Alam 1999.
| Methods | Randomized controlled trial. Duration:1 year 10 months, from July 1995 to May 1997. |
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| Participants | Number of participants: 300 randomized (168 men; 131 women). Inclusion criteria: adult men and women aged 15 to 55 years; history of acute watery diarrhoea for < 24 hours before admission; severe dehydration; stool positive for Vibrio cholerae under dark‐field illumination; successful rehydration with intravenous infusion within 6 hours of admission. Exclusion criteria: suspected pregnancy; bloody diarrhoea; systemic infection requiring intravenous antibiotics; inability to rehydrate with intravenous infusion within 6 hours after admission. |
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| Interventions | (1) ORS ≤ 270 (glucose‐based). (2) ORS ≥ 310 (glucose‐based). See Additional Table 2 for the ORS compositions. Co‐interventions: erythromycin (500 mg orally every 6 hours for 3 days). Food: bread, banana (immediately after rehydration), and standard meals (rice, fish, or meat, vegetables and lentils) 3 times daily. Water: given as desired, usually with meals. |
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| Outcomes | (1) Need for unscheduled intravenous infusion.* (2) Duration of diarrhoea (after randomization, hours).* (3) Vomiting during rehydration during initial 24 hours.* (4) Stool weight (g/kg bodyweight) in first 24 hours after admission/randomization.* (5) Total stool weight, g/kg body weight. (6) Urine volume during initial 24 hours (ml/kg bodyweight). (7) Total urine volume (ml/kg body weight). (8) Initial 24 hours ORS intake (ml/kg body weight). (9) Total ORS intake (ml/kg body weight). (10) Initial 24 hours water intake (ml/kg body weight). (11) Total water intake (ml/kg body weight). (12) Biochemical hyponatraemia (< 130 mmol/L) 24 hours after admission.* (13) Biochemical hyponatraemia (< 125 mmol/L) 24 hours after admission.* (14) Biochemical hyponatraemia (< 120 mmol/L) 24 hours after admission.* | |
| Notes | Location: Bangladesh. (Trial started at two sites, in Bangladesh and Indonesia, but it was discontinued at the latter due to inadequate participant supervision. No data from Indonesia included in the analysis.) Date: July 1995 to May 1997. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomization list ... was prepared ... by use of permuted blocks of variable length." |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | "double‐blind" but method not described. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Data collected on patients withdrawn from the study were included in the analysis up to the time of withdrawal." Loss to follow‐up: Reduced 13/147 (8.8%) and Higher 16/153 (10.5%). |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
| Other bias | Low risk | The study appears to be free of other bias. |