Echinacea Reduces Antibiotics by Preventing Respiratory Infections: A Meta-Analysis (ERA-PRIMA).

Respiratory tract infections (RTIs) are the leading cause of antibiotic prescriptions, primarily due to the risk for secondary bacterial infections. In this study, we examined whether Echinacea could reduce the need for antibiotics by preventing RTIs and their complications, and subsequently investigated its safety profile. A comprehensive search of EMBASE, PubMed, Google Scholar, Cochrane DARE and clinicaltrials.gov identified 30 clinical trials (39 comparisons) studying Echinacea for the prevention or treatment of RTIs in 5652 subjects. Echinacea significantly reduced the monthly RTI occurrence, risk ratio (RR) 0.68 (95% CI 0.61-0.77) and number of patients with ≥1 RTI, RR = 0.75 [95% CI 0.69-0.81] corresponding to an odds ratio 0.53 [95% CI 0.42-0.67]. Echinacea reduced the risk of recurrent infections (RR = 0.60; 95% CI 0.46-0.80), RTI complications (RR = 0.44; 95% CI 0.36-0.54) and the need for antibiotic therapy (RR = 0.60; 95% CI 0.39-0.93), with total antibiotic therapy days reduced by 70% (IRR = 0.29; 95% CI 0.11-0.74). Alcoholic extracts from freshly harvested Echinacea purpurea were the strongest, with an 80% reduction of antibiotic treatment days, IRR 0.21 [95% CI 0.15-0.28]. An equal number of adverse events occurred with Echinacea and control treatment. Echinacea can safely prevent RTIs and associated complications, thereby decreasing the demand for antibiotics. Relevant differences exist between Echinacea preparations.

Efficacy and safety of Echinaforce® in respiratory tract infections.

Echinaforce® is the standardised extract of Echinacea purpurea from Bioforce, Switzerland. Recent studies show immunomodulation and broad antiviral effects against respiratory tract viruses. Haemagglutinin and Neuraminidase are blocked. In contrast to Oseltamivir no resistance is caused by Echinaforce®. A randomised, double-blind, placebo-controlled study over four months confirms that Echinaforce® supports the immune resistance and acts directly against a series of viruses. Echinaforce® is efficacious and safe in respiratory tract infections for long-term and short-term prevention as well as for acute treatment.

Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial.

BACKGROUND: The aim of this trial was to assess the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats. METHODS: This was a multicenter, randomized, double-blind, double-dummy controlled trial carried out in eleven general practices in Switzerland. A total of 154 patients (133 analyzed in per protocol collective) at least 12 years old with acute sore throat present for not more than 72 hours prior to inclusion and with a throat score >/=6 participated in the study. They used either an echinacea/sage spray or a chlorhexidine/ lidocaine spray with two puffs every 2 hours, in a double-dummy blinded manner, up to 10 times daily until they were symptom-free, for a maximum of 5 days. The main outcome measures was the comparison of response rates during the first three days. A response was defined as a decrease of at least 50% of the total symptoms compared to baseline. RESULTS: The echinacea/sage treatment exhibited similar efficacy to the chlorhexidine/lidocaine treatment in reducing sore throat symptoms during the first 3 days (P(x

Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of the herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) compared to placebo. DESIGN: Double-blind, randomized, placebo-controlled, parallel-group, multicenter trial with a group-sequential adaptive design. SUBJECTS: Patients with sinonasal symptoms of at least 7 days duration, and radiographically and clinically confirmed acute rhinosinusitis of presumably bacterial origin with a Sinusitis Severity Score (SSS) of at least 12 out of 24 points at inclusion. INTERVENTIONS: EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides (1: 8-10; extraction solvent: ethanol 11% (w/w)), or matching placebo at a dose of 60 drops three times daily for maximum 22 days. MAIN OUTCOME MEASURES: Change in the SSS after 7 days. RESULTS: 103 patients were recruited until the planned interim analysis. The mean decrease in the SSS was 5.5 points in the EPs 7630 group compared to 2.5 points in the placebo group, a difference of 3.0 points (95% confidence interval 2.0 to 3.9, p < 0.00001). This result was confirmed by all secondary parameters indicating a more favourable course of the disease and a faster recovery in the EPs 7630 group. According to the pre-specified decision rule, the study was stopped after obtaining proof of efficacy for EPs 7630. CONCLUSIONS: EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.

