Wie ist die Evidenzlage bei der nicht-antibiotischen medikamentösen Therapie der Rhinosinusitis?

Zusammenfassung

Hintergrund:

Vor dem Hintergrund einer umfangreichen Literaturrecherche zur Überprüfung der S2-AWMF-Leitlinie zur Rhinosinusitis und Polyposis nasi soll in diesem systematischen Review die Frage beantwortet werden, inwiefern anhand neuerer klinischer Studien neue Empfehlungen gegeben werden können oder bestehende Empfehlungen sich bestätigen lassen oder verändert werden müssen.

Material und Methoden:

Es wurde eine breit angelegte systematische Literaturrecherche in PUBMED, MEDLINE und diversen Datenbanken über MEDPILOT, und im Cochrane Central Register of Controlled Trials bis einschließlich 09/2010 durchgeführt. Die aus den Suchergebnissen durch 2 Reviewer ausgewählten relevanten klinischen Studien wurden anhand einer erweiterten Jadad-Skala hinsichtlich ihrer methodischen Qualität beurteilt und in Blick auf Studiendesign, Therapeutikum/Anwendung, Kontrollgruppe und Ergebnisse ausgewertet. Für die einzelnen Therapeutika wurden Evidenzlevel bestimmt.

Ergebnisse:

Aus 1 346 Abstracts wurden 227 möglicherweise geeignete Originalarbeiten im gesamten Publikationszeitraum identifiziert; 47 thematisch passende Originalarbeiten wurden ab 01/2006 publiziert und für diese Übersichtsarbeit berücksichtigt. Nach Analyse der neuen klinischen Studien und Berücksichtigung aktueller systematischer Reviews können bisherige Empfehlungen zur Sinusitistherapie weitgehend beibehalten werden.

Schlussfolgerung:

Die Evidenzlevel für die topische Steroidtherapie bei akuter und chronischer Rhinosinusitis liegen bei Ia. Es gibt neue Hinweise für den Nutzen einer Anwendung von Salzlösungen nicht nur bei chronischer sondern auch bei akuter Rhinosinusitis. Neuere Therapieansätze werden untersucht, können aber aufgrund bisher ungenügender Evidenz noch nicht empfohlen werden.

Abstract

What is the Evidence for Non-Antibiotic Drug Therapy of Rhinosinusitis?

Background:

The German AWMF-guideline for rhinosinusitis and nasal polyps is to be reassessed. By searching the literature for the reevaluation we investigate in this systematic review to what extent existing recommendations can be affirmed, have to be changed or if there are new recommendations to give.

Material and Methods:

We searched PUBMED, MEDLINE and other databases via MEDPILOT, and the Cochrane Central Register of Controlled Trials without limiting the publication date range. Relevant clinical trials identified by 2 reviewers out of the search results were assessed for their methodical quality using an extended Jadad scale. Datas were extracted and study design, therapy/application, control group and results were analysed. Furthermore, levels of evidence for the different therapeutics have been determined.

Results:

Out of 1 346 search results 227 potentially eligible trials were identified; for this review we considered only the 47 trials published since 01/2006. Former recommendations are mainly supported by the identified relevant publications and several Cochrane reviews published in the last years.

Conclusions:

Levels of evidence are Ia for topical and systemic corticosteroid therapy for acute and chronic rhinosinusitis. Additionally, there is evidence that the application of saline solutions is useful not only for chronic but also for acute rhinosinusitis. New therapy options are under examination, but there is not enough evidence for adding them to actual recommendations.

