Oral rehydration salt solution for treating cholera: ≤ 270 mOsm/L solutions vs ≥ 310 mOsm/L solutions

Alfred Musekiwa; Jimmy Volmink

doi:10.1002/14651858.CD003754.pub3

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Figure 1

Risk of bias graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Risk of bias summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 1 Need for unscheduled intravenous infusion.

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Analysis 1.2

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 2 Biochemical hyponatraemia (serum sodium < 130 mmol/L).

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Analysis 1.3

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 3 Severe biochemical hyponatraemia (serum sodium < 125 mmol/L).

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Analysis 1.4

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 4 Duration of diarrhoea.

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Analysis 1.5

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 5 Stool output in first 24 hours after admission or randomization.

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Analysis 1.6

Comparison 1 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 6 Vomiting during rehydration.

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Analysis 2.1

Comparison 2 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (rice‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 1 Biochemical hyponatraemia (serum sodium < 130 mmol/L).

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Analysis 2.2

Comparison 2 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (rice‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 2 Severe biochemical hyponatraemia (serum sodium < 125 mmol/L).

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Analysis 2.3

Comparison 2 Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (rice‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based), Outcome 3 Duration of diarrhoea.

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Summary of findings for the main comparison. ORS ≤ 270 mOsm/L (glucose‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera

ORS ≤ 270 mOsm/L (glucose‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera
Patient or population: patients with cholera Settings: resource‐limited Intervention: ORS ≤ 270 mOsm/L (glucose‐based) Comparison: ORS ≥ 310 mOsm/L (glucose‐based)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORS ≥ 310 mOsm/L (glucose‐based)	ORS ≤ 270 mOsm/L (glucose‐based)
Death	See comment	See comment	Not estimable	121 (2 studies)	See comment	No deaths occurred in the two trials reporting mortality
Need for unscheduled intravenous infusion	285 per 1000	245 per 1000 (188 to 319)	RR 0.86 (0.66 to 1.12)	616 (5 studies)	⊕⊕⊕⊝ moderate¹
Symptomatic hyponatraemia	See comment	See comment	Not estimable	620 (5 studies)	See comment	No instances of symptomatic hyponatraemia were reported in the five trials reporting this outcome
Biochemical hyponatraemia (serum sodium < 130 mmol/L)	121 per 1000	202 per 1000 (132 to 310)	RR 1.67 (1.09 to 2.57)	465 (4 studies)	⊕⊕⊕⊝ moderate²
Severe biochemical hyponatraemia (serum sodium < 125 mmol/L)	26 per 1000	41 per 1000 (16 to 105)	RR 1.58 (0.62 to 4.04)	465 (4 studies)	⊕⊕⊝⊝ low^1,2
Duration of diarrhoea (in hours)	The mean duration of diarrhoea (in hours) ranged across control groups from 38 to 79	The mean duration of diarrhoea (in hours) in the intervention groups was 2.52 lower (6.71 lower to 1.68 higher)		683 (6 studies)	⊕⊕⊕⊝ moderate³
Stool output in first 24 hours after admission or randomization	The mean stool output in first 24 hours after admission or randomization ranged across control groups from ‐0.76 to 0.05 standard deviations	The mean stool output in first 24 hours after admission or randomization in the intervention groups was 0.13 standard deviations lower (0.43 lower to 0.17 higher)		581 (4 studies)	⊕⊕⊕⊝ moderate⁴	SMD ‐0.13 (‐0.43 to 0.17)
The basis for the assumed risk* (eg the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Serious imprecision: wide 95% CI including both null effect (RR=1) and appreciable benefit (RR=0.75). Downgrade by 1. ² Serious study limitation: all four studies had unclear reporting of allocation concealment and blinding. Downgrade by 1. 3 Serious inconsistency: statistical heterogeneity was high (I² = 76%, Chi² P = 0.0009). The reasons for this are unclear as heterogeneity persisted even after subgrouping children versus adults. Downgrade by 1. 4 Serious inconsistency: statistical heterogeneity was high (I² = 63%. Chi² P = 0.04) due to one study (Faruque 1996) showing a significant treatment effect. Heterogeneity persisted even after subgrouping children versus adults. Downgrade by 1.

