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A Placebo‐Controlled Trial of a Proprietary Extract of North American Ginseng (CVT‐E002) to Prevent Acute Respiratory Illness in Institutionalized Older Adults
Author(s) -
Mcelhaney Janet E.,
Gravenstein Stefan,
Cole Sharon K.,
Davidson Edward,
O'neill Dennis,
Petitjean Sharon,
Rumble Barry,
Shan Jacqueline J.
Publication year - 2004
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/j.1532-5415.2004.52004.x
Subject(s) - medicine , placebo , ginseng , american ginseng , respiratory system , intensive care medicine , traditional medicine , alternative medicine , pathology
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.