Paediatrica Indonesiana

VOLUME 49 January ‡ NUMBER 1

Original Article

Efficacy of dioctahedral smectite in infants with acute

diarrhea: a double blind randomized controlled trial
A. A. Made Widiasa, Soetjiningsih, Putu Gede Karyana

Abstract
Background Acute diarrhea is a sudden diarrhea which lasts less
than seven days on babies and children. The standard treatment
by WHO in managing acute diarrhea is still not satisfactory for
parents whose infants and children suffering from the disease.
Dioctahedral smectite is expected to decrease the volume,
frequency, and duration of diarrhea.
Objective To assess the clinical effects of dioctahedral smectite in
infants with acute diarrhea.
Methods$GRXEOHEOLQGUDQGRPL]HGFOLQLFDOFRQWUROOHGWULDOZDV
SHUIRUPHGRQVL[WRPRQWKVROGLQIDQWVZKRZHUHKRVSLWDOL]HG
in Sanglah Hospital, Denpasar due to acute diarrhea.The subjects
were divided into two groups. The treatment group was given
standard management with adjuvant dioctahedral smectite
while and control group was given standard management with
placebo.
Results)URPLQIDQWVHQUROOHGLQWKLVVWXG\WKHPHDQGXUDWLRQ
of diarrhea was significantly shorter in treatment group compared
D
iarrhea is still a children health problem
LQ ,QGRQHVLD ZKHUH  ZKR VXIIHUV
from diarrhea are under five years old.1 In
WKHLQFLGHQFHRIGLDUUKHDLQ%DOLZDV
)URPOLVWRIFRQVXOWDWLRQWRSULPDU\KHDOWKFDUH
RXWSDWLHQWFOLQLFDQGKRVSLWDOL]HGSDWLHQWVGLDUUKHDLV
always on top three diseases in their monthly census.
In pediatric outpatient clinic, Sanglah Hospital, there
ZHUHSDWLHQWVZLWKGLDUUKHDLQ3
,Q:+2SXEOLVKHGDUDWLRQDOPHGLFDWLRQ
in management of acute diarrhea for infants and
children.4 Oral rehydration effort and early solid food
intake has a positive impact for recovery of diarrhea.
However, parents whose children sufferred from the
disease tend to expect for drugs to shorten the period
WR SODFHER JURXS > KRXUV 6'  YV  KRXUV 6' of diarrhea. Therefore, nowadays, numerous research-
PHDQGLIIHUHQFH&,WR3 @ es have been done to study types of drugs which can
7KH555ZDVDQG$55ZDV.DSODQ0HLHUVXUYLYDO
analysis showed that duration of acute diarrhea was shorter in
be given along with oral rehydration effort.
WUHDWPHQWJURXS>KRXUV6'YHUVXVKRXUV6' Hypersecretion is a problem in diarrhea.
PHDQ GLIIHUHQFH   &,  WR  ORJ UDQN WHVW Dioctahedral smectite (DS) as an anti-secretoric has
3@,QPXOWLYDULDWH&R[UHJUHVVLRQDQDO\VLVLWZDVIRXQG been studied in many countries and most of the results
that dioctahedral smectite influenced the duration of diarrhea
LQLQIDQWVZLWKDFXWHGLDUUKHD>25&,WR
3@
Conclusion Dioctahedral smectite can shorten the duration of
acute diarrhea. [Paediatr Indones. 2009;49:48-53].
From the Department of Child Health, Medical School, Udayana
University, Sanglah Hospital, Denpasar, Bali, Indonesia.
Keywords: acute diarrhea, dioctahedral smectite,
diarrhea duration Reprint request to: A.A. Md Widiasa, MD, Department of Child Health,
Medical School, Udayana University, Sanglah Hospital, Jl. Pulau Nias,
'HQSDVDU%DOL,QGRQHVLD7HO)D[(PDLOika_unud@
yahoo.com

