title: A randomized, controlled trial of Panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia.
abstract: BACKGROUND
  Chronic lymphocytic leukemia (CLL) patients are at high risk for acute respiratory illness (ARI).
  
  
  OBJECTIVE
  We evaluated the safety and efficacy of a proprietary extract of Panax quinquefolius, CVT-E002, in reducing ARI.
  
  
  METHODS
  This was a double-blind, placebo-controlled, randomized trial of 293 subjects with early-stage, untreated CLL conducted January-March 2009.
  
  
  RESULTS
  ARI was common, occurring on about 10% of days during the study period. There were no significant differences of the 2 a priori primary end points: ARI days (8.5 ± 17.2 for CVT-E002 vs 6.8 ± 13.3 for placebo) and severe ARI days (2.9 ± 9.5 for CVT-E002 vs 2.6 ± 9.8 for placebo). However, 51% of CVT-E002 vs 56% of placebo recipients experienced at least 1 ARI (difference, -5%; 95% confidence interval [CI], -16% to 7%); more intense ARI occurred in 32% of CVT-E002 vs 39% of placebo recipients (difference, -7%; 95% CI, -18% to 4%), and symptom-specific evaluation showed reduced moderate to severe sore throat (P = .004) and a lower rate of grade ≥3 toxicities (P = .02) in CVT-E002 recipients. Greater seroconversion (4-fold increases in antibody titer) vs 9 common viral pathogens was documented in CVT-E002 recipients (16% vs 7%, P = .04).
  
  
  CONCLUSIONS
  Serologic evaluation of antibody titers was not tied to a specific illness, but covered the entire study period.
  
  
  CONCLUSIONS
  CVT-E002 was well tolerated. It did not reduce the number of ARI days or antibiotic use; however, there was a trend toward reduced rates of moderate to severe ARI and significantly less sore throat, suggesting that the increased rate of seroconversion most likely reflects CVT-E002-enhanced antibody responses.
authors.affiliation: Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1042, USA. khigh@wfubmc.edu
authors.forename: Kevin P
authors.initials: KP
authors.lastname: High
authors.forename: Doug
authors.initials: D
authors.lastname: Case
authors.forename: David
authors.initials: D
authors.lastname: Hurd
authors.forename: Bayard
authors.initials: B
authors.lastname: Powell
authors.forename: Glenn
authors.initials: G
authors.lastname: Lesser
authors.forename: Ann R
authors.initials: AR
authors.lastname: Falsey
authors.forename: Robert
authors.initials: R
authors.lastname: Siegel
authors.forename: Joanna
authors.initials: J
authors.lastname: Metzner-Sadurski
authors.forename: John C
authors.initials: JC
authors.lastname: Krauss
authors.forename: Bernard
authors.initials: B
authors.lastname: Chinnasami
authors.forename: George
authors.initials: G
authors.lastname: Sanders
authors.forename: Steven
authors.initials: S
authors.lastname: Rousey
authors.forename: Edward G
authors.initials: EG
authors.lastname: Shaw
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000150:complications*; D008297:Male; D008875:Middle Aged; D005894:Panax; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; C511203:COLD-fX; D010936:Plant Extracts