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D-penicillamine for primary biliary cirrhosis
Y Gong1, S L Frederiksen, C Gluud
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Dept. 7102, Blegdamsvej 9, H:S Rigshospitalet, Copenhagen, DK-2100, Denmark. ygong@ctu.rh.dk
The Cochrane Database of Systematic Reviews
|October 21, 2004
Summary
D-penicillamine did not reduce mortality for primary biliary cirrhosis patients but significantly increased adverse events. This review does not support its use in treating this condition.
Area of Science:
- Hepatology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- D-penicillamine is used for primary biliary cirrhosis (PBC) due to its copper-lowering and immunomodulatory effects.
- Clinical trial results for D-penicillamine in PBC have been inconsistent.
- A systematic review is needed to clarify its efficacy and safety.
Purpose of the Study:
- To systematically review the beneficial and harmful effects of D-penicillamine in patients with primary biliary cirrhosis.
- To synthesize evidence from randomized clinical trials on D-penicillamine's impact on PBC outcomes.
Main Methods:
- Systematic review of randomized clinical trials (RCTs) identified through comprehensive electronic and manual searches.
- Data extraction and quality assessment by independent reviewers.
- Analysis of dichotomous outcomes using fixed and random effects models, with subgroup and sensitivity analyses to explore heterogeneity.
Main Results:
- Seven RCTs involving 706 PBC patients were included.
- D-penicillamine showed a trend towards increased mortality (RR 1.34) but with substantial heterogeneity.
- Significant increase in adverse events (RR 3.11) was observed with D-penicillamine compared to placebo.
Conclusions:
- D-penicillamine did not demonstrate a reduction in mortality risk for primary biliary cirrhosis patients.
- The drug significantly increased the incidence of adverse events.
- Current evidence does not support the use of D-penicillamine for primary biliary cirrhosis.