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Clinical investigation of the efficacy of the use of a new plant-based product in children with acute rhinosinusitis
CHERNISHEVA L.
Doctor of Medicine, Professor,
Department of
Infectious Diseases
and
Clinical Immunology in Childhood, Kiev
SINIACHENKO V.
Doctor of Medicine,
Department of Paediatric
Otorhinolaryngology, Kiev
Therapeutics and Clinical Risk Management.
Special Issue in Spanish. Supplement I 2006.
Therapeutics and clinical risk management 2006 - PDF
INTRODUCTION
The inflammatory diseases of the nasal passages are very common not only in adults but also in children. In fact, it is estimated that approximately 5% of the primary care visits are due to this pathology (Barreiro et al 2002; Torralba 2006).
Effective treatment of children with this disease is a subject of keen interest in otorhinolaryngology. The growth in the number of cases of sinusitis and the difficulties in treating children who suffer this disease are related with the development of bacterial strains resistant to antibiotics and to the increase in allergic reactions to drug treatment (Clement et al 1998; Cohen et al 2000; Garcia 2003). This renders it necessary to ensure adequate use of the medicines currently available and to look for new alternatives that act by increasing efficacy, improving symptoms and decreasing the associated complications, without increasing the incidence of side effects (Jones 1999; Brook at al 2000).
This has aroused a keen interest in developing products prepared using plant-based raw materials with the intention of causing the least possible harm to the body during treatment of this disease while at the same time being very effective.
Recently, a new product has been added to our armamentarium. This preparation is a lyophilised preparation of plant extracts. The preparation’s specific action, after intranasal administration, is to facilitate natural drainage of the pathological nasal and paranasal mucus content, reducing the symptoms caused by the associated congestive process (Zasritskaia et al 2006; Khechinashvili et al 2006).
The purpose of this study was to analyse the effect of using the product in children suffering from acute sinusitis and analyse the product’s effect on the symptoms. In order to evaluate these children in depth, the local immunity indexes of the mucous membranes in the upper airways were studied.
PATIENTS AND METHODS
This study was carried out under the direction of the Department of Paediatric Otorhinolaryngology and the Department of Infectious Diseases and Clinical Immunology in Childhood at the “P.L. Shupik” Academy of Postgraduate Studies in Medicine in Kiev, under the Ukrainian Ministry of Health, between 20 November 2003 and 20 March 2004.
The study included 30 children with acute rhinosinusitis, aged between 7 and 14, divided into two groups of 15 patients each.
The patients in the first group (main group) were given the product (one spray in the nasal cavity once a day, in the morning, for 7–10 days); antibiotic therapy with semisynthetic penicillins and clavulanic acid at doses adjusted to the age, 3 times a day, for 7–10 days; short-lasting desensitising therapy with quifenadine and mebhydroline, with a maximum duration of 5 days; irrigation of the nasal passages according to Proetz’s method; and physiotherapy.
The patients in the second group (control group) were given antibiotic therapy with semisynthetic penicillins and clavulanic acid; decongestants belonging to the oxymetazoline and xylometazoline group; desensitising therapy with quifenadine and mebhydroline; irrigation of the nasal passages according to Proetz’s method; and physiotherapy. Each of the patients in the first group received a spray of the new product in the nasal cavity once a day, in the morning, after which an increase in the rhinorrhoea was observed, with purulent mucous secretions lasting for up to 2 hours.
The products' efficacy was assessed from the evolution of the clinical symptoms of the sinusitis. Considering the type of process, it was decided to study the local immunity of the children with rhinosinusitis.
In order to study the local immunity indexes, saliva samples were obtained before and after treatment. The saliva samples were stored at a temperature of -20ºC. The immunoglobulin levels (SIgA, IgA and IgG) in the saliva were determined using Mancini’s radial immunodiffusion method, with monospecific sera supplied by the “M.F. Gamalea” Institute (Moscow). The lysozyme was measured using the method described by N.S. Motavkina et al., using cultures of Micrococcus lysodeicticus to study the lysis. The immunoglobulin and lysozyme levels were determined simultaneously in both sets of saliva samples, obtained before and after treatment. For the statistical analysis of the results obtained, Wilcoxon’s test was used.
RESULTS
The distribution of the groups based on the entry diagnosis is summarised in Table 1. The children in both groups were comparable as regards age and stage of the disease.
TABLE 1. DISTRIBUTION OF CHILDREN WITH SINUSITIS
During treatment, none of the patients in the first group underwent puncture of the maxillary sinuses. However, it was necessary to puncture the maxillary sinuses in 6 of the patients in the second group (control group).
In both groups, the patients complained of headaches, and increases in the body temperature up to 38.5ºС, purulent mucous secretions from the nose and difficulties in breathing through the nose were observed.
Although the mucous membranes of children are susceptible to inflammation, after spraying the preparation into the nasal cavity the congestion of the nasal passages improved and, therefore, it was not necessary to use decongestants. The increased rhinorrhoea as a result of drainage of the nasal mucosa after administration of the preparation did not cause any discomfort to the children, who tolerated it well. Treatment of children with the product did not give rise to any side effects, such as an exacerbation of the headaches, temperature changes or a deterioration in their general condition. After the rhinorrhoea had ended, all of the patients noted a considerable easing in the intensity of the headaches.
It should be pointed out that the children aged 7 or 8 years (compared with the older children) also tolerated the preparation well. No increased severity was observed in the irritant effect or a tendency towards oedema. The clinical course of the disease during administration of the product was similar in all age groups.
The results as regards symptom outcome are shown in Table 2.
