured by the remedies prescribed, based on these symptoms,

the symptoms are verified, and the remedy picture is sup-

ported. If not, the symptom is discarded. Only rarely, and

very recently, has this methodology been brought under crit-

ical scrutiny and used as an experimental model. Reviews

indicate that the vast majority of PTs are largely inadequate

from a methodological point of view.

76,

§

However, it should

be noted that, for homeopathy to work as a therapeutic sys-

tem, usual methodological principles, such as blinding or

quantitative analysis, are considered to be less relevant be-

cause the circular epistemology is said to correct for bias.

Modern PTs that serve more of an apologetic and scruti-

nizing purpose are only partially useful from a homeopathic

clinical point of view. They have been conducted with blind-

ing of participants, and differential symptom pictures have

been obtained that seem to be useful in therapy.

77

When sub-

jected to scrutiny in placebo-controlled trials, however, it is

difficult to separate symptoms experienced with placebo and

symptoms experienced with homeopathic substances.

77–80

Researchers using more recent study designs have reported

that symptoms observed overall are specific and not just

“background noise.”

81–83

Very few studies have been done

with these recent study designs and much remains to be clar-

ified in this field.

Therapeutic trials

Naturally, randomized clinical trials have attracted most

research interest among researchers and are more well-

known. Several high-quality reviews of all published or a

selection of published studies exist (Table 2).

84–89

There is

even a comprehensive review of all clinical studies ever con-

ducted, including early studies published in German. This

review concluded that homeopathy is clinically effective.

,90

In addition, meta-analyses and reviews of several speci-

fic diagnoses have been carried out.

86,91–98

Most of these

reviews and meta-analyses, with some exceptions,

99–101

reached the conclusion that the effects observed in all trials

are not compatible with the hypothesis that homeopathy is

identical with placebo but that too few trials exist in any sin-

gle clinical areas to recommend homeopathy clinically.

Whether homeopathy is a placebo or not is also dependent

on the inclusion and analysis criteria used by a meta-analy-

sis or a review.

102–104

If the analysis is based on studies re-

HOMEOPATHY RESEARCH

817

T

ABLE

1. R

EVIEW OF

P

HYSICOCHEMICAL

E

XPERIMENTS

T

HAT

a

H

AVE

B

EEN

D

ONE TO

I

DENTIFY A

T

HERAPEUTICALLY

A

CTIVE

I

NGREDIENT IN

H

OMEOPATHIC

P

OTENCIES

Method # of publications Years SAPEH

b

score

Dielectric strength 6 1951–1983 1–50

Galvanic effects 5 1971–1992 1–50

Absorption 4 1941–1995 3–50

NMR-spectra shape 8 1966–1992 3–60

NMR-spectra T

1

T

2

10 1985–2001 2–80

Raman-Spectra 7 1975–1992 2–40

Black-box devices 4 1993–2000 1–10

a

According to ref. 72.

b

SAPEH-Score: a quality score that is comprised of Objectives, Controls, Bindings, Randomiza-

tion, Consistency, Standardization, Statistics, and Presentation of the Results. Maximal SAPEH-

Score is 10, SAPEH 6 low quality, SAPEH 7 high quality.

NMR, nuclear magnetic resonance.

§

Dantas F, Fisher P, Walach H, et al. Homoeopathic remedy

provings: An international review. 2003; in preparation.

Dean ME. The Trials of Homeopathy: A Critical-Historical Ac-

count of the Origins, Structure and Development of Hahnemann’s

Scientific Therapeutics, and Two Systematic Reviews of Homeo-

pathic Clinical Trials. York, UK: Department of Health Sciences

and Clinical Evaluation, University of York, 2001.

trievable only through MEDLINE

®

and published in the

peer-reviewed literature, the outcome is normally not dif-

ferent from placebo. If all evidence is included, there is a

difference from placebo. Hence, the conclusion varies with

the decision as to what one is willing to accept as scientific

information.

105

As a result of the bias in the scientific com-

munity against homeopathy, it is easier to publish negative

results in the peer-reviewed literature than positive ones. The

latter are scrutinized more closely for methodological short-

comings than studies with the expected negative outcome,

a prominent example being the recently published meta-

analysis by Shang and colleagues the reporting of which is

unacceptably bad and yet it passed peer-review.

104,¶

Thus,

reviews based on the peer-reviewed literature are likely to

underestimate the effect and those outside of this literature

are likely to overestimate the effect. Moreover, some evi-

dence has been produced that effect-size between placebo

and homeopathy groups decreases, as methodological rigor

increases across studies,

102,106,107

a finding reported in con-

ventional clinical research also.

A summary of studies and conclusions is presented in Ta-

bles 2 and 3.

When reviewing the clinical evidence, one should bear in

mind that the material is quite heterogeneous. One would,

for instance, not ask the question “is conventional medicine

a placebo effect?” subjecting all available trials to a meta-

analysis. Rather, one would want independent evidence for

certain interventions, say statins, to produce a definite out-

come, say a decrease in heart-disease–related mortality. In

the same vein, one would want a series of relatively simi-

lar trials in homeopathy to test for the applicability of home-

opathy in certain clinical areas. Only in a few areas has a

series of studies been carried out and some of those have

been subjected to a meta-analysis (see Table 3). While the

meta-analyses are frequently positive overall, these results

should be approached with caution. The use of a homeo-

pathic preparation to treat postoperative ileus, for instance,

has been shown to be superior to placebo.

91

However, the

largest and most definitive trial in the series yielded nega-

tive results.

108,109

Isopathic preparations for the treatment of

atopic conditions with an allergic basis have been shown to

be more effective than placebo

110–112

and a meta-analysis

was positive also.

98

However, a large trial intended to be a

replication and a definite study was negative, showing only

significant interactions, but no therapeutically beneficial ef-

fect,

113

and other studies in the same area were also incon-

clusive.

114–116

Homeopathic therapy has been shown to be

useful in childhood diarrhea. A definite study building on a

pilot showed clear effects,

117,118

However, a follow-up study

showed effects only for an outcome different from the pre-

defined primary outcome,

119

and only the meta-analysis

found the effect significant.

97

A series of studies on homeopathy for chronic headaches/

migraines were built on an initially promising model

120,121

but were unable to reproduce the effect.

122–124

The same is

true with a seemingly simple and uncontested area: Arnica

for muscle soreness after exertion.

94,100

Only when all Ar-

nica studies are put together, independent of the model, can

effects be seen.

92

Our review shows a prominent feature of clinical home-

opathy research: The problem is not finding a stunning ini-

tial result, as in early studies such as those done with fi-

bromyalgia,

125–127

or with premenstrual syndrome,

128

or

combination homeopathy in ulcers in children with can-

cer,

129

although some recent results from initial studies have

produced negative results.

131–133

The real problem is repli-

cating the effect once it has been seen in a model, poten-

tially in different independent studies. There is, to our

knowledge, no single clinical area where reported effects

have been demonstrated unequivocally. Thus, the overall

picture of clinical evidence that is emerging is quite disap-

pointing for the homeopathic community. Still, the number

of studies is quite few compared to research in conventional

medicine.

