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Study flow diagram.
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Figure 1

Study flow diagram.

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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 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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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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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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Comparison 1 Cyclamen europaeum versus placebo, Outcome 1 Proportion of participants with any adverse event ‐ intention‐to‐treat.
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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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Comparison 1 Cyclamen europaeum versus placebo, Outcome 2 Proportion of participants with any adverse events ‐ best‐case sensitivity analysis.
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Analysis 1.2

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

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

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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
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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]
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Comparison 1. Cyclamen europaeum versus placebo
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