Indonesia_Common Research Guideline on TM

8/13/2019 Indonesia_Common Research Guideline on TM

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DRAFT

ASEAN COMMON GUIDELINE ON

RESEARCH OF HERBAL MEDICINES

[As part of TM/CAM]

(Revse! verso"# $o"s!er"% t&e "p'ts of ')*

+,t& -,+.# Co"s')tatve or0s&op# t&e Mer$'re#

A"$o)1

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Fore2or!

It has been realized by ASEAN Member States that research and developmentpertaining to Traditional Medicine (TM) is an important issue in order to integrate orto synergize TM into the national health care system !esearch and development is

a tool or a step to provide scienti"ic evidence #ith regard o" e""icacy and sa"ety "orhuman use o" TM "or prevention$ treatment$ or rehabilitation$ o" health problems$acting as either alternatives or complementary modalities

In an e""ort to synchronize on ho# research and development o" TM is conductedamongst ASEAN member state in terms o" methodology$ it is important to develop%Common research guideline of herbal medicines. This guideline covers theessential principles o" research methodology on herbal medicines As the documentonly covers the essential principles$ each ASEAN Member State can or should"urther elaborate the document in order to ad&ust #ith their needs and local conte'tbased on their uniue traditional medicine and their regulations The rd ASEAN

*ocal +oint o" Traditional Medicine (AT*TM) Meeting recommended thatdevelopment o" guidelines should be prioritised to the need o" ASEAN and to be inline #ith e'isting guidelines$ such as$ ,eneral ,uidelines "or Methodologies on!esearch and Evaluation on Traditional Medicine (-./ ,uideline) and !eseach,uidelines "or Evaluating Sa"ety and E""icacy o" .erbal Medicine (-+!/)

0eeping in mind that herbal medicines has already been used in the community "romone generation to the ne't generation$ the research guideline #ill try to pay attentionnot only to e""icacy research$ but also the usage pattern research -ith regards tothe elaboration o" usage pattern$ the methodologies that can be used areethnomedicine study$ epidemiological study$ and health system study Mean#hile$"or proving the e""icacies$ the methodologies that can be used are e'perimentalstudy (randomized controlled trials double blind$ randomized trials open label$outcome study 2e"ore A"ter design$ or case report)

*or e""icacy study$ the pipeline o" modern drug development should be "ollo#ed Theresearches begin #ith pre3clinical study$ phase 1$ phase 4$ and phase clinicaltrials$ and then go to mar5eting approval .o#ever$ "or indigenous herbal medicine$#hich has enough e""icacy and sa"ety data "rom ethnomedicine and observationalstudy$ the trials can go directly to randomized clinical trials (phase clinical trial) Inthis case$ the e""icacy3driven approach o" clinical trial or reverse pharmacology

applies "or indigenous herbal medicine

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+age

*ore#ord 4

6ontents I INTRODUCTION 7

11 2ac5ground 7

14 /b&ective 7

1 Scope o" guideline

17 8e"inition o" Terms 9

1: !eseach priorities in ASEAN

19 Interrelation bet#een ASEAN common reseach

guideline #ith guidelines developed by other #or5ing

groups under ASEAN Economic 6ommunity

II GENERAL CONSIDERATIONS IN TM RESEARCH ;

41 E'pected level o" evidence =

III RESEARCH METHODS ON TM 1?

.3+ St'!* of 'sa%e patter" 1?

11 Ethnomedicine study 1?

14 Epidemiological study 1?

1 .ealth services study (health system study) 11

4 St'!* of Eff$a$* a"! Safet* 11

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.3.36 St'!* of eff$a$* a"! safet* of I"!%e"o's &er4a)TM

I USING THE GUIDELINES 1:

ANNEB 19

2I2

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I3 INTRODUCTION

I3+3 Ba$0%ro'"!

