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Use of a new plant extract-based product in inflammatory diseases of the paranasal sinuses.
Results of its administration
KHECHINASHVILI S.
Academician, Doctor of Medicine,
State Academy of Medicine in Tbilisi,
Department of Otorhinolaryngology
KHOKHASHVILI P.
State Academy of Medicine in Tbilisi,
Department of Otorhinolaryngology
Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2006.
Therapeutics and clinical risk management 2006 - PDF
INTRODUCTION
The incidence of inflammation of the mucous membranes of the nostrils and appendicular sinuses – sinusitis – has undergone significant growth in recent years, both in absolute terms and in terms of their weight within the spectrum of ENT diseases (Lopatin 1993, Fokkens 2005). Late or insufficient treatment of rhinosinusitis is closely linked with local (orbital or intracranial) complications and at other levels, giving rise to bronchopulmonary or allergic disorders or changes in local and humoral immunity, which may lead to chronic bronchitis, pneumonia or bronchial asthma. This in turn often leads to disability or significant risks (Cohen et al 2000; Garcia 2003).
Consequently, to reduce the risk of complications caused by rhinosinusitis, it is important to use a suitable treatment that is able to act quickly and effectively.
However, the treatments traditionally used have not been shown to be absolutely effective in eradicating this disease. Thus, although they are very effective, the antibiotics cannot always be used to prevent the complications, including chronification, as has been shown in randomised controlled trials (Hoppe 1996; Clement et al 1998; Barreiro et al 2002).
One of the main reasons for this is that they do not act specifically on the main mechanism by which the rhinosinusitis is caused: the obstruction of the drainage orifices from the paranasal sinuses into the nasal passages. This in turn facilitates bacterial growth and decreases oxygen supply, favouring the growth of anaerobic germs (Cohen 2006).
In recent years, a new product obtained from plant extracts has been developed, which acts on the mucous membrane of the nasal and paranasal sinuses, activating the physiological mechanisms for clearing the nasal mucosa and facilitating drainage of the accumulated secretions. This drainage triggers an intense natural clearing of the paranasal sinuses and, as a result, high effectiveness of the product.
The goal of this study was to analyse the effect of plant extracts on rhinosinusitis by means of a radiographic study, including the use of computerised axial tomography.
PATIENTS AND METHODS
A total of 50 patients were included in the study.
The study was performed at the Otorhinolaryngology Clinic affiliated to the Dzhavakhishvili State University of Tbilisi and the State Academy of Medicine in Tbilisi. The computerized axial tomography was performed at the Institute of Radiological and Surgical Diagnosis of the Georgian Academy of Science, in accordance with current clinical practice.
After diagnosing rhinosinusitis, the conditions were classified with respect to their location, as stated below:
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All of the patients received the plant extract-based product in the form of a nasal spray. The product was given once a day for 10 days consecutively. Each dose contained 0.13 ml of preparation. After administration of the product, the patients usually noticed a slight smarting in the nose, followed after about 15 or 20 minutes by an increase in rhinorrhoea, which lasted about 3 hours. The product caused sneezing in 6 patients (12%) and lacrimation for 3-5 minutes in 2 patients (4%).
RESULTS
Of the total of 50 subjects included in the study, 12 patients (24%) had a prior history of chronic inflammation of the paranasal sinuses with periods of acute exacerbation that had been diagnosed and treated using traditional methods. 32 patients (64%) reported obstruction, congestion, and difficulty in breathing through one or both nostrils. All of the patients had nasal secretions. 27 patients (54%) suffered from headaches, and the other 23 (46%) from impaired sense of smell. They were sensitive to palpation of the frontal walls of the maxillary sinuses: 11 patients (22%); of the frontal sinuses: 3 patients (6%); of both: 1 patient (2%).
The table below summarises the subjective symptoms experienced by the patients included in the study group.
The nasal endoscopy carried out on all of the patients showed hyperaemia and oedema of the mucosa. 17 patients (34%) showed suppurative secretions in the middle meatus and 20 patients (40%) showed serous secretions. Suppurative secretion was observed in one patient in the superior meatus originating from the sphenoid sinus, which was confirmed by the CAT.
