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16028RE: [GIWorld-Hepatitis] FW: NATAP: Milk Thistle Study Found No Benefit

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  • alleypat
    Dec 28, 2005
      didn't seem to help me either way and just seemed like something else for my
      liver to filter out, make it work more. Hope it works for someone.
      Alley


      "If the doctor told me I had six minutes to live, I'd type a little
      faster." --Isaac Asimov

      -----Original Message-----
      From: GIWorld-Hepatitis@yahoogroups.com
      [mailto:GIWorld-Hepatitis@yahoogroups.com]On Behalf Of avansi7465
      Sent: Wednesday, December 28, 2005 4:29 PM
      To: GIWorld-Hepatitis@yahoogroups.com
      Subject: Re: [GIWorld-Hepatitis] FW: NATAP: Milk Thistle Study Found No
      Benefit


      Well, at least it doesn't do any damage...........so.......considering
      that my liver.........for the first time.......is showing signs of
      regeneration, I think I'll stick with the program, which does include Milk
      Thistle.
      Happy New Year!
      Anne

      -----Original Message-----
      >From: alleypat <alleypat@...>
      >Sent: Dec 28, 2005 10:47 AM
      >To: GIWorld-Hepatitis@yahoogroups.com, happyheppers@yahoogroups.com
      >Subject: [GIWorld-Hepatitis] FW: NATAP: Milk Thistle Study Found No
      Benefit
      >
      >Milk Thistle for Alcoholic and/or Hepatitis B or C Liver Diseases: study
      >showed no benefit-A Systematic Cochrane Hepato-Biliary Group Review with
      >Meta-Analyses of Randomized Clinical Trials
      >
      >The American Journal of Gastroenterology
      >Volume 100 Page 2583 - November 2005
      >
      >Andrea Rambaldi, M.D.1, Bradly P. Jacobs, M.D., M.P.H.2, Gaetano
      Iaquinto,
      >M.D.3, and Christian Gluud, M.D., Dr. Med. Sci.1
      >
      >ABSTRACT
      >OBJECTIVES: Our objectives were to assess the beneficial and harmful
      effects
      >of milk thistle (MT) or MT constituents versus placebo or no intervention
      in
      >patients with alcoholic liver disease and/or hepatitis B and/or C liver
      >diseases.
      >
      >METHODS: Randomized clinical trials studying patients with alcoholic
      and/or
      >hepatitis B or C liver diseases were included (December 2003). The
      >randomized clinical trials were evaluated by components of methodological
      >quality.
      >
      >RESULTS: Thirteen randomized clinical trials assessed MT in 915 patients
      >with alcoholic and/or hepatitis B or C liver diseases. The methodological
      >quality was low: only 23% of the trials reported adequate allocation
      >concealment and only 46% were considered double blind. MT versus placebo
      or
      >no intervention for a median duration of 6 months had no significant
      effects
      >on all-cause mortality (relative risk (RR) 0.78, 95% confidence interval
      >(CI) 0.53-1.15), complications of liver disease, or liver histology.
      >Liver-related mortality was significantly reduced by MT in all trials (RR
      >0.50, 95% CI 0.29-0.88), but not in high-quality trials (RR 0.57, 95% CI
      >0.28-1.19). MT was not associated with a significantly increased risk of
      >adverse events.
      >
      >CONCLUSIONS: Based on high-quality trials, MT does not seem to
      significantly
      >influence the course of patients with alcoholic and/or hepatitis B or C
      >liver diseases. MT could potentially affect liver injury. Adequately
      >conducted randomized clinical trials on MT versus placebo may be needed.
      >
      >INTRODUCTION
      >Extracts of milk thistle (MT), Silybum marianum (L) Gaertneri, have been
      >used as medical remedies since the time of ancient Greece and are widely
      >used as an alternative medication (1-3). Silymarin is the collective name
      >for the flavonolignans (silybin or silibinin, silydianin, silychristin)
      >extracted from the MT (2). These extracts have been shown to protect
      animals
      >against various hepatotoxins including acetaminophen (4, 5), radiation
      (6),
      >iron overload (7), phaloidin (8, 9), carbon tetrachloride (10-12), and
      >thioacetamide (13). The "hepatoprotective" actions of MT may include
      >inhibition of lipid peroxide formation, scavenging of free radicals, and
      >changing of the physical properties of cell membranes (1, 14-16).
