An exploration of the relationship between placebo and ... · the brain’s ‘‘inner...

CLINICAL REVIEW

An exploration of the relationship

between placebo and

homeopathy and the implications

for clinical trial design

Claire Haresnape

Barts and the London School of Medicine and Dentistry, Queen Mary University of London, William Harvey Research

Institute, London, EC1M 6BQ, UK

Correspondence to: Claire Haresnape. Email: [email protected]

Summary

Placebo appears to be a real neurobiological phenomenon that has

evolved through the selection pressure to be able to heal ourselves.

The complex language and social structures of humans means that we can

attribute meaning to therapeutic encounters with culturally sanctioned

authority figures and we can use our attachment to such figures to gen-

erate hope for recovery. Different mechanisms may be involved in the

neurobiological aspect of placebo including anxiety, learning, condition-

ing as well as individual genetic variation. Examination of the published

work shows that while some trials do seem to indicate a specific mode of

action for homeopathic remedies other trials do not and this is an issue

that needs to be addressed at the trial design stage. A clinical trial that

includes both a placebo group and a non-participating control arm is the

most powerful design for separating the non-specific and polymorphic

placebo effect from the specific effects of trial medication. The control

variables in a trial of homeopathic medication should also include the

process of consultation as this may assume a meaning for the individual

that can also be associated with a placebo effect.

Introduction

It is a commonly held belief that homeopathy is

‘nothing more’ than a placebo effect, a turn of

phrase which seems to dismiss as ineffective both

homeopathy and the role of the placebo in healing.The aim of this short report is to explore the

relationship between homeopathy and placebo,

how these are connected to self-healing and how

we can design a clinical trial to measure these

interconnected effects.

Recent insights into the changes associated

with placebo may explain why the placebo

response trait could be positively selected for

during our evolutionary history:

‘It is becoming ever more apparent that ‘the

placebo effect’ is polymorphic in both its trig-

ger and its expression, and that the mechan-

isms for placebo responses within the body are

diverse. It is also clear that in all societies heal-

ing modalities have developed to maximize

DECLARATIONS

Competing interests

This article has

been funded by a

grant from

Biological Heilmittel

Heel GmbH and the

author has worked

on a consultancy

basis for BioPathica

Ltd, Ashford, Kent

Funding

This work was sup-

ported by an educa-

tional grant from

Biologische

Heilmittel Heel

GmbH,

Dr.-Reckeweg-Str.

2-4,76532 Baden-

Baden, Deutschland

Ethical approval

Not applicable

Guarantor

CH

Contributorship

Sole authorship

J R Soc Med Sh Rep 2013: 4: 1–19. DOI: 10.1177/2042533313490927 1

the placebo response in an attempt to over-

come assaults to well being. This raises the

question as to whether the placebo response,

like other self-healing mechanisms, may be an

evolutionary adaptation.’1

Given the extreme plasticity of the human brain in

response to experience and the potential differences

due to genetic variation, it is clear that the old

‘nature vs. nurture’ debate has some relevance to

our understanding of placebo. If the range of indi-

vidual placebo responses is wide then this also has

implications for the large sample sizes needed for

meaningful analysis of clinical trial data.

Methods

The evidence for this review was gathered from a

search of the PubMed database (http://www.

ncbi.nlm.nih.gov/pubmed), using the terms

‘homeopathy’, ‘self-healing’ and ‘placebo’, which

yielded 19 published papers.In order to review the trial design of published

trials of homeopathy with a non-treatment group,

a PubMed search was conducted using the search

terms ‘homeopathy’ and ‘clinical trials’ with the

filter ‘last five years’ and excluding surveys with

no placebo, animals and plant studies. This gen-

erated 41 papers for analysis.

In order to find material about trials that showa specific effect for homeopathy, a PubMed search

using the terms ‘homeopathy’þ ‘specific’ and fil-

tered to show clinical trials over the last five years

in human subject returned only 10 studies.

Additional inspiration and material was

sourced at the inaugural meeting of the Pain

Medicine Section of the Royal Society of

Medicine ‘The role of the placebo in clinical care’which was held on Friday 18 November 2011.

Professor Atholl Johnston provided the link to

the data on the discovery of the genetic basis for

the placebo effect in IBS patients. The information

about homeopathy was cited using books from

the author’s own library and details are included

in the bibliography.

Genetic individuality

The individual nature of each patient’s response

has some basis in genetic variation and this is

identified as a fruitful new avenue of research

by Benedetti and Amanzio.2 In a recent study

from Beth Israel Deaconess Medical Centre

(BIDMC) and Harvard Medical School (HMS), sci-

entists claim to have identified genetic differences

between people who respond to placebos during

trials and those who do not.3

Placebo, semiotics andmeaning

Medical or therapeutic treatment happens to

unique individuals, each with their own interpret-

ation of the experience. Walach4 recognizes that

the individual psychological and psychosomaticreceptive action on the part of the patient is rele-

vant to therapeutic success.

Meissner et al.5 confirms that the placebo effect

is ‘a real neurobiological phenomenon and that

the brain’s ‘‘inner pharmacy’’ is a critical deter-

minant for the occurrence of psychobiological

and behavioral changes relevant to healing pro-

cesses and wellbeing’.Meissner6 proposes that verbal suggestions

during placebo interventions may activate associ-

ation networks in the brain that store memories of

the appropriate autonomic response. Organ func-

tions regulated by the Autonomic Nervous

System (ANS) including the cardiovascular,

gastrointestinal and pulmonary systems are

amenable to both placebo and nocebointerventions.

Benedetti and how placeboschange the patient’s brain

The 2011 review of neurobiological findings by

Benedetti et al.7 provides a compelling view of

placebo as a psychosocial context effect wheresocial stimuli such as words and rituals of the

therapeutic act may change the chemistry and cir-

cuitry of the patient’s brain. Benedetti et al. show

that drugs are administered into a complex bio-

chemical environment that varies according to the

patient’s cognitive/affective state and previous

exposure to other pharmacological agents. The

mechanisms activated by placebo are the sameas those activated by drugs, which suggests a cog-

nitive/affective interference with drug actions.

Rather than one common mechanism of action,

they suggest that there is a whole ‘melting pot’ of

different placebo effects operate at different times

Acknowledgements

The author would

like to acknowledge

the help of Prof

Atholl Johnston, Dr

Art Tucker, Dr Carol

Rivas, Mrs Virginia

Shankland, Dr Len

Parkyn, Neil

MacLachlan, Dr Neil

Elnaggar, Sister

Michelle Thomas,

Mr and Mrs Roger

Wilson and Dr

Istvan Zatik

Provenance

Submitted; peer

reviewed by

Heather Goodare

Journal of the Royal Society of Medicine Short Reports

2 J R Soc Med Sh Rep 2013: 4: 1–19. DOI: 10.1177/2042533313490927

and under different circumstances. Sometimes

anxiety is modulated, at other times reward mech-

anisms are involved and in other circumstances

different types of learning, conditioning or even

genetic variants may play a role in placebo

responsiveness.

Placebo in relation to evolution

The role of expectation of benefit and the hope of

healing have also been examined by Benedetti and

Amanzio.2 The expectation of future events is

known to modulate anxiety and to induce physio-

logical changes through reward mechanisms. Thenocebo effect, which is the opposite of the placebo

effect, provides some of the best evidence of the

role that anxiety plays in placebo responses.

There is a survival value to the ability to pre-

pare the body to anticipate and cope with a future

event. The main purpose of perception is to help

predict the future,8 if expectations about the

future change the body’s defensive emotional,behavioural and physiological responses then pla-

cebo responsiveness could be seen as a trait

favoured by natural selection.

From the evolutionary perspective individuals

who can protect themselves, heal themselves and

recuperate from infections, injury and illness are

more likely to survive and reproduce and there-

fore pass these adaptive traits on to theiroffspring.

The connection betweenillness and disease

One of the themes of this approach is the distinc-

tion between disease and illness. Disease may be

considered to be patho-physiological whereas ill-ness is phenomenological. Illness is the lived

experience (emotions) of detriment to health

including the symptomatic manifestation of dis-

ease. Miller et al.9 suggest that the placebo effect

operates predominantly by producing symptom-

atic relief of illness rather than modifying the

physiology of disease.

The role of the ‘healer’ inplacebo

Because the symptoms of illness have themselves

a survival value, it is reasonable to suppose that it

will only be ‘safe’ to ‘turn them off’ when sanc-

tioned by a ‘healer’ or practitioner.

