Documents

Acute rhinosinusitis in adults.
Summary of studies and conclusions.

BEZSHAPOCHNY S.
“Use of a new plant extract-based
product in acute purulent rhinosinusitis”

Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 1-7

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2007.

Therapeutics and clinical risk management 2007 - PDF


SUMMARY

Acute rhinosinusitis is a very common disease in our country. Although several causes have been described for this condition, it is considered that obstruction of the drainage orifices from the paranasal sinuses to the nostrils is the basic cause in the development of this type of condition, both through the retention of secretions, which promotes bacterial growth, and through decreased oxygen supply, which promotes growth of anaerobic germs.

Although a number of treatments have been used for this condition, there a remains a percentage of patients who experience complications caused by rhinosinusitis. In addition, the drugs are also associated with adverse effects. Administration of certain plant extracts activates the physiological cleansing mechanisms, increasing natural secretion within the sinuses and thereby clearing the purulent content accumulated in the sinuses and relieving the symptoms associated with this disease. We present our experience in the use of a plant extract-based product in 28 patients diagnosed with acute purulent rhinosinusitis.


DISCUSSION AND CONCLUSIONS

Our results support the benefit provided by the use of plant extracts in the drainage of secretions in acute rhinosinusitis. These results have been confirmed in other studies of sinonasal diseases and postoperative care (Zasritskaia et al. 2006; Khechinashvili et al. 2006; Chernisheva & Siniachenko 2006).

An appropriate early treatment of the acute rhinosinusitis significantly decreases the need to use antibiotics, which will both reduce costs and the likelihood of side effects (Torralba et al. 2006).

Furthermore, studies analysing the usefulness of antibiotics in acute sinusitis have shown conflicting results, possibly due to the inclusion of patients with viral rhinosinusitis in these studies.

Indeed, as some recommendations have pointed out, antibiotics should not be used when a viral aetiology is suspected (mild-moderate rhinosinusitis, lasting less than 7 days, no fever or persistent headache) (Engels et al. 2000; Piccirillo et al. 2004).

With respect to the patient’s symptoms, including nasal congestion, it is important to facilitate rapid drainage of the mucus secretions retained in the sinuses while at the same time minimising the incidence of side effects.

Clinical symptoms of the disease

The use of this new plant extract-based product is a significant step forward as it is able to act on the very root of the problem, facilitating rapid and effective drainage of the retained mucus, accompanied by symptom relief in more than 90% of the cases. Furthermore, since it acts locally (it is not absorbed by the tissues and does not enter the bloodstream), there are no major side effects. There may be mild side effects (stinging sensation, sneezing) that do not require stopping treatment. Also, being a natural product and containing no irritants or toxic products, allergy to the product is unlikely to appear.

In conclusion, the use of plant extracts provides a rapid, effective and safe alternative.


REFERENCES

  • Chernisheva LI, Siniachenko VV. 2006. Investigación clínica de la eficacia del uso de un nuevo producto de origen vegetal en niños con rinosinusitis aguda. Therapeutics and Clinical Risk Management, Special issue in Spanish:19-23. [1]
  • Engels EA, Terrin N, Barza M, Lau J. 2000. Meta-analysis of diagnostic tests for acute sinusitis. J Clin Epidemiol,53:852-62. [1]
  • Khechinashvili SN, Hojashvili PL, Sujiashvili, D Yu. 2006. Uso en las enfermedades inflamatorias de los senos paranasales de un nuevo producto de extractos de plantas. Resultados de su administración. Therapeutics and Clinical Risk Management, Special issue in Spanish:9-14. [1]
  • Piccirillo JF. 2004. Clinical practice. Acute bacterial sinusitis. N Engl J Med,351:902-10.[1]
  • Torralba M, Lainez S, Pereira A, et al. 2006. Protocolo diagnóstico y terapéutico de la sinusitis aguda. Medicine,9:3489-3491. [1]
  • Zasritskaia IS, Vinnichuk PV, Mironiuk BM. 2006. Valoración de un nuevo producto de extractos vegetales en la rinosinusitis. Therapeutics and Clinical Risk Management, Special issue in Spanish: 15-17. [1]



KHECHINASHVILI S.
“Use of a new plant extract-based product in
inflammatory diseases of the paranasal sinuses.
Results of administration”

Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 9-14

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2007.