      Increased
      >lipid peroxidation is frequent in all stages of liver damage from
      alcoholic
      >and non-alcoholic liver disease (17). MT may also reduce liver
      fibrogenesis
      >(18, 19).
      >
      >This systematic review summarizes the data from randomized clinical
      trials
      >to examine the beneficial and harmful effects of MT for alcoholic and/or
      >hepatitis B or C liver diseases. The reasons for focusing on these
      >disorders, having different etiologies, are the following. First, many
      >trials conducted before the 1980s did not exclude the etiology of
      hepatitis
      >B virus and many trials conducted before the 1990s did not exclude the
      >etiology of hepatitis C virus. Second, alcoholic and viral liver diseases
      >often coexist. Third, alcohol and hepatitis B and/or C constitute the
      major
      >etiologies of chronic liver diseases in the Western World (20).
      >
      >DISCUSSION
      >
      >We found no significant effect of MT on all-cause mortality. We observed
      a
      >potential beneficial effect of MT on mortality in patients with alcoholic
      >liver disease, but this effect could not be confirmed in two high-quality
      >trials. We also observed a potential beneficial effect of MT on
      >liver-related mortality, but again this effect could not be demonstrated
      in
      >three high-quality trials. As the methodological quality of some of the
      >trials was low, we are not able to exclude bias as the cause of our
      positive
      >findings (24-26). The methods and definitions used to establish
      >liver-related mortality varied or were unclear. Therefore, this outcome
      >measure should be cautiously evaluated. Further, publication bias and
      >selective reporting bias must be considered (56, 57). The estimate on
      >all-cause mortality in high-quality trials was a RR of 0.95 (95% CI
      >0.55-1.65). This estimate is compatible with a 45% reduction in all-cause
      >mortality as well as with a 65% increase in all-cause mortality. In
      general,
      >one should only introduce interventions based on findings in high-quality
      >trials (24-26).
      >
      >Our observations confirm two recent meta-analyses on MT for patients with
      >liver disease of any cause (3, 58, 59), in spite of the following facts.
      Our
      >systematic review included five more randomized clinical trials (41, 44,
      52,
      >54, 55), excluded data from quasi-randomized clinical trials (59), which
      may
      >significantly bias estimates of interventions effects (26, 60), and
      included
      >more patients with alcoholic liver disease (3).
      >
      >The statistically significant effect of MT on all-cause mortality
      identified
      >in subgroup analysis of patients with alcohol-related liver disease were
      not
      >confirmed in a further subgroup analysis including patients with
      alcoholic
      >liver disease co-infected by HCV. Further, this effect could not be
      >demonstrated in three high-quality trials (24-26). Therefore our findings
      >are not robust enough to form a fundament for therapeutic
      recommendations.
      >
      >We found that MT significantly improved two liver biochemical variables,
      >s-bilirubin and GGT. For the remainder of our analyses on liver
      biochemistry
      >markers, MT had either effects that were dependent on the statistical
      model
      >we used or had no significant effects. Further, when focusing on
      >high-quality trials we could not demonstrate significant effects (24-26).
      In
      >all circumstances the effects of MT on liver biochemistry were not
      dramatic.
      >
      >This systematic review has a number of potential limitations. First, the
      >small sample size limits the power of our meta-analyses. The CI for the
      >pooled estimate is sufficiently wide, meaning that a substantial benefit
      or
      >harm cannot be excluded. Our review does not preclude the possibility of
      a
      >beneficial or harmful effect of MT in alcoholic liver disease or in other
      >forms of liver disease for that matter. Evidence show how much effects of
      >medical intervention may change over time. Ioannidis and Lau (61) applied
      >"recursive cumulative meta-analyses" of randomized clinical trials to
      >evaluate the relative change in the pooled treatment effect over time for
      60
      >medical interventions within pregnancy/perinatal medicine and cardiology.