Viewed together, the clinical research on homeopathy

compared to placebo is not much different from conven-

tional medicine research where approximately the same pro-

portion of studies are positive and negative.

134

Once un-

published studies are retrieved from drug-licensing agencies,

well-supported substances, such as selective serotonin re-

uptake inhibitors for depression, show diminishing ef-

fects.

135,136

But overall, effect sizes are still statistically ro-

bust, even if diminished. This same result cannot be claimed

for homeopathy, except in a few clearly delineated areas (see

Table 3).

The situation is different for studies on homeopathic sub-

stances compared to active controls or standard treatment.

There are considerably fewer studies in this field.

137–149

But,

when taken together, it seems to be much easier to prove

equivalence to standard treatments than superiority over

placebo. This is certainly a paradox, for standard treatments

are supposed to be superior to placebo, and this is the rea-

son they are standard in the first place. Jonas and colleagues

did a systematic review (SR) of the homeopathic literature

using an established process taken from the behavioral med-

icine literature that avoided the bias toward drug studies pro-

duced by most medical SR approaches. This review allowed

for calculation of a “valence effect” (a measure of confi-

dence in reported effects) of homeopathic compared to con-

ventional treatment or placebo comparison groups. The re-

searchers found that homeopathy produced more favorable

effects when compared to conventional treatments than

compared to placebo studies. Thus, the system of home-

opathy may be more beneficial in actual practice than when

studying the isolated remedies themselves.

150

This situation has led to a new movement: the documen-

tation of homeopathic care and its effects in primary or sec-

WALACH ET AL.

818

See special section at the beginning of this issue regarding the

Shang et al. study and the accompanying editorial in The Lancet.

ondary care. Most randomized controlled studies start from

a rather vague notion of normal practice. Since homeopathy

has been used for centuries, it has a special status in some

European countries. The remedies are registered, but not

tested for efficacy in certain diagnoses. The logic and epis-

temology of testing is often reversed in traditional healing

practices such as homeopathy.

151

In pharmacology, after a

broad basic research and screening process, only few sub-

stances make their way to final phase 3 and phase 4 testing

for efficacy and, only later, is their broad applicability tested

in postmarketing surveillance studies. In homeopathy, there

is a well-known and broad spectrum of potential single

remedies we know little about in terms of classical efficacy.

Thus, testing should start from a broad documentation of

safety, satisfaction, and effects, comparable to postmarket-

ing surveillance studies in modern pharmacology. Compar-

HOMEOPATHY RESEARCH

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H

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LACEBO OR

N

OT

a

Homeopathy N and type

Author (ref.) type/control of studies Results Conclusions

Kleijnen et al. (

a

) All/placebo, 107 CCTs 81 trials reported Available evidence positive

conventional positive results; but not sufficient to draw

most trials low- definitive conclusions

quality, but many

exceptions

Linde et al. (87) All/placebo 89 RCTs OR of all trials over Results not compatible with

placebo, 2.45 (95% the hypothesis that all

CI, 2.05–2.93); in homeopathy is placebo;

better trials, 1.66 no firm evidence for any

(CI, 1.33–2.08) single condition

Linde and Melchart (88) Classical/placebo, 32 RCTs Responder RR vs. Available evidence suggests

conventional placebo, 1.62 (CI, effects over placebo;

1.17–2.23); in evidence not convincing

better-quality trials, because of shortcomings

1.12 (CI, 0.87–1.44) and inconsistencies

Ernst (

b

) Classical/ 3 RCTs, 3 All trials burdened Relative efficacy of classical

conventional CCTs with serious homeopathy compared to

methodological conventional treatments

flaws; results unknown; no evidence of

nonuniform effects greater than placebo

Cucherat et al. (84) All/placebo 17 RCTs Combined p-value Some evidence suggests

for an effect over homeopathy more than

placebo 0.001; effective placebo; studies

for best trials only, of high quality more

p 0.08 likely to be negative

Walach

c

All/placebo 41 RCTs Random-effect size, Effects of homeopathy not

conventional 0.259 (CI, 0.319– significantly different

0.837); fixed-effects, from those of placebo

0.295 (CI, 0.223 to

0.366)

Shang et al. (104) All (unknown)/ 8 RCTs of OR 0.88 (CI 0.65– Effects of homeopathy

placebo, 110 1.19) for  indistinguishable from

conventional homeopathic homeopathy vs. placebo, while effects

vs. 6 RCTs placebo (i.e. no of conventional trials

conventional difference); OR remain different from

0.58 (CI 0.39–0.85) placebo

for conventional

trials (i.e. significant

difference)

CCT, nonrandomized controlled trial; OR, odds ratio; CI, confidence interval; RCT, randomized controlled trial; RR, rate ratio.

Adapted from ref. 86: Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med 2003;138:393–399, with

permission.

a

Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homeopathy. Br Med J 1991;302:316–323.

b

Ernst E. Classical homeopathy versus conventional treatments: A systematic review. Perfusion 1999;12:13–15.

c

Walach H. The importance of non-specific effects of therapy: The example of homeopathy [in German]. Freiburg, Germany:

Philosophische Fakultät, Freiburg, 1997.

WALACH ET AL.

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Homeopathy type/ N and

Author (ref.) Indication control studies trial types Results Conclusions

Linde &  Asthma Various/placebo 3 RCTs Trials highly  Currently available

Melchart  heterogeneous; 2 evidence insufficient

(88) reported statistically to assess possible

significant effects role of homeopathy

for treating asthma

Ernst (

a

) Headache Individualized/ 4 RCTs 1 trial positive;  Trial data do not

prophylaxis placebo 1 partially positive; suggest effect

2 negative over placebo

for prophylaxis

migraine or

headache

Ernst (

b

) Delayed-onset Various/placebo 8 double- Most trials had  Published evidence

muscle  blinded  severe flaws; does not support

soreness trials the 3 RCTs hypothesis that

(3 explicitly showed no homeopathic

RCTs) statistically remedies are

significant effective for

effects muscle soreness

over placebo

Ernst & Pittler All (mainly  Arnica/placebo, 4 RCTs;  2 positive trials; Claims that

(100) trauma conventional 4 CCTs 2 trials with homeopathic Arnica

positive trend; efficacious not

most studies supported by

had severe rigorous trials

flaws

Lüdtke & All trauma and Arnica/placebo, 23 RCTs;  Quality often low; Available evidence

Wilkens  postoperatively no treatment 14 CCTs 13 of 35 studies suggests that

(92) vs. placebo with Arnica can be

statistically efficacious;

significant  further rigorous

results, 10 with trials needed

trend toward

significance

Vickers &  Influenza-like Oscillococcinum/ 7 RCTs No evidence for  Oscillococcinum

Smith (

c

) syndrome placebo preventive effect probably reduces

(3 trials)  duration of influenza-

but reduction of  like syndromes;

length of illness further trials

in treatment  needed

trials

Wiesenauer Pollinosis Galphimia/ 8 RCTs;  Responder RR  Galphima statistically

and placebo 1 CS; for Galphimia significantly more

Lüdtke (93) 2 UCTs vs. placebo  effective than

from 7 trials, placebo

1.25 (95%

CI, 1.09–1.43)

Barnes et al.  Postoperative Various/placebo 4 RCTs;  Time to first flatus Available evidence

(91) ileus 2 CCTs in homeopathy positive but several

statistically caveats preclude

significantly definitive conclusions

shorter; best

trial negative

Jonas et al.  Rheumatic Various/placebo 6 RCTs 4 studies achieved Few high-quality placebo-

(86) conditions good-quality controlled clinical

scores; combined trials on treatment

OR of these four of rheumatic syndromes

studies, 2.11 (CI, with homeopathy and

1.32–3.35) results are mixed

ative effectiveness between two treatments can be tested to

find out about pragmatic usefulness compared to standard

applications. It is at the end of the epistemological chain that

research on mechanisms of action is done.