48‡Paediatr Indones, Vol. 49, No. 1, January 2009

 A. A. Made Widiasa et al: Efficacy of dioctahedral smectite on acute diarrhea
had stated that DS are safe, effective and efficient.
DS has a role in reducing cAMP level and reduce the
leakage of fluid and electrolyte, binds with potential
agents that can cause diarrhea, reduces membrane
permeability, increases amount of mucous area, and
decreases the recovery time of intestine injury in
chronic diarrhea.7 DS has more benefits in decreasing
VHFUHWLRQ LQFUHDVLQJ DEVRUSWLRQ DQG QRUPDOL]LQJ
intestine peristaltic. Based on this mechanism, we
were interested in researching cheap, affordable,
effective, and safe medication which can be added
to standard medication that might accelerate the
recovery time of diarrhea.
Methods
$ GRXEOH EOLQG UDQGRPL]HG FOLQLFDO WULDO ZDV
conducted on Gastroenterology Division, Child
Health Department of Udayana University, from
-DQXDU\ WR -XO\  (OLJLEOH SDWLHQWV ZHUH FKRVHQ
using consecutive sampling. The study had been
approved by the Ethical Clearance from the Ethics
Committee of Medical School, Sanglah Hospital,
Denpasar, and informed consent was obtained from
parents.
The inclusion criteria were patients with mild
to moderate dehydration due to acute diarrhea, aged
PRQWKVROGDQGWKHGXUDWLRQRIGLDUUKHDEHIRUH
KRVSLWDOL]DWLRQ ZDV WZR GD\V RU OHVV ,QIDQWV ZLWK
complicated diarrhea, diarrhea with complication,
and infants whose parents refused to participate in
this study were excluded.
Acute diarrhea was defined as defecation
frequency for more than three times per day or more
than the usual habit accompanied by changes in feces
consistency, with or without blood and or mucous,
lasting for less than seven days.4 Recovery time was
the time needed until the frequency of defecation was
equal to or less than three time per day with normal
stool consistency without any complication. 1,4
Diarrhea with complication was defined as diarrhea
episode accompanied by direct effect of acute
diarrhea such as severe dehydration, metabolic
DFLGRVLVVHL]XUHDQGLOHXVSDUDO\WLF Complicated
according to the WHO standard,4 while nutritional
status was determined based on Z score of weight for
length.9 Patients who did not take either oral DS or
control in the first twelve hours and discharged by
request, were considered as drop-out case. Patients
who had treatment failure were defined as patients
who failed to recover on the fifth day of treatment,
or those who had experienced any complication
before day five, or had co-infection or adverse events
affecting the duration of diarrhea, or patients who
passed away.
4XHVWLRQQDLUHVZHUHXVHGWRUHFRUGWKHEDVHOLQH
characteristics of clinical and duration of diarrhea in
the hospital, frequency of defecation, consistency of
feces, complication, and adverse events. Total study
VXEMHFWV ZHUH  LQIDQWV WKH HVWLPDWLRQ ZDV EDVHG
on A SRZHU7KH\ZHUHUDQGRPL]HGLQWR
two groups; the treatment group who had standard
diarrhea therapy with DS, while the control group
who received standard diarrhea therapy with placebo.
7KH UDQGRPL]DWLRQ SURFHVV ZDV GRQH ZLWK EORFN
UDQGRPL]DWLRQ DQG WKH FRGHV ZHUH NHSW LQ FORVHG
envelopes. The envelopes were kept at Beaufour
Ipsen PT Combiphar and opened after the study was
finished.
All subjects were managed according to the
standard therapy recommended by WHO for acute
diarrhea, with rehydration. All medicines prescribed
before admission was discontinued.
All study subjects were followed-up until
the subjects recovered. To asses the outcome,
we performed evaluation and measurement of
dehydration status, frequency of defecation, stool
consistency, adverse events, and complications every
KRXUVZKLOHHYDOXDWLRQDQGPHDVXUHPHQWRIERG\
weight, compliance of taking DS and placebo, were
GRQH HYHU\  KRXUV ,Q WKLV VWXG\ GURS RXW DQG
treatment failure rates were accepted if the rate was
EHOORZ  6XEMHFWV WKDW FRQVLGHUHG DV GURS RXW
FDVHVRUWUHDWPHQWIDLOXUHVZHUHDQDO\]HGZLWKLQWKH
group and treated afterward. Study procedures are
shown in Figure 1.
'DWDZHUHDQDO\]HGXVLQJFRPSXWHUSURJUDP7KH
mean difference of recovery time was examined using
student’s t test. Additional variables (complications or
diarrhea was defined as acute diarrhea with severe DGYHUVHHYHQWVRQVWXG\GXUDWLRQZHUHDQDO\]HGXVLQJ
malnutrition, severe dysentery, respiratory infection, x test. The primary outcome result was the difference
and anemia.  Dehydration status was assessed in duration of diarrhea between groups showed by

