Effects of additional administration of colchicine in ursodeoxycholic acid-treated patients with primary biliary cirrhosis: a prospective randomized study

Ikeda, Takaaki; Tozuka, Shinichi; Noguchi, Osamu; Kobayashi, Fuminori; Sakamoto, Shigemi; Marumo, Fumiaki; Sato, Chifumi

doi:10.1016/s0168-8278(96)80191-7

Cited by 42 publications

(22 citation statements)

References 28 publications

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“…A subset of patients who have persistent abnormalities under UDCA may progress toward cirrhosis and thus may require adjuvant therapy. So far, three classes of drugs have been tested in combination with UDCA: colchicine, [13][14][15][16] methotrexate, [17][18][19][20] and corticosteroids. [21][22][23][24] Briefly, 1) the benefit of colchicine appeared to be marginal or absent in UDCA-treated patients;…”

Section: Discussionmentioning

confidence: 99%

Clinical significance of serum bilirubin levels under ursodeoxycholic acid therapy in patients with primary biliary cirrhosis

Bonnand

et al. 1999

Hepatology

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We determined whether the normalization of serum bilirubin level (SBL) induced by ursodeoxycholic acid (UDCA) therapy was associated with an improved clinical outcome in patients with primary biliary cirrhosis (PBC). We estimated the prognostic values of SBL measured after 6 months of UDCA treatment for survival free of orthotopic liver transplantation (OLT). We used a database of 548 patients with PBC followed in three trials of UDCA. Among UDCA-treated patients, we compared survival free of OLT in patients with normalized SBL (I17 mol/L) with those who had persistently elevated SBL. Difference in survival was tested between UDCA-treated patients whose SBL normalized with treatment and placebo patients who had normal baseline SBL. We evaluated, in each treatment group, the prognostic value of 6-month SBL. Survival was estimated using the Kaplan-Meier method and compared by the Cox model. Survival free of OLT was significantly longer in patients who had normalized SBL (P F .0001; relative risk [RR]: 3.7, UDCA group). Survival free of OLT was not significantly different between UDCA patients with normalized SBL and placebo patients with a normal baseline SBL (P ‫؍‬ .69). For several cutoffs of 6-month SBL, RRs of OLT or death were similar in UDCA-treated and placebo patients: the RR of OLT or death associated with a 6-month SBL more than 30 mol/L was 6.0 for UDCA and 5.7 for placebo groups. In conclusion, normalization of SBL during therapy is associated with improved clinical outcome. SBL under UDCA therapy is a prognostic factor in PBC. SBL under UDCA therapy should be interpreted as in untreated patients. (HEPATOLOGY 1999;29:39-43.)

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Section: Discussionmentioning

confidence: 99%

Clinical significance of serum bilirubin levels under ursodeoxycholic acid therapy in patients with primary biliary cirrhosis

Bonnand

et al. 1999

Hepatology

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“…Long-term administration can result in ovarian and testicular dysfunction, steatorrhea and Lyell syndrome (Ben Chetrit & Levy, 1998). In addition, it is used for familial Mediterranean fever (FMF), primary biliary cirrhosis (Kershenobich et al, 1988;Ikeda et al, 1996), psoriasis (McKendry et al, 1993), scleroderma (Torres & Furst, 1990), and sarcoidosis (Kaplan, 1960). Colchicine therapy improved BMI slightly, but significantly (Tukmen et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Isolation and anti-inflammatory activity of colchicinoids fromGloriosa superbaseeds

Joshi

Ekambaram

Mathela

2009

Pharmaceutical Biology

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“…Generation of allocation sequence was adequate in four trials (12,14,15,19) and unclear or inadequate in six trials (17,18,(31)(32)(33)(34). Concealment of treatment allocation was adequate in five trials (12,13,15,17,19) and unclear or inadequate in the other five (18,(31)(32)(33)34). Nine trials reported double-blinding and one trial (17) was not blinded.…”

Section: Methodological Quality Of the Trialsmentioning

confidence: 99%

“…Concealment of treatment allocation was adequate in five trials (12,13,15,17,19) and unclear or inadequate in the other five (18,(31)(32)(33)34). Nine trials reported double-blinding and one trial (17) was not blinded. However, the description of the control in the trials reporting double blinding was not sufficient.…”

Section: Methodological Quality Of the Trialsmentioning

confidence: 99%

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Colchicine for Primary Biliary Cirrhosis: A Cochrane Hepato-Biliary Group Systematic Review of Randomized Clinical Trials

Yang

Gluud

2005

Am J Gastroenterology

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OBJECTIVES:Colchicine is used for patients with primary biliary cirrhosis due to its immunomodulatory and antifibrotic potential. The results from randomized clinical trials have, however, been inconsistent. We conducted a systematical review to evaluate the effect of colchicine for primary biliary cirrhosis. METHODS:We identified randomized clinical trials comparing colchicine with placebo/no intervention. We analyzed effects by fixed and random effects model. We investigated heterogeneity by subgroup and sensitivity analyses. RESULTS:We included 10 trials involving 631 patients, four of which were high-quality trials. No significant differences were detected between colchicine and placebo/no intervention regarding mortality (relative risk (RR), 1.21; 95% confidence interval (CI), 0.71-2.06), mortality or liver transplantation (RR = 1.00; 95% CI, 0.67-1.49), liver complications, liver biochemical variables, liver histology, or adverse events. Regarding mortality, an extreme case analysis favoring colchicine did not demonstrate beneficial effects of colchicine, whereas an extreme case analysis favoring placebo/no intervention demonstrated a detrimental effect of colchicine (RR = 2.28; 95% CI, 1.17-4.44). The number of patients without improvement of pruritus significantly decreased in the colchicine group (RR = 0.75; 95% CI, 0.65-0.87). However, this estimate was based on only 156 patients from three trials.CONCLUSIONS: There is insufficient evidence to support the use of colchicine for patients with primary biliary cirrhosis. As we are unable to exclude a risk of increased mortality, we recommend to use colchicine only in randomized clinical trials.(Am J Gastroenterol 2005;100:1876-1885)

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Effects of additional administration of colchicine in ursodeoxycholic acid-treated patients with primary biliary cirrhosis: a prospective randomized study

Cited by 42 publications

References 28 publications

Clinical significance of serum bilirubin levels under ursodeoxycholic acid therapy in patients with primary biliary cirrhosis

Clinical significance of serum bilirubin levels under ursodeoxycholic acid therapy in patients with primary biliary cirrhosis

Isolation and anti-inflammatory activity of colchicinoids fromGloriosa superbaseeds

Colchicine for Primary Biliary Cirrhosis: A Cochrane Hepato-Biliary Group Systematic Review of Randomized Clinical Trials

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