152

Thus, the or-

der of testing is reversed. The goal is to document effects

in clinical practice broadly. Where such studies are being

done, sizeable and stable clinical effects on homeopathy are

reported.

#,153–155

Roughly 70% of all patients using home-

opathy report they are considerably improved after treat-

ment, and these effects remain stable during follow-up pe-

riods of 2–5 years.

In summary, there is an efficacy/effectiveness paradox

(similar to that found in several other areas of complemen-

tary medicine research) with very weak evidence that home-

opathy is different from placebo but yet there is documented

usefulness in general practice

156

: We have a therapy that is

useful when applied in open practice and produces substan-

tial effects, even in patients with chronic diseases. But, ac-

cording to controlled studies, it is difficult to show that

homeopathy is different from placebo.

This leads to the conclusion that, before clinical home-

opathy research can proceed with success, it needs a viable

theory.

THEORETICAL MODELS

Hahnemann himself hated speculation. His approach was

purely empirical, and he was not given to theorize about the

nature of homeopathic effects. We do not have a proper the-

ory of homeopathy from him. He satisfied himself by call-

ing the effect of his remedies “spirit-like,” brought about by

a “vital force” or a “dynamis” (the Greek term for “power”).

This will not do for a modern understanding, since sci-

ence is built on an intricate interplay between theory and

data. Data only make sense in the light of a theory, and the-

ories can only be supported or refuted by data.

HOMEOPATHY RESEARCH

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ONTINUED

)

Homeopathy type/ N and

Author (ref.) Indication control studies trial types Results Conclusions

Taylor et al. Allergic Isopathic  4 RCTs Pooled analysis of  Isopathic nosodes

(98)* conditions nosodes/ 100-mm visual  different from

placebo analogue scores;  placebo on both

scores were  subjective and

9.8 mm (CI, objective measures

4.2–15.4) better

with isopathy

Jacobs et al.  Childhood Classical/ 3 RCTs Combined mean  Individualized homeopathic

(95)* diarrhea placebo effect size  treatment decreases the

differences in duration and number of

duration of stools in children with

diarrhea between acute diarrhea, but

groups 0.66 days sample sizes small

(CI, 0.16–1.15;

p 0.008)

Jacobs  Rheumatic Various/ 4 CCTs Three of four No specific 

et al. (

d

) diseases placebo trials positive; conclusion on

quality poor homeopathy (no

convincing evidence

for alternative

therapies for

rheumatism)

RCT, nonrandomized, controlled trial; CCT, nonrandomized, controlled trial; CS, cohort study; UCS, uncontrolled study; RR, rate

ratio; CI, confidence interval; OR, odds ratio.

*Meta-analytic overviews of researchers of their own trials on the topic.

Adapted from ref. 86: Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med 2003;138:393–399,

with permission.

a

Ernst E. Homeopathic prophylaxis of headaches and migraine? A systematic review. J Pain Symptom Manage 1999;18:353–357.

b

Ernst E. Does homeopathic Arnica montana reduce delayed onset muscle soreness? A meta-analysis. Perfusion 1997;11:29–35.

c

Vickers AJ, Smith C. Homeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane

Database Syst 2000; rev. vol.: CD001957.

d

Jacobs JW, Rasker JJ, Van Rie

 

 

[Elzbieta Malarczyk]

Dr. Elzbieta Malarczyk, PhD, Professor emeritus at the Maria Curie-Sklodowska University in Lublin, Poland. Since 2000, she has been studying the effects of homeopathic dilutions of phenol on the enzyme processes of fungi and bacteria. She has also undertaken studies of classical homeopathy in cooperation with medical doctors; this cooperation yielding many popular articles. Her research confirms what homeopaths have known for over 200 years: increasing potentisation according to the homeopathic principles of dilution and succusion has an obvious and predictable effect on living material even at sub-Avogadro dilutions (those where no molecules of the initial substance remain). The paper has been presented in short at a recent congress on complementary medicine in Florence, Italy, but given the abundance of information available at the congress, its importance seems to have been overlooked. Yet, this research could be rated as having the same importance as the works of Montagnier, no less. 

For those of us who see the effects of accurate homeopathic prescriptions every day, no one would be surprised at the outcome. Some might not even consider that it is necessary to try to convince disbelievers that “homeopathy works” and yet, it is heartening to see that such research is being carried out. One would hope that it attracts the attention it deserves, adding yet another piece of evidence in support of the veracity of homeopathic dilutions. Through such research, it is becoming increasingly difficult

to sweep aside homeopathy as “nonsense” or “against the laws of nature”.

“The activity of enzymes can be modified by homeopathic dilutions of their effectors”

Introduction: The fungal and bacterial materials are very useful for testing the influence of low and very low doses of molecular phenolic effectors on the enzymatic system

of phenoloxidases when they are incubated together in the reaction space.

Aim: To search for a useful model of biological systems in order to study the action of diluted low molecular substances on living organisms, which is based on common physical and biochemical analytical procedures.

Method: The fungal and actinomyecetal bacterial materials from laboratory cultures, as a source of common phenoloxidases, laccase, perioxidase and O-demethylase, as well as the pure plant peroxidise, were used in experiments described earlier (1-5). Subsequent dilutions of low molecular phenolic metabolites, appropriate for the study of enzymatic systems, prepared in 75% ethanol in the proportion of 1:100 (centesimal) and dynamized by shaking, in accordance with homeopathic procedures, were prepared in our laboratory. During experiments with bacterial and fungal materials and a pure plant peroxidise, which were incubated together with subsequent dilutions of proper phenolic effector, different analytic methods were used, including a gel (PAGE) (4) and capillary (MEKCE) electrophoresis (5), spectral and coloricmetric methods as well as electron microscopy.

Results: According to the presented data, the incubation of biological material with diluted phenolic effectors induces various effects on tested enzyme activity.

The activity changed in a sinusoidal manner with a gradual growth of dilution rate of tested effectors, which was distinctly visible on the diagram when the number of dilutions was localised on abacissa and biological activity on the ordinate.

Exemplary results of the chosen experiments will be presented. For tested enzymes: laccase, peroxidise and O-demethylase, the distance between maximal points of enzymatic activity, shown on a sine curve, repeats more often every 10 subsequent centesimal dilutions. Along with the extension of the incubation period, the displacement of maximal and minimal points on the curve were noticed, which revealed a dynamic aspect of the studied phenomenon.

