Обзор опыта применения растительных препаратов для лечения острого риносинусита с позиции доказательной медицины*
Обзор опыта применения растительных препаратов для лечения острого риносинусита с позиции доказательной медицины*
Бахерт К. Обзор опыта применения растительных препаратов для лечения острого риносинусита с позиции доказательной медицины. Consilium Medicum. 2021; 23 (9). DOI: 10.26442/20751753.2021.9.200988
________________________________________________
Bachert С. Review of the experience of using herbal drugs for the treatment of acute rhinosinusitis from the standpoint of evidence-based medicine. Consilium Medicum. 2021; 23 (9).
DOI: 10.26442/20751753.2021.9.200988
Обзор опыта применения растительных препаратов для лечения острого риносинусита с позиции доказательной медицины*
Бахерт К. Обзор опыта применения растительных препаратов для лечения острого риносинусита с позиции доказательной медицины. Consilium Medicum. 2021; 23 (9). DOI: 10.26442/20751753.2021.9.200988
________________________________________________
Bachert С. Review of the experience of using herbal drugs for the treatment of acute rhinosinusitis from the standpoint of evidence-based medicine. Consilium Medicum. 2021; 23 (9).
DOI: 10.26442/20751753.2021.9.200988
Общие сведения. Чрезмерное необоснованное использование антибиотиков, в том числе для лечения неосложненного острого риносинусита (ОРС), способствовало появлению резистентных к антибиотикам штаммов бактерий и привело к необходимости внедрения альтернативных методов лечения. В обзоре представлена оценка качества доказательств применения фитотерапии при ОРС с целью определения ее позиции среди других методов лечения и будущих направлений исследований. В базе данных MEDLINE был произведен поиск рандомизированных контролируемых исследований с применением Синупрета, экстракта Pelargonium sidoides (пеларгония), Cyclamen europaeum (цикламен), цинеола и ГелоМиртола. Был также произведен поиск результатов исследований применения назального спрея с N-ацетилцистеином и мометазона фуроатом (МФ) с целью сравнения эффективности растительных препаратов с данными традиционными средствами, показанными при ОРС. Основное содержание. Наиболее убедительными были доказательства для Синупрета, за которым следовал экстракт Pelargonium sidoides. Их использование при ОРС обосновано двойными слепыми плацебо-контролируемыми исследованиями, демонстрирующими как клиническую эффективность, так и безопасность. Сравнения с традиционными методами лечения, такими как глюкокортикостероиды для местного применения, найдены только для Синупрета и показали сопоставимую эффективность, но на небольшой группе пациентов.
Для других растительных препаратов сводный уровень достоверности доказательств был низким. В результате поиска были найдены два небольших плацебо-контролируемых рандомизированных исследования с применением назального спрея цикламена. В двух исследованиях не было возможности сделать выводы о безопасности и эффективности назального спрея цикламена и сообщалось об отсутствии эффективности цикламена в отношении уменьшения выраженности симптомов. Найдено только одно рандомизированное плацебо-контролируемое исследование для ГелоМиртола и цинеола. Упомянутые исследования указывали на уменьшение выраженности симптомов ОРС при использовании этих двух препаратов, но для подтверждения полученных результатов необходимы повторные более крупные исследования.
Исследования, в которых непосредственно сравнивали растительные препараты, немногочисленны; в одном рандомизированном исследовании цинеол сравнивали с Синупретом, однако результаты требуют подтверждения в дальнейших исследованиях.
Исследования применения N-ацетилцистеина ограничиваются небольшими клиническими исследованиями, в то время как использование назального спрея МФ подтверждено результатами, сопоставимыми по доказательной силе с результатами по Синупрету для соответствующих показаний. Выводы. Доступны современные исследования, демонстрирующие эффективность и безопасность растительных препаратов для лечения ОРС. Учитывая, что доказательства для Синупрета являются наиболее убедительными и сопоставимы с доказательствами для широко доступного кортикостероида для местного применения, МФ, Синупрет® можно рассматривать для лечения неосложненного ОРС.
