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Homeopathy Reserch Hits
Homeopathy Reserch Hits
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Medical Peudocience around the World
Homeopath Reearch Hit New Low
Norert Aut and Viktor Weihäupl
From: Volume 47, No. 3
Ma/June 2023
k hare N Tweet
“Homeopath in Cancer Pa몭ent: Almot Too Good to e True.” That wa the
headline of an ar몭cle in the Octoer 23, 2022, iue of the Autrian weekl new
magazine Pro몭l repor몭ng on an inve몭ga몭on the Autrian Agenc for cien몭몭c
Integrit (OeAWI) (chönerger 2022). The uject of the inve몭ga몭on wa a tud
on the ue of homeopathic adjunct treatment in lung cancer pa몭ent pulihed in
Novemer 2020 in the pre몭giou cien몭몭c journal The Oncologit (Fra et al.
2020). A the concluion of the inve몭ga몭on ummarized, “The Commi몭ee
conclude that there are numerou reache of cien몭몭c integrit in the tud, a
reported in the pulica몭on. everal of the reult can onl e explained data
manipula몭on or fali몭ca몭on.”
Thi rought to a climax an a몭air ini몭ated the Informa몭on Network Homeopath
from German and the Ini몭a몭ve for cien몭몭c Medicine from Autria. The onl
remaining que몭on i whether or not the tud will e retracted from the journal; a
thi magazine went to pre, it ha not een.
Thi incident mark a new low in homeopath reearch. Un몭l now, if poi몭ve reult
occurred in clinical tudie of homeopath, the were tpicall a몭riuted to
weaknee in the tud. For example, a 몭awed tud deign had produced a high
rik of ia, making it likel that the reult were not valid. Alterna몭vel, there were
error in data collec몭on, anali, interpreta몭on, or other inadequacie. However, in
the cae of the Oncologit tud, it i impoile to aume random and uninten몭onal
error. The 몭nding of the OeAWI inve몭ga몭on uggeted that the author quite
delieratel took ac몭on to create poi몭ve reult.
In addi몭on, thi incident draw a몭en몭on to a weakne in current medical reearch
pulica몭on. Although pulihed in a renowned oncolog journal, the error in thi
tud were not iden몭몭ed medical expert in oncolog a part of the journal’ peer
review proce ut intead a group of kep몭c not engaged in medical reearch
who examined the data a몭er pulica몭on. Without their cru몭n, 몭nall leading to
o몭cial dicloure of cien몭몭c miconduct, homeopath could 몭ll rag aout 몭rt
cla cien몭몭c evidence for the e몭ec몭vene of homeopath over placeo.
Reearch on Homeopath
From a purel logical ai, reearch on homeopath doe not make ene—
epeciall in the form of a Phae III tud to tet it e몭ect in pa몭ent—ecaue
homeopathic medicine are o diluted that it i unlikel there i an ac몭ve ingredient
remaining.
Uuall, tudie on homeopath get pulihed in rather duiou journal focuing on
complementar and alterna몭ve medicine, which exit in an atonihing numer. ut
on occaion, author ucceed in pulihing uppoedl poi몭ve tudie on
homeopath in repectale cien몭몭c journal. The profeional pulic ma ignore
them with a hrug of the houlder, ut for upporter of homeopath thee
pulihing uccee erve a uppoedl 몭rtcla evidence, which in turn i
preented to the pulic to promote homeopath. eide the tud under
conidera몭on here, other example include Katharina Gaertner et al. (2022) in
Pediatric Reearch on homeopath and ADHD or Michael Fra et al. (2005) in Chet
on homeopath for pa몭ent with evere lung prolem in the ICU.
We appeal to the variou par몭e involved in pulihing cien몭몭c paper to e ver
kep몭cal aout trial on highl implauile therapie. peci몭call,
cien몭몭c journal hould pulih uch tudie onl a몭er a ver cri몭cal review
that etalihed that the contain olid cien몭몭c reearch.
Peer reviewer hould check poi몭ve reult on homeopath and other ver
implauile therapeu몭c method in great detail for poile error and
inconitencie and provide a clear report to the editor.
