Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis
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Abstract
The objective: the pooled efficacy data of two similar randomized placebo controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials.
Patients and methods. The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3×160 mg BNO 1016 (n=294) or 3 × placebo (n=295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV).
Results. MSS improved during the treatment period by a mean of 10,02±1,61 score points to 2,47±2,55 for BNO 1016 and of 9,87±1,52 to 3,63±3,63 for placebo. Differences between treatment groups at end of therapy (1,16±3,14 score points; p<0,0001) and patient assessed quality of life (p=0,0015) were statistically significant in favor of BNO 1016.
Conclusion. Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis.
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References
Fokkens W.J., Lund V.J., Mullol J., Bachert C., Alobid I., Baroody F. (2012) EPOS 2012: European position рареr on rhinosinusitis and nasal polyps 2012. Rhinology, 1–229.
Masood A., Maoumoulidis I., Panesar J. (2007) Acute rhinosinusitis in adults: an update on current management. Postgrad Med, 83, рр. 402–408.
Hellgren J., Cervin A. Nordling S., Bergman A., Cardell L-O. (2010) Allergic rhinitis and the common coldhigh costs to society. Allergy, 65, рр. 776–83.
Guo R., Canter P.H., Ernst E. (2006) Herbal medicines for the treatment of rhinosinusitis: a systematic review. Otolaryngol Head Neck Surg, 135, рр. 496–506.
Reden J., El Hifnawi D., Zahnert T., Hummel T. (2011) The effect of herbal combination of primrose, gentian root, vervain, elder flowers, and sorrel on olfactory function in patients with a [13] sinonasal olfactory dysfunction. Rhinology, 49, pp. 342–346.
Ismail C. (2005) [Pharmacology of Sinupret. Recent results on the rational for the Sinupret compound.]. HNO, 53, pp. 38–542 (in German).
Bachert C., Mondigler M., Steindl H., Stammer H., Stierna P. [14], Eskotter H. (2013) Multicentre, randomised, double-blind, placebo controlled, parallel group dose finding study of herbal medicine (dry extract) BNO 1016 in acute rhinosinu-sitis (ARhiSi-1). 84th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.
Jund R., Mondigler M., Steindl H., Stammer H., Stierna P., Bachert C. (2012) Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology, 50, pp. 417–426.
Baumann I., Blumenstock G., De Maddalena H., Piccirillo J.F., Plinkert P.K. (2007) Quality of life in patients with chronic sinusitis: validation of the Sino Nasal Outcome Test 20 German Applied Version. HNO, 55, pp. 42–47.
Bachert C., Schapowal A., Funk P., Kieser M. (2009) Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double blind, placebo controlled trial. Rhinology, 47, pp. 51–58.
Meltzer E.O., Bachert C., Staudinger H. (2005) Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol, 116, pp. 1289–1295.
Revicki D.A., Margolis M.K., Thompson C.L., Meltzer E.O., Sandor D.W., Shaw J.W. (2011) Major symptom score utility index for patients with acute rhinosinusitis. Am J Rhinol Allergy, 25, pp. 99–106.
Glatthar Saalmuller B., Tauchhaus U., Rode S., Haunschild J., Saalmuller A. (2011) Antiviral activity of two preparations of the herbal medicinal product SinupretTM against viruses causing respiratory infections. Phytomedicine, 19, pp. 1–7.
Kreindler J.L., Chen B., Kreitman Y., Kofonow J., Adams K.M., Cohen N.A. (2012) 1011 stimulates chloride transport and ciliary beat frequency in human respiratory epithelial cultures. Am J Rhinol Allergy, 26, pp. 439–443.
Meltzer J., Saller R., Schapowal A., Brignoli R. (2006) Systematic review of clinical data with BNO 101 (Sinupret) in the treatment of sinusitis. Forsch Komplementmed, 13, pp. 78–87.
Rossi A., Dehm F., Kiesselbach C., Haunschild J., Sautebin L., Werz O. (2012) The novel Sinupret dry extracts exhibit anti inflammatory effectiveness in vivo. Fitoterapia, 83, pp. 715–720.
Lee J.S., Kim I.S., Kim J.H., Kim D.H., Yun C.Y. (2008) Suppressive effects of Houttuynia cordata Thunb (Saururaceae) extract on Th2 immune response. J Ethnopharmacol, 117, pp. 34–40.
Meltzer E.O., Bachert C., Staudinger H. (2005) Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol, 116, pp. 1289–1295.
Zalmanovici Trestioreanu A., Yaphe J. (2010) Intranasal steroids for acute sinusitis (review). The Cochrane Library, issue 7.
