11
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
Table 3. Meta-analysis of Septilin in RTIs in Comparative Controlled Trials
Study
No. of Patients
Septilin
Comparative Control
Total No. of
Patients
Improvement
Total No. of
Patients
Improvement
1
50
47
50
44
2
30
21
30
18
3
40
40
10
0
4
27
3
25
2
5
25
17
25
10
Total
172
128
a
140
74
a
(74.42%)
(52.86%)
a
P
< .0001 compared to the total number of patients with RTI before treatment.
Table 4. Meta-analysis of Septilin in Terms of Immunoglobulin Levels (total = 2 open trials) (n =
49) Immunoglobulin Levels (mean ± SD)
IgG (mg/dL)
IgM (mg/dL)
IgA (mg/dL)
Before
Treatment
After
Treatment
Before
Treatment
After
Treatment
Before
Treatment
After
Treatment
1456.00 ±
342.80
1715.00 ±
287.10
a
167.80 ±
68.38
195.70 ±
63.21
b
200.80 ±
46.73
241.40 ±
43.26
b
a
P
< .009 compared to the before treatment values.
b
P
< .001 compared to the before treatment values.
Table 5. Adverse Events
Treatment
Adverse Events
No. of Patients
Incidences and
Occurrences (%)
Septilin (n = 2765)
Gastrointestinal
disturbances
11
0.39
Dry mouth
09
0.32
Skin rashes
03
0.11
Comparator
Control Drugs
(n = 140)
Drowsiness and
sedation
21
18
Dry mouth
07
7.78
Dizziness and
incoordination
03
3.3
controlled drugs (140) such as
antibiotics and anti-allergics with
28% as compared to < 1% in Septilin-
treated patients.
Discussion
The number of papers published on
meta-analysis in medical research has
increased sharply in the past decade;
however, the merits and perils of the
meta-analysis continue to be debated
in the medical community.
48,49
A
useful definition of meta-analysis
was given by Huque as, “A statistical
analysis that combines or integrates
the results of several independent
clinical trials considered by the analyst
to be combinable.”
50
A single study
often cannot detect or exclude with
certainty clinically relevant differences
in the effects of 2 treatments.
Cumulative meta-analysis is defined
as the repeated performance of
meta-analysis whenever a new trial
becomes available for inclusion.
Such cumulative meta-analysis can
retrospectively identify the point
in time when a treatment effect
first reached conventional levels of
significance.
51
Meta-analysis thus not
only consists of a combination of data
but also includes the epidemiological
exploration and evaluation of results
(epidemiology of results).
52
Therefore,
new hypotheses that were not posed
in single studies can be tested in
meta-analyses.
53
The number of
patients included in clinical trials is
often inadequate, as in some cases
the required sample size may be
difficult to achieve.
54
Meta-analysis
may, nevertheless, lead to the
identification of the most promising
or urgent research question and may
permit a more accurate calculation
of the sample sizes needed in future
studies.
55
Goals of the meta-analysis
are to enable the overall significance
of an effect to be evaluated, based
on the multiple studies available,
to estimate an overall effect size by
combining the individual estimates
in multiple studies.
56
In this meta-
analysis, clinical trials and their
details were tabulated and analyzed
statistically. The outcome of this
analysis showed marked improvement
with Septilin in patients with RTIs.
Septilin has immunomodulatory,
antioxidant, anti-inflammatory,
anti-allergic, and antimicrobial
actions. It has an excellent short-term
and long-term safety. Septilin is a
multi-herbal preparation and the
effect of the formulation is due
to the synergistic action of the
ingredients.
Tinospora cordifolia
has
potent immunomodulatory and
immunostimulatory actions, which
increase the levels of antibodies and
activate macrophages.
57,58
Emblica
officinalis
enhances cell survival and
increases phagocytosis and
γ
-IFN
production.
59
Glycyrrhizin from
Glycyrrhiza glabra
potentiates the
reticuloendothelial system, enhances
immunostimulation, and acts on
macrophage function in vitro, leading
to stimulation of macrophages
