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Efficacy of terfenadine in the treatment of common cold. A double-blind comparison with placebo.

We have assessed the effects of terfenadine on rhinitis symptoms associated with the common cold in 91 patients in a double-blind placebo-controlled study. The patients received three doses of either terfenadine 60 mg (n = 44) or placebo (n = 47) at about 12-h intervals, starting in most patients within 48 h from the onset of symptoms. Because of deviations from the protocol, 28 cases were classified as not eligible for efficacy evaluation, but were nevertheless analysed. Excellent/good or moderate efficacy was reported by 63% of eligible and 59% of all patients who received terfenadine (placebo 40% and 51% respectively, p = 0.049 and 0.113 respectively). 68% of eligible and 52% of all patients indicated that they would take terfenadine again (placebo 23%, for both p = 0.002). Two h after tablet intake mean nasal airflow was increased by 11 l.min-1, SD 8 (placebo -1 l.min-1, SD 6, p = 0.005). Symptoms were improved and rhinoscopy showed reduced swelling and redness of the mucosa and reduced nasal secretion and obstruction (basically unchanged in the placebo group). Therefore, terfenadine seems to act favourably on the acute rhinitis symptoms associated with the common cold. Since terfenadine is devoid of anticholinergic activity, nose symptoms during the initial stage of the common cold may be mediated to an important degree by histamine.

Adult↗

[Common cold].

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Common Cold↗

[Common cold].

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Common Cold↗

[Common cold].

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Common Cold↗

Efficacy of a standardized echinacea preparation (Echinilin) for the treatment of the common cold: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Recently, echinacea has regained popularity as one of the treatments chosen most commonly by consumers with the expectation that it will reduce the severity and duration of the common cold. However, the results from a limited number of clinical trials for this application have thus far been inconclusive. This incongruity may be the result of investigators utilizing poorly standardized echinacea products, likely devoid of sufficient quantities of active constituents necessary to exert a definitive clinical effect. Therefore, a formulation containing alkamides, cichoric acid, and polysaccharides at concentrations of 0.25, 2.5, and 25 mg/mL, respectively, was prepared from freshly harvested Echinacea purpurea plants (commercially available as Echinilin, Natural Factors Nutritional Products, Inc., Vancouver, BC, Canada). The objective of this study was to test the efficacy of this highly standardized formulation in reducing the severity and duration of symptoms of a naturally acquired common cold. METHODS: In a randomized, double-blind, placebo-controlled trial, 282 subjects aged 18-65 years with a history of two or more colds in the previous year, but otherwise in good health, were recruited. The subjects were randomized to receive either echinacea or placebo. They were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for 7 days. Severity of symptoms (10-point scale: 0, minimum; 9, maximum) and dosing were recorded daily. A nurse examined the subjects on the mornings of days 3 and 8 of their cold. RESULTS: A total of 128 subjects contracted a common cold (59 echinacea, 69 placebo). The total daily symptom scores were found to be 23.1% lower in the echinacea group than in placebo in those who followed all elements of the study protocol (P<0.01). Throughout the treatment period, the response rate to treatments was greater in the echinacea group. A few adverse event profiles were observed in both groups. CONCLUSIONS: Early intervention with a standardized formulation of echinacea resulted in reduced symptom severity in subjects with naturally acquired upper respiratory tract infection. Further studies with larger patient populations appear to be warranted.

Adult↗

The Wisconsin Upper Respiratory Symptom Survey (WURSS): a new research instrument for assessing the common cold.

