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: Sinusitis is a common medical disease with a tremendous economic impact on health care. Our objective was to determine the most cost-effective strategy for the management of acute sinusitis from the societal and payers' perspectives. A Markov disease simulation model was used for comparing four treatment strategies: (1) no antibiotic (Abx), (2) empiric Abx, (3) CT-based Abx, and (4) clinical guideline-based Abx. Empiric Abx treatment was the most cost-effective from the societal perspective. Clinical guideline-based treatment was the most cost-effective strategy from the payers' perspective ($38,515/quality-adjusted life year). Cost and effectiveness of Abx, time lost from work, and prevalence of acute bacterial sinusitis are influential variables. Empiric Abx treatment is a cost-effective strategy from the short-term societal perspective. However, Abx resistance will lead to increased costs and reduced efficacy of this strategy in the long-term. Clinical guidelines provide a low-cost method of targeting therapy.American Journal of Rhinology 01/2007; 21(4):444-51. · 1.36 Impact Factor
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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. · 0.67 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. · 29.98 Impact Factor