Wednesday, July 31, 2013

Study results of with chronic rhinosinusitis

Study results of Specific microendoscopic characteristics of intranasal mucosa in patients presenting with chronic rhinosinusitis and treated with sinuforte


Clinical and instrumental data on treatment with Sinuforte/Nasdoren revealed improvement of general and/or local CRS symptoms, as confirmed by data from contact microendoscopy, in 30 patients (100%).
By day 2 of treatment with Sinuforte/Nasodren, an increase in the quantity of discharge from the nasal cavity of 1.4 times and a decrease in nasal stuffiness of 1.1 times (p<0.001) were observed.
By day 4 of treatment positive changes appeared, both subjective: absence of headache and facial pain in 100% of patients, decrease in nasal stuffiness of 1.8 times (p<0.001) and improve sense of smell; and objective: significant decrease in oedema of the mucosa.

On day 6 after the start of treatment, the intensity of symptoms was significantly reduced in all patients in comparison with parameters on day 4. All subjective improvements were confirmed by objective findings.
At the end of treatment on day 8, 14 (46.7%) patients reported relief from nasal stuffiness, and the remaining patients reported reduced intensity of this symptom; all patients displayed an absence of purulent discharge. Endoscopic examination revealed absence of oedema of the intranasal mucosa in 21 (70%) patients and reduction of oedema in the remaining patients. 
Tolerance of the Cyclamen extract was evaluated as “good” in 100% of cases by patients and the researcher using a point scale. Tolerance at the end of the course of treatment was evaluated as “good” in 90% of cases and “excellent” in 10% of cases. There were no unsatisfactory evaluations.
The efficacy of Sinuforte/Nasodren was evaluated cumulatively after phased treatment, taking into account the dynamics of subjective and clinical parameters at each visit as “good” by day 4 and as “excellent” by day 8.

Key messages from this study
  • Sinuforte/Nasodren is safe and efficacious for the treatment of patients with CRS
  • Sinuforte/Nasodren improves drastically the most frequent symptoms of CRS (facial pain and nasal congestion)
  • Sinuforte/Nasodren alleviate rhinosinusitis symptoms from the first application
  • Subjective improvements correlate with objective findings
  • Sinuforte/Nasodren physiologically resolves CRS exacerbation without disrupting the anatomical integrity of the nasal mucosa
  • Tolerance of Sinuforte/Nasodren is rated as excellent or good for both patients and researchers

Vestn Otorinolaringol 2011; 5: 59 

Thursday, July 18, 2013

Amoxicillin for Acute Rhinosinusitis

Amoxicillin for Acute Rhinosinusitis

A Randomized Controlled Trial
JAMA, February 15, 2012— Vol 307, No.7

Key messages from this study

  • Rhinosinusitis is a common disease (although underdiagnosed)
  • Rhinosinusitis is associated with high direct and indirect costs
  • Quality of life of rhinosinusitis sufferers is poor
  • Symptoms most frequently recorded are facial congestion or fullness and facial pain or pressure.
  • Although evidence to support antibiotic treatment for acute rhinosinusitis is limited, antibiotics are over prescribed
  • Antibiotics are not better than placebo in the treatment of acute rhinosinusitis

Objective: To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with acute rhinosinusitis
Participants: 166 patients
85 amoxicillin, 1500mg/day; 3 doses per day
81placebo; 3 doses per day

Main Outcome Measures: The primary' outcome was improvement in disease Specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome. Secondary outcomes: patient’s retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment.
Results: There was no statistically significant difference in reported symptom improvement at day 3 or at day 10; at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs. 56%, respectively).
No between-group differences were found for any other secondary outcomes.
Conclusions: Among patients with acute rhinosinusitis, a 10day course of amoxicillin compare with placebo did not reduce symptoms at days 3 and 10 of treatment.

