A randomized trial of Chinese herbal medicines for the treatment of symptomatic hepatitis C.
BACKGROUND
Many patients with the hepatitis C virus (HCV) cannot be successfully treated with interferon-based regimens. Chinese herbal medicines have been widely prescribed for HCV in Asia, and many infected patients in the United States have used these agents. However, data to support the efficacy of these medications are limited and, to our knowledge, no published trials have been conducted in a US population.


METHODS
In a double-blinded design, 45 patients with HCV and fatigue were randomized to receive a combination of Chinese herbal medications or a matched placebo for 12 weeks. The main outcome measures were changes in health-related quality of life using the role physical and vitality scale scores from the validated Hepatitis Quality of Life Questionnaire and alanine aminotransferase levels. In addition, other Hepatitis Quality of Life Questionnaire variables, HCV load, and adverse effects were monitored.


RESULTS
In patients with HCV, the herbal medications had no effect on any quality-of-life variables, as measured by the Hepatitis Quality of Life Questionnaire. In addition, no significant changes in alanine aminotransferase or serum HCV RNA levels were noted. No significant adverse effects were observed.


CONCLUSIONS
In this study, a regimen of Chinese herbal medicines did not improve quality of life, liver chemistry results, or viral load in a cohort of patients with HCV. Patients and practitioners should remain cautious about the use of herbal medicines for HCV, because studies have not shown a clear benefit of these agents.
Jakkula
Mrudula
M
Department of Medicine, Hennepin County Medical Center, Minneapolis, Minn, USA.
Boucher
Tacey A
TA
Beyendorff
Ulrich
U
Conn
Shirley M
SM
Johnson
Jennifer E
JE
Nolan
Christopher J
CJ
Peine
Craig J
CJ
Albrecht
Jeffrey H
JH
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000187:drug effects; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006526:Hepatitis C / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D019562:Viral Load
D004365:Drugs, Chinese Herbal; D000410:Alanine Transaminase