An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis
ABSTRACT An exploratory US trial in patients with acute rhinosinusitis was conducted to evaluate the efficacy and safety of Cyclamen europeaum extract, a product marketed in Europe that causes reflex nasal discharge and subsequent decongestion.
Prospective, randomized, placebo-controlled, double-blind, and parallel group.
Outpatients (n = 29) with cardinal symptoms of acute rhinosinusitis and both endoscopic and radiographic (computed tomography [CT] scan) evidence at 25 US centers were randomized to receive intranasal, lyophilized, reconstituted Cyclamen europeaum extract (Cyclamen) or placebo spray for 7 days. Primary outcomes were reduction in percent sinus opacification on CT scans and reduction in PM predose instantaneous total symptom scores measured on a six-point scale. Secondary outcomes included other measures of symptom score change and endoscopic signs of mucopurulence and inflammation.
Cyclamen treatment significantly reduced sinus opacification compared with placebo treatment (P < .045). Although Cyclamen treatment reduced total symptom scores from baseline more than placebo treatment (-2.4 vs. -1.4), there were no significant treatment group differences (P = .312). Cyclamen treatment was well tolerated.
Cyclamen treatment significantly reduced sinus opacification in patients with acute rhinosinusitis. Further exploration of Cyclamen treatment in larger patient populations is warranted.
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ABSTRACT: Antibiotics are often prescribed for viral respiratory infections. The goal of our study was to determine the factors associated with antibiotic prescribing for acute respiratory infections in primary care. We performed an observational study in 15 primary care practices in Michigan using patient and physician surveys distributed during visits for acute respiratory infections. We included patients 4 years or older presenting with symptoms of an acute respiratory infection (n=482). The main outcome measures were prescriptions of antibiotics, signs and symptoms associated with antibiotic prescribing, and clinician-reported reasons for prescribing an antibiotic. We found that patients who were older than 18 years, sick for more than 14 days, and seen in urgent care clinics were more likely to receive antibiotics. Patients expected antibiotics if they perceived that the drug had helped with similar symptoms in the past. In an adjusted model, the variables significantly associated with antibiotic prescribing were physical findings of sinus tenderness (odds ratio [OR]=20.0; 95% confidence interval [CI], 8.3-43.2), rales/rhonchi (OR=19.9; 95% CI, 9.2-43.2), discolored nasal discharge (OR=11.7; 95% CI, 4.3-31.7), and postnasal drainage (OR=3.1; 95% CI, 1.6-6.0). The presence of clear nasal discharge on examination was negatively associated (OR=0.3; 95% CI, 0.2-0.5). Several physical signs play an important role in clinicians' decisions to prescribe antibiotics for respiratory infections. This information will be useful in designing interventions to decrease inappropriate antibiotic prescribing for upper respiratory infections.The Journal of family practice 06/2000; 49(5):407-14. · 0.74 Impact Factor
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ABSTRACT: The emergence and spread of antibiotic-resistant Streptococcus pneumoniae in US communities is due, in part, to the excessive use of antibiotics for acute respiratory tract infections. To decrease total antibiotic use for uncomplicated acute bronchitis in adults. Prospective, nonrandomized controlled trial, including baseline (November 1996-February 1997) and study (November 1997-February 1998) periods. Four selected primary care practices belonging to a group-model health maintenance organization in the Denver, Colo, metropolitan area. Consecutive adults diagnosed as having uncomplicated acute bronchitis. A total of 2462 adults were included at baseline and 2027 adults were included in the study. Clinicians included 56 physicians, 28 physician assistants or nurse practitioners, and 9 registered nurses. The full intervention site received household and office-based patient educational materials, as well as a clinician intervention consisting of education, practice-profiling, and academic detailing. A limited intervention site received only office-based educational materials, and control sites provided usual care. Antibiotic prescriptions for uncomplicated acute bronchitis during baseline and study periods. Antibiotic prescription rates for uncomplicated acute bronchitis were similar at all 4 sites during the baseline period. During the study period, there was a substantial decline in antibiotic prescription rates at the full intervention site (from 74% to 48% [P = .003]), but not at the control and limited intervention sites (78% to 76% [P = .81] and 82% to 77% [P = .68], respectively). Compared with control sites, changes in nonantibiotic prescriptions (inhaled bronchodilators, cough suppressants, and analgesics) were not significantly different for intervention sites. Return office visits (within 30 days of the incident visit) for bronchitis or pneumonia did not change significantly for any of the sites. Antibiotic treatment of adults diagnosed as having uncomplicated acute bronchitis can be safely reduced using a combination of patient and clinician interventions.JAMA The Journal of the American Medical Association 05/1999; 281(16):1512-9. · 30.39 Impact Factor
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ABSTRACT: To evaluate the efficacy and safety of a phytotherapeutic nasal spray containing Cyclamen europaeum (CE) in the treatment of acute rhinosinusitis (ARS). We performed a randomized, double-blind, placebo-controlled trial of CE nasal spray once daily for 15 days in 99 adult patients with moderate-to-severe ARS who also received amoxicillin 500 mg three times daily for the first 8 days. The primary endpoint was the change in mean total symptom scores (TSS) on day 7. Secondary endpoints included individual symptom scores (nasal congestion, mucus secretion, facial pain, impairment of smell) and endoscopic findings on days 7 and 15 and others. No statistically significant difference in TSS was noted for CE versus placebo on day 7. Moreover, the individual scores were not statistically different between the groups for the ITT-population on day 7. However, both a reduction in facial pain and an improvement in endoscopically-assessed mucosal obstruction significantly favoured CE on day 7. The most common adverse events were nasal burning and mild epistaxis, but no severe adverse events were documented. In summary, this is the first randomized controlled trial on phytotherapy in patients with moderate-to-severe ARS demonstrating clinical safety and some encouraging effects of CE which merit to investigate phytotherapeutic products in further large-scale clinical trials.Rhinology 03/2012; 50(1):37-44. · 2.78 Impact Factor