Review Article Tibetan Medicine: A Systematic Review of the … · 2019. 7. 31. · traditional Chinese medicine (TCM) and complementary or alternative medicine (CAM) in general,

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2013, Article ID 213407, 16 pageshttp://dx.doi.org/10.1155/2013/213407

Review ArticleTibetan Medicine: A Systematic Review of the Clinical ResearchAvailable in the West

K. Philip Reuter, Thorolf E. R. Weißhuhn, and Claudia M. Witt

Institute for Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin, 10098 Berlin, Germany

Correspondence should be addressed to K. Philip Reuter; [email protected]

Received 12 December 2012; Revised 17 February 2013; Accepted 18 February 2013

Academic Editor: Myeong Soo Lee

Copyright © 2013 K. Philip Reuter et al.This is an open access article distributed under theCreative CommonsAttribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background. Little is known about Tibetan medicine (TM), inWestern industrialized countries.Objectives. To provide a systematicreview of the clinical studies on TM available in the West. Data Sources. Seven literature databases, published literature lists,citation tracking, and contacts to experts and institutions. Study Eligibility Criteria. Studies in English, German, French, or Spanishpresenting clinical trial results. Participants. All patients of the included studies. Interventions. Tibetan medicine treatment. StudyAppraisal and Synthesis Methods. Included studies were described quantitatively; their quality was assessed with the DIMDI HTAchecklist; for RCTs the Jadad score was used. Results. 40 studies from 39 publications were included.They were very heterogeneousregarding study type and size, treated conditions, treatments, measured outcomes, and quality. Limitations. No Russian, Tibetan,or Chinese publications were included. Possible publication bias. Conclusions. The number of clinical trials on TM available in theWest is small; methods and results are heterogeneous. Implications of Key Findings. Higher quality larger trials are needed, as is ageneral overview of traditional usage to inform future clinical trials. Systematic Review Registration Number. None.

1. Background

Traditional Tibetan medicine (TM), sometimes called“Lamaist” or “Buddhist” medicine, has developed in 1200years into a unique medical system [1–3]. In TM, disease isunderstood as an imbalance of the three “Nyes-pa” (princi-ples) consisting of one or two elements: “rLung” (air, wind),“mKhris-pa” (fire), and “Bad kann” (earth and water) [4].Buddhist philosophy as well as shamanic origins of Tibetanculture form a background of cosmological, mind-body, andspiritual dimensions [1–3]. Treatment may consist of medi-cines (usually preparations of plants [5], seldom minerals oranimals), physical treatments (e.g., massage, baths), life anddiet regulation, or spiritual techniques [4]. Standardizationof the originally individualized medicines, separation fromthe underlying philosophies, and discontinuation of sometechniques (e.g., Tibetan dental medicine, cauterization)have led to derivative forms of TM [6]. We will use theterm “Tibetan medicine” for the traditional TM (with itsindividual life style advice, diet, physical, and spiritualmeans) as well as larger or smaller subsets or varieties of it,down to single formulas.

Besides the regions of the historical Tibet, very similarmedical traditions are practised since the Mongolian con-quest of Tibet in the 13th century in Mongolia, adjacentSiberia, and in the Russian province Kalmykia (Figure 1)[7]. Especially with traditional Mongolian medicine, TM hasa substantial similarity. TM use in Western industrializedcountries (the “West”) originates in a line of descendants ofa Buryat physician migrating westward in the 19th century(Figure 1) [8, 9]. Still, there is little awareness of TM inthe general Western public. Following the rising interest intraditional Chinese medicine (TCM) and complementaryor alternative medicine (CAM) in general, more demandfrom Western countries can be expected in the future. Theamount of available research in the West is small. A Medlinesearch up to December 31, 2010, for example, for “Tibetanmedicine” returned 371 hits, 0.0183 times the number for “tra-ditional Chinese medicine.”The existing literature indicates apalliative, possibly curative potential, especially for chronicdiseases [10], but studies on its multimodal individualizedapproach are scarce and systematic reviews exist only for oneTM product [11–15]. Therefore, we attempted to present inthis paper a systematic overview of clinical research currently

2 Evidence-Based Complementary and Alternative Medicine

TM core regions todayChina: Tibet autonomous regionand partly Qinghai, Sichuan,Yunnan and GansuIndia: LadakhNepal: MustangIndia: SikkimBhutanMongoliaRussia: BuryatiaRussia: Kalmykia

Regions where TM is practicedregularlyRussia:TuvaUst-Ordynski BuryatAgin BuryatChita OblastAmur OblastKhabarovsk KraiChina:Inner Mongolia autonomousregion

(8th–11th century)TM expansion after Mongolianconquest of Tibet (13th century)Spread of Mongolian culture

Asian TM Schools today. North to South: Ulan-Ude, Ulaanbaatar, Xining, Leh, Dharamsala, Lhasa, Thimphu, Darjeeling, and Sarnath

(17th-18th century)

Badmaev family members (19th-20th century)

12

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7

8

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(1)

(2)(3)(4)(5)(6)(7)(8)

(a)(b)(c)(d)(e)(f)

(g)

(I)

(II)

(III)

TM core regions todayChina: Tibet autonomous regionand partly Qinghai, Sichuan,Yunnan and GansuIndia: LadakhNepal: MustangIndia: SikkimBhutanMongoliaRussia: BuryatiaRussia: Kalmykia

Regions where TM is practicedregularlyRussia:TuvaUst-Ordynski BuryatAgin BuryatChita OblastAmur OblastKhabarovsk KraiChina:Inner Mongolia autonomousregion

(8th–11th century)TM expansion after Mongolianconquest of Tibet (13th century)Spread of Mongolian culture

Asian TM Schools today. North to South: Ulan-Ude, Ulaanbaatar, Xining, Leh, Dharamsala, Lhasa, Thimphu,

(17th-18th century)

Badmaev family members (19th-20th century)

12

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7

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(2)(3)(4)(5)(6)(7)(8)

(a)(b)(c)(d)(e)(f)

(g)

(I)

(II)

(III)

Historical development:Main cultural influences on TM

Figure 1: Tibetan medicine in geography and history. Map based on [7, 8, 17–22].

available in theWest onTibetanmedicine, and aim to providedetails on methods and study quality. Some preliminary datacan be found in [16].

2. Methods

A preliminary list of 15 literature databases was tested usingthe search terms “Tibetan medicine,” “Himalaya medicine,”“Tibetan herbal,” and “Lamaistic medicine.” The databaselist had been compiled from recommendations by experts,by Ovid [23], and by Deutsches Institut für Medizinis-che Dokumentation und Information (DIMDI) [24]. Thosereturning the most hits were used for the literature search,together with databases that were recommended by expertsor appeared relevant in their characterization on the websitesof DIMDI or the Charité library [25]. We finally searchedseven databases up to publication date December 31, 2010:ABIM (accessed via Rijksuniversiteit Groningen), AMED(DIMDI), CAMbase (cambase), CCmed (DIMDI), CochraneCollaborative Library (OVID), Embase (OVID), andMedline(PubMed). The search term “(Tibet OR Himalaya OR Mon-golia OR Buddhist) AND (herbal ORmedicine) AND study”

was adapted as necessary to database language and syntax.Similar searches were used on the medical informationservices of DIMDI [24] and ZB MED [26] and by adding“AND clinical study” on Google scholar [27]. The publishedliterature lists [28, 29]were screened.We also contacted Euro-pean experts, research departments of TM medical faculties(Mentsekhang) in Lhasa and Dharamsala, and Europeancentres for TM [30–32]. All identified literature was furtherscreened for relevant citations. Duplicate references wereeliminated throughout the process; of multiple publicationsof a study the most recent one was included. Included papershad to be written in English, German, French, or Spanish andhad to present clinical trial results on a clinical outcome. Nofurther restrictions were applied.

