The World Health Organization oral rehydration solution in US pediatric practice: a randomized trial to evaluate parent satisfaction

BACKGROUND: The World Health Organization's effective, inexpensive oral rehydration solution (WHO-ORS) is used worldwide, but rarely by US practitioners because, in part, of concerns about parent satisfaction. OBJECTIVE: To compare caretaker satisfaction with the WHO-ORS, a packet-based solution requiring preparation, with satisfaction with a commercially prepared oral rehydration solution (C-ORS), (Pedialyte; Ross Nutritionals, Columbus, Ohio). DESIGN AND METHODS: Randomized controlled trial in an urban pediatric clinic and a suburban family medicine clinic. Children aged 3 to 47 months treated as outpatients for diarrhea were randomized to receive either WHO-ORS or C-ORS. After 48 hours of use, caretakers completed a telephone interview measuring satisfaction with aspects of the solution. RESULTS: Of 97 families enrolled, 91 (94%) were available for follow-up interviews. The WHO-ORS and C-ORS groups were comparable at baseline in all respects, except that slightly more caretakers in the latter group had used the C-ORS for the current illness before study enrollment (P= .06). Caretakers in the WHO-ORS group had higher overall satisfaction, satisfaction with cost, willingness to purchase in the future, and to recommend use (P<.001 for all). Differences remained significant after controlling for prior use of the C-ORS. There was no difference in satisfaction with ease of administration (P=.90), appearance (P=.20), and effectiveness (P=.80). No adverse effects attributable to either study solution occurred. CONCLUSIONS: Caretakers who prepared and used the WHO-ORS were more satisfied with their solution than a comparable group who administered C-ORS. Fear of parental dissatisfaction need not be a barrier to use of the WHO-ORS in the United States.     

A comparative study of glycine fortified oral rehydration solution with standard WHO oral rehydration solution

The safety, efficacy and acceptability of glycine-fortified oral rehydration solution (ORS) was compared with that of standard WHO-ORS in a controlled randomized trial. Fifty male infants with acute, watery, non-cholera diarrhea were studied. Glycine-fortified ORS at a concentration of 111 mmol/L (8.4 g/L) was used. The electrolyte and glucose concentrations of both the solutions was identical. The proportion of successfully treated patients was 92%. There were two failures in each group. Both solutions were found to be equally safe in correcting and maintaining the hydration status and in correcting hyponatremia and hypokalemia. The acceptability and efficiency of the solutions were also comparable. Addition of glycine does not add to the efficacy of conventional WHO-ORS, therefore offering no additional advantage but adds to the cost of production.     

A field trial of wheat-based oral rehydration solution among Afghan refugee children

A total of 326 Afghan children aged between 6 months and 5 years with uncomplicated nondysenteric diarrhea for the previous 24 h to 5 days were treated at home by their mothers with either wheat-salt solution (WSS) or World Health Organization recommended glucose-oral rehydration salts (G-ORS). For 7 consecutive days the children were examined in the household and the mothers interviewed to assess the progress, feeding practices, and perception of treatment efficacy. Children treated with WSS recovered significantly earlier; the mean duration on treatment was 4.0 days (SD 1.7 days) on WSS compared to 6.4 days (SD 1.7 days) on G-ORS. By the second day of treatment, significantly more mothers using WSS (56%) reported that their children had formed stools versus 11 % of their G-ORS counterparts; the mean stool frequency after 2 days was also significantly reduced; 3 stools day⁻¹ (SD 2.1) on WSS versus 5 (SD 2.9) on G-ORS. The cereal-based solution was not confused with normal food and led to better feeding patterns. By day 2, 74% of the mothers using WSS had resumed their normal feeding frequencies as opposed to 33% of G-ORS mothers. On recovery the WSS group had gained significantly more weight; the WSS group gained 169 g (SD 142 g) while the G-ORS group lost 150g (SD 174 g). This study suggests by subjective and objective measures that WSS could be considered as an effective home fluid for the first-line treatment of diarrhea.     

Controlled clinical trial on the efficacy of rice powder-based oral rehydration solution on the outcome of acute diarrhea in infants

We report a controlled clinical trial of rice powder-based oral rehydration solution (ORS) versus glucose ORS on the outcome of acute diarrhea in infants. The rice ORS group (n = 30) received ORS containing 50 g rice powder instead of standard WHO solution (20 g glucose, n = 30). Formula-fed male infants were enrolled to enable calculation of milk intake and excretion of urine. Patient allocation to either group depended on the method of random permuted blocks. Both groups were comparable regarding age (4-18 months), duration of diarrhea, number of bowel movements or vomiting per 24 h, rectal temperature, dehydration score, and nutritional status. Results revealed that the rice ORS group had a shorter duration of diarrhea (28.4 +/- 5.1 vs 34.3 +/- 2.3 h) and greater mean weight gain in the first 24 h as percentage of recovery weight (5.7 +/- 0.5% vs 4.1 +/- 0.6%). Furthermore, the mean amount of ORS intake, mean stool output, and mean number of episodes of vomiting were lower in the rice-ORS group as compared with the glucose ORS group. All differences were statistically significant. Due to its observed superiority and low cost, the widespread use of rice ORS should be considered for treatment of acute diarrhea.     