The profeional pulic, when 몭nding ar몭cle aout poi몭ve reult on
homeopath, hould cri몭call ae uch pulica몭on and expre their
concern aout the integrit of the tud in le몭er to the editor.
Repectale journal hould not h awa from admi몭ng error in the peer
review proce and e willing to retract duiou tudie.
Of coure, freedom of reearch and cience i valuale and necear. ut to
maintain their interna몭onal reputa몭on, medical univeri몭e hould take
ac몭on to prevent duiou tudie under their name and hould onl approve
them a몭er ome cri몭cal aement of the project to etalih that the
aump몭on to e teted do not contradict other 몭eld of cience, uch a
chemitr, phic, phiolog, and the like.
The Que몭oned tud
The lead author of the tud i Profeor Michael Fra. He tate hi a몭lia몭on with
Medical Univerit of Vienna, ut at the 몭me of pulica몭on, he had re몭red (Fra et
al. 2020). The tud wa conducted a a doulelinded, randomized, and placeo
controlled compara몭ve trial, performed at everal ite in Autria. Thu, the gold
tandard for tud deign validit wa more than met. The procedure deploed for
linding, randomiza몭on, etc., without dout merit a “low rik of ia” ra몭ng.
The reult of thi apparentl highqualit tud would reall e fanta몭c for
homeopath—if the were valid:
On average cancer pa몭ent in the homeopath group (n = 51) achieved a 70
percent longer urvival 몭me than with placeo (n = 47).
Qualit of life a well a ujec몭ve welleing under homeopath improved
conideral, while the pa몭ent on placeo got progreivel wore.
There wa a third group of pa몭ent who did not want to par몭cipate in the tud and
did not receive an addi몭onal treatment (n = 52). The fared even wore. Thi group
i not conidered here ecaue of the unclear ai for comparion.
If our working group had not taken ac몭on to review the paper and inform the
Medical Univerit Vienna of our 몭nding, thi tud would have paed a 몭rt
cla evidence for the e몭cac of homeopath: a highqualit tud, pulihed in a
pre몭giou peerreviewed journal ielding excellent reult that indicate a
utan몭al clinical e몭ect of homeopathic remedie on a lethal pathological proce.
Thi had never happened efore.
The Protocol
Our anali wa not limited to the pulihed text of the ar몭cle. ecaue thi wa a
preregitered tud, we were ale to include data from the regitr ClinicalTrial.gov
(h몭p://clinicaltrial.gov/ct2/how/NCT01509612), which how the “hitor of
change” to the tud over 몭me
(h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612), a well a the data peci몭ed
when the tud wa originall regitered (ClinicalTrial 2012). In addi몭on, we
included the tud protocol that wa uploaded to the tud regitr, including oth
the original verion (Fra 2011) and the updated verion (Fra 2014).
The 몭rt verion of the protocol, where the parameter were et and the procedure
decried in detail, i dated Januar 10, 2011 (Fra 2011). Thi i one ear efore
the 몭rt regitra몭on with ClinicalTrial.gov in Januar 2012 and the eginning of
pa몭ent enrollment in Feruar 2012. Thu, everthing appear to e in good order.
The odd thing: The protocol more or le meet the detail given in the pulica몭on—
ut the data given in the 몭rt regitra몭on, one ear a몭er the date of the protocol,
di몭er igni몭cantl (ee Tale 1).
There i no wa to undertand what made the author provide completel di몭erent
data with their 몭rt regitra몭on onl one ear a몭er the tud parameter were
etalihed, or wh the original protocol i a much e몭er match to the pulica몭on
data. The onl plauile explana몭on i that the protocol wa not created in Januar
2011 ut at a much later point in 몭me. At leat part of it were compiled together
with the manucript for pulica몭on. Thi i corroorated the following
oerva몭on:
The protocol wa dated Januar 2011 ut uploaded to the regitr on
eptemer 18, 2019, intead (ClinicalTrial 2020), aout two month a몭er data
collec몭on wa completed. Mot proal, thee were no longer linded—
meaning the reearcher could tell who got the homeopathic medicine and
who got placeo—a poten몭al ource of ia.