Thursday, July 11, 2013



There are 15 controlled clinical trials, involving 1300 adults and 300 children, 600 of them included in controlled, randomized clinical trials (450 adults and 150 children), treated for 7 days, and some of them for 10 or 14 days. The earlier studies that evaluated the clinical efficacy and tolerability of Cyclamen extract nasal spray were relatively small, of varying design and conducted in Eastern Europe.
Despite the size of these trials they present coherence in their results, demonstrating the efficacy of Cyclamen extract nasal spray in the resolution or improvement of objective and subjective symptoms with greater, or at least similar, efficacy as standard combined treatment and with only minor adverse events reported in adults and children with rhinosinusitis [1,2, 3, 4-26]. As monotherapy, Cyclamen extract nasal spray is a good first-line treatment option for rhinosinusitis symptoms.
Cyclamen extract nasal spray can contribute to reducing disease progression time, decreasing the need for antibiotics or boosting their effects, as well as reducing the number of complications and chronic outcomes; thus, Cyclamen extract nasal spray has proven clinical benefit as an initial treatment for rhinosinusitis symptoms.
In patients with bacterial infections and with unfavourable progression, Cyclamen extract nasal spray shows evidence of an improvement in treatment efficacy when it is administered in combination with antibiotics Cyclamen extract nasal spray relieves symptoms and provides rapid recovery in acute rhinosinusitis due to its sinonasal drainage properties. The two randomized, double blind placebo-controlled trials show similar results, [4, 5] supporting the earlier studies.

Of particular note, the first large randomized, double-blind, placebo-controlled clinical trial with Cyclamen europaeum in patients with acute rhinosinusitis, showed marked clinical benefits for extract nasal spray [5]. A similar trend had been reported previously in a randomized, controlled, proof-of-concept study of Cyclamen europaeum L. nasal spray conducted in the USA [4].
Thus, Cyclamen extract. nasal spray is an effective and well tolerated treatment for patients with acute or chronic rhinosinusitis of mild-moderate severity. Of note, Cyclamen extract nasal spray is available commercially, and used successfully, worldwide; it can be recommended for use as monotherapy and it has also been shown to increase the efficacy of standard therapy, which generally included an
antibacterial drug and/or topical corticosteroids, shortening the time to symptom resolution and complete cure [27].
Cyclamen extract nasal spray treatment has also been associated with improvements in patient Quality of Life, an important finding in this debilitating disorder. Cyclamen extract. nasal spray has also shown benefits in terms of reducing symptoms when compared with painful, invasive procedures including maximallary sinus punctures.
Clinical studies have reported good tolerability, with no unexpected or serious Adverse events. Adverse events experienced were generally related to the mechanism of action of Cyclamen extract or are symptoms of rhinosinusitis, and included nasal irritation/burning. The clinical benefits of Cyclamen extract nasal spray, along with its good tolerability profile, indicate that it has a favourable benefit-to-risk profile in patients with rhinosinusitis.
This new product, with ideal characteristics and properties to combat rhinosinusitis and avoid its complications, possess some differentiating features

Thursday, July 4, 2013

Cyclamen extract Mechanism of action

Cyclamen extract Mechanism of action

Saponins are present in the plant world and most plants contain them in the form of triterpene and steroid glycosides. The term “saponin” comes from a Celtic word. It means soap and it is found in all the European languages. Saponins have some of the characteristic properties of soap, particularly detergent and surfactant properties, the ability to reduce surface tension and create a fairly stable film and, therefore, the property to form a foam. Due to these properties, the saponins adhere to surfaces, such as those of the mucous membranes.
The extract from the fresh tubers of Cyclamen europaeum in Nasodren® contains saponins. The main saponin component is cyclamin with a triterpenoid structure, which is accompanied by deglucocyclamine, hydrated cyclamine and other structurally related saponins. 
However, this does not mean that the saponins themselves have an anti-inflammatory effect. There is no evidence in the scientific literature that proves any ability of the saponins to act directly on the inflammatory process, for example by inhibiting the formation of inflammation mediators, leukocyte migration, etc. 
The aqueous extract obtained from the Cyclamen europaeum root-tuber is rich in saponins. These substances are known for their surfactant activity, which means they are adsorbed through the nasal mucosa without being absorbed into the bloodstream.

The surfactant action of the cyclamen saponins on the nasal mucosa reduces surface tension, facilitating humidification of the zone in addition to the secretion of mucin by goblet cells. This fluidifies the mucous accumulated in the nasal cavity, facilitating its elimination and thereby relieving congestion.
In addition, the saponins stimulate the sensitive receptors present in the nasal mucosa, inducing a nociceptive response transmitted by the trigeminal nerve. The nasal mucosa is entirely innervated by the trigeminal nerve, and therefore the cholinergic response generated in the nasal cavity is observed throughout the nasal mucosa, favouring opening of the ostium, increasing glandular secretions and increasing ciliar movement in the entire area. The accumulated secretions in the sinuses are consequently drained through the nose, providing rapid symptomatic relief of nasal congestion.