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Marianne Heger - One of the best experts on this subject based on the ideXlab platform.

  • pelargonium sidoides preparation eps 7630 in the treatment of Acute Bronchitis in adults and children
    Phytomedicine, 2007
    Co-Authors: H Matthys, Petra Funk, Wolfgang Kamin, Marianne Heger
    Abstract:

    Abstract Acute Bronchitis, although mostly caused by viral infections, is commonly treated with antibiotics. As antibiotics should only be prescribed upon strict indication, treatment options like a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs® 7630) gain more and more interest. To evaluate the efficacy and safety of treatment with EPs® 7630 in patients with Acute Bronchitis, a multi-centre, prospective, open observational study was conducted in 440 study sites located in Germany. A total of 2099 patients aged 0–93 years with productive cough for less than six days without indication for treatment with antibiotics were given EPs® 7630-solution in an age-dependent dosage for 14 days. The primary outcome criterion was the mean change of the Bronchitis Severity Score (BSS: cough, sputum, rales/rhonchi, chest pain at cough, dyspnoea) from baseline to patient's individual last observation. During treatment, the mean BSS of all patients decreased from 7.1±2.9 points at baseline to 1.0±1.9 points at patients’ individual last visit. Subgroup analysis for children showed a decrease of mean BSS from 6.3±2.8 points to 0.9±1.8 points and analysis of children younger than three years showed a decrease of mean BSS from 5.2±2.5 points to 1.2±2.1 points. Adverse events occurred in 26/2099 (1.2%) patients. Serious adverse events were not reported. In conclusion, EPs® 7630 is an effective and well tolerated treatment of Acute Bronchitis in adults, children and infants outside the strict indication for antibiotic treatment.

  • treatment effect and safety of eps 7630 solution in Acute Bronchitis in childhood report of a multicentre observational study
    Phytomedicine, 2007
    Co-Authors: M Haidvogl, Marianne Heger
    Abstract:

    An open post-marketing surveillance study was conducted to examine the treatment effect and safety of EPs 7630-solution in the treatment of Acute Bronchitis in children. This study included a total of 742 children (aged between 0 and 12 years) with Acute Bronchitis (83.4%) or Acute exacerbations of chronic Bronchitis (14.3%), who were treated with different doses of the herbal drug for up to 14 days. Five Bronchitis specific symptoms (BSS) were summed up to give an overall measure of disease severity. Non-specific disease symptoms (loss of appetite, diarrhoea, headache, vomiting, and fever) were also recorded, together with adverse events and overall ratings of efficacy and tolerability. The overall BSS score decreased during treatment from 6.0+/-3.0 points at baseline to 2.7+/-2.5 points after 7 days and to 1.4+/-2.1 points after 14 days. Remission or improvement in at least 80% of patients was recorded for all the individual component symptoms. The proportion of patients suffering from non-specific symptoms also substantially improved during treatment. For example, loss of appetite was present in 65.8% of patients at study begin, but only in 27.6% at the time point of last observation visit. In 88.3% of cases, the responsible physician rated the treatment as successful. Adverse events were minor and transitory. In conclusion, EPs 7630-solution was shown to be a safe and an effective treatment option for Acute Bronchitis or Acute exacerbations of chronic Bronchitis in children.

  • eps 7630 solution an effective therapeutic option in Acute and exacerbating Bronchitis
    Phytomedicine, 2007
    Co-Authors: H Matthys, Marianne Heger
    Abstract:

    Abstract Acute Bronchitis is one of the most common diagnoses in ambulatory care medicine. Although the benefit of antibiotics for Acute Bronchitis, which is mostly virally induced, is disputed, they are often prescribed. A therapeutic option for respiratory tract infections that do not fall within the strict indication range for antibiotic administration is the liquid herbal drug preparation from the roots of Pelargonium sidoides, EPs® 7630 (Umckaloabo®), which has been tested against placebo in double-blind clinical trials. EPs® 7630 has both antibacterial and immuno-modulating properties. The efficacy and tolerability of EPs® 7630 was investigated in a prospective, open, multicentric outcomes study with 205 patients suffering from Acute Bronchitis or Acute exacerbation of chronic Bronchitis. The main outcome measure was the change in the total score of five symptoms typical for Bronchitis (cough, expectoration, wheezing/whistling on expiration, chest pain during coughing, and dyspnoea), which were each rated using a 5-point scale (from 0=not present to 4=extremely pronounced). Further symptoms (hoarseness, headache, aching limbs and fatigue) were assessed using a four-point scale (from 0=not present to 3=very pronounced). The total score of the typical Bronchitis symptoms amounted to 6.1±2.8 points on average at the start of treatment and decreased by 3.3±3.8 points to 2.8±2.6 points by the final examination on day 7. About 60.5% of the patients assessed their health condition at the end of the study as much improved or free from symptoms. The onset of action appeared after two days on average. Adverse events occurred in a total of 16 patients. There were no serious adverse events. Altogether, 78% of the patients were satisfied or very satisfied with the treatment.