One of the authors (K. P. Reuter) used a predefined formto extract descriptive study data intoMS Access 2003 andMSExcel 2003 [33, 34] data bases, including bibliographic data,and study parameters such as type, methods (including diag-nostics, randomization, and blinding), and patient numbers.Furthermore, data regarding treated diseases, interventions,outcomes, and types of outcome measures (clinical symp-toms, tests, and laboratory parameters) were extracted. If no

Evidence-Based Complementary and Alternative Medicine 3

Additionally from other sources(unique) 𝑛 = 398

Returns from 7 indexes𝑛 = 1488

Unique records𝑛 = 985

Screened records total𝑛 = 1383

Language (DE, EN, FR, SP)𝑛 = 1179

Topic (Tibetan medicine)𝑛 = 159

Method (clinical study)𝑛 = 40

Included publications𝑛 = 39

Included studies𝑛 = 40

Figure 2: The literature search. References from indexing serviceswere collected first, then other sources were added.

primary outcome was defined, the first outcome mentionedin the title or the abstract was extracted, unclear cases werediscussed with another author (C. M. Witt) until consensuswas reached.

Methodological quality of the studies was determinedwith a DIMDI checklist (Table 1) that is used to evaluatestudies for in-/exclusion in health technology assessments(HTA) in Germany [35]. The checklist has up to 31 itemssorted into 7 categories and was used on a descriptive basis.Randomized controlled trials (RCTs) were further evaluatedwith the Jadad score [36, 37]. Descriptive statistics werecalculated using MS Access 2003 andMS Excel 2003 [33, 34].

3. Results

From 1383 screened records, we identified 40 studies reportedin 39 publications (one contains 2 studies [38]), see Figure 2.An additional search without the terms “herbal,” “Buddhist,”and “Mongolian” did not result in fewer relevant publications.Thirty-five of the publications were journal articles, twowere book chapters, and one is treated in this paper as asingle Internet publication, although different findings hadbeen published in several online media reports [39]. Only18 publications were found by the initial data base searches.Most of the others were indeed indexed, as a reverse search(for already known publications) revealed.Written in Englishwere 53.8% (𝑛 = 21) of the publications, the other 46.2% (18)were in German. Most publications came from Poland andSwitzerland (30.8% or 𝑛 = 12 each, all on products of PadmaAG). The Asian studies were from India (15.4%, 𝑛 = 6) orChina (5.1%, 𝑛 = 2).The earliest publication appeared in 1970.Since 1990 every 5 years about 3 new RCTs were publishedand, less evenly distributed, most of the observational studies

(total 𝑛 = 14). The 5 nonrandomized controlled trials werepublished between 1986 and 1991, and the 6 case studies orcase series in 1998 or later (Table 2). The setting of 7 studies(17.5%) was multicentred [40–46]. Four studies (10.0%) wereretrospective [40, 45, 47, 48].

In the RCTs included were 2028 patients, 1020 of themreceived the Tibetan medicine treatment. Study durationranged from 14 days to 12 months (mean = 114 days). MostRCTs investigated Padma 28 (𝑛 = 9) (the first study in[38], and [49–56]) or Padma Lax (𝑛 = 1) [57]. A wholemedical system approach with a complex traditional TMintervention was applied in 3 studies on diabetes mellitus[43], arthritis, [58] or hepatitis B [59]. Tibetan yoga inlymphoma patients [60] and a single TM preparation (ZhiByed 11) for postpartum haemorrhage [44] were each thesubject of 1 RCT. One study [61] was declared an RCT butlacked randomization.

From those publications including herbalmedicines, fourdid not provide details on the used medication [42, 58, 59,62], two provided the name of the preparations but notthe ingredients [43, 48], and two provided the name ofthe preparation and ingredients, but no information on thequantity of the ingredients [44, 63]. Data on both ingredientsand their quantitywas only available for Padma 28 andPadmaLax.

The duration of the non-randomized controlled trials wasbetween 6 weeks and 6months (mean = 43 d), 54% of the 678patients received the verumPadma 28. Four non-randomizedcontrolled trials included children with chronic respiratorytract infections [46, 64, 65] or juvenile arthritis [66]. One trialon adults included angina pectoris patients [61].

In the observational studies included, there were 1824patients. The observation duration ranged from 15 days to 2years (mean= 217 days). In someof the publications, the studyduration was not clearly stated (the second study in [38],and [41]) or varied between participants [42, 45, 63]. Sevenobservational studies investigated Padma 28 (the secondstudy in [38], and [47, 67–71]). One study each investigatedPadma Lax [41] or a jewel pill (Byu-Dmar 13) [63]. ComplexTM treatment was applied in 5 studies [39, 42, 45, 48, 62].

Theduration of the case studies/series rangedwidely fromseveral days to 13.5 years [40]. Padma 28 was investigated in4 case studies [40, 72–74], Padma Lax in 1 [75], and complexTM in another [76].

All studies included a total of 4684 patients, ranging from1 to 967 per trial (mean = 117, SD = 187). Ten studies didnot state the patients’ sex (𝑛 = 1648, 35.2% of all patientsin the present review) [40–42, 47, 56, 63, 65, 67, 71, 77].From the other studies, 1080 patients (23.1%) were male and1956 (41.8%) female. Data on age was available in 31 of 39studies. Children (age 10 months to 16 years, 𝑛 = 955) onlywere included in 5 studies [46, 64, 65, 70, 71]. Only 2 studiesreported on ethnicity (Tibetan patients in both) [42, 58]. In 32studies, dropouts were reported ranging from 0% (15 studies)to 53% [45] with a mean dropout rate of 15%. In 21 of the 28trials of Padma 28 or Padma Lax, the mean drop out rate was6%.

The checklist results for quality assessment are presentedat item level in Table 3 for each study. Depending on study


Table 1: DIMDI HTA checklist items.

Item∗ Item no. (label)∗∗

(A) Selection of participants Participants(1) Were the criteria for in-/exclusion defined sufficiently and clearly? A1 (in-/exclusion)(2) Were the criteria for in-/exclusion defined before intervention? A2 (predefined)(3) Was the health status recorded in a valid and reliable way? A3 (health status)(4) Were the diagnostic criteria of the disease described? A4 (diagnostic criteria)(5) Were the studied/exposed patients representative for the majority of the exposed population or the “standardusers” of the intervention? A5 (representativity)

(B) Allocation and study participation Allocation(1) Were the exposed/cases and nonexposed/controls from the same base population? B1 (basic population)(2) Were intervention/exposed and control/nonexposed groups comparable at baseline? B2 (comparable)(3) Was allocation randomized, with a standardized procedure? B3 (randomization)

(4) Was randomization blinded? B4 (blindedrandomization)(5) Were known/possible confounders considered at baseline? B5 (confounders)(C) Intervention/exposition Intervention(1) Were intervention or exposition recorded in a valid, reliable, and similar way? C1 (recording)(2) Apart from intervention, were intervention and control groups treated similarly? C2 (similar treatment)(3) In case of other treatments, were they recorded in a valid and reliable way? C3 (other treatments)(4) For RCTs: were placebos used for the control group? C4 (placebo use)