Conclusions: Fungal and bacterial cells seem to be a very convenient material for studying the action of diluted metabolites on enzymatic systems due to their popular presence in the environment. Results of all the experiments confirmed the same nature of aforementioned observations. Since other authors had similar conclusions concerning human (6,7) and plant materials (8,9), the described relations seem to be common in the  natural world. It could also be stressed that the therapeutic effect of homeopathic remedies could be based on the mechanism described above, and it is highly probably that it leads to a normalisation of disturbed enzyme systems in living organisms.

For the full articles, click on the following links: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2655704/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2651610/

 

[Dr. Farokh Master]

Research Methodology In Homoeopathy

Research is to discover answers through scientific application of procedures e.g. collecting, analysing and interpreting the data.

The research can be of following types: Dr. Archana Narang and Dr. Aurora has very beautifully classified the methods into following titles.

Applied Research

- This is carried out to find solution or remedies to a particular disease.

Fundamental Research

- It is as the name implies a very basic research, it’s usually undertaken for curiosity rather than to find solutions that we face in our homoeopathic clinical practice.

Exploratory Research

- It is the research we undertake to gain knowledge about the disease or the drug we don’t know at all, here the intension is to bring in new suggestion and idea.

This kind of research is key point to our trials regarding the action of remedies onto various systems in our body and diseases.

Historical Research

- It is the study of past case history and other information sources, with an intension to find the origin and development of a phenomenon/disease/remedy and to discover the

trends in the past, in order to understand the present and to anticipate the future.

Descriptive Research

- It is done to portray accurately the characteristics of a particular individual, situation or a group - i.e., drug pictures, disease pictures, individualized case studies, and research

regarding group studies.

Diagnostic Research

- It is also called clinical research which aims at identifying the solutions e.g. role of glonine in benign hypertension or role of Pulsatilla on ovulation.

Experimental Research

– It is designed to assess the effect of one particular variable on a phenomenon by keeping the other variables constant or controlled. It is done to test a hypothesis of a causal

relationship between variables

– Hypothesis

- Testing Research, i.e., clinical trials of (new or old) drugs on conditions which not appeared during drug proving but were benefitted in therapeutics (action of certain remedies on cancers).

 

• One-time Research- Research confined to a single time period.

• Longitudinal Research

– Research carried on over several time periods. The need of the hour according to me is clinical research: or "Evidence based medicine" is propagated through clinical research everywhere in the world, what is important is to select a best protocol, in my clinic at Bombay I use Karnofsky performance status scale definitions rating criteria along with European Organization for research and treatment of cancer QLQ-C 30,

The protocols used by international agencies like OR, ICMR should always be tried first.

Also one should include lots of experts from other system to evaluate our results and methods. The role of bio statistician can never be ignored in a best clinical trial.

The aim of the clinical research process is to gather scientific data at one place and to support & propagate Homoeopathy as evidence based science.

Clinical verification:

- Here one must do clinical drug proving from different age group, different sex, different occupation, different culture and compare the symptoms and signs that come out, I have been now engaged in this field for more than two decades proving snake remedies with the same idea.

Drug standardization: The drug standardization is conducted to ensure quality, genuiness, and authenticity of raw drugs and to evaluate the safety and efficacy of drugs as favourable results cannot be expected from the remedies until they are of good quality.

Refer aphorism 122 it tells everything in this matter.

Here like allopathic drug companies we as a homoeopath should study the physiology, the metabolic pathways, the neuroendocrine mechanisms, the effects on neuromuscular system and all other Systems including immunological system.

Homoeopathic pathogenetic trials (HPTs): commonly known as Drug Proving is the need of the hour.

Even though the method has not changed much after Hahnemann yet Dr. Jeremy Sherr’s book on drug proving methodologies is very useful. All practicing Homoeopaths can contribute to the research in homoeopathy by contributing cases from their consulting rooms, this will help us to write down most reliable indications of our remedies, next area is repertory verification, if we can do this much I think it’s enough for the present. Let’s see two examples which I love to share with you, the following experiments shows that how beautifully homoeopathy works.

Paulo Bellavite, MD, and a group at the University of Verona (Italy) wrote an excellent review of clinical research in homeopathy in which they concluded:

“Overall, the literature concerning a total of 83 original studies suggests that homeopathy may have significant effects in some conditions, e.g. Galphimia glauca (low homeopathic dilutions/ dynamizations) in allergic oculorhinitis, Anas barbariae (high homeopathic dilution/dynamization) in influenza-like syndromes, classical individualised homeopathy in otitis, in allergic complaints and in fibromyalgia, and a few low-potency homeopathic complexes in sinusitis, rhinoconjunctivitis, arthritis. The evidence for individualised homeopathic therapy in the field of upper respiratory tract infections and for homeopathic immunotherapy in respiratory allergies is more conflicting. Pragmatic equivalence trials suggest that, in primary care, homeopathic treatment is not inferior to conventional treatment. A larger number of observational studies and of clinical trials -conducted in a methodologically correct manner without altering the treatment setting- are needed before sure conclusions concerning the application of homeopathy for specific diseases can be drawn.” (Bellavite, Marzotto, Chirumbolo, 2011)

Autism and the Autism Spectrum

In 2011 an outcomes based study reported the results of treating 123 children with autism who underwent homeopathic treatment between from 1998 to 2009 (Bravalia, 2011).

Treatment effectiveness was determined by the ATEC (Autism Treatment Evaluation Check-list) scoring system, an internationally recognized scoring system to measure changes in autistic symptoms after any treatment. The ATEC has four subsets that measure a range of symptom scores for the following categories: communication, sociability, sensory problems, and health and behavior.

Because ATEC is a system of evaluating the progress of different subsets of autistic children, they found groups of remedies that were valuable for autistic children with sensory problems (touch, sound, smell, vision); kinetic problems (hyperactive, aggressive, destructive, self-injurious, and violent behaviors); regressive problems (involuntary stool or urination and inappropriate sexual symptoms); problematic affects or moods; intense fears (dark, thunderstorms, ghosts, downward motion, being alone, crowds, heights, etc.); those with autistic savant abilities; and strong causation in the child’s history for the onset of autism (for example: the autistic symptoms began after an acute illness, vaccination, use of suppressive medications, or after an acute emotional trauma).

The results of the study were promising. ATEC scores were assessed six months prior to treatment, at baseline when beginning treatment, and were then repeated every three months up to one year after onset of homeopathic treatment. The study had a good cross section of children of various age groups, both genders, and a cross section of children suffering from mild, moderate, and severe autism.

Changes in the ATEC scores were statistically significant with an average ATEC score improvement of 19.72 points (p value < 0.05). The ATEC scores improved almost 34% in the first three months and by 60% by six months into treatment. The quick change in symptoms within the first three months of treatment suggests a strong positive effect of the homeopathic treatment.

Autistic Hyperactivity Scores (AHS), which measures autistic hyperactivity symptoms such as restlessness, spinning, object fixation, fidgety, etc. in a range from 0 to 59, improved significantly after homeopathic treatment from a score of 36 to 14.3 (p value < 0.05).