  • treatment of Acute Bronchitis with a liquid herbal drug preparation from pelargonium sidoides eps 7630 a randomised double blind placebo controlled multicentre study
    Current Medical Research and Opinion, 2007
    Co-Authors: H Matthys, Marianne Heger
    Abstract:

    ABSTRACTObjective: The objective of this study was to examine the efficacy and safety of a herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) in the treatment of Acute Bronchitis in adults outside the very restricted indication for an antibiotic therapy.Research design and methods: This was a randomised, double-blind, placebo-controlled, multicentre study with 217 patients aged between 18 and 66 years with Acute Bronchitis. One hundred and eight patients were given 30 drops of EPs 7630-solution three times daily and 109 patients 30 drops of placebo three times daily for a period of 7 days.Main outcome measures: Individual change in Bronchitis symptom score (BSS) over 7 days, individual symptoms, patient satisfaction and adverse events.Results: After 7 days of treatment, the BSS decreased by 7.6 ± 2.2 points in the EPs 7630 group and by 5.3 ± 3.2 points in the placebo group. The 95% confidence interval for the difference between the effects was calculated as 1.6–3.1, showing highly s...

  • efficacy and safety of an extract of pelargonium sidoides eps 7630 in adults with Acute Bronchitis a randomised double blind placebo controlled trial
    Phytomedicine, 2003
    Co-Authors: H Matthys, Reinhard Eisebitt, Bettina Seith, Marianne Heger
    Abstract:

    Summary Background: New evidence-based treatment options are required to avoid antibiotic overuse in Acute Bronchitis and to replace potentially inefficacious initial antibiotic treatment. Objective: To evaluate the efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) compared to placebo in patients with Acute Bronchitis. Design: Randomized, double-blind, placebo-controlled trial using a multi-stage adaptive design. Setting: 36 primary care physicians (investigators) at the out-patient care setting. Patients: 468 adults with Acute Bronchitis present ≤48 hours, Bronchitis Severity Score (BSS) ≥5 points, and informed consent. Intervention: EPs 7630 or placebo (30 drops three times daily) for 7 days. Measurement: The primary outcome criterion was the change of BSS on day 7. Results: The decrease of BSS from baseline to day 7 was 5.9 ± 2.9 points under EPs 7630 (n = 233), and 3.2 ± 4.1 points under placebo (n = 235). The 95% CI for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as [–3.359; –2.060] showing a significant superiority of EPs 7630 compared to placebo on day 7 (p Conclusion: EPs 7630 was superior in efficacy compared to placebo in the treatment of adults with Acute Bronchitis. Treatment with EPs 7630 clearly reduced the severity of symptoms and shortened the duration of working inability for nearly 2 days.

H Matthys - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of myrtol standardized in Acute Bronchitis a multi centre randomised double blind placebo controlled parallel group clinical trial vs cefuroxime and ambroxol
    Drug Research, 2011
    Co-Authors: H Matthys, C De Mey, Christian Carls, Andrzej Ryś, Angela Geib, Thomas Wittig
    Abstract:

