Abstract
M.Tech. (Homoeopathy)
Upper Respiratory tract viral infections (URTIs), such as influenza and the common cold, are a group of common infections in the human population. They have a seemingly mild nature, but studies have found them to be a major cause of morbidity and mortality worldwide (Wat, 2004). In the western world, the majority of pre-school childrenconsult a doctor for a respiratory infection at least once a year. Conventional medical treatment options are said to be limited, and antibiotics are often unnecessarily prescribed.The frequency of antibiotic prescriptions has caused a resistance of pathogenic bacteria against these antibiotics, and this in turn, has become a major threat to treatment (Schönbeck et al., 2005). A traditional South African herb, Pelargonium sidoides (P. sidoides), has been shown to have antibacterial, antiviral, and immunomodulatory properties in many investigations (Brendler, 2009). No studies have been done to date assessing the efficacy of P. sidoides as a prophylactic for influenza and the common cold in children.
This study aimed at establishing the efficacy of Linctagon® Syrup in the prevention of colds and influenza in pre-school children.
The study was a double- blind, placebo–controlled study whereby thirty healthy children aged four to six years old were placed into two groups using matched pairs according to gender. Fifteen participants were allocated to the experimental group whereby the Linctagon® Syrup was taken for the duration of the study. The other fifteen participants were allocated in the placebo group for the duration of the study and given a placebo syrup.
Parents / guardians were requested to read the Participant Information Leaflet (Appendix B), and sign the Participant Details and Consent Form (Appendix C,) and the participants were requested to sign the Participation of Minor Assent Form (Appendix D). On day 0, the parents / guardians signed the forms and the initial visit took place. The researcher conducted an ear, nose, throat and respiratory examination on each participant and vital signs were measured. The medication was randomised by an independent person at Nativa Laboratories. Each participant received two 150ml bottles of either the Linctagon®
syrup or placebo syrup, and parents / guardians were advised on how to administer the medication (Appendix E), by the researcher. The participants were required to take 2.5ml twice daily for a period of sixty days. A Weekly Progress Questionnaire (Appendix F) was handed to the parents / guardians of each child, and they were requested to fill them in over an eight week period. This questionnaire assessed the wellness of the child for the duration of the study and involved a 4-point rating system to assess the severity of symptoms for both influenza and the common cold. Weekly telephone calls were made to the participants’ parents / guardians to follow up on progress. A final visitation occurred on day 60, and included the collection of the questionnaires. The parents / guardians were requested to fill in a score card at the end of the study, rating the effectiveness of Linctagon® Syrup in the prevention of colds and influenza in their child (Appendix G).
The data was statistically analysed by Statkon at the University of Johannesburg by means of non-parametric tests, namely: descriptive data, Cochran’s test, Chi-square test, cross tabulation, Mann-Whitney U test and the Friedman test.
The research study determined that Linctagon® Syrup did not have a statistically significant effect in the prevention of influenza and the common cold in children, in support of the null hypothesis. Linctagon® Syrup also had no effect on reducing the incidence, frequency or duration of symptoms in those children who became ill, however this may be due to the relativity low dosage prescribed. Further large scale studies are recommended to validate these results.The score card (subjective rating on the efficacy of the syrup) showed a statistically significant result between the two groups, in favour of the treatment group.