Abstract | 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: 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.
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Authors | Janet E McElhaney, Stefan Gravenstein, Sharon K Cole, Edward Davidson, Dennis O'neill, Sharon Petitjean, Barry Rumble, Jacqueline J Shan |
Journal | Journal of the American Geriatrics Society
(J Am Geriatr Soc)
Vol. 52
Issue 1
Pg. 13-9
(Jan 2004)
ISSN: 0002-8614 [Print] United States |
PMID | 14687309
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Adjuvants, Immunologic
- Plant Extracts
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Topics |
- Acute Disease
- Adjuvants, Immunologic
(adverse effects, pharmacology)
- Aged
- Aged, 80 and over
- Chi-Square Distribution
- Double-Blind Method
- Female
- Humans
- Institutionalization
- Male
- Panax
(chemistry)
- Plant Extracts
(adverse effects, pharmacology)
- Respiratory Tract Infections
(immunology, prevention & control, virology)
- Treatment Outcome
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