Cyclamen europaeum extract for acute sinusitis

Anca Zalmanovici Trestioreanu; Ankur Barua; Barak Pertzov

doi:10.1002/14651858.CD011341.pub2

Cochrane Database of Systematic Reviews

Extracto de Cyclamen europaeum para la sinusitis aguda

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DOI:

https://doi.org/10.1002/14651858.CD011341.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

11 mayo 2018see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Infecciones respiratorias agudas

Copyright:

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

Anca Zalmanovici Trestioreanu

Correspondencia a: Clalit Health Services, Tel Aviv District, Tel Aviv, Israel

[email protected]

[email protected]
Ankur Barua

Consultancy, eCommerce, Distribution, Phenix Venture LLC at Delaware, US, Kolkata, India
Barak Pertzov

Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel

Contributions of authors

Anca Zalmanovici Trestioreanu wrote the protocol, entered data into Review Manager 5, and wrote the review.
Ankur Barua signed off on the protocol and participated with Anca in study selection, quality assessment, and data extraction.
Barak Pertzov participated in data analysis, summary of findings Table for the main comparison, and the interpretation of results.

Declarations of interest

Anca Zalmanovici Trestioreanu: None known.
Ankur Barua: None known.
Barak Pertzov: None known

Acknowledgements

Thanks to the following people for commenting on the draft protocol and draft review and for ongoing assistance: Liz Dooley, Acute Respiratory Infections (ARI) Group Managing Editor, and referees Ann Fonfa, Viviana Rodriguez, Romy Lauche, Mio Hu, Romero Rodriguez, Emma Lake, Julie Gildie, Liz Bickerdike, and Michelle Guppy.

We also wish to thank David Honeyman, Information Specialist, ARI Group, for support with searches. Ekaterina Victorovna Yudina and Liliya Eugenevna Ziganshina translated studies from Russian.

Version history

Published

Title

Stage

Authors

Version

2018 May 11

Cyclamen europaeum extract for acute sinusitis

Review

Anca Zalmanovici Trestioreanu, Ankur Barua, Barak Pertzov

https://doi.org/10.1002/14651858.CD011341.pub2

2014 Oct 12

Cyclamen europaeum extract for acute sinusitis

Protocol

Anca Zalmanovici Trestioreanu, Ankur Barua

https://doi.org/10.1002/14651858.CD011341

Differences between protocol and review

We added a post hoc best‐case/worst‐case sensitivity analysis to the review.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Cyclamen europaeum versus placebo, Outcome 1 Proportion of participants with any adverse event ‐ intention‐to‐treat.

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Analysis 1.2

Comparison 1 Cyclamen europaeum versus placebo, Outcome 2 Proportion of participants with any adverse events ‐ best‐case sensitivity analysis.

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Analysis 1.3

Comparison 1 Cyclamen europaeum versus placebo, Outcome 3 Proportion of participants with any adverse event ‐ worst‐case sensitivity analysis.

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Summary of findings for the main comparison. Cyclamen europaeum compared to placebo for acute sinusitis

Cyclamen europaeum compared to placebo for acute sinusitis
Patient or population: adults with acute sinusitis Setting: outpatients in Germany and the USA Intervention:Cyclamen europaeum topical intranasal spray (1.3 mg once daily in each nostril for up to 15 days) Comparison: placebo
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with Cyclamen europaeum
Proportion of participants with resolution or improvement of symptoms up to 30 days	‐	‐	‐	‐	‐	No studies reported this outcome.
Proportion of participants with any adverse event	Study population		RR 2.11 (1.35 to 3.29)	147 (2 RCTs)	⊕⊕⊕⊝ Moderate	We downgraded the quality of the evidence as concealment of allocation to treatment and blinding of outcome assessors were not reported in the studies. Also, 1 study had a small sample size with a high attrition rate.
	240 per 1000	506 per 1000 (324 to 790)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Summary of findings for the main comparison. Cyclamen europaeum compared to placebo for acute sinusitis

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Table 1. Adverse events

Study ID

Cyclamen europaeum

Placebo

Pfaar 2012

67% total

50% nasal irritation mild/moderate

27% mild epistaxis

4% sneezing

3 discontinued treatment

29% total

4% nasal irritation

14% mild epistaxis

4% vertigo

2 discontinued treatment

Ponikau 2012

15.4% total

Influenza, throat irritation, migraine, sneezing

No serious adverse events

Did not discontinue treatment

12.5% total

Headache, ear pain, gastritis, back pain, conjunctival haemorrhage

No serious adverse events

Did not discontinue treatment

Table 1. Adverse events

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Comparison 1. Cyclamen europaeum versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of participants with any adverse event ‐ intention‐to‐treat Show forest plot	2	147	Risk Ratio (M‐H, Fixed, 95% CI)	2.11 [1.35, 3.29]

2 Proportion of participants with any adverse events ‐ best‐case sensitivity analysis Show forest plot	2	147	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.68, 1.30]

3 Proportion of participants with any adverse event ‐ worst‐case sensitivity analysis Show forest plot	2	147	Risk Ratio (M‐H, Fixed, 95% CI)	3.49 [2.30, 5.30]

Comparison 1. Cyclamen europaeum versus placebo

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Extracto de Cyclamen europaeum para la sinusitis aguda

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