    Myrtol standardized (Gelomyrtol® forte) is a phytotherapeutic extract (distillate) consisting mainly of three monoterpenes: (+)α-pinene, d-limonene and 1,8-cineole. Objective: This study describes and compares the efficacy, safety and tolerability of a 2-week treatment with myrtol stand. (4 × 300 mg, day 1-14), cefuroxime (CAS 55268-75-2) (2 × 250 mg daily for day 1-6), ambroxol (CAS 18683-91-5) (3 × 30 mg for day 1-3, 2 × 30 mg for days 4-14) and matched placebo in Acute Bronchitis. Patients: 676 male and female outpatients, aged ≥ 18 years, with Acute Bronchitis of recent onset (within last 5 days), with an FEV1 > 75% of the normal EGKS-value and without evidence or suspicion of chronic pulmonary disease or any further confounding illness were included in the study. Intervention: Patients were randomly assigned to a 2-week treatment course with either myrtol stand. (N = 170), cefuroxime (N = 171), ambroxol (N = 163) or placebo (N = 172) in a double-blind, placebo-matched, parallel-group fashion. Evaluations were at baseline (visit 1), after 1 and 2 weeks of treatment (visits 2 and 3) and at 2 weeks after conclusion of the treatments (visit 4). Criteria: Responder- and non-responder rates (primary), signs (abnormal auscultation), symptoms (daily diary data on nightly cough, coughing fits during the day, sputum consistence and general well-being; visit data on bronchial hyperreactivity and absence/presence of associated symptoms), FEV1, overall efficacy, absence of relapse, safety and tolerability (adverse events, laboratory screens, vital signs and physical examination). Criteria were evaluated for the intention-to-treat data-set (ITT) and the ‘efficacy evaluable’ sample (EAP), i.e. excluding patients with missing values (incl. discontinued non-responders and drop-outs for other reasons) at the time of assessment. Results: The signs and symptoms of Acute Bronchitis regressed readily in all treatment groups, but regression was slower and less complete in the patients treated with placebo. In patients treated with placebo, the Acute Bronchitis was considered to have deteriorated to such an extent that discontinuation was indicated (‘non-responder’) in 36 patients (ITT: 20.9%, 95% CI: 15.1 to 27.8% and EAP: 21.3%, CI: 15.4 to 28.3%) after 1 week (visit 2) and in 19 further patients (ITT: 11.0%, CI: 6.8 to 16.7%; EAP: 14.8%, CI: 9.2 to 22.2%) after 1 further week (visit 3). In contrast, in the group of patients treated with myrtol stand. the non-responder rates at visits 2 and 3 were only 5.3% (ITT, CI: 2.4 to 9.8%; EAP: 5.4%, CI: 2.5 to 10.0%) and 1.2% (ITT, CI: 0.1 to 4.2%; EAP: 1.3%, CI: 0.2 to 4.7%); the responder rates at visit 2 were statistically significantly higher (p Conclusion: Compared to placebo, treatment with myrtol stand. was well tolerated but evidently superior in terms of efficacy, resulting in a more rapid and more complete recovery; although well comparable with the other active treatments, myrtol stand. tended to be superior to cefuroxime and ambroxol for several ancillary criteria. Myrtol stand. is a well-evidenced alternative to antibiotics for Acute Bronchitis without specified infective agent, without the risk to promote the development of bacterial resistance.

  • efficacy and tolerability of eps 7630 tablets in patients with Acute Bronchitis a randomised double blind placebo controlled dose finding study with a herbal drug preparation from pelargonium sidoides
    Current Medical Research and Opinion, 2010
    Co-Authors: H Matthys, Viktor G Lizogub, F A Malek, Meinhard Kieser
    Abstract:

    AbstractObjective:Acute Bronchitis is one of the most frequent health complaints for which patients seek medical advice. Although viral infections prevail, antibiotics are commonly prescribed. In this study, the efficacy and tolerability of EPs 7630 tablets, a herbal drug preparation from the roots of Pelargonium sidoides, were investigated in adults with Acute Bronchitis outside the strict indication for antibiotics.Research design and methods:In this randomised, double-blind, placebo-controlled, multicentre dose-finding trial using an adaptive group-sequential design, 406 patients were randomly assigned to one of four parallel treatment groups (10 mg EPs 7630 tablets three times a day (30-mg group), 20 mg EPs 7630 tablets three times a day (60-mg group), 30 mg EPs 7630 tablets three times a day (90-mg group) or placebo three times a day) for a treatment period of 7 days. Primary endpoint was the change in the total score of Bronchitis-specific symptoms (BSS) from baseline to day 7.Results:Between day 0 ...

  • pelargonium sidoides preparation eps 7630 in the treatment of Acute Bronchitis in adults and children
    Phytomedicine, 2007
    Co-Authors: H Matthys, Petra Funk, Wolfgang Kamin, Marianne Heger
    Abstract:

    Abstract Acute Bronchitis, although mostly caused by viral infections, is commonly treated with antibiotics. As antibiotics should only be prescribed upon strict indication, treatment options like a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs® 7630) gain more and more interest. To evaluate the efficacy and safety of treatment with EPs® 7630 in patients with Acute Bronchitis, a multi-centre, prospective, open observational study was conducted in 440 study sites located in Germany. A total of 2099 patients aged 0–93 years with productive cough for less than six days without indication for treatment with antibiotics were given EPs® 7630-solution in an age-dependent dosage for 14 days. The primary outcome criterion was the mean change of the Bronchitis Severity Score (BSS: cough, sputum, rales/rhonchi, chest pain at cough, dyspnoea) from baseline to patient's individual last observation. During treatment, the mean BSS of all patients decreased from 7.1±2.9 points at baseline to 1.0±1.9 points at patients’ individual last visit. Subgroup analysis for children showed a decrease of mean BSS from 6.3±2.8 points to 0.9±1.8 points and analysis of children younger than three years showed a decrease of mean BSS from 5.2±2.5 points to 1.2±2.1 points. Adverse events occurred in 26/2099 (1.2%) patients. Serious adverse events were not reported. In conclusion, EPs® 7630 is an effective and well tolerated treatment of Acute Bronchitis in adults, children and infants outside the strict indication for antibiotic treatment.