Traditional medicine (TM) has a long history and used #orld #ide$ ho#ever it variesgreatly "rom country to country The practice o" TM is in"luenced by a number o""actors such as culture$ history$ personal attitudes and philosophy In many cases$the theory and application o" TM are uite di""erent "rom those o" conventionalmedicine Even though it is claimed that TM is sa"e and e""ective as it is used "romone generation to another generation$ scienti"ic research is still needed "or providingrigorous evidence in relation to e""icacy and sa"ety

It has been ac5no#ledged that conventional medicine uses the paradigm o"evidence based3 medicine$ meaning that doctors can only use therapeutic modalities

that have been proved by uali"ied research to apply evidence based medicineprinciples The uantity and uality o" the sa"ety and e""icacy data on traditionalmedicine are "ar "rom su""icient to meet the criteria needed "or evidence basedmedicine practices

The reasons "or the lac5 o" research data are due not only to health care policies$ butalso to a lac5 o" adeuate or accepted research methodology "or evaluatingtraditional medicine In order that researchers on herbal medicines have the sameperspective and can conduct uali"ied research$ it is o" importance to establish acommon research guideline o" herbal medicines in ASEAN Member States *romthis document$ it is hoped that research on herbal medicines can be synchronized or

used as a re"erence in terms o" methodology on herbal medicines research amongstASEAN Member States

DNote Addition o" consideration o" -./ and -+!/ guideline

This guideline is a mandate "rom the AT*TM

.erbal medicine is a modality o" TM6AM

I3-3 O47e$tves

To provide Dminimum standards andF common principles in developingadeuate and accepted research methodology "or researching on herbal

medicines as TM6AM modalities in the ASEAN region

To provide scienti"ic data to support the development o" appropriate health

care system regulation as #ell as a milestone to integrate herbal medicines

into the national health care system

To ensure the sa"ety and e""icacy o" herbal medicines used in the health care

system o" AMS

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To strengthen and promote the rational use o" herbal medicines

I3.3 S$ope of G'!e)"e

As TM6AM modalities cover a number o" methods such as &erbal medicines$

acupuncture$ massage manipulation$ steam sauna$ spiritual$ e'ercise

(yoga)$ and diet$ this guideline is addressing research methodology "or herbal

medicines as modalities o" TM6AM

I363 Def"to" of Ter5s

Traditional Medicine is the sum total o" the 5no#ledge$ s5ills and practices

based on the theories$ belie"s and e'periences indigenous to di""erentcultures$ used in the maintenance o" health$ as #ell as in the prevention$diagnosis$ improvement or treatment o" physical and mental illnesses Theterms complementaryalternativenon3conventional medicine are usedinterchangeably #ith traditional medicine in some countries TM6AM consistso" herbal medicine and traditional procedure based therapies

.erbal medicine is a medicine that contains either ra# or processed

ingredients "rom one or more medicinal plants In some traditions$ materials o"animal origin may also be present .erbs include crude plant material such asleaves$ "lo#ers$ "ruits$ seeds$ stems$ #ood$ bar5$ roots$ rhizomes or othersplants parts .erbal medicines in this guideline can be divided into t#ocategories$ namely

o Traditional herbal medicine is herbal medicine that has been used by a

certain community "rom one generation to another generation andbecome indigenous 5no#ledge and practice o" the community

o Ne# herbs or ne# herbal medicine is herbal medicine that is not to be

indigenous 5no#ledge and practice o" the community$ or indigenousherbal medicine that is indicated "or ne# symptoms or ne# indication o"health problems

D Note 6hoice on the use o" GtraditionalH or GindigenousH herbal medicineF

Traditional procedure3based therapies are TM that use various techniues

primarily #ithout the use o" medication$ ie acupuncture$ massage$osteopathy$ naturopathy$ chiropractic$ thermal medicine$ etc

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!esearch is a systematic investigation to prove the truth by the use o"

rigorous research methodology

,uideline is a document to determine a course o" action$ aiming to streamline

particular process according to sound practice

6ommon guideline is a principle document to provide common principles that

can be elaborated "urther to go more operational

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I383Resear$& 9rortes " ASEAN