Treatment of signs and symptoms of the common cold using EPs 7630 - results of a meta-analysis.

The efficacy of Pelargonium sidoides preparation EPs 7630 in the common cold (CC) was assessed by performing meta-analyses of randomized, double-blind, placebo-controlled trials. Mean differences (MD) and risk ratios (RR) with their 95% confidence intervals (CI) were computed. Five trials with a total of 833 patients were included. All trials had a treatment period of ten days with visits at days 3, 5, and 10 after baseline and used a ten-symptom Cold Intensity Score (CIS) as the primary outcome. Significant differences favoring EPs 7630 were observed for total CIS reduction (day 5: MD = -2·30; 95%CI = -4·12,-0·49; day 10: MD = -1·16; 95%CI = -2·22,-0·10), proportion of patients with substantial improvement (day 5: RR = 1·73; day 10: RR = 1·06) and complete remission (day 5: RR = 2·52; day 10: RR = 2·13). Subjects treated with EPs 7630 missed fewer days at work, used less paracetamol and had an improved sleep quality. No serious adverse reactions to EPs 7630 were reported. The results support the efficacy of EPs 7630 in adults with CC.

Echinacea reduces the risk of recurrent respiratory tract infections and complications: a meta-analysis of randomized controlled trials.

INTRODUCTION: Respiratory tract infections are common, and these infections occur frequently in children, susceptible adults, and older persons. The risk for recurrences and complications relates not only to the presence of viruses but also to immune function. Therefore, modulation of the immune system and antiviral interventions such as echinacea might reduce the risk of recurrences and possibly the development of complications. METHODS: MEDLINE, EMBASE, CAplus, BIOSIS, CABA, AGRICOLA, TOXCENTER, SCISEARCH, NAHL, and NAPRALERT were searched for clinical trials that studied recurrent respiratory infections and complications on treatment with echinacea extracts in a generally healthy population. Two independent reviewers selected randomized, placebo-controlled studies of high methodological quality and a Jadad score of ≥4. Relative risks (RRs) with 95% confidence intervals (CIs) were calculated according to a fixed effect model. RESULTS: Six clinical studies with a total of 2458 participants were included in the meta-analysis. Use of echinacea extracts was associated with reduced risk of recurrent respiratory infections (RR 0.649, 95% CI 0.545-0.774; P < 0.0001). Ethanolic extracts from echinacea appeared to provide superior effects over pressed juices, and increased dosing during acute episodes further enhanced these effects. Three independent studies found that in individuals with higher susceptibility, stress or a state of immunological weakness, echinacea halved the risk of recurrent respiratory infections (RR 0.501, 95% CI 0.380-0.661; P < 0.0001). Similar preventive effects were observed with virologically confirmed recurrent infections (RR 0.420, 95% CI 0.222-0.796; P = 0.005). Complications including pneumonia, otitis media/externa, and tonsillitis/pharyngitis were also less frequent with echinacea treatment (RR 0.503, 95% CI 0.384-0.658; P < 0.0001). CONCLUSION: Evidence indicates that echinacea potently lowers the risk of recurrent respiratory infections and complications thereof. Immune modulatory, antiviral, and anti-inflammatory effects might contribute to the observed clinical benefits, which appear strongest in susceptible individuals.

Anti-inflammatory activity of an extract of Petasites hybridus in allergic rhinitis.