Most impressive was the observation nine children had complete reversal of their Childhood Autism Rating Scale (CARS) score below the 30 level, which is in the neurotypical, non-autistic range after only one year of homeopathic treatment.

32 of the children in the study were in a subgroup that was analyzed because they had very pronounced sensory problems at onset of the study. Their ATEC scores began

at 73.68 at the time of starting homeopathic treatment and were reduced to 55.74 after 12 months of treatment, and continued to reduce further to 46.41 after 18 months

of treatment. This significant 43% reduction in symptoms shows that homeopathy can be very effective for treating sensory integration problems in children with autism.

Of interest to practicing homeopaths, the study showed that 1/3 of the children needed sequentially different changes in homeopathic remedies over time as their pattern

of symptoms changed.

This observation is commonly seen in homeopathic clinical practice with patient experiencing long-standing chronic illness like autism where several different homeopathic prescriptions over time are needed as the main problems change.

Bravalia, P. Autism Spectrum Disorder: Holistic Homeopathy.

Homeopathic Links Spring 2011, Vol. 24: pp. 31

 

Hormesis (griech.: „Anregung, Anstoß“, engl.: adaptive response) ist die schon von Paracelsus formulierte Hypothese, dass geringe Dosen schädlicher oder giftiger Substanzen eine positive Wirkung auf den Organismus haben können. Sie wird heute in der Definition weiter gefasst. Bei medizinisch wirksamen Substanzen ist ein solcher dosisabhängiger Umkehreffekt gut nachweisbar (z.B. Digitalis, Colchicin oder Opium). Bei einer Reihe anderer Verbindungen und der Wirkung von radioaktiver Strahlung wird die Hypothese in Fachkreisen sehr kontrovers diskutiert.

Hormetische Effekte zeichnen sich durch eine nach oben oder unten geöffnete J- oder U-förmige Dosis-Wirkungs-Kurve aus (z.B. rote Kurve im Bild rechts). Hormetische Effekte kommen in unterschiedlichen Kontexten vor und haben unterschiedliche ihnen zugrundeliegende Mechanismen.

Verwandte Konzepte

Immunstimulantien (z.B. Echinacea-Produkte) sollen -ohne im Sinn einer Impfung zu wirken- das Immunsystem des Körpers unspezifisch aktivieren, um so Infektionen abzuwehren. Dies ist eine hormetische Wirkung im engeren Sinn, die Effekte sind jedoch meist nicht wissenschaftlich sicher belegt.

Die Homöopathie verwendet Giftstoffe in extrem verdünnter Form als Heilmittel gegen Krankheiten, die vermeintlich dieselben Symptome aufweisen, wie durch die unverdünnten Giftstoffe beim Gesunden verursacht werden. Die Heilwirkung hatte jedoch der Begründer der Homöopathie, Samuel Hahnemann, einer „im innern Wesen der Arzneien verborgene[n], geistartige[n] Kraft“ zugeschrieben. Nach den Vorstellungen der meisten Homöopathen werden durch das Potenzieren ausschließlich die unerwünschten Wirkungen der Substanz reduziert, die erwünschten Wirkungen jedoch nicht. Viele Homöopathen glauben außerdem, dass durch das Zubereitungsverfahren die erwünschte Wirkung verstärkt wird. In der Praxis werden oft so hohe Verdünnungen („Hochpotenzen“) verwendet, dass kaum noch ein Molekül des ursprünglichen Stoffes in einer Medikamentendosis enthalten ist. Zur Begründung der Hochpotenzen ging Hahnemann davon aus, dass sich hier „die Materie […] roher Arznei-Substanzen […] zuletzt gänzlich in ihr individuelles geistartiges Wesen auflöse“. Heute behaupten Protagonisten der Homöopathie einen „Gedächtniseffekt“ des als Verdünnungsmittel benutzten Wassers. Kritiker schreiben etwaige Therapieerfolge dem Placeboeffekt zu. [Aus: Wikipedia]

 

[Farokh Master]

Modus Operandi of Homoeopathy

There surrounds ample debate over whether Homoeopathy works or not. One way to deal with the scepticism is to make people familiar with the extensive scientific research and lab investigations being carried out in this field. It should be clear that this research is not carried out as a necessity to conclude upon a working principle of homoeopathic medicines or how miniscule doses of medicine are used in practice.

Research is carried out to augment and enhance the use of homoeopathic medicines. Some of these researches with explicit results have been published and made available to the public in order to generate an interest in homeopathic healing principles and also to enlighten readers on how to evaluate homeopathic research.

However, it can be rather confusing for readers to refer to research analysis as some studies show that homeopathy works and some say that it doesn’t. To rid readers of this confusion, a very recent development in research is used, called a "meta-analysis," which is a systematic review of a research that evaluates the overall results of experiments instead of single studies.

The following literature has been referred from Consumer's Guide to Homeopathy, Tarcher/Putnam.

In 1991, three professors of medicine from the Netherlands, none of them homoeopaths, performed a meta-analysis of 25 years of clinical studies using homeopathic medicines and published their results in the British Medical Journal. This meta-analysis covered 107 controlled trials, of which 81 showed that homeopathic medicines were effective, 24 showed they were ineffective, and 2 were inconclusive.

The professors concluded, "The amount of positive results came as a surprise to us." With this knowledge, the researchers of the meta-analysis on homeopathy concluded, "The evidence presented in this review would probably be sufficient for establishing homeopathy as a regular treatment for certain indications."

There are different types of homeopathic clinical research, some of which provide research on individualization of remedies; some of which give a commonly prescribed remedy to all patients with similar ailment, and some of which give a combination of homeopathic remedies to people with a similar condition. These form good research material; however there are certain issues that researchers have to be aware of in order to obtain the best objective results.

For instance, if a study shows that there was no difference between those patients given a remedy and those given a placebo, the study does not disprove homeopathy; it simply proves that this one remedy is not effective in treating every person suffering from that ailment and he might most probably need a remedy based on his individualised study.

Some people are under the mistaken impression that homeopathic studies are impossibly complicated due to the need to individualize each remedy for the subjects. This is however not true as evidenced by a clinical trial done on subjects with asthma. Researchers at the University of Glasgow used conventional allergy testing to discover which substances these asthma patients were most allergic to which once was determined, the subjects were randomized into treatment and placebo groups. Those patients chosen for treatment were given the 30c potency of the substance to which they were most allergic (the most common substance was house dust mite). The researchers called this unique method of individualizing remedies "homeopathic immunotherapy" (homeopathic m

edicines are usually prescribed based on the patient's idiosyncratic symptoms, not on laboratory analysis or diagnostic categories). Subjects in this experiment were evaluated by both homeopathic and conventional physicians. This study showed that 82% of the patients given a homeopathic medicine improved, while only 38% of patients given a placebo experienced a similar degree of relief. Along with this recent asthma study, the authors performed a meta-analysis, reviewing all the data from three studies they performed on allergic conditions, which totalled 202 subjects. The researchers found a similar pattern in the three studies. Improvement began within the first week and continued through to the end of the trial four weeks later. The results of this meta-analysis were so substantial (P=0.0004) that the authors concluded that either homeopathic medicines work or controlled clinical trials do not. Because modern science is based on controlled clinical trials, it is a more likely conclusion that homeopathic medicines are effective.

