Treatment of acute bronchitis with a liquid herbal drug preparation from Pelargonium sidoides (EPs 7630): a randomised, double-blind, placebo-controlled, multicentre study.
OBJECTIVE
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.


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.


METHODS
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 significant superiority for the EPs 7630 treatment (p < 0.0001). There were also marked improvements in the individual symptoms, which are the components of BSS - cough, chest pain on coughing, sputum, rales/rhonchi and dyspnoea - in the treatment group, relative to placebo. Patient satisfaction was very good. Only minor and transitory adverse events were recorded. No serious adverse events occurred during the trial.


CONCLUSIONS
EPs 7630-solution is a well tolerated and effective treatment for acute bronchitis in adults outside the very restricted indication for an antibiotic therapy.
Matthys
H
H
Department of Pneumology, University Hospital Freiburg, Freiburg, Germany. hmatthys@t-online.de
Heger
M
M
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D001991:Bronchitis / Q000188:drug therapy*; D002637:Chest Pain / Q000209:etiology; D003371:Cough / Q000209:etiology; D004311:Double-Blind Method; D004417:Dyspnea / Q000209:etiology; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000302:isolation & purification / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D031316:Pelargonium / Q000737:chemistry; D008517:Phytotherapy; D010936:Plant Extracts / Q000302:isolation & purification / Q000627:therapeutic use*; D018517:Plant Roots / Q000737:chemistry; D011446:Prospective Studies; D016896:Treatment Outcome
C476332:EPs 7630; D007155:Immunologic Factors; D010936:Plant Extracts