!esearch priorities "or herbal medicines in ASEAN member states AMS is

geared into health problems that to be the priorities in the member states As

the characteristics o" herbal medicine are more subtle than modern medicine$

it is advisable that the development o" herbal medicine is to address non

communicable diseases and other degenerative diseases$ especilally "or

promotive$ preventive$ treatment o" mild to moderate diseases or ad&unctive

therapies$ as #ell as pallitaive and rehabilitative therapy

+3:3 I"terre)ato" 4et2ee" ASEAN Co55o" Resear$& G'!e)"e 2t&

G'!e)"es Deve)ope! 4* Ot&er or0"% Gro'ps '"!er ASEANE$o"o5$ Co55'"t* 9))ar

[Note: input from the 3rdATFTM Meeting: To engage other related sectoral

working group in the upcoming consultation workshop]

[Note: Include one para how this guideline complements other guidelines,

another para on the issue of claims in connection with commercial product

orientation ]

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II3 GENERAL CONSIDERATION IN TM RESEARCH

II3+3 Le%a) $o"s!erato"

AMS should promote the rational use o" herbal TM that has been scienti"ically

validated To do so$ AMS should set a national policy "or "acilitating research and

rational use o" herbal TM Education and training o" herbal TM either "or health

pro"essionals and traditional healers are needed and should be standardized to

obtain certain level o" competencies !egistration o" TM practitioners is very

important as part o" national policy to guarantee the rational use o" herbal TM

DNote Include inputs "rom +ro" Agus$ regarding the e'isting situation o" TM6AM

#hether tolerant$ inclusive$ or integrative$ as this #ill implicate to research methodsF

II3-3 Et&$a) $o"s!erato"

!esearch on herbal TM has to be carried out in accordance #ith all relevant ethical

guideline either "or animals and human beings !esearch on animals must be carried

out #ith respect to their #el"are !esearch on human sub&ects must be carried out inaccordance #ith "our basic ethical principles$ ie &ustice$ respect "or persons$

bene"icence and autonomy It is advisable that "or research in traditional medicine$

including herbal medicines$ the Ministry o" .ealth research institutes could develop

special Ethical 6ommitee o" .ealth !esearch "or Traditional and 6omplementary

Medicine

II3.3 I"!%e"o's 0"o2)e!%e of &er4a) TM

.erbal TM has been used by traditional system o" health care "rom one generation to

another +rolonged use o" herbal TM may prove the sa"ety and e""icacy There"ore$

the research approach could should be di""erent bet#een indigenous herbal

medicines and the herbal medicine that has not been indigenously practiced in the

community (ne# herbs or ne# "ormulas)

Traditional medicines are usually an integral part o" culture$ #hich #as already

established #ithin certain ethnic group be"ore the development o" modern science

!espect "or the principle o" TM practice (indigenous 5no#ledge) under study must be

ta5en into consideration To appreciate the cultural aspects and local #isdom o"

traditional medicine practice$ the ethnomedicine study approach should be done

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DNote Include inputs "rom +ro" Agus on 2ody o" 0no#ledge$ as basically research

on traditional medicine is raise %indigenous medicine to be %6AM modalities #ith

better evidenceF

II363 Nat'ra) Reso'r$esASEAN tropical geographic areas have a #ealth o" biological resources arious

5inds o" medicinal plants can gro# and produce the best uality "or herbal ra#

materials ASEAN can be the locomotive o" traditional medicine development not

only as support "or the abundant natural resources$ but also as a mar5et having

tremendous potential There"ore$ research on medicinal plants should be carried out

"or better health o" the people

DNote Traditional herbs and ne# herbs should be inserted as AMS resourcesF

II383 9'rposes of resear$&

!esearch on TM may be &usti"ied by a number o" reasons The most important

reason to do research on TM is to evaluate the sa"ety and e""icacy o" TM practice

*or herbal medicines$ the research is conducted to validate a ne#3"ound plant

material or a ne# combination o" herbal medicines$ or even a ne# indication$ a ne#

dosage "orm$ or a ne# administrative route "or e'isting herbal medicines$ as #eel as

to validate the indigenous practice o" herbal medicine in the community .erbal

materials Simplicia$ semi3puri"ied$ or puri"ied herbal medicines may also be used "or

research The reuirement o" evidence (the level o" evidence) to sa"ety and e""icacy

o" TM practice should be ad&usted in terms o" research methodologies in accordance

#ith the purpose o" researchDNote To raise indigenous 5no#ledge to 6AM 5no#ledge #ith better evidence$

