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Clinical insight
P R O B E
• V o l . L I I I • N o . 3 • A p r – J u n 2 0 1 4
Kshirsagar M, et al.
Meta-analysis of Efficacy and Safety Studies of Septilin Tablets
by employees suffering from cold,
the total economic impact of cold-
related work loss exceeds US$ 20
billion per year.
2,3
This accounts for
40% of time lost from work.
4
Most
URTIs occur more frequently during
the winter months. Adults develop
an average of 2 to 4 colds annually.
Antigenic variation of hundreds of
respiratory viruses results in repeated
circulation in the community. Acute
pharyngitis accounts for 1% to 2% of
all visits to outpatient and emergency
departments, resulting in 7 million
annual visits by adults alone.
1
Acute bacterial sinusitis develops in
0.5% to 2% of cases of viral URTIs.
5
Approximately 20 million cases of
acute sinusitis occur annually in
the United States. About 12 million
individuals are diagnosed with
acute tracheobronchitis annually,
accounting for one-third of patients
presenting with acute cough, these
infections are the leading cause of
death.
6
Transmission of organisms
causing URTIs occurs by aerosol,
droplet or direct hand-to-hand
contact with infected secretions, with
subsequent passage to the nares or
eyes.
7
Thus, transmission occurs more
commonly in crowded conditions.
Direct invasion of the respiratory
epithelium results in symptoms
corresponding to the area(s) involved.
On examination, patients with
common colds may have low-grade
fever, nasal vocal tone, macerated
skin over the nostrils and inflamed
nasal mucosa.
8
There is a need for
an effective and safe formulation to
manage respiratory infections.
A number of herbs are claimed to
be effective in the management of
these frequent infections. Septilin is
a multi-herbal formulation claimed
for its efficacy due to the synergistic
action of the ingredients. It provides
immunomodulatory activity that
enhances natural immunity.
A number of clinical studies have been
carried out to evaluate the efficacy
and safety of Septilin in various
respiratory ailments. Results of each
clinical trial showed that Septilin with
its immunomodulatory, antioxidant,
anti-inflammatory, anti-allergic, and
antimicrobial actions was effective
in various RTIs, with excellent
short-term and long-term safety. These
studies need to be meta-analyzed to
know the clinical status of Septilin in
respiratory ailments.
Meta-analysis is a 2-stage process—
first stage is the extraction of data
from each study and calculation of
the result for each and the second
stage involves deciding whether it
is appropriate to calculate a pooled
average result across studies. This
process gives greater weightage to
the results from the studies that give
more information because these
are likely to be closer to the truth.
9
Advantages of meta-analysis include
deriving and statistical testing of
overall factors/effect size parameters
in related studies, generalization to
the population of studies, ability to
control for between study variation,
including moderators to explain
variation. To cumulate the results of
all the studies, a meta-analysis was
carried out to analyze the efficacy and
short-term and long-term safety of
Septilin in RTI.
Aim
The aim of the study was to perform
a meta-analysis on the efficacy and
short-term and long-term safety
studies of Septilin tablets in RTI.
Material andMethods
Study design
This is a cumulative meta-analysis
of 38 published clinical trials of
Septilin tablets in RTIs. Out of the 38
trials, 32 were open, 1 was placebo-
controlled, and 5 were comparative
controlled trials.
Inclusion criteria
All published studies, which evaluated
the role of Septilin in RTIs, were
included in the meta-analysis
irrespective of the study design, that
is, controlled studies or open clinical
studies. There were no restrictions
regarding sex, age, or duration of
the disease. The outcome variables
included measurement data on
changes in clinical symptoms and
signs, laboratory results, and incidence
of adverse events during/after the
treatment and immunoglobulin levels.
Exclusion criteria
Phase 1 studies were excluded from
the meta-analysis.
Study procedures
A meta-analysis of 38 clinical studies
conducted between 1958 and 2001
in 2765 patients with RTI (1613 were
with URTI and 838 were with lower
RTI) at various reputed hospitals all
over India was performed to evaluate
the efficacy and short-term and
long-term safety of Septilin in RTIs.
Duration of the treatment varied from
7 days to 3 months. Adults received
1 tablet QID to 2 tablets TID for
7 days to 3 months. Children one-
quarter tablet QID to 1 tablet TID
for 7 days to 3 months. Improvement
in the symptoms, clinical recovery,
and immunoglobulins were taken into
consideration. Incidence of adverse
events during the study period and
compliance to the drug treatment were
also evaluated.
Primary and secondary
outcomemeasure
Primary predefined outcomes were
clinical recovery from RTIs and
secondary endpoints were safety and
compliance to Septilin tablets.