(5) For RCTs: was the way of placebo administration documented? C5 (placebodocumented)(D) Study administration Administration(1) Are there indications for “overmatching”? D1 (overmatching)(2) In multicentre studies: were the diagnostic and therapeutic methods and the outcome recording in the centresidentical? D2 (multicentre)

(3) Was if assured that participants did not crossover between intervention and control group? D3 (no crossover)(E) Outcome recording Outcome(1) Were patient-centred outcome parameters used? E1 (patient-centred)(2) Were the outcomes recorded in a valid and reliable way? E2 (recording)(3) Was outcome recording blinded? E3 (blinded outcomes)(4) For case series: was the distribution of prognostic factors recorded sufficiently? E4 (prognostic factors)(F) Drop-outs Drop-outs(1) Was the response rate in intervention/control group sufficient, or, for cohort studies, could a sufficient part ofthe cohort be tracked for the full study duration? F1 (evaluable number)

(2) Were the reasons for the dropouts of participants stated? F2 (reasons)(3) Were the outcomes of dropouts described and included in the analysis? F3 (outcomes)(4) If differences were found: were they significant? F4 (significance)(5) If differences were found: were they relevant? F5 (relevance)(G) Statistical analysis Statistics(1) Were the described analytic methods correct and the information sufficient for a flawless analysis? G1 (correct)(2) Were confidence intervals given for means and for significance tests? G2 (CIs given)(3) Were the results presented in graphical form, and were the underlying values stated? G3 (graphics)∗Translated from [35], ∗∗used in Table 3.

type and setting, 10 to 26 items could be answered. Had theassessment been for HTA purposes, only 1 case study [76]and 1 RCT [55] would have been eligible for inclusion in aHTA. Ignoring only one item (G2, provision of confidenceintervals) would have raised that number to 13, including 8

RCTs that the Jadad score rated as good or very good quality.The Jadad score of the 15 RCTs (Table 4) reached a mean± SD of 3.40 ± 1.35 (median = 4). Randomization scored1.40 ± 0.51 (median = 1), blinding 1.20 ± 1.01 (median =2), and drop-out reporting 0.80 ± 0.41 (median = 1). Studies

Evidence-Based Complementary and Alternative Medicine 5Ta

ble2:Inclu

dedstu

dies.

Stud

yTy

pe∗

Cou

ntry

Dise

ase(diagno

stic

syste

m)∗∗

Participants

(meanage),

drop

-outs∗∗∗

Durationof

interventio

nor

study

kind

,doseo

fintervention∗∗∗∗

(1)M

ainou

tcom

e(2)O

ther

outcom

esNotes

Ascho

ffetal.1997

OS

Germany

Migraine(BM

)I:22;D

:06mon

ths(andlonger?)

Byu-Dmar

13jewelpill,1U

/d

(1)S

everity

ofattacksreduced

by82%

(2)F

requ

ency

ofattacksu

nchanged;lessu

seof

analgesic

sinmostp

artic

ipants

Very

briefd

ocum

entatio

n;on

lysubjectiv

eoutcomes

Bommeli

etal.2001

rCS(M

C)Sw

itzerland

Vario

us(78%

patie

nts

w/arteriosclerosis

)(BM,T

M)

I:147;D:18

From

fewdays

to13.5years

P28,varyingdo

ses(∼50%of

patie

nts3×

2U/d)

(1)Improvem

ento

fcom

plaintsin%of

patie

nts:

perip

heralarteryocclu

sived

iseasein94%,

coronary

heartd

iseasein92%,chron

icveno

usinsufficiency

in91%,arthrosisin

80%

Patie

ntsfrom

15ph

ysicians,

nodemograph

ics,no

mon

otherapy,successno

tcle

arlyattributableto

P28

Brun

ner-La

Roccae

tal.2005

RCT(5)

Switzerland

Mild

hypercho

leste

ro-

laem

ia(BM)

I:30;C

:30;

D:0

4weeks

+15dfollo

wup

I:P2

8,3×2U

/dC:

potato

starch

(1)T

otalcholesterolu

nchanged

(2)O

ther

bloo

dlip

idsu

nchanged

Participantsno

ttypical

patie

nts

Brzoskoetal.1991

CT(4

arms)

Poland

Chronicjuvenile

arthritis(BM)

I1:12(11

years);I2:7;

C1:10

(health

y);C

2:10

(inremission)

I1:6

weeks;I2:4weeks

I1:P

28,2–4

U/d

I2:Th

ymus

extract,1sup

positorium/day

(1)Joint

pain

andsw

ellin

g(RitchieInd

ex):

improved

in75%–83%

ofP2

8patie

nts,in

86%of

thym

usextractp

atients

(2)Improvem

ent(comparedto

healthycontrol)of

sedimentatio

nrate,IgG

,IgM

,serom

ucoid,

CD8-Lymph

ocytes,C

D4/CD

8-qu

otient

Con

trolisn

osta

ndard

therapy;comparis

onwith

healthyprob

ands;

immun

ologicalparameters

notveryrelevant

for

contem

porary

diagno

stics

Brzoskoand

Jank

owski1992

OS(M

C)Po

land

HepatitisB

(BM)

I:178

inclu

ding

52child

ren

2years(interventio

n),10years(stu

dy)

I:P2

8,3×2U

/d

(1)“Biochemicalmarkers”(no

tspecified)

improved

in∼90%

(2)Improvem

entsin

Tlymph

ocytes

(CD3,CD

4,CD

8,andCD

4/CD

8)in

90%,hepatocellularv

irus

elim

inated

in15%,improvem

entsin

immun

ohistochemistry

(HBe

-Akincrease

in70%),andclinicalfi

ndings

(in90%)

Very

briefd

escriptio

nof

patie

ntsa

ndou

tcom

es;n

ostatem

entabo

utother

therapies

Changbar

1998

CS India

Chronica

plastic

anaemia(BM,T

M)

I:1m

an(63);

D:0

15mon

ths

Rinchenyusnying

25special,1o

nalternatingdays;Z

hiru,2×on

alternating

days;G

urgu

m8special,4×/d;Se‘bruku

nbd

e,3×

/d;A

gar8

,4×/d;dietary

recommendatio

ns

(1)H

aemoglobin(in

crease

from

3.1to10.4mg/dL

)(2)C

linicalim

provem

ent,redu

ctionof

comedication

Coh

enetal.200

4RC

T(2)

USA

Mentalsym

ptom

saccompanying

lymph

omas

(BM)

I:19;C

:19;D:

9

7weeks

+3mon

thsfollow-up

7weeklysessions

ofguided

yoga

(Tsa

lung

trul

khor

yoga)

(1)S

leep

disorder

improved

(2)D

espair,

anxiety,depressio

n,fatig

ueno

tsig

nificant,patie

nt’sappraisalp

ositive

Manyou

tcom

esin

small

popu

latio

nincreased

prob

abilityof

significant

results

caused

byrand

omvaria

tions;highdrop

-out

rate;low

compliance

Feldhaus

2004

CS Switzerland

Perip

heralarterial

occlu

sived

isease

(BM,unspecified

CAM)

I:1w

oman

(61);D

:0

1year

P28,3×2U

/d;intestin

alcle

ansin

g(in

testinalhydrotherapy

andmicrobacterial

treatment),

chelationtherapy,oxygenation

therapy,orthom

olecular

treatment,IV

treatmentw

ithrib

onucleicacid

(1)G

eneralcond

ition

muchim

proved

after

8mon

ths

(2)W

alking

distance

improved

(<100m

to>2000

m)

Noattributionof

effectto

TMpo

ssible


Table2:Con

tinued.