6hec5 "or terms o" simplicia$ completed #ith t#o domains o" TM6AM research ie

research o" usage and research o" e""icacyF

II3:3 Resear$& approa$&es

!esearch on herbal TM has generally been carried out by individual researchers

#or5ing independently /ne researcher may conduct research on to'icology$ but

another researcher may conduct research directly on human studies This un3systematic$ scattered$ and isolated research approach is not e""ective "or providing

evidence o" sa"ety and e""icacy

A more systematic approach should be done "or conducting research on TM T&e

frst stepis research to collect data (in"ormation) or literature revie# regarding t&e

'se of TM " $o55'"t*#ithin its indigenous system (traditional system) *or this

purpose$ the methodologies that can be used$ "or instance$ ethnomedicine study$

epidemiology study$ and health services (health system) study T&e se$o"! stepis

research to eva)'ate t&e safet* a"! eff$a$* of TM *or this purpose$ research

should be conducted in seuence$ begin #ith pre3clinical study and human study

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(phase 1$ phase 4A$ phase 4 2 and phase clinical trials) .o#ever$ "or indigenous

herbal medicine that had have empirical data "rom ethnomedicine study and

observational study the approach o" reverse pharmacology or e""icacy driven

research can be conducted

6onsider that research on TM reuires an adeuate budget$ in accordance #ith the

conditions o" each AMS$ it is necessary to "ormulate the !esearch Agenda #hich

contains research priorities !esearch priorities on traditional herbal medicine should

consider the bene"its o" overcoming ma&or health problemsJ peoplecommunities are

able to maintain their health by using medicinal plantsJ medicinal plants that could

potentially develop as modern medicineJ and able to accelerate the peopleKs

economy and compete in global mar5et The development o" guideline #ill also be

supplemented by the needs o" individual AMS consider the need o" ASEAN Member

States as #ell as the availability and comprehensiveness o" e'isting guideline

DNote !esearch approach should capture ob&ectives

3 Ne# herbs +re clinical study$ phase 1$ phase 4 a (preliminary$ or early

e""icacy trial) and 4b (as one shot e""icacy trial$ advance e""icacy trial)

3 Indigenous herbs use reverse pharmacology$ enough to do one shot e""icacy

trial

3 Need to de"ine reverse pharmacology

3 +ut the last sentence in the bac5groundThe development bla bla

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II3;3 Approprate E


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3

III3 RESEARCH METHODS ON TM

[Note= 9$t're " A""e< I to 4e p)a$e! &ere a"! starte! 2t& so5e para333 as

"tro33]

III3+3 St'!* of 'sa%e patter"

Study o" usage pattern is basically to identi"y the usage o" TM #ithin indigenous

health system This study is very important to collect data (in"ormation) that can be

used as base3line data "or "urther research to validate its sa"ety and e""icacy The

study o" usage pattern may use ethnomedicine study$ epidemiological study$ and

health services study (health system study)

III3+3+3 Et&"o5e!$"e st'!*

Ethnomedicine is the study o" ho# di""erent cultures vie# disease and ho# they treat

or prevent it$ including the medical belie"s and practices o" indigenous cultures

Ethnomedicine study is very importance to collect base3line data regarding

indigenous practice o" TM Ethnomedicine can apply either "or herbal medicine

practice or "or procedure3based practice 2y conducting ethnomedicine study$ "or

herbal medicines$ it can be identi"ied the species medicinal plants that can be used

"or traditional medicine practice$ as #ell as$ part o" plants used$ ho# to prepare$

dosage (posology)$ indications$ etc *or procedure3based practice$ it can be

identi"ied ho# traditional healers treat the patients #ith procedure3based techniue$

"or e'ample$ massage$ energy trans"er$ spiritual$ manipulation$ etc The research

methods "or ethnomedicine study basically use ualitative approach$ #hich utilize

indepth intervie#$ "ocus group discussion$ participatory observation$ as #ell as$

arte"act inuiry$ as data collection methods It sholud be accentuated that #ithin theethnomedicine study the researchers are the learners and the in"ormans