OBJECTIVE: To develop a sensitive, reliable, responsive, easy-to-use instrument for assessing the severity and functional impact of the common cold. STUDY DESIGN: We created an illness-specific health-related quality-of-life outcomes instrument. This original questionnaire was used in a 1999 randomized trial of echinacea for the common cold. In 2000 we used cognitive interview and focus group qualitative methods to further develop the instrument. Semistructured interviews used open-ended questions to elicit symptoms, terminology, and perceived functional impact. Responses were used to improve the instrument. POPULATION: The randomized trial watched 142 University of Wisconsin students for a total of 953 days of illness. The subsequent qualitative instrument development project recruited 74 adults with self-diagnosed colds for 56 in-person interviews and 3 focus groups. OUTCOMES MEASURED: We measured specific symptoms, symptom clusters (dimensions), functional impact, and global severity. RESULTS: The original questionnaire included 20 questions: a global severity indicator, 15 symptom-severity items using 9-point severity scales, and 4 yes/no functional assessments. Data from the trial provided evidence of 4 underlying dimensions: nasal, throat, cough, and fever and aches, with reliability coefficients of 0.663, 0.668, 0.794, and 0.753, respectively. Qualitative assessments from the interviews and focus groups led us to expand from 15 to 32 symptom-specific items and from 4 to 10 functional impairment items. The original 9-point severity scale was revised to 7 points. Two global severity questions bring the item count to 44. The instrument fits comfortably on the front and back of a single sheet of paper. CONCLUSIONS: The Wisconsin Upper Respiratory Symptom Survey (WURSS) is ready for formal validity testing or practical use in common cold research.

Adult↗

Echinacea for preventing and treating the common cold.

BACKGROUND: Preparations of the plant Echinacea (family Compositae) are widely used in some European countries and in North America for common colds. Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and addition of other components. OBJECTIVES: The objective of this review was to assess whether there is evidence that Echinacea preparations are 1) more effective than no treatment; 2) more effective than placebo; 3) similarly effective to other treatments in A) the prevention and B) the treatment of the common cold. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005); PubMed (1997 to April 2005), EMBASE (1998 to June 2005), AMED (to August 2005), Centre for Complementary Medicine Research (in Munich) (1988 to May 2005), contacted experts, and screened references of reviews. SELECTION CRITERIA: We included randomized controlled trials that compared mono-preparations of Echinacea with a placebo, no treatment, or another treatment for the prevention or treatment of common colds. Trials on combinations of Echinacea and other herbs were excluded. DATA COLLECTION AND ANALYSIS: For all studies, at least two authors independently assessed eligibility and trial quality, and extracted data. Outcomes of interest in prevention trials were: numbers of individuals with one or more colds, and severity and duration of colds; and in treatment trials: total symptom scores, nasal symptoms, and duration of colds. MAIN RESULTS: Sixteen trials including a total of 22 comparisons of an Echinacea preparation and a control group (19 with placebo, 2 with no treatment, 1 with another herbal preparation) met the inclusion criteria. All trials except one were described as double-blind. The majority had reasonable to good methodological quality. Three comparisons investigated prevention of colds and 19 comparisons tested treatment of colds. A variety of different Echinacea preparations were used. None of the three comparisons in the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. More than one trial was available only for preparations based on the aerial parts from Echinacea purpurea (E. purpurea). AUTHORS' CONCLUSIONS: Echinacea preparations tested in clinical trials differ greatly. There is some evidence that preparations based on the aerial parts of Echinacea purpurea might be effective for the early treatment of colds in adults but results are not fully consistent. Beneficial effects of other Echinacea preparations, and for preventative purposes might exist but have not been shown in independently replicated, rigorous randomized trials.

Common Cold↗

Effect of Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, B. bifidum MF 20/5 on common cold episodes: a double blind, randomized, controlled trial.