Paediatr Indones, Vol. 49, No. 1, January 2009‡49

 A. A. Made Widiasa et al: Efficacy of dioctahedral smectite on acute diarrhea

Kaplan-Meier curve. Differences in duration of diarrhea Survival Functions

between two groups were tested using log-rank test. Typess onf intervention

Risk of treatment failure between the two groups was  DS

compared with relative risk reduction (RRR) and Placebo


absolute risk reduction (ARR). We made adjustment
of external variables to duration of diarrhea between

Cum Survival

two groups using cox-regression analysis. P value of
ZLWKFRQILGHQFHLQWHUYDOZHUHFRQVLGHUHG 

as statistically significant.


Results 

     

During the study period, there were 144 infants aged
PRQWKVROGDGPLWWHGWR6DQJODK+RVSLWDOGXHWR
acute diarrhea. Seventy-six infants with acute diarrhea
accompanied with other problems or co-infections
(three infants had severe malnutrition, six infants
had bronchopneumonia, four infants had anemia,
 LQIDQWV KDG DFXWH UKLQRSKDU\QJLWLV  LQIDQWV
had acute tonsilo-pharyngitis, one infant had acute
Duration of diarrhea (hour)
Figure 2-CRNCPŌ/GKGTUWTXKXCNEWTXGQHFWTCVKQP
QHFKCTTJGCKPVJGVTGCVOGPVITQWRCPFEQPVTQNITQWR
QPFC[UVWF[
Mean age of infants in treatment group was 9.9
otitis media, seven infants had acute bronchiolitis, 6'PRQWKVZKLOHLQWKHFRQWUROJURXSZDV
and eight infants refused to participate in the study. 6'PRQWKV%DVHOLQHFKDUDFWHULVWLFVRIWKHWZR
+HQFH WKHUH ZHUH LQIDQWV ZKR ZHUHHOLJLEOHIRU groups are shown in Table 1.
this study. Reduction in frequency of defecation was
VLJQLILFDQWO\ RFFXU LQ WKH WUHDWPHQW JURXS 
KRXU 6'  YHUVXV  KRXUV 6' 
Table 1. $CUGNKPGEJCTCEVGTKUVKEUQHKPHCPVUYKVJCEWVGFKCTTJGCKP
PHDQ GLIIHUHQFH RI  > &,  WR 
VTGCVOGPVCPFEQPVTQNITQWRU 3 @ 5HFRYHU\ RI VWRRO FRQVLVWHQF\ ZDV
6TGCVOGPV 2NCEGDQ significantly had shorter duration in the treatment
%JCTCEVGTKUVKE )TQWR )TQWR JURXS ^ KRXUV 6'  YHUVXV  KRXUV

P
P 6'PHDQGLIIHUHQFHRI>&,
#IG
OQPVJOGCPU
5& 
 

WR3 @
5GZDQ[U  

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ITCO OGCP 
 

Mean duration of diarrhea as a primary result was

5& significantly shorter in the treatment group compared

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)QQF 
 
 KRXUV6'PHDQGLIIHUHQFH>&,
/QFGTCVGOCNPWVTKVKQP 
 
 WR3 @%DVHGRQ.DSODQ0HLHU
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analysis, duration of diarrhea was significantly shorter
$GCUVHGGFKPI 
 

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in treatment group compared to that in control group
$( (QTOWNC 
 
 ORJUDQNWHVW33ULPDU\RXWFRPHLVVKRZHG
$( (QTOWNC OKNMRQTTKIFG 
 
 on Figure 2.
(QTOWNC OKNMRQTTKFIG 
 
 There were two infants who failed in control group
2TGJQURKVCNFKCTTJGC 
 
 due to bronchopneumonia and acute otitis media on

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2TGJQURKVCNFKCTTJGCHTGSWGPE[ 
 