(respondents) are the e'perts .ere ualitative approach o" inuiry should be

considered seriously

III3+3-3 Ep!e5o)o%$a) st'!*

Epidemiology is the study o" the "actors determining and in"luencing the "reuency

and distribution o" disease$ in&ury$ and other health3related events and their causes

in a de"ined human population Epidemiological approach can be used "or TM in

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order to obtain in"ormation regarding the usage pattern o" TM in a de"ined population

(community) *rom this study$ #e can identi"y the prevalence o" TM usage in the

community and "actors that in"luence the usage o" TM in the community The study

covers both descriptive and analytic studies$ depending on the ob&ectives o" the

study This data (in"ormation) is very important to provide the magnitude o" issue (theusage o" TM)$ pattern o" usage$ as #ell as$ "actors that in"luence the usage o" TM

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III3+3.3 Hea)t& serv$es st'!* (&ea)t& s*ste5 st'!*1

.ealth services study$ or health system study$ is the study upon health care system$

especially #ith regard o" e""iciency and e""ectiveness o" the health care system$ asintegral part o" socio3economic development "or population health as a #hole .ealth

system study is very important to get macro perspective o" the health care system

and identi"y its role "or improving health status o" the community In these terms$ it

includes health policy research .ealth system research usually "ocuses on health

problem o" priority$ action oriented$ multi3discipline$ client oriented$ timely conducted$

simple$ and the results are delivered to clients (policy ma5ers) .ealth system

research on TM$ "or instance$ are cost3e""ectiveness analysis study$ study on

management and policy o" TM$ study on regulation o" TM$ etc$ #hich are o"

importance "or policy ma5ers "or the improvement o" program development

III3-3 St'!* of Eff$a$* a"! Safet*

Study o" e""icacy and sa"ety is very important to guarantee the rational use o" TM in

accordance #ith evidence3based medicine principle Study o" e""icacy and sa"ety

begins #ith pre3clinical study (in3vitro and animal study) and continue #ith human

study (clinical study) Animal study is important to obtain data regarding the potency

o" clinical importance (e""icacy)$ pharmaco5inetics and pharmacodynamic pro"ile$ as

#ell as$ sa"ety (acute to'icity$ sub3acute to'icity) .uman study (phase 1$ phase 4$

and phase clinical trials) is important to provide data on e""icacy "or certainindication .o#ever$ as herbal medicines constitues o" multiconstituents o" chemical

compounds$ pharmaco5inetics study can be ommited or #aived

III3-3+3 Lterat're reve2

In assessing the sa"ety andor e""icacy o" TM$ #hether herbal medicines or

procedure3based therapies$ the "irst step is to conduct an evaluation o" literature

reports The literature search should include re"erence boo5s$ revie# articles$

systematic surveillance o" primary sources$ database searches$ and systematicrevie# It should be 5ept in mind$ ho#ever$ that re"erence boo5s and revie# articles

might contain inaccurate in"ormation Nevertheless$ these sources #ill cite primary

re"erences that can be consulted "or in3depth analysis The search pro"ile used

should be recorded$ as should be details o" any re"erences cited$ #hether or not they

are available *or herbal medicines$ the literature search should then be e'tended to

gather in"ormation on closely related plant species "or chemota'onomic correlation

[Note= "$)'!e 5eta>a"a)*ss as o"e 5et&o!o)o%* to stre"%t&e" t&e ev!e"$e

"serte! after .3.3-363 e% post 5ar0et"% s'rva))a"$e]

III3-3-3 ?'a)t* re@'re5e"ts of p)a"t 5atera)s a"! preparato"

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!esearch on traditional herbal medicine must speci"y the uality reuirement o" plantmaterials or the prepapartion to be investigated There"ore$ the study results o" oneresearcher can be veri"ied by another researchers

DNote Statement on uality o" plant materials should be "ully pharmaceutically

standardized$ stablility test and other reuirements as e'planation para e'plainingthe pictureF

The uality reuirements o" herbal medicine as testing materials "or clinical researchare basically as "ollo#s (+icture 4)

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9$t're +@uality reuirements o" herbal medicine as testing materials "or clinical research