Summary of findings for the main comparison. ORS ≤ 270 mOsm/L (glucose‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera

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Summary of findings 2. ORS ≤ 270 mOsm/L (rice‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera

ORS ≤270 mOsm/L (rice‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera
Patient or population: patients with cholera Settings: resource‐limited Intervention: ORS ≤ 270 mOsm/L (rice‐based) Comparison: ORS ≥ 310 mOsm/L (glucose‐based)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORS ≥310 mOsm/L (glucose‐based)	ORS ≤270 mOsm/L (rice‐based)
Death	See comment	See comment	Not estimable	0 (0)	See comment	No trials reported this outcome
Need for unscheduled intravenous infusion	See comment	See comment	Not estimable	0 (0)	See comment	No trials reported this outcome
Symptomatic hyponatraemia	See comment	See comment	Not estimable	39 (1 study)	See comment	No instances of symptomatic hyponatraemia were reported in the one trial that assessed this outcome.
Severe biochemical hyponatraemia(serum sodium < 125 mmol/L)	20 per 1000	7 per 1000 (0 to 162)	RR 0.35 (0.02 to 8.1)	102 (2 studies)	⊕⊕⊝⊝ low¹
Biochemical hyponatraemia(serum sodium < 130 mmol/L)	180 per 1000	119 per 1000 (47 to 304)	RR 0.66 (0.26 to 1.69)	102 (2 studies)	⊕⊕⊝⊝ low¹
Duration of diarrhoea(in hours)	The mean duration of diarrhoea (in hours) ranged across control groups from 38 to 47 hours	The mean duration of diarrhoea (in hours) in the intervention groups was 11.42 lower (13.8 to 9.04 lower)		102 (2 studies)	⊕⊕⊝⊝ low^2,3
Stool output in first 24 hours after admission or randomization	See comment	See comment	Not estimable	0 (0)	See comment	No trials reported this outcome
The basis for the assumed risk* (eg the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Very serious imprecision: the 95% CI is wide and the two trials are small. Downgrade by 2. ² Serious inconsistency: statistical heterogeneity is high (I² = 90%, Chi² P = 0.001). Downgrade by 1. ³ Serious imprecision: the two trials are small. Downgrade by 1.

Summary of findings 2. ORS ≤ 270 mOsm/L (rice‐based) compared to ORS ≥ 310 mOsm/L (glucose‐based) for treating cholera

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Table 1. Detailed search strategies

Search set	CIDG SR*	CENTRAL**	MEDLINE**	EMBASE**	LILACS**
1	cholera	cholera	CHOLERA	CHOLERA	cholera
2	rehydration solutions	oral rehydration solution	cholera	cholera	oral rehydration
3	fluid therapy	fluid therapy	1 or 2	1 or 2	hypotonic
4	hypotonic	hypotonic solution	REHYDRATION SOLUTIONS	FLUID THERAPY	reduced osmolarity
5	ORS	ORS	FLUID THERAPY	HYPOTONIC SOLUTION	2 or 3 or 4
6	‐‐	2 or 3 or 4 or 5	HYPOTONIC SOLUTIONS	ORAL REHYDRATION THERAPY	1 and 5
7	‐‐	1 and 6	OSMOLAR CONCENTRATION	ORAL REHYDRATION SOLUTION	‐‐
8	‐‐	‐‐	oral rehydration solution	oral rehydration solution	‐‐
9	‐‐	‐‐	ORS	ORS	‐‐
10	‐‐	‐‐	osmolar*	OSMOLARITY	‐‐
11	‐‐	‐‐	osmolality	HYPEROSMOLARITY	‐‐
12	‐‐	‐‐	reduced osmolarity	osmolar$	‐‐
13	‐‐	‐‐	hypo‐osmolar	osmolality	‐‐
14	‐‐	‐‐	4‐13/OR	reduced ADJ osmolarity	‐‐
15	‐‐	‐‐	3 and 14	Hypo ADJ osmolar$	‐‐
16	‐‐	‐‐	Limit 15 to human	4‐15/OR	‐‐
17	‐‐	‐‐	‐‐	3 and 16	‐‐
18	‐‐	‐‐	‐‐	Limit 17 to human	‐‐
	*Cochrane Infectious Diseases Group Specialized Register	**Search terms used in combination with the search strategy for retrieving trials developed by The Cochrane Collaboration (Alderson 2004); Upper case: MeSH or EMTREE heading; Lower case: free text term