Stud

yTy

pe∗

Cou

ntry

Dise

ase(diagno

stic

syste

m)∗∗

Participants

(meanage),

drop

-outs∗∗∗

Durationof

interventio

nor

study

kind

,doseo


(1)M

ainou

tcom

e(2)O

ther

outcom

esNotes

Feldhaus

2006

CS Switzerland

Chronicc

onstipatio

nof

tetraplegicp

atients

(BM,unspecified

CAM)

I:3;D:0

1–3mon

ths

I:PL

,1×1-2

U/d;

intestinalcle

ansin

g(in

testinal

hydrotherapy

andmicro

bacterial

treatment),

chelationtherapy,otherC

AM

(1)C

onstipatio

ncuredin

allcases

Noattributionof

effectto

TMpo

ssible

FlückandBu

bb1970

OS(M

C)Sw

itzerland

Chronicc

onstipatio

n(BM)

I:285(256

outpatients,

29inpatie

nts)

“Several”

weeks

PL,1×1U

/d(1)S

ymptom

simproved

in82%

(2)U

nwantedeffectsin

6.3%

Insufficientd

escriptio

nof

popu

latio

n,inclu

sion

criteria

,and

diagno

stics

Füllemann2006

OS

Switzerland

Chronicd

ental

pulpitis(BM

)I:53;D

:415

days

P28,2×2U

/d

(1)P

ain-fre

ewith

in1m

onth

in55%

(2)E

xtractionor

root

canaltreatmentn

otnecessaryin

82%

Com

paris

onwith

expectationfro

mexperie

nce;4drop

-outs

becauseo

fincom

pliance

might

have

caused

false

positiver

esult

Gladysz

etal.1993

OS

Poland

HepatitisB

(BM)

I:34

12mon

ths

P28,3×2U

/d

(1)S

erologicalandliver

functio

nparameters

improved

in76.5%,liver

biop

syim

proved

in55.9%

(2)O

ther

parameters(GGT,GPT

,bilirubin,

and

albu

min)u

nchanged

Authorsc

laim

elim

ination

potentialfor

HBe

Agand

HBV

-DNAsim

ilarto

interfe

ronstandard

therapy;un

wantedeffects

notstated

Gün

sche

2005

CS Switzerland

Bipo

larD

isorder

(BM)

I:1w

oman

(44);D

:011mon

ths

P28,3×2U

/dfor6

weeks,then3×1/d

(1)a

nd(2)D

aytim

esleepiness,concentration

difficulties,and

apathy

muchim

proved

with

in6

weeks,cured

after

11mon

ths

Onlysubjectiv

eoutcomes

Hürlim

ann1979/1

RCT(3)

Switzerland

Perip

heralarterial

occlu

sived

isease

(BM)

I:13;C

:11;D:

0

12weeks

I:P2

8,3×2U

/dC:

Placebo

(1)P

ainfre

ewalking

distance

improved

by54%

(2)O

ther

symptom

simproved

in69%,n

ochange

inplethysm

ograph

y

Goo

dstu

dydesig

n,ho

mogenou

sgroup

s,very

briefp

resentationof

results,

valid

results

Hürlim

ann1979/2

OS

Switzerland

Perip

heralarterial

occlu

sived

isease

(BM)

I:10;D

:0Durationno

tstated

P28,3×2U

/d.

(1)R

estp

ainim

proved

in70%

Very

briefp

resentation,

duratio

nno

tstated

Jank

owskietal.1986

OS

Poland

Recurrentrespiratory

tractinfectio

ns(BM)

I:61

(2years);

D:0

8weeks

P28,3×1U

/dor

3×0.5U

/ddepend

ingon

age,4weeks

P28—

2weeks

pause—

2weeks

P28

(1)F

requ

ency

andintensity

ofinfections

redu

ced

in80%

(2)Immun

oglobu

linsa

ndBcells

unchanged,T

cells

norm

alized,phagocytic

activ

ityof

leucocytes

increased,appetiteincreased

Immun

ologicalanalysisdid

notinclude

allp

articipants

Jank

owskietal.1991

CT Poland


tractinfectio

ns(BM)

I:19;C

:10

(health

y);(3

years);D

:0

8weeks

P28,3×1U

/d,4

weeks

P28—

2weeks

pause—

2weeks

P28

(1)B

acteric

ideind

ex(“spon

taneou

sbacteric

idal

activ

ity”)im

proved

in84%

Effectn

otcle

arly

attributablebecauseo

fhealthycontrols;

teste

dbacteriano

ttypicalfor

disease;un

usualoutcome

parameter


Table2:Con

tinued.

Stud

yTy

pe∗

Cou

ntry

Dise

ase(diagno

stic

syste

m)∗∗

Participants

(meanage),

drop

-outs∗∗∗

Durationof

interventio

nor

study

kind

,doseo


(1)M

ainou

tcom

e(2)O

ther

outcom

esNotes

Jank

owskietal.1992

OS

Poland


tractinfectio

ns(BM)

I:305(4

years)

10weeks

P28,3×1U

P28or

3×0.5U

depend

ingon

age

(1)F

requ

ency

andintensity

ofinfections

redu

ced

in72%

(2)IncreaseinCD

2+,C

D4+

lymph

ocytes,and

CD4/CD

8qu

otient

Possiblyrepu

blish

eddata

from

earlier

studies;

immun

ologicalresults

from

48participantson

ly(rando

mized?)

Korw

in-Piotro

wska

etal.

1992

RCT(2)

Poland

Multip

leSclerosis

(BM)

I:50;C

:50;

D:0

12mon

ths

I:P2

8,3×2U

/dC:

Placebo,symptom

atictre

atment

(1)C

linicalcourse

(relapse

frequ

ency

orprogression)

improved

in44

%(2)E

vokedpo

tentials:

visualim

proved

in33%,

acou

sticu

nchang

ed

Other

treatmentinplacebo

grou

p

Leem

anetal.2001

OS

USA

Breastcancer

(BM,

TM)

I:11;D

I:2

1year

2–4herbalpreparations,2–6×/d;diet,

lifestyleregulation,

prayer;every

3–4

mon

thsa

djustm

ento

fprescrip

tion

(1)N

oun

wantedeffectsgradeIIIor

IV(2)1

patie

nt’stumor

regressed,2weres

tablefor

>12

mon

ths,6progressed

Nopeer-reviewed

publication;

nostatem

ents

abou

tdrop-ou

t’sou

tcom

es(possib

lydiseasep

rogress)

Li2001

OS(M

C)Lh

asaP

refecture,

China

Helicobacter

pylori

associated

gastr

itis

(BM,T

M)

I:86

Max.8

weeks,follow-upof

24patie

ntsa

fter

5mon

ths

TM,m

ax.8

weeks

(1)H

elicobacter

testno

tchanged

(2)C

linicalparametersimproved

in76.3%–100%

(depending

oncategory),symptom

intensity

improved

Therapyaccordingto

Tibetandiagno

sticsin9

“medicationgrou

ps”;

selectionof

follo

wup

grou

pno

tstated

Mansfe

ld1988

CT Switzerland


tractinfectio

ns(BM)