In 45 patients, the X-ray performed in accordance with the traditional method showed a darkening of some of the paranasal sinuses. A computerized axial tomography was performed in 5 patients, which confirmed the existence of localized pathological areas in some of the sinuses, characterised by a hypodense area of 10 - 22 Ha units.
After completing the treatment, all of the patients showed an improvement in their nasal breathing and the absence of nasal secretions. The 27 patients (100%) prone to suffering headaches before treatment confirmed that the headaches had disappeared by the third or fourth day of administration of the drug. Of the patients who reported impaired sense of smell, 19 (83%) indicated restoration of their sense of smell between the fifth and ninth day of treatment. The 15 patients (100%) who were sensitive to palpation of the frontal walls of the maxillary and frontal sinuses ceased to experience unpleasant sensations between the fourth and fifth day of treatment.
The nasal endoscopy performed on the 5th or 6th day of treatment showed an improvement in the state of the mucosa; between days 7 and 12, the hyperaemia and oedema of the mucosa disappeared or was considerably diminished in all of the patients. After the 10th-12th day, no serous or suppurative secretions were detected in the middle meatus.
The follow-up X-ray of the paranasal sinuses, performed on the fourth or fifth day after commencement of treatment, showed a complete normalization of the radiological parameters in 32 patients (89%) and a partial improvement in 4 patients (11%). 9 patients did not report for the follow-up X-ray. The computerized axial tomography of the paranasal sinuses, performed on 5 patients during the fifth or eighth week after commencement of treatment, showed the absence of any viscous or other content in the sinuses and a general improvement of the radiological parameters. These patients’ CAT scans, before and after treatment, are shown below:
Patient 1: 10 years
• Before treatment (Figures 1 and 2)
On both sides, in the maxillary sinuses (Mx) (Figure 2), particularly on the right side, and in the sphenoid sinuses (Sf) (Figure 1), pathological areas of heterogeneous structure appear, occupying practically the whose space of the sinuses.
Conclusion: Bilateral maxillary and sphenoid sinusitis.
• After treatment (Figures 3 and 4)
The mucosa of the right sphenoid sinus (Sf) (Figure 3) is slightly thicker than normal, without this having any clinical significance. Other paranasal sinuses show no areas of pathological density (Mx) (Figure 4).
Conclusion: The clinical situation is clearly improved compared with the situation before treatment.
Patient 2: 29 years
• Before treatment (Figures 1 and 2)
The right maxillary sinus (Mx) (Figure 2) shows a pathological hypodense area (12-18 Ha units), starting from the bottom of the sinus with subsequent cranial distribution, occupying almost half of the sinus. In the ethmoid sinus (Eth) (Figure 1), the mucosa is excessively thick.
Conclusion: Right maxillary and ethmoid sinusitis.
• After treatment (Figures 3 and 4)
The mucosa of the right maxillary sinus (Mx) (Figure 4) is slightly thicker than normal, without this having any clinical significance. Other sinuses (Mx) (Figure 4) and (Eth).
(Figure 3) do not show any areas of pathological density.
Conclusion: The radiological situation is clearly improved compared with the situation before treatment.
Patient 3: 11 years
• Before treatment (Figures 1, 2 and 3)
Both maxillary sinuses (Mx) (Figure 2) show an irregular pathological area, starting from the bottom, with subsequent cranial distribution, occupying almost half of the sinus.
Pathological areas of similar density occupy the ethmoid sinuses (Eth) (Figures 1 and 2). The mucosa of both frontal sinuses (F) (Figure 3) is thickened and enlarged.
In the sphenoid sinuses (Sf) (Figure 1), distinct contours of a pathological area are visible.
Conclusion: The pathology described indicates pansinusitis.
• After treatment (Figures 4, 5 and 6)
Both maxillary sinuses (Mx) (Figure 5), the frontal sinuses (F) (Figure 6) and the ethmoid sinuses (Eth) (Figure 4) show no pathological density, the central area of the sphenoid cavity (Sf) (Figure 4) contains a hypodense area with distinct contours, whose size is visibly diminished compared with the previous study.
