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New Treatment Trends in Acute Rhinosinusitis and Postoperative Care
POPOVICH V.
Head of the Otorhinolaryngology Department.
Ivano-Frankivsk State Medical
University. Ukraine
Present and Future of the Management of Sinonasal Disesase.
Madrid, 11 November 2007.
Keywords Present and Future of the Management of Sinonasal Disesase - PDF
INTRODUCTION
The East European countries have acquired considerable experience in the use of cyclamen europaeum extract; in some of these countries, such as Georgia or the Ukraine, this product was authorised more than five years ago (approval in Spain dates from 2006). This has enabled an extensive body of positive experience to be acquired, a large part of which was presented at this meeting by the Ukrainian expert Vasil I. Popovich, who drew in particular from his own personal experience.
RATIONALE
“The decision to treat with cyclamen extract was taken in the light of the lack of non-invasive therapies and the increasing incidence of sinonasal disease,” this specialist said in his introduction. In recent years, there has been a significant trend towards continued growth of the incidence of disease associated with chronic rhinosinusitis (CRS) and acute rhinosinusitis (ARS). The number of people affected by these conditions increases each year in almost all countries. Quoting data obtained from his own centre, the speaker said that “up to 60% of outpatients and 50-60% of hospitalised patients treated by the ENT Department have this condition.”
However, in spite of their importance, the treatments used to address these diseases are insufficient. As Dr. Popovich said, “In the case of patients with acute rhinosinusitis, it can be said without doubt that the treatment has major failings.” In this area, the trend is currently to choose non-invasive therapies.
The classic strategies for the non-invasive therapy of acute rhinosinusitis are not effective. Treatments based on the use of antibiotics, secretolytics, corticoids or decongestants offer significant benefits but are also associated with some drawbacks. The speaker reminded that “in our country, it has been seen in recent years that the duration of antibiotic therapy for acute rhinosinusitis has increased from a mean of 3 days to 14-16 days and even so, there has been no improvement in the efficacy of this type of approach in these patients.”
Faced with this situation, Dr. Popovich’s research team set itself the goal of improving the quality and efficacy of the treatment used in patients with acute maxillary rhinosinusitis, developing new treatment approaches based on the use of cyclamen europaeum. “The decision to use this product was based on the analysis of its mechanism of action, as it enabled us to ascertain its complex, multifactorial action on different components involved in the development of acute rhinosinusitis,” he said.
Specifically, this drug increases secretion, naturally cleansing the mucous membrane; it also has a cholinergicomimetic action and promotes stimulation of endogenous interferon synthesis. Using an explanatory video, the Ukrainian expert showed cyclamen extract’s mechanism of action.
EXPERIENCE IN ACUTE RHINOSINUSITIS (ARS)
These benefits have been confirmed in a study performed at the Ivano-Frankivsk State Medical University in Ukraine. A total of 130 patients diagnosed with acute rhinosinusitis were included in this study and received a single-agent therapy consisting of cyclamen europaeum extract. The study’s primary goal was to ascertain the treatment’s efficacy 3-4 days after the first administration, applying generally accepted endoscopic and clinical criteria. Depending on the effects recorded on the third day of treatment, the patients were divided into a number of groups.
Group I included those subjects who had a functional drainage orifice by the third day of treatment, as shown by computerised tomography (CT), with only mild oedema (56% of the total number of patients); in this case, it was decided to continue administration of cyclamen extract for 8-10 days.
In the other patients (44%), it was decided to add another concurrent therapy to cyclamen extract. These patients were classified under two subgroups: group II A included those patients who showed a partial blockage of the drainage orifice (21%) and received cyclamen extract combined with systemic decongestants until day 8-10; group II B included the patients who still showed complete obstruction of the drainage orifice on day 3 of the treatment (23%), and in these patients it was decided to add systemic decongestants and antibiotics until day 8-10.
Summarising the main evidence obtained in this study, Dr. Popovich stated that “cyclamen europaeum showed high efficacy in the single-agent treatment of acute rhinosinusitis in 56% of the patients treated, leading to clearance of the nasal passages. In addition, 21% of the patients experienced partial unblockage of the nose after just three days of treatment with this product. Antibiotic therapy was required in 23% of the patients due to total obstruction of the nasal passages.
In total, after 10 days of treatment, 100% of the patients included in the study experienced a complete recovery.” Thus, added the expert, “we have succeeded in showing that cyclamen extract, whether as single-agent therapy or combined with antibiotics, is able to cure patients with acute rhinosinusitis, irrespective of the degree of severity. In addition, treatment duration was shortened: an average of 8-10 days compared with an average of 14-16 days for conventional therapy.
POSTOPERATIVE CARE
However, new clinical evidence supporting the use of this natural product is also being obtained in the postoperative care of patients with chronic rhinosinusitis treated by surgery.
At present, minimally invasive endoscopic surgery is a favoured option in the treatment of chronic rhinosinusitis. The possible postoperative complications include oedema, mucociliary transport dysfunction, congestion, changes in rheological properties and secondary infection.
When these complications appear, it is usually not possible to drain the sinuses by opening a supplementary orifice, as is often done after classic operations.
If the natural orifice is restored, hyperaemia and oedema are common, favouring the development of secondary polyposis. The basic goal pursued by treatment during the early postoperative period is to guarantee physiological regeneration of the sinonasal mucosa, with prompt recovery of its main functions.