OGCP
5& treatment group was also considered as a drop-out case.
#PVKDKQVKEDGHQTGCFOKUUKQP 
 
 The differences of treatment failure between two groups
1$9
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5& 
 
 ZHUHH[SUHVVHGDV555RIDQG$55RI

50‡Paediatr Indones, Vol. 49, No. 1, January 2009

 A. A. Made Widiasa et al: Efficacy of dioctahedral smectite on acute diarrhea

Table 2+PVGTXCTKCDNGUEQPPGEVKQPUVJCVCHHGEVGFCEWVGFKCTTJGCFWTCVKQPKPVTGCVOGPVITQWRXUEQPVTQN
ITQWR
%+
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$
HQT'ZR
$
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2TGJQURKVCNFKCTTJGCFWTCVKQP     VQ
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&5     VQ

In this study, there were no significant difference KRVSLWDOL]DWLRQWKHWUDQVIRUPDWLRQRIIHFDOFRQVLVWHQF\

in the body weight gain between treatment and control to normal was cumulatively significant in 31 infants
groups at the time of admission and discharged from ZLWKLQWKHWUHDWPHQWJURXSFRPSDUHGWRVHYHQ
KRVSLWDO6'YHUVXV6'PHDQ LQIDQWV LQ FRQWURO JURXS  /H[RPERRQ et al
GLIIHUHQFHZDV&,WR3  reported that transformation of fecal consistency to
From multivariate analysis (Cox regression), it QRUPDORQGD\WZRRIKRVSLWDOL]DWLRQZHUHREVHUYHGLQ
was proven that only DS significantly affected the LQIDQWVLQWKHWUHDWPHQWJURXSFRPSDUHGWR
GXUDWLRQ RI GLDUUKHD >25   &,  WR LQIDQWVLQFRQWUROJURXS%DVHGRQWZRVWXGLHV
3@Table 2). In this study, we found above, we conclude that recovery process of acute
no adverse events caused by DS. diarrhea in infants was faster in the treatment group
if compared to the control group. In this study, we also
had a result that duration of diarrhea in hospital was
Discussion VKRUWHULQWKHWUHDWPHQWJURXSKRXUV6'
YHUVXVKRXUV6'3 
Several studies in many countries about DS as an This study result was also similar to Vivatvakin et
adjunctive medication in management of diarrhea al11LQLQIDQWVDJHGEHWZHHQRQHWRPRQWKV7KH
showed a significant result in shortening the duration duration of diarrhea in the treatment group was 43.3
of diarrhea and nursing time in the hospital. A KRXUV6'FRPSDUHGWRKRXUV6'LQ
meta-analysis study by Zue-Shenyen et al IURP control group. The results were statistically significant.
5&7ZLWKLQIDQWVUHSRUWHGWKDW'6VWDWLVWLFDOO\ In study by Madkour et al13ZLWKLQIDQWVDJHGEHWZHHQ
significant to reduce the length of diarrhea. WKUHHWRPRQWKVWKHUHVXOWVZHUHKRXUV6'
Our study revealed that the defecation frequency LQWUHDWPHQWJURXSYHUVXVKRXUV6'LQFRQWURO
was significantly decreased in the treatment group group. Study by Narkeviciute et al14ZLWKLQIDQWVDQG
 KRXUV 6'  YHUVXV WKH FRQWURO JURXS FKLOGUHQDJHGEHWZHHQVL[WRPRQWKVUHYHDOHGWKDW
KRXUV6'0RVWO\RQWKHVHFRQGGD\RI the duration of diarrhea was 43.3 hours in the treatment
KRVSLWDOL]DWLRQIUHTXHQF\RIGLDUUKHDKDGGHFUHDVHG JURXSYHUVXVKRXUVLQFRQWUROJURXS
to less than three times per day, cumulatively there Recovery of acute diarrhea is determined by
ZHUHLQIDQWVYHUVXVVL[LQIDQWV intestinal mucosa recovery. In acute diarrhea, patients
This study result was consistent with the finding from treated with DS have a quicker small intestine
Vivatvakin study group.11 Vivatvakin study showed mucosal recovery through mucous interaction, cells
that frequency of diarrhea reduced on day two of regeneration stimulation, and differentiation of
KRVSLWDOL]DWLRQLQLQIDQWVIURPLQIDQWVLQ mucosal intestine resulting in less fluid excretion,
WKHWUHDWPHQWJURXSYHUVXVLQIDQWVLQFRQWURO increased absorption, and intestinal peristaltic
JURXS7KLVVWXG\DOVRUHYHDOHGTXLFNHUWLPHLH recovery. Dupont et al reported recovery of small
KRXUV 6'  LQ IHFHV FRQVLVWHQF\ WR EHFRPH LQWHVWLQHVWUXFWXUHGHSHQGVRQVL]HRIDGDPDJH6HYHUH
normal, soft, and formed in the treatment group damage would need four days to recover and the
FRPSDUHGWRFRQWUROJURXSKRXUV6'WKH function of absorbing water, electrolyte, and nutrition
PHDQGLIIHUHQFHZDV3 2QGD\WZRRI will be improved in 1.3 days time.

