Effects of the Standardised Ginseng Extract G115(Reg.) in Patients with Chronic Bronchitis: A Nonblinded, Randomised, Comparative Pilot Study

F. Scaglione, K. Weiser, M. Alessandria University of Milan, Milan, Italy

Clin Drug Invest. 2001;21(1) 

In This Article

Patients and Methods

This trial was designed as a nonblinded, randomised, comparative pilot trial to investigate the effects of the standardised ginseng extract G115® (Ginsana®, kindly provided by Pharmaton SA, Lugano, Switzerland) on the bacterial count [number of colony forming units (CFU)] in the bronchial systems of patients with ACB.

To be included in the trial, the individual had to have symptoms of ACBat the time of enrolment. Chronic bronchitis was defined as a productive cough present on most days for a minimum of 3 consecutive months over 2 or more successive years. ACB was defined as a rapid onset of cough with production of purulent sputum. Additionally, the patients (male or female, aged >18 years) had to have one or more of the following: dyspnoea, tachypnoea, wheezing and/or fever (>38°C), and be suitable for therapeutic treatment with amoxicillin and clavulanic acid. They were requested to sign an informed consent form approved by the local ethics review board.

Individuals were excluded from the study if they fulfilled any of the following criteria: concurrent pneumonia, systemic use of an anti-infective drug in the 7 days prior to enrolment, systemic corticosteroid therapy (excluding the use of inhaled or intranasal aerosolised corticosteroids), hypersensitivity to penicillins, a history of significant renal or hepatic impairment, or treatment with a drug within the last 30 days that had not received regulatory approval at the time of study entry. The investigators and their site personnel including their immediate families (the immediate family being defined as a spouse, parent, child or sibling, whether biological or legally adopted) were also excluded from the study.

Seventy-five individuals suffering from ACB were included in the trial, after giving their informed consent. The study was conducted at and funded by the Department of Pharmacology, University of Milan, during the period October 1996 to April 1999. All participants received 875mg amoxicillin and 125mg clavulanic acid twice daily for 9 days. They were then randomised into two groups following a predetermined randomisation list: one group (n = 37) received only the antibacterial treatment, while the second group (n = 38) received 100mg standardised ginseng extract G115® twice daily as oral tablets. The mean duration of treatment was 9 days.

Each morning of the trial period, a sample of bronchial secretion was taken from each patient by protected expectoration (patients carefully rinsed their oral cavity and a small roll of compressed cotton was placed in the gap between the cheeks, the dental arches and the tongue to reduce salivary contamination to a minimum). The sample was then plated out, after 1:10 dilution in a physiological solution (1ml of bronchial secretion in 9ml of saline), onto Petri dishes containing Müller Hinton Agar. The bacterial count and the determination of the CFU was performed after 18 hours' incubation at 37°C.

Patients were considered cured and the antibacterial therapy was stopped upon elimination of signs and symptoms of infections (cough, purulent sputum, dyspnoea, tachypnoea, wheezing). The time to clearance of infection was the main clinical endpoint.

Statistical comparisons between and within groups were performed using ANOVA for repeated measures for the evolution of the total bacterial count and Logrank test (time to clearance), using SAS version 6.12.

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