Previous studies have suggested that histamine and leukotrienes (LTs) play an important pathobiological role in IgE-mediated allergic diseases. In vitro studies suggested that an extract of Petasites hybridus (Ze339) blocks LT synthesis in monocytes and granulocytes. Petasins are considered to be the pharmacologically active fraction within Ze339. Patients suffering from allergic rhinitis received three times a day two tablets of Ze339 standardized to 8 mg petasins within a time period of 1 week. After 5 days of treatment, Ze339 significantly improved primary end points, which were day- and nighttime nasal symptoms. Nasal resistance, which was measured by rhinomanometry, gradually decreased as a consequence of Ze339 treatment reaching normal levels after 5 days (rhinomanometry: from 403.5+/-62.0 to 844.8+/-38.8 ml). Levels of inflammatory mediators in nasal fluids and serum were measured 90 min after drug administration every day in the morning. After 5 days of treatment, a significant reduction of histamine (from 153.7+/-32.1 to 53.0+/-8.4 pg/ml) and LT levels (LTB4: from 313.1+/-46.5 to 180.6+/-32.2 pg/ml; cysteinyl-LT: from 137.0+/-42.2 to 70.1+/-16.5 pg/ml) could be observed. Moreover, quality-of-life scores significantly improved. The drug had no effect on the distribution of lymphocyte subpopulations in the blood as well as on the capacity of blood leukocytes to generate cytokines and lipid mediators. These results suggest that Ze339 is effective in treating allergic rhinitis patients by decreasing levels of nasal inflammatory mediators.

Butterbur Ze339 for the treatment of intermittent allergic rhinitis: dose-dependent efficacy in a prospective, randomized, double-blind, placebo-controlled study.

OBJECTIVES: To investigate whether the efficacy and safety of Butterbur extract Ze339 are related to dosage when administered to patients with intermittent allergic rhinitis. DESIGN: Prospective, randomized, double-blind, placebo-controlled, parallel-group comparison. SETTING: Multicenter, including 6 outpatient general medicine and allergy clinics. PATIENTS: One hundred eighty-six patients were randomized (Butterbur Ze339 high dose, 60; low dose, 65; and placebo, 61 patients). Established diagnostic criteria for intermittent allergic rhinitis were confirmed by skin allergy tests in all patients. INTERVENTIONS: High-dose group, 1 tablet 3 times daily; low-dose group, 1 tablet twice daily; or matching placebo. All groups were treated for 2 consecutive weeks. MAIN OUTCOME MEASURES: The main efficacy variable was change in symptoms from baseline to end point during the daytime. The secondary efficacy variables were Clinical Global Impression score, change in symptoms from baseline to treatment day 7, and responder rates. Statistical analysis was prospective, on an intention-to-treat basis. RESULTS: Improvement in the main efficacy variable was significantly superior in the Butterbur Ze339 groups, relative to placebo, and a significant dose relationship was observed between the 2 Butterbur doses. The clinicians' assessment of efficacy and the overall responder rates were significantly superior for the active groups compared with placebo. The incidence and type of adverse events were indistinguishable across the herbal treatment and placebo groups. CONCLUSIONS: Butterbur Ze339 is an effective treatment for intermittent allergic rhinitis symptoms and is well tolerated. The effects of this herbal medicine are clear to patients and physicians in a double-blind evaluation against placebo.

Medical ethics in peace and in the armed conflict.

Global medical ethics on the basis of the General Declaration of Human Rights by the United Nations is a key subject for the 21st century. World Health Organization's new definition of health includes "spiritual health," a term that has to be defined in international consensus despite different anthropologies, cultures, and religions. Old issues in medical ethics such as assisted suicide are still waiting for global consensus among the "pro-life" and "pro-choice" parties. So far The Netherlands and Belgium are the only countries where euthanasia has been legalized, whereas the U.S. Supreme Court has denied a right of medically assisted suicide. The respect of nature is also the basis for guidelines in new issues in medical ethics such as gene therapy and human cloning, which are controversially discussed. Military medical ethics should provide regulations for morally correct decisions in armed conflicts including the war against international terrorism and in peacekeeping missions. Triage of the wounded, distribution of medical aid, and critical incident stress debriefing for soldiers and their relatives are key issues.

Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis.