DNote crude herbs "ollo# hebal pharmacopeia$ modern preparation (tab$ capsule)reuire standard o" modern preparationF

III3.3 St'!* of eff$a$* a"! safet* of "e2 &er4s / for5')a

III3.3+3 9re>$)"$a) st'!*

+re3clinical study on TM is very important to provide in"ormation on sa"ety (to'icity)

and pharmacological pro"iles

1) To'icity study is to evaluate the sa"ety o" TM on animals

- Acute to'icity$ to evaluate detrimental e""ects o" TM #ithin 47 hours in animal

study

- Sub3chronic to'icity$ to evaluate detrimental e""ects o" TM a"ter the

administration o" TM #ithin 13 months period in animal study

- 6hronic to'icity "or long term use herbs ("or e'ample 8M) L 9 months

-Special to'icity$ to evaluate mutagenic$ carcinogenic and teratogecic e""ect inanimal study *or special to'icity$ it depends on the people to be the target o"

indication

4) +harmacological study$ to evaluate pharmaco5inetics and pharmacodynamics

pro"ile o" TM in animal study +harmaco5inetics is to evaluate the adsorbtion$

distribution$ metabolism$ and e'cretion o" TM (herbal medicines)

+harmacodinamics is to evaluate the e""ect o" TM on human body (clinical

importance) .o#ever$ "or compound herbal medicine$ it is di""icult to evaluate

pharmaco5inetic pro"ile as there are hundreds o" chemical substances in

compound herbal medicines There"ore$ "or herbal medicine the study o"pharmaco5inetics can be ommited or #aived *or ne# compound herbal

1>

@ualityAssurance o"

herbalmedicine

preparations"or clinicalresearch

alidation o"herbal medicine

prepartions

6ontaminationo" other

/rganoleptic

Macroscopic andmicroscopic test

6hemical

Ash content

E'tract content

6hromatographic pro"ile(,6MS *inger printing)

Identi"ying components

+esticide

Microbe counts

.eavy metalcontaminants (As$ +b$


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medicines$ it is proposed that the evaluation o" pharmacodynamic e""ects on

animal is very importance to identi"y the bene"it o" the compound "or clinical

indications

III3.3-3 C)"$a) st'!*

6linical study is important to provide data regarding e""icacy and sa"ety o" TM on

human beings (on clinical use)

III3.3-3+3 9&ase + C)"$a) Tra)

-ith regards to TM that has been established in traditional health care system "romone generation to the ne't$ the phase 1 clinical trial can be #aived It means that theclinical trial can go directly to phase clinical trial (see reverse pharmacology "orindigenous herbal medicine research)

+hase 1 clinical trial is a trial given to 4?3? volunteers (usually healthy persons)2asically phase 1 clinical trial is to obtain data o" (i) sa"ety pro"ile o" TM intervention$(ii) to evaluate the relation bet#een dosage and pharmacological e""ects (posology)*or herbal medicines$ the pharmaco5inetics study can be #aived$ as herbalmedicine is consisting hundreds o" chemical substances It #ould be di""icult todecide #hich substances should be traced "or pharmaco5inetic study There"ore$phase 1 clinial trial o" herbal medicines is to address the issue o" sa"ety andpharmacodynamic e""ects

III3.3-3-3 9&ase -A C)"$a) Tra)

+hase 4 clinical trials are aimed to evaluate the sa"ety and early e""icacy o" TM inhuman study +hase 4 clinical trial uses a bigger sample (1??3?? sub&ects) Thebest design is !andomized 6ontrolled Trial (!6T) double blinds 2y using thisdesign$ the study can control the bias (sampling bias and intervention bias) *or TM$ho#ever it sometimes di""icult to conduct double blinds !6T design There"ore$ "orTM it is enough to have the design o" !6T #ithout blinding (a randomized open labelclinical trial) 2ut$ "or modern preparation types o" herbal mdecinice li5e tablets orcapsules$ it is still possible to implement a randomized double blind clinical trial

DNote 4 options$ 1st option another term "or herbal medicine

early e""icacy trial$4nd still use the +hase 4a and 4b but rede"ine the terms$- Add another e'planation paragraph

