July 2001
MARYLAND RICE-BASED ORS PRODUCT CLINICALLY SUPERIOR TO GLUCOSE-BASED ORAL
REHYDRATION SALTS
STUDY IN SWEDISH PEDIATRIC JOURNAL ACTA PAEDIATRICA
Cost effective - decreased doses compared to World Health Organization ORS
WHAT:
A study of 167 boys with cholera compared the safety and efficacy of CeraLyte, a rice-based oral rehydration solution (ORS) to the standard "World Health Organization formula" glucose ORS, concluding that the
CeraLyte ORS, as in other studies with long-chain rice carbohydrate, is more
effective than glucose ORS. The boys, ages 5 to 15 years, suffered severe
dehydrating diarrhea, with losses equivalent to about 30% of their body weight while hospitalized. On average, these boys were admitted 14 hours
after their illness began, by which time they had already lost 14% of their
body weight to dehydration. Thus, total average volume lost during illness
was about 44%.
In a controlled study, the boys who received CeraLyte-90 had a significantly
lower rate of diarrhea during the critical first eight to 12 hours: "The
mean stool output was 20% less in the rice ORS group," according to the article titled, 'ORS among children with cholera and cholera-like illness,'
Acta Paediatrica, May 2001, Stockholm, by K. Zaman, MBB, PhD, Md. Yunus,
MBBS, MSc, A Rahman, MBBS, H.R. Chowdhury, MBBS, MSc, and D.A. Sack, MD.
The article continues, ".the outputs during the other time periods were
similar in the two groups." Antibiotics and food given to the boys leveled
the two groups after the 8 to 12 hour period.
Severe purging is "a major problem to simple treatment of cholera
patients. None of the patients in this
study died but it is likely that more than 50%.admitted into the study would have died without the treatment
provided," according to the article. All children in this study had cholera
or cholera-like illnesses, were malnourished and, thus, at high risk.
Cera Products donated its packet form of rice-based CeraLyte 90 for the study. CeraLyte comes in three sodium strengths. CeraLyte-90 is for the
most severe cases, such as cholera, where a healthy adult can die in as short a time as eight hours. Although glucose ORS packets are subsidized
in Bangladesh, and one liter of CeraLyte costs about 50 cents, the article's
authors believe the increased cost is marginal because it is offset by the
decreased amount of CeraLyte required compared to glucose ORS.
WHERE:
The study took place at the rural treatment center in Matlab, of the
International Centre for Diarrhoeal Disease Research Bangladesh (ICDDR, B)
in conjunction with the Johns Hopkins University School of Hygiene and Public Health.
Cera Products(8265-I Patuxent Range Road, Jessup, Maryland, 20794) is a young, applied bio-technology firm that produces a patented line of
advanced rice-based products, including oral hydration and drug delivery
products for health and wellness markets in the U.S. and abroad. Charlene
Riikonen, Cera's President, worked at the ICDDR,B in the 1980s. The ICDDR,B
received the first Gates Foundation Global Health award in Washington, D.C.,
at the annual Global Health Council meeting on May 31, 2001.
CALL:
For press, contact Vivienne Stearns-Elliott, 410-252-2232
For product information and medical/health inquiries, call
Cera Products,
301-490-4941, www.ceralyte.com
| www.ceraproductsinc.com
The article concludes, "Additional studies with CeraLyte may be warranted
for other conditions where optimized absorption of an oral rehydration solution is needed. These might include short bowel syndrome, other severe
diarrheal diseases and possibly dengue hemorrhagic fever."
Although freshly prepared rice ORS is currently used at the ICDDR,B, the
article's authors praise CeraLyte for its advantages compared to freshly
prepared rice ORS, namely, "convenience, safety and shelf life. It does not
require grinding, cooking, cooling and final preparation at the point of
use. There is less danger of improper mixing that can occur with home-made
solutions."
Other companies' previous attempts at making an easy, ready-to-use packet of
rice-based ORS had problems with "infestation, spoiling, poor solubility,
and poor mixing between the rice and salt components." The taste and consistency of the earlier packets were also unappealing.
"CeraLyte is actually being marketed widely in the U.S., Central America,
and Europe, and is not a theoretical product. It was thus crucial to have
clinical studies reporting the validation of its safety and efficacy in severe diarrhea particularly cholera."
Established in Maryland in 1993, Cera Products scientifically developed its
high performance rehydration products along with world health experts - including physicians at Johns Hopkins, the Mayo Clinic, Harvard University,
University of Maryland, and Tufts University Schools of Medicine, the Food
and Drug Administration, Centers for Disease Control - and with experts at
leading food and pharmaceutical manufacturing companies. With distribution
nationwide and in Central America, Europe and the Middle East, Cera Products
has established alliances with distributors in the medical/healthcare markets, as well as natural foods, sports and nutrition marketing.
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