Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)

Purpose: We investigated the effects of testosterone replacement therapy (TRT) on the Fibrosis-4 (FIB-4) index among hypogonadal patients who were extracted from a randomized controlled study in Japan (the EARTH study). Materials and Methods: Data of 186 patients (88 in the TRT group; 98 in the co...

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Main Authors: Kazuyoshi Shigehara, Yuki Kato, Rei Shinzawa, Hiroyuki Konaka, Shohei Kawaguchi, Takahiro Nohara, Kouji Izumi, Mikio Namiki, Atsushi Mizokami
Format: Article
Language:English
Published: Korean Society for Sexual Medicine and Andrology 2025-07-01
Series:The World Journal of Men's Health
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author Kazuyoshi Shigehara
Yuki Kato
Rei Shinzawa
Hiroyuki Konaka
Shohei Kawaguchi
Takahiro Nohara
Kouji Izumi
Mikio Namiki
Atsushi Mizokami
author_facet Kazuyoshi Shigehara
Yuki Kato
Rei Shinzawa
Hiroyuki Konaka
Shohei Kawaguchi
Takahiro Nohara
Kouji Izumi
Mikio Namiki
Atsushi Mizokami
author_sort Kazuyoshi Shigehara
collection DOAJ
description Purpose: We investigated the effects of testosterone replacement therapy (TRT) on the Fibrosis-4 (FIB-4) index among hypogonadal patients who were extracted from a randomized controlled study in Japan (the EARTH study). Materials and Methods: Data of 186 patients (88 in the TRT group; 98 in the control group) were collected. The patients in the TRT group received intramuscular administration of testosterone enanthate (250 mg) every 4 weeks for 12 months. The patients’ background information such as current medical history and lifestyle habits were collected. Waist circumference, body mass index, and body fat volume were measured at baseline and 12-month visit. Fasting blood sugar (FBS), hemoglobin A1c, total cholesterol, triglyceride (TG), and high-density lipoprotein cholesterol levels were collected at baseline and 12-month visit. The FIB-4 index was calculated according to age, aspartate aminotransferase, alanine transaminase, and platelet count. Results: Except for serum FBS values, most of baseline characteristics were comparable between the TRT and control groups. When comparing the changes of each variable from baseline at 12-month visit in both groups, significant differences were found in waist circumference (p=0.00248), fat volume (p=0.00812), and platelet counts (p=0.0478), whereas a FIB-4 index did not change. On the contrary, in a subanalysis including only patients with a FIB-4 index ≥1.30 at baseline, a significant difference in a FIB-4 index (−0.10±0.39 vs. 0.04±0.44; p=0.0311) was observed with significant decreases in waist circumference, body fat volume, and TG levels, and an increase in platelet counts. The FIB-4 index was significantly decreased by TRT from 1.98±0.52 to 1.87±0.60 (p=0.0277). Conclusions: TRT for 12 months improved the FIB-4 index among hypogonadal men with a higher baseline FIB-4 index.
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spelling doaj-art-5cc46c32537e40a1bb1fec462ec6946d2025-08-20T03:29:23ZengKorean Society for Sexual Medicine and AndrologyThe World Journal of Men's Health2287-42082287-46902025-07-0143366166810.5534/wjmh.240066Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)Kazuyoshi Shigehara0https://orcid.org/0000-0002-2118-9135Yuki Kato1https://orcid.org/0000-0002-1833-5381Rei Shinzawa2https://orcid.org/0009-0002-1781-2817Hiroyuki Konaka3https://orcid.org/0000-0002-6193-0274Shohei Kawaguchi4https://orcid.org/0000-0001-6847-9861Takahiro Nohara5https://orcid.org/0000-0001-9792-2068Kouji Izumi6https://orcid.org/0000-0002-8480-9100Mikio Namiki7https://orcid.org/0000-0002-0415-650XAtsushi Mizokami8https://orcid.org/0000-0002-5643-2182Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Urology, Kanazawa Red Cross Hospital, Kanazawa, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanDepartment of Urology, Hasegawa Hospital, Toyama, JapanDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, JapanPurpose: We investigated the effects of testosterone replacement therapy (TRT) on the Fibrosis-4 (FIB-4) index among hypogonadal patients who were extracted from a randomized controlled study in Japan (the EARTH study). Materials and Methods: Data of 186 patients (88 in the TRT group; 98 in the control group) were collected. The patients in the TRT group received intramuscular administration of testosterone enanthate (250 mg) every 4 weeks for 12 months. The patients’ background information such as current medical history and lifestyle habits were collected. Waist circumference, body mass index, and body fat volume were measured at baseline and 12-month visit. Fasting blood sugar (FBS), hemoglobin A1c, total cholesterol, triglyceride (TG), and high-density lipoprotein cholesterol levels were collected at baseline and 12-month visit. The FIB-4 index was calculated according to age, aspartate aminotransferase, alanine transaminase, and platelet count. Results: Except for serum FBS values, most of baseline characteristics were comparable between the TRT and control groups. When comparing the changes of each variable from baseline at 12-month visit in both groups, significant differences were found in waist circumference (p=0.00248), fat volume (p=0.00812), and platelet counts (p=0.0478), whereas a FIB-4 index did not change. On the contrary, in a subanalysis including only patients with a FIB-4 index ≥1.30 at baseline, a significant difference in a FIB-4 index (−0.10±0.39 vs. 0.04±0.44; p=0.0311) was observed with significant decreases in waist circumference, body fat volume, and TG levels, and an increase in platelet counts. The FIB-4 index was significantly decreased by TRT from 1.98±0.52 to 1.87±0.60 (p=0.0277). Conclusions: TRT for 12 months improved the FIB-4 index among hypogonadal men with a higher baseline FIB-4 index.fibrosishypogonadismliver cirrhosismetabolic syndrometestosterone
spellingShingle Kazuyoshi Shigehara
Yuki Kato
Rei Shinzawa
Hiroyuki Konaka
Shohei Kawaguchi
Takahiro Nohara
Kouji Izumi
Mikio Namiki
Atsushi Mizokami
Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
The World Journal of Men's Health
fibrosis
hypogonadism
liver cirrhosis
metabolic syndrome
testosterone
title Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
title_full Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
title_fullStr Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
title_full_unstemmed Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
title_short Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study)
title_sort testosterone replacement therapy can improve a biomarker of liver fibrosis in hypogonadal men a subanalysis of a prospective randomized controlled study in japan earth study
topic fibrosis
hypogonadism
liver cirrhosis
metabolic syndrome
testosterone
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