The purpose of this study was to assess the effectiveness of echinacea for the prevention of experimental rhinovirus colds. Infection occurred in 44 and 57% and illness occurred in 36 and 43% of the echinacea-and placebo-treated subjects, respectively. This preparation of echinacea had no significant effect on either the occurrence of infection or the severity of illness.Since the Dietary Supplement Health and Education Act was enacted by Congress in 1994 to modify the Food and Drug Administration regulation of dietary supplements, there has been a dramatic increase in the marketing and sale of these products. Echinacea is one of the most popular herbal remedies and is reported to have immunomodulatory activity that is beneficial for the treatment of common cold symptoms. Clinical studies on the effect of echinacea on the common cold have used a variety of different echinacea preparations and study designs (8,13,16). Different preparations of echinacea differ in chemical composition due variation in the plant species or the part of the plant that is used as the starting material or because of differences in the manufacturing process or dosage form (1, 3). The purpose of this study was to use the experimental cold model to evaluate the effectiveness of an echinacea preparation with a defined chemical profile for the prevention of rhinovirus colds.Subjects Ն18 years of age were recruited for these studies from the university community of the Medical University of South Carolina. Volunteers with a serum titer of neutralizing antibody to the study virus of Յ1:4 were treated with echinacea (300 mg) or a placebo three times each day for 14 days prior to virus challenge. All volunteers were challenged with 100 to 300 50% tissue culture-infective doses of rhinovirus type 23, and then the treatment was continued for 5 days after the virus challenge. Virus infection was documented by virus cultures and antibody responses, and illness severity was assessed by a modification of a previously published method (12,14). The echinacea preparation used in this study was analyzed by reversed-phase high-pressure liquid chromatography by Rudolf Bauer (Institut für Pharmazeutische Biologie, Düsseldorf, Germany) using published methods (2-6) and found to contain 0.16% cichoric acid with almost no echinacosides or alkamides. Written informed consent was obtained prior to study participation, and subjects were compensated for participation.One hundred seventeen subjects were enrolled in the trial and treated with either echinacea (63 subjects) or a placebo (54 subjects) for 2 weeks. Sixteen subjects (eight active, eight placebo) had a respiratory illness on day 0 and were not challenged with rhinovirus, four subjects in each group withdrew from the study prior to challenge, and one subject treated with echinacea was removed from the study due to an adverse event. The remaining 92 subjects were challenged with rhinovirus type 23 and continued on study medication as outpatients for an additional 5 days. On day 0 prior to virus challenge, ...

This was a randomized, double-blind vehicle controlled study aimed at investigating the effects on nasal function of 7 days treatment with the topical decongestant oxymetazoline (0.05% w/v). Fifty healthy volunteers took part in the study and these were randomly allocated to three treatment groups (i) daily oxymetazoline (b.i.d. 150 microliters per nostril) (ii) intermittent oxymetazoline, with oxymetazoline being substituted for vehicle at the morning doses on days 1, 3, and 7; and (iii) daily vehicle (b.i.d. 150 microliters per nostril). The nasal airway was assessed by measurement of nasal airway resistance (NAR) using posterior rhinomanometry, subjective scaling of nasal patency by means of a visual analogue scale (VAS), and clinical visual examination. On days 1, 2, 3, and 7, NAR and VAS measurements were obtained before the morning dose and up to 6 hours after dosing; clinical visual examinations were also performed before dosing on these days. NAR and VAS measurements were also made following withdrawal of treatment on Days 8 and 9. Nonparametric analysis of the results showed that therapeutic tolerance to oxymetazoline did not develop over the 7-day treatment period, and visual examination of the nasal mucosa failed to find significant evidence of rhinitis. Evidence of rebound nasal congestion was found following 3 days of oxymetazoline treatment, with baseline NAR within the daily and intermittent oxymetazoline groups being significantly greater on Day 3 compared to Day 1 (p < 0.05). However, there was a trend toward increasing baseline NAR in the vehicle group over the course of the study, suggesting that the vehicle may have contributed to the rebound congestion. Following the withdrawal of treatments, only the intermittent oxymetazoline group had significantly higher NAR on Days 8 and 9 compared to Day 1 (p < 0.05). Subjective VAS measurements generally followed trends in NAR.