BACKGROUND & AIMS: The aim of this study was to investigate whether the consumption of Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, B. bifidum MF 20/5 (5 x 10(7) cfu/tablet) during at least 3 months influences the severity of symptoms and the incidence and duration of the common cold. METHODS: A randomized, double-blind, placebo-controlled intervention study was performed over at least 3 months during two winter/spring periods. Four hundred and seventy nine healthy adults (aged 18-67) were supplemented daily with vitamins and minerals with or without the probiotic bacteria. Cellular immune parameters were evaluated in a randomly drawn subgroup of 122 volunteers before and after 14 days of supplementation. During common cold episodes, the participants recorded symptoms daily. Stool samples were collected before and after 14 days of probiotic supplementation to quantify fecal Lactobacilli and Bifidobacteria using qRT-PCR. RESULTS: The total symptom score, the duration of common cold episodes, and days with fever during an episode were lower in the probiotic-treated group than in the control group: 79.3+/-7.4 vs. 102.5+/-12.2 points (P = 0.056), 7.0+/-0.5 vs. 8.9+/-1.0 days (P = 0.045), 0.24+/-0.1 vs. 1.0+/-0.3 days (P = 0.017). A significantly higher enhancement of cytotoxic plus T suppressor cells (CD8+) and a higher enhancement of T helper cells (CD4+) was observed in the probiotic-treated group. Fecal lactobacilli and bifidobacteria increased significantly after probiotic supplementation. CONCLUSIONS: The intake of probiotic bacteria during at least 3 months significantly shortened common cold episodes by almost 2 days and reduced the severity of symptoms.

Adolescent↗

The effects of oral pseudoephedrine on nasal patency in the common cold: a double-blind single-dose placebo-controlled trial.

A placebo-controlled double-blind randomized trial was carried out to assess the efficacy of pseudoephedrine in relieving nasal congestion in the common cold. Fifty-four previously healthy persons who had a common cold for at least 5 days or less at the start of the study with moderate to severe nasal congestion were recruited, 52 completed the trial. Following a single dose of oral pseudoephedrine (60 mg capsule) or placebo, symptoms of congestion improved significantly compared with placebo at times 60, 90, 120, and 150 min after the dose. Total nasal minimum cross-sectional area and nasal volume measured by acoustic rhinometry increased significantly compared to placebo (P = 0.018 and P = 0.003, respectively) after the dose. There was no significant change in nasal area as measured by active posterior rhinomanometry after pseudoephedrine compared to placebo. We conclude that in the acute common cold, a single 60 mg dose of pseudoephedrine produces significant increases in the dimensions of the nasal cavity compared to placebo and this is associated with a reduction in the symptom of congestion.

Acoustics↗

Treatment of the picornavirus common cold by inhibitors of viral uncoating and attachment.

The human rhinoviruses are the leading cause of the ubiquitous, mild, and self-limiting infections generally referred to as the common cold. Considerable research effort has been expended in the search for well tolerated antiviral agents capable of preventing and treating the common cold. Although no antirhinovirus drug is yet commercially available, considerable progress has been made in the discovery and development of novel, viral specific inhibitors of rhinovirus replication. This report reviews the history and current status of the research that has focused on inhibitors of the early steps in the virus life cycle: attachment to the cellular receptor and uncoating of the viral RNA. Molecules directed at these targets currently possess the greatest potential for generating a safe and efficacious treatment for the rhinovirus common cold.

Antiviral Agents↗

[Self-medication of the common cold].

Self-medication can be useful in the multisymptomatic management of the common cold and other preferentially non-febrile flu-like symptoms, especially as at present multicomponent remedies are available, which may make self-medication significantly easier with consequent better compliance of adult patients. Children, on the contrary, are not suitable acceptants of self-medication mediated by their parents because the sickness exhibits in children nearly exclusively febrile progress. The procedure of the therapy to be really effective and safe must be necessarily concentrated into pharmacies, where safety and efficacy of therapy are ensured by the pharmacist as the last link of contact between the patient and the drug. Any other distribution of the OTC drugs is therefore strictly unacceptable. Patients suffering from the common cold usually exhibit simultaneously various symptoms of the disease. These different symptoms are, however, experienced during the day with different intensity. During the day and often also in the course of the labour process there is a need to concentrate on the most bothersome symptoms, notably the relief of the nasal congestion with the exploration of the safest and most effective drug, such as pseudoephedrine. In addition, it is necessary to administer an effective nonsteroidal anti-inflammatory drug, preferably ibuprofen, which provides relief from symptoms caused by release of inflammatory mediators. In the night time there is a need of a multisymptom therapy which may relieve cough and any other disturbing cold symptoms to allow satisfactory beneficial, continuous, and refreshing sleep.

