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Let me show you this table from the paper and the discussions. It is very frustrating that no one seems to study this more thoroughly.
Table 2 Liver enzymes in patients with chronic liver disease including hepatitis C before and after treatment with silymarin or
placebo
Study ALT (U/L) AST (U/L) GGT (U/L) Bilirubin (lmol/L)
Buzzelli [63]
Silymarin baseline 145 ± 22 107 ± 21 64 ± 12 17.1 ± 3.4
After silymarin 120 ± 20 88 ± 18* 71 ± 13 15.4 ± 3.4
Placebo baseline 108 ± 13 79 ± 8 58 ± 13 17.1 ± 3.4
After placebo 122 ± 20 80 ± 14 57 ± 12 13.7 ± 1.7
Buzzelli [8]
Silymarin baseline 115.9 ± 12.9 88 ± 13.3 51.4 ± 9.3 13.0 ± 1.4
After silymarin 82.5 ± 10.6*, 69.5 ± 7.5*, 41.3 ± 4.2*, 9.1 ± 0.7*
Placebo baseline 97.9 ± 12.8 93.3 ± 13.5 64.9 ± 8.6 15.4 ± 1.9
After placebo 90.5 ± 11.1 90.5 ± 13.7 59.7 ± 7.6* 12.8 ± 2.2
Par [66]
Silymarin baseline 96.7 ± 23.3 128.5 ± 28 38.3 ± 11.5
After silymarin 49.8 ± 11* 66.1 ± 12.4* 23.8 ± 6.2*
Pares [53]
Silymarin baseline 50 ± 41 68 ± 47 168 ± 153 39.3 ± 34.2
After silymarin 50 ± 37 58 ± 37 137 ± 150 34.2 ± 44.5
Placebo baseline 52 ± 45 71 ± 53 183 ± 203 44.5 ± 39.3
After placebo 41 ± 34 50 ± 34 99 ± 106 44.5 ± 95.8
Vailati [65]
Silymarin 360 mg
daily baseline
101.8 ± 4.6 98.1 ± 6.3 138.4 ± 18.7 23.6 ± 1.5
After silymarin
360 mg daily
53.3 ± 6.1* 39.3 ± 5.0* 88.1 ± 7.6* 20.2 ± 1.4*
*Statistically significant difference compared with baseline.
Statistically significant difference compared with placebo.
DISCUSSION
Studies of the effects of silymarin in patients with hepatitis B
or C are limited by the small number of participants, the lack
of double-blinding or placebo controls, the grouping of
hepatitis of various aetiologies under one category (e.g. as
chronic, nonalcoholic hepatitis), the confounding effect of
alcohol, and the use of multiple interventions carried out at
once, with no possibility of distinguishing their respective
effects. The biochemical markers and other outcomes studied
were often not reported according to HCV status. The different
dosage regimens, treatment durations, and endpoints
used also make drawing meaningful comparisons between
studies difficult. Furthermore, it is not known how surrogate
outcomes, such as biochemical response, can be translated
into patient-relevant outcomes including progression to endstage
liver disease and mortality [7]. This warrants further
investigation.
Silymarin treatment resulted in a statistically significant
decrease in transaminases in four studies compared with
baseline and in one compared with placebo in patients with
chronic viral hepatitis. It is not clear whether a reduction
in transaminase levels (with or without normalization) has
any clinical significance. However, in some long-term,
uncontrolled follow-up studies it has been found that HCV
patients with sustained biochemical but not virological response
to interferon therapy had a significantly reduced
incidence of cirrhosis and hepatocellular carcinoma compared
with biochemical nonresponders [69,70], suggesting
that patients may benefit from therapies that do not eliminate
the virus. Thus a purely biochemical response may be
beneficial.
It is worth bearing in mind that ribavirin, when used
alone in patients with hepatitis C, has no effect on viraemia,
while it does decrease ALT. However, when ribavirin is used
in combination with interferon, the sustained virological
response rate is increased over that achieved with interferon
alone [71]. By analogy, if silymarin does indeed lower ALT
levels and help achieve a biochemical response, it may also
act synergistically with interferon to increase the rates of
sustained virological response, but this hypothesis has yet to
be clinically investigated.
A multi-centre study is underway in Germany, in which
840 mg/day silymarin is given to patients with chronic
hepatitis C resistant to interferon and ribavirin combination
therapy. The study is scheduled to last 2 years, and has
fibrosis progression as the primary endpoint. The authors did
not state if the study is randomized or placebo-controlled
[72]. The National Centre for Complementary and Alternative
Medicine (NCCAM) also lists two phase II trials that
are currently investigating silymarin treatment in hepatitis C
To date, no studies have examined the effect of combining
silymarin with interferon or ribavirin therapy in patients
with hepatitis C, and only a few studies have been conducted
on the effects of silymarin alone in hepatitis B or C. Until RCTs
of adequate size and duration are performed with a patient
population with serologically proven hepatitis B or C, excluding
other causes of liver disease such as alcohol, no definitive
conclusion can be drawn. Future studies should also
have clearly defined primary endpoints, utilize intention-totreat
analysis, and report reasons for withdrawal. Given the
prevalence of patients who take milk thistle as complementary
or alternative therapy, it would be important to determine
if there are any interactions or possible synergistic
effects with the standard treatment so both physicians and
patients can make more evidence-based treatment decisions.
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楼主: lifevendor
发表于 2011-8-4 18:51
