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MEDICAL UPDATES
VOL.
1 Series No. MU004-2011
A Double Blind Randomized Controlled Trial On
The Efficacy Of Arthrospira
platensis (Cellife Powder) As An Adjunct To Oral
Rehydrating Solution and Zinc Sulfate In The
Treatment Of Acute Non-Bloody Diarrhea Among
6-36 Months Old At The Out-Patient Department,
UDMC: Pilot Study
Jocelyn S. Bongco, M.D.,
Department of Pediatrics, United Doctors Medical
Center- (2009)
ABSTRACT
BACKGROUND:
Diarrhea is best defined as excessive loss of
fluid and electrolyte in the stool and adjunct
therapies are now being added for its prevention
and treatment. Arthrospira platensis (Cellife
Powder) is a multicellular edible algae that
contains therapeutic nutrients that can be
beneficial to the treatment of diarrhea.
OBJECTIVE:
To determine the efficacy and safety of
Arthrospira platensis (Cellife Powder) as an
adjunct to oral rehydrating solution and zinc
sulfate in the treatment of acute non-bloody
diarrhea among 6-36 months old children at the
Out-Patient Department, UDMC.
STUDY DESIGN AND SETTING:
Randomized Double Blind Controlled Clinical
Trial in a tertiary private hospital.
SUBJECTS:
40 children, 6 to 36 months old, who present
with acute non-bloody diarrhea (<2 days in
duration), with minimal or no signs of
dehydration. Subjects may or may not have fever
or vomiting accompanying diarrhea.
METHODOLOGY:
A pilot trial was carried out from 10
participants, it revealed a beneficial role of
Arthrospira platensis (Cellife Powder) in the
treatment of diarrhea and thus, the present
study was further taken to explore its effect.
Forty subjects were randomized into Placebo
group (n=20) and Arthrospira platensis (Cellife
Powder) group (n=20). The subjects were given
either Arthrospira platensis (Cellife Powder) or
placebo, 1 sachet four times a day for five
days. They were also given oral rehydrating
solution and zinc sulfate as part of the
mainstay management. Duration of diarrhea,
frequency, consistency of stool, amount of
stool, condition of subjects and adverse
reactions were monitored.
STATISTICAL ANALYSIS:
T test, Mann Whitney U test, Chi-square test and
Exact Fisher test were used to determine
significant difference between the two groups.
Level of statistical significance was pegged at
0.05. A 95% confidence interval of estimates was
computed. Post ad hoc power of the study was
also computed to determine whether a larger
sample was needed.
RESULTS:
The demographic characteristics of the two
groups were similar, proven by all with p values
>0.05. The mean duration of diarrhea between the
two groups showed a significant difference with
p values <0.0001. Arthrospira platensis (Cellife
Powder) group has a shorter duration by 1.14
days than the placebo group. There is a
significant difference in comparing the mean
frequency of stool between the Arthrospira
platensis (Cellife Powder) and placebo group,
with the p values <0.05. Mean decreased was 3.43
from 0 to day 5 on the Arthrospira platensis (Cellife
Powder) group and only 2.15 in the placebo
group. Comparison on the consistency of stool
was statistically significant in the Arthrospira
platensis (Cellife Powder)
group as compared to the placebo group on
day 2 (pasty stool – 38% vs 0%), day 3 (pasty
stool – 42.9% vs 15%) (Semi-formed to formed
stool – 52.4% vs 0%)], day 4 (semi-formed to
formed stool – 76.2% vs 0%) and day 5
(semi-formed to formed stool - 95.2 vs 30%) with
all have p values <0.05. The difference in the
amount of stool and the condition of the patient
were also statistically significant in the
Arthrospira platensis (Cellife Powder) group as
compare to the placebo group which with all have
p values <0.05. No adverse reactions were noted.
Post ad hoc power of the study resulted with
80%, thus the sample size was enough and the
results were significant.
CONCLUSION:
Arthrospira platensis (Cellife Powder)
60mg/sachet, 1 sachet 4 time a day) is
efficacious and safe as adjunct in the
management of acute non-bloody diarrhea.
KEYWORDS:
Acute non-bloody diarrhea, Arthrospira platensis
(Cellife
Powder),
adjunct |
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