Abstract

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.

Highlights

  • The mention studies have showed a reduction in acute rhinosinusitis (ARS) symptoms with these two drugs, but larger studies are needed to confirm these findings

  • 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 mometasone furoate (MF) nasal spray has been confirmed with results comparable in evidence to Sinupret® for the respective indications

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Summary

Двойное слепое клиническое исследование

Пациенты с ОВРС с затемнением на простой рентгенограмме синуса n=81 в группе Синупрета (BNO 101); n=79 в группе плацебо. Первичный исход: число пациентов с MSS≤1 по оценке исследователя составило 48,4% в группе Синупрета и 35,8% в группе плацебо (p=0,0063). Показатель NNT для пациентов с MSS≤1 составил 8 Вторичные исходы: MSS по оценке пациента, SNOT-20 GAV и УЗИ показали лучшие результаты для Синупрета, чем плацебо. Вторичный исход: балл MSS по оценке исследователя составил 2,07±0,18 в группе Синупрета и 3,47±0,28 в группе плацебо (p=0,0001). Показатель NNT для пациентов с MSS≤1 составил 7. Объединенный анализ двух РКИ n=294 в группе Синупрета (BNO 1016); n=295 в группе плацебо. Первичный исход: показатель MSS улучшился в течение периода лечения в среднем с 10,02±1,61 до 2,47±2,55 балла для Синупрета и с 9,87±1,52 до 3,63±3,63 балла для плацебо. Различия между группами лечения по окончании терапии (1,16±3,14 балла; р

Открытое исследование
Нерандомизированное исследование
Двойное слепое РКИ
Pelargonium sidoides в сравнении с плацебо
Кокрановский метаанализ
Pelargonium sidoides в сравнении с другими методами лечения
Cyclamen europaeum
Цикламен в сравнении с плацебо
Неинтервенционное исследование
Цинеол в сравнении с плацебо
Сравнительные исследования растительных препаратов
Двойное слепое рандомизированное исследование
Одностороннее слепое рандомизированное исследование
Findings
Назальный спрей на основе МФ в сравнении с плацебо или амоксициллином
Full Text
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