Characteristics of included studies
| Study author | Setting, country | Participants | Intervention | Outcomes measured | Comments |
|---|---|---|---|---|---|
| Lachaux et al15 | Inpatient, France | Number: 36 (diosmectite=17; placebo=19) Age: 2–24 months Inclusion: acute diarrhoea of <4 days with moderate or severe dehydration | Dose: <1 year=3 g/day >1 year=6 g per day Duration: not mentioned | Termination of diarrhoea (from the first drug administration to the passage of the last liquid stool prior to a formed stool); cure rate at 72 h and day 5; adverse events. | Open label trial. ITT analysis. Aetiological (microbiological) data not available. |
| Gilbert et al16 | Inpatient, France | Number: 36 (diosmectite=18; placebo=18) Age: 2–24 months Inclusion: moderate to severe diarrhoea | Dose: 3–6 g/day Duration: not mentioned | Termination of diarrhoea (return to the average number of daily stools frequency); adverse events. | Double-blind trial. No ITT analysis. Aetiological (microbiological) data not available. |
| Osman et al17 | Inpatient and outpatient, Egypt | Number: 60 (diosmectite=30; placebo=30) Age: <36 months Inclusion: acute diarrhoea of <7 days with mild to moderate dehydration | Dose: 4.5 g/day (<10 kg); 6 g/day (>10 kg) Duration: 5 days | Termination of diarrhoea (return of stools to the formal formed consistency and to the average number of daily stool frequency); stool output (volume, g/kg); stool output (frequency); adverse events. | Open label trial. No ITT analysis. Aetiological (microbiological) data not available. |
| Vivatvakin et al18 | Inpatient, Thailand | Number: 62 (diosmectite=32; placebo=30) Age: 1–24 months Inclusion: acute diarrhoea of <3 days with mild or moderate dehydration | Dose: 1.5 g at the beginning of rehydration and then 3 g/day (<3 kg); 4.5 g/day (4–10 kg); 6 g/day (11–15 kg) Duration: 48–120 h | Termination of diarrhoea (from the first drug administration to the passage of the last liquid stool prior to a formed stool); cure rate at 48 h, 72 h and day 5; adverse events. | Double-blind trial. ITT analysis. Aetiological (microbiological) data not available. |
| Madkour et al19 | Inpatient, Egypt | Number: 90 (diosmectite=45; placebo=45) Age: 3–24 months Inclusion: acute diarrhoea of <5 days with mild, moderate or severe dehydration | Dose: 6 g/day Duration: 3 days | Termination of diarrhoea (from the first drug administration to the passage of the last liquid stool); cure rate at 48 h, 72 h and day 5; stool output (volume, g/kg); stool output (frequency); adverse events. | Double-blind trial. ITT analysis. Only male children included. Rotavirus: antigen detected by ELISA in 15.6% (diosmectite group) and 17.8% (placebo group) |
| Lexomboon et al20 | Outpatient, Thailand | Number: 66 (diosmectite=34; placebo=32) Age: 1–24 months Inclusion: acute diarrhoea of <48 h with no, mild or moderate dehydration | Dose: 3 g/day Duration: not mentioned | Termination of diarrhoea (from the beginning of therapy to passage of two soft or solid stools); cure rate at 48 h, 72 h and day 5; stool output (frequency); adverse events | Open label trial. ITT analysis. Bacteriological stool examination: positive in 26% (diosmectite group) and 22% (placebo group) for Salmonella, Shigella, Campylobacter, Enterotoxigenic Escherichia coli or Plesiomonas sp. Rotavirus: antigen detected by ELISA in 29% (diosmectite group) and 25% (placebo group). |
| Zong et al21 | Outpatient, China | Number: 30 (diosmectite=20; placebo=10) Age: <36 months Inclusion: acute viral diarrhoea <5 days | Dose: <1 year=3 g/day >1 yr=6 g/day Duration: 3–6 days | Termination of diarrhoea (from the beginning of therapy to passage of ≤4 soft stools). | Open label trial. ITT analysis. Rotavirus: antigen detected by ELISA in 75% of the included cases. |
| Guarino et al22 | Outpatient, Italy | Number: 804 (diosmectite=406; placebo=398) Age: 3–60 months Inclusion: acute diarrhoea with mild or moderate dehydration | Dose: <1 yr=3 g/day >1 yr=6 g/day Duration: 5 days | Termination of diarrhoea (from the beginning of therapy to passage of the last liquid stool); cure rate at day 7; stool output (frequency); adverse events. | Open label trial. No ITT analysis. Aetiological (microbiological) data not available. |
| Narkeviciute et al23 | Inpatient, Lithuania | Number: 54 (diosmectite=28; placebo=26) Age: 6–48 months Inclusion: acute diarrhoea of <72 h with mild or moderate dehydration | Dose: 3 g at the beginning and then 4.5 g/day (<10 kg) or 6 g/day (10–20 kg) Duration: for 24 h after occurrence of normal stool | Termination of diarrhoea (one of the following was met: (1) passage of the first formed stool; (2) passage of the second semisolid stool; (3) passage of the last semisolid stool if no stools were passed for 24 h); adverse events. | Open label trial. No ITT analysis. Bacteriological stool examination: positive in 10.7% (diosmectite group), and 11.5% (placebo group). Rotavirus: antigen detected by ELISA in 64.3% (diosmectite group) and 76.9% (placebo group). |
| Dupont et al24 | Inpatient and outpatient, Malayasia and Peru | Number: 602 (diosmectite=299; placebo=303) Age: 1–36 months Inclusion: acute diarrhoea of <72 h with mild or moderate dehydration | Dose: 6 g/day for 3 days and then 3 g/day (1–12 months); 12 g/day for 3 days and then 6/day (13–36 months) Duration: until recovery. | Termination of diarrhoea (time from the first sachet intake to the first formed stool for Peru, to the first soft or formed stool for Malaysia, followed by a non-watery stool or 24 h without stools); stool output (volume, g/kg); adverse events. | Double-blind trial. ITT analysis. Only male children were included. Rotavirus: antigen detected by ELISA in 19.6% (diosmectite group) and 20.5% (placebo group). |
| Widiasa et al25 | Inpatient, Indonesia | Number: 68 (diosmectite=34; placebo=34) Age: 6–12 months Inclusion: acute diarrhoea of <48 h with mild or moderate dehydration | Dose: Not mentioned. Duration: Not mentioned. | Termination of diarrhoea (from the beginning of therapy to passage of ≤3 times/d stool with normal consistency); cure rate at 48 h; stool output (frequency); adverse events. | Double-blind trial. ITT analysis. Only male children were included. Aetiological (microbiological) data not available. |
| Mujawar et al26 | Inpatient and outpatient, India | Number: 117 (diosmectite=58; placebo=59) Age: 24–60 months Inclusion: acute diarrhoea of <48 h with mild or moderate dehydration | Dose: 3 g/day (<12 months); 4.5 g/day (12–24 months) Duration: 5 days | Termination of diarrhoea (from the beginning of therapy to passage of first stool of prediarrhoeal consistency); adverse events. | Open label trial. No ITT analysis. Aetiological (microbiological) data not available. |
| Rehman et al27 | Inpatient, Pakistan | Number: 196 (diosmectite=99; placebo=97) Age:6–24 months Inclusion: acute diarrhoea of <72 h with some or severe dehydration | Dose: 4.5 g/day. Duration: 5 days | Termination of diarrhoea (from the beginning of therapy to passage of stool with normal consistency); cure rate at day 7; adverse events. | Open label trial. No ITT analysis. Aetiological (microbiological) data not available |
ITT, intention-to-treat.