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

Abstract and Introduction

Objective: To investigate the effects of G115® ginseng extract in reducing the bacterial count in the lungs of patients undergoing an acute attack of chronic bronchitis.
Design: Nonblinded, randomised, comparative pilot trial.
Setting: One centre in Milan, Italy.
Patients: 75 patients with acute attacks of chronic bronchitis.
Interventions: All patients received 875mg amoxicillin and 125mg clavulanic acid twice daily for 9 days. They were then further randomised into two groups, one (n = 37) receiving only the antibacterial treatment, the second (n = 38) also receiving 100mg standardised ginseng extract G115® twice daily. The total duration of treatment was 9 days.
Main Outcome Measures and Results: Of the 75 patients included in the trial, 44 were evaluable. Significant group and time effects were found after analysis of the evolution of bacterial count. Significant differences between treatment groups were found on days 4, 5, 6 and 7, while a borderline trend was found on day 8. 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 those receiving antibacterials alone (median 7 days, mean 6.7 days, SD 0.3).
Conclusions: In the group receiving G115® ginseng extract, bacterial clearance was significantly faster than in those receiving antibacterials alone. These results indicate a beneficial effect of G115® ginseng extract on the reduction of bacterial counts in the bronchial systems of patients with acute attacks of chronic bronchitis. Patients in whom the elimination of bacteria from the bronchial system is particularly difficult may benefit from the use of ginseng.

At any one time, 5% of patients with chronic bronchitis worldwide are experiencing acute attacks, resulting in extensive social and economic consequences.[2,3] 50 to 70% of the acute attacks are caused by bacteria,[4] and antibacterials are therefore widely used to treat these patients. Although antibacterial treatment is clearly beneficial, antibacterials are not always effective in sterilising the whole bronchial system. In particular, patients with concomitant diseases, a medical history of frequent infections and severe obstruction of the respiratory system only partly benefit from antibacterial treatment. The need for an effective, ancillary treatment in such patients is therefore obvious.

Ginseng (Panax ginseng C.A. Meyer) is a plant that has a long history of use in China and Korea for the treatment of various ailments. Only in the last few decades has standardisation of the ginseng extract to specifications established by high performance liquid chromatography (HPLC) assays made it possible to generate reproducible results in animal studies and human clinical trials.

Some reports have indicated that ginseng may enhance antibody production and natural killer (NK) cell activity. Singh et al.[1,5] observed that G115® ginseng extract in methanol acts as a mitogen on human lymphocytes cultured in vitro and induces increased production of interferon. Three studies have examined the effect of G115® ginseng extract on the immune response. One study demonstrated that G115® ginseng extract stimulates a number of components of the immune system, and that the stimulatory activity increases in most instances with the duration of the ginseng administration.[6] A second study showed that G115® ginseng extract treatment may increase the potency of vaccination against influenza by increasing the immune response.[7] In a third report, Scaglione et al.[8] evaluated the effects of the standardised ginseng extract G115® using the activity of alveolar macrophages obtained from patients suffering from chronic bronchitis. Two groups of 20 patients each were treated with either 100mg G115® ginseng extract twice daily or placebo for 8 weeks. Alveolar macrophages were collected by bronchial lavage before and after 4 and 8 weeks of treatment. The phagocytic activity and ability to kill Candida albicans were evaluated. The results showed that treatment with G115® ginseng extract improved the immune response of alveolar macrophages in chronically compromised individuals.

Gross et al.[9] investigated in a nonblinded, non-comparative study the effects of G115® ginseng extract on pulmonary function, oxygenation and walking capacity in 15 patients with severe chronic respiratory diseases. Treatment with 100mg G115® ginseng extract twice daily for 3 months was shown to improve pulmonary functions and oxygenation capacity compared with baseline measurements.

These findings suggest that G115® ginseng extract may play an important role in the prevention and therapy of respiratory disorders.

More recently, Song et al.[10] have shown that ginseng may favour the elimination of Pseudomonas aeruginosa from the bronchial system of experimentally infected mice. The authors postulated that this effect may be the result of an increased immune response in the bronchial system.

A beneficial effect of ginseng may therefore be expected in patients with acute bacterial attacks of chronic bronchitis (ACB). The aim of this non-blinded, comparative pilot trial was to investigate the effects of ginseng in reducing bacterial counts in the bronchial systems of patients with ACB.

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