الفهرس 
Epidemiology of the common coldOnly 14 pages are availabe for public view
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Abstract
Summary
Common cold is one of the most prevalent acute illnesses worldwide. It is implicated in about 40% of time lost from employment and 30% of time lost from education , and is one of the leading reasons for physician visits mainly when becomes complicated.
There is no proven treatment for the common cold. Symptomatic relief and supportive therapies is the mainstay of treatment. However, they have no true therapeutic benefit toward eliminating the viral challenge.
Most of Cold and cough medications are over-the-counter which are among the top 20 substances leading to death in children younger than five years when being misused. In 2008, the U.S. Food and Drug Administration recommended that over-the-counter cough and cold medications should be avoided in children younger than two years. Also, because viruses cause most colds, antibiotics are also ineffective without evidence of bacterial superadded infections.
Zinc is a metal which is called an essential trace element because very small amounts of zinc are necessary for human health. Zinc affects the human body through a large number of channels. It is involved in the regulation of nucleoproteins and the activity of various inflammatory cells and plays a role in growth, tissue repair and wound healing. It is also involved in the immune response and the response to infection. Zinc deficiency is associated with impaired phagocytic function, lymphocyte depletion and decreased immunoglobulin production. The World Health Organization advocates zinc supplementation for severe malnutrition, diarrhea and malaria infections. Zinc supplements help to prevent diseases and reduce mortality, especially among children with low birth weight or stunted growth.
Many earlier studies were conducted to examine the therapeutic and prophylactic use of the zinc in common cold. Most of these studies were among adults and in western countries. Studies regarding therapeutic use of zinc in common cold show a trend toward decreased dura-tion of cold symptoms when it is taken within the first 24 hours of symptom onset Zinc when used prophylactically for at least five months reduces the incidence of viral colds, absences from school, and anti¬biotic use in children. As regard the reported adverse effects, bad taste and nausea, are more common with zinc lozenges than with syrup or tablets. Zinc nasal products, including intranasal zinc gluconate, may be associated with long-standing or permanent loss of sense of smell and are not recommended for children. Recently in a 2011 Cochrane review of 15 randomized controlled studies spanning all age groups, zinc was found to be beneficial and to have few side effects when compared with placebo. However, other clinical trials showed no effect of zinc on cold symptoms. It has been argued that the studies which did not find zinc to be effective is mainly due to inadequate doses or incorrect formulations of zinc were used or the time of starting the treatment.
As we can see, till now the results of previous trials are conflicting. Also, as there is no proven method of prevention or treatment for the common cold, any medication that is only partially effective in the treatment and prevention of common cold could markedly reduce morbidity and economic losses due to this illness especially if it is safe and low in cost.
So this study was done to add a support or not to the literature and to test the efficacy of zinc sulfate in reducing the duration and or severity of symptoms and prevent occurrence of complications among a group of Egyptian children 2-6 years old who attending a family health care center at El-Abour city aiming to help in improving the health of children by aborting the common cold episodes, avoiding the frequent use of antibiotics and ineffective remedies and to avoid the possible serious complications following common cold episodes.
This study was a triple-blind, randomized, controlled clinical trial. Seventy-two consecutive children presenting to the outpatient clinics in the center, suffering from common cold symptoms and meeting the eligibility criteria in the period between 1 January 2015 and 1 May 2015 were recruited to the study. After taking a written consent from the children parents/caregivers, an interview Arabic questionnaire was used to collect data about the children inclusion and exclusion criteria and the demographic characteristics beside detailed history about the current episode symptoms (10 common cold symptoms and their severity level). Total baseline symptoms severity score was calculated and reported by the researcher in the clinic. In order to facilitate reporting of symptoms and categorization of their severity to the parents/ caregivers during the follow up period, an Arabic log was given to the parents with pictures describing each symptom severity level. Parents/caregivers were asked to grade each symptom (if present) by the end of the day as 0 for none, 1 for mild, 2 for moderate, and 3 for severe. Total symptom scores were calculated by the researcher by summing the scores of the 10 symptoms for each day till one day after resolution of the symptoms for maximum 14 days.
