Standard WHO-ORS versus reduced-osmolarity ORS in the management of cholera patients. Controlled trial of hypo-osmalar versus World Health Organization oral rehydration solution. Turning off the diarrhea: the role of food and ORS. Evaluation of oral hypo-osmolar glucose-based and rice-based oral rehydration solutions in the treatment of cholera in children. Efficacy and safety of oral rehydration solution with reduced osmolarity in adults with cholera: a randomised double-blind clinical trial. CHOICE study group. Is a low-osmolarity ORS solution more efficacious than standard WHO ORS solution? Reduced osmolarity oral rehydration salt in Cholera. Food-based oral rehydration salt solution for acute childhood diarrhoea. Effects of food with two oral rehydration therapies: a randomised controlled clinical trial. Multicentre evaluation of reduced-osmolarity oral rehydration salts solution. International Study Group on Reduced-osmolarity ORS solutions. Cereal-based oral rehydration solutions in Sudanese children with diarrhoea: a comparative clinical trial of rice-based and sorghum-based oral rehydration solutions. Treatment of acute infantile diarrhoea with a commercial rice-based oral rehydration solution. Efficacy of a packaged rice oral rehydration solution among children with cholera and cholera-like illness. Is rice based oral rehydration therapy effective in young infants? Safety and efficacy of a premixed, rice-based oral rehydration solution. Comparative efficacy of rice-based and glucose-based oral rehydration salts plus early reintroduction of food. Efficacy of standard glucose-based and reduced-osmolarity maltodextrin-based oral rehydration solutions: effect of sugar malabsorption. Efficacy of oral hyposmolar glucose-based and rice-based oral rehydration salt solutions in the treatment of cholera in adults. Alanine- and glucose-based hypo-osmolar oral rehydration solution in infants with persistent diarrhoea: a controlled trial. Controlled clinical trial on the efficacy of rice powder-based oral rehydration solution on the outcome of acute diarrhea in infants. Comparative study of rice-based oral rehydration salt solution versus glucose-based oral rehydration salt solution (WHO) in children with acute dehydrating diarrhoea. Randomized, controlled, clinical trial of rice versus glucose oral rehydration solutions in infants and young children with acute watery diarrhoea. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Hypotonic oral rehydration solution in acute diarrhoea: a controlled clinical trial. A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose. Multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of a reduced osmolarity oral rehydration salts solution in children with acute watery diarrhea. Prevention of travellers' diarrhoea by oral B-subunit/whole-cell cholera vaccine. Rice-starch oral rehydration therapy in neonates and young infants. Effect of home-based water chlorination and safe storage on diarrhea among persons with human immunodeficiency virus in Uganda. Safety and efficacy of a rice-based oral rehydration salt solution in the treatment of diarrhea in infants less than 6 months of age. A controlled trial comparing the efficacy of rice-based and hypotonic glucose oral rehydration solutions in infants and young children with gastroenteritis.
The study compared the safety and efficacy of an oral rehydration salts (ORS) solution, containing 75 mmol/L of sodium and glucose each, with the standard World Health Organization (WHO)-ORS solution in the management of ongoing fluid losses, after initial intravenous rehydration to correct dehydration. The study was conducted among patients aged 12-60 years hospitalized with diarrhoea due to cholera. One hundred seventy-six patients who were hospitalized with acute diarrhoea and signs of severe dehydration were rehydrated intravenously and then randomly assigned to receive either standard ORS solution (311 mmol/L) or reduced-osmolarity ORS solution (245 mmol/L). Intakes and outputs were measured every six hours until the cessation of diarrhoea. During maintenance therapy, stool output, intake of ORS solution, duration of diarrhoea, and the need for unscheduled administration of intravenous fluids were similar in the two treatment groups. The type of ORS solution that the patients received did not affect the mean serum sodium concentration at 24 hours after randomization and the relative risk of development of hyponatraemia. However, patients treated with reduced-osmolarity ORS solution had a significantly lower volume of vomiting and significantly higher urine output than those treated with standard WHO-ORS solution. Reduced-osmolarity ORS solution was as efficacious as standard WHO-ORS solution in the management of cholera patients. The results indicate that reduced-osmolarity ORS solution is also as safe as standard WHO-ORS solution. However, because of the limited sample size in the study, the results will have to be confirmed in trials, involving a larger number of patients. To compare the safety and efficacy of a hyposmolar oral rehydration solution (H-ORS) (245 mmol/liter) with the World Health Organization oral rehydration solution (WHO ORS) in cholera and acute non-cholera diarrhea.
                Controlled clinical trial.
                Diarrhea training and treatment unit.
                Thirty-five culture proven cholera and 135 acute non-cholera diarrheal patients randomly received H-ORS or WHO-ORS. Intake and output were measured every 4 hours.
