Table 2.
Clinical studies on immune response and COPD
| Author, year/literature | Number of participants | Dose of G115 | Sample | Trial design | Outcome measures | Results |
|---|---|---|---|---|---|---|
| Wu et al (2014) [106] | 10 randomly assigned to the G115 group (n = 5) or the placebo group (n = 5) | 200 mg twice daily for four weeks. Participants were enrolled for 10 weeks (2 weeks for run-in; 4 weeks for treatment; and 4 weeks for follow-up). | Patients with COPD (mean age of 64.8 years). Inclusion criteria: COPD diagnosed spirometrically, FEV1 between 20% and 79% ; FER less than 70%; not experienced an acute exacerbation of COPD for at least 4 weeks before the trial; not been hospitalized in the past 6 months. |
R, pilot study | The primary outcomes: rate of exacerbation, as a change in baseline dyspnea, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcomes: six-minute walk test, FEV1, FVC, and adverse events. |
No change in mean FEV1, FVC, or FER in the G115 or placebo groups. The small sample size and short study duration were probably related to the absence of differences in outcomes. |
| Engels et al (2003) [102] | 27 participants (15 for the G115 group and 12 for the control group) | 400 mg per day (200 mg twice a day) for 8 weeks | Active healthy adults | DB, PC, R | The SIgA secretion rate and the relation of SIgA to total protein, absolute SIgA, and salivary protein concentrations. | S-SIgA, SIgA:protein ratio, and SFR were lower after exercise at baseline (p < 0.05). Both peak and mean mechanical power output declined (p < 0.01) across consecutive Wingate tests. |
| Gross et al (2002) [104] | 92 (49 for the G115 group plus 43 for the placebo control) | 200 mg daily (100 mg twice daily) for 3 months | Inclusion criteria: COPD of moderate severity (FEV1.0); clinical stability in the six months preceding the study and ability to exercise without hemodynamic instability. | R, PC | PFTs, MVV, and MIP before treatment and every two weeks for the 3-month study period. Exercise test and VO2 max before the beginning and after six weeks and three months. | All parameters significantly increased when compared with the placebo group. FVC: 32.5%, FEV1.0: 27.0%, PEF: 27.5%, FEF50: 45.4%, FEF75: 56.9%, MVV: 40.4%, MIP: 47.0%, and VO2 max: 37.5%. |
| Scaglione et al (2001) [101] | 75 patients (37 for the G115 group plus 38 for the placebo control) | 200 mg per day (100 mg twice a day) for 9 days | Patients experiencing acute attacks of chronic bronchitis | R, comparative PS | Effects in reducing the bacterial count in the bronchial system of patients undergoing an acute attack of chronic bronchitis treated with amoxicillin and clavulanic acid twice daily | Both groups of patients responded positively to the antibacterial treatment. In the G115 group, bacterial clearance was significantly faster than in the participants receiving the antibacterial medication alone. |
| Scaglione et al (1996) [100] | 227 participants (114 for the G115 group and 113 for the placebo control) | 200 mg per day (100 mg twice a day) for 12 weeks. | Healthy participants | 12 weeks multicenter, R, PC, DB | Resistance to influenza and common cold measured as NK cell activity, at Weeks 8 and 12 in participants who have received an antiinfluenza polyvalent vaccine at Week 4 | Antibody titers at Week 8 were > after G115 treatment (272 units vs 171 units after placebo), and natural killer cell activity in the treatment group was almost twice as high as in the placebo group. |
| Gross et al (1995) [103] | 15 | 200 mg/day (100 mg twice daily) for 3 months | Patients with severe chronic respiratory diseases (mean age, 67 ± 12 years) under home oxygen treatment. | PS | FVC, FEF50, FEF75; FEV1, FEV1/FVC, PEF, MVV, arterial blood gases, and walking distance. | Significantly improved FVC, FEV1, PEFR, MVV, oxygenation. |
| Scaglione et al (1990) [98] | 60 (20 patients in each group, that is, placebo, aqueous ginseng extract, and G115) | 200 mg per day (100 mg twice a day)/ 200 mg per day of aqueous liquid extract (100 mg twice a day)/placebo for 8 weeks. | Healthy people (18-50 years). | 8 weeks, DB, PC | Immunological parameters determined on leukocytes before and the 4th and 8th weeks after the onset of the treatment. | Increase in chemotaxis of polymorphonuclear leukocytes, phagocytic index, and the total number of T3 and T4 lymphocytes after 4 and 8 weeks of G115. Increased T4:T8 ratio and the activity of natural killer cells. |
| Scaglione et al (1994) [99] | 40 (20 in each group) | 200 mg per day (100 mg twice a day) for 8 weeks | Patients suffering from chronic bronchitis | SB, PC | Function of alveolar macrophages by measuring the phagocytic activity and killing power toward Candida albicans | The phagocytosis and intracellular killing significantly increased at the eighth week of treatment with G115. |
COPD, chronic obstructive pulmonary disease; CO, crossover; DB, double-blind; FER: forced expiratory ratio, FEV1, forced expiration volume in one second; FEV1/FVC, ratio of FEV1/FVC; FVC: forced vital capacity; LA, lipoic acid; MVV, maximum ventilation volume; FEF50, forced expiratory flow50; FEF75, forced expiratory flow75; PEF, peak expiratory flow; PC, placebo-controlled; PFTs, pulmonary function tests; PS, pilot study; R, randomized; SB, single-blind; SFR, saliva flow rate; SIgA, secretory immunoglobulin A; S-SIgA, SIgA secretion rate; NK, natural killer; MIP, maximal inspiratory pressure.