In the protocol, the o몭ware ued for data anali i peci몭ed a “IM P
ta몭몭c 25.0” (Fra 2011), ut according to the P li몭ng on Wikipedia,
that verion wa not releaed un몭l Jul 2017! In Januar 2011, the current
verion numer wa 19; the reearcher could not have ued a o몭ware
verion that had et to e developed.
In the text of the protocol, a upercript numer 25 appear in the decrip몭on
of the que몭onnaire F36 looking imilar to a literature reference (Fra
2011). ut that nota몭on make no ene there ecaue the protocol ha no
iliograph. However, thi upercript numer correpond with reference
numer 25 in the pulica몭on, which refer to a paper decriing the F36
que몭onnaire (Fra et al. 2020). Reference 1 through 24 contain ten paper
that had not et een pulihed at the 몭me the protocol wa otenil
wri몭en. The onl poile explana몭on for thi upercript numer eem to e
that it originate from a omewhat failed copandpate tranfer from
manucript to protocol.
In Ma 2021, we pulihed our reult and poted the nglih verion on dzard
rnt’ log (Aut and Weihäupl 2021). We contacted the author and aked for
their comment on our crucial 몭nding (ee elow). We received no repl; however,
on June 14, 2021, a new protocol verion wa uploaded to clinicaltrial.gov
(ClinicalTrial 2021). Thi ear the date of Feruar 6, 2014, which would e two
ear into the tud, at which point the 몭rt uject might have jut reached the
end of their followup 몭me (Fra 2014). The limited data availale at that 몭me were
mot certainl 몭ll linded. In a rigorou trial, thi would e the lat chance to
pulih a change to the protocol without raiing concern aout poile ia caued
knowledge of the earl pa몭ent reult.
In thi econd verion, all data including the numer of excluion criteria and the
followup 몭me had een adjuted to match the pulica몭on. On the other hand, the
previou verion of the protocol i not men몭oned at all, which would e een몭al for
tranparenc on how the trial progreed.
Thi econd verion did not et exit prior to eptemer 18, 2019, otherwie thi
verion would have een uploaded to the regitr. Thi remove all poile dout:
preda몭ng the protocol cannot have happened a a caual error. Onl one
interpreta몭on i reaonale: the reader i led to elieve the procedure were
etalihed at an earl tage of the trial and then followed conequentl un몭l the
ver end.
Pot Hoc Adjutment of xcluion Criteria
If the verion of protocol that wa actuall ued wa created aout the ame 몭me a
the manucript of the pulica몭on, then all the procedure reported there mut e
regarded a pot hoc, i.e., a a uequent modi몭ca몭on of rule a몭er the outcome
data were known to the author.
Under thee circumtance, it would e poile to adjut the tud parameter in
uch a wa that the reult are hi몭ed in a certain direc몭on. Thi procedure i
decrip몭vel called the Texa harphooter Fallac: a gunlinger hoot at a arn
door and paint a ullee target around the ullet hole a몭er the fact.
In thi cae, two major parameter were modi몭ed pot hoc, namel a reduced follow
up 몭me (ee elow) and an increae in the numer of excluion criteria—the
ju몭몭ca몭on given for elimina몭ng a par몭cipant’ data from the tud. oth are
men몭oned for the 몭rt 몭me in the 몭rt verion of the protocol. A of Augut 15,
2018, when the regitr wa updated the lat 몭me efore the protocol wa
uploaded, the parameter 몭ll indicated that the pa몭ent would e followed up for
104 week, and onl one ingle excluion criterion wa declared.
At the onet of the trial, onl pregnant women were to e excluded from
par몭cipa몭on (ClinicalTrial 2012). In the pulica몭on, no fewer than twenttwo
di몭erent excluion criteria were de몭ned (Fra et al. 2020). Furthermore, the criteria
eem to e aritrar with no conitent underling ai which the could have
een etalihed. Kidne dieae, liver dieae, lood dieae, coronar heart
dieae, and man other condi몭on that ecome more prevalent with age led to
excluion without an clear ra몭onale provided. In contrat, other maladie common
in thi age group, uch a diaete, hpertenion, and gatric or inte몭nal dieae,
did not lead to excluion.