  • treatment of Acute Bronchitis with a liquid herbal drug preparation from pelargonium sidoides eps 7630 a randomised double blind placebo controlled multicentre study
    Current Medical Research and Opinion, 2007
    Co-Authors: H Matthys, Marianne Heger
    Abstract:

    ABSTRACTObjective: The objective of this study was to examine the efficacy and safety of a herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) in the treatment of Acute Bronchitis in adults outside the very restricted indication for an antibiotic therapy.Research design and methods: This was a randomised, double-blind, placebo-controlled, multicentre study with 217 patients aged between 18 and 66 years with Acute Bronchitis. One hundred and eight patients were given 30 drops of EPs 7630-solution three times daily and 109 patients 30 drops of placebo three times daily for a period of 7 days.Main outcome measures: Individual change in Bronchitis symptom score (BSS) over 7 days, individual symptoms, patient satisfaction and adverse events.Results: After 7 days of treatment, the BSS decreased by 7.6 ± 2.2 points in the EPs 7630 group and by 5.3 ± 3.2 points in the placebo group. The 95% confidence interval for the difference between the effects was calculated as 1.6–3.1, showing highly s...

  • efficacy and safety of an extract of pelargonium sidoides eps 7630 in adults with Acute Bronchitis a randomised double blind placebo controlled trial
    Phytomedicine, 2003
    Co-Authors: H Matthys, Reinhard Eisebitt, Bettina Seith, Marianne Heger
    Abstract:

    Summary Background: New evidence-based treatment options are required to avoid antibiotic overuse in Acute Bronchitis and to replace potentially inefficacious initial antibiotic treatment. Objective: To evaluate the efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) compared to placebo in patients with Acute Bronchitis. Design: Randomized, double-blind, placebo-controlled trial using a multi-stage adaptive design. Setting: 36 primary care physicians (investigators) at the out-patient care setting. Patients: 468 adults with Acute Bronchitis present ≤48 hours, Bronchitis Severity Score (BSS) ≥5 points, and informed consent. Intervention: EPs 7630 or placebo (30 drops three times daily) for 7 days. Measurement: The primary outcome criterion was the change of BSS on day 7. Results: The decrease of BSS from baseline to day 7 was 5.9 ± 2.9 points under EPs 7630 (n = 233), and 3.2 ± 4.1 points under placebo (n = 235). The 95% CI for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as [–3.359; –2.060] showing a significant superiority of EPs 7630 compared to placebo on day 7 (p Conclusion: EPs 7630 was superior in efficacy compared to placebo in the treatment of adults with Acute Bronchitis. Treatment with EPs 7630 clearly reduced the severity of symptoms and shortened the duration of working inability for nearly 2 days.

Ralph Gonzales - One of the best experts on this subject based on the ideXlab platform.

  • one size does not fit all evaluating an intervention to reduce antibiotic prescribing for Acute Bronchitis
    BMC Health Services Research, 2013
    Co-Authors: Sara L Ackerman, Ralph Gonzales, Melissa Stahl, Joshua P Metlay
    Abstract:

    Overuse of antibiotics for upper respiratory tract infections (URIs) and Acute Bronchitis is a persistent and vexing problem. In the U.S., more than half of all patients with upper respiratory tract infections and Acute Bronchitis are treated with antibiotics annually, despite the fact that most cases are viral in etiology and are not responsive to antibiotics. Interventions aiming to reduce unnecessary antibiotic prescribing have had mixed results, and successes have been modest. The objective of this evaluation is to use mixed methods to understand why a multi-level intervention to reduce antibiotic prescribing for Acute Bronchitis among primary care providers resulted in measurable improvement in only one third of participating clinicians. Clinician perspectives on print-based and electronic intervention strategies, and antibiotic prescribing more generally, were elicited through structured telephone surveys at high and low performing sites after the first year of intervention at the Geisinger Health System in Pennsylvania (n = 29). Compared with a survey on antibiotic use conducted 10 years earlier, clinicians demonstrated greater awareness of antibiotic resistance and how it is impacted by individual prescribing decisions—including their own. However, persistent perceived barriers to reducing prescribing included patient expectations, time pressure, and diagnostic uncertainty, and these factors were reported as differentially undermining specific intervention components’ effectiveness. An exam room poster depicting a diagnostic algorithm was the most popular strategy. Future efforts to reduce antibiotic prescribing should address multi-level barriers identified by clinicians and tailor strategies to differences at individual clinician and group practice levels, focusing in particular on changing how patients and providers make decisions together about antibiotic use.

