<i>Cyclamen europaeum</i>
 extract for acute sinusitis

Trestioreanu, Anca Zalmanovici; Barua, Ankur; Pertzov, Barak

doi:10.1002/14651858.cd011341.pub2

Cited by 4 publications

(6 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It is also possible that the immediate irritative effect of CE might have compromised the blinding of treatment in both trials. The Cochrane meta-analysis published in 2018 based on these two trials concluded that the efficacy of CE is unknown, while adverse events including nasal and throat irritation, mild epistaxis, and sneezing were more frequent with CE nasal spray than with placebo (risk ratio [RR]: 2.11; 95% CI 1.35 to 3.29) [30]. This meta-analysis found an overall low risk of selection, performance and detection bias in the two studies included.…”

Section: Ce Versus Placebomentioning

confidence: 99%

See 1 more Smart Citation

Evidence-based management of acute rhinosinusitis with herbal products

Bachert

2020

Clin Phytosci

View full text Add to dashboard Cite

Background The overuse of antibiotics for unjustified indications such as the management of acute uncomplicated rhinosinusitis has contributed to the emergence of antibiotic-resistant strains of bacteria and prompted the need for alternative treatments. This review assesses the quality of evidence for the management of acute rhinosinusitis with herbal products, with the goal of positioning them among other treatments and identifying future research directions. The MEDLINE database was searched for randomized controlled trials with Sinupret®, Pelargonium sidoides extract, Cyclamen europaeum (CE), cineole, and GeloMyrtol®. Searches with N-acetylcysteine and mometasone furoate nasal spray (MFNS) were performed to compare the strength of evidence of herbal products to these conventional products, which are indicated for acute rhinosinusitis. Main body Evidence was strongest for Sinupret, followed by Pelargonium sidoides extract. Their use in acute rhinosinusitis is supported by randomized placebo-controlled trials demonstrating both clinical efficacy and safety. Comparative data with conventional treatments such as topical glucocorticosteroids were found only for Sinupret and suggested comparable efficacy in a small study. For other herbal products, the overall level of evidence was low. The search retrieved two small-scale placebo-controlled randomized studies with CE nasal spray. The two trials were not powered to draw conclusions about the safety and efficacy of CE nasal spray and reported a lack of efficacy with CE on symptom reduction. Only one randomized placebo-controlled trial was identified for GeloMyrtol and cineole. These suggested an improvement in acute rhinosinusitis symptoms with both products, but the results warrant replication in larger trials. Studies directly comparing herbal products are scarce; one randomized trial has compared cineole with Sinupret, but the results need confirmation in further studies. Studies with N-acetylcysteine are limited to small-scale clinical trials, while MFNS is supported by a strength of evidence comparable to Sinupret in this indication. Conclusion State-of-the-art studies demonstrating the efficacy and safety of herbal products for the management of acute rhinosinusitis are available. Given that the evidence for Sinupret is the strongest and comparable to that of a widely available topical corticosteroid, MFNS, Sinupret may be considered for the management of acute uncomplicated rhinosinusitis.

show abstract

Section: Ce Versus Placebomentioning

confidence: 99%

“…This meta-analysis found an overall low risk of selection, performance and detection bias in the two studies included. The authors also emphasized the need for further randomized controlled trials to evaluate the efficacy of this treatment for acute rhinosinusitis [30].…”

Section: Ce Versus Placebomentioning

confidence: 99%

Evidence-based management of acute rhinosinusitis with herbal products

Bachert

2020

Clin Phytosci

View full text Add to dashboard Cite

show abstract

“…Также возможно, что немедленное раздражающее действие цикламена могло поставить под угрозу слепой режим обоих исследований. Кокрановский метаанализ, опубликованный в 2018 г. на основе этих двух исследований, показал, что эффективность цикламена неизвестна, в то время как НЯ, включая раздражение в носу и горле, несильное носовое кровотечение и чиханье, были чаще отмечены при использовании назального спрея цикламена, чем при применении плацебо (относительный риск -ОР 2,11; 95% ДИ 1,35-3,29) [30]. Этот метаанализ показал общий низкий риск систематической ошибки, связанной с отбором, эффективностью и выявлением определенного исхода в двух включенных исследованиях.…”

Section: цикламен в сравнении с плацебоunclassified

Review of the experience of using herbal drugs for the treatment of acute rhinosinusitis from the standpoint of evidence-based medicine

Bachert¹

2021

View full text Add to dashboard Cite

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.

show abstract

“…It is thought that 75% of patients with acute RS take antibiotics unnecessarily [3]. Clinical symptoms do not always indicate the necessity of antibiotics, and more reliable tools for an efficient RS diagnosis are still needed [4]. As part of the treatment, oral steroids, antihistamines, nasal irrigation, mucolytics, analgesics and local or systemic adrenergic decongestants are usually administered to suppress vascular circulation and gland secretion [5].…”

Section: Introductionmentioning

confidence: 99%

“…Several clinical trials have been carried out to assess herbal extract efficacy in RS patients. Cyclamen saponins freeze-dried extract reduces the symptoms of acute RS, restores muco-ciliary movements, and improves the rate of remission when compared to a placebo [4]. In these studies, the number of adverse effects was higher in the treatment group, mainly due to irritation at the treatment site.…”

Section: Introductionmentioning

confidence: 99%

Ex-Vivo and In-Vivo Assessment of Cyclamen europaeum Extract After Nasal Administration

et al. 2019

View full text Add to dashboard Cite

Rhinosinusitis is a prevalent disorder with a severe impact on the health-related quality of life. Saponins of Cyclamen europaeum exert a clinically proven curative effect on rhinosinusitis symptoms when instilled into the nasal cavity, however, more extensive preclinical assessment is required to better characterize the efficacy of this botanical extract. This work evaluates the potential use of a natural freeze-dried extract of C. europaeum given as topical nasal administration. Permeation experiment on porcine nasal mucosa was performed with Franz diffusion cells. Experiments in rabbits were performed to test for any toxicological, hematological, biochemical or histological evidence of systemic action. No theoretical levels of saponins were found in the receptor chamber of Franz diffusion cells. Hematological data did not show significant differences between control and experimental animals (p > 0.05). Histological studies also showed that enhanced secretory activity in response to intranasal administration was not accompanied by any visible signs of injury. An examination of the brain, lungs, liver, kidneys, spleen, and gastrointestinal organs did not reveal any abnormality. The absence of mucosal permeation of saponins and negligible probability of C. europaeum saponins absorption in the course of a therapeutic application was demonstrated.

show abstract

Cyclamen europaeum extract for acute sinusitis

Abstract: The effectiveness of Cyclamen europaeum for people with acute sinusitis is unknown. Although no serious side effects were observed, 50% of participants who received Cyclamen europaeum reported adverse events compared with 24% of those who received placebo.

Cited by 4 publications

References 43 publications

Evidence-based management of acute rhinosinusitis with herbal products

Evidence-based management of acute rhinosinusitis with herbal products

Review of the experience of using herbal drugs for the treatment of acute rhinosinusitis from the standpoint of evidence-based medicine

Ex-Vivo and In-Vivo Assessment of Cyclamen europaeum Extract After Nasal Administration

Contact Info

Product

Resources

About