In addi몭on to the lack of ra몭onale, the author did not dicloe how man pa몭ent
were excluded thi wa (Fra et al. 2020): Neither the CONORT diagram—which
how the 몭ow of pa몭ent and their aignment to experimental group—nor the
text of the pulica몭on provide thi informa몭on. ight pa몭ent were excluded a몭er
randomiza몭on due to “late detec몭on of muta몭on,” ut no other excluion are
men몭oned. It i implauile that thi contella몭on of excluion criteria wa
introduced while the tud wa eing conducted et no pa몭ent were a몭ected.
We have demontrated what can e achieved with the pot hoc excluion of tet
uject in a numeric model (ee Figure 1; Aut and Weihäupl 2021).
Figure 1. Numerical model of data manipula몭on (ee text for explana몭on).
Two et of random ditriu몭on were modi몭ed to repreent two equivalent urvival
func몭on (thin line in Figure 1). Thee curve how how man pa몭ent were 몭ll
alive at a given 몭me. The median life몭me for oth curve i twenteight week,
which 몭me exactl 50 percent of the pa몭ent in each group have died.
ach et conit of eight element. If a random 몭몭een of the 몭rt twent death
are dropped from the lue curve repreen몭ng homeopath, the thick lue line
emerge. Thi ample now ha ixt몭ve element intead of eight, ut thi 몭ll i
100 percent of the element preent. Thu, the origin i maintained, ut the curve
hi몭 upward due to the now miing earl death. The thick red curve, uppoedl
repreen몭ng placeo, emerge when a random 몭몭een of the twent pa몭ent that
urvived the longet are dropped. Again, thi curve maintain it origin at 100
percent, ut the curve de몭ect downward due to the lack of longterm urvivor.
Comparing oth thick curve, certain feature ma e oerved:
The di몭erence in urvival i et during the 몭rt twelve week onl. With the
lue curve, eight pa몭ent die during thi 몭me marked the ver몭cal green line
in Figure 1. With the red curve, twentthree pa몭ent die. A몭er that, for the
next ixteight week, aout the ame numer of pa몭ent die in oth group:
thirtix and thirteven for lue and red, repec몭vel. A몭er that, the curve
tart to converge again, ecaue at ome future point in 몭me all pa몭ent will
eventuall have died.
The median urvival 몭me of the red curve decreae eight to nineteen
week.
The median urvival 몭me of the lue curve increae twelve to thirtnine
week.
xactl thee characteri몭c can e found in the urvival func몭on preented in
Figure 1 of the Fra et al. (2020) pulica몭on in Oncolog:
The advantage of the homeopath group arie in the 몭rt nine week onl.
Two of 몭몭one (4 percent) homeopath pa몭ent die, ut eleven of fort
even (23 percent) pa몭ent of the placeo group die. From then onward to the
end of the followup, virtuall the ame numer of pa몭ent die in oth group:
twentix under homeopath (51 percent) and twent몭ve under placeo (53
percent).
The median urvival 몭me in the placeo group i onl 257 da. Thi i
igni몭cantl horter than the 303 da expected under conven몭onal care
alone, a the author cite from prior inve몭ga몭on.
The median urvival 몭me in the homeopath group i 435 da, igni몭cantl
higher than the expected value of 303 da.
Concluion: The improved urvival under homeopath ma have een produced
data manipula몭on—peci몭call, dropping unfavorale data from two prac몭call
equivalent ample for no dicernile, legi몭mate reaon. Thi would e pa몭ent
ding earl under homeopath and long urvivor in the placeo group. For example,
if a pa몭ent in the homeopath group with an autoimmune dieae (uch a
rheuma몭m) died earl, ut there were no uch pa몭ent in the placeo group, or if
uch a pa몭ent urvived for a long 몭me, then the excluion criterion “autoimmune
dieae” ma e introduced to exclude an unfavorale data point. nough elec몭ve
incluion and omiion could produce the reult preented in the pulihed tud.