Paediatr Indones, Vol. 49, No. 1, January 2009‡51

 A. A. Made Widiasa et al: Efficacy of dioctahedral smectite on acute diarrhea

There was no significant difference between management of acute diarrhea in infants routinely in
ERWKJURXSVDIWHULQWHUYHQWLRQ>6'YHUVXV gastroenterology division of child health in Udayana
 6' @ DOWKRXJK ZHLJKW JDLQ WHQGHG WR
be slightly higher in control group. This result was
probably due to rehydration factor because DS did
not show any influence in weight gain in short period
of time. Similar study was done by Madkour et al13
which found that there was no statistically significant
GLIIHUHQFHLQZHLJKWJDLQEHWZHHQFRQWUROJURXS
gram) and treatment group (94.9 gram). Vivatvakin
et al11 reported that there was a significant difference
LQLQFUHPHQWRIERG\ZHLJKWJUDPVERG\ZHLJKW
LQ WKH WUHDWPHQW JURXS FRPSDUHG WR  JUDPV LQ
the control group. Both studies were influenced by
different period of monitoring. In Vivatvakin11, the
PRQLWRULQJWLPHZDVRQWKHth day after treatment,
whereas in our study, it was only performed when the
SDWLHQWZDVKRVSLWDOL]HG
,Q WKLV VWXG\ 555 VKRZHG  GHFUHDVH RU
$55RIGHFUHDVHLQLQWHUYHQWLRQJURXSFRPSDUH
to control group. Based on covariate analysis (cox
regression), DS only affected the duration of diarrhea
episode. Other factors such as age, nutrition status,
nutrition type, duration of diarrhea prior to admission,
and antibiotic intervention were not statistically
significant to influence the duration of diarrhea.
Adverse effects and complications were not
encountered in our study. Meta-analysis study by
6]DMHZVNDet al showed that there was no adverse
effects, which was caused by gut inability to absorb
DS into the systemic circulation, found in nine
UDQGRPL]HGFRQWUROOHGWULDOVZLWKSDUWLFLSDQWV
To strengthen its validity, the calculation on
intention to treat analysis was also included in this
study. We included the drop-out and failure-to-
treatment subjects in our final analysis, with the worst
assumption of subject’s results as expected.
The weakness in our study was that there was no
University, Sanglah Hospital, Denpasar.
Acknowlegments
Our respect and gratitude to Head of Beafour IPSEN International
PT. Combiphar for his support and assistance in accommodating
DS, particularly Smecta and Smecta without DS as a control. Our
respect and gratitude to all staffs and paramedic Department of
Child Health, Udayana University, Sanglah Hospital, Denpasar.
Also to all patients and their family who were admitted, especially
to those participating in this study.
Conflict of Interest
Beafour IPSEN International PT. Combiphar provided
DS and Placebo. This study was not ordered or
belonged to Beafour IPSEN International PT.
Combiphar. The researchers did not receive any
stipend or allowance in any form.
References
1. Sudigbia. Pengobatan biotika. Semarang: Buletin IKA FK
81',3
 'LQDV.HVHKDWDQ3URSLQVL%DOL5HJLVWUDVL30Denpasar:
'LQDV.HVHKDWDQ3URSLQVL%DOLS
3. Registrasi Kunjungan Poliklinik Anak Rumah Sakit Sanglah
7DKXQ
4. Suraatmaja S. Kapita selekta gastroenterologi. Diare Akut.
'HQSDVDU60),.$).818'S
 .DQGXQ ,1HGLWRU 8SD\D 3HQFHJDKDQ GLDUH GLWLQMDX GDUL
DVSHNNHVHKDWDQPDV\DUDNDW3URFHHGLQJRIWKHQG1DWLRQDO
Congress of Badan Koordinasi Gastroenterologi Anak Indonesia
further investigation on the cause of diarrhea especially %.*$,-XO\%DQGXQJ,QGRQHVLD
rotavirus, which had been known as the most common  'HSDUWHPHQ .HVHKDWDQ 5, (SLGHPLRORJL GDQ HWLRORJL
causeof diarrhea in children less than two years old. diare. Buku ajar diare. Jakarta: Departemen Kesehatan RI,
Due to the study limitation, its etiology remained Direktorat Jenderal Pemberantasan Penyakit Menular dan
unknown.
In conclusion, DS could be used as an alternative
therapy on treating acute diarrhea in infants. However,
the standard procedure of acute diarrhea recommended
by WHO remained to be the main protocol. Based on
its safety, DS is considered to be a treatment used in
52‡Paediatr Indones, Vol. 49, No. 1, January 2009
3HQ\HKDWDQ/LQJNXQJDQ3HPXNLPDQ'LWMHW30 3/3
S
 /H[RPERRQ8+DULNXO6/RUWKRORU\2&RQWUROUDQGRPL]HG
study of rehydration with dioctahedral smectite in ambulatory
7KDLLQIDQWVZLWKDFXWHGLDUUKHD1(QJO-0HG

