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ABSTRACT: The common cold is a major and recurrent cause of morbidity, on average affecting children and adults two or more times each year. Nasal congestion is its commonest symptom and many therapies are marketed for its relief. There is no meta-analysis of controlled clinical trials on the effects of nasal decongestants in the common cold.
To assess the efficacy of nasal decongestants at reducing the symptom of nasal congestion in adults and children with the common cold and to identify possible adverse effects associated with their use.
In this updated review in 2006, the following databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2006, issue 3); MEDLINE (January 1996 to September 2006); OLDMEDLINE (1951 to 1965); EMBASE (1980 to Week 36, 2006). We contacted known principal investigators and pharmaceutical companies.
Randomised, placebo controlled trials of single-active oral and topical nasal decongestants in adults and children suffering from common cold.
Two review authors (DT, GJL) independently extracted data. All outcomes variables were continuous. Subjective outcomes were normalised to a common scale and a weighted mean difference (WMD) was calculated. A standardised mean difference (SMD) was calculated for the objective outcomes.
Seven studies in adults, but none in children, fitted all inclusion criteria. There was a small but statistically significant 6% decrease in subjective symptoms after a single dose of decongestant compared with placebo. This was supported by a significant decrease in nasal airways resistance. With repeated doses, nasal decongestants produce a very small statistical benefit of 4% over three to five days, again supported by a decrease in nasal airways resistance. Two studies provided safety data for this meta-analysis, showing a relatively small number of adverse events and only a small increased risk of insomnia with pseudoephedrine compared to placebo.
A single oral dose of nasal decongestant in the common cold is modestly effective for the short term relief of congestion in adults, and these drugs also provide benefit in some individuals after regular use over three to five days. Adverse events in adults are rare and mild. There is insufficient data on the use of these medications in children and therefore they are not recommended for use in children younger than 12 years of age with the common cold.
Cochrane database of systematic reviews (Online) 02/2009; · 5.72 Impact Factor
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ABSTRACT: The 2005 southern hemisphere formulation of the inactivated split-virion influenza vaccine Vaxigrip unintentionally contained a lower concentration of haemagglutinin (HA) than European Pharmacopoeia (EP) and WHO specifications for one of the three strains.
To evaluate the immunogenicity of the 2005 southern hemisphere formulation of an influenza vaccine containing 9 microg/dose of HA for A/Wellington/1/2004(H3N2) strain, and 15 microg/dose for each of the A/New Caledonia/20/99(H1N1) strain and B/Shanghai/361/2002-like strains.
In an open, non-controlled multicentre clinical trial, 75 healthy adults (18-59 years) and 65 healthy older adults (> or =60 years) were vaccinated once. Serum samples were obtained on D0 and 21 for haemagglutination inhibition (HAI) antibody titration.
A high proportion of adults (64%) and elderly (68%) were already seroprotected (HAI titre of > or =40) against A/Wellington/1/2004(H3N2) before vaccination, probably due to high circulation of an antigenically similar H3N2 strain and a high 2004 vaccination rate. By D21, seroprotection rates against H3N2 attained 93.8% and 96.0% in adults and elderly respectively. The other two immunogenicity criteria for annual licensure of influenza vaccines in Europe were also met in both age groups for the H3N2 strain, and also for the H1N1 and B strains.
These results enabled the 2005 southern hemisphere vaccine to be used in expectation that it would provide satisfactory protection against influenza, despite the reduced H3N2 antigen content.
Influenza and Other Respiratory Viruses 06/2008; 2(3):93-8. · 4.16 Impact Factor
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ABSTRACT: 1. The aim of the present study was to assess the efficacy of pseudoephedrine in coryza. 2. In a double-blind, randomized, placebo-controlled design, 48 adults with acute coryza received a single oral dose of 60 mg pseudoephedrine (Sudafed; Pfizer Consumer HealthCare Group, Caringbah, NSW, Australia) or matching placebo. Before and after dosing, nasal airway resistance (NAR), nasal volume, the minimum intranasal cross-sectional area (MCA) and the symptom of nasal congestion were measured. 3. Pseudoephedrine produced a significant decrease in NAR (P = 0.005; 95% confidence interval (CI) 0.073, 0.383). Nasal volume increased, but this did not reach significance (P = 0.07; 95% CI -0.842, 0.034). There was no change in MCA and symptoms. 4. In conclusion, pseudoephedrine has a moderate effect in decreasing objective measures of nasal congestion in coryza.
Clinical and Experimental Pharmacology and Physiology 08/2004; 31(7):429-32. · 1.85 Impact Factor
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ABSTRACT: To validate the measurement of nasal volume by acoustic rhinometry, acoustic rhinometry (AR) measures before and after decongestion were compared to a reference volume measurement in 10 healthy volunteers over 3 visits each. The reference method was hydraulic infusion with manometry, involving slow constant-rate infusion of isotonic saline into each nasal cavity while the subject was appropriately positioned. Consecutive 10 mm nasal segments were measured, and hydraulic volume derived. AR volume and hydraulic volume measures were compared. Within subject reproducibility of hydraulic volume and AR volume measures over 3 study days was better than 16% and 11%, respectively. Pre-decongestant, highly significant correlations between AR volume and hydraulic volume in the 20-40 mm segment were found. The mean ratios of AR volume/hydraulic volume ranged from 1.01-1.14. Post decongestant, significant correlations were found in the 30-50 mm segments. The mean AR volume/hydraulic volume ratios were significantly lower (0.88-1.03). Hence, the magnitude of the AR volume change after decongestant was less than the hydraulic volume change (ratio range 0.8 to 1.01), but there were still significant correlations between hydraulic volume and AR volume in the 20-50 mm segments of the cavity. Since hydraulic volume is expected to be similar to anatomical nasal volume, we conclude that changes in AR volume before and after vasoconstriction are similar to anatomical changes in nasal vasculature. AR volume measurements provide a sensitive, reliable and accurate assessment of vasoactive drugs in the nasal cavity.
