BACKGROUND: Xylometazoline is a nasal decongestant spray that constricts nasal blood vessels and increases nasal airflow, enabling patients with a blocked nose to breathe more easily. The purpose of this study was to characterize objectively and subjectively the decongestant and additional effects of xylometazoline in the common cold.
METHODS: A double-blind, placebo-controlled, parallel group study was performed. Patients with a common cold (n = 61) were treated with xylometazoline 0.1% (n = 29) or placebo (saline solution; n = 32; 1 spray three times a day for up to 10 days). The primary objective was to determine the decongestant effect (nasal conductance); the secondary objectives were to determine the peak subjective effect (visual analog scale), duration of relief of nasal congestion, total and individual cold symptoms and general well-being (patients' daily diary), and adverse events (AEs).
RESULTS: The decongestant effect of xylometazoline was significantly greater than placebo, as shown by the nasal conductance at 1 hour (384.23 versus 226.42 cm(3)/s; p <or= 0.0001) and peak subjective effect (VAS, 20.7 mm versus 31.5 mm; p = 0.0298). Nasal conductance was significantly superior for up to 10 hours (p = 0.0009) and there was a trend in favor of xylometazoline for up to 12 hours (not statistically significant). Xylometazoline significantly improved total and some individual common cold symptoms scores (p < 0.05), leading to significantly greater patient general evaluation and satisfaction with treatment (p < 0.05). Nineteen AEs were reported: 8 with xylometazoline (all mild-moderate) and 11 with placebo (1 severe).
CONCLUSION: Xylometazoline is an effective and well-tolerated decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the common cold and provided long-lasting relief with just 1 spray, helping patients to breathe more easily for a longer period of time.
ACHTERGROND: Het doel van deze gerandomiseerde, dubbelblinde, placebo-gecontroleerde studie was om de werkzaamheid van zink sulfaat te bepalen van de duur en ernst van de verkoudheid bij kinderen. Methode: Kinderen die ten minste twee van de 10 symptomen van verkoudheid binnen de 24-48 uur na het begin van de ziekte in aanmerking kwamen voor de studie. Kinderen werden gerandomiseerd om ofwel orale zink met zinksulfaat of een placebo te ontvangen. Een dagboek werd afgerond om de symptomen en negatieve effecten op te nemen. De symptomen werden gescoord als afwezig (0), licht (1), matig (2), of ernstige (3). RESULTATEN: Honderd en vijftig kinderen namen deel aan de studie, en 120 kinderen opgenomen in de uiteindelijke analyse. De mediane duur van alle symptomen van verkoudheid was 6 dagen (P = 0,20), en de mediane duur van nasale symptomen was 5 dagen in beide groepen (P = 0,09). De totale ernst van de symptomen scores waren significant lager in de zink-groep, te beginnen vanaf de tweede dag van het onderzoek. De lagere scores in de zink-groep waren grotendeels te danken aan verbetering van de neus-symptoom scores. Bijwerkingen waren vergelijkbaar in beide groepen. Conclusie Zinksulfaat had geen effect op de duur van verkoudheid. Het blijkt echter effectief in het verminderen van de ernst van de symptomen in koude gezonde kinderen.
BACKGROUND: Single-dose studies indicate that pseudoephedrine (PSE) provides moderate relief for congestion in coryza, but there is a lack of repeated-dose studies.
METHODS: 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.
RESULTS: 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.
CONCLUSION: PSE showed small but nonsignificant improvements in objective assessments of nasal congestion relative to placebo after a single dose.
This study sought to investigate the efficacy of dextromethorphan (DM), diphenhydramine (DPH), and placebo (PL) for symptoms attributed to upper respiratory infections as determined by children, and to evaluate the concordance of perception of nocturnal symptoms between children and parents. A total of 37 children age 6 to 18 years of age were randomized in a double-masked fashion to receive a single bedtime dose of DM, DPH, or PL. Children found no significant difference in the effect of DM, DPH, or PL for any study outcome, and responses by parents and children were significantly correlated.
BACKGROUND: Zinc is an essential mineral. Beneficial zinc absorption takes place via enteral, parenteral, or cutaneous routes. However, direct application to the olfactory epithelium has been reported to cause loss of smell. Recently, intranasal zinc gluconate has been recommended as a treatment for the common cold. Severe posttreatment hyposmia and anosmia have been observed.
METHODS: The case report of a typical patient is presented and analyzed in detail, followed by a series of patients with severe hyposmia or anosmia after the use of intranasal zinc gluconate.
RESULTS: Although interindividual variation in drug response and drug effect is apparent, the severe hyposmia or anosmia appears to be long lasting or permanent in some cases. The mechanism of olfactory loss is thought to be the direct action of the divalent zinc ion on the olfactory receptor cell.
