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Assessment of a new plant extract-based product in rhinosinusitis

ZASRITSKAIA I.
Professor,
Kolomiychenko Institute of Otorhinolaryngology,
Ukrainian Academy of Medical Science

ZABOLOTNY D.
Member of he Ukrainian Academy of Medical Science,
Kolomiychenko Institute of Otorhinolaryngology,
Ukrainian Academy of Medical Science

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2006.

Therapeutics and clinical risk management 2006 - PDF


INTRODUCTION

Rhinosinusitis is defined as the inflammation of the nasal and paranasal sinus mucosa, which have a ciliated cylindrical epithelium characteristic of the airways (Matiño et al 2003). In spite of the treatments currently available, its incidence continues to increase. It is estimated that in adults, 0.5-2% of the common colds become complicated with rhinosinusitis and, of these, a small number of cases may generate intracranial and periorbital problems (Torralba et al 2006). In addition, health expenditure on rhinosinusitis continues to increase and shows no signs of diminishing. Indeed, it is estimated that each year in the United States, 3.5 billion dollars are spent on direct health care for sinusitis and 13 million days’ work are lost (Ray et al 1999; Jackson et al 2006).

Although a number of mechanisms have been described in the aetiopathogenesis of rhinosinusitis (impaired ciliar activity, bacterial overgrowth, among others), it seems that the most important mechanism for the development of rhinosinusitis is the obstruction of the drainage orifices from the paranasal sinuses into the nasal passages, giving rise to the accumulation of secretions which forms an ideal culture medium for the growth of germs (Oliver & Tolosa 1992; Matiño et al 2003).

The treatments currently used have not managed to solve the problem nor, in some cases, prevent chronification of the disease. Therefore, it has become necessary to find new alternatives that improve this situation.

In recent years, a plant extract-based product has become available. After intranasal administration, it facilitates natural secretion and drainage of the retained mucus, clearing the purulent content accumulated in the nasal and paranasal area (Khechinashvili et al 2006; Chernisheva & Siniachenko 2006).

This study has been performed to assess the usefulness of this new product in rhinosinusitis.


PATIENTS AND METHODS

Two groups of patients with a diagnosis of rhinosinusitis confirmed by the usual means have been included in this study. The study included 11 children aged between 8 and 15 years (6 boys and 6 girls), and 24 adults aged between 16 and 62 (12 women and 12 men). The study was performed at the Kolomiychenko Institute of Otorhinolaryngology at the Ukrainian Academy of Medicine, in the inflammatory diseases and paediatric departments.

The product was administered intranasally into the nasal cavity once a day for 6-8 days using a spray device.
The patients who did not experience any changes in their general condition or show symptoms of systemic infection — 3 children and 9 adults — were treated with the product. The patients with fever above 38.0ºС, intense headaches and evident malaise received a combined therapy with antibiotics,decongestants and the new product. Its effect was assessed on the basis of the evolution of the symptoms and by ultrasound scan of the paranasal sinuses. The results were expressed as a score, with the following scale:

  • 0 - no symptoms
  • 1 - mild symptoms
  • 2 - moderate symptoms
  • 3 - severe symptoms

The measurements were carried out at the baseline, and on the fourth and eighth days of treatment.


RESULTS

On the fourth day of treatment, the headaches diminished considerably or disappeared altogether in 21 patients (60%), and, by the eighth day, this result was achieved by 32 patients (91.4%). Upon completion of the treatment (8 days), the pathological suppurations had disappeared or diminished considerably in 30 patients (85%), while 29 patients (82.8%) obtained relief of the congestion and improved nasal breathing.
At the same time, progress was assessed by an ultrasound scan of the paranasal sinuses performed using a Sinuscan device. It should be mentioned that two children, in addition to rhinosinusitis, also had exudate in the middle ear, and the results of the tympanometry performed after treatment with the product confirmed elimination of the exudate.

The main study data are summarised in the table below.

TABLE 1. SYMPTOMS EXPERIENCED BY THE PATIENTS INCLUDED IN THE STUDY GROUP

DISCUSSION

It is clear that the more specific a treatment is, the more effective it is during use. This could explain, at least in part, what has happened with the treatments that have been used routinely in the treatment of rhinosinusitis (Barreiro et al 2002). So it is easy to understand why there are still relapses of the disease even today, with chronification of the condition and increased likelihood of complications (Clement et al 1998; Cohen et al 2000). Furthermore, the treatments that are normally used are associated with side effects. Considerable reflection is therefore required to ensure optimised use of resources (Lopatin 1992; Varonen & Sainio 2004).

This new plant extract-based product activates the physiological nasal clearing mechanisms and facilitates natural secretion, which leads to an effective and natural drainage of the nasal and paranasal area. Our results confirm effectiveness of its use, both alone and when given with antibiotics and decongestants.

On the other hand, since it is not absorbed by the tissues nor does it enter the bloodstream, the few side effects that this product may cause in a small percentage of patients are purely local, without causing systemic effects. These results are consistent with other studies, confirming an efficacy greater than 90% in relieving the main symptoms of rhinosinusitis, that is, improving the congestion and nasal breathing, reducing and/or eradicating the pathological secretions thanks to its drainage effect, and eliminating the headache and pain upon palpation, among others (Khechinashvili et al 2006; Chernisheva & Siniachenko 2006).

To conclude, it can be stated that this new plant extract-based product is highly effective for symptom relief in patients with acute exudative rhinosinusitis or acute exacerbations of the chronic form of the disease.


REFERENCES

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Assessment of a new plant extract-based product in rhinosinusitis - Abstract

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