Therapeutics and clinical risk management 2007 - PDF


SUMMARY

The incidence of rhinosinusitis continues to increase year after year, in spite of the therapies currently available. Although antibiotics have been used extensively for the treatment of rhinosinusitis, their insufficient efficacy has sometimes contributed to aggravating the problem, as their indiscriminate use eliminates vital saprophytic flora and leads to the creation of strains that are resistant to antibiotics. This has led several authors to reflect on the need for a more rational use of the medication currently used in the treatment of rhinosinusitis.

In recent years, a product has been developed which, when applied in the nasal cavity, activates the physiological nasal mucosa clearing mechanisms, promoting natural secretion, cleansing and drainage of the accumulated purulent content. Our purpose was to analyse this new plant extract-based product’s effect on rhinosinusitis. Computerised axial tomographies were obtained from 50 patients. The results of our study indicate that the plant extracts promote effective drainage of the retained secretions in rhinosinusitis, thereby facilitating symptom relief for the patient.


DISCUSSION AND CONCLUSIONS

In spite of the considerable interest that has existed from some years now in the treatment of rhinosinusitis, there still exists a significant percentage of patients who suffer complications, sometimes rendering necessary drainage of the mucus or even sinus punctures. However, in spite of these treatments, this condition sometimes becomes chronic, giving rise to severe discomfort for the patient and is the cause of a significant number of days lost from work or school (Piskunov 1995; Henriksson et al. 1996; Pluzhnikov 2003).

Although various methods are currently available for the treatment of acute suppurative rhinosinusitis, traditionally the treatments prescribed have sought to eradicate the causal agents of the inflammation, focusing on removing the suppuration from the sinuses, combined with treatment with antibiotics and vasoconstrictive antihistamine preparations. However, the insufficient efficacy associated with these treatments has led to a greater trend towards relapses and chronification, which in turn has raised the need to continue researching in this field. In recent years, further data have appeared that confirm the ineffectiveness of treatment with antibiotics in certain situations (Barreiro et al. 2002).

Indeed, by eliminating the indispensable saprophytic flora and generating resistant bacterial strains, antibiotics can worsen the problem in certain cases. Furthermore, many of the antibiotics commonly used today have an immunosuppressive action (Pluzhnikov 2003). This has led several authors to reflect on the need for a more rational use 3of the conventional therapy for sinusitis so that the resources currently available can be used more suitably, given their limited efficacy and the not insignificant presence of adverse effects (Lopatin 1992; Werk & Bauchner 1998; Turnidge 2001; Varonen & Sainio 2004).

Clinical symptoms of sinusitis

Consequently, the use of a natural product for draining accumulated secretions that also propitiates relief of the symptoms caused by the congested mucosa may be highly useful. This new product with plant extracts is effective in draining secretions while it has few side effects. Our results indicate that its action on the nasal mucosa facilitates a reflex secretion and, by activating physiological mechanisms, it is able to naturally and effectively clear the retained secretions.
This data has been confirmed in other studies, which showed an efficacy rate greater than 90% in eliminating the main symptoms of rhinosinusitis (difficulty in nasal breathing, decrease and/or disappearance of pathological secretions, disappearance of headache and tenderness, among others) (Zasritskaia et al. 2006; Chernisheva & Siniachenko 2006). Furthermore, being a natural product, the likelihood of adverse effects and allergic reactions is minimal. In fact, the incidence of adverse effects found both in our study and in others was very low, such effects being local and transient, since the product is neither absorbed by tissues nor does it enter the bloodstream.

In conclusion, our assessment of the study’s results clearly shows that the use of plant extracts is an alternative that promotes clinical improvement in those conditions requiring drainage of retained mucus secretions.