General background. The overuse of antibiotics, including for the treatment of uncomplicated acute rhinosinusitis (ARS), has contributed to the emergence of antibiotic-resistant bacterial strains and has led to the need for alternative therapies. The review provides an assessment of the quality of evidence for the use of phytotherapy in ARS in order to determine its position among other therapies and future directions of research. The MEDLINE database was searched for randomized controlled studies of Sinupret®, Pelargonium sidoides extract (pelargonium), Cyclamen europaeum (cyclamen), cineole and GeloMyrtol®. We also searched for results from studies of a nasal spray with N-acetylcysteine and mometasone furoate (MF) in order to compare the effectiveness of herbal preparations with these traditional agents indicated for ARS. Main content. The strongest evidence was obtained for Sinupret®, followed by Pelargonium sidoides extract. Their use for treatment of ARS is supported by double-blind, placebo-controlled studies demonstrating both clinical efficacy and safety. Comparisons with traditional treatments such as topical glucocorticosteroids were found only for Sinupret® and they showed comparable efficacy, but in a small group of patients.
For other herbal drugs, the pooled level of evidence was low. The search identified 2 small, placebo-controlled, randomized studies of cyclamen nasal spray. In two studies, it was impossible to make conclusions about the safety and efficacy of cyclamen nasal spray and reported no efficacy of cyclamen in reducing symptoms. We found only one randomized placebo-controlled study of GeloMyrtol® and cineol. The mention studies have showed a reduction in ARS symptoms with these two drugs, but larger studies are needed to confirm these findings.
There are few studies that directly compared herbal drugs. In one randomized study, cineol was compared with Sinupret®, but the results need to be confirmed in further studies.
Studies of N-acetylcysteine are limited to small clinical trials, while the use of MF nasal spray has been confirmed with results comparable in evidence to Sinupret® for the respective indications. Conclusions. There are modern studies that demonstrate the efficacy and safety of herbal drugs for ARS treatment. Given that the evidence for Sinupret® is the strongest and comparable to that for the widely available topical corticosteroid, MF, Sinupret could be considered for the treatment of uncomplicated ARS.
Keywords: acute rhinosinusitis, herbal medicine, herbal drug, traditional treatment, antibiotics
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1. Fokkens WJ, Lund VJ, Mullol J, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012;50:1-12. DOI:10.4193/Rhino50E2
2. Worrall G. Acute sinusitis. Can Fam Physician. 2011;57:56577.
3. Orlandi RR, Kingdom TT, Hwang PH. International consensus statement on allergy and rhinology: rhinosinusitis executive summary. Int Forum Allergy Rhinol. 2016;6(Suppl. 1):S3-21. DOI:10.1002/alr.21694
4. Sharma P, Finley R, Weese S, et al. Antibiotic prescriptions for outpatient acute rhinosinusitis in Canada, 2007–2013. PLoS One. 2017;12:e0181957. DOI:10.1371/journal.pone.0181957
5. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA. 1998;280:1569-75. DOI:10.1001/jama.280.18.1569
6. Guo R, Pittler MH, Ernst E. Herbal medicines for the treatment of allergic rhinitis: a systematic review. Ann Allergy Asthma Immunol. 2007;99:483-95. DOI:10.1016/S1081-1206(10)60375-4
7. Koch AK, Klose P, Lauche R, et al. A systematic review of phytotherapy for acute rhinosinusitis. Forsch Komplementmed. 2016;23:165-9. DOI:10.1159/000447467
8. Macchi A, Terranova P, Castelnuovo P. Recurrent acute rhinosinusitis: a single blind clinical study of N-acetylcysteine vs ambroxol associated to corticosteroid therapy. Int J Immunopathol Pharmacol. 2012;25:207-17. DOI:10.1177/039463201202500123
9. Neubauer N, Marz RW. Placebo-controlled, randomized double-blind clinical trial with Sinupret(R) sugar coated tablets on the basis of a therapy with antibiotics and decongestant nasal drops in acute sinusitis. Phytomedicine. 1994;1:177-81. DOI:10.1016/S0944-7113(11)80061-9
10. Rossi A, Dehm F, Kiesselbach C, et al. The novel Sinupret(R) dry extract exhibits antiinflammatory effectiveness in vivo. Fitoterapia. 2012;83:715720. DOI:10.1016/j.fitote.2012.02.008
11. Marz RW, Ismail C, Popp MA. Profile and effectiveness of a phytogenic combination preparation for treatment of sinusitis. Wien Med Wochenschr. 1999;149:202-8.
