title: Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C.
abstract: Several studies have suggested that lactoferrin administration may decrease the serum level of hepatitis C virus (HCV) RNA in patients with chronic hepatitis C. The aim of the present study was to confirm the efficacy of orally administered bovine lactoferrin (bLF) in patients with chronic hepatitis C. The patients with chronic hepatitis C randomly received either oral bLF at a dose of 1.8 g daily for 12 weeks, or an oral placebo. The primary endpoint was the virologic response, defined as a 50% or greater decrease in serum HCV RNA level at 12 weeks compared with the baseline. The secondary endpoint was the biochemical response, which was defined as a 50% or greater decrease in the serum alanine aminotransferase (ALT) level at 12 weeks compared with the baseline. One hundred and ninety-eight of 199 patients were evaluable for efficacy and safety. bLF treatment was well tolerated and no serious toxicities were observed. A virologic response was achieved in 14 of 97 patients (14.4%) in the bLF group, and 19 of 101 (18.8%) in the placebo group. There was no significant difference in virologic response rates between the two groups (-4.4%, 95% confidence interval -14.8, 6.1). In addition, bLF intake did not have any favorable effect on the serum ALT level. The virologic responses were not different between two groups in any subgroup analysis. In conclusion, orally administered bLF does not demonstrate any significant efficacy in patients with chronic hepatitis C.
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp
authors.forename: Hideki
authors.initials: H
authors.lastname: Ueno
authors.forename: Tosiya
authors.initials: T
authors.lastname: Sato
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Katsuaki
authors.initials: K
authors.lastname: Tanaka
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohkawa
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Takagi
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokosuka
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Hidetsugu
authors.initials: H
authors.lastname: Saito
authors.forename: Akira
authors.initials: A
authors.lastname: Sawaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kasugai
authors.forename: Yukio
authors.initials: Y
authors.lastname: Osaki
authors.forename: Shigetoshi
authors.initials: S
authors.lastname: Fujiyama
authors.forename: Keiko
authors.initials: K
authors.lastname: Sato
authors.forename: Keiji
authors.initials: K
authors.lastname: Wakabayashi
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000818:Animals; D002417:Cattle; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012367:RNA, Viral / Q000097:blood; D017211:Treatment Failure
chemical_list: D010919:Placebos; D012367:RNA, Viral; D000410:Alanine Transaminase; D007781:Lactoferrin