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[e-farmacos] Consulta sobre diosmectita (cont.)


  • From: " Davila, Ever" <cimed@minsa.gob.ni>
  • Date: Mon, 22 Nov 2004 10:21:33 -0600

Estimada Ninoska,

Dioctahedral smectite, desde 1992, ha sido evaluada para su registro. Te envio algunos resumenes de estudios clinicos. Debo advertirte, que estos estudio deben ser evaluados, es decir valorar la calidad metodologica, para determinar su utilidad en la practica clinica en el manejo de la diarrea.

Ever Davila
CIMED-MINSA
(Nicaragua)

SmectaPreparation (Fr.) Beaufour, Fr.Active ingredients: a. Smectite beidellitique Indications: Gastrointestinal disorders

SmectaPreparation (Hong) Beaufour-Ipsen, Hong KongActive ingredients: a. Dioctahedral smectite Indications: Diarrhoea; irritable bowel syndrome

SmectaPreparation (Singapore) Beaufour-Ipsen, SingaporeActive ingredients: a.. Dioctahedral smectite Indications: Diarrhoea

SmectaPreparation (Thai.) Beaufour-Ipsen, Thai.Active ingredients: a.. Dioctahedral smectite Indications: Diarrhoea
Copyright 2003 The Pharmaceutical Press.

1: Eur J Gastroenterol Hepatol. 2002 Apr;14(4):419-24. Management of Lithuanian children's acute diarrhoea with Gastrolit solution and dioctahedral smectite. Narkeviciute I, Rudzeviciene O, Leviniene G, Mociskiene K, Eidukevicius R. Centre of Paediatrics, Vilnius University, Santariskiu 4, LT-2600 Vilnius, Lithuania. irena.narkeviciute@rvuvl.vu.lt
OBJECTIVE: Acute gastroenteritis represents a major cause of morbidity and mortality worldwide among children, and rehydration treatment has been one of the cornerstones in the management strategy. The natural clay dioctahedral smectite (Smecta) increases intestinal barrier function and is effective against infectious diarrhoea in children. The purpose of this work was to compare the efficacy and tolerance of Lithuanian children's diarrhoea treatment with dioctahedral smectite combined with hypotonic oral rehydration solution (ORS)--Gastrolit--versus Gastrolit alone to establish the influence of Smecta on serum electrolyte balance in young children with diarrhoea and mild or moderate dehydration. METHODS: Smecta combined with ORS (study group) and ORS alone (control group) were evaluated in a multicentre, open, randomized trial in 54 children aged 6-48 months hospitalized for acute diarrhoea (mostly rotavirus aetiology) and signs of mild and moderate dehydration. The main outcomes examined were duration of diarrhoea, fever, number of vomiting episodes, and serum electrolyte balance before and after treatment. RESULTS: The mean duration of diarrhoea was significantly shorter in the study group (42.3 +/- 24.7 h) than in the control group (61.8 +/- 33.9 h). No side effects of Smecta were observed. The changes of sodium, potassium, chloride and calcium concentrations after treatment were minimal and in the normal range. CONCLUSIONS: Smecta significantly reduced the duration of diarrhoea, was safe and well tolerated, and had no impact on the adsorption of electrolytes. Smecta could be used together with ORS in children suffering from acute gastroenteritis (without uncontrollable vomiting) with mild and moderate dehydration.
Publication Types: Clinical Trial Multicenter Study Randomized Controlled Trial PMID: 11943957 [PubMed - indexed for MEDLINE]

2: J Pediatr Gastroenterol Nutr. 2001 Jan;32(1):71-5. Smectite in the treatment of acute diarrhea: a nationwide randomized controlled study of the Italian Society of Pediatric Gastroenterology and Hepatology (SIGEP) in collaboration with primary care pediatricians. SIGEP Study Group for Smectite in Acute Diarrhea. Guarino A, Bisceglia M, Castellucci G, Iacono G, Casali LG, Bruzzese E, Musetta A, Greco L; Italian Society of Pediatric Gastroenterology and Hepatology Study Group for Smectite in Acute Diarrhea. Department of Pediatrics, University Federico II, Naples, Italy. alfguari@unina.it
BACKGROUND: Childhood gastroenteritis is associated with considerable health costs. The natural clay dioctahedral smectite increases intestinal barrier function and is effective against infectious diarrhea in children in developing countries. The purpose of this work was to investigate the efficacy of smectite in Italian children with acute diarrhea of mild to moderate severity. METHODS: A national, prospective, randomized, case-controlled study was performed in collaboration with primary care pediatricians. Children seen by pediatricians for acute gastroenteritis were treated with oral rehydration solution (ORS) alone or ORS with smectite. Parents returned a form in which total duration of diarrhea, incidence of vomiting and fever, persistence of diarrhea for more than 7 days and hospital admissions were recorded. RESULTS: Eight hundred four children with acute diarrhea were randomly assigned to treated or control groups. Administration of smectite was associated with significant reduction of the duration of diarrhea, as judged by stool frequency and consistency. The incidence and duration of vomiting and fever were not different. Diarrhea lasted more than 7 days in 10% of treated and in 18% of control children (P < 0.01). Hospital admission was necessary in seven treated and six control children. No side effects were observed. CONCLUSIONS: Smectite reduces the duration of diarrhea and prevents a prolonged course. It may therefore consistently reduce the costs of gastroenteritis.
Publication Types: Clinical Trial Randomized Controlled Trial PMID: 11176329 [PubMed - indexed for MEDLINE]