      >When 2,000 patients have been randomized, the pooled RR may change by a
      >factor 0.7 to 1.3. At present, only about 1,000 patients with alcoholic
      >liver disease and/or hepatitis B and C have been randomized to MT versus
      >placebo or no intervention. Second, we chose to include only alcoholic
      liver
      >disease and viral liver disease in the review. The major reason is that
      >viral and alcohol-related liver diseases frequently coexist in the same
      >patient. Several trials were old and did not check for viral liver
      disease
      >in patients with suspected alcoholic liver disease. Further, hepatitis B
      or
      >C marker positivity was not an exclusion criterion for the entry of the
      >patient in one of the trials on patients with alcoholic liver disease
      (50).
      >Other liver diseases like non-alcoholic liver disease and toxic liver
      >diseases should be considered in other reviews. Finally, the duration of
      >treatment as well as the dosing and the preparation of MT varied. This
      may
      >have caused variable intervention effects. However, none of our subgroup
      >analyses revealed that these factors were responsible for our finding of
      >lack of intervention effects.
      >
      >Among the randomized clinical trials reporting adverse drug events, MT
      >appeared safe and well tolerated. We recognize it is difficult to
      interpret
      >the risk of adverse events from the literature for several reasons (62).
      >Events may be missed since search terms related to adverse events are
      often
      >not indexed, and causality is difficult to discern when events are
      published
      >in a case report or case series. Among the studies that we excluded were
      >some randomized clinical trials considering 180 patients with unspecified
      >form of liver diseases (63). MT seemed to be well tolerated in this
      trial,
      >although adverse events have been reported in the literature (64).
      >
      >In conclusion, although MT constituents have been used as a medical
      >intervention for more than 2,500 yr, there remains insufficient evidence
      to
      >support or to refute its use for liver patients. We need to conduct
      >high-quality, placebo-controlled randomized trials before MT or MT
      >constituents can be advocated for patients with alcoholic and/or viral
      liver
      >disease.
      >
      >
      >RESULTS
      >
      >Search Results
      >
      >We identified 1,833 references through electronic searches of The
      Cochrane
      >Hepato-Biliary Group Controlled Trials Register (n = 40), The Cochrane
      >Library (n = 75), and MEDLINE and EMBASE (n = 1,716) and through reading
      >bibliographies (n = 2) (Fig. 1). Of these, 1,766 were in vitro studies,
      >animal studies, studies unrelated to liver disease, duplicate reports, or
      on
      >other patient types. Therefore, these references did not meet our
      inclusion
      >criteria and were excluded. The remaining 67 publications were on
      patients
      >with alcoholic and/or hepatitis B or C liver diseases treated with MT. Of
      >these, 41 publications were excluded because they were observational
      studies
      >or randomized trials that did not fulfil our inclusion criteria.
      >Accordingly, 26 references referring to 13 randomized clinical trials
      could
      >be included (30-55).
      >
      >Included Trials
      >
      >Eleven of the 13 randomized clinical trials were described in full paper
      >articles (30, 31, 34, 39, 41, 44, 48-52) and two in abstract only (54,
      55).
      >
      >The experimental treatment consisted of silymarin orally in 10 randomized
      >clinical trials (30, 34, 39, 44, 48-52, 55); IdB1016 orally in two
      >randomized clinical trials (IdB1016 is a lipophilic complex with silybin
      and
      >phosphatidylcholine in a molar ratio of 1:1) (31, 54); and
      >silybin-N2-cyclodextrin, a new oral formulation containing silybin, in
      one
      >randomized clinical trial (41).
      >
      >The randomized clinical trials could be divided into four groups
      according
      >to etiology:
      >
      >o chronic alcoholic liver disease included 657 patients, of which
      the
      >majority had cirrhosis (30, 34, 39, 41, 44, 48, 51, 52, 55);
      >o hepatitis B included 8 patients with acute hepatitis B (49);
      >o hepatitis C included 10 patients with chronic hepatitis C (54);
      >o alcoholic and/or hepatitis B or C liver diseases (31, 50), of
      which
      >one trial included 20 patients with hepatitis B and hepatitis C (31) and
      the
      >other included 200 patients with alcoholic liver disease with or without
      HCV
      >antibody positivity (50). Anti-HCV antibodies were positive in 29 (13
      >receiving MT and 16 receiving placebo) of the 75 patients for whom stored
      >sera were available after completion of the trial (50).