If, on the other hand, homeopath were an e몭ec몭ve treatment, then the e몭ect
hould e oviou throughout the whole followup; ou would expect the curve to
diverge more or le con몭nuoul throughout the whole trial un몭l the inevital
tart to converge again. However, here thi reaking point eem to e outide the
followup oerva몭on.
Thi pa몭ern of reult ugget that the pot hoc introduc몭on of a large numer of
excluion criteria wa part of a delierate e몭ort to manipulate the data in the
direc몭on of a poi몭ve outcome. Preda몭ng the protocol to a 몭me efore the tud
wa tarted and not men몭oning thi change in the pulica몭on further upport thi
hpothei. And 몭nall, the reult how telltale characteri몭c that can originate
from preciel uch manipula몭on. It i ver hard to elieve that thi kind of
manipula몭on did not occur.
Pot Hoc Reduc몭on of Oerva몭on Time
The econd major change to the original reearch plan concern the followup 몭me
for meaurement of qualit of life (QoL) and ujec몭ve welleing, oth of which
were primar outcome of the tud—that i, the main meaured e몭ect. With the
몭rt verion of the protocol, thi followup 몭me wa reduced from 104 to eighteen
week. QoL and welleing are ver important for pa몭ent in the late tage of
cancer, o it i reaonale to de몭ne thee meaure a primar outcome with
urvival a a econdar outcome. ut it i hard to undertand wh QoL and well
eing are conidered in the earl phae of treatment onl—and not un몭l the follow
up for urvival wa complete.
And at the eginning of the trial, the author eemed to hare the ame opinion. The
overall dura몭on of the tud wa planned to e even ear (ClinicalTrial 2012).
With a planned recrui몭ng period of 몭ve ear, thi ield a minimal followup of two
ear. Thi wa conducted for urvival and wa indicated in the regitr to e applied
to QoL and welleing a well. Up to Augut 2018, thi wa the plan (ClinicalTrial
2018):
“Primar Outcome Meaure
1. Life Qualit
[Time Frame: 7 Year]
Life Qualit i evaluated uing the reult of the ORTCQLQC30 que몭onnaire.”
Thi unamiguoul indicate a data collec몭on period of two ear or more. ven
the pulica몭on give informa몭on in thi direc몭on (Fra et al. 2020): “Pa몭ent were
followed up ever nine week un몭l death. … Pa몭ent were aked to complete again
the que몭onnaire the anwered on tud entr.”
However, for the 몭rt 몭me with the uploaded protocol, the oerva몭on period wa
reduced to eighteen week (Fra 2011). Thi mean that out of 104 week, onl the
몭rt eighteen are preented, reul몭ng in over 80 percent of the data eing ignored.
Wh would ou oerve and report urvival a the econdar outcome for two ear
and the primar outcome for eighteen week onl? The author did not provide an
reearch ra몭onale for thi change in the plan.
uch elec몭ve outcome repor몭ng i a evere 몭aw in an tud. If the data to e
reported are elected a몭er unlinding—and the elec몭on i in tark contrat to the
original tated method, a occurred here—the pa몭ern of event i highl ugge몭ve
of data manipula몭on. The reult re몭ect onl a ver earl tage of the trial—likel
ecaue thi cherrpicked uet of data repreented the mot favorale outcome
for homeopath oerved within the whole trial. Valuale informa몭on—how the
pa몭ent performed in the long term—ha een withheld, and important criteria for
evalua몭ng the interven몭on were kept ecret. An analog would e reearcher
agreeing on a protocol to tet 100 fali몭ale pchic predic몭on and, when
completed, 몭nding the overall ucce rate no e몭er than chance ut then onl
repor몭ng an accurate treak of twent intead of the whole hundred. tud
regitrie uch a ClinicalTrial.gov are et up to help detect (and deter) preciel thi
ort of ia.
The oerva몭on proal ended when data looked par몭cularl good for
homeopath, further enhanced the elec몭ve excluion dicued aove. And the
data did look great to an incredil high degree (Figure 2).
Figure 2. Qualit of life and ujec몭ve welleing reult rela몭ve to aeline (L) at followup 1 (1. FU)
and followup 2 (2. FU). Poi몭ve change are indicted upward movement and nega몭ve
downward movement.