CONCLUSIONS: Zinc ions are toxic to olfactory epithelium. Reports of severe hyposmia with parosmia or anosmia have occurred after intranasal use of zinc gluconate.
Background: Previous studies suggest that zinc salts may be effective in treating the common cold. Since rhinovirus infections occur primarily in the nasal cavity, an attempt to arrest the infection at the portal of entry seems logical. Aim: To assess the ability of zinc nasal gel to shorten the duration and reduce the severity of the common cold in healthy adults. Study design: Randomized, double blind, placebo-controlled study. Methods: Of 1087 patients screened by telephone, 80 patients were enrolled, all presenting within 24-48 h of the onset of illness. They received one dose per nostril of a nasal gel spray containing either 33 mmol/l zincum gluconicum, or an identical placebo four times daily until their symptoms resolved, for a maximum of 10 days. Results: Median duration of cold symptoms in the zinc group was significantly shorter than in the placebo group (median [IQR] 4.3 days [2.5-5.5] vs. 6 days [5-8.5], p=0.002). Nasal drainage, nasal congestion, hoarseness, and sore throat were the symptoms most affected. Significant reduction of total symptom scores started from the second day of the study. Adverse effects (mainly nasal stinging) were similar in both groups. Discussion: Zincum gluconicum nasal gel shortens duration and reduces symptom severity of the common cold in healthy adults, when started within 24-48 h of the onset of illness.
BACKGROUND: Fifty percent of Australians use complementary and alternative medicines (other than vitamins) in any 12-month period, of which echinacea-containing products are increasingly popular. Recent reports have highlighted the risk of allergic reactions to complementary medicines in atopic patients.
OBJECTIVE: To determine the characteristics of adverse reactions linked to use of the popular herbal remedy echinacea.
METHODS: Five privately referred patients were evaluated by the authors in their office practice via skin prick testing (SPT) on the volar aspect of the forearm and radioallergosorbent test after adverse reactions to echinacea. As there was little published information on adverse reactions to echinacea, reports to the Australian Adverse Drug Reactions Advisory Committee were reviewed. Those suggestive of possible allergic reactions were evaluated in greater detail by anonymously surveying the healthcare professionals who had reported the cases and from one unreported case. Serum was collected for further analysis where possible.
RESULTS: Five cases of adverse reactions to echinacea were personally evaluated by the authors. Two patients suffered anaphylaxis and a third had an acute asthma attack 10 minutes after their first ever dose of echinacea. The fourth patient suffered recurrent episodes of mild asthma each time echinacea was ingested, and the fifth developed a maculopapular rash within 2 days of ingestion which recurred when rechallenged. Three of the patients had positive SPT results. Three reported repeated spontaneous "challenges" and symptoms after further ingestion of echinacea. Fifty-one Australian adverse drug reports implicating echinacea were also reviewed. There were 26 cases suggestive of possible immunoglobulin E-mediated hypersensitivity (4 anaphylaxis, 12 acute asthma, 10 urticaria/angioedema). Of these 26 patients, age ranged from 2 to 58 years, 78% were female and >50% were known to be atopic. Four were hospitalized, 4 reacted after their first known exposure, and 1 patient suffered multiple progressive systemic reactions. Twenty percent of 100 atopic subjects who had never taken echinacea also had positive SPT results to this substance when tested by one of the authors in his office practice.
CONCLUSION: Some atopic subjects have positive SPT results to echinacea in the absence of known exposure. Atopic subjects are also overrepresented in those experiencing reactions to echinacea. The possibility that cross-reactivity between echinacea and other environmental allergens may trigger allergic reactions in "echinacea-naïve" subjects is supported by the Australian data. Given its widespread (and largely unsupervised) community use, even rare adverse events become inevitable. Atopic patients should be cautioned appropriately.
OBJECTIVE: Constitutional factors might play a role in the susceptibility to clinical illness during the common cold. This study seeks to determine if the likelihood of developing frequent common colds persists during childhood.
DESIGN: The Tucson Children's Respiratory Study involves 1246 children enrolled at birth and followed prospectively since 1980 and 1984. Parents reported the occurrence of frequent (> or =4) colds during the past year by questionnaire at 2, 3, 6, 8, 11, and 13 years of age. Blood for ex vivo interferon-gamma responses was obtained at 9 months and 11 years of age.
RESULTS: After adjustment for potential confounding variables, children with frequent colds at year 2 or 3 were twice as likely to experience frequent colds at year 6 (relative risk [RR], 2.8; 95% confidence interval [CI], 2.1-3.9), year 8 (RR, 2.6; 95% CI, 2.1-3.3), year 11 (RR, 2.4; 95% CI, 1.8-3.1), and year 13 (RR, 2.1; 95% CI, 1.4-3.3) compared with children who had infrequent colds at years 2 and 3. At 9 months of age, children who ultimately experienced persistent frequent colds had lower interferon-gamma titers than children without persistent frequent colds (3.05 +/- 1.61 vs 3.74 +/- 1.39, P =.016); this finding persisted at 11 years of age.
