ArticlePDF Available

Clinical Trial of the Phytoestrogen-rich Herb, Pueraria mirifica as a Crude Drug in the Treatment of Symptoms in Menopausal Women

Authors:

Abstract

The clinical trial to evaluate the estrogenic effects of the crude drug derived from dry powder of a phytoestrogen-rich Thai herb Pueraria mirifica (White Kwao Krua) in five female volunteers with menopausal symptoms showed that the crude drug clearly improved the signs and symptoms related to menopause such as, hot flushes, frustration, sleep disorder, skin dryness, high blood cholesterol, oligomenorrhoea and amenorrhoea, with no change in the blood cells, liver and kidney functions, as well as other physiological status after four months of treatment. In four volunteers, treatments were continued to complete the one-year test period with half the dose and was found to maintain their satisfied menopausal relief status. The crude drug dosage was administered at 200 mg daily for three weeks a month during the first four months of treatment and 200 mg every other day for 20 days per month for the remaining of eight months. These doses were effective and safe as phytoestrogen treatment of menopausal symptoms.
Clinicaf Triaf of the Phytoestrogen-rich
Herb, Pueraria
mirifrca as a Crude Drug in the Tleatment
of
Symptoms
Yeraiing Muangman, M.D.*
Wichai Cherdshewasart,
D.Sc**
in Menopausal Women
pos&.or, phyldrosen-d.h
rh.r h.rb
P'.Nkanile
twh:r.Kvto
Krua) infivc rco,j. votune.B
d in..tud.
drus chrrty inproved
dt!
jGE
rnd synpbm dat.d
,
lrut'ddn,
d..p disrd.., skin drynd,
hjd blmd .hotdker,
G odr.r
physiotogisr
sbtu.fb.fou. dor.bs or.n'b.nr In
lourrolunb
b.dnpLe aom-y.'r b{Fedod ,id
harlrhr dos r.d ws round b n'i
0 m3 4!r, orherdar rdr 20
d!r,
F.
mdnrb3. Tnde dds n.e.rddy.
&d eL s
phyhrns.n.bim.nt
ot m
i.ri.HqnGnr.innin!.{4!ln#n'ttrlt,F
trrL.!d! }di,nnrr,1!
mdnunii$1.Trr'ri!n!r
hlnarltqaAlda{.
Ad*t"dd1dql,
lr!/a1L1sr,1ttd.
enarolittun,s
':lnrtnbr
la4aa,'alniifitivl1
Atut6nn.1dsi..tr1r$rn!tu1ivo1ir,
fitArnlzsaa $ 3aa4as.
nrf, nbrMrn6nnroimu!Filqrlrlroii1(wtr#loisli1n!iun!'o!ii{l]!ht
iiidTklnLoilon{{rir
p!e€,a
mtit€ rtnnmiLriiom!
hfii1.liinn,r.llhiomi
s hu nuir
.i(ni1imi!.rrMssri! nriri!rnltir!filr:ir60!,i!
ornahllln nr:tunred10
lodnvra-!'b[n!it:oi!I,liiMosih'Aor0!
!'y ir6oM:lJi!ne!fu
"';n!.tinr:4do!
bbljjim'
'D.puktdt
.! su(o Frcntt .4
M.dicrz,
4Depatnflt
a! Riot
e\
FQutft of scnne.
chltatonskatlt u^tu.dt,
Baryt'L tB3a, fhoib,n.
inf, o!r$irNiini!$6sx!1lrnifl
r11llooderi!{c
'ddllwlswiqin'doi
vir;u!du6:1r
i!fum1rmdi'iMu6!1 lioiun':mlmfi
n,iofur!a
L6su oldrliara.
diudl.ttdrtaourwrur
nhrron{#r mrlfln r0"!.!i1!Toin!mri!
6mwis'i1itd fnN!.'1lrllnti1frtuU
a !6!!Fniatun:
,00 !n
Inilafirod!
3 ftlt.dh$tiiafit!
ri:ioNL'6o
,00 !n. tlL&iu
6i!6: ,o lirq bi1qm1;!v6i6n
s '6i! milltlt1liurdr.iti
lravinrntrn:liitnodivilldLnllnlnmdlin
urin!md!mm'6r!iir3!