Schlüsselwörter

Rhinosinusitis - medikamentöse Therapie - Steroide - Salzlösungen - Sinusitis

Key words

rhinosinusitis - drug therapy - steroids - saline - sinusitis

• Literatur

• 1 Elies W, Bestehorn M, Thate-Waschke I. Häufigkeit und Therapie der Sinusitis. Chemother J 2007; 16: 167-175
• 2 Stuck BA, Bachert C, Federspil P, Hosemann W, Klimek L, Mösges R, Pfaar O, Rudack C, Sitter H, Wagenmann M, Hörmann K. Rhinosinusitis guidelines of the German Society for Otorhinolaryngology, Head and Neck Surgery. HNO 2007; 55: 758-760 762–754, 766–777
• 3 Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17: 1-12
• 4 Lim M, Citardi MJ, Leong J-L. Topical antimicrobials in the management of chronic rhinosinusitis: A systematic review. Am J Rhinol 2008; 22: 381-389
• 5 Joe SA, Thambi R, Huang J. A systematic review of the use of intranasal steroids in the treatment of chronic rhinosinusitis. Otolaryngol Head Neck Surg 2008; 139: 340-347
• 6 Kalish LH, Arendts G, Sacks R, Craig JC. Topical steroids in chronic rhinosinusitis without polyps: a systematic review and meta-analysis. Otolaryngol Head Neck Surg 2009; 141: 674-683
• 7 Zalmanovici A, Yaphe J. Intranasal steroids for acute sinusitis. Cochrane Database Syst Rev 2009; 4 CD005149
• 8 Patiar S, Reece P. Oral steroids for nasal polyps. Cochrane Database Syst Rev 2007; 1 CD005232
• 9 Kassel JC, King D, Spurling GK. Saline nasal irrigation for acute upper respiratory tract infections. Cochrane Database Syst Rev 2010; 3 CD006821
• 10 Harvey R, Hannan SA, Badia L, Scadding G. Nasal saline irrigations for the symptoms of chronic rhinosinusitis. Cochrane Database Syst Rev 2007; 3 CD006394
• 11 Johansson L, Oberg D, Melen I, Bende M. Do topical nasal decongestants affect polyps?. Acta Otolaryngol 2006; 126: 288-290
• 12 Bachert C, Meltzer EO. Effect of mometasone furoate nasal spray on quality of life of patients with acute rhinosinusitis. Rhinology 2007; 45: 190-196
• 13 Williamson IG, Rumsby K, Benge S, Moore M, Smith PW, Cross M, Little P. Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial. JAMA 2007; 298: 2487-2496
• 14 Desrosiers M, Hussain A, Frenkiel S, Kilty S, Marsan J, Witterick I, Wright E. Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Otolaryngol Head Neck Surg 2007; 136: 605-609
• 15 Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg 2009; 135: 303-307
• 16 Alobid I, Benitez P, Pujols L, Maldonado M, Bernal-Sprekelsen M, Morello A, Picado C, Mullol J. Severe nasal polyposis and its impact on quality of life. The effect of a short course of oral steroids followed by long-term intranasal steroid treatment. Rhinology 2006; 44: 8-13
• 17 Benítez P, Alobid I, de Haro J, Berenguer J, Bernal-Sprekelsen M, Pujols L, Picado C, Mullol J. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope 2006; 116: 770-775
• 18 Blomqvist EH, Lundblad L, Bergstedt H, Stjarne P. A randomized prospective study comparing medical and medical-surgical treatment of nasal polyposis by CT. Acta Otolaryngol 2009; 129: 545-549
• 19 Stewart RA, Ram B, Hamilton G, Weiner J, Kane KJ. Montelukast as an adjunct to oral and inhaled steroid therapy in chronic nasal polyposis. Otolaryngol Head Neck Surg 2008; 139: 682-687
• 20 Pujols L, Benitez P, Alobid I, Martinez-Antón A, Roca-Ferrer J, Mullol J, Picado C. Glucocorticoid therapy increases COX-2 gene expression in nasal polyps in vivo. Eur Respir J 2009; 33: 502-508
• 21 Pujols L, Alobid I, Benítez P, Martínez-Antón A, Roca-Ferrer J, Fokkens WJ, Mullol J, Picado C. Regulation of glucocorticoid receptor in nasal polyps by systemic and intranasal glucocorticoids. Allergy 2008; 63: 1377-1386
• 22 Valera FC, Queiroz R, Scrideli C, Tone LG, Anselmo-Lima WT. Evaluating budesonide efficacy in nasal polyposis and predicting the resistance to treatment. Clin Exp Allergy 2009; 39: 81-88
• 23 Jankowski R, Klossek JM, Attali V, Coste A, Serrano E. Long-term study of fluticasone propionate aqueous nasal spray in acute and maintenance therapy of nasal polyposis. Allergy 2009; 64: 944-950
• 24 Demirel T, Orhan KS, Keles N, Deger K. Comparison of the efficacy of nasal drop and nasal spray applications of fluticasone propionate in nasal polyps. Kulak Burun Bogaz Ihtis Derg 2008; 18: 1-6
• 25 Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg 2009; 135: 296-302
• 26 Stjarne P, Blomgren K, Caye-Thomasen P, Salo S, Soderstrom T. The efficacy and safety of once-daily mometasone furoate nasal spray in nasal polyposis: a randomized, double-blind, placebo-controlled study. Acta Otolaryngol 2006; 126: 606-612
• 27 Stjärne P, Mösges R, Jorissen M, Passàli D, Bellussi L, Staudinger H, Danzig M. A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis. Arch Otolaryngol Head Neck Surg 2006; 132: 179-185
• 28 Kang IG, Yoon BK, Jung JH, Cha HE, Kim ST. The effect of high-dose topical corticosteroid therapy on prevention of recurrent nasal polyps after revision endoscopic sinus surgery. Am J Rhinol 2008; 22: 497-501