Rhinology 10/2002; 40(3):135-40. · 1.32 Impact Factor
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ABSTRACT: Aims The effects of a single dose of oxymetazoline nasal spray on nasal patency have been compared with placebo using three separate measuring systems in normal subjects. Methods The study was a placebo-controlled, randomised double-blind crossover trial. Subjects without ear, nose or throat disease and with resting nasal airways resistance >0.15 Pa s cm−3 were selected so that a fall in airways resistance could be detected. Nasal airways resistance (NAR) was measured by NR6–2 rhinomanometer. Acoustic rhinometry (SR-2000 rhinometer) provided the sum of the minimum cross-sectional areas (tMCA) and volume (tVOL) of the left and right nasal cavities. Symptoms of congestion were assessed on a visual analogue scale (CON, range 0–100). Measurements were made for 60 min before and for 120 min after bilateral administration of oxymetazoline nasal spray (0.9 mg) or placebo (0.9% saline). Crossover occurred 7–21 days later. Results for all measures were analysed as change from average baseline value by trapezoidal AUC, and statistical significance was tested by 2-way anova. Results NAR, tMCA, tVOL and CON did not change after placebo, but NAR and CON fell and tMCA and tVOL increased significantly at all timepoints after oxymetazoline. NAR_AUC, tVOL_AUC, tMCA_AUC were significantly different between placebo and oxymetazoline (P<0.001) as was CON_AUC (P=0.012). The day-to-day intraindividual repeatability of baseline NAR tMCA and tVOL was <10%. Conclusions Normal subjects can be used to detect the effects of nasally vasoactive drugs with a variety of complementary systems, with the advantages of easy subject recruitment and low variability.
British Journal of Clinical Pharmacology 06/1999; 48(1):53 - 56. · 2.96 Impact Factor
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ABSTRACT: We examined whether the use of two different external nasal dilator devices influenced the size of the nasal valve area and symptoms of nasal congestion.
This was a randomized blind-allocation, open three-way crossover study of Breathe Right, Side Strip Nasal Dilators, and placebo. We studied 12 healthy subjects (10 female, 2 male; age range 26-56 years). Measures of total volume and total minimum cross-sectional area were collected. Subjective symptoms were collected using a visual analog scale and an ordinal scale.
With both products, there was significant increase in the size of the minimum cross-sectional area compared to placebo, p = 0.004. This is supported by the decrease in the subjective reports of congestion; on the visual analog scale, compared to placebo p = 0.012 and the ordinal scale, compared to placebo, p = 0.004.
Both devices significantly increase the size of the nasal valve area and reduce congestion in normal subjects.
American Journal of Rhinology 19(2):215-9. · 1.36 Impact Factor
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ABSTRACT: Single-dose studies indicate that pseudoephedrine (PSE) provides moderate relief for congestion in coryza, but there is a lack of repeated-dose studies.
Two hundred sixteen subjects participated in this double-blind, randomized placebo-controlled trial over 3 days. Measurements included posterior rhinomanometry, acoustic rhinometry, and subjective measures of congestion using a categorical scale and visual analog scale (VAS). Treatment was with one 60-mg PSE tablet four times daily or matching placebo.
After the first dose, PSE relative to placebo consistently showed small improvements for all objective assessments of nasal congestion. The prespecified primary efficacy outcome (day 1 nasal airway resistance area under the curve) was not significantly different between groups. PSE produced a 5.5% (p = 0.031) increase in total nasal volume for 0.5-3 hours after dosing. A pooled analysis of days 1 and 3 data showed a VAS score decrease of 7.0% (p = 0.072) for the 0.5- to 3-hour period on PSE.
PSE showed small but nonsignificant improvements in objective assessments of nasal congestion relative to placebo after a single dose.
American Journal of Rhinology 21(4):452-5. · 1.36 Impact Factor
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ABSTRACT: Objectives: To evaluate the effectiveness of small group tutorials in teaching senior medical students the requirements of prescription writing. Design: Random allocation to interactive tutorial or didactic lecture with blinded evaluation. Subjects: All 1999 6 th year medical students, the University of Adelaide. Results: The Tutorial Attenders (mean 13.3, SD 2.6) performed significantly better than the Lecture Group (mean12.2, SD 3.0) p=0.041 and the Non-attenders (mean10.7, SD 3.1) p=<0.001. The 13 individual OSCE items formed four logical subgroups, and the Tutorial Attenders performed significantly better in Prescription Writing in all comparisons. Conclusion: A single, one-hour interactive tutorial is likely to be the minimum amount of intervention that will be effective in improving prescribing skills.