‘From a psychodynamic perspective the hea-

ler’s authority and ability to comfort may be

a projection of parental care, operating by a

process of transference.’10

Ernst and Resch11 have noted that procedures

intimately involving the patient as well as those

that are invasive, like acupuncture or ultrasound

are associated with a more powerful true placebo

effect than oral drug treatment. In these situations

the ‘healer’ is playing an immediate and activerole and the ‘patient’ is interpreting this as some-

how more powerful, direct and significant.

The context of the clinical encounter and the

relationship between the healer and the patient

are imbued with meaning and enshrined in

ritual. Dr Cecil Helman12 relates how his consult-

ing room is a type of stage-set where small human

dramas are played out every day. ‘Props, cos-tumes, sets and a precise choreography’ achieve

the creation of a ‘certain atmosphere of belief and

expectation’.

Self-healing and homeopathy

‘We are inclined to attribute recovery from dis-

ease to the ministrations of healers when, in

point of fact, it is often due to self-limiting dis-

eases and the automatic natural healing of the

organism.’9

It is important to distinguish interpersonal heal-

ing from two other forms of healing, natural healing

and technological healing, because homeopathy is

often described as ‘natural’ and perceived as analternative to ‘technological’ healing options:

‘Natural healing is the spontaneous or automatic

response of the body to disease or injury, exem-

plified by internal mechanisms of fighting infec-

tion and wound healing. Technological healing

consists of the full array of medical and surgical

treatment that have pharmacological or physio-

logical properties capable of promoting cure,

disease control, or symptomatic relief.’9

The homeopathic consultation process is a two-

way process in which the patient narrative

An exploration of the relationship between placebo and homeopathy


is received by the therapist and generates ques-

tions or reflections. This must involve a psycho-

logical transaction between patient and therapist

that will be perceived through the frame of their

previous experiences. The patient is conscious,

active and ‘being heard’.Benedetti has explored the role of the pre-

frontal cortex in placebo responses and concluded

that if prefrontal functioning is impaired, placebo

responses are reduced or totally lacking, as occurs

in dementia of the Alzheimer’s type.7

The homeopathic clinical encounter will

involve healing on many levels as there will be

interpersonal transactions including psycho-dynamic effects, the ritual associated with con-

sultation and perhaps lifestyle advice and

education. The patients may also be receiving con-

current technological healing from their medical

practitioners as well as being prescribed a homeo-

pathic preparation to aid ‘natural healing’.

The philosophy of homeopathy

The philosophy of homeopathy is built around the

concept of vital force, this is understood to be a

dynamic life force which ‘steers all the functions

of life’.13 The concept of vital force was introduced

by Hahnemann in the early editions of the

Organon,14 and is based on the concept of

‘Vitalism’ which existed at that time.

‘The task of the vital force is to maintain har-

mony and order in the organism. Every com-

ponent of the organism, every organ and every

cell is influenced and guarded by the vital

force. The vital force protects us from ill.’13

According to this homeopathic approach, theorigin of disease lies in the disturbance of this

energy matrix not in the organic physical matrix

of the body, ‘The origins of illness are to be found in theweakened vital force.’13 Healing therefore must also

influence this vital force and homeopathic medi-

cines are believed to stimulate and strengthen the

vital force to promote self-healing and returning

them to equilibrium of mind, body and spirit.

‘The goal of homoeopathic treatment is not

to directly remove or suppress a symptom

rather to strengthen and harmonize the vital

force.’13

Later homeopaths such as Vithoulkas15 have ela-

borated on this concept to propose the primary

and secondary action of homeopathic remedies:

‘Every agent that acts upon the vitality, every

medicine, deranges more or less the vital

forces, and causes a certain alteration in the

health of the individual for a longer or shorter

period. This is termed primary action.

Although a product of the medicine and vital

powers conjointly, it is principally due to the

former power. To its action our vital force

endeavors to oppose its own energy. This

resistant action is a property, is indeed an auto-

matic action of our life-preserving power,

which goes by the name of secondary action

or counteraction.’15

The capacity to self-heal is therefore seen as an

innate ‘energy’ which can be strengthened and

stimulated by the application of the homeopathic

medicine because the medicine itself has been pre-pared by a series of dilutions and succussions to

reduce its primary effect of medication and

awaken its latent dynamic power:

‘By means of this manipulation of crude drugs

are produced preparations which only in

this way reach the full capacity to forcibly

influence the suffering parts of the sick organ-

ism.’ §27014

The correct selection of that medicine is of para-

mount importance because the choice requires the

therapies to take a detailed individual case history

during which the patient is required to describe

their symptoms. It has been suggested16 that

‘The non-specific therapeutic effects of the

doctor-patient relationship are likely to be

increased by the patient’s expectations of the

homeopathic method which meshes with the

specific therapeutic effects of the medicines.’

Self-healing and homeopathy

It is clear that homeopathy includes the concept of

self-healing in its philosophy and practice, and

there is a recognition that the ability to self-regu-

late or return to health is innate in humans.



Homeopaths attribute this to a ‘vital force’ and

believe that this innate process can be aided by

the administration of a specially prepared

‘remedy’ that supports the body in the process.

Homeopathy pays attention to the idea that phys-

ical changes relate to a prior ‘energetic’ change andthat good health encompasses spiritual, mental,

emotional and physical dimensions (Table 1).

Designing a clinical trial tomeasure the true placeboeffect

An important question remains as to how we sep-arate and measure the specific ‘medicine’ effects

from the non-specific ‘brain’ effects when we

attempt to evaluate homeopathy?

This dilemma was highlighted as early as

199511 when it was suggested that most authors

confuse the perceived placebo effect with the trueplacebo effect. The true placebo effect can only be

identified by including an untreated controlgroup in clinical trials. By doing so the other non-

specific effects that contribute to the perceived

placebo effect (such as natural course, regression

to the mean, other time effects and unidentified

parallel interventions), can be excluded.

Clinical trials

Two types of trial are therefore of interest when

considering these issues: those trials of homeop-

athy that compare a placebo group, active drug

group with a no treatment group and trials that

seek to reproduce specific effects of homeopathic

remedies.

In order to investigate the first group I con-

ducted a PubMed search of published work inthe last five years using the keywords

Homeopathy and Clinical Trials, excluding surveys

with no placebo, and those with animal and plant

subjects. Forty trials were identified of which only

three (7.5%) included a non-intervention group.

This analysis of the published work shows that

only a small percentage of trials of homeopathic

medicine use a non-participating control groupand that that this kind of group may be used for

different reasons. Future studies of homeopathy

should seek to include an untreated control

group in order to help distinguish the true placebo

effect from other nonspecific effects.

Trials that seek to reproducespecific effects of homeo-pathic remedies

A PubMed search using the terms ‘homeop-

athy’þ ‘specific’ and filtered to show clinicaltrials over the last five years in human subjects

returned only 10 studies (Table 2).

The eczema study17 showed that both homeo-

pathic and conventional treatment groups

improved similarly over a 12-month period but

as this was a observational study of a cohort

there was no control group and no placebo.

A migraine study18 showed improvement forpatients seeking homeopathic relief but the study

was designed to observe real-life conditions and

did not aim to determine the specific effect of a

homeopathic remedy. The study was also not

designed to measure the placebo effect.

The fifth study from the Institute for Social

Medicine, Epidemiology and Health Economics;

Charite University Medical Center; D-10098Berlin, Germany, concluded that while their

results confirm the toxicological and clinical

effects of Galphimia glauca compared to placebo,

the ICCH criteria for proving symptoms were not

suitable to distinguish between specific and

unspecific symptoms.

The work of Bell et al.19,20 explores the role of

electroencephalography (EEG) as a sensitive toolfor measuring the specific changes due to the

administration of homeopathic remedies.

Walach et al. take the most direct approach to

the question of specific vs. non-specific symptoms

of homeopathy. The 2001 study of the effects of

homeopathic Belladonna 30CH in healthy volun-

teers21 tested the hypothesis that symptoms pat-

terns are due to specific effects of a homeopathicremedy but found no indication that Belladonna

30CH produces symptoms different from placebo.

This was followed in 2004 by a pilot study

using a small number of participants and the

remedy Cantharis22 showed that homeopathic

proving symptoms appeared to be specific but

the trial needed replication. This was achieved

in 200823 and 200924 when they used a three-armed, double-blind, placebo-controlled rando-

mized study design in which volunteers took

either one of two homoeopathic remedies,

Natrum muriaticum or Arsenicum album in

30CH or identical placebo. Their main outcome



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ring

cli-

mac

teri

cye

ars

byho

meo

path

icth

erap

y.