• 29 Kroflic B, Coer A, Baudoin T, Kalogjera L. Topical furosemide versus oral steroid in preoperative management of nasal polyposis. Eur Arch Otorhinolaryngol 2006; 263: 767-771
• 30 Bolger WE, Joshi AS, Spear S, Nelson M, Govindaraj K. Gene expression analysis in sinonasal polyposis before and after oral corticosteroids: a preliminary investigation. Otolaryngol Head Neck Surg 2007; 137: 27-33
• 31 Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol 2010; 125: 1069-1076 e4
• 32 www.clinicaltrials.gov Identifier: NCT00480298
• 33 Friese KH, Zabalotnyi DI. Homeopathy in acute rhinosinusitis: a double-blind, placebo controlled study shows the efficiency and tolerability of a homeopathic combination remedy. HNO 2007; 55: 271-277
• 34 Bachert C, Schapowal A, Funk P, Kieser M. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7 630: a randomized, double-blind, placebo-controlled trial. Rhinology 2009; 47: 51-58
• 35 Tesche S, Metternich F, Sonnemann U, Engelke JC, Dethlefsen U. The value of herbal medicines in the treatment of acute non-purulent rhinosinusitis. Results of a double-blind, randomised, controlled trial. Eur Arch Otorhinolaryngol 2008; 265: 1355-1359
• 36 Pauli C, Fintelmann R, Klemens C, Hilgert E, Jund F, Rasp G, Hagedorn H, Kramer MF. Polyposis nasi – improvement in quality of life by the influence of leukotrien receptor antagonists. Laryngo-Rhino-Otol 2007; 86: 282-286
• 37 Gevaert P, Lang-Loidolt D, Lackner A, Stammberger H, Staudinger H, Van Zele T, Holtappels G, Tavernier J, van Cauwenberge P, Bachert C. Nasal IL-5 levels determine the response to anti-IL-5 treatment in patients with nasal polyps. J Allergy Clin Immunol 2006; 118: 1133-1141
• 38 Mukerji SS, Pynnonen MA, Kim HM, Singer A, Tabor M, Terrell JE. Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. Otolaryngol Head Neck Surg 2009; 140: 202-208
• 39 Friedman M, Vidyasagar R, Joseph N. A randomized, prospective, double-blind study on the efficacy of dead sea salt nasal irrigations. Laryngoscope 2006; 116: 878-882
• 40 Gelardi M, Mezzoli A, Fiorella ML, Carbonara M, Di Gioacchino M, Ciprandi G. Nasal irrigation with lavonase as ancillary treatment of acute rhinosinusitis: a pilot study. J Biol Regul Homeost Agents 2009; 23: 79-84
• 41 Hauptman G, Ryan MW. The effect of saline solutions on nasal patency and mucociliary clearance in rhinosinusitis patients. Otolaryngol Head Neck Surg 2007; 137: 815-821
• 42 Liang KL, Su MC, Tseng HC, Jiang RS. Impact of pulsatile nasal irrigation on the prognosis of functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg 2008; 37: 148-153
• 43 Passali D, Fiorella R, Camaioni A, Villari G, Mora E, Passali GC, Passali FM, Crisanti A, Bellussi L. Glucan solution nasal spray vs saline in the treatment of chronic rhinosinusitis: a multi-centric double blind randomised clinical trial. Clin Ter 2007; 158: 139-145
• 44 Passali FM, Crisanti A, Passali GC, Cianfrone F, Bocchi M, Messineo G, Bellussi L, Passali D. Efficacy of inhalation therapy with water of Salsomaggiore (Italy) in chronic and recurrent nasosinusal inflammation treatment. Clin Ter 2008; 159: 175-180
• 45 Passali D, Lauriello M, Passali GC, Passali FM, Cassano M, Cassano P, Bellussi L. Clinical evaluation of the efficacy of Salsomaggiore (Italy) thermal water in the treatment of rhinosinusal pathologies. Clin Ter 2008; 159: 181-188
• 46 Pinto JM, Elwany S, Baroody FM, Naclerio RM. Effects of saline sprays on symptoms after endoscopic sinus surgery. Am J Rhinol 2006; 20: 191-196
• 47 Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg 2007; 133: 1115-1120
• 48 Staffieri A, Abramo A. Sulphurous-arsenical-ferruginous (thermal) water inhalations reduce nasal respiratory resistance and improve mucociliary clearance in patients with chronic sinonasal disease: preliminary outcomes. Acta Otolaryngol 2007; 127: 613-617
• 49 Ural A, Oktemer TK, Kizil Y, Ileri F, Uslu S. Impact of isotonic and hypertonic saline solutions on mucociliary activity in various nasal pathologies: clinical study. J Laryngol Otol 2009; 123: 517-521
• 50 Wang YH, Yang CP, Ku MS, Sun HL, Lue KH. Efficacy of nasal irrigation in the treatment of acute sinusitis in children. Int J Pediatr Otorhinolaryngol 2009; 73: 1696-1701
• 51 Ansari N, Naghdi S, Farhadi M. Physiotherapy for chronic rhinosinusitis: The use of continuous ultrasound. Int J Ther Rehabil 2007; 14: 306-310
• 52 Hosoien E, Lund AB, Vasseljen O. Similar effect of therapeutic ultrasound and antibiotics for acute bacterial rhinosinusitis: a randomised trial. J Physiother 2010; 56: 29-32
• 53 Sertel S, Bergmann Z, Ratzlaff K, Baumann I, Greten HJ, Plinkert PK. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study. Am J Rhinol Allergy 2009; 23: e23-e28
• 54 Desrosiers M, Bella Z, Javer A, al-Mot S, Kemeny L, Koreck A, Hamid Q. Ultraviolet light: a potential new therapy for nasal polyps. J Allergy Clin Immunol 2008; 121 Abstract No. 1022