Adult↗

[An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine [corrected] hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold].

OBJECTIVE: To evaluate the efficacy and safety of compound pseudoephedrine [corrected] hydrochloride (New Contact sustained release capsules) in the treatment of the nasal symptoms associated with common cold or influenza. METHOD: Open label multi-center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza. RESULTS: A total of 416 patients were eligible for efficacy and safety analysis. The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study. Forty adverse events (AE's) with an incidence of 8% were developed in 35 patients. The most frequent AE's were drowsiness (24/416, 6%) and dry mouth (5/416, 1%). All AE's were in mild or moderate degree. CONCLUSION: The results indicated that New Contact sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well-tolerated.

Adolescent↗

Knowledge and beliefs of primary care physicians, pharmacists, and parents on antibiotic use for the pediatric common cold.

The aim of this study is to investigate knowledge and beliefs of primary care physicians (e.g. family practitioners and pediatricians), pharmacists, and parents regarding the use of antibiotics for the pediatric common cold, using a self-administered questionnaire for physicians and pharmacists and a telephone interview for parents. This article suggests that parents' expectation for antibiotics is a minor factor, and health care providers' unfounded beliefs in the effectiveness of antibiotics and exaggeration of parents' demand for antibiotics may be the major contributing factor underlying antibiotic over-prescription for the pediatric common cold in Korea. Most physicians and pharmacists knew the correct cause of the pediatric common cold, but majorities of the physicians and pharmacists believed that antibiotics could treat and reduce its complications. On the other hand, 34% of the parents believed that antibiotics could prevent complications. Seventy three per cent of the physicians reported that they perceived expectations for antibiotics from parents, but only 2% of the parents reported asking their physicians for antibiotics. In summary, this study suggests that physicians' knowledge and faulty beliefs can be more important factors for inappropriate antibiotic prescription.

Anti-Bacterial Agents↗

The common cold in patients with a history of recurrent sinusitis: increased symptoms and radiologic sinusitislike findings.

BACKGROUND: We evaluated whether the symptoms and signs and radiologic findings during a common cold are similar in patients who have and have not suffered from recurrent sinusitis. METHODS: We recruited 2 series of volunteer cases from February 1, 1996, to December 31, 1996. Twenty-three adults who claimed to have suffered from recurrent sinusitis and 25 who had never had sinusitis were examined during the period of a self-diagnosed cold of 48 to 96 hours' duration and again after 21 days. Symptom scores were recorded, nasoendoscopy and computed tomography scans were performed, and viral and bacterial specimens were taken. RESULTS: The patients with a history of sinusitis had significantly higher symptom scores than the control patients (P=.04) and had radiologic sinusitislike changes more often (65% [15] vs 36% [9]; difference 29% [95% confidence interval, 2%-56%]; P=.04). The viral etiology of the common cold (verified in 67% of the episodes) was similar in both groups. Pathogenic bacteria were isolated from the middle meatus in 24% (6) of the control patients and only 9% (2) of the sinusitis-prone patients (P=.15). On the basis of the symptomatology, radiologic findings, and bacterial cultures only 2 patients in the sinusitis-prone group should have been treated with antimicrobials. CONCLUSIONS: Some patients are susceptible to both sinusitislike symptoms and radiologic findings during viral common colds. This may cause them to consult their physicians earlier and more often during viral colds, which may result in unnecessary antibiotic treatments. Nasopharyngeal bacteriological cultures may prove to be useful in ruling out bacterial sinusitis.

Adult↗

Public views and use of antibiotics for the common cold before and after an education campaign in New Zealand.