Nay

akC

,Sin

ghV,

Sin

ghK

,S

ingh

H,

Gup

taJ,

Lam

baC

D,

Sha

rma

A,

Sha

rma

B,

Indi

raB

,B

huva

nesh

war

iS

,B

indr

aS

K,

Luxm

iK

S.

JA

ltern

Com

plem

ent

Med

.20

11N

ov;1

7(11

):103

7–42

.P

MID

:22

0876

13[P

ubM

ed–

inde

xed

for

MED

LIN

E]

An

open

,mul

ticen

tre,

pros

pect

ive,

obse

rvat

iona

lstu

dyw

asca

rrie

dou

tto

asce

rtai

nth

eus

eful

ness

ofho

meo

path

ictr

eatm

ent

indi

stre

ssdu

ring

clim

acte

ric

year

s(D

DC

Y).

Pat

ient

sw

ere

enro

lled

from

the

gene

ral

outp

atie

ntde

part

-m

ent

ofth

esi

xIn

stitu

tes/

Uni

tsof

Cen

tral

Cou

ncil

for

Res

earc

hin

Hom

oeop

athy

(CC

RH

)an

dw

ere

requ

ired

toco

mpl

ete

afo

llow

-up

peri

odof

one

year

aspe

rth

epr

otoc

olde

sign

edby

the

CC

RH

.A

unifo

rmqu

estio

nnai

reas

sess

ing

15pr

edef

ined

sym

ptom

sof

men

opau

sew

asad

opte

d,w

ithas

sess

men

tof

each

sym

ptom

atev

ery

visi

t.Le

vels

ofse

rum

FSH

and

lipid

prof

ilew

ere

mon

itore

dat

entr

yan

dat

com

-pl

etio

n.Ef

fect

size

ofth

est

udy

was

also

calc

ulat

ed.

CA

RA

Sof

twar

ew

asus

edfo

rre

pert

oriz

atio

nof

the

pres

entin

gsy

mpt

oms

ofm

enop

ause

alon

gw

ithth

ech

arac

teri

stic

attr

ibut

esof

each

patie

ntto

arri

veat

asi

mill

imum

.Th

ese

lect

edm

edic

ine

was

pres

crib

edin

asi

ngle

dose

aspe

rth

eho

meo

path

icpr

inci

ples

.Th

eas

sess

men

tof

the

resu

ltsw

asm

ade

thro

ugh

stat

istic

alan

alys

isus

ing

the

Wilc

oxon

sign

ed-r

ank

test

onS

tatis

tical

Pac

kage

for

Soc

ialS

cien

ces

(SP

SS

)co

mpa

ring

sym

ptom

scor

eat

entr

yan

dco

mpl

etio

nof

one

year

oftr

eatm

ent

and

tte

stfo

ran

alys

ing

impr

ove-

men

tin

labo

rato

ryfin

ding

s.

No

Mea

suri

ngth

eef

fect

iven

ess

ofho

meo

path

icca

reth

roug

hob

ject

ive

and

shar

edin

dica

tors

.

Leon

eL,

Mar

chiti

ello

M,

Nat

illi

M,

Rom

ano

MF.

Hom

eopa

thy.

2011

Oct

;100

(4):2

12–1

9.P

MID

:21

9621

95[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Indi

cato

rsof

hosp

italis

atio

nan

ddr

ugus

ew

ere

obta

ined

from

the

Hea

lthS

tatis

tical

Doc

umen

tatio

nS

yste

mof

Tusc

any

for

two

hom

eopa

thic

cent

res

inth

eLo

cal

Hea

lthA

utho

rity

ofP

isa,

Ital

y.C

ompa

red

hom

eopa

thic

user

sw

ithth

ege

nera

lpo

pula

tion

inth

esa

me

area

and

byco

mpa

ring

patie

nts

befo

rean

daf

ter

hom

eopa

thic

trea

tmen

t.

Yes

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

An

expl

orat

ory

stud

yon

scie

ntifi

cin

vest

igat

ions

inho

meo

path

yus

ing

med

ical

anal

yzer

.

Mis

hra

N,

Mur

alee

dhar

anK

C,

Par

anjp

eA

S,

Mun

taD

K,

Sin

ghH

,N

ayak

C.

JA

ltern

Com

plem

ent

Med

.20

11A

ug;1

7(8)

:705

–10.

PM

ID:

2178

7219

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Pre

-an

dpo

stin

terv

entio

nal

vari

abili

tysp

ectr

aof

hear

tra

tean

dbl

ood

flow

of77

subj

ects

wer

ere

cord

edw

ithth

eM

edic

alA

naly

zer

Sys

tem

,ad

min

iste

ring

hom

eopa

thic

prep

arat

ions

ofA

coni

tum

nape

llus

(6c,

10M

),A

rsen

icum

albu

m(2

00c,

1M

),G

else

miu

mse

mpe

rvir

ens

(200

c,1

M),

Pho

spho

rus

(200

c,1

M),

Pul

satil

lani

gric

ans

(200

c)an

dS

ulph

ur(2

00c,

1M

)ve

rsus

plac

ebo

cont

rol.

The

ampl

itude

ofth

epe

aks

viz.

low

-fre

quen

cy,

med

ium

-fre

quen

cy,

and

high

-fre

quen

cyw

asm

easu

red

for

post

inte

rven

tion

anal

ysis

.A

nin

crea

sein

the

ampl

itude

ofan

yva

lidpe

akby

100%

ora

decr

ease

by50

%w

asco

nsid

ered

assi

gnifi

cant

chan

ge.

No

The

feas

ibili

tyof

apr

agm

atic

rand

o-m

ised

cont

rolle

dtr

ialt

oco

mpa

reus

ual

care

with

usua

lca

repl

usin

divi

dua-

lised

hom

eopa

thy,

inch

ildre

nre

quir

ing

seco

ndar

yca

refo

ras

thm

a.

Thom

pson

EA,

Sha

wA

,N

icho

lJ,

Hol

lingh

urst

S,

Hen

ders

onA

J,Th

omps

onT,

Sha

rpD

.H

omeo

path

y.20

11Ju

l;100

(3):1

22–3

0.P

MID

:21

7843

28[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Ina

prag

mat

icpa

ralle

lgr

oup

rand

omis

edco

ntro

lled

tria

l(R

CT)

desi

gn,

child

ren

onst

ep2

orab

ove

ofth

eB

ritis

hTh

orac

icS

ocie

tyA

sthm

aG

uide

lines

(BTG

)w

ere

rand

omly

allo

cate

dto

UC

orU

Cpl

usa

five

visi

tpa

ckag

eof

hom

eo-

path

icca

re(H

C).

Out

com

em

easu

res

incl

uded

the

Juni

per

Ast

hma

Con

trol

Que

stio

nnai

re,Q

ualit

yof

Life

Que

stio

nnai

rean

da

reso

urce

use

ques

tionn

aire

.Q

ualit

ativ

ein

terv

iew

sw

ere

used

toga

infa

mili

es’a

ndhe

alth

prof

essi

onal

s’vi

ews

and

expe

rien

ces.

No

Hom

eopa

thic

Plu

mbu

mm

etal

licum

for

lead

pois

onin

g:a

rand

omiz

edcl

inic

altr

ial.

Pad

ilha

RQ

,R

iera

R,

Ata

llah

AN

.H

omeo

path

y.20

11Ju

l;100

(3):1

16–2

1.P

MID

:21

7843

27[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Dou

ble-

blin

dra

ndom

ized

tria

l.N

o

Hom

eopa

thic

ear

drop

sas

anad

junc

tto

stan

dard

ther

apy

inch

ildre

nw

ithac

ute

otiti

sm

edia

.

Tayl

orJA

,Ja

cobs

J.H

omeo

path

y.20

11Ju

l;100

(3):1

09–1

5.P

MID

:21

7843

26[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Chi

ldre

nw

ithA

OM

wer

een

rolle

din

the

stud

yat

the

time

ofdi

agno

sis

and

rand

omis

edto

rece

ive

eith

erst

anda

rdth

er-

apy

alon

eor

stan

dard

ther

apy

plus

aho

meo

path

icea

rdr

opso

lutio

nth

atw

asto

beus

edon

asne

eded

basi

sfo

rup

tofiv

eda

ys.P

aren

tsof

child

ren

inbo

thtr

eatm

entg

roup

sra

ted

the

seve

rity

of5

AO

Msy

mpt

oms

twic

eda

ilyfo

rfiv

eda

ysin

asy

mpt

omdi

ary.

