Background: Chronic hepatitis C is one of the major causes of end-stage
liver disease with a high
incidence rate , amounting to a grave and serious problem of
public health . Currently,
interferon -based (with or without
ribavirin )
antiviral therapy has limited use due to its stringent indications, possible
contraindications and side effects.
Traditional Chinese medicine (TCM) may have advantages in the prevention and
treatment of
chronic hepatitis C and it is of significant value to discover the advantages. Through this
research , a safe and effective
treatment protocol of TCM or integrated TCM and Western
medicine for
chronic hepatitis C can be formed. To this end, during
China 's Eleventh Five-Year Plan, special
research projects on
acquired immune deficiency syndrome (
AIDS ), viral
hepatitis and the other major
infectious diseases were established. Our studies on
chronic hepatitis C constitute one of the major special
research topics.
Methods and
design: Clinical information of
patients with
chronic hepatitis C will be first collected in a large, multicenter epidemiological
survey . Positive symptoms
will be analyzed by rapid
cluster analysis , principal constituent
analysis and
factor analysis , and
syndrome types
will be diagnosed based on expert advice. Concurrently, a large, multicenter, randomized, parallel-group
prospective study will be launched based on evidence-based medical principles to evaluate the effects and
safety of the
treatment protocol for
chronic hepatitis C . The evaluated indexes
will include the normalization rate of
liver function, virological improvement and
quality of life improvement for the short-term
efficacy and the
incidence of
liver cirrhosis and (or) primary
liver cancer and
mortality for the long-term
efficacy .
Discussion: This study
will investigate the TCM
syndrome differentiation norms and the
syndrome distribution rules of
chronic hepatitis C and evaluate the
efficacy and
safety of a
treatment protocol for
chronic hepatitis C based on TCM theory or combined
treatment of TCM and Western
medicine . The study results
will be helpful to developing a TCM
treatment program for
chronic hepatitis C . Trial registration The
research program was registered in the
Chinese Clinical Trial Registry in English and
Chinese in January 2010. Registration number ChiCTR-TRC-10000770.