I:218;C:

205;

(11y

ears);D:

3

6weeks,thenob

servationfor6

–12mon

ths

I:P2

8,3×

1U/d,biomedicinew

henneeded,

mou

ntainairc

ure

C:biom

edicinew

henneeded,m

ountainair

cure

(1)F

requ

ency

andseverityof

infections

tend

edto

improve(no

tsignificant)

(2)Immun

oglobu

lines

andinflammation

parametersn

otsig

nificant

Parentsa

ssessedinfection

severity;othertherapies

might

have

maskedP2

8effect

Mehlse

netal.1995

RCT(5)

Denmark

Perip

heralarterial

occlu

sived

isease

I:20;C

:20;

D:4

4mon

ths

I:P2

8,2×2U

/dC:

gelatine

(1)M

ax.w

alking

distance

improved

(2)P

ain-fre

ewalking

distance

improved,n

ochange

inbloo

dpressure

andbloo

dpressure

ratio

ankle/up

pera

rm

Excellent

study

desig

n

Miller

etal.200

9RC

T(5)(MC)

LhasaP

refecture,

China

Post-

partum

haem

orrhage(BM

,TM

)

I:480;C:

487;

D:7

Sing

ledo

seI:Zh

iByed11,

3U,and

placebo

C:Miso

prostol,60

0𝜇g,andplacebo

(1)M

isoprostolsup

eriortoZh

iByed11for:

Hem

orrhage,maternaldeath,needforu

terotonics

(2)N

osig

nificantd

ifference

form

eanandmedian

bloo

dloss

Nam

duletal.2001

RCT(1)(MC)

India

Type

2Diabetes(BM

,TM

)

I:100;C:

100;

D:88(64

after

12weeks)

24weeks

I:Ky

ura-6,Aru-18,Yu

ng-4,and

Sugm

el-19,

daily

+lifes

tyleregu

latio

n+dietaccording

toAmerican

DiabetesA

ssociatio

nC:

lifes

tyleregulation+dietas

above

(1)F

astin

gbloo

dglucoser

educed

(2)P

ostprand

ialblood

glucosea

ndHbA

1credu

ced,we

ight,blood

pressure,and

bloo

dlip

ids

unchanged

Interventio

ngrou

pmoreill

despite

rand

omization;

values

ofinterventio

ngrou

ptakenas

baselin

e;high

drop

-out

ratewith

out

furthera

nalyses


Table2:Con

tinued.

Stud

yTy

pe∗

Cou

ntry

Dise

ase(diagno

stic

syste

m)∗∗

Participants

(meanage),

drop

-outs∗∗∗

Durationof

interventio

nor

study

kind

,doseo


(1)M

ainou

tcom

e(2)O

ther

outcom

esNotes

Neshar2

000

OS

India

Diabetesm

ellitus

(BM,T

M)

I:82;D

:0(study

ofpatie

ntfiles)

Min.6

mon

ths

Yung

-4,K

yuru-6,C

hinn

i-Aru-18,and

Sugm

el-10,daily

+lifestyleanddiet

regu

latio

n

(1)B

lood

glucoseimproved

in70%,stabilized

in100%

(2)Improvem

entsin

subjectiv

esym

ptom

s(92%),

andneed

forb

iomedicinein68%

Regardinggeneral

improvem

ent

discrim

inationbetween

TMalon

eorw

ithadditio

nalbiomedicine:itis

notclear

whether

biom

edicinew

asgivenat

baselin

eorb

ecam

enecessarydu

ringstu

dy;

mostd

atar

efer

toa

subp

opulationof

24thatis

notd

escribed:selectio

nbias?

Neshar2

007

OS

India(

MC)

Cancer

(BM,T

M)

I:647;D:340

Varyingdu

ratio

nTradition

alTM

(not

furtherspecified)

(1)G

eneralhealth

statemuchim

proved

(2)Improvem

entsin

progression,

infections,pain,

sidee

ffectso

fchemotherapy

andradiationtherapy

Selectionof

patie

ntsn

otrepresentativ

e,high

drop

-out

rate

Pauw

vlietetal.1997

OS

Netherla

nds

Rheumaticdisorders

(BM,T

M)

I:35;D

:76mon

ths

Tradition

alTM

(not

furtherspecified)

(1)S

everity

ofdiseaseimproved

(2)Improvem

entsin

pain,num

bero

fdise

ased

partsg

eneralwell-b

eing

,and

mentalcom

plaints

Highdrop

-out

rate,4

ofthem

becauseo

faggravation;

prepub

lication

with

outlaboratorydata

Prusek

etal.1987

CT(6

arms)(M

C)Po

land


tractinfectio

ns(BM)

I:30;C

1:23;

C2:10;C3

:29;C

4:25;

C5:20;(4

years);D

:0

11mon

ths

I:P2

8,3×1U

/dfor1

mon

thC1

:levam

isole,

3mg/kg:for

2×3d

C2:thymus

factorx,1m

g/kg

for3

weeks

C3:bacteria

llysate,3.5m

g/dfor3×10d

C4:clim

atec

urefor

6weeks

C5:health

yprob

ands

(1)F

requ

ency

andseverityof

infections

improved

in57%(le

ssthan

controls)

(2)Immun

oglobu

lines

notchanged,T

cells

improved

Com

parabilityof

grou

psun

clear

(allo

catio

nby

clinicalind

ication);

statistic

alevaluatio

nno

tsufficient

Rüttg

ers2

004

CS Switzerland

Chronicv

enou

sinsufficiency

(BM)

I:1;D:0

3mon

thsa

ndfollo

w-up

P28,3×1U

/dandbiom

edicalstandard

(no

prim

arily

angiological)therapy

(1)Infl

ammationim

proved

(2)O

edem

aand

pain

improved;rem

issionfor>

6mon

ths;healingfaste

rund

erP2

8

Ryan

1997

RCT(3)

India

Arthritis(BM

,TM)

I:15;C

:15;D:

2

3mon

ths

I:tradition

alTM

(not

furtherspecified)

C:biom

edicaltre

atment

(1)M

otilityof

extre

mities

improved,in86%of

the

matched

pairs

theT

Mpatie

ntbette

rthan

respectiv

econ

trol

Inclu

sionby

Tibetan

diagno

sis;nofurtherd

etails

tomatched

pairs

;onlytwo

pairs

ofarthritispatie

nts

Sallo

netal.1998

RCT(4)

Israel

Perip

heralarterial

occlu

sived

isease

(BM)

I:37;C

:35;D:

13

6mon

ths

I:P2

8,2×2U

/dC:

potato

starch

(1)A

nkle-brachial-ind

exun

changed

(2)Improved:pressured

ecrease,isc

haem

iatim

e,andpatie

nt’sassessment

Sallo

netal.2002

RCT(4)

Israel

Chronicc

onstipatio

n(BM)

I:42;C

:38;

D:19

12weeks

I:PL

,2×2U

/d,

C:po

tato

starch

(1)Improved

intestinalpassage

(2)Improved

abdo

minalpain

(physic

ian’s

assessment)andeveryday

activ

ity(patient’s

assessment)

Com

prehensiv

estudy

documentatio

n


Table2:Con

tinued.