Asy

mpt

omsc

ore

was

com

pute

dfo

rea

chas

sess

men

tw

ithlo

wer

scor

esde

notin

gle

ssse

vere

sym

p-to

ms.

Par

ents

ofch

ildre

nra

ndom

ised

tore

ceiv

eea

rdr

ops

also

reco

rded

info

rmat

ion

rega

rdin

gsy

mpt

oms

bein

gtr

ea-

ted

and

resp

onse

totr

eatm

ent.

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

An

initi

alre

port

onth

eef

ficac

yof

am

illes

imal

pote

ncy

Ars

enic

umA

lbum

LM0/

3in

amel

iora

ting

arse

nic

toxi

city

inhu

man

sliv

ing

ina

high

-ris

kar

seni

cvi

llage

.

Khu

da-B

ukhs

hA

R,

Ban

erje

eA

,B

isw

asS

J,K

arm

akar

SR

,B

aner

jee

P,P

atha

kS

,G

uha

B,

Haq

ueS

,D

asD

,D

eA

,D

asD

,B

ouje

dain

iN

.X

iZ,

He

YJan

dB

aoX

.20

11Ju

n;9(

6):5

96–6

04.

PM

ID:

2166

9162

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

This

stud

yw

asca

rrie

dou

ton

volu

ntee

rsliv

ing

inan

arse

nic-

affe

cted

villa

gew

here

noar

seni

c-fr

eedr

inki

ngw

ater

isav

aila

ble.

Twen

ty-e

ight

volu

ntee

rsfr

omth

evi

llage

ofD

asdi

ya,

inH

arin

ghat

abl

ock

unde

rN

adia

Dis

tric

t,W

est

Ben

gal,

Indi

a,an

arse

nic-

cont

amin

ated

villa

gew

here

wel

lsco

ntai

n55

to95m

g/L

arse

nic,

wer

ese

lect

edto

unde

rtak

ea

doub

le-b

lind

and

plac

ebo-

cont

rolle

dtr

ial.

The

subj

ects

prov

ided

sam

ples

ofbl

ood

and

urin

ebe

fore

and

afte

rtw

om

onth

sof

taki

ngei

ther

‘ver

um’

or‘p

lace

bo’.

Ano

ther

18su

bjec

tsliv

ing

inan

arse

nic-

free

villa

gese

rved

asth

ene

gativ

eco

ntro

ls.

Yes

Pul

pade

ntis

D30

for

acut

ere

vers

ible

pulp

itis:

apr

ospe

ctiv

eco

hort

stud

yin

rout

ine

dent

alpr

actic

e.

Ham

reH

J,M

ittag

I,G

lock

man

nA

,K

iene

H,

Trog

erW

.A

ltern

Ther

Hea

lthM

ed.

2011

Jan–

Feb;

17(1

):16–

21.

PM

ID:

2161

4940

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Pro

spec

tive,

obse

rvat

iona

l,op

en-l

abel

,si

ngle

-arm

coho

rtst

udy.

No

Hom

eopa

thy

for

depr

essi

on–

DEP

-H

OM

:stu

dypr

otoc

olfo

ra

rand

omiz

ed,

part

ially

doub

le-b

lind,

plac

ebo

con-

trol

led,

four

arm

edst

udy.

Adl

erU

C,

Kru

ger

S,

Teut

M,

Ludt

keR

,B

arts

chI,

Sch

utzl

erL,

Mel

cher

F,W

illic

hS

N,

Lind

eK

,W

ittC

M.

Tria

ls.2

011

Feb

14;1

2(1)

:43.

PM

ID:

2132

0338

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ara

ndom

ised

,pa

rtia

llydo

uble

-blin

d,pl

aceb

o-co

ntro

lled,

four

-arm

edtr

ial

usin

ga

2�

2fa

ctor

ial

desi

gnw

itha

six-

wee

kst

udy

dura

tion

per

patie

ntw

illbe

perf

orm

ed.

228

patie

nts

diag

nose

dw

ithm

ajor

depr

essi

on(m

oder

ate

epi-

sode

)by

aps

ychi

atri

stw

illbe

incl

uded

.Th

epr

imar

yen

d-po

int

isth

eto

tal

scor

eon

the

17-i

tem

Ham

ilton

Dep

ress

ion

Rat

ing

Sca

leaf

ter

six

wee

ks.

Sec

onda

ryen

dpo

ints

are:

Ham

ilton

Dep

ress

ion

Rat

ing

Sca

leto

tals

core

afte

rtw

oan

dfo

urw

eeks

;res

pons

ean

dre

mis

sion

rate

s,B

eck

Dep

ress

ion

inve

ntor

yto

tal

scor

e,qu

ality

oflif

ean

dsa

fety

attw

o,fo

uran

dsi

xw

eeks

.S

tatis

tical

anal

yses

will

beby

inte

ntio

n-to

-tr

eat.

The

mai

nen

dpoi

ntw

illbe

anal

ysed

bya

two-

fact

oria

lan

alys

isof

cova

rian

ce.

With

inth

ism

odel

gene

ralis

edes

ti-m

atio

neq

uatio

nsw

illbe

used

toes

timat

edi

ffer

ence

sbe

twee

nve

rum

and

plac

ebo,

and

betw

een

both

type

sof

case

hist

ory.

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

Hom

eopa

thy

has

clin

ical

bene

fits

inrh

eum

atoi

dar

thri

tispa

tient

sth

atar

eat

trib

utab

leto

the

cons

ulta

tion

pro-

cess

but

not

the

hom

eopa

thic

rem

edy:

ara

ndom

ized

cont

rolle

dcl

inic

altr

ial.

Bri

enS

,La

chan

ceL,

Pre

scot

tP,

McD

erm

ott

C,

Lew

ithG

.R

heum

atol

ogy

(Oxf

ord)

.20

11Ju

n;50

(6):1

070–

82.

Epub

2010

Nov

13.

PM

ID:

2107

6131

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Expl

orat

ory

doub

le-b

lind,

rand

omis

edpl

aceb

o-co

ntro

lled

tria

lco

nduc

ted

from

Janu

ary

2008

toJu

ly20

08,

inpa

tient

sw

ithac

tive

stab

leR

Are

ceiv

ing

conv

entio

nal

ther

apy.

Eigh

ty-t

hree

part

icip

ants

from

thre

ese

cond

ary

care

UK

outp

atie

ntcl

inic

sw

ere

rand

omiz

edto

24w

eeks

oftr

eatm

ent

with

eith

erho

meo

path

icco

nsul

tatio

n(f

urth

erra

ndom

ized

toin

divi

dual

ized

hom

eopa

thy,

com

plex

hom

eopa

thy

orpl

a-ce

bo)

orno

n-ho

meo

path

icco

nsul

tatio

n(f

urth

erra

ndom

ized

toco

mpl

exho

meo

path

yor

plac

ebo)

.Co-

prim

ary

outc

omes

:A

CR

20%

impr

ovem

ent

(AC

R20

)cr

iteri

aan

dpa

tient

mon

thly

glob

alas

sess

men

t(G

A).

Sec

onda

ryou

tcom

es:2

8-jo

int

DA

S(D

AS

-28)

,te

nder

and

swol

len

join

tco

unt,

dise

ase

seve

rity

,pa

in,

wee

kly

patie

ntan

dph

ysic

ian

GA

and

pain

,an

din

flam

mat

ory

mar

kers

.

No

Effe

cts

ofho

meo

path

icm

edic

ines

onpo

lyso

mno

grap

hic

slee

pof

youn

gad

ults

with

hist

orie

sof

coff

ee-r

elat

edin

som

nia.

Bel

lIR

,H

ower

ter

A,

Jack

son

N,

Aic

kin

M,

Bal

dwin

CM

,B

ootz

inR

R.

Sle

epM

ed.

2011

May

;12(

5):5

05–1

1.Ep

ub20

10Ju

l29

.P

MID

:20

6736

48[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Youn

gad

ults

ofbo

thse

xes

(age

s18

–31)

with

abov

e-av

erag

esc

ores

onst

anda

rdiz

edpe

rson

ality

scal

esfo

rei

ther

cyni

cal

host

ility

oran

xiet

yse

nsiti

vity

(but

not

both

)an

da

hist

ory

ofco

ffee

-ind

uced

inso

mni

apa

rtic

ipat

edin

the

mon

th-l

ong

stud

y.A

t-ho

me

poly

som

nogr

aphi

cre

cord

ings

wer

eob

tain

edon

succ

essi

vepa

irs

ofni

ghts

once

per

wee

kfo

ra

tota

lof

eigh

tre

cord

ings

(nig

hts

1,2,

8,9,

15,

16,

22,

23).

