A Placebo-Controlled Trial of a Proprietary Extract of North American Ginseng (CVT-E002) to Prevent Acute Respiratory Illness in Institutionalized Older Adults

• Published in: Journal of the American Geriatrics Society (JAGS) 2004-01, Vol.52 (1), p.13-19
• Main Authors: Mcelhaney, Janet E., Gravenstein, Stefan, Cole, Sharon K., Davidson, Edward, O'neill, Dennis, Petitjean, Sharon, Rumble, Barry, Shan, Jacqueline J.
• Format: Article
• Language: English
• Subjects: Acute Disease; acute respiratory illness; Adjuvants, Immunologic - adverse effects; Adjuvants, Immunologic - pharmacology; Aged; Aged, 80 and over; Alternative medicine; Biological and medical sciences; Chi-Square Distribution; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Double-Blind Method; elderly; Elderly people; Female; Ginseng; ginseng extract; Humans; Influenza; Institutionalization; Male; Medical sciences; Neurology; Neuropharmacology; nursing facility; Nursing homes; Panax - chemistry; Pharmacology. Drug treatments; Placebo effect; Plant Extracts - adverse effects; Plant Extracts - pharmacology; Prevention; Preventive medicine; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Randomized controlled trials; Respiratory diseases; Respiratory system; Respiratory Tract Infections - immunology; Respiratory Tract Infections - prevention & control; Respiratory Tract Infections - virology; Service assisted housing; Treatment Outcome; USA
• ISSN: 0002-8614; 1532-5415
• DOI: 10.1111/j.1532-5415.2004.52004.x

Objectives: To compare a proprietary extract of American ginseng, CVT‐E002, with placebo in preventing acute respiratory illness (ARI) in an institutional setting during the influenza season. Design: Two randomized, double‐blind, placebo‐controlled trials conducted late in the 2000 (8 week) and 2000–2001 (12 week) influenza seasons. Setting: Long‐term care setting that included nursing home and assisted living at three sites. Participants: Eighty‐nine (2000) and 109 (2000–2001) enrolled subjects, average age 81 and 83.5, respectively; 74% women. Approximately 90% had received influenza vaccine in each of the 2 years. Intervention: Oral twice‐daily administration of a proprietary ginseng extract, CVT‐E002, 200 mg or placebo. Measurements: ARI was defined as two new respiratory symptoms or one with a constitutional symptom. Confirmation of viral ARI was by culture (influenza or respiratory syncytial virus (RSV)) or serology for influenza. Laboratory safety monitoring was done at 0, 4, and 8 or 12 weeks. Results: An intent‐to‐treat analysis of pooled data corrected for drug exposure time showed that the incidence of laboratory‐confirmed influenza illness (LCII) was greater in placebo‐ (7 cases/101 subjects) than CVT‐E002‐treated (1/97) groups (odds ratio (OR)=7.73, P=.033). Combined data for LCII and RSV illness were also greater in placebo‐ (9/101) than CVT‐E002‐treated (1/97) groups (OR=10.50, P=.009), for an overall 89% relative risk reduction of ARI in the CVT‐E002 group. Conclusion: CVT‐E002 was shown to be safe, well tolerated, and potentially effective for preventing ARI due to influenza and RSV.