- 4nd optionrede"ining phase 4A "or herbal medicinesF

III3.3-3.3 9&ase -B . C)"$a) Tra)s

+hase clinical trial is aimed to evaluate the sa"ety and e""icacy o" TM in the realclinical setting In phase 4 clinical trial$ the trial is done in closely controlled setting$ interms that everything is under strict control /n the contrary$ phase clinical trialsare done in the real clinical setting$ to obtain the data o" sa"ety and e""icacy "or real

health care services *or conducting phase clinical trials$ multicenter study isapplied The best design is !andomized 6ontrolled Trial (!6T) double blinds As

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again$ it is di""icult to conduct double blinds !6T design$ there"ore$ "or traditionalherbal medicine$ it is enough to apply the design o" !6T #ithout blinding (an openlabel randomized trial) 2ut$ "or modern preparation types o" herbal mdecinice li5etablets or capsules$ it is still possible to implement a randomized double blind clinicaltrial

DNote need to rede"ine phase 42 6linical Trial "or herbal medicineF

III3.3-363 9ost 5ar0et"% s'rve))a"$e-ill be "illed later based on agreement

D 8r 0anchit -here possible and applicable$ post mar5eting surveillance "or drugside e""ect should be applied by the *8A authorityF

III3.3.3 C)"$a) O't$o5e Meas're5e"t

The proponents o" TM argue that the philosophy o" TM is di""erent #ith that o"modern medicine (allopathic medicine) The philosophy o" TM is holistic medicine8iseases are seen as imbalance (dis3ease) o" the #hole individuals #ith theirenvironment 8isease is seen as multi"actorial and comple' interaction o" thepsycho$ body$ mind$ spirit$ and environments The modalities o" therapy (herbalmedicines and procedure3based therapies) are trying to normalize the individuals bypromoting the potency o" healing by the individuals themselves

*or these reasons$ the clinical outcome variables "or clinical trials should ta5e intoconsideration not only ob&ective parameters but also ta5e into considerationsub&ective parameters The ob&ective parameters are basically the parameters thatare measured by medical devices and laboratory analysis to obtain clinicalparameters "rom e'pert vie# (health pro"essionals) *rom anthropologicalperspective$ this 5ind o" variables are named etic (without h) perspective$ meaning#hat the e'pert vie# regarding %the disease /b&ective parameters$ to mention$ areblood pressure$ body #eight$ body temperature$ radiologic e'amination$ bloodpathologic parameters$ chemical analysis$ and the li5e

.o#ever$ "or holistic approach$ sub&ective parameters are also o" importanceoutcome The sub&ective parameters are basically the parameters that are e'plored"rom the perspective o" the patient by structured uestionnaire$ semi3structured

uestionnaire$ or un3 structured uestionnaire 8isease score improvement$uestionnaire o" uality o" li"e (-./ @uality o"


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DNote Therapeutic claim to be mentioned hereAdd more e'planation on etic and emic perspectives as a holistic measurementF

III3.363 St'!* of eff$a$* a"! safet* of "!%e"o's &er4a) TM

*or the study o" e""icacy and sa"ety o" indigenous herbal TM$ the method that can be

used is e""icacy driven research method In some o" the literatures$ e""icacy driven

research method is called reverse pharmacology 2asically$ the study starts #ith

ethnomedicine study (study #ithin the conte't that the TM is used and practiced)$

then to see the e""icacy and sa"ety #ithin the conte't o" community is done an

observational study$ eg to see the e""icacy and sa"ety #ithin the conte't o"indigenous practice I" there is a potency o" e""icacy and sa"ety$ the study can go

directly to phase 4 clinical trial or go directly to phase clinical trials It depend to

#hat e'tent the evidence obtained "rom obervational study (clinical observation)

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The "lo# o" e""icacy driven research in Indigenous herbal herbal medicine ascompared to conventional pharmaceutical development is as illustrated in +icture 1