CONCLUSION: These data suggest the existence of a common cold constitution, whereby some children are more susceptible to infection and/or the expression of clinical symptoms when infected than are other children.
PURPOSE: We performed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of 0.12% zinc sulfate nasal spray for reducing the duration and severity of acute upper respiratory infections.
SUBJECTS AND METHODS: Patients with acute onset of upper respiratory illness of less than 24 hours' duration were eligible for the study. A nasopharyngeal swab was obtained at the time of enrollment for viral culture. Participants were randomly assigned to receive either 0.12% zinc sulfate or isotonic placebo spray. The medication was administered as two inhalations in each nostril four times a day. Each patient completed a diary card twice a day to record oral temperature, symptoms, and adverse effects. Symptoms were scored as absent (0), mild (1), moderate (2), or severe (3).
RESULTS: One hundred eighty-five subjects volunteered to participate, and 160 met the criteria for enrollment. The median duration of all symptoms was 7 days in both groups (P = 0.45), and the median duration of nasal symptoms was 6 days in both groups (P= 0.12). After adjustment for baseline differences in severity, patients receiving zinc had a significant reduction in the total symptom score (P= 0.02) and the nasal symptom score (P= 0.02) on day 1, but not on any of the other days. Adverse effects were mild and had no significant association with the use of zinc. A respiratory virus was identified in 9 of the 160 participants; 6 of these were rhinovirus.
CONCLUSION: A low concentration of zinc sulfate nasal spray had no effect on the duration of the common cold.
BACKGROUND: Phenylpropanolamine is commonly found in appetite suppressants and cough or cold remedies. Case reports have linked the use of products containing phenylpropanolamine to hemorrhagic stroke, often after the first use of these products. To study the association, we designed a case-control study.
METHODS: Men and women 18 to 49 years of age were recruited from 43 U.S. hospitals. Eligibility criteria included the occurrence of a subarachnoid or intracerebral hemorrhage within 30 days before enrollment and the absence of a previously diagnosed brain lesion. Random-digit dialing identified two matched control subjects per patient.
RESULTS: There were 702 patients and 1376 control subjects. For women, the adjusted odds ratio was 16.58 (95 percent confidence interval, 1.51 to 182.21; P=0.02) for the association between the use of appetite suppressants containing phenylpropanolamine and the risk of a hemorrhagic stroke and 3.13 (95 percent confidence interval, 0.86 to 11.46; P=0.08) for the association with the first use of a product containing phenylpropanolamine. All first uses of phenylpropanolamine involved cough or cold remedies. For men and women combined, the adjusted odds ratio was 1.49 (95 percent confidence interval, 0.84 to 2.64; P=0.17) for the association between the use of a product containing phenylpropanolamine and the risk of a hemorrhagic stroke, 1.23 (95 percent confidence interval, 0.68 to 2.24; P=0.49) for the association with the use of cough or cold remedies that contained phenylpropanolamine, and 15.92 (95 percent confidence interval, 1.38 to 184.13; P=0.03) for the association with the use of appetite suppressants that contained phenylpropanolamine. An analysis in men showed no increased risk of a hemorrhagic stroke in association with the use of cough or cold remedies containing phenylpropanolamine. No men reported the use of appetite suppressants.
CONCLUSIONS: The results suggest that phenylpropanolamine in appetite suppressants, and possibly in cough and cold remedies, is an independent risk factor for hemorrhagic stroke in women.
Xylometazoline is a nasal decongestant spray that constricts nasal blood vessels and increases nasal airflow, enabling patients with a blocked nose to breathe more easily. The purpose of this study was to characterize objectively and subjectively the decongestant and additional effects of xylometazoline in the common cold.
METHODS:
A double-blind, placebo-controlled, parallel group study was performed. Patients with a common cold (n = 61) were treated with xylometazoline 0.1% (n = 29) or placebo (saline solution; n = 32; 1 spray three times a day for up to 10 days). The primary objective was to determine the decongestant effect (nasal conductance); the secondary objectives were to determine the peak subjective effect (visual analog scale), duration of relief of nasal congestion, total and individual cold symptoms and general well-being (patients' daily diary), and adverse events (AEs).
RESULTS:
The decongestant effect of xylometazoline was significantly greater than placebo, as shown by the nasal conductance at 1 hour (384.23 versus 226.42 cm(3)/s; p
CONCLUSION:
Xylometazoline is an effective and well-tolerated decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the common cold and provided long-lasting relief with just 1 spray, helping patients to breathe more easily for a longer period of time.