      >
      >Excluded Studies
      >
      >A total of 33 studies on MT for liver diseases, described in 43
      publications
      >(available on request), were excluded mainly because they were
      observational
      >studies or case series.
      >
      >Methodological Quality of Included Trials
      >
      >Only one (51) of the 13 randomized clinical trials provided a sample size
      >estimation that was based on liver histology.
      >
      >The method to generate the allocation sequence was considered adequate in
      >six (46.2%) of the trials (30, 39, 41, 44, 50, 51).
      >
      >Only three (23.1%) of the trials described adequate allocation
      concealment
      >(44, 50, 51).
      >
      >All but one of the trials (52) were described as double blinded (92.3%).
      >However, only six (46.2%) trials described the use of placebo with
      identical
      >presentation in the control arm (31, 39, 41, 44, 50, 51). None of the
      trials
      >checked the success of blinding.
      >
      >There was a fair description of follow-up and withdrawals/drop-outs in 12
      >(92.3%) trials (30, 31, 34, 39, 41, 44, 48-52, 54). None of the trials
      >stated that they used an intention-to-treat method to evaluate their
      data.
      >All the trials but three (30, 41, 44) presumably used intention-to-treat
      >analysis.
      >
      >All-Cause Mortality
      >
      >Combining the results of the 13 randomized clinical trials demonstrated
      no
      >significant effect of MT given for a median duration of 6 months (range 1
      wk
      >to 41 months) on all-cause mortality (RR 0.78, 95% CI 0.53-1.15). There
      was
      >no significant heterogeneity (I2= 5.9%). In the MT group, 36/456 (7.9%)
      >patients died versus 45/459 (9.8%) patients in the control group (Fig.
      2).
      >
      >Subgroup analyses stratifying the randomized clinical trials according to
      >the single methodological quality components (generation of the
      allocation
      >sequence, allocation concealment, blinding, and follow-up) did not
      >demonstrate significant differences regarding the effect of MT on
      all-cause
      >mortality between trials with and without adequate methodology.
      >
      >Subgroup analysis stratifying the randomized clinical trials into trials
      >with all components adequate, trials having some components adequate, and
      >trials without any of components adequate (not estimable since no events
      >occurred in this group) (Fig. 3), did not demonstrate significant effects
      of
      >MT on all-cause mortality.
      >
      >MT did not significantly influence all-cause mortality in the trials with
      a
      >treatment duration less than 6 months (RR 0.35; 95% CI 0.04-3.22) or in
      the
      >trials with a duration of treatment of at least 6 months (RR 0.81, 95% CI
      >0.54-1.20); or in the trials including patients with chronic liver
      disease
      >(data not shown); the RR in the trials including patients with acute
      liver
      >disease was not estimable since no events occurred in this group. A
      >worst-case scenario analysis considering all patients who dropped out or
      >were withdrawn dead did not find a significant effect of MT (RR 1.09; 95%
      CI
      >0.75-1.58). None of the trials reported mortality data distributed on
      Child
      >class or other prognostic classification.
      >
      >MT significantly decreased all-cause mortality in patients with alcoholic
      >liver disease (RR 0.58, 95% CI 0.34-0.98; p= 0.04) (30, 34, 39, 41, 44,
      48,
      >51, 52, 55). There was no significant heterogeneity (I2= 0%). In the MT
      >group 16/325 (4.9%) patients died versus 28/332 (8.4%) in the control
      group.
      >This finding could not be confirmed nor refuted in two high-quality
      trials
      >(RR 0.34, 95% CI 0.06-2.11) (44, 51).
