Evidence map›Paper›PMID 26400476›Full record

Trial reportBMC complementary and alternative medicine2015

A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury.

Chote Luangchosiri, Ammarin Thakkinstian, Sermsiri Chitphuk, Wasana Stitchantrakul, Supanna Petraksa, Abhasnee Sobhonslidsuk

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC complementary and alternative medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 7 pooled it
5.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01800487 nacompletednot on this map

The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs

TypeinterventionalSponsorRamathibodi HospitalRan2012 to 2013Enrolled80ConditionsTuberculosisArmssilymarin, Placebo
NCT07058090 phase1not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi

TypeinterventionalSponsorLiaquat National Hospital & Medical CollegeRan2025 to 2026Enrolled410ConditionsDrug Induced Liver Injury, Tuberculosis (TB)ArmsSilymarin 420 mg, N Acetyl Cysteine, Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 7 syntheses or guidelines pooled it, 74 citations in OpenAlex.

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  9. HBV/HCV coinfection and anti-tuberculosis drug-induced liver injury: from risk assessment and exploration of mechanisms to preventive considerations.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Chote LuangchosiriDivision of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Ammarin ThakkinstianSection for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Sermsiri ChitphukResearch Center, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Wasana StitchantrakulResearch Center, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Supanna PetraksaDivision of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Abhasnee SobhonslidsukDivision of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Abhasnee.sob@mahidol.ac.th.
Ramathibodi Hospital · THMahidol University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatitis is a common adverse effect of antituberculosis drugs. Silymarin prevented drug-induced hepatoxicity in animals with anti-oxidative mechanisms but its effect in human has been unknown. We aimed to evaluate the efficacy of silymarin for preventing antituberculosis-drug induced liver injury (antiTB-DILI) in patients with tuberculosis.

methodsA double-blind randomized placebo-controlled trial was performed. Tuberculosis patients were randomly allocated to receive placebo or silymarin. The outcomes of interests were antiTB-DILI and the maximum liver enzymes at week 4. Antioxidative enzymes (i.e., superoxide dismutase (SOD), glutathione and malondialdehyde assays) were assessed. The risks of antiTB-DILI between the two groups were compared. A number need to treat was estimated.

resultsA total of 55 out of 70 expected numbers of patients were enrolled. There were 1/27 (3.7%) and 9/28 (32.1%) patients who developed antiTB-DILI in the silymarin and the placebo groups. Risk reduction was 0.28 (0.10, 0.47), i.e., receiving silymarin was 28% at lower risk for antiTB-DILI than placebo. This led to prevention of 28 patients from being antiTB-DILI among 100 treated patients. Median (IQR) of ALT levels at week 4 in the placebo and the silymarin group were 35.0 (15, 415) IU/L and 31.5 (20, 184) IU/L (p = 0.455). The decline of SOD level at week 4 in the silymarin group was less than the placebo group (p < 0.027).

conclusionsSilymarin reduced the incidence of antiTB-DILI. The benefit of silymarin may be explained from superoxide dismutase restoration. Larger clinical trials are required to confirm the result of our small study [Clinicaltrials.Gov Identifier Nct01800487].

Indexed as

AdolescentAdultAgedAged, 80 and overAnimalsAntitubercular AgentsChemical and Drug Induced Liver InjuryDouble-Blind MethodFemaleHumansMaleMalondialdehydeMiddle AgedProtective AgentsSilymarinSuperoxide DismutaseAntitubercular AgentsMalondialdehydeProtective AgentsSilymarinSuperoxide Dismutase

Identifiers

PMID26400476
PMCPMC4580123
OpenAlexW2144634052

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.