                Analysis of the total cases revealed rehydration phase (p=0.048, 95% CI 0.64-0.99) and overall (p=0.046, 95% CI 0.70-0.99) frequency of stools to be significantly less in the H-ORS group. In the severely malnourished, the rehydration phase (p=0.032, 95% CI 0.55-97), maintenance phase (p=0.035, 95% CI 0.51-0.97) and overall (p=0.011; 0.95% CI 0.55-0.93) stool frequency were significantly decreased in the H-ORS group. The amount of ORS consumed in the maintenance phase of the cholera cases was significantly (p=0.04, 95% CI 0.44-0.98) less in the H-ORS group. All other parameters, despite showing a decreasing trend, were statistically comparable in the cholera, non-cholera and total cases. The amount of intravenous fluid needed was significantly more in the noncholera and total cases on H-ORS. In the non-breastfed cases, under two years of age, the total duration of diarrhea was significantly decreased (p=0.03; 95% CI 11.07-11.45) but the need for intravenous fluids significantly increased (p=0.02; 95% CI 109.8-112.1) in the H-ORS group. The proportion of children vomiting, the weight gain, urine passed in 24 hours, serum sodium, caloric intake and failure rate were comparable.
                H-ORS is as safe and effective as the WHO-ORS and may have some additional benefits in malnourished children. Ninety-three boys aged 5 years or less who had diarrhea due to Vibrio cholerae were randomly assigned to treatment with glucose oral rehydration salt (ORS) or rice-based ORS. For the first 24 h, ORS only was given to all the patients. During the next 24 h, ORS and normal food were given. The efficacy of the two types of ORS was compared in terms of ORS intake, stool output, change in hematocrit reading, serum specific gravity, and increase in body weight. At the end of the first 24 h of treatment, a 50% reduction in ORS intake and stool output was observed in the 47 patients randomly assigned to receive rice ORS as compared with the 46 patients who received glucose ORS. During the second 24 h of treatment, a significant reduction in the stool output was noticed in the glucose ORS group, making the efficacy of glucose ORS equal to that of rice ORS. The study suggests that normal food can impart some of the superiority of "super" ORS to standard glucose ORS with regard to reduction of stool volume. In a randomized controlled clinical trial, the efficacy of a low-sodium low-glucose oral rehydration solution (ORS) and a low-sodium rice-based ORS was compared with standard WHO glucose ORS in the treatment of severe cholera in children aged 2-10y. In total, 120 children were evaluated for the study, of whom 58 patients were positive for Vibrio cholerae and were included in the study. Of these 58 cases, 19 received rice-based hypo-osmolar ORS, 20 received WHO-ORS and 19 received glucose-based hypo-osmolar ORS. The clinical characteristics (age, preadmission duration of diarrhoea, frequency of stool before admission, incidence of vomiting, body weight and volume of initial fluid requirement) were comparable in the three treatment groups. All patients received tetracycline in a dose of 50 mg/kg/d of body weight in 4 divided doses for 3 d.
                Patients who received rice-based hypo-osmolar ORS had subsequently reduced (p < 0.05) stool output, ORS consumption and diarrhoea duration than the patients who received either WHO-ORS or glucose-based hypo-osmolar ORS. The effects of oral rehydration solution (ORS) with reduced osmolarity on children with acute watery diarrhoea are known, but little is known about the effects of such ORS on adults with cholera. We aimed to compare the efficacy and safety of an ORS with reduced osmolarity with that of standard WHO ORS in adults with cholera.
                We undertook a double-blind, controlled clinical trial in adults with severe cholera at the International Centre for Diarrhoeal Disease Research, Bangladesh. Our primary outcomes were mean stool output in the 24 h after randomisation, proportion of patients who needed unscheduled intravenous therapy, and proportion of patients with biochemical hyponatraemia 24 h after randomisation.
                147 patients received ORS with reduced osmolarity and 153 received standard WHO ORS. There was no significant difference between the two groups in terms of main outcome variables: mean initial 24 h and total stool output (reduced osmolarity vs standard WHO ORS 212 [SE 8] vs 207 [8] and 284 [13] vs 273 [13] g/kg respectively), duration of diarrhoea (46 [1.5] vs 43 [1.5]). The proportion of patients vomiting during the first 24 h and the proportion who received unscheduled intravenous infusion during the first 24 h was similar between groups. More patients on reduced osmolarity ORS than on standard WHO ORS developed hyponatraemia during the first 24 h, defined as serum sodium concentration below 130 mmol/L (29 of 142 vs 16 of 150; odds ratio 2.1 [95% CI 1.1-4.1]). However, all hyponatraemic patients in both groups were symptom-free and the proportion of patients with serum sodium concentration below 125 mmol/L was similar between groups.
