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

Results

Forty-four of the 75 patients (22 in the antibacterials plus ginseng group and 22 in the antibacterials-only group) were evaluable. Reliable bacterial counts were not obtained at all time-points for 22 subjects and nine patients discontinued the trial spontaneously. The results of the trial are depicted in figures 1 and 2.

Evolution of the bacterial count in patients receiving amoxicillin 875mg plus clavulanic acid 125mg twice daily with or without additional standardised ginseng extract G115® 100mg twice daily. The mean count is expressed in log units. A value of 2 was the cutoff point for detection. * p <0.05vs antibacterials alone.

Time to clearance of bacteria from the bronchial system in patients receiving amoxicillin 875mg plus clavulanic acid 125mg twice daily with or without additional standardised ginseng extract G115® 100mg twice daily. 1 Term used to identify patients who have follow-up data to enter a particular interval in a life-table analysis, but whose most current follow-up data do not extend to the end of the interval. The number of patients withdrawn during this interval is then used for the survival analysis.

Significant group and time effects were found after analysis of the evolution of bacterial counts. Statistically significant differences between treatment groups were observed on days 4, 5, 6 and 7 (p = 0.0049, p = 0.0104, p = 0.0175, p = 0.0182, respectively), while a borderline trend was seen on day 8 (p = 0.0554) [table I].

The log rank test showed a significant difference between the treatment groups after analysis of time to clearance of infection (chi2 = 6.2127, p = 0.0127). The median time to reach the point where no bacteria were detected was lower in the antibacterial plus ginseng group [median 6 days, mean 5.9 days, standard deviation (SD) 0.3] than in the antibacterials-only group (median 7 days, mean 6.7 days, SD 0.3). Five censored observations 1 were considered, all in the antibacterials-only group.

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