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      Associations between prescribed Chinese herbal medicine and risk of hepatocellular carcinoma in patients with chronic hepatitis B: a nationwide population-based cohort study

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          Abstract

          Objective

          Patients with chronic hepatitis B (CHB) are reported to exhibit higher risk of subsequent hepatocellular carcinoma (HCC). However, it remains unclear if Chinese herbal medicine (CHM), an important category of traditional Chinese medicine (TCM), may lower HCC risk in this population. So this study aimed to investigate the effects of CHM on HCC risk among patients with CHB.

          Methods

          This cohort study used the Taiwanese National Health Insurance Research Database to identify 21 020 newly diagnosed patients with CHB from 1998 to 2007. Among them, 8640 received CHM products after CHB onset (CHM users), and the remaining 12 380 patients were designated as a control group (non-CHM users). All enrolees were followed until the end of 2012 to measure the incidence rate and HR of HCC.

          Results

          During 15 years of follow-up, 371 CHM users and 958 non-CHM users developed HCC, representing an incidence rate of 5.28% and 10.18% per 1000 person-years, respectively. CHM users had significantly lower HCC risk compared with non-CHM users (adjusted HR=0.63, 95% CI 0.56 to 0.72). The predominant effect was observed in those receiving CHM products for more than 180 days (adjusted HR=0.52). Some CHM products, such as Hedyotis diffusa, Scutellaria barbata, Rehmannia glutinosa, Isatis tinctoria, Yi Guan Jian, Xiao Chai Hu Tang, Wu Ling San and Gan Lu Yin, were significantly associated with lower risk of HCC.

          Conclusions

          The use of CHM was associated with a significantly reduced HCC risk in patients with CHB, which supports the integration of TCM with CHM into clinical practice to influence a favourable prognosis.

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          Most cited references38

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          Hepatitis B virus infection.

          Yun-Fan Liaw, Chia-Ming Chu (2009)
          Since the introduction of the hepatitis B vaccine and other preventive measures, the worldwide prevalence of hepatitis B infection has fallen. However, chronic infection remains a challenging global health problem, with more than 350 million people chronically infected and at risk of hepatic decompensation, cirrhosis, and hepatocellular carcinoma. An improved understanding of hepatitis B virology, immunology, and the natural course of chronic infection, has identified hepatitis B virus replication as the key driver of immune-mediated liver injury and disease progression. The approval of potent oral antiviral agents has revolutionised hepatitis B treatment since 1998. Conventional and pegylated interferon alfa and nucleoside and nucleotide analogues are widely authorised treatments, and monotherapy with these drugs greatly suppresses virus replication, reduces hepatitis activity, and halts disease progression. However, hepatitis B virus is rarely eliminated, and drug resistance is a major drawback during long term therapy. The development of new drugs and strategies is needed to improve treatment outcomes.
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            HBx gene of hepatitis B virus induces liver cancer in transgenic mice.

            C M Kim, K. Koike, I Saito … (1991)
            The exact role of hepatitis B virus in the development of liver cancer is not known. The recent identification of a viral regulatory gene HBx suggests a possible direct involvement of the virus whereby the HBx protein, acting as a transcriptional transactivator of viral genes, may alter host gene expression and lead to the development of hepatocellular carcinoma. We have tested this possibility of placing the entire HBx gene under its own regulatory elements directly into the germline of mice. Transgenic animals harbouring this viral gene succumbed to progressive histopathological changes specifically in the liver, beginning with multifocal areas of altered hepatocytes, followed by the appearance of benign adenomas, and proceeding to the development of malignant carcinomas. Male mice developed disease and died much earlier than females. This transgenic animal model appears ideal for defining the molecular events that follow the expression of the viral HBx gene and are responsible for the development of liver cancer.
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              Association of nucleos(t)ide analogue therapy with reduced risk of hepatocellular carcinoma in patients with chronic hepatitis B: a nationwide cohort study.

              Chun-Ying Wu, Jaw-Town Lin, Hsiu Ho … (2014)
              Treatment for hepatitis B virus infection reduces the risk of hepatocellular carcinoma (HCC). However, the long-term protective effects for subgroups of patients with chronic hepatitis B are unclear. We conducted a retrospective nationwide cohort study using data from Taiwan's National Health Insurance Research Database (from January 1, 1997, through December 31, 2010). Cumulative incidences were calculated and multivariable analyses were carried out after adjusting for competing mortality. Propensity scores were used to match 21,595 patients with chronic hepatitis B who received nucleoside analogue therapy for at least 90 days (treated cohort) with 21,595 untreated patients with chronic hepatitis B (controls), who received hepatoprotectants for at least 90 days. Data were collected from the treated cohort for a mean period of 3.46 years and from controls for 5.24 years. The treated cohort had a significantly lower 7-year incidence of HCC (7.32%; 95% confidence interval [CI], 6.77%-7.87%) than controls (22.7%; 95% CI, 22.1%-23.3%; P < .001). After adjusting for competing mortality and other confounders, nucleos(t)ide analogue treatment was associated with a reduced risk of HCC, with an adjusted hazard ratio of 0.37 (95% CI, 0.34-0.39; P < .001). Sensitivity analyses confirmed the association between nucleos(t)ide analogue treatment and reduced risk of HCC. Age, sex, cirrhosis, and diabetes mellitus modified this association. Based on a retrospective, nationwide study in Taiwan, nucleoside analogue therapy use is associated with reduced risk of HCC in patients with chronic hepatitis B virus infection. Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2017
                Publication date (Electronic): 25 January 2017
                Volume: 7
                Issue: 1
                Electronic Location Identifier: e014571
                Affiliations
                [1 ]Department of Medical Research, Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation , Chiayi, Taiwan
                [2 ]Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University , Tainan, Taiwan
                [3 ]Department of Nursing, Tzu Chi College of Technology , Hualien, Taiwan
                [4 ]Rehabilitation Counseling Program, Portland State University , Portland, Oregon, USA
                [5 ]Division of Gastroenterology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Foundation , Chiayi, Taiwan
                [6 ]School of Medicine , Hualien, Taiwan
                [7 ]School of Post-Baccalaureate Chinese Medicine, Tzu Chi University , Hualien, Taiwan
                [8 ]Division of Allergy, Immunology and Rheumatology, Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation , Chiayi, Taiwan
                [9 ]Department of Chinese Medicine, Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation , Chiayi, Taiwan
                Author notes
                [Correspondence to ] Professor Chia-Chou Yeh; yehcc0530@ 123456gmail.com
                Article
                Publisher ID: bmjopen-2016-014571
                DOI: 10.1136/bmjopen-2016-014571
                PMC ID: 5278254
                PubMed ID: 28122837
                SO-VID: 2acaa541-e251-4092-ba0f-339c06ef7b36
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                Date received : 4 October 2016
                Date revision received : 7 December 2016
                Date accepted : 21 December 2016
                Categories
                Subject: Complementary Medicine
                Subject: Research
                Subject: 1506
                Subject: 1685
                Subject: 1695

                ScienceOpen disciplines: Medicine
                Keywords: chronic hepatitis b,hepatocellular carcinoma,chinese herbal medicine,cohort study
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: chronic hepatitis b, hepatocellular carcinoma, chinese herbal medicine, cohort study

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