9$t're +The "lo# o" e""icacy driven research in Indigenous herbal herbal medicine as

compared to conventional pharmaceutical development

To conduct a reverse pharmacology study "or indigenous herbal medicine$ the"ollo#ing suggested approach can be considered "or practical implementation

a Ethnomedicine study and anthropological study to obtain the conte't$philosophical understanding$ dan utilization pattern o" herbal medicines2asically$ ethonomedicine and anthropological study apply ualitativeapproach (constructivism approach) !esearchers are considered as learners$respondents (in"ormans) as e'perts There"ore$ researchers are to learn theconte't$ the meanings$ the e'perience o" themes being investigated "rom therespondents

b /bservational study (clinical observation) "or traditional practitioners to obtainsa"ety data and early e""icacy data The design o" observational study can bee""ectiveness study (#ith more "le'ible design)$ or clinical observation (#ith

standardization o" herbal medicine preparation as testing materials)

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6onventional pharmaceuticaldevelopment

E""icacy driven research "orindigenous herbal medicine


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c 6linical trial study to obtain the e""icacy and sa"ety data in more rigorousmethod 8epending on the strength o" evidence in observational study$ thetrials can go to phase 4 or phase clinical trials The consideration o" designis depending on the prior evidence obtained$ the practicality o" trials$ as #ellas the types o" herbal medicine preparation as material testing (crude herbs

poeder$ tablets$ capsules$ etc) *or practicality$ a pragmatic clinical trial canbe used as an optional design *or crude herbs (simplicia) a randomized$open label$ clinical trial can be used In "acts$ "or modern preparation (tablets$capsules)$ a randomized$ double blind$ controlled trial can be conducted.ere$ there is a "le'ibility o" selecting the design depending on the level o"evidence to achieve

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I3 USING THE GUIDELINES

This research guideline on TM "or ASEAN countries is a %common guideline As a

common guideline$ this document is proposed to be used "or synchronizing the

research methodology amongst ASEAN member states$ in terms o" basic principles

.o#ever$ as the common guideline document$ this document is only covering the

important essential principles under agreement amongst ASEAN member states

There"ore$ to use this common guideline$ the ASEAN member states can or should

"urther elaborate the guideline$ depending on local needs and conte't$ in line #ith

member statesH traditional medicine and culture In "acts$ "or researchers o" herbal

medicines must elaborate the credible re"erence or te'tboo5 regarding the method

being used *or e'ample$ "or ethnomedine method$ the investigator should elaborate

the detail method in ethnomedicine methodology resource materials *or

epidemilogocal study$ the investigator should e'plore the detail method inepidemiology te'tboo5 *or randomized clinical trial$ the investigator should re"er to

randomized clinical trial te'tboo5$ and so on

Note= I"p't fro5 I4' I"!a& re%ar!"% a"ot&er ta4)e

4


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A""e< +

Steps of Resear$& o" TM

[Note= I"$)'!e a"ot&er se$to" o" "for5ato" s&ar"% 4et2ee" AMS]

47

St'!* of

Use

9atter"

Ethnomedicine study

Epidemiology study .ealth services

research study (healthsystem study)

St'!* of

safet* a"!

eff$a$*

+re3clinical study

+hase 1 clinical trial

+hase 4 clinical trial +hase clinical trial

+ost3mar5eting

survaillance

Integration into national health

care system

Evidence o" sa"ety and

/bservational study "or

sa"ety and e""icacy

+hase 4 clinical trial

+hase clinical trial

+ost3mar5eting

survaillance

Indigenous *ormulas

Ne# .erbs *ormulas


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BIBLIOGRA9H

1 8esigning and 6onducting .ealth System !esearch -orld .ealth /rganization,eneva$ 4??

4 .o""mann$ 8 Medical .erbalism$ The Science and +ractice o" .erbal Medicine .ealingArt +ress$ !ochester3ermont$ India$ 4??

$ 4??1

= -./ ,uidelines on ,ood Agricultural and 6ollection +ractices (,A6+) "or Medicinal+lants -orld .ealth /rganization ,eneva$ 4??

1? -./ Traditional Medicine Strategy 4??434??: -orld .ealth /rganization ,eneva$4??4

11 -./3T8! /perational guidance In"ormation needed to support clinical trials o" herbal

medicines14 -isnes5i

Indonesia_Common Research Guideline on TM

Documents

Transcript of Indonesia_Common Research Guideline on TM