INTRODUCTTON
d
vcd rmm d.crcaFd brood
etuog.n lavek amons
middle .ged fcmalca
Esrosen RePhccmcir
T.erapy
(ERT)
has becn enployed
1o
probd
and
suci 6
lir*ryle chms6 wd.
ptuposd ro minimize
thc nenopausl symphmdr
nl rheEpi*,
q\pccially
soy
pmducb {hich
6ibii
signlfican!
lcvck or
phyro.dlos.ns, nsmely
rcfiavoicr,
*erc shown b be nor
oily.ftedive ii
P ,irf.a
(Airy
sha{
d suvdabadhu) or
vhib Kwao Kna s a Thri
iidisercus herb wi6
'
rnd nenrr. The
hcd ea lisr broush(o
ptrblic
a!
remior ii I932
by a rpon $ar fte lubctu$
mor ot
rnjnal cxpe meni rrd
dliiical tial in a hospibl by
ad m inBrcrins
,lcoholi. cflde ertrer or
rhc hc6 .
such hud,n benefit
ws also coinmcd
by am&er
nudy,'.
Th. hdb Ms inirially
r.osiized N ,!t c
!psr',
and vas linally idcdificd
otrd d.arly e$
bblkhcd s Pcu.ra
rtifa
r.
Acrive inFedici6
vd. isolrtd and 3ed-
i'rd rrcm the herb,l
rtrbei dd vs round b co
M
efi@r s cponed rom rhe nudics
ii inD'rurc te
'irbnnej|andovuelodizednb'"'Averyrner
edms rqdt
els obraiied tom r dinj6l
tid ii iin.
'ie
ingrudicn fiom r 'i4ie muld be admjnF
']!idzii,dsidaii,eenhrein,oumedml. ninficin'r,
senisritr!!,
pucrdin!
and k*rkhrrin! The
phy.
pEv.d
6one
los.l! Drid,.ii wa ftponed b have
infrui..il$n.iis
rcriviry-, inhibirory mrion on
iiducd luig mebd6is" and on spcciric
fuhs..
riciryr. censr.in
Ntr
sho*n
ro havc , icgativc a
brcasi c er celr
prolirmtjoii'rl s ftll s rcduc
tosen supplcnciarnd
an ad{n.op.msn asenr}.
rovdiis {,ion."
p
sirsGrcr *a sho*n b rcdu@
hciicn
pmndc
hypcalasian
r!
and inhibil hum
.olon camer
crcwrh{.
d
lere
m,nficoumcsh
r.d
rtifk wi'h r lons his'ory or consunption @ord.
med ormenopruel symprors,
rhis
pr.limii&y
cliii
cil tial vj'h c u'int.!
iiT hsi romon could help
eriluds ib
p{bdi,l u$ tor lo is renn
phyroshsetr
innitu,
ftrll'sle chndhil. such a tialcoull
MATERIALS AND MEIIIODS
rhD fHh ruber or r ,titm uhjYar
cxduded,Fiveecepledvolunben{crelheou'Pa.
liefuo'RinalhibodjHospirlF&u]ly.fM.ilicilc,
MahidolUnNesitn Bm8to[,T
b,]l,id, wi$ri rgc
bin. haendocrit, blood
urd nihscn, dtudiiind,
scoT,scPr..ho|csml.tic|ycsidssidmiidy
sis Tbc *h.bd
voluiEA had ro be i0 r noflil
hcald
enh ionnsl blood ch.mical milysn resulrs.
llrey
vcr lcrb,lry inromed rbour the debil of rhe
rhe 126 month lte
volude6 hd sisicd, vn!c[
1rrebody
weishr. heth', br
,wrillft
hlpsirsorddvolhtcswcrcrccordcdltr$prior'o
3.2 Mldiclr
In..ni€q
@ns
wid,
$ijdad
qusrioN
ju(
enoi
b 'ic rs, $
bn
pc.idd,
rid
4
rhd
sid ofrh. tzd nonrh E{
RESULTS
yerr
ludy rom fivc scrcdcd vornihn,tu
jndjyi.
ks, bcjshr I 47
n, rrad exp.n.ned amenonho.a
pe
.xhibil.d as hol flus|ts, iiNtdioi, s|ccP di$rdq
loblbloodcouil,idblodd.hchislryala]Fn'*.8
iod, ir *rs fouid
6!!
