Tuesday, March 5, 2013

Clinical investigation of the efficacy of a new plant extract product in children with acute rhinosinusitis

Clinical investigation of the efficacy of a new plant extract product in children with acute rhinosinusitis.


In spite of the treatments currently available, the incidence of rhinosinusitis continues to be high in children. Furthermore, the treatments currently available are not without adverse effects. A product obtained from natural plant extracts has been introduced recently whose action consists of promoting a natural drainage of pathological nasal and paranasal mucus secretions after intranasal
administration. The purpose of this study was to assess the use of the product in children suffering from acute rhinosinusitis and study its effects on the condition’s symptoms.
With a view to performing a complete study of these children, the local immunity indexes of the upper airway mucous membranes were also analysed. Thus, 30 children aged between 7 and 14 with acute rhinosinusitis were included. The children were divided into two groups of 15 patients each. In the first group, the plant extract-based product was combined with standard therapy and the
second group received the standard therapy only. The study’s results indicate that, compared with the basic therapy, the treatment that included administration of the plant extracts as part of the therapy showed a more positive evolution of the clinical symptom scores and a greater correction of local mucosal immune reactivity. Consequently, use of the product in children with acute rhinosinusitis is highly effective and very safe.




CONCLUSIONS
The results of this study show that the use of this new product containing plant extracts, including cyclamen, is associated with a significant clinical benefit. This positive mucus secretion drainage effect not only avoids having to perform maxillary sinus punctures in some cases but also does so without increasing the incidence of side effects. This is possible for two reasons.



The first is that it is a natural compound. Consequently, the likelihood of developing allergic conditions, which would worsen the disease, is much lower. The second reason is because of its mechanism of action. After administration in the nasal cavity, this plant extract activates the physiological cleansing mechanisms of the mucosa in the nasal cavity, favouring natural secretion and drainage in the nostrils and paranasal sinuses and clearing the accumulated mucopurulent content. In addition, this compound has apurely local action. As it is not absorbed by tissues nor does it enter the bloodstream, a systemic effect is avoided and the likelihood of developing side effects is limited.



This study has established the efficacy of this plant extract-based product in children. Other studies have shown an efficacy in excess of 90% in eliminating the main symptoms of rhinosinusitis, both alone and when combined with other treatments, and both in adults and children (Zasritskaia et al. 2006; Khechinashvili et al. 2006).
Another important aspect of this study is the analysis of local immunity in the saliva of both groups and the changes this immunity undergoes. It had already been pointed out in an earlier study that acute rhinosinusitis is associated with an imbalance in inflammatory cytokine levels (Seleznov et al. 2001). Our study shows that the rapid decrease in nasal and paranasal congestion is accompanied by a correction of local mucosal immune reactivity.
None of the products administered hampered production of the natural secretions
synthesized by the mucosal epithelium.


This fact provides further support for the benefit provided by this plant extract in
acute rhinosinusitis.



THUS, IT CAN BE CONCLUDED THAT:
· Compared with the basic therapy, the additional administration of the plant extract
to patients as part of their treatment was associated with a more positive evolution of clinical symptom scores and a reduction in the condition’s duration.

· The time required for improvement of the general condition, relief of the rhinosinusitis symptoms and restoration of a normal rhinoscopic picture was shorter.

· Administration of the product was associated with a rapid decrease in the nasal and paranasal congestion, which was accompanied by a correction of the local mucosal immune reactivity. In spite of its topical intranasal administration, the product does not hamper production of the natural secretions synthesized by the mucosal epithelium and which are an integral part of secretory immunoglobulin A (SIgA).
· The improvement is accompanied by an increase in the initially low local immunity indexes.
· Use of the product as part of a combined therapy enabled puncture of the upper maxillary sinuses to be avoided in some patients.


· On the basis of the above, we consider that use of this new plant extract-based product in children with acute rhinosinusitis is highly effective and very safe.

THERAPEUTICS AND CLINICAL RISK MANAGEMENT
A NEW TREATMENT ALTERNATIVE IN RHINOSINUSITIS USING PLANT EXTRACTS
Chernisheva L.
Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 19-23.

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