Evidence map›Paper›PMID 34386935›Full record

Trial reportHepatology international2021

First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients.

Jee-Fu Huang, Chia-Yen Dai, Chung-Feng Huang, Pei-Chien Tsai, Ming-Lun Yeh, Po-Yau Hsu, Shiu-Feng Huang, Ming-Jong Bair, Nai-Jen Hou, Ching-I Huang and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01068444 (A Double-Blind, Randomized, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis), which is not on this map. Cited by 33 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 8 pooled it
5.1field-weighted citation impact, top 4% 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.

NCT01068444 phase2completednot on this map

A Double-Blind, Randomized, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis

TypeinterventionalSponsorKaohsiung Medical University Chung-Ho Memorial HospitalRan2009 to 2020Enrolled90ConditionsHepatitisArmsPioglitazone, placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 8 syntheses or guidelines pooled it, 61 citations in OpenAlex.

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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

18 authors at 3 institutions in 1 country.

Jee-Fu HuangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.ORCID http://orcid.org/0000-0002-2752-7051
Chia-Yen DaiHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Chung-Feng HuangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Pei-Chien TsaiHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Ming-Lun YehHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Po-Yau HsuHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Shiu-Feng HuangInstitute of Molecular and Genomic Medicine, National Health Research Institutes, Miaoli, Taiwan.
Ming-Jong BairDivision of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan.
Nai-Jen HouHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Ching-I HuangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Po-Cheng LiangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Yi-Hung LinHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Chih-Wen WangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Ming-Yen HsiehHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Shinn-Chern ChenHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Zu-Yau LinHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan.
Ming-Lung YuHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan. fish6069@gmail.com.
Wan-Long ChuangHepatobiliary Division and Hepatitis Center, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou Road, Kaohsiung, Taiwan. waloch@cc.kmu.edu.tw.
Kaohsiung Medical University · TWMackay Memorial Hospital · TWNational Health Research Institutes · TW

Funding

Kaohsiung Medical University KMU-TC108A04-3Kaohsiung Medical University KMU-TC109B05Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH106-6R08Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH107-7R05Ministry of Science and Technology, Taiwan MOST 107-2314-B-037-083-MY3
6 · The paper itself

Abstract

backgroundThe efficacy and safety of insulin sensitizer in Asians with non-alcoholic steatohepatitis (NASH) remain elusive.

aimsThe double-blind, randomized, placebo-controlled trial was conducted aiming to investigate the efficacy and safety of pioglitazone in NASH patients.

methodsA total of 90 NASH patients (66 males, age = 44.1 ± 12.7 years) were prospectively randomized into oral pioglitazone 30 mg/day (Arm A) or placebo (Arm B) for 24 weeks. The primary endpoint was the efficacy of pioglitazone in reducing inflammation and liver fat at end-of-treatment (EOT). NASH resolution/improvement without fibrosis worsening was also evaluated.

resultsAt EOT, there was a significantly decline of alanine aminotransferase (86.9 ± 34.3 to 45.7 ± 35.8 IU/L, p = 0.003) level in Arm A patients. In intention-to-treat analysis among 66 patients who completed paired biopsies, The NAFLD activity score (NAS) of 30 Arm A patients significantly decreased from 4.27 ± 1.14 at baseline to 2.53 ± 1.63 at EOT (p < 0.0001), whereas there was no significant change in patients of Arm B (3.94 ± 1.41 vs 3.94 ± 1.51, p = 1.0). NASH improvement without worsening of fibrosis was achieved in 46.7% (14/30) patients in Arm A, compared to 11.1% (4/36) patients in Arm B (p = 0.002). Liver fat content reduced (20.2 ± 9.0 to 14.3 ± 6.9%, p < 0.0001) on MRI-PDFF in Arm A compared to their counterparts. No significant difference of adverse events occurred between groups.

conclusionsA 24-week pioglitazone treatment was well-tolerated and effective in improving liver histology and reducing liver steatosis in Asian NASH patients. (ClinicalTrials.gov number: NCT01068444).

Indexed as

Non-alcoholic Fatty Liver DiseaseAdultAsian PeopleDouble-Blind MethodFemaleHumansInsulinLiverMaleMiddle AgedTreatment OutcomeInsulinAsiansClinical trialFibrosisInsulin resistanceInsulin sensitizerLiver inflammationMagnetic resonance imaging–proton density fat fractionNon-alcoholic steatohepatitisSafetySteatosis

Identifiers

PMID34386935
OpenAlexW3177390597

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.