title: A randomized, double-blind, placebo-controlled, clinical dose-response trial of an extract of Baptisia, Echinacea and Thuja for the treatment of patients with common cold.
abstract: The aim of this study was to verify the efficacy and safety of an herbal medication containing an extract of a mixture of Baptisiae tinctoriae radix, Echinaceae pallidae/purpureae radix and Thujae, occidentalis herba (SB-TOX) in the treatment of upper respiratory tract infections (URIs), and to test whether SB-TOX's clinical efficacy is dose dependent. A total of 91 adults (mean age 42.1 +/- 13.0 years) were randomised to receive 19.2 mg of SB-TOX (n=31), 9.6 mg SB-TOX (n=29) or placebo (n=31) three times daily for 3-12 days. Since a "running nose" is the main symptom of a common cold, the total number of facial tissues used throughout the clinical duration of their cold was the primary efficacy parameter. In the intention-to-treat analysis, this total number of tissues decreased with increasing extract dose. The slope across groups according to the Jonckheere test was significant (p = 0.0259). In the high-dose group, the standardised effect size delta/SD was 0.46 compared with placebo. Time to relevant improvement in cold symptoms (measured as the time until less than 30 tissues per day were used) was 1.1 days (95% CI 0.52; 1.67), 0.76 days (95% CI 0.28; 1.24) and 0.52 days (95% CI 0.22; 0.82) in the placebo, low-dose and high-dose groups, respectively (p(LogRank) = 0.0175). No adverse events were reported. This study demonstrates the efficacy and safety of SB-TOX in the treatment of URIs, and that its efficacy is dose dependent.
authors.affiliation: Schaper & Brtunmer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter, Germany. belal.naser@schaper-bruemmer.de
authors.forename: B
authors.initials: B
authors.lastname: Naser
authors.forename: B
authors.initials: B
authors.lastname: Lund
authors.forename: H H
authors.initials: HH
authors.lastname: Henneicke-von Zepelin
authors.forename: G
authors.initials: G
authors.lastname: Köhler
authors.forename: W
authors.initials: W
authors.lastname: Lehmacher
authors.forename: F
authors.initials: F
authors.lastname: Scaglione
mesh_terms: D000328:Adult; D000368:Aged; D003139:Common Cold / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D020900:Echinacea; D007887:Fabaceae; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D029783:Thuja; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; C026057:Esberitox