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Efficacy of cyclamen in acute rhinosinusitis
MASSEGUR H.
ENT Department. Hospital de la
Santa Creu y Sant Pau. Barcelona.
New Horizons in the Non-Invasive Management of Sinonasal Disorders.
International ENT Medical Summit.
Barcelona, 19 September 2007.
Keywords of New Horizons in the Non-Invasive management of sinonasal disorders - PDF
INTRODUCTION
The diagnosis of acute rhinosinusitis is based on the detection of two or more of the following symptoms (with the necessary presence of one of the first two): nasal obstruction, significant mucus secretion, facial pain or pressure, and/or impaired or lost sense of smell.
However, the existence of endoscopic signs of disease is also important, which include the release of mucopurulent matter from the middle meatus or obstruction of the mucosa in the middle meatus (or the presence of oedema) (Figure 1). Radiology and, more specifically, computerised tomography are not a frequently used diagnostic resource for this disease, although it may be useful in certain cases.
EXPERIENCE WITH CYCLAMEN
Once the diagnosis has been made, the next question is what treatment should be given.
The initial experience acquired by Dr. Massegur’s group with cyclamen extract was limited to a group of 17 patients diagnosed with acute rhinosinusitis and in whom a prior antibiotic therapy had failed. A single daily dose was given for 7 days, documenting an improvement in all cases. Many cases presented a mild rhinorrhoea as persistent symptom; no other noteworthy complications were reported.
On the basis of this evidence, a second study has been undertaken to confirm these findings. A total of 10 patients meeting the criteria for acute rhinosinusitis (8 women, 2 men), with an average age of 42 years (28-64) and severe disease, received Nasodren®. The patients, in general, presented severe symptoms, including nasal obstruction, mucopurulent secretion, facial pain and impaired sense of smell. In the follow-up after administration of the treatment, a significant reduction was noted in the disease’s severity after 7-10 days in all cases. Only 1 relapse was reported after 15 days.
These isolated studies concur with other findings obtained by other treatment groups. As Dr. Massegur remarked, “there is a lack of controlled, randomized studies that could enable the efficacy of different phytotherapeutic resources to be compared with the reference treatments currently used in acute rhinosinusitis. It has not yet been possible to start these studies in Spain, although, in other countries, the first steps have already been taken to correct this shortcoming.”
He added, “Without these scientific studies that enable us to confirm that cyclamen extract offers at least the same benefits as the standard therapies, we will never be able to generalise its use.” However, there is indirect evidence that points very strongly towards the benefits of cyclamen extract.
A landmark trial by Meltzer et al. has shown that administration of topical corticoids twice daily is more effective than the monotherapy and treatment with amoxicillin in acute rhinosinusitis patients; it is also known that the combination of topical corticoids and antibiotics improves the outcome in the management of acute rhinosinusitis.
These findings suggest, as the speaker pointed out, that “if the obstruction and inflammation that are characteristic of rhinosinusitis are improved, we will probably be able to avoid using antibiotics in patients with mild or moderate disease”.
In addition, in recent years, there have been a growing number of studies, most of them from former Soviet Union countries, that consistently show the benefits obtained with the administration of cyclamen extract in rhinosinusitis patients.
THE FUTURE OF CYCLAMEN EXTRACT
A large part of the current effort in the clinical research of cyclamen extract is focused on defining what its indications could be in the future and how it should be administered, whether as an adjuvant therapy or as monotherapy.
Compared with the current reference treatment for rhinosinusitis, it has been observed that the add-on administration of cyclamen extract induces a very positive evolution of the clinical symptoms documented and shortens the disease’s duration; furthermore, a clear improvement in the patient’s general condition is seen, with increased symptom relief and faster regression of the endoscopic signs of disease after only 2-3 days of treatment.
Administration of Nasodren® also helps reduce congestion of the nasal and paranasal mucosa, helping to reduce occlusion of the natural openings (the original cause of the sinus inflammation).
For Dr. Massegur, “Nasodren® may be a valid treatment option for mild/moderate acute rhinosinusitis, although we need prospective, controlled, randomised studies that show that it can be at least as valid an option as the topical corticoids or as an alternative to the antibiotics.
If by using of this product we can reduce the use of antibiotics in patients with acute rhinosinusitis, this will enable us to reduce the rate of antibiotic resistance and save considerable expense.”
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