Differences between groups in the parameters observed before treatment


REFERENCES

  • Barreiro G, Alonso JJ, Canovas A, et al. 2002. Protocolo diagnóstico y terapéutico empírico de la sinusitis aguda. Medicine,8:3541-3542.[1]
  • Chernisheva LI, Siniachenko VV. 2006. Investigación clínica de la eficacia del uso de un nuevo producto de origen vegetal in niños con rinosinusitis aguda. Therapeutics and Clinical Risk Management, Special issue in Spanish:19-23. [1]
  • Henriksson G, Westrin KM, Kumlien J, et al. 1996. A 13-year report on childhood sinusitis: Clinical presentations, predisposing factors and possible means of prevention. Rhinology,34:171-5. [1]
  • Lopatin AS. 1992. The problem of drug side effects. Ter Arkh,64:6-8.[1]
  • Piskunov SZ. 1995. Treatment methods for acute rhinogenic orbital conditions. Russian Review of Rhinology,2:18. [1]
  • Pluzhnikov MS. 2003. Local therapy of purulent sinusitis with roncoleukin. Physician’s manual. Saint Petersburg, 40.[1] [2]
  • Turnidge J. 2001. Responsible prescribing for upper respiratory tract infections. Drugs,61:2065-77. [1]
  • Varonen H, Sainio S. 2004. Patients’ and physicians’ views on the management of acute maxillary sinusitis. Scand J Prim Health Care,22:22-6.[1]
  • Werk LN, Bauchner H. 1998. Practical considerations when treatment children with antimicrobials in the outpatient setting. Drugs,55:779-90.[1]
  • Zasritskaia IS, Vinnichuk PV, Mironiuk BM. 2006. Valoración de un nuevo producto de extractos vegetales en la rinosinusitis. Therapeutics and Clinical Risk Management, Special issue in Spanish: 15-17. [1]



ZASRISTKAIA I.
“Assessment of a new plant extract-based
product in rhinosinusitis”

Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 15-17

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2007.

Therapeutics and clinical risk management 2007 - PDF


SUMMARY

In spite of the treatments currently available for the treatment of sinusitis, there is a not insignificant percentage of patients who suffer from complications caused by rhinosinusitis, with relapses and chronification of the process in certain cases.

It is therefore necessary to look for other alternatives that can improve efficacy, reduce symptoms and possible complications, without being associated with side effects.

In recent years, a product has been developed from plant extracts that favours natural secretion from the nasal cavity and paranasal sinuses, thereby clearing the accumulated mucus. The purpose of this study was to analyse the effect of plant extracts on rhinosinusitis in a sample of 11 children and 24 adults. The results of our study indicate that plant extracts are useful in acute rhinosinusitis.


DISCUSSION AND CONCLUSIONS

It is obvious that the more specific a treatment is, the greater the efficacy obtained from its use. This could account, at least in part, for what has happened with the therapies that have been used for the treatment of rhinosinusitis (Barreiro et al. 2002). It is clear to us why there are still recurrences of the disease in our time, with chronification of the condition, which in turn increases the likelihood of complications (Clement et al. 1998; Cohen et al. 2000).

In addition, the treatments routinely used are not without side effects, which renders necessary a process of profound reflection in order to optimise resources (Lopatin 1992; Varonen & Sainio 2004).

This new product with plant extracts activates the physiological nasal drainage mechanisms and facilitates natural secretion, clearing the nasal and paranasal area naturally and effectively. Our results show the usefulness of this product, both when given alone and with antibiotics and decongestants.

Furthermore, since it is not absorbed by tissues and does not enter the bloodstream, the few side effects that this product may cause in a small percentage of patients are purely local, with no systemic effects. These results are consistent with other studies, which confirm a level of efficacy greater than 90% in relieving the main symptoms of rhinosinusitis, such as improving nasal congestion and breathing, diminishment and/or disappearance of pathological secretions due to its drainage effect, and the disappearance of headache and tenderness, among others (Khechinashvili et al. 2006; Chernisheva & Siniachenko 2006).

In conclusion, it can be said that this new product with plant extracts is highly effective in obtaining symptom relief in patients with acute exudative rhinosinusitis or acute exacerbations of chronic rhinosinusitis.