TABLE 2. EVOLUTION OF THE CLINICAL SYMPTOMS OF SINUSITIS
On the second day of use of the product, the general condition of the patients in the group that received the plant extract improved and the clinical symptoms decreased. On the second or third day, almost all of the patients (14 patients, that is, 93%) noted an improvement in the congestion and nasal breathing. Only one child showed a slight difficulty in breathing. At the end of the treatment, nasal breathing was restored in all of the children (100%). On the second or third day, the purulent secretions had been reduced considerably in 12 patients (80%), while on the fourth or fifth day, all of the patients (100%) reported the disappearance or a considerable reduction in the purulent secretions from the nasal cavity.
By the fourth or fifth day, the rhinoscopic findings were normal in 14 children (93%). By the seventh or eighth day, all of the children were considered clinically cured.
In the patients included in the second group, who received the traditional treatment with antibiotics, desensitising drugs and decongestants, and, in some cases, sinus punctures (6 patients), the evolution of the clinical symptoms of sinusitis was as follows: the patients' general condition improved and the clinical symptoms of rhinosinusitis had decreased by the third or fourth day of treatment.
On the second or third day, only 3 children (20%) indicated an improvement in their nasal breathing. On the fifth day, this percentage rose to 87% (13 patients). On the second or third day, the purulent secretions had decreased considerably in 4 children (27%), while on the fourth or fifth day, 11 patients (73%) reported the absence or a considerable reduction in these secretions. On the fifth day of treatment, the rhinoscopic findings were normal in 10 children (77%), and, by the eighth or tenth day, the children were considered clinically cured.
In order to study the course of the local immunity of the nasopharyngeal mucous membranes, the immunity indexes were determined in the saliva of the children with acute rhinosinusitis in the main group (treated with the product) and in the control group (not treated with the product), before and after treatment.
The results are shown in Table 3.
TABLE 3. LOCAL IMMUNITY INDEXES IN THE SALIVA
OF CHILDREN WITH ACUTE SINUSITIS
# -P<0.05 - DIFFERENCES BETWEEN GROUPS IN THE INDEXES OBSERVED BEFORE TREATMENT
* -P<0.005 - DIFFERENCES BEFORE AND AFTER TREATMENT
** -P<0.01 - DIFFERENCES BEFORE AND AFTER TREATMENT
The data in Table 3 show differences between the baseline local immunity parameters of the group receiving plant extracts and the control group. Before treatment, all of the local immunity indexes studied were higher in the group treated with plant extracts, which shows that the inflammatory process in these children was more intense. The differences between the SIgA and IgA levels in the saliva were statistically significant. As these preliminary studies of local immunity in bacterial rhinosinusitis have shown, some children have relatively high local immunity indexes during the disease, while others have low indexes.
After treatment, the mean local immunity indexes tended to become balanced. In the control group, an increase in the local immunity indexes studied was observed after completion of the treatment. After administration of the treatments, the main local immunity indexes - SIgA, IgG and IgA – had very similar values in both the control group and the main group.
With the goal of investigating in greater depth the local immunity indexes, the evolution of the lowest baseline local immunity indexes in the saliva was analysed. The children with SIgA values <0.3 g/l before treatment showed increases in all cases (from 0.22+0.06 g/l to 0.34+0.02 g/l). The same evolution was observed in the cases with low baseline indexes of IgA in the saliva (0.03 g/l). All of the children in the main group who had low levels of IgA showed an increase in these values after treatment, from 0.026+0.002 g/l to 0.45+0.01 g/l. In the case of the children with lysozyme indexes <0.008 g/l (before treatment), these values increased 10-fold after cure (from 0.0027+0.0003 g/l to 0.028+0.022 g/l).
Another important aspect of this study is the analysis of local immunity in saliva samples in both groups and its variations. It had already been pointed out that there is an imbalance in inflammatory cytokine levels in acute rhinosinusitis (Selezn'ov et al 2001).
Our study shows that the rapid remission of the nasal and paranasal congestion is accompanied by a correction of local immune reactivity in the mucosae. None of the products given hampered synthesis of secretions by the mucous membrane epithelium.
This is a further fact that supports the benefits of this plant extract in acute rhinological conditions.
DISCUSSION
The results of this study show the considerable clinical benefit obtained from the use of this new product made using plant extracts, including cyclamen. This mucous secretion drainage effect not only renders it unnecessary to perform maxillary sinus punctures in some cases but also does this without increasing the incidence of side effects. This is possible for two reasons.
The first is that it is a natural compound. Consequently, the likelihood of developing allergic conditions, which would worsen the disease, is less.
The second is a consequence of its mechanism of action. After administration in the nasal cavity, this plant extract activates the nasal cavity’s physiological clearing mechanisms, facilitating natural secretion and drainage of the nasal passages and paranasal sinuses, thereby removing the accumulated mucopurulent content. Furthermore, this compound’s action is purely local since it is not absorbed by tissues and does not enter the bloodstream. This prevents a systemic effect and thus limits the likelihood of developing side effects.
This study has shown this plant extract-based product’s efficacy in children. Other studies have shown an efficacy greater than 90% in eradicating the main symptoms of rhinosinusitis, both when given alone or combined and both in adults and in children (Zasritskaia et al 2006; Khechinashvili et al 2006).
CONCLUSIONS
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REFERENCES
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Use of a plant-based product in children with acute rhinosinusitis - Abstract
Therapeutics and clinical risk management 2006 - Index
Use in the early postoperative care of patients with productive rhinosinusitis - Next abstract
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