12. Melzer J, Saller R, Schapowal A, Brignoli R. Systematic review of clinical data with BNO-101 (Sinupret) in the treatment of sinusitis. Forsch Komplementmed. 2006;13:78-87. DOI:10.1159/000091969
13. Jund R, Mondigler M, Stammer H, et al. Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis. Acta Otolaryngol. 2015;135:42-50. DOI:10.3109/00016489.2014.952047
14. Jund R, Mondigler M, Steindl H, et al. Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology. 2012;50:417-26. DOI:10.4193/Rhino12.015
15. Jund R, Mondigler M, Steindl H, et al. Clinical efficacy of a herbal drug combination in acute viral rhinosinusitis. MMW Fortschr Med. 2015;157:6-11. DOI:10.1007/s15006-015-2934-4
16. Passali D, Loglisci M, Passali GC, et al. A prospective open-label study to assess the efficacy and safety of a herbal medicinal product (Sinupret) in patients with acute rhinosinusitis. ORL J Otorhinolaryngol Relat Spec. 2015;77:27-32. DOI:10.1159/000370123
17. Weber U, Luedtke R, Friese KH, et al. A non-randomised pilot study to compare complementary and conventional treatments of acute sinusitis. Forsch Komplementarmed Klass Naturheilkd. 2002;9:99‑104. DOI:10.1159/000057271
18. Schoetz K, Erdelmeier C, Germer S, Hauer H. A detailed view on the constituents of EPs 7630. Planta Med. 2008;74:667-74. DOI:10.1055/s-2008-1074515
19. Bladt S, Wagner H. From the Zulu medicine to the European phytomedicine Umckaloabo. Phytomedicine. 2007;14(Suppl. 6):2–4. DOI:10.1016/j. phymed.2006.11.030
20. Kayser O, Kolodziej H, Kiderlen AF. Immunomodulatory principles of Pelargonium sidoides. Phytother Res. 2001;15:122-6. DOI:10.1002/ptr.785
21. Michaelis M, Doerr HW, Cinatl J Jr. Investigation of the influence of EPs(R) 7630, a herbal drug preparation from Pelargonium sidoides, on replication of a broad panel of respiratory viruses. Phytomedicine. 2011;18:384-6. DOI:10.1016/j.phymed.2010.09.008
22. Lizogub VG, Riley DS, Heger M. Efficacy of a Pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial. Explore (NY). 2007;3:573-84. DOI:10.1016/j.explore.2007.09.004
23. Riley DS, Lizogub VG, Zimmermann A, et al. Efficacy and tolerability of high-dose pelargonium extract in patients with the common cold. Altern Ther Health Med. 2018;24:16-26.
24. Bachert C, Schapowal A, Funk P, Kieser M. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial. Rhinology. 2009;47:51-8.
25. Perić A, Gacesa D, Barac A, et al. Herbal drug EPs 7630 versus amoxicillin in patients with uncomplicated acute bacterial rhinosinusitis: a randomized, open-label study. Ann Otol Rhinol Laryngol. 2020;129:969-76. DOI:10.1177/0003489420918266
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