REFERENCES

  • Barreiro G, Alonso JJ, Canovas A, et al. 2002. Protocolo diagnóstico y terapéutico empírico de la sinusitis aguda. Medicine,8:3541-3542.[1]
  • Chernisheva LI, Siniachenko VV. 2006. Investigación clínica de la eficacia del uso de un nuevo producto de origen vegetal in niños con rinosinusitis aguda. Therapeutics and Clinical Risk Management, Special issue in Spanish:19-23. [1]
  • Clement P, Bluestone CD, Gordts E, et al. 1998. Management of rhinosinusitis in children. Arch Otorlaryngol Head Neck Surg,124:31-4.[1]
  • Cohen JT, Hochman II, DeRowe A, Fliss DM. 2000. Complications of Acute Otitis Media and Sinusitis. Curr Infect Dis Rep,2:130-140. [1]
  • Khechinashivili SN, Hojashvili PL, Sujiashvili, D Yu. 2006. Uso en las enfermedades inflamatorias de los senos paranasales de un nuevo producto de extractos de plantas. Resultados de su administración. Therapeutics and Clinical Risk Management, Special issue in Spanish:9-14.[1]
  • Lopatin AS. 1992. The problem of drug side effects. Ter Arkh,64:6-8.[1]
  • Varonen H, Sainio S. 2004. Patients' and physicians' views on the management of acute maxillary sinusitis. Scand J Prim Health Care,22:22-6.[1]



CHERNISHEVA L.
“Clinical investigation of the efficacy of a new plant product
in children with acute rhinosinusitis”

Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 19-23

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2007.

Therapeutics and clinical risk management 2007 - PDF


SUMMARY

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.


DISCUSSION AND 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 a purely 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 (Selezn'ov 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.

REFERENCES

  • Khechinashivili SN, Hojashvili PL, Sujiashvili, D Yu. 2006. Uso en las enfermedades inflamatorias de los senos paranasales de un nuevo producto de extractos de plantas. Resultados de su administración. Therapeutics and Clinical Risk Management, Special issue in Spanish:9-14.[1]
  • Selezn'ov KH, Barynov EF, Iel's'kyi, et al. 2001. Interleukin-2 and interleukin-4 blood levels in sinusitis. Fiziol Zh, 47:69-73 [1]
  • Zasritskaia IS, Vinnichuk PV, Mironiuk BM. 2006. Valoración de un nuevo producto de extractos vegetales en la rinosinusitis. Therapeutics and Clinical Risk Management, Special issue in Spanish: 15-17.[1]



POPOVICH V.
“Use of a new plant extract-based product in the early
postoperative care of patients with productive rhinosinusitis.”

Therapeutics and Clinical Risk Management,
Suppl.1, 2006. 25-32

Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2007.

Therapeutics and clinical risk management 2007 - PDF


SUMMARY

The incidence of chronic paranasal sinus conditions continues to increase in spite of the treatments currently available. Endoscopic surgery seeks to restore drainage and ventilation of the paranasal sinuses. However, in spite of the significant progress achieved with this technique, there remains a significant percentage of patients who suffer further obstruction after surgery. Among other reasons, this is due to the inflammatory congestive process, tissue oedema and hyperaemia caused by the surgical aggression. The use of products that facilitate natural nasal and paranasal secretion and help cleanse the accumulated content takes on particular significance in this field.

The purpose of this study was to determine the usefulness of a new plant extract-based product in patients operated for productive rhinosinusitis and maxillary sinus cysts after administration in the early postoperative period. Our results show that its use as monotherapy after surgery is associated with a rapid clearing of the nasal meatus and sinuses, restoring normal rhinoscopic findings between the fifth and sixth day after administration of the preparation.


CASE REPORT

Surgery for polypous ethmoiditis

Figure 1. Surgery for polypous ethmoiditis


BASELINE.
REMOVAL OF THE POLYPS AND OPENING OF THE MEATUS CONNECTING THE MAXILLARY SINUS.








