Academic journal article Journal of Health Population and Nutrition

Rice-ORS versus Glucose-ORS in Management of Severe Cholera Due to Vibrio Cholerae O139 Bengal: A Randomized, Controlled Clinical Trial

Academic journal article Journal of Health Population and Nutrition

Rice-ORS versus Glucose-ORS in Management of Severe Cholera Due to Vibrio Cholerae O139 Bengal: A Randomized, Controlled Clinical Trial

Article excerpt

INTRODUCTION

During 1992-1993, outbreaks of cholera-like diarrhoea were reported from southern India and Bangladesh (14). The illness was not caused by the most common Vibrio cholerae O1 but by another strain of V. cholerae (5-6). The pathogen was later confirmed as a new serovar of V. cholerae designated as V. cholerae O139 synonym Bengal (7,8). Its clinical presentation and immunobiological characteristics are similar to those of cholera caused by V. cholerae O1 (9-11).

Although oral rehydration solution (ORS) has been shown to be useful in the treatment of all types of watery diarrhoea, including cholera due to V. cholerae O1, its role has not been evaluated in cholera caused by V. cholerae O139. The World Health Organization (WHO) recommends glucose-based ORS (G-ORS) for oral rehydration therapy (ORT), and it has been shown to be effective in the prevention and correction for loss of water and salts in diarrhoeal diseases, including cholera, in adults and children (12-14). G-ORS reduces neither stool volume nor duration of diarrhoea which prompted scientists to identify an alternative ORT which can address the current limitations of ORS. One such alternative has been to replace glucose with rice. In several studies, rice-based ORS (R-ORS) was found to be superior to G-ORS both in cholera due to V. cholerae O1 and non-cholera diarrhoea (15,16). Therefore, the primary aim of this study was to evaluate the efficacies of R-ORS and G-ORS in the management of severe cholera due to V. cholerae O139 Bengal in adult males.

MATERIALS AND METHODS

Study design and setting

This randomized, controlled clinical trial was conducted at the Clinical Research and Service Centre (CRSC) of ICDDR,B: Centre for Health and Population Research, Dhaka, Bangladesh, during September-November 1995.

Informed written consent was obtained from each patient before enrollment in the study.

Inclusion criteria

Patients were eligible for the study if they were male patients aged 18-60 years, attending CRSC from 9.00 am to 12.00 noon for treatment of watery diarrhoea of less than 16 hours duration, with signs of severe dehydration and presence of V. cholerae on dark-field microscopic examination of fresh stool (17,18).

Patients were not eligible for enrollment in the study if they had any concomitant illnesses, including pneumonia, meningitis, clinically-suspected septicaemia, or had received any antimicrobial therapy or ORS for the present illness before reporting to CRSC.

Randomization procedure

A computer-generated randomization plan was used. Patients were assigned a sequential study number, and such numbers were pre-assigned to either R-ORS or GORS. A senior staff member, who was not involved in the study in any way, prepared the randomization table and list of subjects' identification numbers with corresponding treatment assignments for individual patients in sealed envelopes that were kept in the pharmacy. The pharmacy provided appropriate ORS corresponding to the identification number of patients enrolled in the study and supplied those to the study nurse when a subject was ready for enrollment in the study. Because of the nature of the suspension formed by rice-ORS, blinding of the treatment regimen was not possible. However, neither the investigators nor the patients and their attendants knew which of the two ORSs a particular patient would receive.

Case management

Upon initial recruitment into the study, patients were weighed on an electronic weighing scale (Sartorius, Gottingen, Germany) with 10 g precision and were placed on a cholera cot (19). A research physician obtained the medical history either from the patients or from their attendants, performed thorough physical examinations, including assessment of dehydration, following the WHO guidelines (20), and recorded all the findings on pre-designed and pre-tested forms. …

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