Sub

ject

s(N¼

54)

rece

ived

plac

ebo

pelle

tson

nigh

t8

(sin

gle-

blin

d)an

dve

rum

pelle

tson

nigh

t22

(dou

ble-

blin

d)in

30c

dose

sof

one

oftw

oho

meo

path

icre

med

ies,

Nux

Vom

ica

orC

offe

aC

ruda

.S

ubje

cts

com

plet

edda

ilym

orni

ngsl

eep

diar

ies

and

wee

kly

Pitt

sbur

ghsl

eep

qual

ityin

dex

scal

es,

asw

ell

aspr

ofile

ofm

ood

stat

essc

ales

atbe

dtim

eon

poly

som

nogr

aphy

nigh

ts.

No

Pro

toco

lfo

ra

phas

e1

hom

eopa

thic

drug

prov

ing

tria

l.Te

utM

,H

irsc

hber

gU

,Lu

edtk

eR

,S

chne

ggC

,D

ahle

rJ,

Alb

rech

tH

,W

ittC

M.

Tria

ls.

2010

Jul

22;1

1:80

.P

MID

:20

6499

79[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Mul

ti-ce

ntre

,ra

ndom

ised

,do

uble

-blin

d,pl

aceb

o-co

ntro

lled

phas

e1

tria

lwith

30he

alth

yvo

lunt

eers

.The

stud

yco

nsis

tsof

ase

ven

day

run-

inpe

riod

,a

five-

day

inte

rven

tion

peri

odan

da

16-d

aypo

st-i

nter

vent

ion

obse

rvat

ion

peri

od.S

ubje

cts,

inve

stig

ator

san

dth

est

atis

ticia

nsar

ebl

inde

dfr

omth

eal

loca

tion

toth

est

udy

arm

and

from

the

iden

tity

ofth

eho

meo

path

icdr

ug.

The

inte

rven

tion

isa

high

lydi

lute

dho

meo

path

icdr

ug(p

oten

cyC

12¼

1024

),D

ose:

five

glob

ules

take

nfiv

etim

espe

rda

yov

era

max

imum

peri

odof

five

days

.

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

The

plac

ebo

cons

ists

ofan

optic

ally

iden

tical

carr

ier

sub-

stan

ce(s

ucro

segl

obul

es).

Sub

ject

sdo

cum

ent

the

sym

p-to

ms

they

expe

rien

cein

ase

mi-

stru

ctur

edon

line

diar

y.Th

epr

imar

you

tcom

epa

ram

eter

isth

enu

mbe

rof

spec

ific

sym

ptom

sth

atch

arac

teri

seth

ein

terv

entio

nco

mpa

red

toth

epl

aceb

oaf

ter

ape

riod

ofth

ree

wee

ks.

Sec

onda

ryou

t-co

me

para

met

ers

are

qual

itativ

edi

ffer

ence

sin

prof

iles

ofch

arac

teri

stic

and

prov

ing

sym

ptom

san

dth

eto

tal

num

ber

ofal

lpr

ovin

gsy

mpt

oms.

The

num

ber

ofsy

mpt

oms

will

bequ

antit

ativ

ely

anal

ysed

onan

inte

ntio

n-to

-tre

atba

sis

usin

gA

NC

OV

Aw

ithth

esu

bjec

t’sex

pect

atio

nan

dba

selin

eva

lues

asco

vari

ates

.C

onte

ntan

alys

isac

cord

ing

toM

ayri

ngis

adap

ted

tosu

itth

eho

meo

path

icqu

alita

tive

anal

ysis

proc

edur

e.

Hom

eopa

thic

trea

tmen

tof

patie

nts

with

mig

rain

e:a

pros

pect

ive

obse

rva-

tiona

lst

udy

with

a2-

year

follo

w-u

ppe

riod

.

Witt

CM

,Lu

dtke

R,

Will

ich

SN

.J

Alte

rnC

ompl

emen

tM

ed.

2010

Apr

;16(

4):3

47–5

5.P

MID

:20

4232

06[P

ubM

ed–

inde

xed

for

MED

LIN

E]

This

was

apr

ospe

ctiv

em

ultic

ente

rob

serv

atio

nal

stud

y.C

onse

cutiv

epa

tient

sbe

ginn

ing

hom

eopa

thic

trea

tmen

tin

prim

ary

care

prac

tices

wer

eev

alua

ted

over

two

year

sus

ing

stan

dard

ized

ques

tionn

aire

s.Th

eda

tare

cord

edin

clud

eddi

agno

ses

(Int

erna

tiona

lC

lass

ifica

tion

ofD

isea

ses,

Nin

thR

evis

ion)

and

curr

ent

com

plai

nts,

incl

udin

gth

eir

seve

rity

(num

eric

ratin

gsc

ale¼

0–10

),he

alth

-rel

ated

qual

ityof

life

(QoL

,36

-ite

mS

hort

-For

mH

ealth

Sur

vey)

,m

edic

alhi

stor

y,co

nsul

tatio

ns,

hom

eopa

thic

and

conv

entio

nal

trea

tmen

ts,

asw

ell

asot

her

heal

thse

rvic

eus

e.

No

Trau

mee

lS

for

pain

relie

ffo

llow

ing

hallu

xva

lgus

surg

ery:

ara

ndom

ized

cont

rolle

dtr

ial.

Sin

ger

SR

,A

mit-

Koh

nM

,W

eiss

S,

Ros

enbl

umJ,

Mao

zG

,S

amue

lsN

,Lu

kasi

ewic

zE,

Free

dman

L,P

altie

lO

,It

zcha

kiM

,N

iska

M,

Obe

rbau

mM

.B

MC

Clin

Pha

rmac

ol.2

010

Apr

12;1

0:9.

PM

ID:

2038

0750

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

We

perf

orm

eda

rand

omiz

ed,

doub

le-b

lind,

plac

ebo-

con-

trol

led

tria

lto

eval

uate

the

effic

acy

ofth

eho

meo

path

icpr

epar

atio

nTr

aum

eel

Sin

min

imis

ing

post

-ope

rativ

epa

inan

dan

alge

sic

cons

umpt

ion

follo

win

gsu

rgic

alco

rrec

tion

ofha

llux

valg

us.E

ight

yco

nsec

utiv

epa

tient

sw

ere

rand

omiz

edto

rece

ive

eith

erTr

aum

eel

tabl

ets

oran

indi

stin

guis

habl

epl

aceb

o,an

dto

okpr

imar

yan

dre

scue

oral

anal

gesi

csas

need

ed.

Max

imum

num

eric

alpa

insc

ores

atre

stan

dco

n-su

mpt

ion

ofor

alan

alge

sics

wer

ere

cord

edon

day

ofsu

r-ge

ryan

dfo

r13

days

follo

win

gsu

rger

y.

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

No

effe

ctof

aho

moe

opat

hic

com

bin-

atio

nof

Arn

ica

mon

tana

and

Bry

onia

alba

onbl

eedi

ng,

infla

mm

atio

n,an

dis

chae

mia

afte

rao

rtic

valv

esu

rger

y.

Cor

nuC

,Jos

eph

P,G

ailla

rdS

,B

auer

C,

Ved

rinn

eC

,B

isse

ryA

,M

elot

G,

Bos

sard

N,

Bel

onP,

Leho

tJJ

.B

rJ

Clin

Pha

rmac

ol.

2010

Feb;

69(2

):136

–42.

PM

ID:

2023

3176

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

One

day

befo

resu

rger

y,92

adul

tpa

tient

sw

ere

rand

omly

assi

gned

toa

doub

le-b

lind

para

llel

tria

lw

ithei

ther

hom

-oe

opat

hic

gran

ules

ora

mat

chin

gpl

aceb

oun

til4

days

afte

rsu

rger

y.Th

epr

imar

you

tcom

ew

asth

evo

lum

eof

bloo

d/liq

uid

inth

edr

ains

atth

eir

rem

oval

.Th

ese

cond

ary

out-

com

esin

clud

edpo

stop

erat

ive

bloo

d/liq

uid

loss

esat

12an

d24

has

wel

las

C-r

eact

ive

prot

ein

(CR

P),

pain

,te

mpe

ratu

rean

dpl

asm

atr

opon

inIc

.

No

Hom

eopa

thic

trea

tmen

tof

elde

rly

patie

nts

–a

pros

pect

ive

obse

rvat

iona

lst

udy

with

follo

w-u

pov

era

two

year

peri

od.