urd plriofs
appdire incE?sed,
'hebodyweighindtsdby0s|qsdENeEd
rmm ho' nushc, fflshrioi 3nd skin dryrcs
(4pc.
riod.
the recorded nenopausar symproms showcd
rior, sl*pdnord*, and skin dryi*s
Tod
blood
counlandb|oodch.nkl-yamlysjsrcv.a|edlhdlhc
rrr
pdjcrr's
iccordcd weighr i.qeNd
by 0.5 ks
m:in!rq';nNiinixsurnl]lllrtiinl'f
oodliniqij
riod,
rhc fs.ial skm had b40N
tum
llrlc
rhd
hody
flrbodyveishriocrcNedby
3kB
sibrcrssvsre
.hohicror rcver
tnif 247 ro 205
q* (
r?.0% dc
[g$dc(mi@o|d'cmd[trulo{Amlob
pEviouny co'ded reovc.y
rbm mcnopausrsymP.
rhoeiforTmoifis'*d$bmn@nbhgn$4ery
(PDA
I'sdi.D) l3
yeirs
ago.
lodlho rcgularly su,-
un.lrhecidol
rz nonh.Ir vas round rhdJ*P
.bsn( and 6d
vohihr feh d'ar she !a ii a
sodd
rlon
pdiod,
aod rhus, was dasifidd
*olico'ienor
loblb|o0dcoun[lndbLdoddtfktrf,ana|ysisverc
iod,ftchrof
rsrc|[diid€asdby2.5cm.stunil
nu
conplcrior of r[c 4imonth red
P
dy$riaws iiv$rigded'nd vhireblood.ells(6.r0
cdls/HPF)weEroudinurire.shew6tatd'b
ofioxrcin
ror
7
days ad sc
rymprom
vs
errmr
.ryan'yeswcEDomdexccllbloodcholAlero|
At@r
conprerion
oroE
2i
modh Ed
p*
'|e9'9mdhipci(flnfddcsmdih.bodyweigb'
Afrd cohprcrioi of rhc
3d
hood rn
po.
nnfy,n'ysnulciormslcx.cp|bloodchdl4.
kindThcbodyweigh'hadin.f*dlbylkg{hlh
'ioi orr 4i4t.a
code drug.ic sunmart{d
m
ljde erf{ts r soi,naiz.d ri llbG
2.
DISCUSSION
of,? drira dlrive wi.hi.nr w6
Gscd id tlr
m.iorthom synproms
rne En was d.sisnEd
tor 4
The resulrs
(Tabr.
r)
4vcared rhar rwo
ai *hscm
uooN ro fte crude dng $d rdncd.d
4ri6e ouryar wrchai
nr .xhibnd hphrc
efrE6
phyro{roseis
fton
orh* sourc*
T
he rophic
dleds
qere
mcr likely rtrliy ruicoonal
jt
rhc ubrur
rhe nsina ws iod
^ r sisn orrdveBe clld
(Tabte
2). r' wa non rikcry b
cux from cdvi.'t ,ndlor
'fth
rindiic hcrps.offm
fid srosen 6.prd
(ER)
p
k
pcso'
in 'he rMa csjl{
q qgin.r
riniic
ard m rcsesd b
p
''ri6a
pby'cnrcsft
as
!dr.
T.hle
1, Nunbrorssd
surfdrins
wi
irinr\ninNnAnirNdE{!l}rinnul
lrrslen0xd!
305 i':tui dd:,'!,ll! Ln$irii
;
he advcAD
eflmb ,trer ron monrhs omumphon or P rirtr.a crude
or brear nsues b rq
nird.c
nhybshsqs
by {
risid, N rrMys mors by sroc$
i's'
prior
b ,he
hs rspoi$ 'o P attnn
rrcdnsnr
Such
lccumuLni.! wduld dcfinircly c
rbat ERlr is
prescd
abundm'ly ii 'heskio md 'lus
ryp. oi c\poNc ir rry uo(ruu i.r
r
nr rfca phyroA
s'ogei 's
pry'osbecis
no'i r 4t./r4
qrurd
'inyorsksen
rheirfluciceof
P/,rt.anpon
oood
of
rhc crudc dru3 dsiLd |n,m P ,rirrc,
oL
'iijlynishchnggniLdlya'Ibcdo$o'|000ng/
ds4eof|0mdl00mg/tg3w{lii*d{,sc{m.
