Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial. Is an antihistamine-decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children? Is acetaminophen as effective as an antihistamine-decongestant-acetaminophen combination in relieving symptoms of acute nasopharyngitis in children? A randomised, controlled trial. Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial. Management for the children with otitis media with effusion in the tertiary hospital. Prevention and therapy of serous otitis media by oral decongestant: a double-blind study in pediatric practice. The effectiveness of the nonsedating antihistamine loratadine plus pseudoephedrine in the symptomatic management of the common cold. A comparative trial of slow-release aminophylline, salbutamol and a half dose combination in the prevention of childhood asthma. Comparison of fluticasone propionate and sodium cromoglycate for the treatment of childhood asthma (an open parallel group study).
We tested the hypothesis that antihistamine-decongestant combinations cause no clinically significant relief of the symptoms of upper respiratory tract infections in young children by randomly assigning 96 children to one of three treatment groups: antihistamine-decongestant, placebo, and no treatment. There were no differences among the three study groups in the proportion of children considered "better" overall by the parent 48 hours after the initial assessment (drug, 67%; placebo, 71%; no treatment, 57%; p = 0.53). There were no differences among groups in individual or composite symptom score changes. Two thirds of parents whose children were eligible for the drug trial believed that their child needed medicine for cold symptoms. In the proportion of parents believing that their child needed medicine, there was no difference between those who consented to participate and those who refused. Parents who wanted medicine at the initial visit reported more improvement at follow-up, regardless of whether the child received drug, placebo, or no treatment. We conclude that there is no clinically significant improvement in symptoms of upper respiratory tract infection, including no significant placebo effect, in young children for whom an antihistamine-decongestant is prescribed. To determine whether an antihistamine-decongestant combination (ADC) is superior to placebo in temporarily relieving symptoms of upper respiratory tract infection (URI) in preschool children.
                Randomized, double-blind, placebo-controlled trial.
                Four pediatric offices in the Seattle, Wash, area.
                Children 6 months through 5 years of age with a URI of less than 7 days' duration.
                Children were randomly assigned to receive an ADC (brompheniramine maleate-phenylpropanolamine hydrochloride) or placebo as needed for URI symptoms. Two hours after each dose of study medication, changes in the child's runny nose, nasal congestion, cough, and sleep status were assessed by means of a standardized questionnaire.
                A total of 175 responses were recorded for 59 patients. There were no statistically significant differences in symptom improvement between the ADC and the placebo group (runny nose, p = 0.48; nasal congestion, p = 0.94; cough, p = 0.66). However, the proportion of children asleep 2 hours after receiving the ADC was significantly higher than the proportion receiving placebo (46.6% vs 26.5%; p = 0.01). Results were unchanged after control for the correlated nature of repeated responses, age, symptom duration, use of acetaminophen, time that the medication was given, and parental desire for medication.
                The ADC was equivalent to placebo in providing temporary relief of URI symptoms in preschool children. However, the ADC did have significantly greater sedative effects than did placebo. To determine the efficiency of drugs, which include antihistaminic-decongestant-acetaminophen agents versus only acetaminophen in symptomatic treatment of acute nasopharyngitis in children.
                This clinical, randomized, controlled, single blind drug efficacy comparison research was conducted in 148 patients with acute nasopharyngitis between ages 2 and 12 years. After randomization, Group-1 consisted of cases (n: 86), which used OTC drugs [acetaminophen+diphenhydramine+pseudoephedrin] and Group-2 consisted of cases (n: 62), which used only acetaminophen. After receiving nasal swab for showing the viral etiology, symptoms were scored clinically on admission and then on 10 days follow-up period, and re-evaluated on the third and fifth days of the drug therapy with the same scoring scale. Any complications were noted during the 1-month follow-up period after taking the drugs.
                The virus isolation rate in Group-1 was 27.9% and in Group-2 was 22.6%. At the first day of study, before medication, clinic scores of the groups did not show a significant difference (Group-1 1.7 versus Group-2 2.0). Clinic scores in both groups on the third (Group-1 4.0 versus Group-2 4.1) and fifth days of therapy (Group-1 1.7 versus Group-2 2.0) were not different either. Also, the complication rate was not different during the 1-month follow-up period (Group-1 2.3% versus Group-2 8.0%, p: 0.12). The family response for the drug satisfaction in both groups was similar and positive.