Teut

M,

Ludt

keR

,S

chna

bel

K,

Will

ich

SN

,W

ittC

M.

BM

CG

eria

tr.

2010

Feb

22;1

0:10

.P

MID

:20

1758

87[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Inth

issu

bgro

upan

alys

isof

apr

ospe

ctiv

e,m

ultic

entr

eco

hort

stud

yto

tally

incl

udin

g39

81pa

tient

str

eate

dby

hom

eopa

thic

phys

icia

nsin

prim

ary

care

prac

tices

inG

erm

any

and

Sw

itzer

land

,da

taw

asan

alys

edfr

omal

lpa

tient

s>

70ye

ars

cons

ultin

gth

eph

ysic

ian

for

the

first

time.

The

mai

nou

tcom

em

easu

res

wer

e:as

sess

men

tby

patie

ntof

the

seve

rity

ofco

mpl

aint

s(n

umer

icra

ting

scal

es)

and

qual

ityof

life

(SF-

36)a

ndby

the

phys

icia

nof

the

seve

rity

ofdi

agno

ses

(num

eric

ratin

gsc

ales

)atb

asel

ine,

and

afte

r3,

12,

and

24m

onth

s.

No

Chr

onic

prim

ary

inso

mni

a:ef

ficac

yof

hom

eopa

thic

sim

illim

um.

Nau

deD

F,S

teph

anie

Cou

chm

anIM

,M

ahar

ajA

.

Hom

eopa

thy.

2010

Jan;

99(1

):63–

8.Er

ratu

min

:H

omeo

path

y.20

10A

pr;9

9(2)

:151

.P

MID

:20

1291

78[P

ubM

ed–

inde

xed

for

MED

LIN

E]

30pa

rtic

ipan

tsw

ere

sele

cted

inac

cord

ance

with

DS

M-I

VTR

(200

0)(1

)cr

iteri

on30

7.42

Pri

mar

yIn

som

nia

and

then

rand

omly

divi

ded

betw

een

trea

tmen

tan

dpl

aceb

ogr

oups

.Th

em

easu

rem

ent

tool

sus

edw

ere

aS

leep

Dia

ry(S

D)

and

the

Sle

epIm

pair

men

tIn

dex

(SII

).(2

)A

fter

anin

itial

con-

sulta

tion,

two

follo

w-u

pco

nsul

tatio

nsat

two-

wee

kin

terv

als

took

plac

e.H

omeo

path

icm

edic

atio

nw

aspr

escr

ibed

atth

efir

stan

dse

cond

cons

ulta

tions

.Th

eS

IIw

asco

mpl

eted

atea

chco

nsul

tatio

nan

dpa

rtic

ipan

tsw

ere

inst

ruct

edat

the

first

cons

ulta

tion

tost

art

the

SD

.

No

[Eff

ectiv

enes

sof

acl

assi

cal

hom

eo-

path

ictr

eatm

ent

inat

opic

ecze

ma.

Ara

ndom

ised

plac

ebo-

cont

rolle

ddo

uble

-blin

dcl

inic

altr

ial].

Sie

benw

irth

J,Lu

dtke

R,

Rem

yW

,Rak

oski

J,B

orel

liS

,R

ing

J.Fo

rsch

Kom

plem

entm

ed.

2009

Oct

;16(

5):3

15–2

3.Ep

ub20

09S

ep3.

Ger

man

.P

MID

:19

8878

10[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Sin

gle-

cent

re,

rand

omis

ed,

doub

le-b

lind

clin

ical

tria

lco

m-

pari

ngho

meo

path

icre

med

ies

with

plac

ebo

inyo

ung

adul

ts(a

ge18

–35)

with

atop

icde

rmat

itis.

Hom

eopa

thic

rem

edie

sw

ere

indi

vidu

ally

adm

inis

tere

dac

cord

ing

toth

eru

les

ofcl

assi

calh

omeo

path

y.A

fter

anun

trea

ted

base

line

peri

odof

four

wee

ks,

all

patie

nts

wer

etr

eate

dan

dm

onito

red

for

32w

eeks

.Thr

ough

outt

hest

udy,

co-m

edic

atio

nw

asal

low

ed

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

only

with

indi

ffer

ent

emol

lient

s.Th

em

ain

outc

ome

para

m-

eter

was

dise

ase

seve

rity

asas

sess

edby

Cos

taan

dS

aura

t’sm

ulti-

para

met

erat

opic

derm

atiti

ssc

ore

(MP

-sc

ore)

.

Hom

oeop

athi

cve

rsus

conv

entio

nal

ther

apy

for

atop

icec

zem

ain

child

ren:

med

ical

and

econ

omic

resu

lts.

Witt

CM

,B

rink

haus

B,

Pac

hD

,Rei

nhol

dT,

Wru

ckK

,R

oll

S,

Jack

elT,

Sta

abD

,W

egsc

heid

erK

,W

illic

hS

N.

Der

mat

olog

y.20

09;2

19(4

):329

–40.

Epub

2009

Oct

13.

PM

ID:

1982

8937

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ina

pros

pect

ive

mul

ticen

tre

com

para

tive

obse

rvat

iona

lno

n-ra

ndom

ised

stud

y,13

5ch

ildre

n(h

omeo

path

yn¼

48vs

.co

nven

tiona

ln¼

87)

with

mild

tom

oder

ate

atop

icec

zem

aw

ere

incl

uded

.Th

epr

imar

you

tcom

ew

asth

eS

CO

RA

D(S

cori

ngA

topi

cD

erm

atiti

s)at

6m

onth

s.Fu

rthe

rou

tcom

esat

six

and

12m

onth

sal

soin

clud

edqu

ality

oflif

eof

pare

nts

and

child

ren,

use

ofco

nven

tiona

lm

edic

ine,

trea

tmen

tsa

fety

and

dise

ase-

rela

ted

cost

s.

No

Effe

ctiv

enes

sof

the

hom

eopa

thic

prep

arat

ion

Neu

rexa

nco

mpa

red

with

that

ofco

mm

only

used

vale

rian

-bas

edpr

epar

atio

nsfo

rth

etr

eatm

ent

ofne

r-vo

usne

ss/r

estle

ssne

ss–

anob

serv

a-tio

nal

stud

y.

Hub

ner

R,

van

Has

elen

R,

Kle

inP.

Sci

entif

icW

orld

Jour

nal.

2009

Aug

11;9

:733

–45.

PM

ID:

1970

5035

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Apr

ospe

ctiv

e,no

nran

dom

ized

,no

nint

erve

ntio

nal,

obse

rva-

tiona

lst

udy,

usin

gco

nven

tiona

lor

CA

Mpr

actic

es,

was

cond

ucte

din

49G

erm

anpr

actic

es.

Each

prac

tice

coul

din

clud

eup

to15

subj

ects

trea

ted

with

eith

erth

eho

meo

-pa

thic

prep

arat

ion

Neu

rexa

nor

with

com

bina

tion

form

ula-

tions

base

don

vale

rian

extr

acts

.Th

ere

was

nopl

aceb

ogr

oup.

No

Hom

eopa

thic

trea

tmen

tof

min

orap

h-th

ous

ulce

r:a

rand

omiz

ed,

plac

ebo-

cont

rolle

dcl

inic

altr

ial.

Mou

savi

F,M

ojav

erYN

,A

sadz

adeh

M,

Mir

zaza

deh

M.

Hom

eopa

thy.

2009

Jul;9

8(3)

:137

–41.

PM

ID:

1964

7206

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ara

ndom

ized

,si

ngle

blin

d,pl

aceb

o-co

ntro

lled

clin

ical

tria

lof

indi

vidu

alis

edho

meo

path

y.O

nehu

ndre

dpa

tient

sw

ithm

inor

apht

hous

ulce

rw

ere

trea

ted

with

indi

vidu

alis

edho

meo

path

icm

edic

ines

orpl

aceb

oan

dfo

llow

edup

for

six

days

.P

atie

nts

rece

ived

two

dose

sof

indi

vidu

alis

edho

meo

path

icm

edic

ines

inth

e6

Cpo

tenc

yas

oral

liqui

dat

base

line

and

12h

late

r.P

ain

inte

nsity

and

ulce

rsi

zew

ere

reco

rded

atba

selin

edu

ring

and

atth

een

dof

the

tria

l(m

orni

ngs

ofda

ys4

and

6).

