Clinical Research > Product Research > Bronchial Irritations

Bronchial Irritations

Treatment

STUDY: Chuchalin AG, Berman B, Lehmacher W. Explore (NY). 2005 Nov;1(6):437-45. Russian Research Institute of Pulmonology, Moscow, Russia.

OBJECTIVE: To evaluate the efficacy and safety of a Pelargonium sidoides preparation (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) compared with placebo.

DESIGN: Randomized, double-blind, placebo-controlled trial using a design with planned interim analyses.

SETTING: Six outpatient clinics.

PATIENTS: One hundred twenty-four adults with chest cold (bronchial symptoms) for 48 hours or less, and having a symptom score, (BSS) >/=five points, and informed consent. The BSS consisted of five symptoms: coughing, sputum production, sounds heard upon use of stethoscope that are characteristic of obstruction of airway by secretions (called pulmonary rales at auscultation), chest pain while coughing, and shortness of breath/labored breathing (called dyspnoea). The severity of each of these symptoms was rated on a scale from 0 (not present) to 4 (very severe), for a maximum total BSS of 20.

INTERVENTION: EPs 7630 or placebo (30 drops three times daily) for seven days.

MEASUREMENTS: The primary outcome criterion was the change of BSS on day seven.

RESULTS: The decrease of BSS from baseline to day seven was 7.2 +/- 3.1 points with EPs 7630 (n = 64) and 4.9 +/- 2.7 points with placebo (n = 60). The superiority of EPs 7630 over placebo was obvious at the first follow-up visit (day 3-5), at which time the active group had a BSS score of 4.2 ± 2.2 points whereas the placebo group had a BSS of 6.2 ± 2.5 (p < 0.0001). By day 7, 95.3% of patients in the EPs 7630 group had a BSS of < 5 points while only 58.3% in the placebo group had a BSS of < 5 points (p < 0.0001). A decrease in BSS of at least 5 points was observed in 90.6% of patients in the EPs 7630 group compared with 51.7% of patients treated with the placebo (p < 0.0001). Rapid recovery (defined as a BSS of < 5 points and a decrease in BSS of at least 5 points) was observed in 90.6% of EPs 7630 patients compared with 41.7% receiving the placebo (p < 0.0001). After 7 days, 78.2% of patients in the EPs 7630 group were able to pursue their daily activities again, whereas only 34.8% of patients receiving placebo could do so (p = 0.001). Adverse events occurred in 25 of 124 patients (EPs 7630: 15/64 patients, placebo: 10/60 patients). All adverse events were assessed as non-serious. 98.4% of subjects in the EPs 7630 group rated the treatment “very good” or “good” in terms of tolerability (compared to 96.7% in the placebo group).

CONCLUSIONS: EPs 7630 was superior in efficacy compared with placebo.


Efficacy and Safety

STUDY: Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630). A randomised, double-blind, placebo-controlled trial. Matthys H, Eisebitt R, Seith B, Heger M. Phytomedicine. 2003;10 Suppl 4:7-17. Lungs at Home, Freiburg i. Br., Germany

BACKGROUND: New evidence-based treatment options are required.

OBJECTIVE: To evaluate the efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) compared to placebo.

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 chest cold (bronchial symptoms) for 48 hours or less, and having a symptom score (BSS) > or = 5 points, and informed consent. The BSS consisted of five symptoms: coughing, sputum production, sounds heard upon use of stethoscope that are characteristic of obstruction of airway by secretions (called rales/rhonchi), chest pain while coughing, and shortness of breath/labored breathing (called dyspnoea). The severity of each of these symptoms was rated on a scale from 0 (not present) to 4 (very severe), for a maximum total BSS of 20.

