Review question

We assessed the effectiveness of Cyclamen europaeum frozen, dried, natural fluid extract, an herbal medicine from the tuber of Cyclamen europaeum, given as a nasal spray compared with sham treatment (placebo) to resolve or improve acute sinusitis in adults and children.

Background

Acute sinusitis is a common condition that occurs when the bone cavities in the vicinity of the nose become inflamed from infection. Symptoms can include thick nasal mucus, congested nose, facial pain, headache, fever, and cough. Symptoms last up to eight weeks in adults and up to 12 weeks in children. Acute sinusitis is most often caused by viruses; complications can occur if the infection spreads. Acute sinusitis is a common condition that imposes significant costs.

A range of conservative treatments are available to treat acute sinusitis. Antibiotics are commonly prescribed, but clinical guidelines disagree about when antibiotics should be given to treat acute sinusitis. The few studies on Cyclamen europaeum extract given as nasal spray suggest that it may help by relieving nasal congestion.

Search date

The evidence is current to 18 January 2018.

Study characteristics

We included two studies involving 147 adults with acute sinusitis. Participants were randomly allocated to receive Cyclamen europaeum delivered as an intranasal spray or a non-active substance for up to 15 days.

Study funding sources

Pharmaceutical companies funded both studies.

Key results

We wanted to find out the proportion of participants whose symptoms resolved or improved up to 14 days and 30 days, but did not find any evidence. The included studies provided data for changes in symptom scores for acute sinusitis with treatment. One study reported improvement in facial pain up to seven days. Neither study reported complications or days off school or work.

People who received Cyclamen europaeum rather than a non-active substance reported more side effects like nasal irritation, sneezing, and mild nasal bleeding. No major side effects occurred.

We found no evidence as to whether Cyclamen europaeum is effective or not.

Quality of the evidence

We assessed the quality of both studies and judged the evidence to be moderately reliable for the only outcome that could be assessed, that is side effects. One study had a high dropout rate (60%), but dropouts were described and balanced between study arms. We found consistent results between studies for adverse events. Neither study reported whether the outcomes assessors knew which treatments the participants received. Due to the small number of participants and weaknesses in study design, we cannot be sure of the result.