No

Mon

thly

itrac

onaz

ole

vers

uscl

assi

cho

meo

path

yfo

rth

etr

eatm

ent

ofre

curr

ent

vulv

ovag

inal

cand

idia

sis:

ara

ndom

ised

tria

l.

Witt

A,

Kau

fman

nU

,B

itsch

nau

M,

Tem

pfer

C,

Ozb

alA

,H

ayto

uglu

E,G

rego

rH

,K

iss

H.

BJO

G.

2009

Oct

;116

(11)

:149

9–50

5.Ep

ub20

09Ju

l7.

PM

ID:

1958

3713

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Wom

enw

ere

rand

omis

edin

toth

ree

grou

ps:

itrac

onaz

ole

with

lact

obac

illi

(gro

up1)

,itr

acon

azol

ew

ithou

tla

ctob

acill

i(g

roup

2)an

dC

H(g

roup

3).I

trac

onaz

ole

trea

tmen

tof

acut

ein

fect

ion

was

follo

wed

bya

6-m

onth

mai

nten

ance

regi

men

with

mon

thly

sing

le-d

ayitr

acon

azol

e(2

00m

gbi

d).W

omen

ingr

oup

1w

ere

give

nad

ditio

nalv

agin

alla

ctob

acill

ifor

6da

yspe

rm

onth

thro

ugho

utth

em

aint

enan

cere

gim

enTh

erea

fter

,pa

tient

sw

ere

follo

wed

with

out

trea

tmen

tfo

rsi

xm

onth

s.C

Htr

eatm

ent

was

perf

orm

edfo

r12

mon

ths

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

Hom

eopa

thic

path

ogen

etic

tria

lspr

o-du

cesp

ecifi

csy

mpt

oms

diff

eren

tfr

ompl

aceb

o.

Mol

linge

rH

,S

chne

ider

R,

Wal

ach

H.

Fors

chK

ompl

emen

tmed

.20

09A

pr;1

6(2)

:105

–10.

Epub

2009

Apr

9.P

MID

:19

4209

56[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Thre

ear

med

,do

uble

-blin

d,pl

aceb

oco

ntro

lled

rand

omis

edex

peri

men

tal

path

ogen

etic

stud

yin

25he

alth

yvo

lunt

eers

who

took

eith

eron

eof

two

hom

eopa

thic

rem

edie

s,N

atru

mm

uria

ticum

and

Ars

enic

umal

bum

in30

CH

orid

entic

alpl

a-ce

bo.M

ain

outc

ome

para

met

erw

asth

enu

mbe

rof

rem

edy-

spec

ific

sym

ptom

spe

rgr

oup.

No

Hea

lthca

repr

ovid

edby

aho

meo

path

asan

adju

nct

tous

ual

care

for

Fibr

omya

lgia

(FM

S):

resu

ltsof

api

lot

Ran

dom

ised

Con

trol

led

Tria

l.

Rel

ton

C,

Sm

ithC

,R

awJ,

Wal

ters

C,

Ade

bajo

AO

,Th

omas

KJ,

Youn

gTA

.H

omeo

path

y.20

09A

pr;9

8(2)

:77–

82.

PM

ID:

1935

8959

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ina

prag

mat

icpa

ralle

lgr

oup

RC

Tde

sign

,ad

ults

with

adi

agno

sis

ofFM

S(A

CR

crite

ria)

wer

era

ndom

lyal

loca

ted

tous

ual

care

orus

ual

care

plus

adju

nctiv

eca

reby

aho

meo

-pa

th.

Adj

unct

ive

care

cons

iste

dof

five

inde

pth

inte

rvie

ws

and

indi

vidu

alis

edho

meo

path

icm

edic

ines

.Th

epr

imar

you

tcom

em

easu

rew

asth

edi

ffer

ence

inFi

brom

yalg

iaIm

pact

Que

stio

nnai

re(F

IQ)

tota

lsc

ore

at22

wee

ks.

No

Hom

eopa

thic

trea

tmen

tof

patie

nts

with

dysm

enor

rhea

:a

pros

pect

ive

obse

rvat

iona

lst

udy

with

2ye

ars

follo

w-u

p.

Witt

CM

,Lu

dtke

R,

Will

ich

SN

.A

rch

Gyn

ecol

Obs

tet.

2009

Oct

;280

(4):6

03–1

1.Ep

ub20

09Fe

b20

.P

MID

:19

2295

44[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Pro

spec

tive

mul

ticen

ter

obse

rvat

iona

lstu

dyin

prim

ary

care

,us

ing

stan

dard

ized

ques

tionn

aire

sto

reco

rdfo

rtw

oye

ars

dise

ases

,qu

ality

oflif

e,m

edic

alhi

stor

y,co

nsul

tatio

ns,

all

trea

tmen

ts,

othe

rhe

alth

serv

ices

use.

No

Igna

tiain

the

trea

tmen

tof

oral

liche

npl

anus

.M

ousa

viF,

She

rafa

tiS

,M

ojav

erYN

.H

omeo

path

y.20

09Ja

n;98

(1):4

0–4.

PM

ID:

1913

5958

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Inth

issi

ngle

blin

dra

ndom

ized

cont

rol

clin

ical

tria

l,30

cons

ecut

ive

patie

nts

with

oral

lesi

ons

cons

iste

ntcl

inic

ally

and

hist

olog

ical

lyw

ither

osiv

ean

d/or

atro

phic

OLP

wer

ere

crui

ted.

The

patie

nts

wer

era

ndom

lydi

vide

din

totw

ogr

oups

tore

ceiv

eIg

natia

orpl

aceb

o.Th

eyw

ere

trea

ted

for

four

mon

ths.

No

Eval

uatio

nof

the

qual

ityof

life

afte

rin

divi

dual

ized

hom

eopa

thic

trea

tmen

tfo

rse

ason

alal

lerg

icrh

initi

s.A

pro-

spec

tive,

open

,no

n-co

mpa

rativ

est

udy.

Goo

ssen

sM

,Lae

kem

anG

,A

ertg

eert

sB

,B

untin

xF;

AR

CH

stud

ygr

oup.

Hom

eopa

thy.

2009

Jan;

98(1

):11–

16.

PM

ID:

1913

5954

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Apr

ospe

ctiv

e,op

en,n

on-c

ompa

rativ

est

udy

was

cond

ucte

din

Bel

gium

.Pat

ient

sag

edbe

twee

n14

and

68ye

ars

with

SA

Rw

ere

trea

ted

byon

eof

seve

nho

meo

path

icph

ysic

ians

.P

atie

nts

com

plet

edth

eR

QLQ

atba

selin

ean

dag

ain

afte

rth

ree

and

four

wee

ksof

hom

eopa

thic

trea

tmen

t.

No

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

How

heal

thy

are

chro

nica

llyill

patie

nts

afte

rei

ght

year

sof

hom

eopa

thic

trea

tmen

t?–

Res

ults

from

alo

ngte

rmob

serv

atio

nal

stud

y.

Witt

CM

,Lu

dtke

R,

Men

gler

N,

Will

ich

SN

.B

MC

Pub

licH

ealth

.20

08D

ec17

;8:4

13.

PM

ID:

1909

1085

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ina

pros

pect

ive,

mul

ticen

tre

coho

rtst

udy

with

103

hom

eopa

thic

prim

ary

care

prac

tices

inG

erm

any

and

Sw

itzer

land

,dat

afr

omal

lpat

ient

s(a

ge>

1ye

ar)

cons

ultin

gth

eph

ysic

ian

for

the

first

time

wer

eob

serv

ed.

The

mai

nou

tcom

em

easu

res

wer

e:th

epa

tient

s’pe

rcei

ved

chan

gein

com

plai

ntse

veri

ty(n

umer

icra

ting

scal

esfr

om0¼

noco

mpl

aint

to10¼

max

imal

seve

rity

)an

dqu

ality

oflif

eas

mea

sure

dby

the

SF-

36at

base

line,

and

afte

rtw

oan

dei

ght

year

s.

No

Aho

moe

opat

hic

prov

ing

ofG

alph

imia

glau

ca.

Teut

M,D

ahle

rJ,

Sch

negg

C;

Wils

ede

Stu

dyG

roup

for

Hom

oeop

athi

cP

rovi

ngs.

Fors

chK

ompl

emen

tmed

.20

08A

ug;1

5(4)

:211

–17.

Epub

2008

Aug

15.