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 superiority of EPs 7630 over placebo was obvious at the first follow-up visit (day 3-5), at which time the active group had a BSS score of 4.8 ± 2.3 points whereas the placebo group had a BSS of 6.2 ± 3.0 (p < 0.0001). By day 7, 64% of patients in the EPs 7630 group had a BSS of < 3 points while only 37.9% in the placebo group had a BSS of < 3 points (p < 0.0001). A decrease in BSS of at least 7 points was observed in 43.3% of patients in the EPs 7630 group compared with 23.0% of patients treated with the placebo at day 7 (p < 0.0001). Rapid recovery (defined as a BSS of < 3 points and a decrease in BSS of at least 7 points) was observed in 34.3% of EPs 7630 patients compared with 20.4% receiving the placebo (p < 0.0001). In the EPs 7630 group, cough disappeared or improved in 89.2% of patients compared with 56.6% of patients in the placebo group (p < 0.0001), and sputum disappeared or improved in 66% of patients in the active group compared with 47.7% of those in the placebo group (p < 0.0002). On day 7, fever had disappeared in 96.9% of patients in the active group compared with 58.4% of those in the placebo group (p < 0.0001). Finally, patients in the EPs 7630 group were able to return to work nearly two days earlier than the placebo-treated group (p < 0.0001). Adverse events (AEs) occurred in 36/468 patients (EPs 7630: 20/233 patients, placebo: 16/235 patients). All events were assessed as non-serious. 96.1% of patients in the EPs 7630 group rated the treatment “very good” or “good” for tolerability (compared to 88.1% of patients in the placebo group).

CONCLUSION: EPs 7630 was superior in efficacy compared to placebo. Treatment with EPs 7630 clearly reduced the severity of symptoms and shortened the duration of working inability by nearly 2 days.


Observational Study in Adults & Children

STUDY: Pelargonium sidoides preparation (EPs 7630) in the treatment of adults and children. Matthys H, Kamin W, Funk P, Heger M. Phytomedicine. 2007;14 Suppl 6:69-73. Epub 2006 Dec 20. Department of Pneumology, University Hospital, Freiburg, Germany.

BACKGROUND: Treatment options like a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) gain more and more interest.

OBJECTIVE: To evaluate the efficacy and safety of treatment with EPs 7630 in patients.

DESIGN: Multi-centre, prospective, open observational study.

SETTING: 440 study sites located in Germany.

PATIENTS: A total of 2099 patients aged 0-93 years with productive cough for less than six days without indication for treatment with antibiotics.

INTERVENTION: EPs 7630-solution in an age-dependent dosage for 14 days.

MEASUREMENTS: The primary outcome criterion was the mean change from baseline to patient's individual last observation.

RESULTS: 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.

CONCLUSION: In conclusion, EPs 7630 is an effective and well tolerated treatment in adults, children and infants.


Systematic Review & Meta-Analysis

STUDY: Pelargonium sidoides: a systematic review and meta-analysis. Agbabiaka TB, Guo R, Ernst E. Phytomedicine. 2008 May;15(5):378-85. Epub 2008 Jan 28. Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, UK. taofikat.agbabiaka@pms.ac.uk

OBJECTIVE: To critically assess the efficacy of Pelargonium sidoides.

DATA SOURCES: Systematic literature searches were performed in 5 electronic databases: (Medline (1950 - July 2007), Amed (1985 - July 2007), Embase (1974 - July 2007), CINAHL (1982 - July 2007), and The Cochrane Library (Issue 3, 2007) without language restrictions. Reference lists of retrieved articles were searched, and manufacturers contacted for published and unpublished materials.

REVIEW METHODS: Study selection was done according to predefined criteria. All randomized clinical trials (RCTs) testing P. sidoides extracts (mono preparations) against placebo or standard and assessing clinically relevant outcomes were included. Two reviewers independently selected studies, extracted and validated relevant data. Methodological quality was evaluated using the Jadad score. Meta-analysis was performed using a fixed-effect model for continuous data, reported as weighted mean difference with 95% confidence intervals.

RESULTS: Six RCTs met the inclusion criteria, of which 4 were suitable for statistical pooling. Methodological quality of most trials was good. One study compared an extract of P. sidoides, EPs 7630, against conventional non-antibiotic treatment (acetylcysteine); the other five studies tested EPs 7630 against placebo. All RCTs reported findings suggesting the effectiveness of P. sidoides. Meta-analysis of the four placebo-controlled RCTs suggested that EPs 7630 significantly reduced BBS in patients by day 7. No serious adverse events were reported.

CONCLUSION: There is encouraging evidence from currently available data that P. sidoides is effective compared to placebo.

 

 
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