3: Southeast Asian J Trop Med Public Health. 1994 Mar;25(1):157-62. Control randomized study of rehydration/rehydration with dioctahedral smectite in ambulatory Thai infants with acute diarrhea. Lexomboon U, Harikul S, Lortholary O. Pediatric Gastroenterology Unit, Children's Hospital, Bangkok, Thailand.
The study was performed to assess the efficiency, acceptability and safety of dioctahedral smectite (DS) associated with rehydration in ambulatory infants with acute diarrhea. Sixty-six Thai infants, aged 1-24 months were randomly divided into 2 groups. One group of 32 infants (control group) received oral or intravenous rehydration, the other group of 34 infants (DS group) received the rehydration with DS. Both groups were comparable for sex, age, weight, diet, duration of diarrhea, body temperature, nutritional and dehydration status. Bacteriological stool examination was positive in 22% in control group and 26% in DS group for Salmonella, Shigella, Campylobacter, enterotoxigenic Escherichia coli and Plesiomonas sp. Rotavirus was found in 25% of the control group and 29% of the DS group. Seventy-two hours after therapy, 34% of infants were cured in the control group compared to 71% in DS group (p < 0.01) and 5 days after the beginning of treatment, 34% still had diarrhea in the control group compared to 12% in DS group (p = 0.04). The acceptability of DS was considered to be good in 30 infants (88%). No major side effect was observed. In conclusion, DS with rehydration shortens the course of acute diarrhea in ambulatory infants and may reduce the occurrence of prolonged diarrhea. DS is well tolerated in infants with acute diarrhea.
Publication Types: Clinical Trial Randomized Controlled Trial PMID: 7825006 [PubMed - indexed for MEDLINE]

4: J Pediatr Gastroenterol Nutr. 1993 Aug;17(2):176-81. Comment in: J Pediatr Gastroenterol Nutr. 1994 May;18(4):505-6. Smectite in acute diarrhea in children: a double-blind placebo-controlled clinical trial. Madkour AA, Madina EM, el-Azzouni OE, Amer MA, el-Walili TM, Abbass T. Alexandria University, Faculty of Medicine, Egypt.
Dioctahedral smectite (DS) a natural adsorbent clay capable of adsorbing viruses, bacteria, and other intestinal irritants in vitro, is claimed to possess beneficial "antidiarrheal" properties. This study tested the effect of DS on the duration of diarrhea and the frequency and amount of liquid stools. Ninety well-nourished boys, aged 3-24 months, with acute watery diarrhea and mild, moderate, or severe dehydration were included in a randomized double-blind, placebo-controlled trial. After initial rehydration, they received DS or placebo (1.5 g freshly dissolved in 50 ml of water, four times daily for 3 days) along with oral rehydration solution (ORS) and adequate feeding. The clinical characteristics of both groups were comparable on admission. Patients in the smectite group had a significantly shorter duration of diarrhea (mean +/- SD, 54 +/- 16 vs. 73 +/- 13 h) and significantly fewer stools (2.6 +/- 0.8 vs. 3 +/- 0.7 on second day; 1.9 +/- 0.7 vs. 2.4 +/- 0.7 on third day; and 11.3 +/- 3.2 vs. 13.8 +/- 3 overall). The amount of liquid stools was not significantly reduced. Weight gain at 24, 48, and 72 h and on recovery was significantly higher in the smectite group despite the comparable fluid and food intake in both groups. These results suggest a beneficial effect of DS in shortening the duration of diarrhea and reducing the frequency of liquid stools in children rehydrated with ORS.
Publication Types: Clinical Trial Randomized Controlled Trial PMID: 8229544 [PubMed - indexed for MEDLINE]

5: Southeast Asian J Trop Med Public Health. 1992 Sep;23(3):414-9. Control study of oral rehydration solution (ORS)/ORS + dioctahedral smectite in hospitalized Thai infants with acute secretory diarrhea. Vivatvakin B, Jongpipatvanich S, Harikul S, Eksaengri P, Lortholary O. Department of Pediatrics, Chulalongkorn University Hospital, Bangkok, Thailand.
Dioctahedral smectite, a non systemic antidiarrheal agent, is mucoprotective and absorbs enterotoxins and rotavirus as demonstrated in animal models. Smectite has been successfully used in various countries in children and adults with acute diarrhea. This study was to assess the efficiency of smectite associated with rehydration in infants with acute secretory diarrhea. Sixty-two hospitalized Thai infants, aged 1-24 months, with acute secretory diarrhea were randomly divided into 2 groups receiving (1) oral rehydration solution (ORS) (30 cases), (2) ORS and Smectite (3.6 g/day) (32 cases). Both groups were comparable for age, weight, nutritional status and duration of symptoms before treatment. All 62 infants received lactose free formula and chicken rice soup as the standard diet. Stool frequency, weight change and duration of diarrhea were recorded. The mean duration of diarrhea was 84.7 +/- 48.5 hours in group 1, and 43.3 +/- 25.1 hours in group 2 (p = 0.005). The number of infants with diarrhea was significantly lower in group 2 on Day 1 (p < 0.01) and Day 3 (p = 0.001); furthermore 27% of infants in group 1 and 3% in group 2 had still diarrhea on Day 5. The stool frequency and weight changes were not statistically different in the two groups. No major side effects were observed except two cases of vomiting and hardened stools. It is concluded that (1) Smectite shortens the course of acute secretory diarrhea in Thai infants; (2) smectite may reduce the occurrence of prolonged diarrhea; furthermore (3) in our study dioctahedral smectite was found to be safe in children aged 1 to 24 months.
Publication Types: Clinical Trial Randomized Controlled Trial PMID: 1488694 [PubMed - indexed for MEDLINE]