                There was no difference in clinical outcome between cholera patients treated with reduced osmolarity ORS solution and those treated with standard WHO ORS. The risk of increased incidence of symptom-free hyponatraemia in patients with cholera treated with an ORS with reduced osmolarity should be further assessed by meta-analysis. The risk should be taken into account when choice of ORS is made in areas in which cholera is endemic. The clinical efficacy of a diluted oral rehydration salts (ORS) solution was compared in a pilot study with that of intravenous (i.v.) therapy and of standard World Health Organization (WHO)/United Nations Childrens Fund (UNICEF) ORS solution in children with acute diarrhea. Sixty-one boys aged 3 to 24 months, admitted to hospital with acute diarrhea and signs of dehydration, were randomly assigned to groups receiving standard ORS solution, diluted ORS solution, or i.v. therapy. In children treated with standard ORS solution and small amounts of plain water, the total fluid intake was 25-39% greater, the stool output was 58-77% greater (p < 0.01), and the duration of diarrhea was 30-55% greater than in the other treatment groups. Intake of plain water, taken separately or added to the ORS solution, was greater in children given diluted ORS solution (73 +/- 23 ml/kg) than in those given standard ORS solution (21 +/- 32 ml/kg) (p < 0.001). The mean serum sodium concentration increased by 2.2 mEq/L in children given standard ORS solution, whereas it decreased by 2.9 mEq/L in those given diluted ORS solution. This study shows that some children develop worsening diarrhea and increasing serum sodium concentrations when treated with standard ORS solution and given only small amounts of plain water. This is probably caused by the slight hypertonicity of standard ORS solution combined with transient partial glucose malabsorption. This can be avoided if water, breast milk, or another low-solute drink is given liberally during maintenance therapy with ORS solution, as recommended by the WHO. In a controlled clinical trial conducted in 34 adults with severe cholera diarrhoea, the use of a relatively dilute oral rehydration salt (ORS) solution (sodium 67, potassium 20, chloride 66, citrate 7, glucose 89 mmol/l, osmolality 249 mOsmol/kg) caused a 29% (p=0.003) reduction in stool output over the first 24 h and a 37% (p=0.001) reduction over the first 48 h compared with 29 controls who received the hyperosmolar WHO/UNICEF ORS. No controls but 3 study-group patients had marked but asymptomatic hyponatraemia (sodium <125 mmol/l) at 24 h. Twenty-four % of controls and 12% of patients receiving the dilute ORS needed unscheduled intravenous therapy for recurrence of dehydration. The ORS intake was twice the 48 h stool volume in controls and 3 times in the study group. The test ORS with a reduced glucose and sodium concentration is more efficient than the WHO/UNICEF ORS in preserving net intestinal fluid balance in severe cholera. The efficacy in acute childhood diarrhoea of oral rehydration therapy (ORT) based on staple foods (maize, millet, wheat, sorghum, rice, or potato) was compared with that of standard ORT based on glucose. 266 children aged 1-5 years, with a history of acute diarrhoea for 48 h or less, moderate to severe dehydration, and no complications, were assigned to treatment with one of the food-based oral rehydration salt solutions (ORS) or standard ORS. The mean stool output over the first 24 h of treatment in the group receiving standard ORS was significantly higher than that of any other treatment group, and the groups receiving food-based ORT showed substantial reductions in stool output compared with the standard ORT group. Abnormalities in electrolyte concentrations were corrected in all treatment groups with similar efficiency. The digestibility of the food-based ORS was assessed by the stool pH, glucose content before and after acid hydrolysis, and osmolality; there were no significant differences between the standard ORS and food-based ORS groups. Food-based ORT should be more acceptable to users in developing countries since the mixtures are similar to traditional weaning foods and since, unlike standard ORT, it reduces stool output substantially. To evaluate the impact of food on the efficacy of oral rehydration solution (ORS), a randomised, controlled clinical trial was conducted in 182 adults with cholera. After initial rehydration with an intravenous polyelectrolyte solution for four hours, the patients were randomised to receive one of four rehydration therapies: glucose based ORS and no food for the first 24 hours (group A), glucose based ORS plus food from the beginning of treatment (group B), rice based ORS with no food for the first 24 hours (group C), and rice based ORS plus food from start of therapy (group D). Tetracycline was given after 72 hours to all patients. No significant differences in ORS intake, stool output, and duration of diarrhoea were noted between groups A and B and between groups C and D. A substantial and significant reduction in stool output was, however, shown in the groups who received rice based ORS irrespective of feeding. These results show that food does not potentiate the efficacy of either glucose based or rice based ORS in adults with cholera. Rice based ORS compared with glucose ORS substantially reduces purging in cholera patients. In developed countries, use of oral rehydration salts (ORS) solution with osmolarity lower than that of plasma has been recommended because of the risk of hypernatraemia. We compared the clinical efficacy of reduced-osmolarity ORS and standard ORS solutions in children with acute diarrhoea in four developing countries. 