Figure 2 how three diagram we compiled from the numerical data given in the
appendix of the pulica몭on howing the reult of two que몭onnaire for qualit of
life (F36) and ujec몭ve welleing in two cale (QLQ30; Fra et al. 2020). All
three diagram deal with mptom uch a fa몭gue, nauea, vomi몭ng, pain, etc., or
how well the pa몭ent i coping in dail life. The data are arranged o that favorale
value are oriented upward and unfavorale one downward. For eae of
comparion, the curve were hi몭ed o that for each item, the mean value of all
par몭cipant at the eginning (L = aeline) i et to zero.
Apparentl, homeopath pa몭ent fared con몭nuoul e몭er in all repect—
urpriingl, even with repect to 몭nancial prolem—while placeo pa몭ent were
ale to maintain their level in rare cae onl; mot of the 몭me the fared poorl,
and their indice and cale worened over 몭me.
Wh did the author omit the further development during the next nine followup
appointment that a pa몭ent experienced during the tud if he urvived to it end?
According to all life experience, one ma afel aume that the endpoint, aritraril
According to all life experience, one ma afel aume that the endpoint, aritraril
et with knowledge of the outcome data, wa choen in uch a wa that the reult
for homeopath pa몭ent repreent the mot advantageou 몭me point. Thi cannot
e concluivel proven, ut elec몭ve outcome repor몭ng i conidered a eriou
tud 몭aw, ecaue thi i exactl what cannot e ruled out. What if the
homeopath pa몭ent had not fared e몭er in the further coure ut conideral
wore?
Further Inadequacie
When we reviewed and analzed the pulica몭on, we found man more 몭aw and
inadequacie that omehow ecaped the peer reviewer’ a몭en몭on. Here we preent
a few example:
Diagram given in Figure 2 and 3 of Fra et. al. 2020 do not match. oth
repreent the 몭ow of pa몭ent. In Figure 2, ome eligile pa몭ent refued to
par몭cipate in the tud ut gave their conent to e oerved for urvival.
ome of thee received homeopath. Thi group i not preent in the
CONORT몭owchart in Figure 3.
One criterion to par몭cipate wa a hitologicall con몭rmed cancer tage no
more than eight week prior to incluion. However, 몭me point zero i not
de몭ned for thee pa몭ent: I it the date of diagnoi or intead the 몭rt
homeopathic conulta몭on? Thi dicrepanc could e a gap of da to month,
and with a followup 몭me of onl eighteen week in the primar outcome, thi
uncertaint might e important.
The numer of par몭cipant wa determined to ield a u몭cient ta몭몭cal
power for the econdar outcome—ut not the primar one, which i quite
unuual. 몭ll the author failed to recruit the appropriate numer of pa몭ent
and the tud i vatl underpowered (nineteight pa몭ent in two group
intead of 300).
The devata몭ng reult of the 몭rt group (which received conven몭onal
treatment onl and fared even wore than the placeo group, with urvival
몭me well elow what conven몭onal treatment uuall ield) i never
dicued.
OeAWI Inve몭ga몭on
Unfortunatel, the 몭nal detailed report of the Autrian Agenc for cien몭몭c Integrit
i not availale to the pulic. The onl pulic ource i the ar몭cle in the Autrian
weekl new magazine Pro몭l from Octoer 23, 2022, with numerou quote of the
몭nding in German (chönerger 2022) ut including everal quota몭on from the
original nglih report.
The OeAWI commiion deploed other method than we did and had acce to
The OeAWI commiion deploed other method than we did and had acce to
original data and the protocol preented to the ethic commi몭ee. Neverthele,
overall, the came to ver imilar concluion a we did:
OeAWI cri몭cize the huge numer of amendment of trial parameter while
the tud wa underwa that were not men몭oned in the pulica몭on. The
conider thi lack of tranparenc “unacceptale” and ugge몭ve of data
manipula몭on.
The de몭ni몭on of the excluion criteria in the protocol lead OeAWI to the
concluion that man pa몭ent were excluded pot hoc, which ugget data
manipula몭on.