Conclusion: The radiological situation is clearly improved compared with the situation before treatment.
Patient 4: 12 years
• Before treatment (Figures 1, 2 and 3)
On both sides, the maxillary (Mx) (Figure 2), sphenoid (Sf) (Figure 1), frontal (F) (Figure 3) and ethmoid (Eth) sinuses show irregular pathological areas (generally hypodense), occupying almost half of the left maxillary sinus (Mx) (Figure 2) and almost all of the other sinuses (Mx, Sf, F, Eth) (Figures 1, 2, 3).
Conclusion: Pansinusitis.
• After treatment (Figures 4, 5 and 6)
The paranasal sinuses (Sf, Eth, Mx, F) (Figures 4, 5 and 6) show no areas of pathological density.
Conclusion: The situation is clearly improved compared with the situation before treatment.
Outside of the study, three patients received treatment who had been operated previously for polyposis of the nose and paranasal sinuses, after which their sinuses again had mucohaemorrhagic content, together with nasal congestion, after two or three weeks.
Instead of the usual irrigations of the sinuses, the product was administered intranasally for 6 days.
The results of the treatment were positive: the mucus was drained, the sinuses were quickly cleared and the patients’ symptoms improved.
DISCUSSION
In spite of the considerable interest that the treatment of rhinosinusitis has aroused for some years, there is still a significant percentage of patients who suffer from complications and, in some cases, it is necessary to puncture the sinuses to drain the mucus that has accumulated. In spite of this, this condition sometimes becomes chronic, causing the patient significant malaise and is associated with a significant number of absences from work and school (Piskunov 1995; Henriksson et al 1996; Pluzhnikov 2003).
Although there currently exist several methods for treating acute suppurative rhinosinusitis, the treatment has traditionally sought to eradicate the agents causing the inflammation, focussing on removing the suppuration from the sinuses combined with antibiotic therapy and vasoconstrictive antihistamine preparations.
However, given their insufficient efficacy, which has led to an increased trend towards relapse and chronification, it is necessary to continue researching in this field. Also, in recent years, more data have appeared that confirm the inefficacy of antibiotic therapy in certain situations (Barreiro et al 2002). Furthermore, by eliminating the indispensable saprophytic flora and generating resistant strains, the antibiotics can sometimes worsen the problem. Likewise, many of the antibiotics that are currently used are immunosuppressive (Pluzhnikov 2003). This has led several authors to reflect on the need for a more rational use of the conventional therapy for sinusitis. In other words, the resources currently available should be used more selectively, given their limited efficacy and the not insignificant presence of adverse effects (Lopatin 1992; Werk & Bauchner 1998; Turnidge 2001; Varonen & Sainio 2004).
Consequently, it may be very useful to have a natural product for draining accumulated secretions that provides relief of the symptoms caused by congested mucosa.
This new plant extract-based product acts effectively to drain secretions with few side effects. Our results indicate that its action on the nasal mucosa promotes reflex secretion and, by activating physiological mechanisms, it is able to naturally clear the accumulated secretions. This data has been confirmed in other studies, which showed an efficacy greater than 90% in relieving the most common symptoms of rhinosinusitis (less difficulty in breathing through the nose, decrease and/or disappearance of pathological secretions, disappearance of headache and pain on palpation, among others) (Zasritskaia et al 2006; Chernisheva & Siniachenko 2006). Furthermore, being a natural product, the possibility of adverse side effects and allergic reactions is minimal. In fact, the adverse effects found both in our study and other studies that have been performed show that the incidence of side effects was very low, being local and passing as it is a product that is not absorbed through the tissues nor enters the bloodstream.
In conclusion, the assessment of the study’s results clearly shows that the use of plant extracts is an alternative that promotes clinical improvement in those acute conditions in which it is necessary to drain accumulated mucus secretions.
REFERENCES
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Use of a new plant extract-based product in inflammatory diseases... - Abstract
Therapeutics and clinical risk management 2006 - Index
Assessment of a new plant extract-based product in rhinosinusitis - Next abstract
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