447 boys aged 1-24 months, admitted to hospitals in four countries with acute diarrhoea and signs of dehydration, were randomly assigned either standard ORS (311 mmol/L) or reduced-osmolarity ORS (224 mmol/L) solution. Total stool output was 39% greater (95% CI 11-75), total ORS intake 18% greater (3-33), and duration of diarrhoea 22% longer (2-45) in the standard ORS group than in the reduced-osmolarity ORS group. The risk of requiring intravenous infusion after completion of the initial oral rehydration was greater in children given standard ORS solution than in those given reduced-osmolarity ORS solution in three of the four countries (all-country relative risk 1.4 [0.9-2.4]). This relative risk was significantly increased only in non-breastfed children (2.0 [1.0-3.8], p < 0.05). In breastfed children, the relative risk of requiring intravenous infusion was not affected by the ORS solution (0.9 [0.4-2.0]). The mean sodium concentration 24 h after admission was significantly lower in the reduced-osmolarity ORS group than in the standard ORS group (135 [134-136] vs 138 [136-139] mmol/L, p < 0.01). Reduced-osmolarity ORS solution has beneficial effects on the clinical course of acute diarrhoea. Our findings support the use of reduced-osmolarity ORS solution in children with acute non-cholera diarrhoea in developing countries. Further studies are needed to find the best formulation and whether such a solution would be satisfactory for the treatment of cholera. A randomized controlled study was carried out at the Children's Emergency Hospital, Khartoum to evaluate the acceptability, safety and efficacy of (rice or sorghum) cereal-based oral rehydration solutions (ORS) relative to that of the standard WHO ORS formulation in children with acute diarrhoea. Ninety-six children whose ages ranged from 6 to 40 months were enrolled in the study. Thirty-two of them were allocated to the rice-based ORS group, 34 to the sorghum-based ORS group and 30 to the control group. Cereal-based ORS solutions were found to shorten the duration of diarrhoea and to reduce both the stool volume and the frequency of diarrhoea and vomiting as well as the mean total ORS intake. These effects were more marked with the sorghum-based ORS than with the rice-based ORS. By the end of day 3, 50% of patients in the rice ORS group and 67.6% in the sorghum ORS group had recovered compared with 40% from the standard ORS group. This randomized clinical trial compared the efficacy of an oral rehydration solution (ORS) formulated with commercial rice powder, 50 g/l, with that of a glucose-based WHO/UNICEF-recommended ORS in the management of 48 inpatients aged 3-24 months, with acute dehydrating watery diarrhoea. Stool outputs were generally high in these patients, and 11 patients (22%) required additional intravenous rehydration solutions. The stool output (ml/kg) in the first 24 hours was [geometric mean, (95% confidence intervals)] 213 (153-353) in the rice-ORS group versus 146 (108-232) in the glucose-ORS group, while the total stool output was 455 (298-933) versus 307 (209-625); (p value not significant). The mean (+/- SD) duration of diarrhoea in hospital was: 72 +/- 10 hours in the study group versus 77 +/- 12 hours in the control group (p value NS). Enteropathogens were found in 94% of the patients, rotavirus being prevalent in 85% of the cases. It is concluded that the rice-ORS used in this trial is no more efficacious than the standard glucose-ORS advocated by WHO/UNICEF in the treatment of infants with watery non-cholera dehydrating diarrhoea. In some cases, ORS formulated with the commercial cereal-based products might actually increase the stool losses in infants with high-output non-cholera diarrhoea. In past studies, patients with cholera and cholera-like diarrhoea treated with rice oral rehydration solution (ORS) had lower purging rates and a shorter illness duration. We evaluated a new packet form of rice ORS (CeraLyte-90) in 167 boys aged 5 to 15 y, with acute, dehydrating cholera and cholera-like diarrhoea in Bangladesh. The patients were randomized to receive either CeraLyte-90 (n = 85) or glucose ORS (n = 82) and were given early feeding and early antibiotics. The efficacy of the two solutions was compared for stool output during the first 8 h, the first 24 h, and total output, duration of diarrhoea, hematocrit, serum electrolytes and requirement for unscheduled intravenous fluids. The clinical and laboratory characteristics of the two groups were comparable on admission, and most of the patients had cholera (88% and 84% in the CeraLyte and glucose groups, respectively). The mean (+/- SE) stool output was 20% less in the rice ORS group during the first 8 h of treatment (86.2+/-6.6 ml/Kg vs 108.8+/-7.9 ml/Kg, p < 0.05), but the outputs during the other time periods were similar in the two groups, although children in the rice ORS group had slightly more vomiting on day one (p < 0.05). The mean serum electrolyte concentrations in both groups of children remained within normal range.