The anali of urvival ielded that homeopath eemed e몭ec몭ve at certain
몭me period onl with long interval of ine몭ec몭vene in etween. Thi i
conidered implauile ut conitent with the aump몭on of data
manipula몭on.
In the original data availale to OeAWI, the commiion found everal pa몭ent
who had een excluded a몭er the tud wa completed ut whoe removal wa
not reported in the pulica몭on. Thi i alo ugge몭ve of data manipula몭on.
Among completed que몭onnaire, everal have the top core in all ixtix
item of F36 and QLQC30 que몭onnaire. In addi몭on, the homeopath
group howed an average qualit of life core that exceeded that of the
general Autrian popula몭on (and wa in fact even e몭er than the upper
quar몭le of the popula몭on). Thi i ver implauile for pa몭ent in the 몭nal
tage of lung cancer.
In a ta몭몭cal tud, pa몭ent’ qualit of life data were compared with their
urvival 몭me. There wa a clear correla몭on in the placeo group: pa몭ent
who felt wore alo had a lower life expectanc. There wa no uch correla몭on
in the homeopath group: ome of the pa몭ent who reported feeling excellent
died a few month later. Thi, alo, i poile ut highl unlikel.
The concluion of the OeAWI read, “The Commi몭ee conclude that there are
numerou reache in cien몭몭c integrit in the tud, a reported in the pulica몭on.
everal of the reult can onl e explained data manipula몭on or fali몭ca몭on. The
pulica몭on i not a fair repreenta몭on of the tud.”
The OeAWI informed u of their 몭nding in a peronal communica몭on and indicated
that the had relaed them to the Medical Univerit of Vienna, Autria. The OeAWI
alo informed the editorinchief of The Oncologit of their 몭nding and demanded a
retrac몭on of the pulica몭on. The Oncologit ha o far complied to the extent that it
ha iued a (much milder) “xpreion of Concern” (2022) tagged to the pulica몭on.
The editor indicate that there are allega몭on of data manipula몭on and fali몭ca몭on
aociated with the pulica몭on, origina몭ng from a credile ource. The reult
hould e regarded a invalid un몭l their own inve몭ga몭on i completed.
hould e regarded a invalid un몭l their own inve몭ga몭on i completed.
Author’ Reac몭on
In the Pro몭l ar몭cle, the lead author, Profeor Michael Fra, had the opportunit to
comment on the allega몭on (chönerger 2022). He 몭rml rejected an accua몭on
of data manipula몭on or fali몭ca몭on. Indeed, Pro몭l report that he 몭ll i aolutel
convinced that he ha preented a clean and rigorou tud. Hi ummarizing
tatement: “The accua몭on are all known to u and aolutel incomprehenile.
We can anwer all of them. Our work wa carried out in compliance with all
cien몭몭c tandard. The accua몭on of viola몭on of cien몭몭c integrit ha no ai
whatoever. It i oviou to u that not all document were included in the
evalua몭on. For thi reaon, we have aked to get acce to the 몭le to undertand
the ai for the concluding tatement” (original in German, tranla몭on the
author). Meanwhile, homeopath organiza몭on have announced that legal ac몭on to
force the OeAWI to retract it concluion will e taken if necear.
One wonder what addi몭onal documenta몭on Fra could produce to explain the
preda몭ng of the protocol or the diappearance of pa몭ent a몭er randomiza몭on.
Man point of our and OeAWI’ cri몭que are, a몭er all, fairl oviou from the data in
the pulica몭on and the weite www.clinicaltrial.gov; anod with acce to the
internet can check the 몭nding. From our point of view, Fra ha ovioul not
quite undertood the itua몭on: The prolem i not that we or the OeAWI have
excluded document ut rather that we have included all availale document in our
anali, epeciall previou regitra몭on data.
Note
A verion of thi ar몭cle previoul appeared in the German magazine kep몭ker.
Reference
Aut, N., and V. Weihäupl. 2021. A thorough anali of Prof. M. Fra’ recent
Homeopath Trial cat eriou dout on it reliailit. dzard rnt log (June 11).