OBJECTIVES: To compare the efficacy and tolerability of butterbur (Petasites hybridus) with cetirizine in patients with seasonal allergic rhinitis (hay fever). DESIGN: Randomised, double blind, parallel group comparison. SETTING: Four outpatient general medicine and allergy clinics in Switzerland and Germany. PARTICIPANTS: 131 patients were screened for seasonal allergic rhinitis and 125 patients were randomised (butterbur 61; cetirizine 64). INTERVENTIONS: Butterbur (carbon dioxide extract tablets, ZE 339) one tablet, four times daily, or cetirizine, one tablet in the evening, both given for two consecutive weeks. MAIN OUTCOME MEASURES: Scores on SF-36 questionnaire and clinical global impression scale. RESULTS: Improvement in SF-36 score was similar in the two treatment groups for all items tested hierarchically. Butterbur and cetirizine were also similarly effective with regard to global improvement scores on the clinical global impression scale (median score 3 in both groups). Both treatments were well tolerated. In the cetirizine group, two thirds (8/12) of reported adverse events were associated with sedative effects (drowsiness and fatigue) despite the drug being considered a non-sedating antihistamine. CONCLUSIONS: The effects of butterbur are similar to those of cetirizine in patients with seasonal allergic rhinitis when evaluated blindly by patients and doctors. Butterbur should be considered for treating seasonal allergic rhinitis when the sedative effects of antihistamines need to be avoided.

Systematic review of clinical data with BNO-101 (Sinupret) in the treatment of sinusitis.

BACKGROUND: The herbal formula BNO-101 (containing Gentianae radix, Primulae flos, Rumicis herba, Sambuci flos and Verbenae herba; ratio 1:3:3:3:3) has been widely employed as a 'mucoactive' agent in Germany for 70 years for the symptoms of respiratory infections. This paper reviews the clinical evidence of BNO-101 in sinusitis. METHODS: The systematic search identified 22 studies with BNO-101. Out of these, 6 controlled trials on sinusitis were reassessed according to predefined criteria. 4 trials had almost identical designs and could be examined by meta-analysis. RESULTS: The database comprised approximately 900 patients, mostly young adult males. After 2 weeks of treatment, verum was significantly superior to placebo (2 RCTs, 159 vs. 160 patients, both add-on to antibacterial treatment). The benefit regards the patients' assessment ('cured': verum = 61.1%, placebo = 34.5%), reduction of drain obstruction, headache and radiological signs (all p < 0.05). Comparing BNO-101 to ambroxol (2 RCTs, 151 vs. 150 patients, add-on to antibacterials in 13% of the cases) the patients' assessment after 2 weeks showed no difference, although it favoured BNO-101 in chronic cases ('cured' BNO-101 = 37.1%, ambroxol = 12.5%; p < 0.05). It also favoured BNO-101 concerning pyorrhoea and headache (p < 0.05). No significant differences were reported in 2 open randomised trials vs. N-acetyl-cysteine and vs. the herbal product Myrtol std. CONCLUSIONS: BNO-101, combined with standard antibacterial therapy, significantly reduces the acute symptoms and signs of sinusitis. The effects are of the same order of magnitude as observed with other mucoactive agents. In the trials investigated BNO-101 had a favourable risk/benefit ratio, with an incidence of adverse events similar to placebo.

Treating intermittent allergic rhinitis: a prospective, randomized, placebo and antihistamine-controlled study of Butterbur extract Ze 339.

BACKGROUND: Intermittent allergic rhinitis (IAR) causes patients distress and impairs their work performance and quality of life. A variety of medicines are used by sufferers whose anguish frequently leads to trying new treatments, increasingly from herbal sources. METHODS: Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. The primary efficacy variable was a change in symptoms from baseline to endpoint during daytime. The secondary efficacy variables were: (a) as per primary variable (evening/night); (b) Physician's global assessment; (c) Responder rates. Safety was closely monitored. FINDINGS: Both active treatments were individually significantly superior to placebo (p<0.001) in improving symptoms of IAR, while there were no differences between the two active treatments (p=0.37). Superiority to placebo was similarly shown during the evening/night (p<0.001), by physicians' own assessment and by responder rates. Both treatments were well tolerated. INTERPRETATION: Butterbur Ze 339 and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur Ze 339 has now been subject to a series of well controlled trials and should be considered as an alternative treatment for IAR.