                The study documents the safety and efficacy of the new, packaged rice ORS. Rice based oral rehydration therapy (ORT) solutions have been shown to be superior to glucose oral rehydration salts (World Health Organisation (WHO) ORS) in reducing stool volume and duration of diarrhoea in children and adults. Rice based ORT has been used only sparingly in young infants, however, because of theoretical concerns about digestibility. A randomised controlled trial of rice based ORT (50 g rice and electrolytes identical to WHO ORS) and WHO ORS was carried out in 52 male infants less than 6 months old with moderately severe acute diarrhoea to evaluate efficacy and digestibility. Nineteen (70%) of 27 children who received rice based ORT and 18 (72%) of 25 children who received WHO ORS were treated successfully. The mean (SD) diarrhoeal stool output for the first 24 hours of treatment was significantly lower in the infants receiving the rice based ORT than in those receiving WHO ORS (101.0 (60.5) v 137.1 (74.6) g/kg). The stool output was also significantly less in the rice based ORT group in the second 24 hours. Infants in the rice based ORT group drank significantly less rehydration solution than infants in the WHO ORS group (mean (SD) 165.4 (77.4) v 217.9 (86.1) during the first 24 hours of treatment. There was no difference in the duration of diarrhoea between the groups. The volume of breast and formula feeding was similar in the two groups. No difference was seen in the frequency of finding reducing substances or acid pH in the stools of either group of children. The results suggest that rice based ORT is as effective as WHO ORS in infants with moderately severe diarrhoea and that rice based ORT is as well tolerated as WHO ORS in infants. The authors compared the safety and efficacy of a ready-to-use, premixed, rice-based oral rehydration solution (R-ORS) with a glucose-based oral rehydration solution (G-ORS), each containing 75 mmol/L sodium, in Mexican children with acute diarrhea for less than 5 days.
                One hundred eighty-nine boys 3 to 24 months old admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either G-ORS or R-ORS. Intake and output were measured every 3 hours.
                In the group treated with R-ORS, significantly fewer patients required supplemental intravenous fluids during the rehydration phase compared to the G-ORS group (1% v 8.7%; P < 0.01). Mean stool output, percent weight gain, ORS intake, urine output, and number of patients who vomited during rehydration were similar in the two groups. The mean total stool output after the first 24 hours of maintenance phase was significantly lower in the R-ORS group than in the G-ORS group.
                The authors found rice-based ORS to be safe, and its use reduced the rate of intravenous fluid therapy in comparison with the use of a glucose-based ORS. The use of oral rehydration salts (ORS) to restore fluid balance in children with diarrhoea is universally accepted. However, there is uncertainty about whether glucose-based ORS or ORS based on precooked rice powder is more effective. In a randomised trial we compared the two types of ORS in children who were given food immediately after completion of rehydration. 460 boys aged 3-18 months, admitted to hospital with acute diarrhoea and signs of dehydration, were randomly assigned to groups receiving rice-based and glucose-based ORS solution (230 to each group). After full rehydration (4-12 h), a weaning food consisting of rice and mixed vegetables was given until the diarrhoea stopped. Continuing losses of liquid stool and vomitus were replaced with the assigned ORS solution. There were no differences between the groups during the rehydration phase in stool volume, volume of ORS solution taken, duration of rehydration phase, or weight gain. However, after initiation of feeding, the glucose-based ORS group had significantly lower stool volumes than the rice-based ORS group (142 [95% CI 117-173] vs 96 [77-120] g/kg); they also took a smaller amount of ORS solution (153 [127-185] vs 111 [90-136] mL/kg) and had a shorter duration of diarrhoea (55 [SD 35] vs 44 [35] h). Glucose-based ORS solution was more effective than rice-based ORS solution for the treatment of diarrhoea in children when feeding with a rice-based diet was started soon after correction of dehydration. These results support the continued recommendation of glucose-based ORS solution as standard therapy for treatment of children with acute diarrhoea and emphasize the importance of resuming feeding as soon as dehydration has been corrected. Previously we reported that standard oral rehydration salts (ORS) solution is not as effective as a reduced-osmolarity glucose-based ORS for the treatment of children with acute noncholera diarrhoea: with standard ORS the diarrhoea lasts longer, stool output is greater, serum sodium is higher, and there is more need for supplemental intravenous infusion. We studied a reduced-osmolarity maltodextrin (MD)-based ORS to determine whether it had similar benefits, and also the effect of sugar malabsorption on the efficacy of standard