AIMS: To assess changes in public knowledge, attitudes, and reported behaviour of antibiotic use in the management of the common cold and to compare with results of a 1998 study. The context is a nationwide project to reduce the consumption of antibiotics. METHOD: Cross-section survey: telephone interviews of random sample of consenting Auckland telephone subscribers aged over 15 years comparing 1998 and 2003 responses. RESULTS: A 55% response rate of eligible participants was recorded. No change was noted between 1998 and 2003 in public awareness that antibiotics are not helpful in treating viral infections (38%). However there was a significant reduction in those attending doctor for the common cold (24% to 15%). In 2003, patients were less likely to receive antibiotic prescription and more likely to receive a delayed prescription. CONCLUSIONS: The majority of general public still do not understand that the common cold does not need antibiotic treatment. The advertising campaign may have reduced doctor prescribing hence the reduction in antibiotic use from 1998 to 2003.

Adolescent↗

Effects on the nasal mucosa of upper respiratory viruses (common cold).

Delineation of the pathogenesis of symptoms during common colds is the overall aim of this work. The studies included in this thesis have focused on the histopathologic changes in the nasal mucosa produced by infection with respiratory viruses. The accepted concept when these studies were undertaken was that cold symptoms were caused by destruction of nasal epithelium by virus and that epithelial damage sometimes led to secondary bacterial infection evidenced by purulent nasal secretions. The pathogenesis of cold symptoms has been reviewed in this thesis based on investigations by others and my own research. Chapter 1 described the clinical design of a naturally acquired cold model and an experimental rhinovirus cold model which were used. The advantages of the experimental model over the natural cold model are that the viral etiology is known and that volunteers can be studied beginning at viral inoculation rather than onset of symptoms. Unfortunately, the experimental model is very expensive. Chapter 2 reviewed the histopathology of the nasal mucosa during colds. The degree of destruction of the mucosa during naturally acquired colds reported in the literature has varied. We did not detect any discernible damage of the epithelium by light and scanning electron microscopy in naturally acquired colds. We repeated the study in volunteers with rhinovirus colds and again did not find any damage to the surface epithelium (light microscopy). Although different viruses may cause epithelial damage in naturally acquired colds, in rhinovirus colds the epithelium of the anterior part of the inferior turbinate is not destroyed. There was an early influx of neutrophils into the nasal mucosa in patients both with naturally acquired colds (day 2 after onset) and with experimental rhinovirus colds. This discovery in combination with the minimal damage of the nasal epithelium led to formulation of a new hypothesis of how cold symptoms may be produced. The influx of neutrophils might be a direct response to viral infection and/or may reflect the release of a cascade of inflammatory mediators which are responsible in part for the symptoms. Naclerio et al (1988) has since shown that the number of neutrophils in nasal secretions increases early in rhinovirus colds. This increase correlated nicely with the symptoms. In addition, Turner (1988) demonstrated the elaboration of a chemoattractant factor for neutrophils by cell cultures infected with rhinovirus type 39. Chapter 3 focused on the location of rhinovirus replication in the nose and nasopharynx. The entire mucosal lining of the nasal cavities was not infected during the first week of a rhinovirus colds.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Trials as Topic↗

Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing associated with the common cold.

Limited data support the use of first-generation antihistamines for treatment of the common cold. The purpose of this study was to test the effectiveness of clemastine fumarate, a first-generation antihistamine, for treatment of sneezing and rhinorrhea associated with naturally occurring common colds. Four hundred three subjects (202 clemastine fumarate recipients and 201 placebo recipients) who reported new onset (< 24 hours) of cold symptoms that included rhinorrhea or sneezing were studied. At baseline (day 1), the mean symptom-severity scores +/- SEM for the clemastine fumarate and placebo groups were not significantly different. The mean rhinorrhea-severity score +/- SEM was not different on day 2; however, on day 3, the mean rhinorrhea-severity score +/- SEM was 1.02 +/- 0.07 for the clemastine fumarate group and 1.39 +/- 0.07 for the placebo group (P < .001). This treatment effect persisted on day 4. A significant effect on sneezing was noted on days 2-4. Sedation occurred in 14% of the clemastine fumarate-treated subjects and 1.5% of the placebo-treated subjects (P < .0001).

Adolescent↗