Table 1. Detailed search strategies

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Table 2. Composition of oral rehydration solutions used in the trials

ORS type	Trials	Sodium^a	Potassium^a	Chloride^a	Citrate^a	Glucose^a	Rice powder^b	Total osmolarity^a
ORS ≥ 310 (glucose‐based)	All trials	90	20	80	10	111	‐‐	311
ORS ≤ 270 (glucose‐based)	Dutta 2001	60	20	50	10	84	‐‐	224
"	Faruque 1996	67	20	66	7	89	‐‐	249
"	Bhattacharya 1998 Dutta 2000	70	20	80	8	90	‐‐	268
"	Alam 1999 Choice 2001 Pulungsih 2006	75	20	65	10	75	‐‐	245
ORS ≤ 270 (rice‐based)	Bhattacharya 1998 Dutta 2000	70	20	80	8	‐‐	50	178

ORS: oral rehydration solution; ^ammol/L; ^bg

Table 2. Composition of oral rehydration solutions used in the trials

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Comparison 1. Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Need for unscheduled intravenous infusion Show forest plot	5	616	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.66, 1.12]

1.1 Children	2	93	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.29, 1.11]
1.2 Adults	3	523	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.70, 1.24]
2 Biochemical hyponatraemia (serum sodium < 130 mmol/L) Show forest plot	4	465	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [1.09, 2.57]

2.1 Children	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.53, 4.74]
2.2 Adults	3	426	Risk Ratio (M‐H, Fixed, 95% CI)	1.69 [1.06, 2.69]
3 Severe biochemical hyponatraemia (serum sodium < 125 mmol/L) Show forest plot	4	465	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.62, 4.04]

3.1 Children	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.02, 8.10]
3.2 Adults	3	426	Risk Ratio (M‐H, Fixed, 95% CI)	1.91 [0.68, 5.31]
4 Duration of diarrhoea Show forest plot	6	683	Mean Difference (IV, Random, 95% CI)	‐2.52 [‐6.71, 1.68]

4.1 Children	2	97	Mean Difference (IV, Random, 95% CI)	‐2.75 [‐9.79, 4.29]
4.2 Adults	4	586	Mean Difference (IV, Random, 95% CI)	‐2.72 [‐8.83, 3.39]
5 Stool output in first 24 hours after admission or randomization Show forest plot	4	581	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.43, 0.17]

5.1 Children	1	58	Std. Mean Difference (IV, Random, 95% CI)	0.03 [‐0.49, 0.55]
5.2 Adults	3	523	Std. Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.57, 0.20]
6 Vomiting during rehydration Show forest plot	2	363	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.92, 1.40]

6.1 Children	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Adults	2	363	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.92, 1.40]

Comparison 1. Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (glucose‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based)

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Comparison 2. Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (rice‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Biochemical hyponatraemia (serum sodium < 130 mmol/L) Show forest plot	2	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.26, 1.69]

1.1 Children	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.31, 3.62]
1.2 Adults	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.08, 1.74]
2 Severe biochemical hyponatraemia (serum sodium < 125 mmol/L) Show forest plot	2	102	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.02, 8.10]

2.1 Children	1	39	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.02, 8.10]
2.2 Adults	1	63	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Duration of diarrhoea Show forest plot	2	102	Mean Difference (IV, Fixed, 95% CI)	‐11.42 [‐13.80, ‐9.04]

3.1 Children	1	39	Mean Difference (IV, Fixed, 95% CI)	‐9.13 [‐11.89, ‐6.37]
3.2 Adults	1	63	Mean Difference (IV, Fixed, 95% CI)	‐18.0 [‐22.68, ‐13.32]

Comparison 2. Oral rehydration solution (ORS) formulations ≤ 270 mOsm/L (rice‐based) versus ORS formulations ≥ 310 mOsm/L (glucose‐based)

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