nod wihDr
aiy $rioN idvere efrcds otu orrhc
ns6isrqlinM6nirorurit!1n:;ifi
ar\ihroalo:rNgr
307
1,:iitri !'enL, ii,
'i*Arinri
P ,i4r.a
rhyro6toscN
lko exhibncd
hor flNh$ in
3 cd*,
wqc ttrlly rccovcd
'nd F
rL,cd
by
a
hdd
mood
io d'o$ 4 d{c
a wdr *
bdtr .ppdirc
ii one cac
T
hcsc lLndin$
we had
lqy imporr(
in mcnopasil
womci
as $6s tom
bd mNd tr frsh,ioi
id orv
'nsEd rhc
$bi.d
iilcso,somcmiiorbdicfireffldslcrca|sol'ouod
rhi
rh! nude druP
could exhibn
n'oE bc
n dMi
,dvctrelliscllidconsudpliotr'Forgxanple.dE
v's dsJricd d adyd.
crred ii ooc
hxnd as ir did
also bc
rc.ognyd
I tophic cffsr
ir rhe othd
hrnd
pdcmia Thc 6tsr
sLe iDdcrc
was cl.silicd
is
r rtirr(cul'ilarwidit
III coda
sie
nili.rnlimoudofisonavoicainily?aibyhjgh
ssiry
ddded rodineLy
by $n
mchodr
'!r.
I vs
mii chenical
ndker rn rhd
dud. drus,
dd
prt
of
ftis iudy
.otrLd rcsulr
prnirlly fton rhe hish
koflrdc
6Ns' ir
c 4i4te sllils
wtrhai-trl
isoll orc
r'oh r ,tilim
qDu
al$ *h'br
ilfrcol
ahoui' ofesrqci. e
ati6cl
phyrcsrqctr
Drrird ii oeron4$l
wdH vi ' 'ne
lhm d
*togen could 6d
3 narunl choi*
lbr csrcser
sd
on rhs olhd
h'id, due ro thc
aeoihric effsb ot
phyroahscm which aE ncdiy
robtly domlnatd
phy
tocrogcn $
opl.'ncnarion
especi,lly
ge
n istcir
4 or r2
oodhs $udied
pqiod. Ii mry bc cAonrblc
bqrrrudc
dd 2 ,itirie
cul'ivtu wiclrar III
dddc
drus
d tlis dos may hc
ii rho high doeg€ rcvd
lid
thtrs
cxhjbns mainly
.ytoroxic or n0utll
bd r01
trophic efrcd ro
rh.
prc.xisrin!
brcd.yn
(ir
prcsd).Irar$dosmisimuhtrdcmcunnccorr
rcw brcfr.y$.
All animal rrcdcd
wirh x ,rrirt.4
or
mne\hl
rhe key chcnic,r
of P i,tlri.,
tso .i
hibitd
ro rcpon ol btu$r
cmcer o(unngiL!x!r,
a5 {dl xs rhccliric,i!i,l
witb mrc$td!
sough 'o concl
c 'ha' P ,t[rc,
.an
Prc'ed
orP t4f.a exhddnd'ry
'o the breasr er
wl'dn3.
pruscd rlr chorce olerodivc
t.dmenr lnr
lrh
,tro
m kr nrcnss Lhf
'hdc oI $y whid
s a
ror rcssrch.s b inv6'i3de
d.eply inb
P u tf.z
placen.d
rnmey
eRD
toi mercprsr
wonen
wirh r reduc.n
.ncrtIisk which h6 bcer
prcviotrdy
2lmoiT'ststAc.HufttrMPiysbdq4i3c
4B'idDD.UnbehDM'Lmd.d.|l|.aJDtbry
6 ADedM,i
A
Polhin
300iqdsic. e d. tuerer
6cBc) by ndoie lid
ion orc
phybqtdeis
x
AC(NOWLEDGEMDNTS
iso0avoneinalysiswirhrhc$dplcof
whn
(wao
Kna.