                For relieving symptoms of acute nasopharyngitis in children, acetaminophen without any combination is as effective as OTC drugs containing acetaminophen, decongestant, and antihistaminics. In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children. Recently, new evidence-based recommendations have been introduced for diagnosing and managing otitis media with effusion (OME) in children. However, there are some difficulties to follow the general guidelines in the tertiary hospitals. The purpose is to evaluate the efficiency of antibiotics or antihistamines for treatment of children with OME in the tertiary hospital with a randomized prospective clinical study.
                Eighty-four children with OME who had been diagnosed in the tertiary hospital were randomized to receive 5 different medications for 2 weeks. We prescribed antibiotics (amoxicillin-clavulanate syrup) in Group I (n=16), antibiotics/steroids (prednisolone) in Group II (n=18), antibiotics/antihistamines (ebastine) in Group III (n=15), antibiotics/steroids/antihistamines in Group IV (n=17), and mucolytics (ivy leaf extract) in Group V (n=17) for control. We followed-up children every 2 weeks and evaluated the state of OME at 3 months.
                Thirty six (42.9%) of 84 children were resolved within average 6.9 weeks after the treatments. Thirty-six (42.9%) were treated with ventilation tube insertion and 12 patients (14.3%) were observed. There was no difference in the resolution rates of OME among the five different protocols (P>0.05). There was no difference in the resolution rates among groups who used steroids, antihistamines, steroids and antihistamines, or other medications to manage 42 children with allergies (P>0.05).
                In the tertiary hospital, the cure rate of children with OME was not as high as well-known, and antibiotics or anti-allergic medications were not more effective than control. We may, therefore, need any other guidelines which are different from the previous evidence-based recommendations, including early operation in the tertiary hospitals. We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no siginificant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM. A multicentered trial compared the effects of the non-sedating antihistamine, loratadine, 5 mg plus pseudoephedrine 120 mg with a placebo on the signs and symptoms of the common cold. One hundred forty-two (142) subjects were treated with the loratadine/pseudoephedrine combination and 141 subjects were treated with placebo twice daily for five days. Evaluations by both subjects and physicians suggest that this antihistamine/decongestant combination is superior to placebo in relieving symptoms of the common cold. Specific differences were found in symptoms including nasal congestion, sneezing, postnasal drainage, and nasal discharge. Differences between groups for the following side effects were found: dry mouth (9% for the combination vs 2% for placebo), insomnia (6% vs 3%), and nervousness (4% vs 2%). There were no differences between groups for the frequency of drowsiness. The effect of slow-release aminophylline, salbutamol and a half dose combination of both was compared in children with chronic asthma. Drugs were given over three consecutive 5-week periods during which patients recorded daily peak flow measurements and symptom scores. At the end of each treatment period pulmonary function tests were done. Sixteen of twenty-nine children completed the trial satisfactorily and their results have been used for analysis. The data show slow-release aminophylline and salbutamol to be equally effective and the half dose combination as effective as either drug alone. The results suggest there may be a therapeutic advantage in combining a beta 2 agonist with theophylline when high doses of either drug alone are not fully effective or when toxic effects occur. Inhaled corticosteroids are highly effective in the treatment of asthma at all ages and their use in younger children is increasing. As concerns exist about the long-term systemic side-effects of high dose inhaled corticosteroids, current guidelines continue to recommend sodium cromoglycate (SCG) as first line regular medication for children with frequent symptoms. Few published studies have compared the safety and efficacy of inhaled corticosteroids with SCG in children. This study compares SCG with the new inhaled corticosteroid, fluticasone propionate (FP), which has theoretical advantages over other currently available corticosteroids due to its negligible oral bioavailability. This was a randomized, open, multi-centre, parallel group comparison of 50 micrograms FP twice daily and 20 mg SCG four times daily over 8 weeks, preceded by a 2-week baseline period. Sixty-two general practices and two hospital centres enrolled 225 asthmatic children aged 4-12 years (110 received FP; 115 received SCG). Outcome measures improved in both groups, with a significant difference in favour of FP for the key variables of mean morning and evening % predicted PEFR and % of symptom-free days and nights. No significant difference was observed for FEV1, or relief medication use. Two children taking FP and 10 children taking SCG withdrew because of adverse events. This study showed that low dose FP was effective and superior to SCG in young children with mild-moderate asthma. Safety studies of longer duration are needed before changing the current recommendations for inhaled corticosteroid therapy.
Current evidence suggests that antihistamine-analgesic-decongestant combinations have some general benefit in adults and older children. These benefits must be weighed against the risk of adverse effects. There is no evidence of effectiveness in young children.