Efficacy of dioctahedral smectite in infants with acute diarrhea: a double blind randomized controlled trial
Keywords:
acute diarrhea, dioctahedral smectite, diarrhea duration
Abstract
Background Acute diarrhea is a sudden diarrhea which lasts lessthan 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 A double-blind, randomized clinical controlled trial was
performed on six to 12 months-old infants who were hospitalized
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 From 68 infants enrolled in this study, the mean duration
of diarrhea was significantly shorter in treatment group compared
to placebo group [39.03 hours (SD 2.03) vs 70.58 hours (SD
3.78), mean difference 31.6 (95% CI 22.90 to 40.19), P=0.001].
The RRR was 50%, and ARR was 29%. Kaplan-Meier survival
analysis showed that duration of acute diarrhea was shorter in
treatment group [36 hours (SD 1.7) versus 72 hours (SD 4.18),
mean difference 36.0 (95% CI 21.81 to 50.19), log rank test,
P<0.0001]. In multivariate Cox regression analysis, it was found
that dioctahedral smectite influenced the duration of diarrhea
in infants with acute diarrhea [OR 4.403 (95% CI 2.39 to 8.12),
P<O.OOOl].
Conclusion Dioctahedral smectite can shorten the duration of
acute diarrhea.
References
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UNDIP; 2000.
2. Dinas Kesehatan Propinsi Bali. Registrasi P2M. Denpasar:
Dinas Kesehatan Propinsi Bali; 2002. p.6-12.
3. Registrasi Kunjungan Poliklinik Anak Rumah Sakit Sanglah
Tahun 2003.
4. Suraatmaja S. Kapita selekta gastroenterologi. Diare Akut.
Denpasar: SMF IKA FK UNUD; 2002; p.1-28.
5. Kandun IN,editor. Upaya Pencegahan diare ditinjau dari
aspek kesehatan masyarakat. Proceeding of the 2nd National
Congress ofBadan Koordinasi Gastroenterologi Anak Indonesia
(BKGAI); 2003 July 3-5; Bandung, Indonesia;2003.
6. Departemen Kesehatan RI. Epidemiologi dan etiologi
diare. Buku ajar diare. Jakarta: Departemen Kesehatan RI,
Direktorat Jenderal Pemberantasan Penyakit Menular dan
Penyehatan Lingkungan Pemukiman (Ditjet P2M & PLP);
1995; p. 3-100.
7. Lexomboon U, Harikul S, Lortholory 0. Control randomized
study of rehydration with dioctahedral smectite in ambulatory
Thai infants with acute diarrhea. N Eng! J Med. 1994;25:
157-62.
8. Ismail R,editor Diare bermasalah: Shigelosis. Proceeding of the
2nd National Congress ofBadan Koordinasi Gastroenterologi
Anak Indonesia (BKGA!); 2003 July 3-5; Bandung,
Indonesia; 2003.
9. Soetjiningsih, !KG Suandi, Dwi Lingga Utama. Tumbuh
kembang & gizi. Denpasar: Bag /SMF Ilmu Kesehatan Anak
Fakultas Kedokteran UNUD/RS Sanglah,1995; p. 39-41.
10. Zui Shen Yen, Mei Shu Lai. Smectite for acute diarrhea in
children. Emerg Med J. 2006; 23(1):65-66.
11. Vivatvakin D, Harikul S, Eksarnyri P. Control study of
oral rehidration solution, ors +dioctahedral smectite in
hospitalized thai infants with acute secretory diarrhea. J Trop
Med Public Health. 1992;23:414-9.
12. Lexomboon U, Harikul S, Lortholory 0. Control randomized
study of rehidration with dioctahedral smectite in ambulatory
Thai infants with acute diarrhea. N Eng! J Med. 1994;25:
157-62.
13. Medkour A, Madina E, Amer M. Smectite in acute diarhea
in children a double-blind placebo-controlled clinical trial.
J Pediatr Gastroentrol Nutr. 2000;368: 176-81.
14. Norkeviciute I, Rudzeviciene 0, Leviniene G, Mociskiene
K. Management of lituanian children's acute diarrhoea
with gastrolit solution and dioctahedral smectite. Eur J
Gastroenterol Hepatol. 2002; 14:419-24.
15. Dupont H.L. Hornick R.B. Adverse efect of smectite
therapy in diarrhea. SE Asian J Trop Med Pub! Hlth. 2000;
24:224-9.
16. Szajweska, Dziecheciarz P, Mrukowicz J. Meta - Analysis:
Smectite in the treatment of acute diarrhea in chidren.
Aliment Pharmacol Ther. 2006;23:217-27.
Published
2009-03-01
How to Cite
1.
Widiasa AA, Soetjiningsih S, Karyana P. Efficacy of dioctahedral smectite in infants with acute diarrhea: a double blind randomized controlled trial. PI [Internet]. 1Mar.2009 [cited 29Apr.2024];49(1):48-3. Available from: https://www.paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/455
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Received 2016-09-05
Accepted 2016-09-05
Published 2009-03-01
Accepted 2016-09-05
Published 2009-03-01