Background: The common cold is the most frequently experienced infection among humans, but limited data exist to characterize the onset, duration, severity and intersection of symptoms in community-acquired colds. A more complete understanding of the symptom frequency and burden in naturally occurring colds is needed. Methodology: We characterized common cold symptoms from 226 cold episodes experienced by 104 male or female subjects. Subjects were enrolled in the work environment in an attempt to start symptom evaluation (frequency and severity) at the earliest sign of their cold. We also assessed the symptom that had the greatest impact on the subject by asking them to identify their single most bothersome symptom. Results: Symptom reporting started within 24 hours of cold onset for most subjects. Sore throat was a harbinger of the illness but was accompanied by multiple symptoms, including nasal congestion, runny nose and headache. Cough was not usually the most frequent symptom, but was present throughout the cold, becoming most bothersome later in the cold. Nasal congestion, pain (eg, sore throat, headache, muscle pains) or feverishness and secretory symptoms (eg, runny nose, sneezing), and even cough, were simultaneously experienced with high incidence over the first 4 days of illness. The single most bothersome symptom was sore throat on day 1, followed by nasal congestion on days 2-5 and cough on days 6 and 7. Conclusion: There is substantial overlap in the appearance of common cold symptoms over the first several days of the common cold. Nasal congestion, secretory and pain symptoms frequently occur together, with cough being somewhat less prominent, but quite bothersome when present. These data establish the typical symptomatology of a common cold and provide a foundation for the rational treatment of cold symptoms typically experienced by cold sufferers.

Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-beta serine (rIFN-beta ser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 X 10(6) units of rIFN-beta ser (139 subjects) or placebo (157) were administered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-beta ser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 X 10(6) units of rIFN-beta ser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-beta ser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-beta ser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-alpha 2b.

Background: A glycerol throat spray containing cold-adapted cod trypsin (GCTS) deactivates common cold virus in vitro and decreases pharyngeal rhinovirus load after inoculation in humans. We relied on early self-diagnosis and evaluated two different scales to detect a treatment effect in naturally occurring common colds. Methods: Adults were enrolled in this randomised, prospective, parallel group, single-blind study to begin treatment six times daily at first sign of a common cold or were assigned to a non-treated group. Jackson′s symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 quality of life (QoL) domain were recorded daily by subjects and area under the curve over 12 days (AUC1-12) calculated. Results: Treatment resulted in reduced symptoms with an AUC1-12 of 45.1 ± 32.5 for Jackson scores compared to 53.8 ± 35.7 in the controls (p=0.023). AUC1-12 for the 9-item WURSS-21 QoL domain was likewise improved, 113.6 ± 107.7 and 152.7 ± 126.3 (p=0.006), respectively. During the first four days fewer of the treated subjects (35.3%) used rescue medication than did the control group (50.4%, p=0.014). Conclusions: Reduction in common cold symptoms was seen with treatment with a glycerol throat spray containing cold-adapted cod trypsin. This effect was best detected with the 9-item WURSS-21 QoL domain.

We conclude that the nasal challenge model is a reproducible method to evaluate the efficacy of anti-allergic medications. For nasal corticosteroid trials, sneezing, symptom scores and albumin levels are recommended as the most reproducibly suppressive outcome measures.

Antiviral and symptomatic therapies for the common cold have been evaluated in studies that use either natural colds in the community or colds induced by experimental infection with rhinovirus. The purpose of this study was to compare the severity and natural history of experimentally induced and naturally occurring colds of undetermined etiology. Forty-one subjects with natural colds were compared to 24 subjects with experimental rhinovirus colds. The highest mean daily symptom score, rhinorrhea score, and nasal obstruction score in the natural cold subjects were 14.2, 2.1, and 2.5 re3pectively. In contrast, the highest mean daily symptom score, rhinorrhea score, and nasal obstruction score in the experimental rhinovirus colds were 9.3, 1.8, and 1.8, respectively (P < 0.005 compared to natural colds). Similarly, the highest mean daily mucus weight in the natural colds, 2.9 gms, was significantly higher than in the experimental colds, 2.3 gms (P = 0.01).There was no significant difference in the lowest mean nasal airflow in the natural and experimental models, .552 l/sec and .508 lisee, respectively. These results suggest that subjects with natural colds have more severe symptoms than subjects with experimental colds, however, these differences may be due to selection bias inherent in the natural cold study design. Both study designs have potential advantages and selection of the most appropriate design is dependent on the specific aims of the study.

The neurological mouse mutant dystonia musculorum exhibits bizarre appendicular and truncal dystonia without known cerebellar histopathology. We evaluated striatal dopamine and cerebellar norepinephrine metabolism in this mutant and compared the results with those obtained in wild-type BALB/c and B6C3 controls. Tyrosine hydroxylase activity and dopamine metabolite levels (homovanillic acid and 3,4-dihydroxyphenylacetic acid) in the striatum of the mutant were similar to controls. Tyrosine hydroxylase activity and the steady-state level of 3-methoxy-4-hydroxyphenethyleneglycol, a metabolite of norepinephrine, in the cerebellum were 38% and 42-66%, respectively, greater in the mutant. However, the level of norepinephrine was similar (approximately 350 ng/g). Further, a Purkinje cell-specific marker, cGMP-dependent protein kinase, was unchanged in the mutant and no Purkinje cell pathology was observed with light microscopy. The lack of Purkinje cell derangement and similar levels of cerebellar norepinephrine and cGMP-dependent protein kinase activity suggest that increased norepinephrine metabolism in the cerebellum of this mutant is not a morphological response to gross target cell loss during morphogenesis. The observed changes may be a reaction to abnormal impulse traffic or altered input/output pathways to the mutant cerebellum during its development.