Online at h몭p://edzardernt.com/2021/06/athoroughanaliofprofmfra
recenthomeopathtrialcaterioudoutonitreliailit/.
ClinicalTrial. 2012. tud NCT01509612: umi몭ed Date: Januar 13. Online at
h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612?V_2=View#tudPageTop.
———. 2018. tud NCT01509612: umi몭ed Date: Augut 15. Online at
h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612?V_7=View#tudPageTop.
h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612?V_7=View#tudPageTop.
———. 2020. tud NCT01509612: umi몭ed Date: Octoer 29. Online at
h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612?V_8=View#tudPageTop.
———. 2021. tud NCT01509612: umi몭ed Date: June 14. Online at
h몭p://clinicaltrial.gov/ct2/hitor/NCT01509612?V_10=View#tudPageTop.
xpreion of Concern. 2022. xpreion of concern: Homeopathic treatment a an
addon therap ma improve qualit of life and prolong urvival in pa몭ent with
nonmall cell lung cancer: A propec몭ve, randomized, placeocontrolled, doule
lind, threearm, mul몭center tud. The Oncologit 27(12): e985. Online at
h몭p://doi.org/10.1093/oncolo/oac221.
Fra, M. 2011. Homeopath in cancer (HINC)—tud protocol; Verion date:
Januar 10. Online at
h몭p://clinicaltrial.gov/ProvidedDoc/12/NCT01509612/Prot_AP_000.pdf.
———. 2014. Homeopath in Cancer (HINC)—tud protocol; Verion date: Feruar
6. Online at
h몭p://clinicaltrial.gov/ProvidedDoc/12/NCT01509612/Prot_AP_001.pdf.
Fra, M., C. Dielacher, M. Linkech, et al. 2005. In몭uence of potaium dichromate
on tracheal ecre몭on in cri몭call ill pa몭ent. Chet 127: 936–941. Online at
h몭p://doi.org/10.1378/chet.127.3.936.
Fra, M., P. Lechleitner, C. Gründling, et al. 2020. Homeopathic treatment a an
addon therap ma improve qualit of life and prolong urvival in pa몭ent with
nonmall cell lung cancer: A propec몭ve, randomized, placeocontrolled, doule
lind, threearm, mul몭center tud. The Oncologit 25(12): 1–26 (Open Acce).
Online at h몭p://doi.org/10.1002/onco.13548.
Gaertner, K., M. Teut, and H. Walach. 2022. I homeopath e몭ec몭ve for a몭en몭on
de몭cit and hperac몭vit diorder? A metaanali. Pediatric Reearch. Online at
h몭p://doi.org/10.1038/41390022021273.
chönerger, A. 2022. Homöopathie ei Krepa몭enten: Fat zu chön, um wahr zu
ein. Pro몭l (Octoer 28 [in German]). Online at
h몭p://www.pro몭l.at/wiencha몭/homoeopathieeikrepa몭entenfatzu
choenumwahrzuein/402198219.
Norert Aut and Viktor Weihäupl
Norert Aut hold a doctoral degree in mechanical engineering and ha
worked in variou management poi몭on in the vacuum pump and
compreor indutr, including R&D and qualit management. A몭er he
몭nihed hi ac몭ve career, he turned to kep몭cal topic in energ and power
and in peudomedicine. In 2016, he ini몭ated the Homeopath Informa몭on
Network, a group of cien몭t and other individual triving to 몭ght
miconcep몭on aout homeopath a a valid therapeu몭c approach. He can
e reached at aut@gwup.org. Viktor Weihäupl hold a PhD in chemitr
from the Univerit of Vienna, Autria, a Medical Licen몭ate and a pecialit
Diploma in Anetheiolog from the Univerit of Oulu, Finland, and an MD
from the Univerit of Vienna. He worked a an anetheiologit in ter몭ar
care center in Oulu and Vienna. ince hi re몭rement, he ha worked againt
the promo몭on of peudomedicine the Autrian Medical Aocia몭on and
the Autrian Health Minitr. He can e reached at weihaeupl@in몭a몭ve
wiencha몭lichemedizin.at.
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