ArticleInternational journal of clinical and experimental medicine2015
An open-label, randomized and multi-center clinical trial to evaluate the efficacy of Silibinin in preventing drug-induced liver injury.
Article in International journal of clinical and experimental medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Are alterations needed in Silybum marianum (Silymarin) administration practices? A novel outlook and meta-analysis on randomized trials targeting liver injury.BMC complementary medicine and therapies · 2025Pooled it
- Systematic review and network meta-analysis of efficacy and safety of interventions for preventing anti-tuberculosis drug induced liver injury.Scientific reports · 2023Pooled it
- Silymarin as Supportive Treatment in Liver Diseases: A Narrative Review.Advances in therapy · 2020Pooled it
- Prophylactic Therapy of Silymarin (Milk Thistle) on Antituberculosis Drug-Induced Liver Injury: A Meta-Analysis of Randomized Controlled Trials.Canadian journal of gastroenterology & hepatology · 2019Pooled it
- Current and future directions in the treatment and prevention of drug-induced liver injury: a systematic review.Expert review of gastroenterology & hepatology · 2016Pooled it
- The Effect of Prophylactic Hepatoprotective Therapy on Drug-Induced Liver Injury in Patients Undergoing Chemotherapy for Cervical Cancer: A Retrospective Analysis Based on Propensity Score Matching.Current oncology (Toronto, Ont.) · 2025Article
- Silymarin: Unveiling its pharmacological spectrum and therapeutic potential in liver diseases-A comprehensive narrative review.Food science & nutrition · 2024Review
- Interventions to prevent post-tuberculosis sequelae: a systematic review and meta-analysis.EClinicalMedicine · 2024Article
- The Effectiveness of Silymarin in the Prevention of Anti-tuberculosis Drug-induced Hepatotoxicity: A Randomized Controlled Clinical Trial.International journal of preventive medicine · 2023Article
- Hepatoprotective drugs for prevention of liver injury resulting from anti-tuberculosis treatment: A meta-analysis of cohort studies.Infectious medicine · 2022Article
- Mechanism of drug-induced liver injury and hepatoprotective effects of natural drugs.Chinese medicine · 2021Review
- Overview of drug induced liver injury in Brazil: What is the role of public health policy on the evidence?World journal of gastrointestinal pharmacology and therapeutics · 2021Article
- Article
- Oxidative Stress in Drug-Induced Liver Injury (DILI): From Mechanisms to Biomarkers for Use in Clinical Practice.Antioxidants (Basel, Switzerland) · 2021Review
- Novel Therapies for the Treatment of Drug-Induced Liver Injury: A Systematic Review.Frontiers in pharmacology · 2021Review
- The Effect of acetyl-L-carnitine, Alpha-lipoic Acid, and Coenzyme Q10 Combination in Preventing Anti-tuberculosis Drug-induced Hepatotoxicity: A Randomized, Double-blind, Placebo-controlled Clinical Trial.Iranian journal of pharmaceutical research : IJPR · 2021Article
- An Evaluation of the In Vitro Roles and Mechanisms of Silibinin in Reducing Pyrazinamide- and Isoniazid-Induced Hepatocellular Damage.International journal of molecular sciences · 2020Article
- Drug-Induced Liver Injury from Anti-Tuberculosis Treatment: A Retrospective Cohort Study.Medical science monitor : international medical journal of experimental and clinical research · 2020Article
- Pre-treatment With PLGA/Silibinin Nanoparticles Mitigates Dacarbazine-Induced Hepatotoxicity.Frontiers in bioengineering and biotechnology · 2020Article
- Evaluation of Silymarin for management of anti-tuberculosis drug induced liver injury: a randomized clinical trial.Gastroenterology and hepatology from bed to bench · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledTo assess the clinical efficacy and safety of Silibinin in preventing drug-induced liver injury (DILI) in the general population (high-risk patients with non-drug induced liver injury).
methodA prospective, multi-center, randomized, open-label and controlled trial was conducted with 568 patients undergoing primary treatment of pulmonary tuberculosis. The study included 277 patients in experimental group and 291 patients in control group. The patients in the two group were treated with conventional 2HREZ (S)/4HR for tuberculosis (TB), and additional Silibinin capsules (oral administration of 70 mg/time, 3 times/day for 8 weeks in experimental group. Outcomes of liver function, interruption of anti-TB treatment and therapeutic results, as well as adverse reactions were observed and analyzed.
resultsAt 2, 4 and 8 weeks of treatment, the incidences of liver injury in experimental group were 3.97%, 1.44% and 2.17%, respectively; the incidences in control group were 4.12%, 4.12% and 2.41%, respectively. Statistical analysis showed that there was no difference in the incidence between the two groups at each treatment period (P>0.05). At 8 weeks, the numbers of patients diagnosed of DILI were 18 (7.22%) and 27 (9.28%) in experimental and control groups, respectively (P>0.05). 34.30% and 27.49% of the patients in experimental and control groups had transient abnormal liver function or symptoms, respectively; similar percentages (3.25% and 6.19%) of the patients in two groups have liver function injury and symptoms, and were suspended for anti-TB treatment (P>0.05). The incidence of anorexia and nausea symptoms was lower in experimental group than in control group, and the differences were significant at 4 and 8 weeks (P<0.05). 8 weeks after the treatment, 98.30% of the sputum smear culture were negative in experimental group, which was significantly higher (P<0.01) than that in control group (92.98%).
conclusionPreventive hepatoprotective therapy in the general population may reduce drug discontinuation rate, improve patient's compliance and outcomes of anti-TB treatment.
Indexed as
Identifiers
26064348PMC4443182W2339158755What OpenQuestion holds
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.