In order to determine whether cyclamen extract offers therapeutic benefits in the postoperative control of chronic rhinosinusitis, Dr. Popovich’s research group has performed a study on 110 patients. The primary goal was to assess the efficacy of combined therapy with cyclamen extract in patients with chronic rhinosinusitis treated with surgery. Most of the patients had a polypous ethmoid- maxillary sinusitis (48%), while the remainder had polypous ethmoid sinusitis (38%) or rhinogenous nasal cysts (13%).
In the first stage of the combined therapy, all of the patients underwent endoscopic surgery based on the diagnosis reported. A sinusotomy was performed on all patients and 55.4% underwent concurrent plastic surgery (68% on the septum and 32% on the conchae). All of the patients started treatment on the second day after surgery: the control group received saline solution (30 patients), while the treatment group was given cyclamen extract and saline solution (n=80).
Certain requirements had to exist before cyclamen europaeum could be used: the surgery had to have removed all of the morphological conditions that could cause obstruction of the nasal sinuses and there had to be a need for effective drainage of the sinuses.
Both clinical (nasal secretion, nasal obstruction and headache) and rhinoscopic criteria (status of the mucociliary transport system and temperature of the sinonasal mucosa) were used to assess the efficacy of each of the treatment options.
Regarding the individual tolerance of cyclamen extract, it was concluded that the product is safe and, as a general rule, well tolerated. Rhinorrhoea appears just 13-15 minutes after administration; the patients noted a slight smarting sensation in the nose.
None of the patients experienced strong stinging, headache or watery eyes. In almost all cases, mucus secretion continued for an average period of 1.5-2 hours. After the rhinorrhoea had stopped, the patients noted a significant improvement in nasal breathing and a sensation of dryness.
It was seen in the clinical assessment of the two treatments tested that, during the first day of use, most of the patients (about 80%) had headache, nasal obstruction and nasal secretion, with the percentages being similar in both study groups. However, a drastic reduction in these symptoms is seen by the third day, which is slightly greater in the group treated with saline solution plus cyclamen, and they have virtually disappeared by day 7 of the postoperative period (no clinical symptoms of nasal obstruction or headache are documented among the patients receiving cyclamen extract and the percentage of patients with nasal secretion is minimum).
The rhinoscopic inspection provides conclusive information on the efficacy of cyclamen extract. No major differences were observed between either of the two treatment groups on day 1 of the postoperative period as regards the presence of hyperaemia, oedema or pathological secretions (although a lower rate of occurrence of these findings is seen among the cyclamen-treated patients).
By day 3, the situation has progressed from one in which almost all of the patients have these symptoms to one in which these symptoms are markedly reduced, with the reduction being much greater in the treatment group (cyclamen + saline solution).
Thus, more than 30% of the subjects included in the control group still had hyperaemia, compared with approximately 8% in the group treated with cyclamen extract and saline solution; likewise, there is a substantial difference in the percentage of patients with oedema: almost 29% in the control group vs. 7% in the treatment group; as regards the pathological secretions, this was reported by more than 20% of the patients receiving saline solution only and by less than 15% of the patients receiving the combined therapy.
By day 7 of the postoperative period, the hyperaemia and oedema have disappeared among the patients in the treatment group (while 2.5% of the patients in the control group still reported them) and the rate of pathological secretions is less than 2% (but greater than 6% in the control group).
No less significant are the findings obtained from the study of mucociliary clearance. By day 3 of the postoperative period, the mucociliary clearance time is noticeably less with cyclamen; statistically significant differences are observed between the control group and the treatment group, and these differences continue to be significant on the 7th day. After one week, mucociliary clearance in the patients treated with cyclamen extract has attained normal values.
In the measurements of the sinonasal mucosa temperature, the mean values obtained in the treatment group are 1 degree less both on day 3 (30.9ºC vs. 29.7ºC) and on day 7 (30.1ºC vs. 28.8ºC). The spiral computerised tomography is an objective method for monitoring postoperative care of patients who have undergone surgery for chronic rhinosinusitis. Using this technology, it has been seen that by the 7th day after surgery and postoperative rehabilitation, the symptoms of rhinosinusitis seen in the tomography had disappeared completely in the patients treated with cyclamen extract.
Summarising his experience in the use of cyclamen extract in postoperative care, Dr. Popovich stated that “this product is an effective resource in the postoperative management of chronic rhinosinusitis patients when combined with routine therapy.” He pointed out that “the disease’s subjective symptoms (such as headache, difficulty in breathing through the nose, and nasal secretion) disappear within 5-6 days after starting treatment, accompanied by restored nasal function.
Furthermore, a positive evolution has been seen in the temperature of the nasal mucosa; by the 7th day of treatment, the local temperature was only 0.3ºC higher than in normal conditions (after a mean temperature decrease of 2.5ºC as a result of the treatment with cyclamen).”
By way of final remarks, this expert underscored that “our data, combined with other studies, have proven the clinical efficacy of cyclamen europaeum in the treatment of acute rhinosinusitis, both as a single-agent therapy and when part of a combined therapy. During the first days of postoperative rehabilitation, after the obstruction of the orifices has been removed surgically, singleagent treatment with this product speeds up physiological regeneration and enables early recovery of sinus functions; consequently, the next step in the treatment process can be started earlier (corticoids,...). As a general rule, cyclamen extract facilitates rapid symptom relief in patients with acute rhinosinusitis.”
In short, “we have new possibilities in the management of rhinosinusitis which enable us to treat this disease very effectively while minimising the administration of systemic medication.”
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