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*,3
Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran
Faculty of Pharmacy; and Pharmaceutical Sciences Research Center; and Endocrinology & Metabolism Research
Center, Tehran University of Medical Sciences, Tehran 1417614411, Iran
Abstract: Objectives: Diarrhea the second leading cause of death in childhood is caused by a variety of organisms.
Rehydration reduces the risk of death but it is not effective in shortening duration of disease. Recently, probiotics
have been recommended for prevention or treatment of gastrointestinal disorders including diarrhea. Considering
existing documents from different aspects, it seems that results are somehow controversial or non-conclusive. Thus, we
aimed to meta-analyze clinical trials to show actual benefit of probiotics in treatment of diarrhea.
Methodology: The literature search provided 1228 articles while only 19 articles focusing on the analyses performed
on children were eligible to be included in the meta-analysis with a total of 3867 patients enrolled in the study.
Studies in adults diarrhea, HIV patients, diarrhea induced by Clostridium difficile, radiation and chemotherapy
were also systematically reviewed.
Results: The meta-analysis showed that probiotics decrease the duration of diarrhea and fever significantly in
children while their effects on the duration of hospitalization, vomiting and number of stools per day were not
significant. The results of systematic review on adults diarrhea, amoebiasis, clostridium difficile-associated diarrhea,
diarrhea in HIV positive patients, radiation-induced diarrhea, and chemotherapy-induced diarrhea did not support
efficacy of probiotics in acute diarrhea.
Conclusion: Probiotics may reduce duration of diarrhea and fever in children but their exact efficacy in treatment of
diarrhea is not obvious yet.
44
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Salari et al.
EFFICACY
STATISTICAL ANALYSIS
Data from selected studies were extracted in the form of
2 2 tables. Included studies were weighted and pooled. Data
were analyzed using StatsDirect software version 2.7.8.
Effect size for weighed mean difference and 95% confidence
intervals (95% CI) were calculated using the Hedges-Olkin
Table 1.
Author
Duration
Intervention
No. of
Patients
Jadad
Score
7 days
293
3 days
Lactobacillus acidophilus/Placebo
80
10 days
99
5 days
87
5 days
Saccharomyces boulardii/Placebo
100
5 days
203
5 days
160
5 days
75
14 days
Bifilac /Placebo
80
7 days
664
6 days
Saccharomyces boulardii/Placebo
72
3 days
98
5 days
200
5 months
913
not specified
212
7 days
Lactobacillus rhamnosus/Placebo
58
5 days
89
5 days
69
7 days
235
not specified
80
-4.0
-2.4
-0.8
0.8
2.4
Fig. (2a). Individual and pooled effect size for the outcome of duration of diarrhea in the studies considering probiotics comparing
to placebo therapy.
Bias assessment plot
Standard error
0.0
0.1
0.2
0.3
0.4
-3
-2
-1
1
Effect size
Fig. (2b). Publication bias indicators for the outcome of duration of diarrhea in the studies considering probiotics comparing to
placebo therapy.
-0.61
-0.31
-0.01
0.29
0.59
Fig. (3a). Individual and pooled effect size for the outcome of duration of fever in the studies considering probiotics comparing to
placebo therapy.
0.15
0.20
0.25
0.30
-1.0
-0.5
0.0
0.5
Effect size
Fig. (3b). Publication bias indicators for the outcome of duration of fever in the studies considering probiotics comparing to
placebo therapy.
-6
-4
-2
0.075
0.150
0.225
0.300
-6
-4
-2
2
Effect size
Fig. (4b). Publication bias indicators for the outcome of duration of hospitalization in the studies considering probiotics comparing
to placebo therapy.
-0.90
-0.65
-0.40
-0.15
0.10
0.35
0.10
0.15
0.20
0.25
-0.70
-0.45
-0.20
0.05
0.30
0.55
Effect size
Fig. (5b). Publication bias indicators for the outcome of duration of vomiting in the studies considering probiotics comparing to
placebo therapy.
-3
-2
-1
Fig. (6). Individual and pooled effect size for the outcome of number of stools per day in the studies considering probiotics comparing
to placebo therapy.
Inflammation & Allergy - Drug Targets, 2012, Vol. 11, No. 111
111
CONCLUSION
Obviously there are major differences in design of
studies or their results. Our review indicates that number of
studies in adults diarrhea or diarrhea caused by radiation,
chemotherapy, and HIV is not adequate to reach a
convincing conclusion. Although, the present meta-analysis
of children studies showed benefits of probiotics in
decreasing the duration of diarrhea and fever, it is notable
that design of the studies, type and dose of the probiotics can
potentially affect the results. From the present review, we
learned that researchers need to agree on definition of
termination of diarrhea and thus design of studies and their
outcome results would be harmonized.
Although no adverse effect was reported in most of
studies, some investigators had concerns about the risk of
fungaemia by S. boulardii especially in HIV or critically ill
patients [64-66].
It is notable that when animal studies [67, 68] or major
reviews [69, 70] are considered, it is clear that diarrhea
might be a symptom of a hidden or undiagnosed
inflammatory bowel disease. The efficacy of probiotics in
such cases return to their potential in regulating body and
intestinal immune status.
Taken together there is still doubt and no sufficient
evidence for the efficacy of probiotics in different types of
diarrhea in children or adults. Therefore, further
investigations on special types of the probiotics, their origin,
their purity, and their combination with prebiotics may be
much helpful.
ACKNOWLEDGEMENT
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