Reduced-Osmolarity oral rehydration salts solution multicentre trial: Implications for national policy

World Health Organization (WHO) recommended standard ORS solution has sodium (90 mmol/L) and glucose (111 mmol/L) almost in the ratio of 1∶1 and a total osmolarity of 311 mmol/L. There are concerns that the sodium or glucose concentration and the overall osmolarity in the formulation is not appropriate. Therefore, the efficacy of standard and reduced-osmolarity ORS solutions in young children with acute diarrhea was evaluated in a recent WHO supervised multicentre trial conducted in India (New Delhi), Brazil, Mexico and Peru. The implications of trial results are discussed. In non-cholera diarrhea, both the standard and reduced osmolarity ORS solutions were effective in achieving clinical rehydration. The stool output was 39% higher in the standard ORS solution group as compared to the reduced-osmolarity ORS solution group. The duration of diarrhea was 22% higher in the standard ORS solution group. The risk of requiring supplementary intravenous infusion was increased in children treated with standard ORS solution [relative risk 1.4 (0.9–2.4)]; this benefit was not observed in Indian patients due to high breast feading rate. The mean sodium concentration at 24 hours after admission was lower in the reduced osmolarity ORS solution group [135 (134–136) vs 138 (136–139), p<0.01). The low osmolarity ORS deserves to be evaluated in adult cholera to determine its efficacy and any excess hyponatreamia. Meanwhile, it is reassuring that the WHO formulation was effective and its use was not associated with hypenatremia even in young children. Efforts must continue to be made to promote WHO-ORS while research to improve it further is welcome.     

Hypotonic oral rehydration solution in acute diarrhoea: a controlled clinical trial

In a controlled trial, a hypotonic oral rehydration solution (ORS) (Na⁺67, K⁺20, CP66, citrate 7, glucose 89mmol/1 osmolality 249 mosmol/kg) was compared with a standard WHO-ORS (Na⁺90, K⁺20, Cl^-80, citrate 10, glucose lllmmol/1, osmolality 311 mosmol/kg) in 60 children aged 5-24 months with acute watery diarrhoea. In the hypotonic ORS group, stool frequency, proportion of children who vomited, ORS requirements and purging rate over 24-48 h were reduced by 33% ( p = 0.01), 30% ( p = 0.02), 21% ( p = 0.067) and 21% ( p = 0.03), respectively. The proportion of children who vomited and the purging rate over 48 h were reduced by 23% ( p = 0.03) and 10% ( p = 0.097), respectively. Serum electrolytes after 48 h were comparable. The beneficial effect of hypotonic ORS was most marked in, and largely contributed by, the subgroup negative for rotavirus.     

关于口服补液配方的讨论

对于世界卫生组织(WHO)推荐并在我国广泛应用的口服补液(ORS)配方,有几点需要讨论。在20世纪70年代,WHO推荐的ORS配方为：氯化钠3．5g、碳酸氢钠2．5g、氯化钾1．5g、无水葡萄糖20g,加水至1L。ORS中Na^ 含量为90mmol／L、K^ 为20mmol／L、Ck^-为80mmol／L、HCO3^-为30mmol／L、无水葡萄糖为111mmol／L,电解质渗透压为220mmol／L,总渗透压为311mmol／L。     

Bacterial contamination of reconstituted oral rehydration solution

The extent and nature of bacterial contamination in oral rehydration solution reconstituted for use by individuals and for group of patients was studied. Twenty three volunteers (all qualified doctors) were asked to reconstitute a packet of prepackaged salt in half litre of clean unboiled water obtained from taps at their residence. Five ml aliquots of ORS were collected at 6, 12 and 24 hours after reconstitution for bacteriologic study. The water used by volunteers to reconstitute the ORS as well as throat swabs, peri-anal swabs and nail clippings of volunteers yielded pathogenic bacteria in all the subjects/samples. All the 23 specimens of ORS prepared by volunteers when cultured at 6 hours after reconstitution yielded pathogenic bacteria. The bacterial colony counts were found to be unacceptably high at 12 hours. Five ml samples of reconstituted ORS prepared in bulk in the children ward of PGIMER, Chandigarh were cultured at 12, and again at 24 hours after reconstitution on 10 different days. These yielded Klebsiella pneumoniae in 8 specimens (80%) and E. coli in 2 (20%). The bacterial colony count was unacceptably high, 12 hours after reconstitution.     