P z'i'.:6e .ultive wic[,i III. ro Rma'nibodi
krA A aPdLd rujurddoi r sBh sN Nd isl
s.rodtr.
w
Ddn M. Hodwcg w A^ cfosn.
'ri6dr@rta
0.4dm*)rrcnliairud,yidd
nituibr ft.n P@rcrb ainlro I Endotrhor
i
96r I
d|eqhtdft midbnontoidduEotbrcmor
PMdintt@
NliE te6a.1$, n1r11.
3dioi
or
P@en4 'r4.@ rcok zNdutu$i sqc
nom 0. ru'otr@a'b
uinl@ z NdudqEh sqc
d o
0.46iu'usti
ac-srrslhon*oie o
rnnnurqrinr:nn!n!oi!1drl!
rlrn!nD'r'o'0!'oni!E!
.sryeside
fren
Apronu tlt e Phrr€b4nq
P4Bt4r'dd@B
zNibd.rdssc
rrtT:12r
khi&H'Udug]r'fiEiKddPdmlioi.f&!d
son
filt
.ttas8
i ktBavuq Mlhdbr
n'
lFjffcih6lolofuyrcsje.{EiicPfotii|irs'J
vgn.sP'sJonorcE'co|diB.c[on[4d
FailiP'Moo-F
g.tMc.c.4z.d'|fre
ftsderA, Meilq ae
sorbreL- cddd
4i
j6b
Ed r cLii Nft De3 5rr 34 r43
do@obnd,esr*[ddidorbdoru sioleml
(piyb,cdD
tu de ldrher deiisn
pordrc
iy
vo Hdr RL, Fir cs. A'd AE.
0
sro$trd ml
aqd AB.
%D HdE n, corc rP. d d
04lsbrel
P4?e;o nr.trca. Irsk M. sc. Fftd.y of sdde
chddolgkdnUiidsi}sgngkor'frfuid'l9l
dcrcds dPcron niriir@. z N{mfond s.i c
chmal.@s.hhihvaT.sdiH.dd'IdddnadoD
ordcoqnicshl 6 'he&Mr rjlEmdr8
pdodpL
d K"ro K{/, P,.E& n,il.d.
trr
kmvD
wiiiu z. $j s. Mdiin s. d d. Enrce, d4br
(ER)
p,
a mdddioi oi ERd h 6e d.di Eoc Ndl
chihF,
s. cidihE@s P. RdhajaEoj s. dr.
rdti'y nudy of
P@Etu 'ind ^iry shiv d
ooi& frcn P@rcni tuitn od s.n dqht eli
... Of these, 1052 were excluded because they were duplicated (227 articles), investigated Butea superb Roxb (red kwao krua) (68 studies), or other plant species (37 studies), not relevant to P.mirifica (484 articles), not clinical studies of P.mirifica in humans (234 articles), studied cosmetic effects of P.mirifica (2 articles). Two US patent applications containing identical data were excluded because participants were non-menopausal or included in Muangman and Cherdshewasart (2001). Nine studies met our inclusion criteria (Chandeying and Lamlertkittikul, 2007;Chandeying and Sangthawan, 2007;Lamlertkittikul and Chandeying, 2004;Manonai et al., 2007;Manonai et al., 2007Manonai et al., , 2008Muangman and Cherdshewasart, 2001;Okamura et al., 2008;Suwanvesh et al., 2017;Virojchaiwong et al., 2011) (Fig. 1, Table 1). ...
... Two US patent applications containing identical data were excluded because participants were non-menopausal or included in Muangman and Cherdshewasart (2001). Nine studies met our inclusion criteria (Chandeying and Lamlertkittikul, 2007;Chandeying and Sangthawan, 2007;Lamlertkittikul and Chandeying, 2004;Manonai et al., 2007;Manonai et al., 2007Manonai et al., , 2008Muangman and Cherdshewasart, 2001;Okamura et al., 2008;Suwanvesh et al., 2017;Virojchaiwong et al., 2011) (Fig. 1, Table 1). Manonai et al. (2007) and Manonai et al. (2008) were the same study but analysed different endpoints. ...
