Original Article
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Abstract iarrhea is still a children health problem
Background Acute diarrhea is a sudden diarrhea which lasts less LQ ,QGRQHVLD ZKHUH ZKR VXIIHUV
than seven days on babies and children. The standard treatment from diarrhea are under five years old.1 In
by WHO in managing acute diarrhea is still not satisfactory for
WKHLQFLGHQFHRIGLDUUKHDLQ%DOLZDV
parents whose infants and children suffering from the disease.
Dioctahedral smectite is expected to decrease the volume, )URPOLVWRIFRQVXOWDWLRQWRSULPDU\KHDOWKFDUH
frequency, and duration of diarrhea. RXWSDWLHQWFOLQLFDQGKRVSLWDOL]HGSDWLHQWVGLDUUKHDLV
Objective To assess the clinical effects of dioctahedral smectite in always on top three diseases in their monthly census.
infants with acute diarrhea. In pediatric outpatient clinic, Sanglah Hospital, there
Methods$GRXEOHEOLQGUDQGRPL]HGFOLQLFDOFRQWUROOHGWULDOZDV
SHUIRUPHGRQVL[WRPRQWKVROGLQIDQWVZKRZHUHKRVSLWDOL]HG
ZHUHSDWLHQWVZLWKGLDUUKHDLQ3
in Sanglah Hospital, Denpasar due to acute diarrhea.The subjects ,Q:+2SXEOLVKHGDUDWLRQDOPHGLFDWLRQ
were divided into two groups. The treatment group was given in management of acute diarrhea for infants and
standard management with adjuvant dioctahedral smectite children.4 Oral rehydration effort and early solid food
while and control group was given standard management with
intake has a positive impact for recovery of diarrhea.
placebo.
Results)URPLQIDQWVHQUROOHGLQWKLVVWXG\WKHPHDQGXUDWLRQ However, parents whose children sufferred from the
of diarrhea was significantly shorter in treatment group compared 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&,WR3 @ 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
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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
had stated that DS are safe, effective and efficient. according to the WHO standard,4 while nutritional
DS has a role in reducing cAMP level and reduce the status was determined based on Z score of weight for
leakage of fluid and electrolyte, binds with potential length.9 Patients who did not take either oral DS or
agents that can cause diarrhea, reduces membrane control in the first twelve hours and discharged by
permeability, increases amount of mucous area, and request, were considered as drop-out case. Patients
decreases the recovery time of intestine injury in who had treatment failure were defined as patients
chronic diarrhea.7 DS has more benefits in decreasing who failed to recover on the fifth day of treatment,
VHFUHWLRQ LQFUHDVLQJ DEVRUSWLRQ DQG QRUPDOL]LQJ or those who had experienced any complication
intestine peristaltic. Based on this mechanism, we before day five, or had co-infection or adverse events
were interested in researching cheap, affordable, affecting the duration of diarrhea, or patients who
effective, and safe medication which can be added passed away.
to standard medication that might accelerate the 4XHVWLRQQDLUHVZHUHXVHGWRUHFRUGWKHEDVHOLQH
recovery time of diarrhea. characteristics of clinical and duration of diarrhea in
the hospital, frequency of defecation, consistency of
feces, complication, and adverse events. Total study
Methods VXEMHFWV ZHUH LQIDQWV WKH HVWLPDWLRQ ZDV EDVHG
on A SRZHU7KH\ZHUHUDQGRPL]HGLQWR
$ GRXEOH EOLQG UDQGRPL]HG FOLQLFDO WULDO ZDV two groups; the treatment group who had standard
conducted on Gastroenterology Division, Child diarrhea therapy with DS, while the control group
Health Department of Udayana University, from who received standard diarrhea therapy with placebo.
-DQXDU\ WR -XO\ (OLJLEOH SDWLHQWV ZHUH FKRVHQ 7KH UDQGRPL]DWLRQ SURFHVV ZDV GRQH ZLWK EORFN
using consecutive sampling. The study had been UDQGRPL]DWLRQ DQG WKH FRGHV ZHUH NHSW LQ FORVHG
approved by the Ethical Clearance from the Ethics envelopes. The envelopes were kept at Beaufour
Committee of Medical School, Sanglah Hospital, Ipsen PT Combiphar and opened after the study was
Denpasar, and informed consent was obtained from finished.
parents. All subjects were managed according to the
The inclusion criteria were patients with mild standard therapy recommended by WHO for acute
to moderate dehydration due to acute diarrhea, aged diarrhea, with rehydration. All medicines prescribed
PRQWKVROGDQGWKHGXUDWLRQRIGLDUUKHDEHIRUH before admission was discontinued.
KRVSLWDOL]DWLRQ ZDV WZR GD\V RU OHVV ,QIDQWV ZLWK All study subjects were followed-up until
complicated diarrhea, diarrhea with complication, the subjects recovered. To asses the outcome,
and infants whose parents refused to participate in we performed evaluation and measurement of
this study were excluded. dehydration status, frequency of defecation, stool
Acute diarrhea was defined as defecation consistency, adverse events, and complications every
frequency for more than three times per day or more KRXUVZKLOHHYDOXDWLRQDQGPHDVXUHPHQWRIERG\
than the usual habit accompanied by changes in feces weight, compliance of taking DS and placebo, were
consistency, with or without blood and or mucous, GRQH HYHU\ KRXUV ,Q WKLV VWXG\ GURS RXW DQG
lasting for less than seven days.4 Recovery time was treatment failure rates were accepted if the rate was
the time needed until the frequency of defecation was EHOORZ 6XEMHFWV WKDW FRQVLGHUHG DV GURS RXW
equal to or less than three time per day with normal FDVHVRUWUHDWPHQWIDLOXUHVZHUHDQDO\]HGZLWKLQWKH
stool consistency without any complication. 1,4 group and treated afterward. Study procedures are
Diarrhea with complication was defined as diarrhea shown in Figure 1.