As valuable as clinical studies are, laboratory researches too are equally important to conclude responses from homoeopathic treatment. Lab researches show biological activity of homeopathic medicines that cannot be explained as a placebo response, a common accusation of sceptics. Laboratory researches also shed some light on the mechanism of action of homeopathic medicines.

Where clinical research determines improvement in the health of a person, laboratory research measures changes in biological systems like cells, tissues and organs.

It is true that homeopaths are not entirely certain of the working principle of homeopathic medicines, but there are present numerous persuasive and convincing theories about their mechanism of action. Besides, to be entirely honest, there are contemporary modern medicines, including aspirin and certain antibiotics, whose mode of action is not completely known. Yet, practitioners of modern medicine do not hesitate to prescribe these medicines that they have incomplete knowledge of. For centuries now, the most common subject of scepticism towards homoepathy has been the exceedingly small doses of medicines being used in the treatment and cure of patients. Sceptics of homeopathy have asserted that there is "nothing" in the medicines because there are no molecules left in the highly diluted solutions.

However, new research published in the prestigious Annals of the New York Academy of Sciences (1999) suggests that there may be something active in homeopathic medicines after all. In the article ‘The Thermodynamics of Extremely Diluted Solutions” - New Scientific Evidence for Homeopathic Micro doses by Dana Ullman, he mentions an experiment by Two Italian professors of chemistry, Vittorio Elia and Marcella Niccoli. They measured the amount of heat emanating from plain double-distilled water and compared that with double-distilled water in which a substance was placed. Both the control water and the treated water underwent consecutive dilution between one to thirty times, with vigorous shaking in-between each dilution, which represents the common pharmacological method in which homeopathic medicines are made. The researchers conducted over 500 experiments, approximately half of which were made with double-distilled water that was mixed with a specific acid and base substance and half were in the control group of only double-distilled water. The researchers found that 92% of the test solutions with the added acid or base

substance had higher than expected heat emanating from them (sodium chloride was one of the salt substances and a type of vinegar was one of the acid substances tested).

Dr. Vittorio Elia, the lead researcher, asserted, "We are setting the basis for a new science: the physics-chemistry of homeopathic water. These results make for a strong support to the hypothesis of the existence of a memory of water." "This study confirms that there is something there in homeopathic water," affirmed Dana Ullman. "It should now be known that physicians and scientists who assume that there is nothing in homeopathic medicines are showing their own ignorance of the scientific literature."

It is common perception that, in treating a disease, the higher or more potent the dose, the quicker, or better the cure. This common misconception has not only been proved incorrect but the opposite of this has been proved right. It was seen in a series of experiments and research that rather than a drug simply having increased effects as its dose becomes larger, exceedingly small doses of a drug will have the opposite effects of large doses. For instance, it is known that normal medical doses of atropine acts on the parasympathetic nerves, blocking it and causing mucous membranes to dry up, while exceedingly small doses of atropine cause increased secretions to mucous membranes. This pharmacological principle was concurrently discovered in the 1870s by two separate researchers, Hugo Schulz, a conventional scientist, and Rudolf Arndt, a psychiatrist and homeopath. Initially, this principle was called the Arndt-Schulz ‘law’, law being defined as a sequence of events that has

been observed to occur with unvarying uniformity under the same conditions. More specifically, these reseachers discovered that weak stimuli accelerate physiological activity, medium stimuli inhibit physiological activity, and strong stimuli halt physiological activity. For example, very weak concentrations of iodine, bromine, mercuric chloride, and arsenious acid will stimulate yeast growth, medium doses of these substances will inhibit yeast growth and large doses will kill the yeast. In the recent past there has been a surge of experiments confirming and reconfirming this general principle. Unfortunately though, these experiments have been carried out by non-homoeopaths or those with little knowledge of homoeopathy, hence there isn’t any indisputable evidence to prove this principle with respect to homeopathic principles.

Despite the now strong evidence that homeopathic medicines promote biological activity and clinical efficacy, there is still great resistance to them. Recently, the Lancet published the research on the homeopathic treatment of asthma. In a press release announcing this research, they emphasized that although homeopathic medicines may provide some benefit to people with asthma, conventional medicines offer greater benefit.

This statement is bizarre firstly because the study didn't compare homeopathic and conventional medicine; it only compared homeopathic medicine with a placebo and secondly, the Lancet refused to openly acknowledge that homeopathic medicines may work after all.

It is given in the ‘Journal of the French Academy of Sciences‘ evidence of the bias that "defenders of science" have against homeopathy is their refusal to publish or even comment on the increasing body of research accruing to homeopathic medicine.

Science is supposed to be objective, though both physicists and psychologists teach us that objectivity is impossible. Science's long-term antagonism to homeopathy is slowly breaking down but not without significant reaction, fear, anxiety, and sometimes downright attack against homeopaths. Change is the basis of science. We seek to explore new territories to build mankind a better present and future. However, change is difficult, and significant change is even more difficult. Even though science advances from new knowledge, it tends to be unwilling to accept perspectives and knowledge that do not fit contemporary concepts and scientific theories.

 

[Farokh Master/Fernandes]

The Most Useful Method of Learning Materia Medica

The essence of homoeopathy is individualization, with each drug having its own distinct personality. We have to get acquainted with different remedies in the Materia Medica and understand them as if they were our friends.

1st step in learning Materia Medica is feeling the remedies.

2nd step is to learn the mental symptoms of a drug, before the physical symptoms of the drug, as the mind is the most distinct and innermost part of a person. Unfortunately, our Materia Medica does not have fully developed mental aspects of drugs of most remedies.

3rd step is to study the aggravations and ameliorations by meteorological conditions, motion, heat, jar, position, touch etc. The characteristic desires and aversions of a remedy are

of great importance. Sometimes, in a drug, there are contradictions in this sphere of remedies, for e.g. desire as well as aggravation to fish in Natrum muriaticum.

4th step is to know the causation of disease typical of different remedies i.e. the ailments from in the remedy.

E.g. Ailments from mortification - Staphysagria

Ailments from suppressed diarrhea - Abrotanum

Ailments from injury - Nat-sulph.

When we have mastered the above points then we have to proceed to learn the physical symptoms to which the remedy specially applies.

For eg: Cardiovascular system of Veratrum viride,

Cerebro- spinal system of Zincum metallicum.

Also we must study the affinity of drugs for particular organs and tissue. For e.g. Kali carbonicum and its affinity for serous membranes.

We must be able to visualize the characteristic symptoms of a drug, like the cracked tongue in the center of Rhus venenata,

zigzag sensation of Calc.

5th step is to select the few peculiar, strange keynote symptoms out of the bulk of symptoms of a remedy. These may form similes, as we have

The Ragged Philosopher - Sulphur.

The Human Barometer - Merc-sol.

6th step is to get clearly in the mind the bodily functions such as micturition, defecation, digestion, menstruation and pregnancy.

7th step is to understand the alternating conditions e.g.

headache alternating with piles - Aloe,

cough alternating with eruptions - Croton tigrinum

and the concomitants of the remedy e.g.

coryza accompanied by diarrhoea -Sanguinaria canadensis. In the second edition of the Kent's repertory, these are given under a separate heading as alternations, but in the third edition

it is scattered through the book.