In search of a super solution: controlled trial of glycine-glucose oral rehydration solution in infantile diarrhoea

In a double blind trial a glycine fortified oral glucose electrolyte solution was evaluated in a group of infants and small children (n=25) with moderate to severe dehydration due to acute diarrhoea, and was compared with a matched control group (n=26) receiving only glucose based oral rehydration solution. It is seen that the diarrhoea stool output, duration of diarrhoea, and volume of oral rehydration fluid required to achieve and maintain hydration are significantly lower in the group receiving glycine fortified glucose electrolyte solution. The possibility of developing an oral rehydration solution which could also act as an absorption promoting drug is discussed.     

Oral therapy of neonates and young infants with World Health Organization rehydration packets: a controlled trial of two sets of instructions

The World Health Organization (WHO) recommends an oral rehydration solution (ORS) that has been linked with a risk of hypernatremia in young infants when extra water or dilute milk is withheld. A controlled, randomized study was therefore undertaken in 50 male infants aged 0-3 months to evaluate the relative safety, efficacy, and practicability of two methods of obviating this risk without negating the concept of a universal rehydrating packet. Twenty-five infants in Group A were rehydrated with a 2:1 regimen (two parts, i.e., 60 ml, WHO-ORS followed by one part, i.e., 30 ml, plain water in an alternating manner) whereas 25 infants in Group B received diluted WHO-ORS (1.5 L water instead of 1 L). In two patients, one in each group, oral therapy failed and they were excluded from analysis. Sub-Group Ac was comprised of 15 cases in Group A in whom the rehydrating instructions were followed correctly. Diluted WHO-ORS provided as safe and effective rehydration as the 2:1 regimen administered properly (sub-Group Ac). Both methods adequately corrected and maintained the hydration status and serum sodium levels, but a few infants in each group had subnormal serum K+/HCO-3 levels during therapy. Rehydrating instructions in Group A were misinterpreted in nine (37.5%) cases. Excessive ORS intake in five infants resulted in hypernatremia (three cases, 12.5%), periorbital edema (three cases, 12.5%), excessive irritability (two cases, 8.3%), and mild pedal edema (one case, 4.2%). Excessive water intake in comparison to ORS in four infants was responsible for delayed rehydration (three cases, 12.5%) and asymptomatic hyponatremia and hypokalemia (two cases, 8.3%).(ABSTRACT TRUNCATED AT 250 WORDS)     

Oral rehydration in infantile diarrhoea. Controlled trial of a low sodium glucose electrolyte solution.

The paper describes the first controlled trial of an oral glucose electrolyte solution designed on the basis of the optimum pathophysiological needs for rehydration in infantile diarrahoea. The solution, having a sodium concentration of 50 mmol/l, was tried in a group of 20 infants with moderate to severe dehydration due to acute diarrhoea and was compared with a matched group of 19 infants predominantly under 2 years of age taking a 'standard' oral solution with a sodium concentration of 90 mmol/l. They could be hydrated as well with a low sodium oral solution alone as with the standard solution. Intravenous fluid was not required in either group. The group treated with the high soldium 'standard' solution appeared to develop hypernatraemia and/or periorbital oedema more frequently than the other group. Also, the low sodium solution eliminated the need for additional free water orally.     

Community-based randomized controlled trial of reduced osmolarity oral rehydration solution in acute childhood diarrhea.

