Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C.
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.
Ueno
Hideki
H
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp
Sato
Tosiya
T
Yamamoto
Seiichiro
S
Tanaka
Katsuaki
K
Ohkawa
Shinichi
S
Takagi
Hitoshi
H
Yokosuka
Osamu
O
Furuse
Junji
J
Saito
Hidetsugu
H
Sawaki
Akira
A
Kasugai
Hiroshi
H
Osaki
Yukio
Y
Fujiyama
Shigetoshi
S
Sato
Keiko
K
Wakabayashi
Keiji
K
Okusaka
Takuji
T
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
D010919:Placebos; D012367:RNA, Viral; D000410:Alanine Transaminase; D007781:Lactoferrin