Stud

yTy

pe∗

Cou

ntry

Dise

ase(diagno

stic

syste

m)∗∗

Participants

(meanage),

drop

-outs∗∗∗

Durationof

interventio

nor

study

kind

,doseo


(1)M

ainou

tcom

e(2)O

ther

outcom

esNotes

Samocho

wiece

tal.

1987

RCT(4)

Poland

Perip

heralarterial

occlu

sived

isease

(BM)

I:55;C

:45

4mon

ths

I:P2

8,2×2U

/dC:

lactose

(1)Improved

max.w

alking

distance

(2)U

pper

arm

bloo

dpressure

unchanged,

improved:totalbloo

dlip

ids,𝛽-lipo

proteins,

thrombo

cyteaggregationthreshold

Nopatie

ntdemograph

ics;

comparis

onon

lyto

baselin

e,no

tbetween

grou

ps

Sang

moetal.2007

RCT(2)

India

HepatitisB

(BM,T

M)

I:24;C

:25;

D:1

6mon

ths

I:SpecialT

M,(no

tfurther

describ

ed)

C:Tradition

alTM

(1)N

odifferences

betweengrou

ps(2)B

othgrou

pstend

edto

improvem

entsin

liver

functio

nandim

proved

clinically

SpecialT

Mgrou

pmoreill

atbaselin

e;almostn

oappraisalofresults;

possibly

overtesting

;very

comprehensiv

edo

cumentatio

nalso

ofTibetandiagno

stics

Schleicher

1990

OS

Germany

Acqu

iredim

mun

edeficiencysynd

rome

(BM)

I:15;D

:56mon

ths

P28,3×3U

/d

(1)T

otalTcells

stabilized

(2)S

tabilized:sup

pressor-cytotoxicc

ells,

helper-in

ducerc

ells,

andlymph

ocytes;

unchanged:Bcells

andkillerc

ells;

increase

ingranulocytes

andph

agocytosis

Nopatie

nt-centre

dparameters;progno

stically

mostrele

vant

CD4cell

coun

tand

viralloadno

tdo

cumented

Schrader

etal.1985

RCT(4)

Switzerland

Perip

heralarterial

occlu

sived

isease

(BM)

I:27;C

:26;

D:10

4mon

ths

I:P2

8,3×2U

/dC:

lactose

(1)Improved

max.w

alking

distance

(2)Improved

pain-fr

eewalking

distance

Smulskiand

Wojcicki1994

RCT(5)

Poland

Perip

heralarterial

occlu

sived

isease

(BM,T

M)

I:50;C

:50;

D:7

4mon

ths

I:P2

8,2×2U

/dC:

lactose

(1)M

ax.w

alking

distance

improved

(2)P

atient’sassessmentm

orep

ositive,improved

totalblood

lipids,triglycerid

es,low

density

lipop

roteins

Com

paris

onof

grou

pson

lyforw

alking

dista

nce

Split

etal.1998

RCT(2)

Poland

Apop

lexy

(BM)

I:60;C

:60

14days

I:P2

8,3×2U

/d+biom

edicalstandard

therapy

C:biom

edicalstandard

therapy

(1)B

etterg

eneralsta

tus(Ka

rnofskyfunctio

nal

efficiency

scale,KF

ES)

(2)B

etterT

cells,B

cells,and

clinicalprogress

Age

notstated,no

blinding

,no

placebo,comparis

onon

lyun

derstand

ablefor

KFES

,therapy

effectn

otdiscerniblefrom

placebo

effect

Wojcickietal.1986

CT Poland

Coron

aryheart

disease,angina

pectoris(BM)

I:50

6weeks

Placebo,2weeks—P2

8,2×2U

/d,2

weeks—placebo,2weeks

(1)N

itroglycerin

eneedredu

ced

(2)Improvem

ento

fexercise

capacity,platele

taggregation,

andbloo

dlip

ids

Norand

omization

(con

traryto

publication

statem

ent);

descrip

tion

difficultto

understand

;selectionof

patie

ntsfrom

larger

popu

latio

nno

tclear;

shortverum

perio

d∗

(r)C

S:(retrospectiv

e)case

study

;CT:

controlledtrial(no

trando

mized);OS:ob

servationalstudy

;RCT

:rando

mized

controlledtrial(with

Jadadsum

score);M

C:multic

entre

study.

∗∗

BM:B

iomedicine(the“

Western”“conventio

nal”medicine);T

M:T

ibetan

medicine;CA

M:com

plem

entary

oralternativem

edicine.

∗∗∗

I:interventio

ngrou

p(TM);C:

controlgroup

(other

treatment,placebo);D

:totaldrop

outs.

∗∗∗∗

U:unit(tablet,capsule,

orpill);/d:perd

ay;P

28:Padma2

8;PL

:PadmaL

ax.

10 Evidence-Based Complementary and Alternative MedicineTa

ble3:DIM

DIH

TAchecklist

results.

Participants

Allo

catio

nInterventio

nAd

ministratio

nOutcome

Drop-ou

tsStatistics

Stud

y

Itemno.(label)∗

A1(in-/exclusion)

A2(pre-defined)

A3(healthstatus)

A4(diagnosticcriteria)

A5(representativity)

B1(basicpopulation)

B2(comparable)

B3(randomization)

B4(blindedrandomization)

B5(confounders)

C1(recording)

C2(similartreatment)

C3(othertreatments)

C4(placebouse)

C5(placebodocumented)

D1(overmatching)

D2(multicentre)

D3(nocrossover)

E1(patient-centred)

E2(recording)

E3(blindedoutcomes)

E4(prognosticfactors)

F1(evaluablenumber)

F2(reasons)

F3(outcomes)

F4(significance)

F5(relevance)

G1(correct)

G2(CIsgiven)

G3(graphics)

Rand

omized

controlled

trials

Brun

ner-LaRo

ccae

tal.2005

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YN

YY⋅

YY

Y⋅⋅

YN

YCoh

enetal.200

4Y

YY

NY

YY

?Y

YY

Y⋅

N⋅

N⋅

YY

YN⋅

?Y

N⋅⋅

YY

NHürlim

ann1979/1

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

Y?⋅

Y⋅⋅⋅⋅

YN

NKo

rwin-Piotro

wskae

tal.1992

YY

YN

YY

Y?

NY

YN

NN⋅

N⋅

YY

Y?⋅

Y⋅⋅⋅⋅

YN

NMehlse

netal.1995

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

YY

N⋅⋅

YY

NMiller2009

YY

YY

YY

Y?

YY

YY⋅

YY

N?

YY

YY⋅

YY

N⋅⋅

YN

NNam

duletal.2001

YY

YY

YY

Y?

??

YY⋅

N⋅

NY

YY

Y?⋅

YN

N⋅⋅

YN

NRy

an1997

YY

YY

?Y

Y?

?Y

YY

YN⋅

N⋅

YY

YN⋅

YN

N⋅⋅

YN

NSallo

netal.1998

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

?Y

N⋅⋅

YY

YSallo

netal.2002

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

YY

N⋅⋅

YN

YSamocho

wiece

tal.1987

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

Y⋅⋅⋅⋅

YN

YSang

moetal.2007

YY

YY

YY

Y?

??