and MD-based ORS. A total of 90 boys aged 3-24 months with acute noncholera diarrhoea and moderate dehydration were randomly assigned to either standard ORS (glucose 20 g/l, osmolarity 311 mmol/l) or MD-ORS (MD 50 g/l, osmolarity 227 mmol/l). There were no differences in treatment results. Some 46% of subjects had a high total stool output (> 300 g/kg), which was unrelated to the type of ORS given. High stool output was significantly associated with a longer duration of diarrhoea (33 vs. 15 hours; P < 0.001), a persistently elevated serum sodium (149 vs. 144 mmol/l at 24 h; P < 0.02), the need for intravenous infusion (11/41 vs. 0/48; P < 0.002), and an increase in faecal reducing substances (10.8 vs. 3.4 g/l at 24 h; P < 0.001). We conclude that some children given standard ORS develop osmotic diarrhoea owing to the combined effect of transient sugar malabsorption and slight hypertonicity of the ORS. Earlier studies show that this adverse outcome can largely be avoided when extra water is given in reduced-osmolarity glucose-based ORS. Reduced osmolarity has no benefit, however, when glucose is replaced by maltodextrin, probably because the sugars released by hydrolysis of MD, when malabsorbed, raise the intraluminal osmolarity to equal or exceed that of standard ORS. Thus, reduced-osmolarity glucose-based ORS is superior to both standard ORS and reduced-osmolarity solutions based on maltodextrin and probably other complex carbohydrates. Studies are in progress to define the optimal formulation of reduced-osmolarity glucose-based ORS. Recent animal experiments and clinical trials have shown that both osmolarity and rice as the organic components are important factors for net intestinal absorption of an oral rehydration salt solution.
                In a controlled clinical trial 123 male adult patients with severe cholera, after initial rehydration with intravenous Ringer's lactate solution, were randomly assigned to receive one of the four oral rehydration salt solutions: WHO ORS, ORS containing 70 mmol/l Na+ and 16.2 g/l glucose, rice ORS containing 50 g/l rice and 90 mmol/l Na+, and rice ORS containing 50 g/l rice and 70 mmol/l Na+. All patients received 300 mg of doxycycline as a single dose.
                Patients who received rice-low-sodium ORS subsequently had lower (P < 0.05) stool output, ORS consumption, and diarrhoea duration than the other three ORS groups.
                We conclude that rice-based low-sodium ORS is superior for treating adult cholera. 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/l), hypo-osmolar ORS containing L-alanine and glucose (osmolality 255 mosmol/l) and i.v. polyelectrolyte solutions (osmolality 293 mosmol/l) 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 0-24 h (p = 0.04), 0-48 h (p = 0.01), 0-72 h (p = 0.04) and 0-96 h (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. 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. One hundred children with acute dehydrating diarrhoea were studied. They were divided into two groups: Group A (n = 50) were given rice-based oral rehydration salt (ORS) solution and group B (n = 50) were given glucose-based ORS solution (WHO). There was no significant decrease in mean stool output and percentage weight gain with rice-based ORS. Both the groups were comparable for volume of ORS solution consumed, time taken for initial rehydration, mean stool output and for correcting biochemical abnormalities. A randomized clinical trial was carried out to compare a packaged ready-to-mix rice oral rehydration solution (ORS) to the standard glucose ORS for the treatment of childhood diarrhoea. Children were of either gender, aged 3-35 months, presenting with a history of watery diarrhoea for 72 h or less. The main outcomes examined were stool output, ORS intake, duration of diarrhoea and nutritional recovery during follow-up at 16 d of illness. Stool output in the first 24 h (106 vs 107 g kg(-1)), ORS intake in clinic (93 vs 102 ml per motion) and duration of diarrhoea (88 h vs 81 h) were similar in the two treatment groups. The few episodes that became persistent were similar (2%) in the two groups. The weight gain during follow-up was similar in the two ORS groups. To evaluate the utility of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers.
                Nineteen subjects with either insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (NIDDM) and foot ulcers were randomly assigned to the polymeric dressing or conventional wet-to-dry saline dressings. Subjects had foot ulcer site measurements performed every 3 weeks. The subjects using conventional therapy were allowed to cross over to polymeric dressing after 2 months.
                At the end of 2 months, in the patients using the polymeric dressing, ulcer size was reduced to 35 +/- 16% of baseline. The patients on conventional therapy had an ulcer size of 105 +/- 28% of baseline (P < 0.03, polymeric vs. conventional). Patients initially treated with wet-to-dry saline were crossed over into the polymeric membrane treatment and demonstrated a decrease to 35 +/- 11% of baseline size (p < 0.02) after an additional 2 months.
