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

ABSTRACT

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.

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 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.

Conclusion: EPs 7630-solution is a well tolerated and effective treatment for acute bronchitis in adults outside the very restricted indication for an antibiotic therapy.

Key words: :

• Acute bronchitis
• Bronchitis symptom score
• EPs 7630
• Herbal medicine
• Umckaloabo