8th step is to study the pharmacology of drug including its effects in potentized form.

e.g.

Opium - It contains two main groups of alkaloids. Phenanthrenes include morphine, codeine, and thebaine and are the main narcotic constituents. Isoquinolines such as

papaverine have no significant central_nervous_system effects. Morphine is by far the most prevalent and important alkaloid in opium, consisting of 10%-16% of the total, and

responsible for most of its effects such as lung edema, respiratory difficulties, coma, or cardiac or respiratory collapse.

In Cannabis the most prevalent group of psychoactive substances is delta- tetrahydrocannabinol. Other psychoactive substances are   Tetrahydrocannabivarin,  Cannabivarin,

Cannabidiol, but it is only found in small amounts.

Effects of tetrahydrocannabivarin are altered consciousness and perception, anxiety, paranoia, increased libido, increased heart rate, dryness of mouth.

Cannabinoids affect the basal ganglia, cerebellum and the hippocampus bringing about a change in movement and co-ordination.

9th step is to study the particular sphere of action of drugs.

For e.g. the action of Natrum muriaticum on the pituitary - thyroid axis.

The action of Nitric acid on mucocutaneous junction.

The action of Pulsatilla on venous system.

 

THEORETICAL MODELS

Hahnemann himself hated speculation. His approach was

purely empirical, and he was not given to theorize about the

nature of homeopathic effects. We do not have a proper the-

ory of homeopathy from him. He satisfied himself by call-

ing the effect of his remedies “spirit-like,” brought about by

a “vital force” or a “dynamis” (the Greek term for “power”).

This will not do for a modern understanding, since sci-

ence is built on an intricate interplay between theory and

data. Data only make sense in the light of a theory, and the-

ories can only be supported or refuted by data.

HOMEOPATHY RESEARCH

821

T

ABLE

3. S

YSTEMATIC

R

EVIEWS OF

C

LINICAL

T

RIALS ON

H

OMEOPATHY FOR

S

PECIFIC

C

ONDITIONS

(C

ONTINUED

)

Homeopathy type/ N and

Author (ref.) Indication control studies trial types Results Conclusions

Taylor et al. Allergic Isopathic  4 RCTs Pooled analysis of  Isopathic nosodes

(98)* conditions nosodes/ 100-mm visual  different from

placebo analogue scores;  placebo on both

scores were  subjective and

9.8 mm (CI, objective measures

4.2–15.4) better

with isopathy

Jacobs et al.  Childhood Classical/ 3 RCTs Combined mean  Individualized homeopathic

(95)* diarrhea placebo effect size  treatment decreases the

differences in duration and number of

duration of stools in children with

diarrhea between acute diarrhea, but

groups 0.66 days sample sizes small

(CI, 0.16–1.15;

p  0.008)

Jacobs  Rheumatic Various/ 4 CCTs Three of four No specific 

et al. (

d

) diseases placebo trials positive; conclusion on

quality poor homeopathy (no

convincing evidence

for alternative

therapies for

rheumatism)

RCT, nonrandomized, controlled trial; CCT, nonrandomized, controlled trial; CS, cohort study; UCS, uncontrolled study; RR, rate

ratio; CI, confidence interval; OR, odds ratio.

*Meta-analytic overviews of researchers of their own trials on the topic.

Adapted from ref. 86: Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med 2003;138:393–399,

with permission.

a

Ernst E. Homeopathic prophylaxis of headaches and migraine? A systematic review. J Pain Symptom Manage 1999;18:353–357.

b

Ernst E. Does homeopathic Arnica montana reduce delayed onset muscle soreness? A meta-analysis. Perfusion 1997;11:29–35.

c

Vickers AJ, Smith C. Homeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane

Database Syst 2000; rev. vol.: CD001957.

d

Jacobs JW, Rasker JJ, Van Riel PL, et al. Alternative treatment methods in rheumatic diseases: A literature review. Ned Tijdschr

Geneeskd 1991;135:317–322.

#

Becker-Witt C, Lüdtke R, Baur R, Willich SN. Homeopathic

medical practice: Long-term results of a cohort study with 3981

patients. BMC Public Health 2005, submitted.

Theories, in the sense of full-fledged models explaining

homeopathy from production to therapeutic effects, do not

exist. However, there are speculative attempts to explain

parts of the puzzle.

157,158

These attempts can be broadly di-

vided into two classes: local mechanistic models and non-

local models.

Local models

Local models start from the assumption that the produc-

tion process produces some kind of template, image or im-

print of the original substance, and that this “information”

is the active ingredient. Memory of water is claimed as one

potential mechanism.

159,160

Exactly how this memory

should operate is not clear. Several possibilities have been

proposed: A selection of water isotopes specific to an orig-

inally dissolved substance

161

; an ordering of water mole-

cules to macrostructures, called clathrates,

159,162–164

that

contain the information about substances in the geometry of

their ordering; and a selective change in hydrogen bonding,

long-range coherence between water molecules that gives

potencies laser-like behavior

165

are a few of the more promi-

nent ideas. Some of these have been theoretically discussed

at a high level of specification, some of them remain purely

speculative. However, none have been proven. For instance,

the lifespan of water macrostructures is in the region of pi-

coseconds, which is far too short to guarantee stability.

166

Even if these theories could be proven a couple of problems

remain: Some remedies are not produced by succussion at

all, but by trituration with milk sugar. Would the theories

also hold for this special case? Some theories discuss only

water. In homeopathy, there is nearly always a variable mix

of water and alcohol. Would the chemistry and physics be

the same? Hahnemann, in later days, ordered his patients

just to sniff medications (i.e., open bottles and smell them)

and allow only volatile molecules to make contact. Would

those theories also explain this curious situation? If a mate-

rial information carrier could be demonstrated, precisely

how would the organism use this information to produce

health again? It has been observed that the data are com-

patible with a network theory of health, claiming that some

“ordering information” is given to the organism that allows

it to come out of a state of suboptimal equilibrium, which

is the chronically ill state.

167,168

This model would demand

only a minimal energetic impulse or even no impulse at all

but just the right information to get the system stimulated.

Local models claim that such information is contained in

homeopathic remedies.

The combined data of homeopathy research are not com-

patible with that argument, at least not at the moment. If this

were the case, we would expect a similar situation as in con-

ventional pharmacology, namely, that a series of studies suc-

ceed in distilling out an effect from such information com-

pared to what happens with controls. What we see in variable

models is strong effects in either direction that, when

summed up, often cancel each other out. While the devia-

tions from expectation are frequently very strong, defying

the argument of random fluctuation, these deviations are

rather unsystematic and, up to now, have not been suffi-

ciently stable in any single model to convince critics.

Nonlocal models

It was this situation that has led some researchers to

postulate nonlocal mechanisms,

169–179

in line with Hahne-

mann’s general way of theorizing.

