TUDCA for Liver Cirrhosis

Verdict: Weak evidence; surrogate markers only, no proven cirrhosis benefit

For liver cirrhosis, TUDCA rests on a single tiny human trial that nudged liver-enzyme numbers but did not improve fibrosis or any meaningful clinical outcome. It is not an established treatment, and no major regulator or medical society endorses the supplement for this condition.

C 🟠 C Weak Evidence Published with Warning

🔬Why this grade7-layer evidence engine

Direct human evidence is thin. Just one small double-blind RCT (PMID 23592128, n=18, 26 weeks) tested TUDCA in actual cirrhosis: it significantly lowered ALT, AST and ALP and raised albumin, but serum fibrosis markers did not change meaningfully and only a single patient showed histological improvement. These are surrogate lab numbers, not proof the disease itself improves.

The remaining trials sit outside established cirrhosis. A dose-response study in primary biliary cirrhosis (PMID 8674405, n=24) cut liver enzymes but also lowered HDL cholesterol at higher doses, while an HCV chronic-hepatitis trial (PMID 9840118, n=150) reduced aminotransferases versus placebo (p<0.001). The encouraging fibrosis-regression data (PMID 40299532) are from rats and cells only and do not establish a human benefit.

No trial has shown a hard-outcome benefit (mortality, decompensation, or transplant-free survival), which caps the grade at weak. Mayo Clinic, Cleveland Clinic, Harvard Health, and AASLD/EASL offer no TUDCA-for-cirrhosis guidance; society and regulatory backing applies to the related prescription drug UDCA in primary biliary cholangitis, a different indication. The FDA has not cleared the TUDCA supplement, and EFSA and other regulators treat it as a medicinal substance rather than a food supplement.

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Scoring transparency

All scores computed by a 7-layer evidence engine — fully auditable
Raw score 0.48
D
C
B
A
S
← counter-evidence / ineffectiveeffective / strong evidence →
Final grade
C · Published with Warning
Confidence
77%
Broadly consistent
Evidence level
E6
Multiple smaller RCTs (n<500)

How strongly each layer supports this effect

lower = less supportive
L2 PubMedPrimary literature
0.45
L1 ExamineGlobal benchmark
0.50
L3 MechanismPlausibility
0.50
L5 Clinical bodiesAuthoritative stance
0.50
L11 AI re-checkIndependent read
0.50
Against Mixed Supports
View the full decision path (audit trail)
  1. compute_raw_score — 加權公式: L2×0.30 + L3×0.25 + L5×0.25 + L11×0.10 + L1×0.10 = 0.485
  2. tier_from_score — 依分數區間映射至 tier letter
  3. apply_hec_rules — 無高階證據可裁決
  4. tier_strict_requirement_check — Tier 條件達標,未降階
  5. detect_disputes — 偵測到 0 個 hard + 0 個 soft dispute
  6. decide_status — 依 tier + dispute 結果決定 status

📄PubMed studies (4)L2 · primary research & systematic reviews

Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: a double-blind randomized controlled trial
PMID: 23592128 2013 RCT (double-blind) n = 18
Finding: TUDCA significantly reduced serum ALT, AST and ALP from baseline; serum albumin rose significantly in both TUDCA and UDCA groups. Serum fibrosis markers decreased only slightly with no significant difference in either arm. Only one TUDCA patient showed significant histological improvement. Authors concluded TUDCA appeared more effective than UDCA in improving biochemistry.
🟠 Limited quality Effect size: Significant within-group ALT/AST/ALP reduction; fibrosis markers NS
View on PubMed
Tauroursodeoxycholic acid for treatment of primary biliary cirrhosis. A dose-response study
PMID: 8674405 1996 隨機對照試驗 n = 24
Finding: Serum liver enzyme levels decreased significantly after the first month with all three doses. Plasma total and HDL cholesterol fell significantly at higher doses (1000-1500 mg). Diarrhea was the only adverse effect. Authors recommended ~10 mg/kg/day for future long-term studies.
🟠 Limited quality Effect size: Significant liver-enzyme reduction across all doses
View on PubMed
Tauroursodeoxycholic acid for the treatment of HCV-related chronic hepatitis: a multicenter placebo-controlled study
PMID: 9840118 1998 RCT (double-blind) n = 150
Finding: TUDCA-treated patients showed a consistent and progressive decrease in aminotransferase levels versus placebo (p<0.001); authors concluded TUDCA improves the biochemical expression of chronic hepatitis. Not a cirrhosis population — included as nearest-adjacent TUDCA hepatitis evidence.
Effect size: Aminotransferase reduction vs placebo, p<0.001
View on PubMed
Tauroursodeoxycholic Acid Induces Liver Regeneration and Alleviates Fibrosis Through GATA3 Activation
PMID: 40299532 2025 Animal Study
Finding: TUDCA promoted hepatocyte proliferation and liver regeneration and ameliorated CCl4-induced fibrosis in rats via GATA3 activation; blocking GATA3 abolished the effect. Animal-only evidence — does not establish a human cirrhosis benefit.
🟠 Limited quality Government Effect size: Mechanistic; not human
View on PubMed

🏛️Regulatory & authoritative positionsL4/L5 · FDA / EMA / NIH ODS / Cochrane / Mayo …

L4a US FDA
Cautious
TUDCA is a US Food and Drug Administration-approved hydrophilic bile acid for the treatment of certain cholestatic liver diseases source↗
L4b EU EFSA
Against
L4d TW TFDA / 衛福部
Against
含URSO(Ursodeoxycholic acid,去氧熊膽酸)成分之單方製劑統一為醫師處方用藥,適應症統一為「膽固醇系膽結石之溶解、原發性膽道肝硬化(primary biliary cirrhosis, PBC)之肝功能改善」。 source↗
L5e Specialty Society (condition-mapped)
Not addressed
PMID 100% verifiedevery citation checked via NCBI Entrez
🔬4 PubMed studiesindependently re-checked by multiple sub-agents
engine_version: v1.0 claim_id: CLM-COND-liver-cirrhosis-INT-tudca-001 繁體中文版 →