Thursday, May 30, 2013

Microendoscopy Study results

Study of specific microendoscopic characteristics of intranasal mucosa in patients presenting with chronic rhinosinusitis and treated with Sinuforte

Key messages from this study
  • Sinuforte is safe and efficacious for the treatment of patients with Chronic Rhinusitis (CRS)
  • Sinuforte improves drastically the most frequent symptoms of CRS (facial pain and nasal congestion)
  • Sinuforte alleviate rhinosinusitis symptoms from the first application
  • Subjective improvements correlate with objective findings
  • Sinuforte physiologically resolves CRS exacerbation without disrupting the anatomical integrity of the nasal mucosa
  • Tolerance of Sinuforte is rated as excellent or good for both patients and researchers
Study: Randomized open clinical and instrumental study with a control group
Objective: to assess the efficacy of the treatment of chronic rhinosinusitis (CRS) in the patients treated with Sinuforte using the contact microendoscopic technique.
Patients: 30 patients diagnosed with CRS, based on clinical observation, endoscopic and microendoscopic examination of intranasal mucosa and functional tests, in accordance with the EPOS 2007 (European Position Paper on Rhinosinusitis and Nasal Polyps).

Study methods: basic criteria for inclusion were: exacerbated CRS of moderate severity and absence of gross deformations of intranasal anatomical structures.

Effectiveness of treatment was evaluated using a questionnaire, instrumental examination (endoscopic and microendoscopic), and functional tests (laser Doppler flowmetry) on day 1 of the study, and also on days 2, 4, 6, and 8 after the start of treatment. 

Results: clinical and instrumental data on treatment with Sinuforte revealed improvement of general and/or local CRS symptoms, as confirmed by data from contact microendoscopy, in 30 patients (100%).

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 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.

Vestn Otorinolaringol 2011; 5: 59

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