Figure 2. Surgery for polypous ethmoiditis 2


DAY 2.
THE POSTOPERATIVE AREA IS CLEANED ON THE 2ND DAY, OBSERVING ABUNDANT MUCOHAEMORRHAGIC SECRETION IN THE MIDDLE MEATUS






Evolution

Figure 3. Surgery for polypous ethmoiditis 3


DAY 3.
ON THE THIRD DAY OF TREATMENT WITH NASODREN, AN ABUNDANT SECRETION WHICH CLEANS THE NASAL CAVITIES IS OBSERVED.






Figure 4. Surgery for polypous ethmoiditis 4


DAY 7.
ON THE SEVENTH DAY OF TREATMENT WITH NASODREN®, THE MIDDLE MEATUS IS SEEN TO BE DECONGESTED, WITH RESTORATION OF A HEALTHY NASAL MUCOSA.





DISCUSSION AND CONCLUSIONS

In spite the development of endoscopic surgery in the field of otorhinolaryngology in recent years and particularly in the effective treatment of chronic conditions affecting the paranasal sinuses to restore natural drainage and ventilation, there remains a significant percentage of patients who suffer further obstruction after surgery.

Among other reasons, this is due to the inflammatory congestive process, tissue oedema and hyperaemia caused by the surgical aggression. Although various treatments have been used in the postoperative period to palliate this problem, the results are not yet as satisfactory as they should be (Gerber et al. 2003; Aukema & Fokkens 2004; Cohen 2006).

The plant extracts studied have the advantage that they naturally favour drainage of the secretions from the nasal passages and paranasal sinuses, helping to clear the mucus content accumulated after surgery. The results of our study clearly show that their use helps in this process in the immediate postoperative period in patients operated for productive rhinosinusitis and maxillary sinus cysts. Furthermore, it is not only effective but the effect is quicker than other alternatives. Thus, the use of natural plant extracts rapidly drains the sinuses and nasal meatus. The rhinoscopic findings become normal between the fifth and sixth day of treatment, which is three or four days sooner than with the traditional methods of postoperative care, such as nasal irrigation. The images included with this study clearly illustrate this new product’s usefulness. In addition, its efficacy in other nasal or paranasal conditions has been shown in other studies (Zasritskaia et al. 2006; Khechinashvili et al. 2006; Chernisheva & Siniachenko 2006).

A particular feature of its use in the early postoperative period is the relatively low sensitivity of the mucous membrane to the product. As a result, patients only feel a slight smarting after administration. When the product’s action has ended, almost all patients report a slight dryness in the nose. This good tolerability is due, among other reasons, to the fact that it is a completely natural product.

In conclusion, the results obtained in this study show that use of this new plant extract-based product provides an effective treatment in the early postoperative care of patients after endoscopic surgery for productive rhinosinusitis.


REFERENCES

  • Aukema AA, Fokkens WJ. 2004. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med,3:97-105.[1]
  • Chernisheva LI, Siniachenko VV. 2006. Investigación clínica de la eficacia del uso de un nuevo producto de origen vegetal in niños con rinosinusitis aguda. Therapeutics and Clinical Risk Management, Special issue in Spanish:19-23.[1]
  • Cohen NA. 2006. Sinonasal mucociliary clearance in health and disease. Ann Otol Rhinol Laryngol Supl,196:20-6. [1]
  • Gerber VKh, Buskina AV, Dergachev VS. 2003. Application of ultrasonic cavitation in combined treatment of polypous rhinosinusitis. Vestn Otorinolaringol,4:25-7.[1]
  • Khechinashivili SN, Hojashvili PL, Sujiashvili, D Yu. 2006. Uso en las enfermedades inflamatorias de los senos paranasales de un nuevo producto de extractos de plantas. Resultados de su administración. Therapeutics and Clinical Risk Management, Special issue in Spanish:9-14.[1]
  • Zasritskaia IS, Vinnichuk PV, Mironiuk BM. 2006. Valoración de un nuevo producto de extractos vegetales en la rinosinusitis. Therapeutics and Clinical Risk Management, Special issue in Spanish: 15-17.[1]

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