                The semipermeable polymeric membrane dressing is a useful therapeutic option for treating uncomplicated chronic diabetic foot ulcers. In a controlled trial, a hypotonic oral rehydration solution (ORS) (Na+67, K+20, Cl-66, citrate 7, glucose 89 mmol/l osmolality 249 mosmol/kg) was compared with a standard WHO-ORS (Na+90, K+20, Cl-80, citrate 10, glucose 111 mmol/l, 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. To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea.
                One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours.
                In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups.
                The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. To compare the efficacy of a reduced osmolarity oral rehydration salts (ORS) solution (75 mmol/L of sodium [Na], 20 mmol/L of potassium [K], 65 mmol/L of chloride, 10 mmol/L of citrate, and 75 mmol/L of glucose; osmolarity, 245 mosm/L) with that of the standard World Health Organization (WHO) ORS solution.
                A multicenter, double-blind, randomized, controlled clinical trial conducted in children with acute diarrhea in 5 developing countries to measure mean stool output in the 24 hours after randomization, proportion of children who required unscheduled intravenous therapy, proportion of children who vomited in the first 24 hours, and diarrhea duration after randomization.
                A total of 675 children who ranged in age from 1 to 24 months and who had acute diarrhea and dehydration were enrolled in the trial; 341 were randomized to receive reduced osmolarity ORS solution, and 334 were randomized to receive the WHO ORS solution. The mean (SE) stool output (g/kg) in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 114 [4] vs 125 [5]) and during the total study period (reduced osmolarity ORS solution vs WHO ORS solution = 320 [18] vs 331 [18]) were comparable. The proportion of children who vomited in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 58% vs 62%) and the diarrhea duration in the 2 treatment groups, compared by log rank test, were similar. The proportion of children who required unscheduled intravenous therapy was significantly lower in children who received reduced osmolarity ORS solution (10%) as compared with those who received the WHO ORS solution (15%; odds ratio = 0.6, 95% confidence interval = 0.4-1.0). There was no significant difference in the incidence of hyponatremia (serum Na <130 mmol/L) at 24 hours between the 2 treatment groups (11% in reduced osmolarity ORS solution group vs 9% in the WHO ORS solution group; odds ratio = 1.3; 95% confidence interval = 0.8-2.2). The frequency of patients with serum Na <125 mmol/L at 24 hours was 13 of 341 (4%) in children who were treated with reduced osmolarity ORS solution versus 7 of 334 (2%) in children who received the WHO ORS solution.
                Treatment with reduced osmolarity ORS solution was associated with a 33% reduction in the need for unscheduled intravenous therapy and had no apparent effect on stool output and illness duration when compared with treatment with the standard WHO ORS solution. Children with acute diarrhea, therefore, may benefit from a reduced osmolarity ORS solution. The results of trials that examine the efficacy and safety of reduced osmolarity ORS solution in adult patients with cholera have to be taken into consideration before consensus on composition of oral rehydration formulation can be reached. B-subunit/whole-cell cholera vaccine (BS-WC) has been shown to give Bangladeshi mothers and children only 3 months' protection against severe diarrhoea due to enterotoxigenic Escherichia coli (ETEC). Since a long-lasting effect is not necessary for protection against travellers' diarrhoea, a prospective double-blind study was conducted among tourists who went to Morocco from Finland. 307 tourists received two oral doses of BS-WC, whereas 308 controls received a placebo before departure. A research team went out with tourists and a laboratory for enteric pathogens was set up on location. A faecal specimen was taken from 100 randomly selected subjects before departure, from all travellers with diarrhoea, and routinely after return. Enteropathogenic bacteria were not isolated from any of the pre-departure specimens but were present during or after the holiday in 47% of tourists with travellers' diarrhoea, and in 14% of those without diarrhoea. BS-WC induced a 52% protection (p = 0.013) against diarrhoea caused by ETEC. The protection was better for mixed infections (65%, p = 0.016). The protective efficacy against a combination of ETEC and any other pathogen was 71% (p = 0.02), and that against ETEC plus Salmonella enterica even better at 82% (p = 0.01). Partial protection against travellers' diarrhoea is thus obtainable by active immunisation with BS-WC. Rice-starch based oral rehydration solution (ORS) has been shown to be a suitable alternative to glucose-based ORS in the treatment of both choleragenic and non-choleragenic dehydration in older infants and children. However, in young infants, the wider use of rice-starch ORS has been impeded because of theoretical concern about the poor digestibility of starch. The present study was conducted to evaluate the safety and efficacy of rice-starch ORS in the rehydration of acute diarrhoeal