NY⋅

N⋅

N⋅

YY

YN⋅

YY

N⋅⋅

YN

NSchrader

etal.1985

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

YY

N⋅⋅

YN

NSm

ulskiand

Wojcicki1994

YY

YY

YY

YY

YY

YY⋅

YY

N⋅

YY

YY⋅

YY

N⋅⋅

YY

YSplit

etal.1998

YY

NN

?Y

Y?

??

YY⋅

N⋅

N⋅

YY

Y?⋅

Y⋅⋅⋅⋅

YN

N

Con

trolled

trials

Brzoskoetal.1991

YY

YY

YY

NN⋅

NY

Y⋅⋅⋅

N⋅

YY

YN⋅

Y⋅⋅⋅⋅

YN

NJank

owskietal.1991

YY

YY

YN

NN⋅

NY

N⋅⋅⋅

N⋅

YN

YN⋅

Y⋅⋅⋅⋅

YN

NMansfe

ld1988

YY

YN

YY

?N⋅

?Y

Y⋅⋅⋅

N⋅

YY

?N⋅

Y⋅⋅⋅⋅

YN

YPrusek

etal.1987

YY

YY

YY

NN⋅

NY

?⋅⋅⋅

NN

YY

?N⋅

Y⋅⋅⋅⋅

YN

NWojcickietal.1986

YY

YY

YY

YN⋅

YY

Y⋅⋅⋅

N⋅

YY

YN⋅

Y⋅⋅⋅⋅

YN

N

Observatio

nstu

dies

Ascho

ffetal.1997

YY

YY

Y⋅⋅⋅⋅

YY

NN⋅⋅⋅⋅⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NBrzoskoandJank

owski1992

YY

?N

Y⋅⋅⋅⋅

?Y

?⋅⋅⋅⋅⋅⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NFlückandBu

bb1970

YY

YY

Y⋅⋅⋅⋅

NY

?⋅⋅⋅⋅

Y⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NFü

llemann2006

YY

YY

Y⋅⋅⋅⋅

YY

NN⋅⋅⋅⋅⋅

YY⋅⋅

YY

YN

NY

NN

Gladysz

etal.1993

YY

YY

Y⋅⋅⋅⋅

YY

Y⋅⋅⋅⋅⋅⋅

NY⋅⋅

Y⋅⋅⋅⋅

YN

NHürlim

ann1979/2

YY

YY

Y⋅⋅⋅⋅

?Y

?⋅⋅⋅⋅⋅⋅

YN⋅⋅

Y⋅⋅⋅⋅

YN

NJank

owskietal.1986

YY

YY

Y⋅⋅⋅⋅

NY

?⋅⋅⋅⋅⋅⋅

YY⋅⋅

Y⋅⋅⋅⋅

YY

N


Table3:Con

tinued.

Participants

Allo

catio

nInterventio

nAd

ministratio

nOutcome

Drop-ou

tsStatistics

Stud

y

Itemno.(label)∗

A1(in-/exclusion)

A2(pre-defined)

A3(healthstatus)

A4(diagnosticcriteria)

A5(representativity)

B1(basicpopulation)

B2(comparable)

B3(randomization)

B4(blindedrandomization)

B5(confounders)

C1(recording)

C2(similartreatment)

C3(othertreatments)

C4(placebouse)

C5(placebodocumented)

D1(overmatching)

D2(multicentre)

D3(nocrossover)

E1(patient-centred)

E2(recording)

E3(blindedoutcomes)

E4(prognosticfactors)

F1(evaluablenumber)

F2(reasons)

F3(outcomes)

F4(significance)

F5(relevance)

G1(correct)

G2(CIsgiven)

G3(graphics)

Jank

owskietal.1992

YY

YY

Y⋅⋅⋅⋅

NY

Y⋅⋅⋅⋅⋅⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NLeem

anatal.2001

YY

YN

Y⋅⋅⋅⋅

NN

NN⋅⋅⋅⋅⋅

YY⋅⋅

YN

N⋅⋅

YN

NLi

2001

YY

YY

Y⋅⋅⋅⋅

YN

Y⋅⋅⋅⋅

Y⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NNeshar2

000

YN

YY

Y⋅⋅⋅⋅

NY⋅⋅⋅⋅⋅⋅⋅

YN⋅⋅

?⋅⋅⋅⋅

NN

NNeshar2

007

YY

?Y

?⋅⋅⋅⋅

?Y⋅⋅⋅⋅⋅

Y⋅

YY⋅

NY

NN⋅⋅

YN

NPauw

vlietetal.1997

YY

YY

Y⋅⋅⋅⋅

?Y

NY⋅⋅⋅⋅⋅

YY⋅⋅

Y⋅⋅⋅⋅

YN

NSchleicher1990

YY

YY

Y⋅⋅⋅⋅

NY

?N⋅⋅⋅⋅⋅

NY⋅⋅

?⋅⋅⋅⋅

YN

N

Case

studies

Bommeli

etal.2001

YY

YY

Y⋅⋅⋅⋅

YY

NN⋅⋅⋅

Y⋅

YY⋅

NY

YN⋅⋅

YN

NCh

angbar

1998

Y⋅

YY

N⋅⋅⋅⋅⋅

Y⋅⋅⋅

Y⋅⋅⋅

YY⋅

NY⋅⋅⋅⋅⋅⋅

NFeldhaus

2004

Y⋅

YY

N⋅⋅⋅⋅

?Y⋅⋅⋅⋅⋅⋅⋅

YY⋅

NY⋅⋅⋅⋅⋅⋅

NFeldhaus

2006

YY

YY

Y⋅⋅⋅⋅

?Y

N⋅⋅⋅⋅⋅⋅

YY⋅

NY⋅⋅⋅⋅⋅⋅

NGün

sche

2005

Y⋅

YY

N⋅⋅⋅⋅

YY⋅⋅⋅⋅⋅⋅⋅

YN⋅

NY⋅⋅⋅⋅⋅⋅

NRü

ttgers2

004

Y⋅

YY

N⋅⋅⋅⋅

NY⋅⋅⋅⋅⋅⋅⋅

YN⋅

NY⋅⋅⋅⋅⋅⋅

NY:

yes;N:no;?:un

clear/not

stated;⋅:not

applicable.

∗

Fullitem

text

inTable1.


Table 4: Jadad Score Results for Included RCTs.Randomization Blinding Drop-outs Sum score

Brunner-La Rocca et al. 2005 2 2 1 5Cohen et al. 2004 2 0 0 2Hürlimann 1979/1 1 2 0 3Korwin-Piotrowska et al. 1992 1 0 1 2Mehlsen et al. 1995 2 2 1 5Miller 2009 2 2 1 5Namdul et al. 2001 1 0 0 1Ryan 1997 2 0 1 3Sallon et al. 1998 1 2 1 4Sallon et al. 2002 1 2 1 4Samochowiec 1987 1 2 1 4Sangmo et al. 2007 1 0 1 2Schrader et al. 1985 1 2 1 4Smulski and Wojcicki 1994 2 2 1 5Split et al. 1998 1 0 1 2

on Padma 28 or Padma Lax had higher Jadad scores thanstudies on other treatments: 3.70 ± 1.06 (median = 4) versus2.60 ± 1.51 (median = 2).

All studies followed conventional “Western” medicaldiagnoses. Additional traditional TM diagnostics wererecorded in 11 studies that investigated the traditional mul-timodal treatment. In 9 of them, the Tibetan diagnosis wasused to plan the therapy [39, 42, 43, 45, 48, 58, 59, 62, 76].