180

Several of these mod-

els exist and vary in their degree of explicitness and general

approach, and also in the way they include the remedy and

the practitioner in the equation. Generally speaking, the

starting point for these theories is the observation that, in

quantum mechanics, so-called nonlocal correlations in well-

defined quantum systems are operative. While these decay

through interaction with the environment, it might be the

case that under similar, isomorphic conditions nonlocal cor-

relations are established in analogy to holistic quantum cor-

relations. A theoretical framework exists that predicts such

nonlocal correlations,

181

and some efforts have been made

to apply such a scenario to homeopathy.

177

While some ob-

servations speak in favor of such models,

182

direct experi-

mental evidence for the existence of nonlocal correlations

outside the realm of quantum mechanics is still wanted.

These models have a common consequence: If homeo-

pathic effects are the result of nonlocal correlations, by de-

finition, they cannot be distilled out as causal signals, like

in drug therapy. Attempts at strict and direct replication, are

doomed to failure. This has to do with a rather technical ar-

gument that prohibits the use of nonlocal correlations as di-

rect signals.

179

(Otherwise, time-reversal paradoxes could

be created that contradict special relativity.) As long as the

original context is not disturbed and no signal can be dis-

tilled out of a setup using such correlations, they could be

a very elegant way of coordinating behavior.

The practical consequence of this theory is that clinical

research is best conducted by not disturbing the normal clin-

ical practice through experimental interventions such as

blinding and randomization and that the placebo-controlled

trial is probably a suboptimal method of testing, not only

for homeopathy but also for conventional pharmacology. A

serious problem with the nonlocal model is that it may not

be directly testable in the clinical setting and so cannot be

proven as an explanation for homeopathy. Only indirect ex-

perimentation is a potential avenue to prove it and this has

yet to be established.

CONCLUSIONS

Our health system has become more effective for treat-

ing acute diseases. The downside of it is that chronic dis-

eases have moved into the foreground of health care. Even

WALACH ET AL.

822

if future medical interventions will be able to solve these

problems, it is questionable whether our societies will be

able to afford these treatments.

183

In this situation, home-

opathy might be an attractive alternative, since it is a min-

imal intervention with no known and documented side-ef-

fects, capitalizing on the individual organism’s capacity to

self-heal. Focused conventional intervention, when applied

in the complex networks of living organisms, is bound to

produce an array of unwanted effects. Thus, the homeopathic

strategy may also be helpful for reducing adverse effects

from treatment.

184,185

Homeopathy may thus offer an alternative, if we are will-

ing to set aside the need to know whether its effects are spe-

cific. What strategies are the most useful to both study and

use homeopathy? We offer a few suggestions about what

routes research should and could take in the future:

1. Clinical research is probably most effective if it uses ex-

actly this strength of homeopathy to regulate the system

with minimal side-effects and tries to document options

and limitations. This could be done in large outcomes

studies. These studies should look at homeopathy as it is

practiced and provide data on the real-life effects in pa-

tients. If well-described cohorts are used, and these co-

horts are followed for a long time and compared to con-

ventionally treated ones, this will allow us to estimate the

usefulness of homeopathy in practice. Ideally, such an

approach would be combined with economic research on

costs and feasibility.

2. The next step would be pragmatic comparisons between

homeopathy and conventional treatments, which ideally,

of course, would be conducted as randomized trials.

Since patients seeking homeopathic care often would not

like to be randomized, nonrandomized comparisons

would also have to be conducted.

3. Placebo-controlled trials are the state of the art in clini-

cal research. Thus, researchers and some authorities will

want evidence from such trials. Before conducting such

studies, however, it would be advisable to build on ex-

tensive pilot data giving an indication of the anticipated

effect size, condition, outcome parameters, and length of

time of each study.

4. Ideally, the question regarding the nature of homeopathic

remedies is directed toward solid laboratory research with

plant, in vitro or in vivo models that are controlled, ob-

jective, and easily replicable. Since placebo-controlled

clinical trials presuppose that there is a causal signal to

be isolated in the first place, they may be the wrong

method of testing, if the nonlocality hypothesis is cor-

rect. Thus, it should be high priority to establish the na-

ture of homeopathic dilutions in fundamental experi-

mental laboratory models. It is mandatory to find a testing

system that is broadly accepted and can, in theory, be

handled by any competent researcher in the area. If one

wants to drill a large hole through a massive wall, it is

best to not start drilling a new hole every couple of inches

but to stick to one initial groove and carry on drilling.

This analogy applies here: One, or at the most, very few

different systems should be established and probed, ide-

ally, by independent researchers. If the prediction of a

subtle causal information carrier in homeopathic dilu-

tions is borne out, one would expect that a series of well-

controlled trials should be able to isolate such a signal,

even if it is very weak. If the hypothesis of a nonlocal

process is true, we would expect no strict replicability,

but a deviation toward the predicted and sometimes to-

ward the unpredicted direction, sometimes for the pri-

mary, sometimes for the secondary outcomes. Neverthe-

less, it should be possible to document deviations from

chance randomness, if two preconditions are observed:

(a) The testing system must not be too restricted. For in-

stance, deviations should not be forced to be one-

sided, but should comprise overall deviation statis-

tics, ideally combining an array of parameters, e.g.

different parameters of growth.

(b) It is unlikely that the effect will be seen in every test.

Thus, a testing model should be chosen that is com-

paratively low-cost to replicate and a meta-analytic ap-

proach should be used to synthesize long series of data.

Thus, experimental testing in simple models would allow

us to clarify the nature of homeopathic potencies.

5. In parallel, theory development should proceed. History

of science teaches that anomalous data are only incor-

porated into the corpus of science, once a sound theory

is available to understand the data. However, no theory

has ever changed the direction of science without good

data to support it. Thus, both developments need to go

hand-in-hand.

6. The big movement at the moment is toward healing in

integrative care, in which different healing modalities

have their special places. Homeopathy is not a cure-all.

What is needed is to find out in which areas homeopa-

thy works well, or better, than other modalities and to

seek cooperation with other modalities for optimal care.

For instance, it might be that homeopathy is especially

effective for children or for mitigating stress-related dis-

eases. In these cases, it would be worthwhile to establish

model clinics in which integrated care is practiced and

could be studied as a whole practice against other prac-

tices.

7. Only little attention has been paid to patient–practitioner

interaction. Part of the secret may be buried here, and in-

tensive qualitative and process-like studies might be able

to unveil some of it.

We believe that Hahnemann’s discovery is still worth-

while in the twenty-first century. To be recognized as such,

HOMEOPATHY RESEARCH

823

it is necessary that one legacy of Hahnemann’s is strictly

discarded, however—his tendency to quarrel and fight with

everyone who did not share his opinions. This was his

shadow side and it is still haunting homeopathy. And thus

homeopaths go on fighting—each other and colleagues of

different training and opinions, medical authorities and other

doctors, and the health system at large. This is a waste of

time and energy, and we suppose that homeopathy would

have been easier to integrate had it not been for this ten-

dency. It is time to drop this and to adopt a more mature

stance that is aware both of the strengths and the weaknesses

of homeopathy, and that is willing to look openly at both

and to learn continually from experience. The latter is a

theme, common both to science and homeopathy.

ACKNOWLEDGMENTS

The authors thank Cindy Crawford, B.A., for valuable

help in the background.

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