  • a cluster randomized trial of decision support strategies for reducing antibiotic use in Acute Bronchitis
    JAMA Internal Medicine, 2013
    Co-Authors: Ralph Gonzales, Tammy Anderer, Charles E Mcculloch, Judith H Maselli, Frederick J Bloom, Thomas R Graf, Melissa Stahl, Michelle Yefko, Julie Molecavage, Joshua P Metlay
    Abstract:

    Background National quality indicators show little change in the overuse of antibiotics for uncomplicated Acute Bronchitis. We compared the effect of 2 decision support strategies on antibiotic treatment of uncomplicated Acute Bronchitis. Methods We conducted a 3-arm cluster randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed decision support intervention sites (11 practices) received decision support for Acute cough illness through a print-based strategy, the computer-assisted decision support intervention sites (11 practices) received decision support through an electronic medical record–based strategy, and the control sites (11 practices) served as a control arm. Both intervention sites also received clinician education and feedback on prescribing practices, as well as patient education brochures at check-in. Antibiotic prescription rates for uncomplicated Acute Bronchitis in the winter period (October 1, 2009, through March 31, 2010) following introduction of the intervention were compared with the previous 3 winter periods in an intent-to-treat analysis. Results Compared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed decision support intervention sites (from 80.0% to 68.3%) and at the computer-assisted decision support intervention sites (from 74.0% to 60.7%) but increased slightly at the control sites (from 72.5% to 74.3%). After controlling for patient and clinician characteristics, as well as clustering of observations by clinician and practice site, the differences for the intervention sites were statistically significant from the control sites (P = .003 for control sites vs printed decision support intervention sites and P = .01 for control sites vs computer-assisted decision support intervention sites) but not between themselves (P = .67 for printed decision support intervention sites vs computer-assisted decision support intervention sites). Changes in total visits, 30-day return visit rates, and proportion diagnosed as having uncomplicated Acute Bronchitis were similar among the study sites. Conclusions Implementation of a decision support strategy for Acute Bronchitis can help reduce the overuse of antibiotics in primary care settings. The effect of printed vs computer-assisted decision support strategies for providing decision support was equivalent. Trial Registration clinicaltrials.gov Identifier: NCT00981994

  • unintended consequences of a quality measure for Acute Bronchitis
    The American Journal of Managed Care, 2012
    Co-Authors: Serena Roth, Ralph Gonzales, Judith H Maselli, Frederick J Bloom, Thomas R Graf, Melissa Stahl, Tammy Hardinganderer, Joshua P Metlay
    Abstract:

    OBJECTIVES To determine whether diagnostic coding shifts might undermine apparent improvements resulting from the 2007 Healthcare Effectiveness Data and Information Set (HEDIS) measure on avoidance of antibiotics for the treatment of adults with Acute Bronchitis (International Classification of Diseases, Ninth Revision, Clinical Modification code 466.0). STUDY DESIGN Time series analysis within a primary care network for 3 successive winter seasons from 2006 to 2009. METHODS All initial adult visits with a primary diagnosis code of 466.0 or 490 (Bronchitis, not otherwise specified) were analyzed. Multivariable analysis accounted for clustering of observations by physician. RESULTS The percentage of visits treated with antibiotics declined significantly for code 466.0 (76.8% to 74.4% to 27.0% of visits over the 3-year study period; P <.0001 for trend) but did not decline for code 490 (86.6% to 87.6% to 82.1% of visits; P = .33 for trend). Use of the 490 code rose significantly over the study period, from 1.5% of total Bronchitis visits in year 1 to 84.6% of total Bronchitis visits in year 3. As a result, the odds of an antibiotic prescription for codes 466 and 490 combined decreased slightly in year 3 compared with year 1 (odds ratio 0.88; 95% confidence interval 0.78-0.99). CONCLUSIONS While performance on the specific HEDIS measure improved dramatically during this study period, overall antibiotic prescribing did not decline substantially. Quality measures that assess performance on specific diagnosis codes are imperfect and do not account for shifts in diagnosis coding.

  • principles of appropriate antibiotic use for treatment of uncomplicated Acute Bronchitis background
    Annals of Emergency Medicine, 2001
    Co-Authors: Ralph Gonzales, John G Bartlett, Richard E Besser, Richelle J Cooper, John Hickner, Jerome R Hoffman, Merle A. Sande
    Abstract:

    The following principles of appropriate antibiotic use for adults with Acute Bronchitis apply to immunocompetent adults without complicating comorbid conditions, such as chronic lung or heart disease. The evaluation of adults with an Acute cough illness or a presumptive diagnosis of uncomplicated Acute Bronchitis should focus on ruling out serious illness, particularly pneumonia. In healthy, nonelderly adults, pneumonia is uncommon in the absence of vital sign abnormalities or asymmetrical lung sounds, and chest radiography is usually not indicated. In patients with cough lasting 3 weeks or longer, chest radiography may be warranted in the absence of other known causes. Routine antibiotic treatment of uncomplicated Acute Bronchitis is not recommended, regardless of duration of cough. If pertussis infection is suspected (an unusual circumstance), a diagnostic test should be performed and antimicrobial therapy initiated. Patient satisfaction with care for Acute Bronchitis depends most on physician--patient communication rather than on antibiotic treatment.