... Of the included clinical studies, two were randomized placebo controlled trials (Manonai et al., 2007;Okamura et al., 2008); two were head-to-head comparisons with conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) (Chandeying and Sangthawan, 2007;Suwanvesh et al., 2017); six also had no control groups (Chandeying and Lamlertkittikul, 2007;Chandeying and Sangthawan, 2007;Lamlertkittikul and Chandeying, 2004;Muangman and Cherdshewasart, 2001;Virojchaiwong et al., 2011;Suwanvesh et al., 2017). ...
Article
Ethnopharmacological relevance: Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed. Materials and methods: International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines. Results: Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores. Conclusions: The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance.
... The useful part of P. mirifica comes from tuberous roots which play an important role in the accumulation of phytoestrogen substances including chromene (miroestrol, deoxymiroestrol) isoflavones (daidzein, genistein), isoflavone glycoside (daidzin, genistin, mirificin, puerarin) and coumestan (coumestrol, mirificoumestan) (Cherdshewasart et al., 2008). Currently, due to the mechanism of action being similar to estrogen, P. mirifica is being used in various forms of powder as an animal feed additive or cream as a rejuvenating drug and pills for estrogen replacement in humans (Muangman and Cherdshewasart, 2001). ...
... The administration of a crude drug extract of PM to women improved their symptoms of menopause; no other physiological changes including changes in renal function, blood cells, and liver function were observed. [87,88] Notwithstanding, some studies have found evidence that PM had toxic effects which should also be taken into account. It is known that prolonged consumption of synthetic estrogen increases the risk of breast cancer [89] and endometrial cancer. ...
... Later, it was tested in laboratory animals for its efficacy on tumor incidence [4], bone remodeling [5], and cardiovascular diseases [6]. PME from the roots has minimal toxicity to cardiovascular function, blood lipid levels, and liver enzyme activity in rabbits [6] and menopausal women [7,8]. The major bioactive components of PME are isoflavones [9], with PUE being the main (highest amount) one [4]. ...
Article
Pueraria mirifica is an endemic Thai plant that has been used for rejuvenation and in the relief of various aging diseases. Puerarin is one of the major isoflavones found in this plant and shows several pharmacological activities in relation to the Thai traditional use of P. mirifica. Therefore, comparative pharmacokinetics of pure puerarin alone and that in a P. mirifica extract in cynomolgus monkeys were conducted in order to investigate the pharmacokinetic profiles of the 2 preparations. To this end, puerarin and P. mirifica extract, at an equivalent dose of 10 mg/kg of puerarin, were orally dosed to adult female monkeys for 7 consecutive days. A single intravenous injection of puerarin at a dose of 1 mg/kg was also peformed. Serial blood samples and excreta were collected from 0–24 h and 0–48 h after dosing. Determination of the puerarin levels and its metabolites in biological samples was conducted by liquid chromatography tandem mass spectrometry. Plasma levels of aspartate aminotransferase, alanine aminotransferase, and creatinine fluctuated in the normal range, with no abnormal physical signs in the animal. The absolute oral bioavailability of puerarin was approximately 1% in both preparations. Accumulation of puerarin was found after oral dosing for 7 consecutive days in both groups. Major metabolites of puerarin found in monkeys were hydroxylation and deglycosylation products. A negligible amount of unchanged puerarin was detected in urine and feces. Pharmacokinetic profiles obtained from this study could help to design the prescribed remedy of puerarin and P. mirifica extract phytopharmaceutical products for human use.
... The use of oral Kwao Krua Kao has been shown to be similarly effective as estrogen therapy on systemic symptoms of postmenopausal women. 18,19 Previous studies have found that the estrogenic effects of Pueraria mirifica can alleviate various vulvovaginal symptoms, and also reduce signs of vaginal atrophy in healthy postmenopausal women. [20][21][22] Evaluation of the safety of Pueraria mirifica revealed no significant changes in lipid levels, hormone levels, breast density, endometrial thickness, liver, and renal function. ...
Article
Objective To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women. Study design In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel. Main outcome measure Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment. Results After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7% (2/30) and 23.3% (7/30), respectively (p = 0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p < 0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05). Conclusion A 12-week course of treatment with 5%P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.