      >
      >In patients with alcoholic liver disease or alcoholic liver disease with
      HCV
      >antibody positivity (50), MT demonstrated no significant effect on
      all-cause
      >mortality (RR 1.11, 95% CI 0.62-1.99). In the MT group 20/103 (19.4%)
      >patients died versus 17/97 (17.5%) in the control group. In patients with
      >hepatitis B (49) none of the patients died out of the 13 in the MT and 15
      in
      >the control group. In patients with hepatitis C (54) none of the patients
      >died out of the 5 in the MT and 5 in the control group. In patients with
      >hepatitis B and hepatitis C (31) none of the patients died out of the 10
      in
      >the MT and 10 in the control group.
      >
      >Liver-Related Mortality
      >
      >Among the 13 trials only four reported liver-related mortality (Fig. 4)
      (39,
      >44, 50, 51). Three of the trials included patients with alcoholic liver
      >disease (39, 44, 51) and the Pares et al. trial included patients with
      >alcoholic liver disease or alcoholic liver disease with HCV antibody
      >positivity (50). These trials found a significant effect of MT on
      >liver-related mortality (RR 0.50, 95% CI 0.29-0.88; p= 0.02). There was
      no
      >significant heterogeneity (I2= 0%). In the MT group, 16/422 (3.8%)
      patients
      >died versus 31/422 (7.3%) patients in the control group.
      >
      >Subgroup analysis demonstrated no significant effect of MT on
      liver-related
      >mortality in the three trials having all four methodological components
      >adequate (RR 0.57, 95% CI 0.28-1.19) whereas MT significantly decreased
      >mortality in the trials having only one or more components adequate (RR
      >0.41, 95% CI 0.17-0.97). This effect was based on only one trial with
      less
      >than 100 patients randomized (39). There was no significant difference
      >between the two estimates (test of interaction z = 0.57). The effect of
      MT
      >on liver-related deaths in the trials with no adequate methodological
      >component was not estimable due to any deaths. A worst-case scenario
      >analysis of patients with alcoholic liver disease (all patients who
      >dropped-out or were withdrawn were considered dead) changed the estimate
      to
      >no significant effect of MT on liver-related mortality (RR 0.81, 95% CI
      >0.58-1.13).
      >
      >Liver-Related Complications
      >
      >In the only trial reporting individual liver-related complications, MT
      did
      >not significantly affect the incidence of patients with ascites, hepatic
      >encephalopathy, or gastro-intestinal bleeding (50). MT demonstrated no
      >significant effect on combined liver-related complications (44, 50).
      >
      >Liver Biochemistry and Liver Histology
      >
      >MT significantly decreased s-bilirubin concentration and GGT activity in
      >both fixed effect and random effects model analyses:
      >
      >o s-bilirubin: WMD -4.68 N<mol/L (95% CI -7.72 to -1.64 N<mol/L; p<
      >0.05) (fixed effect model). There was no significant heterogeneity (I2=
      0%)
      >o GGT: WMD -26.80 U/L (95% CI -32.86 to -20.73 U/L; p< 0.05) (fixed
      >effect model). There was significant heterogeneity (I2= 68%).
      >
      >MT showed a significant beneficial effect on AST and ALT when analyzed by
      >the fixed effect model, but not in the random effects model. MT did not
      >significantly influence prothrombin or s-albumin. There were no
      significant
      >effects of MT on liver biopsy findings in the only trial reporting this
      >outcome (51).
      >
      >Adverse Events
      >
      >In the MT group 0/456 patients had serious adverse events versus 0/459
      >patient in the control group. MT did not significantly affect the
      occurrence
      >of non-serious adverse events (RR 0.83, 95% CI 0.46-1.50). In the MT
      group,
      >16/456 (3.5%) patients had non-serious adverse events versus 20/459
      (4.4%)
      >patients in the control group. The adverse events observed in the MT
      group
      >encompassed impotence (one patient), pruritus (four patients), cephalea
      >(three patients), and nausea (one patient). The authors did not report
      the
      >type of adverse event in seven patients. The adverse events observed in
      the
      >control group were pruritus (11 patients), cephalea (four patients), and
      >nausea (one patient). The authors did not report the type of adverse
      events
      >in four patients.