  • principles of appropriate antibiotic use for treatment of Acute Bronchitis in adults
    Annals of Internal Medicine, 2001
    Co-Authors: Vincenza Snow, Christel Motturpilson, Ralph Gonzales
    Abstract:

    In this guideline, evidence is presented and specific recommendations are made about how clinicians can differentiate between bacterial and viral causes of Acute Bronchitis and about when the use of antibiotics in Acute Bronchitis is beneficial. The numbers in square brackets are cross-references to the numbered sections in the accompanying background paper, “Principles of Appropriate Antibiotic Use for Treatment of Acute Bronchitis in Adults: Background,” which is part 2 of this guideline (see pages 521-529).

Meinhard Kieser - One of the best experts on this subject based on the ideXlab platform.

  • treatment of Acute Bronchitis with eps 7630 randomized controlled trial in children and adolescents
    Pediatrics International, 2012
    Co-Authors: Wolfgang Kamin, F A Malek, Lidia I Ilyenko, Meinhard Kieser
    Abstract:

    Background:  The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from Acute Bronchitis, outside the strict indication for antibiotics. Methods:  A total of 220 patients with Acute Bronchitis were randomized and given either verum containing EPs 7630 (1–6 years/>6–12 years/>12–18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of Bronchitis-specific symptoms (BSS) from day 0 to day 7. Results:  The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0–day 7: 4.4 ± 1.6 vs 2.9 ± 1.4 points; P < 0.0001). Improvements were most pronounced for ‘coughing’ and ‘rales at auscultation’. Tolerability was similarly good in both groups. Conclusions:  EPs 7630 proved to be an efficacious and well-tolerated option for the treatment of Acute Bronchitis in children and adolescents outside the strict indication for antibiotics.

  • efficacy and tolerability of eps 7630 tablets in patients with Acute Bronchitis a randomised double blind placebo controlled dose finding study with a herbal drug preparation from pelargonium sidoides
    Current Medical Research and Opinion, 2010
    Co-Authors: H Matthys, Viktor G Lizogub, F A Malek, Meinhard Kieser
    Abstract:

    AbstractObjective:Acute Bronchitis is one of the most frequent health complaints for which patients seek medical advice. Although viral infections prevail, antibiotics are commonly prescribed. In this study, the efficacy and tolerability of EPs 7630 tablets, a herbal drug preparation from the roots of Pelargonium sidoides, were investigated in adults with Acute Bronchitis outside the strict indication for antibiotics.Research design and methods:In this randomised, double-blind, placebo-controlled, multicentre dose-finding trial using an adaptive group-sequential design, 406 patients were randomly assigned to one of four parallel treatment groups (10 mg EPs 7630 tablets three times a day (30-mg group), 20 mg EPs 7630 tablets three times a day (60-mg group), 30 mg EPs 7630 tablets three times a day (90-mg group) or placebo three times a day) for a treatment period of 7 days. Primary endpoint was the change in the total score of Bronchitis-specific symptoms (BSS) from baseline to day 7.Results:Between day 0 ...

  • efficacy and tolerability of eps 7630 in patients aged 6 18 years old with Acute Bronchitis
    Acta Paediatrica, 2010
    Co-Authors: Wolfgang Kamin, V Maydannik, F A Malek, Meinhard Kieser
    Abstract:

    Aim:  For EPs-7630, a herbal drug preparation from Pelargonium sidoides roots, therapeutic effects in respiratory tract infections outside the strict indication for antibiotics have already been demonstrated in adults. Now, a dose-finding study for EPs-7630 was performed in children and adolescents. Methods:  A total of 400 patients (aged 6–18 years) were randomized to receive either 30 mg, 60 mg or 90 mg EPs-7630 or placebo daily. Primary outcome criterion was the change in the Bronchitis Severity Score (BSS) from day 0 to day 7. Results:  After 7 days of treatment, the change in the BSS total score was significantly better in the 60 mg and 90 mg groups compared with placebo that of the without relevant differences between these two dosages. Especially ‘coughing’, ‘sputum’ and ‘rales at auscultation’ improved under EPs-7630. Onset of effect was faster, time of bed rest shorter and treatment outcome and satisfaction with treatment were rated better. Tolerability was comparable with placebo in all treatment groups. Conclusion:  EPs-7630 is effective in Acute Bronchitis outside the strict indication for antibiotics in 6–18 years old patients, with a dose of 60 mg or 90 mg daily offering the best benefit/risk ratio. EPs-7630 significantly reduces the severity of symptoms, leads to a more favourable course of the disease and a faster recovery from Acute Bronchitis compared with the placebo, and is well tolerated.