... A number of bioactive compounds have been identified in tubers, mainly isoflavones such as puerarin, diadzin, genistin, tuberosin and so on (Zhou et al. 2014). Dietary intakes of Isoflavonoids have a significant impact on human health and has the capability to decrease the risk of osteoporosis, attenuate the symptoms of menopause in women (Muangman and Cherdshewasart 2018;Yoshiara et al. 2018), possess anticancer (Zhao et al. 2018), anti-diabetic (Dong et al. 2018), anti-inflammatory, antioxidant (Liu et al. 2006), neuroprotective (Yang et al. 2012), wound healing (Kambhoja and Murthy 2007;Mukai et al. 2012), hypolipidemic (Takahashi et al. 2009), nootropic (Bagheri et al. 2011 activities. Recently daidzein has shown potential anti-inflammatory and cell inhibitory activity in endometriosis (Takaokaa et al. 2018;Yu et al. 2016). ...
Article
Pueraria tuberosa known as “Kudzu” is a vulnerable perennial woody liana and native to South–East Asia. The tuber of this plant is used in traditional medicine system and possesses various pharmacological properties due to presence of various Isoflavonoids. The present study has been aimed to create GIS map of P. tuberosa with special reference to South Rajasthan. Analysis of total isoflavonoids content in tuber and its correlation with size and geographical distribution has also been done. HPLC profiling of different sized tuber revealed that palatable tubers are watery and very poor in puerarin (0.3 mg/g DW), diadzin (0.17 mg/g DW) and genistin (0.87 mg/g DW). The biggest tuber (~ 4.5 kg) contained highest amount of Puerarin (100.79 mg/g DW) obtained from one geographical region while the biggest tuber (~ 180 g) from another geographical region contained no detectable puerarin and high diadzin (10.4 mg/g DW). Further germination pattern of seeds revealed that a systematic management practice may increases the survival of seedlings up to 70%.
... The studies of Lei et al., showed that morphine decreased kidney weight by damaging the kidneys and causing disorder in the body's metabolism (19). The effects of phytoestrogen compounds of the soy studied in animal models and human populations and their positive effects on the lipid profile improvement, including cholesterol have been reported (20). It has been shown that morphine reduces feeding, physical activity and digestive system function in animals (21). ...
... Especially isoflavones, it was reported that they showed strong estrogenic activity [14]. Many studies have reported that white Kwao Krua shows estrogenic effects in cell line experiments, animal experiments, and clinical trials, as well as anti-oxidative and anti-osteoporotic effects [16,[18][19][20][21][22]. Therefore, white Kwao Krua is an important natural source of isoflavones, similar to reputable natural sources, such as soybean and its products, legumes (lentils, beans, and peas), and sesame. ...
Article
The tuberous roots of Pueraria candollei Grah. ex Benth. (Fabaceae), commonly known as white Kwao Krua, are used to relieve menopausal symptoms in Thai traditional medicine because they contain phytoestrogens. Black and red Kwao Krua crude drugs exist as well, but they have different botanical origins and pharmacological activities. There is a high demand for white Kwao Krua products, but because of the limited availability of the plant material, it is suspected that the adulteration and misidentification of white Kwao Krua crude drugs and products occur. In this study, we authenticated white Kwao Krua products collected from Thai herbal markets by molecular, chemical, and microscopic analyses. The nucleotide sequences in the internal transcribed spacer (ITS) and trnH–psbA regions of 23 samples of authentic P. candollei were analyzed, and both regions were found to have intraspecific DNA polymorphisms. Based on the single nucleotide polymorphisms in the ITS1 region, species-specific primer sets of P. candollei were designed to authenticate white Kwao Krua and differentiate it from red and black Kwao Krua. Only the PCR products of KWP02 were not amplified by the primer sets. Isoflavonoid contents and microscopic features were used to support the results of molecular analysis to clarify the botanical origin of white Kwao Krua. Molecular, chemical and microscopic methods confirmed that all the Thai Kwao Krua products examined in this study contained authentic “white Kwao Krua” as claimed on their labels.
... The use of oral Kwao Krua Kao has been shown to be similarly effective as estrogen therapy on systemic symptoms of postmenopausal women. 18,19 Previous studies have found that the estrogenic effects of Pueraria mirifica can alleviate various vulvovaginal symptoms, and also reduce signs of vaginal atrophy in healthy postmenopausal women. [20][21][22] Evaluation of the safety of Pueraria mirifica revealed no significant changes in lipid levels, hormone levels, breast density, endometrial thickness, liver, and renal function. ...