OBJECTIVE: The standard oral rehydration solution (ORS) recommended by WHO and UNICEF does not reduce the volume or frequency of stools or the length of the episode. Hospital-based studies from developing and developed countries and intestinal perfusion studies suggest a beneficial effect on water and sodium absorption with reduced osmolarity ORS as compared with standard ORS. We conducted a community-based study comparing the efficacy of reduced osmolarity ORS (224 mmol/l) with standard ORS (311 mmol/l) in acute childhood diarrhea in a West African community. METHODS: Infants and toddlers age 0 to 30 months having 738 episodes of diarrhea identified by weekly household visits were randomly assigned to treatment with either standard ORS (n = 376) or reduced osmolarity ORS (n = 362). The children were followed by daily home visits to assess ORS intake and clinical characteristics. Duration of diarrhea was compared by proportional hazards regression analysis, the hazard ratio being interpreted as the relative recovery rate between the children receiving the two types of ORS. Because earlier reports have suggested that weaning status might be an important modifier for the performance of reduced osmolarity ORS, the effect was assessed overall and as an interaction between type of ORS and weaning status and age. Maternal satisfaction was assessed in a paired analysis among mothers whose children participated at least twice in the study. RESULTS: In the overall analysis reduced osmolarity ORS was as efficacious as standard ORS as assessed by duration of diarrheal episode and total number of stool evacuations on Days 1 and 2. Non-breast-fed toddlers (i.e. children ages 12 to 30 months) treated with reduced osmolarity ORS had significantly shorter diarrheal episodes [1.14 days vs. 1.78 days with standard ORS; hazard ratio, 1.50; 95% confidence interval (CI), 1.07 to 2.09] and lower total number of stool evacuations on Days 1 and 2 (3.9 stool evacuations vs. 5.0 stool evacuations with standard ORS; ratio of geometric means, 0.77; 95% CI 0.60 to 1.01). No significant difference was found for breast-fed toddlers or for infants. There was no statistically significant difference in the ORS intake between the two treatment groups. The odds ratio for the mother preferring reduced osmolarity ORS to standard ORS was 1.92 (95% CI 0.97 to 3.85). CONCLUSIONS: Reduced osmolarity ORS was as efficacious as standard ORS. Non-breast-fed children treated with reduced osmolarity ORS had significantly shorter diarrheal episodes and a tendency toward lower stool frequency. These findings may be of importance, especially in developing countries where early weaning is common.     

Alanine- and glucose-based hypo-osmolar oral rehydration solution in infants with persistent diarrhoea: a controlled trial

To evaluate the efficacy of a hypo-osmolar and a standard (World Health Organization) oral rehydration salt (ORS) solution in persistent diarrhoea, a randomized controlled clinical trial was conducted in 55 children. After a 1-day observation period the children were assigned to one of three solutions: standard ORS (WHO-ORS) (osmolality 311 mosmol/1), hypo-osmolar ORS containing L-alanine and glucose (osmolality 255 mosmol/1) and iv polyelectrolyte solutions (osmolality 293 mosmol/1) for ongoing replacement of stool loss for the next 4 days. Excellent acceptability of ORS (101-160 ml/kg body weight/day) by the children was observed. There were no significant differences in the total intake of solutions and food, and frequency of stools among the groups Stool outputs were significantly less in infants receiving hypo-osmolar ORS than in those receiving WHO-ORS for 0-24h (p = 0.04), 0-48h (p = 0.01), 0-72h (p = 0.04) and 0-96h (p = 0.03). The results indicate a sufficient scope of ORS practice in persistent diarrhoea. Furthermore, we found that a hypo-osmolar ORS containing L-alanine and glucose is as efficacious as an iv solution and more effective than WHO-ORS for replacement of ongoing stool loss in persistent diarrhoea. Alanine-glucose ORS, hypo-osmolar solution, oral rehydration solution, persistent diarrhoea     

Rice solution and World Health Organization solution by gastric infusion for high stool output diarrhea

We sought to determine the efficacy of three different types of treatment in children with acute diarrhea who, during the oral rehydration period, had high stool output (greater than 10 mL/kg per hour). Sixty-six children, aged 1 to 18 months, with an average stool output of 22.6 mL/kg per hour were randomly distributed into three groups: group 1 received a rice flour solution, group 2 received the World Health Organization rehydration solution by gastric infusion, and group 3 continued to receive this solution orally. In all three groups, a decrease in stool output was observed, with the higher decrease observed in group 1 patients. Such a decrease facilitated rehydration of all 22 patients in group 1 (100%) in 3.3 +/- 1.5 hours, 16 (73%) in group 2 in 4.3 +/- 2.1 hours, and 15 (69%) in group 3 in 4.9 +/- 2.0 hours. No complications were observed. These data indicate that the rice flour solution is effective in children with high stool output diarrhea.     

Controlled trial of rice powder and glucose rehydration solutions as oral therapy for acute dehydrating diarrhea in infants

A controlled, randomized trial was conducted in 50 infants (3 to 18 months old) hospitalized with acute noncholera dehydrating diarrhea to compare the safety, efficacy, and acceptability of the standard World Health Organization (WHO) recommended glucose oral rehydration solution (ORS) (Group A: 25 infants) with that of a rice powder ORS (Group B: 25 infants), containing 30 g/L of rice powder instead of glucose (20 g/L). The electrolyte composition of both solutions was identical. The proportion of successfully treated patients in each group was 92%, and the two rehydrating solutions proved comparable in correcting and maintaining the hydration status and the serum sodium and potassium levels. The mean rehydration time, stool output, stool frequency, ORS intake, weight gain, and urine output were comparable (p greater than 0.05) in both groups. It is concluded that rice powder ORS is safe, effective, and acceptable as the standard WHO glucose ORS for the treatment of acute noncholera dehydrating diarrhea in infants.