 A. A. Made Widiasa et al: Efficacy of dioctahedral smectite on acute diarrhea

 ,VPDLO5HGLWRU'LDUHEHUPDVDODK6KLJHORVLVProceeding of the 7KDLLQIDQWVZLWKDFXWHGLDUUKHD1(QJO-0HG

QG1DWLRQDO&RQJUHVVRI%DGDQ.RRUGLQDVL*DVWURHQWHURORJL 
$QDN ,QGRQHVLD %.*$,  -XO\  %DQGXQJ
,QGRQHVLD
9. Soetjiningsih, IKG Suandi, Dwi Lingga Utama. Tumbuh
NHPEDQJ JL]L'HQSDVDU%DJ60),OPX.HVHKDWDQ$QDN
)DNXOWDV.HGRNWHUDQ818'566DQJODKS
 =XL6KHQ<HQ0HL6KX/DLSmectite for acute diarrhea in
13. Medkour A, Madina E, Amer M. Smectite in acute diarhea
in children a double-blind placebo-controlled clinical trial.
-3HGLDWU*DVWURHQWURO1XWU
 1RUNHYLFLXWH,5XG]HYLFLHQH2/HYLQLHQH*0RFLVNLHQH
K. Management of lituanian children’s acute diarrhoea
with gastrolit solution and dioctahedral smectite. Eur J
FKLOGUHQ(PHUJ0HG-
11. Vivatvakin D, Harikul S, Eksarnyri P. Control study of
oral rehidration solution, ors +dioctahedral smectite in
KRVSLWDOL]HGWKDLLQIDQWVZLWKDFXWHVHFUHWRU\GLDUUKHD-7URS
0HG3XEOLF+HDOWK
 /H[RPERRQ8+DULNXO6/RUWKRORU\2&RQWUROUDQGRPL]HG
study of rehidration with dioctahedral smectite in ambulatory
*DVWURHQWHURO+HSDWRO
 'XSRQW +/ +RUQLFN 5% $GYHUVH HIHFW RI VPHFWLWH
WKHUDS\LQGLDUUKHD6($VLDQ-7URS0HG3XEO+OWK

 6]DMZHVND ']LHFKHFLDU] 3 0UXNRZLF] - 0HWD ² $QDO\VLV
Smectite in the treatment of acute diarrhea in chidren.
$OLPHQW3KDUPDFRO7KHU
Paediatr Indones, Vol. 49, No. 1, January 2009‡53