THE INFLUENCE OF TREATMENT WITH SWEETENED ECHINACEA AND PROPOLIS EXTRACT ON THE DEVELOPMENT OF WINTER ILLNESSES IN CHILDREN AND ON THE USE OF ANTIBIOTICS
/A DOUBLE BLIND CLINICAL STUDY/
A. Shalev, MD, E. Ran, MSc, I. Tamir, Msc
Echinacea and Propolis are used for the purpose of strengthening and stimulating the immune system and improving the manner in which winter diseases are coped with - owing to their antibacterial and antiviral action. The aim of the current study was to determine the effect of a sweetened syrup based on Echinacea and Propolis (Protec Kid) on the incidence of winter illnesses in children with initial signs of disease over a period of six weeks. The results of the study show that the regular use of Protec Kid, prophylactically or therapeutically, significantly reduces the chance of winter illnesses in children with initial signs, reduces the need for the use of antibiotics, and reduces the severity of symptoms.
Key words: phytotherapy, echinacea, propolis
In recent years, the use of a combination of Echinacea and Propolis in dealing with the "winter diseases" (primarily common cold and influenza), and strengthening and supporting the immune system, has been increasing. The reason for the widespread use of these ingredients is, among other things, the search for a solution to the problem of providing treatment of various pathogenic viruses and the of the reduced efficacy of antibiotics against resistant strains of bacteria.
The Echinacea purpurea plant is one of the familiar and known therapeutic plants in the world, used for the prevention and treatment of infection and inflammation of viral or bacterial origin, primarily in cases of common cold or influenza, while generally strengthening the immune system (1-6).
Propolis is a natural substance, known for the past 3000 years, produced by bees in a special process, the raw material being juice collected from flowers and tree trunks. Propolis assists in the treatment of infections of bacterial, viral or fungal origin, in providing relief while suffering from the common cold, influenza or throat infections, and in the cicatrization of skin wounds (7-15). The value of Propolis is known owing to the selective nature of its antibacterial action, and its unique mechanism of action (16-17).
The aim of this study is to determine the influence of the use of a sweetened syrup containing Echinacea and Propolis extracts during the course of the winter months on the prevention and treatment of winter illnesses in children.
MATERIALS AND METHODS
"Protec Kid", manufactured by Herbamed Swiss, is a natural product, produced in compliance with G.M.P. Medication standards. Protec Kid is a special syrup for children, derived from a fresh concentrated Echinacea extract, combined with Propolis extract. Protec Kid is unique in being based on organically grown plants with no preservatives or chemical pesticides, and is alcohol-free. The product is a food supplement, not a medication, and is licensed by the Israeli Ministry of Health for marketing.
A particularly concentrated extract is obtained by preparing the product using Swiss know-how, based on the German Pharmacopea standards (G.H.P) (18).
Participants who belonged to the groups which took Protec Kid ("experimental group") or placebo ("control group") used the doses specified in Table 1, depending on the age group and on the state of health of each individual. The children received a prophylactic dose when they were healthy (with no signs of illness at all), and a therapeutic dose when they were sick (in the presence of signs of illness).
Table 1 The recommended dose (prophylactic and therapeutic) of Protec Kid Syrup. Half a teaspoon = 2.5 ml
The study was "double blind", and was conducted over a period of six weeks during January-February 1996. Thirty children aged 1 - 14.5 years, participated. The research was conducted under the supervision of a qualified physician who is a specialist in the field of pediatrics.
At the commencement of the study, "initial signs of illness" were diagnosed among the participants, primarily in the upper respiratory tract, but participation was allowed only if symptoms of an inflammatory state had not yet been diagnosed.
In order to describe and estimate the development of "winter illnesses", i.e. the transition from "initial signs of illness" to the "advanced stage of illness", the following three characterizing parameters were assessed:
1. Days of absence from kindergarten (or school) due to the child "not feeling well" (as decided by the parents and/or the attending physician).
2. Whether the children had to receive antibiotic therapy.
3. Whether the children suffered from a running nose.
At the conclusion of the six weeks of the study, the number of days during which each of the above parameters appeared was determined. The appearance of parameters 1 and/or 2 indicates that the child is in the "advanced stage of illness".
To determine the differences between the two groups, the sample size was determined, the means and standard deviations were calculated, and the values were calculated as percentages.
In order to determine whether the use of Protec Kid influences the development of "winter illnesses" in children with initial signs of illness, the number of children in the "advanced stage of illness" during the course of the study was determined. Of the 30 children who participated in the study until its completion, only two children in the treatment group were found to be at the advanced stage of illness, as compared to seven children in the control group (Figure 1).
Figure 1 The influence of treatment with Protec Kid or placebo on the number of children who progressed to the advanced stage of illness.
The number of children who were positive for any one of the parameters separately (children whom the physician advised to take antibiotics, children who were not sent to kindergarten/school and children who suffered from a running nose) during the course of the six weeks was also determined.
From the results, it can be seen that significant differences exist between the two groups of patients. In the treatment group, only one child required antibiotic therapy, as compared to the control group, in which six of the children required antibiotic therapy. Similar results were obtained as regards the number of days of absence from kindergarten: only one child from the treatment group was absent, as compared to 4 children from the control group who were absent (Figure 2). The total number of days of absence from kindergarten for all study participants was 10 days in the treatment group as compared to 37 days in the control group (Figure 3). No difference was found between the two groups in the number of children with a running nose (Figure 2).
Figure 2 The influence of treatment with Protec Kid or placebo on the number of children in whom parameters characterizing the development of "winter illness" was diagnosed.
Figure 3 The influence of treatment with Protec Kid or placebo on the total number of days of absence from kindergarten.
In order to determine whether the use of Protec Kid reduces the duration of presence of the parameters, the average number of days of the presence of each of the parameters investigated was calculated. It can be seen from the results that among those children who progressed to the advanced stage of illness, the duration of the presence of a running nose was shorter for children in the experimental group (mean of 19 days) than for children in the control group (mean of 28 days) (Figure 4).
Figure 4 The influence of treatment with Protec Kid or placebo on the mean number of days running nose in children who suffered from running nose during the course of the study.
The data are shown as the mean number of days ± standard deviation.
"Winter illnesses" are very common in children during the winter period. These illnesses, caused by viral or bacterial infection, are not necessarily adequately addressed in the framework of conventional medicine. In all events, it is desirable to reserve the antibiotic option only for cases in which it is necessary.
The results of the current study show that the prophylactic and therapeutic use of Protec Kid prevents to a large degree the development of winter illnesses in children with initial signs of illness: Whereas 46% of the children in the control group became ill, only 13% of patients in the group which received Protec Kid became ill.
Regular use of Protec Kid reduces, to a large extent, the need to use antibiotics. It can be seen that children who received placebo required antibiotics six times more frequently than children who received Protec Kid.
Regular use of Protec Kid reduces the number of days of absence from kindergarten (or school) to a marked extent. Children who received placebo were absent from kindergarten four times more than children in the treatment group.
Treatment with Protec Kid reduces the severity of the symptoms of illness and reduces the number of days of running nose in children with initial signs of illness by more than a week, even though it does not prevent the appearance of a running nose.
In summary, it can be said that the use of Protec Kid, prophylactically and therapeutically, significantly reduces the risk of suffering from winter diseases in children with initial signs of illness, reduces the use of antibiotics, reduces the number of days of absence from kindergarten or school, and relieves the severity of symptoms.
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