Thirty studies including 3497 patients (74.7% from allincluded studies) investigated single formulations: Padma 28(𝑛 = 25 studies), Padma Lax (3), Byu-Dmar 13 (1), andZhi Byed 11 (1). The complex traditional Tibetan treatmentwas studied in 9 trials that included a total of 1140 (24.3%)patients.Here, and in the Padma 28 studies, the treated condi-tions varied widely. For example, Padma 28 was investigatedfor arteriosclerosis, infections, neurological disorders, venousinsufficiency, arthritis, and hypercholesteraemia.

Assessed outcomes included clinical outcomes such assymptom scales (𝑛 = 37 studies), laboratory tests (19), clinicaltests (such as ankle/brachial pressure index, blood pressure,or weight; 9), and other (9), such as microbiology, histology,or the need for conventional medication. The authors drewpositive conclusions on their data in 34 studies. In 2 RCTs,TM was found to be inferior to conventional medicine,but better than placebo [44, 46]. In one study, only 1 of 5outcomes improved [60]; in 2 studies the primary outcomedid not change significantly while secondary outcomes did[42, 52]. The comparison of the traditional and a not furtherspecified “special” Tibetan medicine [59] resulted in compa-rable clinical improvements.The remaining studies found nosignificant differences to controls [49, 65], or their authorswere doubtful about the observed effects [39]. Statementsabout adverse effects were included in 23 studies, in 11 ofthem no adverse effects were reported, and 2 studies did notmention the number of patients with adverse effects [39, 53].The remaining 10 studies reported adverse effects with a rangefrom 5% to 55% of the patients.

Some disease groups were researched in several trials.Peripheral arterial occlusive disease was treated with Padma

28 in 9 studies (6 RCTs, (the first study in [38], [51–55]))1 observation study, (the second study in [38]) and 2 casestudies [40, 72]. Maximum walking distance increased in 5studies (the first study in [38], and [51, 53–55]). Both casestudies and the observational study reported a general clinicalimprovement. The ankle/brachial pressure index in 1 RCT[52] was unchanged. All authors made a positive conclusionregarding Padma 28.

Five studies (3 non-randomized controlled trials [46, 53,65] and 2 observation studies [70, 71]) investigated Padma28 for recurrent respiratory tract infections in children.Improvements were seen for frequency of infections [70, 71]or spontaneous bacterial activity [64]. In 1 of the controlledtrials, no significant difference to standard therapy was found[65], and in another study, inferiority to other therapies wasreported [46].

Osteoarthritis or rheumatoid arthritis was treated inthree trials: 1 RCT [58] and 1 observational study [62] withthe traditional multimodal approach, and with Padma 28in 1 controlled trial [66]. All studies reported pre-/post-improvements or superiority to controls regarding symptomseverity.

Padma Lax in chronic constipation was the subject ofthree studies (1 RCT [57], 1 controlled trial [75], and 1 obser-vational study [41]). All reported clinical improvements.

In 3 other trials, hepatitis B patients were either treatedwith a “special” TM (that was not further specified) incomparison to traditional TM (1 RCT [59]) or with Padma 28(2 observational studies [47, 69]). All publications reportedpositive results for laboratory outcomes. The comparison oftraditional and “special” traditional TM found comparableimprovements but did not achieve seroconversions.

4. Discussion

In this paper, we presented an overview of the clinicalresearch on traditional Tibetan medicine (TM) that is cur-rently available in the West. Three quarters of the includedstudies tested single formulations, most of them products of


a single company. One quarter investigated the traditionalmultimodal TM approach. Studies were very heterogeneousregarding study type and size, treated conditions, treatments,measured outcomes, and quality.

In this, to our knowledge, first systematic overview ofclinical TM research available in the West, we tried tominimize subjectivity using pre-defined systematic methodswherever possible (data extraction sheets, established qualityassessment tools). However, the small number of trials scat-tered over a whole medical system and very heterogeneoustreated diseases prohibitedmore formal or in-depth analyses.

Despite the broad literature search, some studies may nothave been identified, for various reasons. Although Mongo-lian and Tibetan medicine are not completely identical, wehave included “mongolian” in the search terms in order tofind asmuch relevant literature as possible.We did not searchfor single TM interventions such as bathing or bloodlettingand assumed that they are well covered under the umbrellaterm “medicine.” Although we detected with this search astudy on Tibetan yoga [60], we possibly missed other studies.Furthermore, publication bias could have had occurred, assome papers [11, 15, 58] indicated the existence of studiesthat have not been published (or at least not in indexedjournals) [77–82]. Several papers were not identified byour search strategy in the literature databases, but couldhave been found searching for “Padma 28” or “Padma Lax.”Clearer labelling of TM studies in the future would behelpful. On the other hand, our search seems to have beenpartly redundant, as all identified publications could havebeen found with fewer search terms. The main limitation isthat our language restriction excluded articles in Russian,Tibetan, and Chinese. This literature was not accessiblefor us. Furthermore, we learned from our field work andfrom discussions with Western and Chinese manufacturersduring an interdisciplinary symposium on TM [16] thatmost literature on clinical research published in Tibetan isnot available in indexed journals and that most researchpublished in Chinese addresses preclinical questions.

The evaluated literature presented a high number ofstudies without a control group. Only a few single productswere subject to in-depth investigation. Both facts indicate anearly stage of research in a new and largely unexplored fieldwhere only few focused inquiries exist. The predominatingcountries of origin (>2/3 European) and the 70% of studieson Padma products among the included literature are conse-quences of the language restrictions of our search as well asof the historical development of TM utilization in the West.Although they are prescribed in a standardized and nonindi-vidualized fashion, the Padma products are a genuine Tibetanmedication according to manufacturers, study authors, andindependent experts [17, 83, 84]. Adaptation of constituentsto local situation and ecology is an accepted practice in TM.It was done in one study when Tibetan physicians reducedthe traditional Byu-Dmar 25 by 12 ingredients to comply withTibetan pharmacopoeia and European regulations, resultingin Byu-Dmar 13 [63]. A similar strategymight have been usedin two other studies [39, 62].

The heterogeneous nature of the included studiesdemanded the use of quality assessment instruments that

were suitable for diverse study designs, but have the generaldisadvantage of allowing only rough estimates of theassessed quality. Nevertheless, they allowed spotting themore obvious deficiencies that are symptomatic of researchat an early stage and that future research can avoid withimproved methodology on the grounds of evidence-basedmedicine. Case studies and observational studies are usefulto gather information on traditional usage and settings andto identify areas where controlled studies seem promising.Then, to provide higher-level evidence, more RCTs willbe needed. Methodological issues such as small samples,insufficiently described populations in many studies,pre-/post-comparisons of treatment within a group, orcomparator treatments without clinical relevance all indicatethat TM research as seen through the Western literatureis still at a nascent stage. Furthermore, the quality of moststudies and the heterogeneity of interventions and outcomesmake clear conclusions impossible.

5. Conclusion

The clinical research on traditional Tibetan medicine (TM)that is available in Western industrialized countries is scarceand scattered over a whole medical system, but showsinteresting results. Better research methodology should beapplied, and larger trials are needed, as is a general overviewof traditional usage to inform future clinical research.

Acknowledgments

This work was supported within a grant of the Chair forComplementary Medicine Research, funded by the Karl andVeronica Carstens Foundation, Essen, Germany.The authorsstate that they have no conflict of interests.

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