  • efficacy and tolerability of eps 7630 in children and adolescents with Acute Bronchitis a randomized double blind placebo controlled multicenter trial with a herbal drug preparation from pelargonium sidoides roots
    Principles and Practice of Constraint Programming, 2010
    Co-Authors: Wolfgang Kamin, F A Malek, V Maydannik, Meinhard Kieser
    Abstract:

    OBJECTIVE The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with Acute Bronchitis outside the strict indication for antibiotics. MATERIALS AND METHODS A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 x 10 drops/d; > 6 - 12 years: 3 x 20 drops/d; > 12 - 18 years: 3 x 30 drops/d) or placebo for 7 consecutive days. PRIMARY OUTCOME MEASURE change in the total score of Bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. RESULTS From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 +/- 1.8 vs. 1.2 +/- 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. CONCLUSION EPs 7630 was shown to be efficacious and safe in the treatment of Acute Bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.

Lorne A Becker - One of the best experts on this subject based on the ideXlab platform.

  • antibiotics for Acute Bronchitis
    Cochrane Database of Systematic Reviews, 2017
    Co-Authors: Susan M Smith, Tom Fahey, John Smucny, Lorne A Becker
    Abstract:

    Background The benefits and risks of antibiotics for Acute Bronchitis remain unclear despite it being one of the most common illnesses seen in primary care. Objectives To assess the effects of antibiotics in improving outcomes and to assess adverse effects of antibiotic therapy for people with a clinical diagnosis of Acute Bronchitis. Search methods We searched CENTRAL 2016, Issue 11 (accessed 13 January 2017), MEDLINE (1966 to January week 1, 2017), Embase (1974 to 13 January 2017), and LILACS (1982 to 13 January 2017). We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 5 April 2017. Selection criteria Randomised controlled trials comparing any antibiotic therapy with placebo or no treatment in Acute Bronchitis or Acute productive cough, in people without underlying pulmonary disease. Data collection and analysis At least two review authors extracted data and assessed trial quality. Main results We did not identify any new trials for inclusion in this 2017 update. We included 17 trials with 5099 participants in the primary analysis. The quality of trials was generally good. At follow-up there was no difference in participants described as being clinically improved between the antibiotic and placebo groups (11 studies with 3841 participants, risk ratio (RR) 1.07, 95% confidence interval (CI) 0.99 to 1.15). Participants given antibiotics were less likely to have a cough (4 studies with 275 participants, RR 0.64, 95% CI 0.49 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) 6) and a night cough (4 studies with 538 participants, RR 0.67, 95% CI 0.54 to 0.83; NNTB 7). Participants given antibiotics had a shorter mean cough duration (7 studies with 2776 participants, mean difference (MD) -0.46 days, 95% CI -0.87 to -0.04). The differences in presence of a productive cough at follow-up and MD of productive cough did not reach statistical significance. Antibiotic-treated participants were more likely to be improved according to clinician's global assessment (6 studies with 891 participants, RR 0.61, 95% CI 0.48 to 0.79; NNTB 11) and were less likely to have an abnormal lung exam (5 studies with 613 participants, RR 0.54, 95% CI 0.41 to 0.70; NNTB 6). Antibiotic-treated participants also had a reduction in days feeling ill (5 studies with 809 participants, MD -0.64 days, 95% CI -1.16 to -0.13) and days with impaired activity (6 studies with 767 participants, MD -0.49 days, 95% CI -0.94 to -0.04). The differences in proportions with activity limitations at follow-up did not reach statistical significance. There was a significant trend towards an increase in adverse effects in the antibiotic group (12 studies with 3496 participants, RR 1.20, 95% CI 1.05 to 1.36; NNT for an additional harmful outcome 24). Authors' conclusions There is limited evidence of clinical benefit to support the use of antibiotics in Acute Bronchitis. Antibiotics may have a modest beneficial effect in some patients such as frail, elderly people with multimorbidity who may not have been included in trials to date. However, the magnitude of this benefit needs to be considered in the broader context of potential side effects, medicalisation for a self limiting condition, increased resistance to respiratory pathogens, and cost of antibiotic treatment.

  • beta2 agonists for Acute cough or a clinical diagnosis of Acute Bronchitis
    Cochrane Database of Systematic Reviews, 2015
    Co-Authors: Lorne A Becker, Jeffrey Hom, Miguel Angel Villasiskeever, Johannes C Van Der Wouden
    Abstract:

    Background The diagnosis of Acute Bronchitis is made on clinical grounds and a variety of clinical definitions have been used. There are no clearly effective treatments for the cough of Acute Bronchitis. Beta2-agonists are often prescribed, perhaps because clinicians suspect many patients also have reversible airflow restriction (as seen in asthma or chronic obstructive pulmonary disease (COPD)) contributing to the symptoms. Objectives To determine whether beta2-agonists improve Acute Bronchitis symptoms in people with no underlying pulmonary disease (such as asthma, COPD or pulmonary fibrosis). Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2015, Issue 5, MEDLINE (January 1966 to May 2015), EMBASE (1974 to May 2015), Web of Science (2011 to May 2015) and LILACS (1982 to May 2015). Selection criteria Randomised controlled trials (RCTs) which allocated people (adults, or children over two years of age) with Acute Bronchitis or Acute cough and without known pulmonary disease to beta2-agonist versus placebo, no treatment or alternative treatment. Data collection and analysis Three review authors independently selected outcomes and extracted data while blinded to study results. Two review authors independently assessed each trial for risk of bias. We analysed trials in children and adults separately. Main results Two trials of moderate quality in children (n = 134) with no evidence of airflow restriction did not find any benefits from oral beta2-agonists. Five trials in adults (n = 418) had mixed results but overall summary statistics did not reveal any significant benefits from oral (three trials) nor from inhaled (two trials) beta2-agonists. Three studies with low-quality evidence demonstrated no significant differences in daily cough scores, nor in the percentage of adults still coughing after seven days (control group 71%; risk ratio (RR) 0.86, 95% confidence interval (CI) 0.63 to 1.18; 220 participants). In one trial, subgroups with evidence of airflow limitation had lower symptom scores if given beta2-agonists. The trials that noted quicker resolution of cough with beta2-agonists were those with a higher proportion of people wheezing at baseline. Low-quality evidence suggests that adults given beta2-agonists were more likely to report tremor, shakiness or nervousness (RR 7.94, 95% CI 1.17 to 53.94; 211 participants; number needed to treat for an additional harmful outcome (NNTH) 2). Authors' conclusions There is no evidence to support the use of beta2-agonists in children with Acute cough who do not have evidence of airflow restriction. There is also little evidence that the routine use of beta2-agonists is helpful for adults with Acute cough. These agents may reduce symptoms, including cough, in people with evidence of airflow restriction. However, this potential benefit is not well supported by the available data and must be weighed against the adverse effects associated with their use.

  • beta2 agonists for Acute Bronchitis
    Cochrane Database of Systematic Reviews, 2011
    Co-Authors: Lorne A Becker, Jeffrey Hom, Miguel Angel Villasiskeever, Johannes C Van Der Wouden
    Abstract:

    BACKGROUND The optimal treatment for Acute Bronchitis is not clear. Because many patients with Acute Bronchitis have airflow limitation as well as cough, beta2-agonists may be useful. OBJECTIVES To determine whether beta2-agonists improve the symptoms of Acute Bronchitis in patients who do not have underlying pulmonary disease. SEARCH STRATEGY The Cochrane Library (through August 2000), MEDLINE (1966 to 2000), EMBASE (1974 to 2000), and Conference Proceedings using "bronchodilator (exp)", "adrenergic beta-agonist (exp)", or "sympathomimetics (exp)" and "Bronchitis" or "cough"; Science Citation Index for referenced publications; and letters to manufacturers of beta2-agonists. An updated search of the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2003); MEDLINE (January 2000 to July 2003); EMBASE (January 2000 to July 2003) was run in July 2003. SELECTION CRITERIA Trials in which patients (adults or children over two years of age) without known pulmonary disease who were diagnosed with Acute Bronchitis or Acute cough without other cause were randomized to beta2-agonist versus placebo, no treatment, or alternative treatment. DATA COLLECTION AND ANALYSIS Three reviewers independently first selected outcomes and evaluated trial quality while blinded to study results, and then extracted data. Trials in children and in adults were analyzed separately. MAIN RESULTS Two trials in children (n = 109) with Acute cough and no evidence of airway obstruction did not find any benefits from beta2-agonists. Combined data did not show a significant difference in daily cough scores between patients given oral beta2-agonists and those in the control groups. Five trials in adults (n = 418) with Acute cough or Acute Bronchitis had mixed results, but overall summary statistics did not reveal any significant benefits from oral (three trials) nor inhaled (two trials) beta2-agonists. There were no significant differences in daily cough scores nor in the number of patients still coughing after seven days (control rate 73%; RR = 0.77, 95% CI 0.54-1.09). Subgroups of patients with evidence of airflow limitation had lower symptom scores if given beta2-agonists in one trial; and the trials that did note quicker resolution of cough in patients given beta2-agonists were those that had a higher proportion of patients with wheezing at baseline. Patients given beta2-agonists were more likely to report tremor, shakiness, or nervousness than patients in the control groups (for trials in children control rate 0%; RR 6.76, 95% CI 0.86 to 53.12, NNH 9, 95% CI 5 to 100; for trials in adults, control rate 11%; RR 7.94, 95% CI 1.17 to 53.94, NNH 2.3, 95% CI 2 to 3). REVIEWER'S CONCLUSIONS There is no evidence to support using beta2-agonists in children with Acute cough who do not have evidence of airflow obstruction. There is also little evidence that the routine use of beta2-agonists for adults with Acute cough is helpful. These agents may reduce symptoms, including cough, in patients with evidence of airflow obstruction; but this potential benefit is not well-supported by the available data and must be weighed against the adverse effects associated with beta2-agonists.