      >
      >PATIENTS AND METHODS
      >
      >Inclusion Criteria
      >
      >We applied The Cochrane Collaboration methodology (21) and followed our
      >predefined, peer-reviewed, published Cochrane Hepato-Biliary Group
      protocol
      >(22). Only randomized clinical trials were included (22). Patients with
      >alcoholic liver cirrhosis, liver fibrosis, hepatitis, and/or steatosis as
      >well as patients with viral induced liver disease (hepatitis B and/or
      >hepatitis C) according to the diagnostic work-up used in the individual
      >trial were included (22). The trials should have administered MT or any
      MT
      >constituent at any dose or duration versus placebo or no intervention
      (22).
      >
      >Types of Outcome Measures
      >
      >The primary outcome measure was the number of patients dying (22).
      Secondary
      >outcomes measures were the development of clinical symptoms and
      >complications analyzed separately and combined, liver biochemistry, liver
      >biopsy findings, as well as number and type of adverse events (22).
      >
      >Search Strategy for Trials
      >
      >The following databases were searched: The Cochrane Hepato-Biliary Group
      >Controlled Trials Register (December 2003), The Cochrane Central Register
      of
      >Controlled Trials on The Cochrane Library (Issue 4, 2003), MEDLINE (1966
      to
      >December 2003), and EMBASE (1974 to December 2003) using the search terms
      >"milk thistle" or "silymarin" or "silybin" or "silibinin" or "silydianin"
      or
      >"silychristin" or commercial names (LegalonB., SilipideB., RealsilB.,
      >CarsilB., SiliphosB.) and "liver disease" or "alcoholic liver disease" or
      >"viral liver disease" or "hepatitis B" or "hepatitis C" (22). The MEDLINE
      >search was combined with the search strategy of The Cochrane
      Hepato-Biliary
      >Group (23).
      >
      >The principal authors of the identified trials were approached and
      inquired
      >about additional randomized clinical trials. Pharmaceutical companies
      >involved in the production of MT products were contacted in order to
      obtain
      >unidentified published or unpublished randomized clinical trials.
      >
      >Patient Characteristics, Diagnosis, and Interventions
      >
      >The following items were recorded from the individual randomized clinical
      >trials: mean (or median) age, sex ratio, liver disease according to the
      >etiology, duration of liver disease, severity of liver disease at entry,
      >alcohol consumption at entry, type and dose of MT-intervention, and type
      of
      >control intervention. Development of clinical symptoms and complications,
      >liver biochemistry (serum (s)-bilirubin, prothrombin time, s-albumin,
      >s-aspartate aminotransferase (AST), s-alanine aminotransferase (ALT),
      >s-alkaline phosphatases (AP), s-gamma-glutamyl transferase (GGT)), liver
      >biopsy findings, alcohol consumption, quality of life, and adverse events
      >during follow-up were registered.
      >
      >Assessment of Methodological Quality
      >
      >The methodological quality of the randomized clinical trials was assessed
      >using individual components of methodological quality (22, 24-26). We
      >registered whether the randomized clinical trial reported the use of
      >intention-to-treat analysis, i.e., all patients randomized must be
      retained
      >in the trial (22). Data on the number of patients with each outcome by
      >allocated treatment group, irrespective of compliance of follow-up, were
      >sought to allow an intention-to-treat analysis.
      >
      >Statistical Analyses
      >
      >The meta-analyses were performed in Review Manager Software (version
      4.2.7)
      >from The Cochrane Collaboration (http://www.cochrane.org). We examined
      all
      >outcomes with both the random effects model and the fixed effect model
      (27,
      >28). Dichotomous data were analyzed by calculating the relative risk (RR)
      >and continuous outcomes as weighed mean difference (WMD), both with 95%
      >confidence intervals (CI). Heterogeneity was examined by the O2 test (p<
      >0.1) and a useful statistic for quantifying inconsistency (I2=[(Q -
      >df )/Q]C 100%, where Q is the O2 statistic and df is its degrees of
      >freedom) (29). Potential causes for heterogeneity were explored by
      >performing subgroup analyses.
      >
      >
      >
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