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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
Clinical Efficacy and Safety of Septilin Tablets in
Respiratory Tract Infections: A Meta-analysis
Kshirsagar M, et al
Indian J Clin Pract
. 2010;20(8).
A B S T R A C T
The aim of this study was to perform
meta-analysis on the efficacy and short-term
and long-term safety of Septilin tablet in
respiratory tract infections (RTIs), as reported in
38 published studies conducted between 1958 and
2001 in 2765 patients with RTI. Adults received 1 to
2 tablets, TID for 7 days to 3 months. Children were
administered one-quarter tablets QID to 1 tablet TID for
7 days to 3 months. Duration of the treatment varied from
7 days to 3 months. Improvement in the symptoms, clinical
recovery, and immunoglobulins were taken into consideration.
Results of the study showed statistically significant improvement
in patients with RTI. Of the 1613 patients with upper RTI
(URTI), 1211 patients responded to the Septilin therapy and
among the 838 patients with lower RTI (LRTI), 720 patients
responded to the therapy. In comparative control trials conducted
with Septilin in RTIs, 74.42% of patients treated with Septilin
improved as compared to the other treatment (52.86%). But with
Septilin treatment, the improvement was better with minimal
adverse effects. Immunoglobulin (IgG, IgA, IgM) levels showed
significant improvement with Septilin. Adverse effects included
gastrointestinal disturbances in 11 cases (0.39%), dry mouth
in 9 cases (0.32%), skin rashes in 3 patients (0.11%). Adverse
effects were mild and no patient withdrew from the study on
their account. Whereas patients in the comparative controlled
drugs (antibiotics and anti-allergics), reported drowsiness
and sedation in 21 cases (18%), dry mouth in 7 patients
(7.78%) and dizziness and improper coordination of
movements in 3 cases (3.33%). Therefore, it can be
concluded that Septilin tablets are effective and safe in
treating RTIs.
Key Words:
Meta-analysis, Septilin,
respiratory tract infection
Introduction
The term respiratory tract infection
(RTI) describes acute infections
involving the nose, paranasal sinuses,
pharynx, larynx, trachea, and
bronchi. Viruses cause most upper
RTIs (URTIs), with rhinovirus,
parainfluenza virus, coronavirus,
adenovirus, respiratory syncytial
virus, coxsackie virus, and influenza
virus accounting for most cases.
1
In
the United States, the common cold
leads to 75 to 100 million physician
visits annually at a conservative cost
estimate of US$ 7.7 billion per year.
Americans spend US$ 2.9 billion on
over-the-counter drugs and another
US$ 400 million on prescription
medicines for symptomatic relief.
2,3
More than one-third of patients,
who saw a doctor, received an
antibiotic prescription, which has
implications for antibiotic resistance
from overuse of such drugs.
3
An
estimated 22 to 189 million school
days are missed annually due to
cold. As a result, parents missed 126
million workdays to stay home to
care for their children. When added
to the 150 million workdays missed