Article
Objectives: To compare the effects of a 12-week treatment with Pueraria mirifica (PM) gel or a conjugated estrogen cream on vaginal maturation index, vaginal symptom score, vaginal health assessment score, and vaginal flora in postmenopausal women. Methods: In a prospective, noninferiority, randomized controlled study, 82 postmenopausal women with at least one vulvovaginal symptom, that is, dryness, soreness, irritation, dyspareunia, or discharge, were recruited. Participants were randomly assigned into two groups for treatment with either PM gel or conjugated estrogen cream (CEE). The treatment regimen consisted of application of 0.5 g of product intravaginally daily for 2 weeks, and then decreased to three times per week for 10 weeks. Vaginal maturation index, vaginal symptoms score, and vaginal health assessment score were evaluated before the beginning of the study and at 6 weeks and 12 weeks after treatment with PM or CEE. Results: The vaginal maturation index increased significantly in both treatment groups at week 12, from 22.44 ± 22.28 to 47.56 ± 29.00 and from 27.07 ± 26.12 to 66.90 ± 22.42 in the PM and the CEE groups, respectively (P < 0.05). A significantly higher effect was, however, observed in the CEE group (P < 0.05). Vaginal symptom scores decreased significantly after treatment in both groups, from 4.37 ± 2.79 to 0.95 ± 1.88 and from 4.15 ± 2.16 to 0.68 ± 1.64 in the PM and the CEE groups, respectively (P < 0.05), with no statistically significant different between the two groups (P > 0.05). Conclusions: The use of a 12-week treatment regimen with Pueraria mirifica gel was shown to be efficacious and safe for the treatment of vulvovaginal atrophy. Conjugated estrogen cream was found to be more effective compared to Pueraria mirifica gel in improving signs of vaginal atrophy and restoring vaginal epithelium at 6 and 12 weeks.
... The large-sized tubers of this plant have long been used in traditional Thai medicine for rejuvenating purposes and are found in at least 29 provinces of Thailand (1). The plant tubers are rich in phytoestrogens, especially miroestrol (2), deoxymiroestrol (3), and isoflavonoids (1), and have been shown to be effective as an alternative treatment of menopausal symptoms (4). Consumption of the tuberous powder generates a strong estrogenic activity as revealed by the induction of vaginal cornification in ovariectomized rats (5,6) and by the MCF-7 cell proliferation assay (7). ...
Article
Full-text available
Pueraria mirifica is a Thai phytoestrogen-rich herb traditionally used for the treatment of menopausal symptoms. Pueraria lobata is also a phytoestrogen-rich herb traditionally used in Japan, Korea and China for the treatment of hypertension and alcoholism. We evaluated the mutagenic and antimutagenic activity of the two plant extracts using the Ames test preincubation method plus or minus the rat liver mixture S9 for metabolic activation using Salmonella typhimurium strains TA98 and TA100 as indicator strains. The cytotoxicity of the two extracts to the two S. typhimurium indicators was evaluated before the mutagenic and antimutagenic tests. Both extracts at a final concentration of 2.5, 5, 10, or 20 mg/plate exhibited only mild cytotoxic effects. The plant extracts at the concentrations of 2.5, 5 and 10 mg/plate in the presence and absence of the S9 mixture were negative in the mutagenic Ames test. In contrast, both extracts were positive in the antimutagenic Ames test towards either one or both of the tested mutagens 2-(2-furyl)-3-(5-nitro-2-furyl)-acrylamide and benzo(a)pyrene. The absence of mutagenic and the presence of anti-mutagenic activities of the two plant extracts were confirmed in rec-assays and further supported by a micronucleus test where both plant extracts at doses up to 300 mg/kg body weight (equivalent to 16 g/kg body weight plant tuberous powder) failed to exhibit significant micronucleus formation in rats. The tests confirmed the non-mutagenic but reasonably antimutagenic activities of the two plant extracts, supporting their current use as safe dietary supplements and cosmetics.
ResearchGate has not been able to resolve any references for this publication.