PM

ID:

1878

7330

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Ran

dom

ised

,do

uble

-blin

d,pl

aceb

o-co

ntro

lled

tria

lw

itha

one-

wee

kba

selin

e,fo

ur-w

eek

prov

ing,

and

two-

wee

kpo

st-

obse

rvat

iona

lpe

riod

.S

ubje

cts:

15he

alth

yph

ysic

ians

and

med

ical

stud

ents

volu

ntee

red

aspr

over

s;11

wer

era

ndo-

mis

edto

veru

man

dfo

urto

plac

ebo.

Pro

ving

subs

tanc

e:ga

lphi

mia

glau

caC

12co

mpa

red

topl

aceb

o;m

axim

umin

take

offiv

eda

ys.

Out

com

em

easu

res:

prov

ing

sym

ptom

sac

cord

ing

toIC

CH

defin

ition

and

the

num

ber

ofpr

ovin

gsy

mpt

oms.

The

prov

ing

sym

ptom

sw

ere

anal

ysed

qual

ita-

tivel

yus

ing

the

Boe

nnin

ghau

sen

met

hod.

No

Hom

eopa

thic

path

ogen

etic

tria

lspr

o-du

cem

ore

spec

ific

than

non-

spec

ific

sym

ptom

s:re

sults

from

two

doub

le-

blin

dpl

aceb

oco

ntro

lled

tria

ls.

Wal

ach

H,

Mol

linge

rH

,S

herr

J,S

chne

ider

R.

JP

sych

opha

rmac

ol.

2008

Jul;2

2(5)

:543

–52.

PM

ID:

1870

1641

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

We

cond

ucte

dtw

opa

ralle

l,bl

inde

dho

meo

path

icpa

tho-

gene

tictr

ials

cond

ucte

dat

two

diff

eren

tsi

tes

tode

term

ine

whe

ther

sym

ptom

sre

port

edby

heal

thy

volu

ntee

rsw

ere

sign

ifica

ntly

diff

eren

tfo

rho

meo

path

icre

med

ies

than

for

plac

ebos

.S

tudy

1us

eda

two-

arm

edde

sign

,te

stin

goz

one

agai

nst

plac

ebo.

Stu

dy2

used

ath

ree-

arm

edde

sign

,tes

ting

ozon

ean

dir

idiu

mag

ains

tpl

aceb

o.

No

The

role

ofa

hom

oeop

athi

cpr

epar

-at

ion

com

pare

dw

ithco

nven

tiona

lth

erap

yin

the

trea

tmen

tof

inju

ries

:an

obse

rvat

iona

lco

hort

stud

y.

Sch

neid

erC

,Sch

neid

erB

,H

anis

chJ,

van

Has

elen

R.

Com

plem

ent

Ther

Med

.20

08Fe

b;16

(1):2

2–7.

Epub

2007

Jul

12.

PM

ID:

1834

6625

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

Mul

ti-ce

ntre

,pr

ospe

ctiv

e,co

mpa

rativ

eob

serv

atio

nal

coho

rtst

udy

ofpa

tient

sw

ithva

riou

sm

uscu

losk

elet

alin

ju-

ries

.G

erm

anph

ysic

ians

who

wer

eus

ing

hom

eopa

thy

inad

ditio

nto

conv

entio

nal

med

icin

ein

clud

edpa

tient

s.P

atie

nts

trea

ted

with

Trau

mee

lw

ere

com

pare

dw

ithpa

tient

sm

anag

edco

nven

tiona

lly.

The

prim

ary

outc

ome

mea

sure

was

the

rate

ofre

solu

tion

ofth

epr

inci

pal

sym

p-to

ms

(i.e.

pain

and

infla

mm

ator

ysy

mpt

oms)

atth

een

dof

ther

apy.

No

beca

use

ther

eco

uld

bea

plac

ebo

effe

ctin

both

grou

psso

ther

eis

noco

ntro

lfo

rpl

aceb

o

(continued)



Tabl

e1.

Con

tinu

ed.

Title

Aut

hors

and

refe

renc

eTr

ial

desi

gnN

on-t

reat

men

tgr

oup

used

asa

com

pari

son

Effe

ctof

hom

eopa

thy

onan

alge

sic

inta

kefo

llow

ing

knee

ligam

ent

reco

n-st

ruct

ion:

aph

ase

III

mon

ocen

tre

ran-

dom

ized

plac

ebo

cont

rolle

dst

udy.

Par

isA

,G

onne

tN

,C

haus

sard

C,

Bel

onP,

Roc

ourt

F,S

arag

aglia

D,

Cra

cow

ski

JL.

Br

JC

linP

harm

acol

.20

08Fe

b;65

(2):1

80–7

.P

MID

:18

2517

57[P

ubM

ed–

inde

xed

for

MED

LIN

E]

This

was

anad

d-on

rand

omiz

edco

ntro

lled

stud

yw

ithth

ree

para

llelg

roup

s:a

doub

le-b

lind

hom

eopa

thic

orpl

aceb

oar

man

dan

open

-lab

elno

nint

erve

ntio

nal

cont

rol

arm

.El

igib

lepa

tient

sw

ere

18–6

0ye

ars

old

cand

idat

esfo

rsu

rger

yof

the

ante

rior

cruc

iate

ligam

ent.

Trea

tmen

tw

asad

min

iste

red

the

even

ing

befo

resu

rger

yan

dco

ntin

ued

for

thre

eda

ys.

The

prim

ary

end-

poin

twas

cum

ulat

edm

orph

ine

inta

kede

liver

edby

PC

Adu

ring

the

first

24h

infe

rior

orsu

peri

or/e

qual

to10

mg

day(�

1).

Yes

The

effe

ctof

addi

ngho

meo

path

ictr

eatm

ent

tore

habi

litat

ion

onm

uscl

eto

neof

child

ren

with

spas

ticce

rebr

alpa

lsy.

Saj

edi

F,A

lizad

V,A

laed

dini

F,Fa

tem

iR

,M

azah

erin

ezha

dA

.C

ompl

emen

tTh

erC

linP

ract

.20

08Fe

b;14

(1):3

3–7.

Epub

2007

Dec

27.

PM

ID:

1824

3940

[Pub

Med

–in

dexe

dfo

rM

EDLI

NE]

This

stud

yw

asa

doub

le-b

lind

clin

ical

tria

l.Tw

enty

-fou

rsu

bjec

tsw

ere

recr

uite

dfr

oma

deve

lopm

enta

ldi

sord

ers

clin

icin

Tehr

anin

2004

.Sub

ject

sw

ere

divi

ded

into

case

and

cont

rol

grou

ps.

The

rout

ine

reha

bilit

atio

nte

chni

ques

wer

eca

rrie

dou

tfo

rfo

urm

onth

son

both

the

grou

ps.T

heco

ntro

lgr

oup

rece

ived

plac

ebo

and

the

case

grou

pre

ceiv

edho

m-

eopa

thy

drug

s.B

oth

grou

psw

ere

eval

uate

dan

dco

mpa

red

for

mus

cle

tone

befo

rean

dfo

urm

onth

saf

ter

trea

tmen

tus

ing

the

Mod

ified

Ash

wor

thS

cale

.

No

Trea

ting

hot

flush

esin

men

opau

sal

wom

enw

ithho

meo

path

ictr

eatm

ent

–re

sults

ofan

obse

rvat

iona

lst

udy.

Bor

det

MF,

Col

asA

,M

arijn

enP,

Mas

son

J,Tr

icha

rdM

.H

omeo

path

y.20

08Ja

n;97

(1):1

0–15

.P

MID

:18

1947

60[P

ubM

ed–

inde

xed

for

MED

LIN

E]

Ope

n,m

ulti-

natio

nal

pros

pect

ive,

prag

mat

ican

dno

n-co

m-

para

tive

obse

rvat

iona

lst

udy

ofho

meo

path

ictr

eatm

ents

pres

crib

edan

dth

eir

effe

ctiv

enes

s,ob

serv

ing

thei

rim

pact

onqu

ality

oflif

e.

No

Hom

otox

icol

ogic

alre

med

ies

vers

usde

smop

ress

inve

rsus

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.de

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ucsd

.edu

Inte

grC

ance

rTh

er.

2008

Sep

;7(3

):122

–9.

(continued)



parameter was the number of remedy-specific

symptoms per group. They concluded that

homeopathic remedies do produce different

symptoms from placebo.

The specific effects of the homeopathic consult-

ation itself have been examined by Brien et al.25

who conducted a double-blind, randomized pla-

cebo-controlled trial in patients with active stable

rheumatoid arthritis (RA). They concluded that

the impact of the homeopathic consultation is of

clinical relevance to patients and clinicians and

that a further study would be justified.

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� 2013 The Author(s)

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