episode accompanied by direct effect of acute 'DWDZHUHDQDO\]HGXVLQJFRPSXWHUSURJUDP7KH
diarrhea such as severe dehydration, metabolic mean difference of recovery time was examined using
DFLGRVLVVHL]XUHDQGLOHXVSDUDO\WLF Complicated student’s t test. Additional variables (complications or
diarrhea was defined as acute diarrhea with severe DGYHUVHHYHQWVRQVWXG\GXUDWLRQZHUHDQDO\]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
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 Duration of diarrhea (hour)
PRQWKVROGDGPLWWHGWR6DQJODK+RVSLWDOGXHWR
acute diarrhea. Seventy-six infants with acute diarrhea Figure 2-CRNCPŌ/GKGTUWTXKXCNEWTXGQHFWTCVKQP
accompanied with other problems or co-infections QHFKCTTJGCKPVJGVTGCVOGPVITQWRCPFEQPVTQNITQWR
(three infants had severe malnutrition, six infants QPFC[UVWF[
had bronchopneumonia, four infants had anemia,
LQIDQWV KDG DFXWH UKLQRSKDU\QJLWLV LQIDQWV
had acute tonsilo-pharyngitis, one infant had acute 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
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Mean duration of diarrhea as a primary result was
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5& treatment group was also considered as a drop-out case.
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The differences of treatment failure between two groups
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Table 2+PVGTXCTKCDNGUEQPPGEVKQPUVJCVCHHGEVGFCEWVGFKCTTJGCFWTCVKQPKPVTGCVOGPVITQWRXUEQPVTQN
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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 University, Sanglah Hospital, Denpasar.
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 Acknowlegments
of time. Similar study was done by Madkour et al13
which found that there was no statistically significant Our respect and gratitude to Head of Beafour IPSEN International
GLIIHUHQFHLQZHLJKWJDLQEHWZHHQFRQWUROJURXS PT. Combiphar for his support and assistance in accommodating
gram) and treatment group (94.9 gram). Vivatvakin DS, particularly Smecta and Smecta without DS as a control. Our
et al11 reported that there was a significant difference respect and gratitude to all staffs and paramedic Department of
LQLQFUHPHQWRIERG\ZHLJKWJUDPVERG\ZHLJKW Child Health, Udayana University, Sanglah Hospital, Denpasar.
LQ WKH WUHDWPHQW JURXS FRPSDUHG WR JUDPV LQ Also to all patients and their family who were admitted, especially
the control group. Both studies were influenced by to those participating in this study.
different period of monitoring. In Vivatvakin11, the
PRQLWRULQJWLPHZDVRQWKHth day after treatment,
whereas in our study, it was only performed when the Conflict of Interest
SDWLHQWZDVKRVSLWDOL]HG
,Q WKLV VWXG\ 555 VKRZHG GHFUHDVH RU Beafour IPSEN International PT. Combiphar provided
$55RIGHFUHDVHLQLQWHUYHQWLRQJURXSFRPSDUH DS and Placebo. This study was not ordered or
to control group. Based on covariate analysis (cox belonged to Beafour IPSEN International PT.
regression), DS only affected the duration of diarrhea Combiphar. The researchers did not receive any
episode. Other factors such as age, nutrition status, stipend or allowance in any form.
nutrition type, duration of diarrhea prior to admission,
and antibiotic intervention were not statistically
significant to influence the duration of diarrhea. References
Adverse effects and complications were not
encountered in our study. Meta-analysis study by 1. Sudigbia. Pengobatan biotika. Semarang: Buletin IKA FK
6]DMHZVNDet al showed that there was no adverse 81',3
effects, which was caused by gut inability to absorb 'LQDV.HVHKDWDQ3URSLQVL%DOL5HJLVWUDVL30Denpasar:
DS into the systemic circulation, found in nine 'LQDV.HVHKDWDQ3URSLQVL%DOLS
UDQGRPL]HGFRQWUROOHGWULDOVZLWKSDUWLFLSDQWV 3. Registrasi Kunjungan Poliklinik Anak Rumah Sakit Sanglah
To strengthen its validity, the calculation on 7DKXQ
intention to treat analysis was also included in this 4. Suraatmaja S. Kapita selekta gastroenterologi. Diare Akut.
study. We included the drop-out and failure-to- 'HQSDVDU60),.$).818'S
treatment subjects in our final analysis, with the worst .DQGXQ ,1HGLWRU 8SD\D 3HQFHJDKDQ GLDUH GLWLQMDX GDUL
assumption of subject’s results as expected. DVSHNNHVHKDWDQPDV\DUDNDW3URFHHGLQJRIWKHQG1DWLRQDO
The weakness in our study was that there was no 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. 3HQ\HKDWDQ/LQJNXQJDQ3HPXNLPDQ'LWMHW30 3/3
In conclusion, DS could be used as an alternative S
therapy on treating acute diarrhea in infants. However, /H[RPERRQ8+DULNXO6/RUWKRORU\2&RQWUROUDQGRPL]HG
the standard procedure of acute diarrhea recommended study of rehydration with dioctahedral smectite in ambulatory
by WHO remained to be the main protocol. Based on 7KDLLQIDQWVZLWKDFXWHGLDUUKHD1(QJO-0HG
its safety, DS is considered to be a treatment used in