Both zinc sulphate and placebo liquids were put in similar bottles (shape and color) without labels and a random code was given for each bottle by the company which was not disclosed to the researcher nor the statistician till the end of the study. The bottles were given to the center pharmacist; each bottle contained 80 ml for 5 days supplementation.
Enrollment of participants according to predetermined exclusion and inclusion criteria was carried out by the clinic pediatricians. Each participant’s caregiver selected randomly a sealed opaque envelope containing the code of the bottle which he/she will receive from the pharmacy in between 72 envelopes prepared by the company. All parents were asked to revisit the center within 1 day of noting that their children cold symptoms had resolved or worsen. At this visit, they returned the unused syrup so that adherence to the protocol could be checked and the treating physician could confirm that cold symptoms had resolved or confirmed the presence of side effects. In case of deterioration, the child was withdrawn from the study and gave him/her the appropriate treatment. The main Outcome measures of the study were the duration of the cold which was defined as the time from the start of study-medication administration to the first of the 2 consecutive symptom scores ≤1. Also Severity of symptoms was the second main outcome measure. Adverse events were also reported.
The analysis was carried out using SPSS software package version 20. The researcher followed the intention to treat analysis protocol. Survival analysis was used to compare the median cold duration in both groups. A clinically significant decrease in duration of illness was defined as a statistically significant reduction in median duration that was at least 1 day shorter in the treatment group than in the placebo group. Also, a clinically significant decrease in severity of the symptoms was defined as a reduction in symptoms severity score of at least 10% that was also statistically significant. All the suitable required statistical tests were performed and all the research ethical considerations were maintained all through the study period.
Baseline characteristics of the two groups; the demographic and personal characteristics, were almost similar in the two groups. The mean age of the zinc group was 42.72 (±13.64) months compared to 45.92 (±13.52) months in the placebo group and the sex ratio (boys/girls) was 1 and 0.6 respectively. Also the difference in the baseline mean severity score (day 0) between the two groups was statistically insignificant
No one child at both groups completed the 14 days of the study with remaining symptoms.
The median duration of illness was significantly reduced by zinc. The median duration of illness in zinc sulphate recipients was 5 days, in comparison to 8 days in the placebo recipients (37.5 % reduction) and the difference was clinically significant (> 1 day difference) and the difference in survival distributions was statistically highly significant using log rank test (P0.000)
As regard the mean symptom severity score, it was significantly higher in placebo group than the zinc group starting from day 2 to day 7 then the significant difference disappeared by day 8. The reduction in the mean score from the baseline to the subsequent study days in the zinc group was faster than in the placebo one reaching the clinical reduction 2 days earlier.
Sixteen patients; 12 (33.3%) of the placebo group and 4 (11.1%) of the zinc group reported that their conditions had worsened and needed to be treated with antibiotics for lower respiratory tract bacterial infection and otitis media and the difference was statistically significant (X2 =5.14, p = 0.023).
As regard the adverse effects; including refusal to take the medicine (bad taste/irritation in the
mouth), vomiting, diarrhea , abdominal pain and decrease in appetite, there was no significant
difference between the two groups. The most common reported side effect among both groups
was refusal to take the syrup, which reported by 10 children in the zinc group and 8 in
placebo group and its incidence in the zinc group (27.8 %) was higher than its incidence in the
placebo group ( 22.2 %) but this difference was statistically non significant since x2 = 0.29, P =
0.59, OR (95% CI) = 1.35 (0.46-3.93).
Among the most important limitations of this study were the subjectivity of the severity score which was used and the exclusion of children at risk for common cold.
The study concluded that Sulphozinc syrup was effective in reducing the cold duration, severity of symptoms and also the complications if used within 24h of the episode among the Egyptian children 2-6 years old.