dehydration in infants below 6 months of age. Sixty-three infants with clinical features of acute gastroenteritis were randomly allocated to two groups. Group A, comprising 31 infants, received a rice-starch ORS and group B, comprising 32 infants, received a glucose-based ORS. The response to treatment was monitored by weight gain, stool frequency, and decrease in vomiting. The mean weight gain in moderately dehydrated and mildly dehydrated infants in both groups A and B were closely similar at 12, 24, and 48 h after treatment with the respective ORS solution. The infants without dehydration receiving rice-starch ORS had significantly greater weight gain at 12 h compared to those receiving glucose ORS. However, this difference was not observed at 24 and 48 h. The results of this study show that rice-starch ORS is as safe and efficacious as glucose-based ORS in young infants. Diarrhea is frequent among persons infected with human immunodeficiency virus (HIV) but few interventions are available for people in Africa. We conducted a randomized controlled trial of a home-based, safe water intervention on the incidence and severity of diarrhea among persons with HIV living in rural Uganda. Between April 2001 and November 2002, households of 509 persons with HIV and 1,521 HIV-negative household members received a closed-mouth plastic container, a dilute chlorine solution, and hygiene education (safe water system [SWS]) or simply hygiene education alone. After five months, HIV-positive participants received daily cotrimoxazole prophylaxis (160 mg of trimethoprim and 800 mg of sulfamethoxazole) and were followed for an additional 1.5 years. Persons with HIV using SWS had 25% fewer diarrhea episodes (adjusted incidence rate ratio [IRR] = 0.75, 95% confidence interval [CI] = 0.59-0.94, P = 0.015), 33% fewer days with diarrhea (IRR = 0.67, 95% CI = 0.48-0.94, P = 0.021), and less visible blood or mucus in stools (28% versus 39%; P < 0.0001). The SWS was equally effective with or without cotrimoxazole prophylaxis (P = 0.73 for interaction), and together they reduced diarrhea episodes by 67% (IRR = 0.33, 95% CI = 0.24-0.46, P < 0.0001), days with diarrhea by 54% (IRR = 0.46, 95% CI = 0.32-0.66, P < 0.0001), and days of work or school lost due to diarrhea by 47% (IRR = 0.53, 95% CI = 0.34-0.83, P < 0.0056). A home-based safe water system reduced diarrhea frequency and severity among persons with HIV living in Africa and large scale implementation should be considered. The safety and efficacy of a rice-based oral rehydration salt (ORS) solution for the treatment of acute diarrhea in infants < 6 months of age was compared to those of a standard glucose-based ORS solution. A total of 97 infants aged 1-6 months who had a history of acute diarrhea for 120 h or less and showed signs of mild to moderate dehydration and no complications was recruited. Subjects were assigned to two treatment groups and received either standard glucose-based ORS solution or rice-based ORS solution until cessation of diarrhea. There was no significant difference between the two treatment groups with regard to the main outcome variables, including total stool output (84 [95% confidence interval (CI), 56-126] vs. 106 (95% CI, 76-148) g/kg], total ORS solution intake [171 (95% CI, 149-197) vs. 187 (95% CI, 161-218) ml/kg], or duration of diarrhea (35 +/- 31 vs 38 +/- 32 h). In addition, the fact that there was no difference between treatment groups in the presence of reducing substances in the stools suggests that rice was digested and absorbed by these infants. The results of our study support the conclusion that for infants < 6 months of age, rice-based ORS solution is safe and as efficacious as standard glucose-based ORS solution in the treatment of acute diarrhea. A prospective randomized trial was conducted to compare the efficacy of a rice-based oral rehydration solution (ORS) with glucose ORS in infants and children under 5 years of age with acute diarrhoea and mild to moderate dehydration (< 10%). One hundred children presenting to a large metropolitan teaching hospital were eligible for entry to the study and were randomized to receive rice ORS or glucose ORS. Outcome measures were stool output (SO), duration of illness (DD) and recovery time to introduction of other fluids (RTF) and diet (RTD). Significant differences were found for all outcome measures in favour of the rice ORS group. Mean SO was lower (160 vs 213 mL; P < 0.02), mean DD was reduced (17.3 vs 24.3 h; P = 0.03) and median RTF was decreased (12.7 vs 18.1 h; P < 0.001) in the rice ORS group compared with the glucose ORS group. The median time to introduction of diet and mean length of hospital stay showed similar significant reductions. Our study has shown rice ORS to be an acceptable alternative to glucose ORS in young children and have shown that it is significantly more effective in reducing the course of diarrhoeal illness and the time taken to return to normal drinking and eating habits.
Polymer-based ORS shows some advantages compared to ORS ≥ 310 for treating all-cause diarrhoea, and in diarrhoea caused by cholera. Comparisons favoured the polymer-based ORS over ORS ≤ 270, but the analysis was underpowered. If specialists consider a potential role for polymer-based ORS, further trials against the current standard (ORS ≤ 270) will be required.