Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial

Objective To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue (调肝健脾和血) and Tiaogan Jiedu Huashi (调肝解毒化湿) fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients. Methods A total of 605 HBeAg-positive Chin...

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Published in:Chinese journal of integrative medicine 2020-05, Vol.26 (5), p.330-338
Main Authors: Li, Xiao-ke, Zhang, Ming-xiang, Shao, Feng-zhen, Zhou, Da-qiao, Xue, Jing-dong, Liu, Tie-jun, Chi, Xiao-ling, Lu, Bing-jiu, Wang, Xian-bo, Li, Qin, Li, Jun, Mao, De-wen, Yang, Hua-sheng, Yang, Hong-zhi, Zhao, Wen-xia, Li, Yong, Zhang, Guo-liang, Zhao, Yi-ming, Zou, Jian-dong, Liu, Meng-yang, Zhang, Ke-ke, Yang, Xian-zhao, Gan, Da-nan, Li, Ying, Zhang, Peng, Li, Zhi-guo, Li, Shuo, Ye, Yong-an
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creator Li, Xiao-ke
Zhang, Ming-xiang
Shao, Feng-zhen
Zhou, Da-qiao
Xue, Jing-dong
Liu, Tie-jun
Chi, Xiao-ling
Lu, Bing-jiu
Wang, Xian-bo
Li, Qin
Li, Jun
Mao, De-wen
Yang, Hua-sheng
Yang, Hong-zhi
Zhao, Wen-xia
Li, Yong
Zhang, Guo-liang
Zhao, Yi-ming
Zou, Jian-dong
Liu, Meng-yang
Zhang, Ke-ke
Yang, Xian-zhao
Gan, Da-nan
Li, Ying
Zhang, Peng
Li, Zhi-guo
Li, Shuo
Ye, Yong-an
description Objective To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue (调肝健脾和血) and Tiaogan Jiedu Huashi (调肝解毒化湿) fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients. Methods A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented. Results The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P
doi_str_mv 10.1007/s11655-020-3250-0
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Methods A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented. Results The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P&lt;0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns. Conclusion Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).</description><identifier>ISSN: 1672-0415</identifier><identifier>EISSN: 1993-0402</identifier><identifier>DOI: 10.1007/s11655-020-3250-0</identifier><identifier>PMID: 31919749</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Medicine ; Medicine &amp; Public Health ; Original Article</subject><ispartof>Chinese journal of integrative medicine, 2020-05, Vol.26 (5), p.330-338</ispartof><rights>The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c344t-687f53b55a95a513773337caa8dd21149f1fde7116d2ce49ba0880d2591144b83</citedby><cites>FETCH-LOGICAL-c344t-687f53b55a95a513773337caa8dd21149f1fde7116d2ce49ba0880d2591144b83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31919749$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Xiao-ke</creatorcontrib><creatorcontrib>Zhang, Ming-xiang</creatorcontrib><creatorcontrib>Shao, Feng-zhen</creatorcontrib><creatorcontrib>Zhou, Da-qiao</creatorcontrib><creatorcontrib>Xue, Jing-dong</creatorcontrib><creatorcontrib>Liu, Tie-jun</creatorcontrib><creatorcontrib>Chi, Xiao-ling</creatorcontrib><creatorcontrib>Lu, Bing-jiu</creatorcontrib><creatorcontrib>Wang, Xian-bo</creatorcontrib><creatorcontrib>Li, Qin</creatorcontrib><creatorcontrib>Li, Jun</creatorcontrib><creatorcontrib>Mao, De-wen</creatorcontrib><creatorcontrib>Yang, Hua-sheng</creatorcontrib><creatorcontrib>Yang, Hong-zhi</creatorcontrib><creatorcontrib>Zhao, Wen-xia</creatorcontrib><creatorcontrib>Li, Yong</creatorcontrib><creatorcontrib>Zhang, Guo-liang</creatorcontrib><creatorcontrib>Zhao, Yi-ming</creatorcontrib><creatorcontrib>Zou, Jian-dong</creatorcontrib><creatorcontrib>Liu, Meng-yang</creatorcontrib><creatorcontrib>Zhang, Ke-ke</creatorcontrib><creatorcontrib>Yang, Xian-zhao</creatorcontrib><creatorcontrib>Gan, Da-nan</creatorcontrib><creatorcontrib>Li, Ying</creatorcontrib><creatorcontrib>Zhang, Peng</creatorcontrib><creatorcontrib>Li, Zhi-guo</creatorcontrib><creatorcontrib>Li, Shuo</creatorcontrib><creatorcontrib>Ye, Yong-an</creatorcontrib><title>Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial</title><title>Chinese journal of integrative medicine</title><addtitle>Chin. J. Integr. Med</addtitle><addtitle>Chin J Integr Med</addtitle><description>Objective To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue (调肝健脾和血) and Tiaogan Jiedu Huashi (调肝解毒化湿) fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients. Methods A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented. Results The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P&lt;0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns. Conclusion Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. 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J. Integr. Med</stitle><addtitle>Chin J Integr Med</addtitle><date>2020-05-01</date><risdate>2020</risdate><volume>26</volume><issue>5</issue><spage>330</spage><epage>338</epage><pages>330-338</pages><issn>1672-0415</issn><eissn>1993-0402</eissn><abstract>Objective To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue (调肝健脾和血) and Tiaogan Jiedu Huashi (调肝解毒化湿) fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients. Methods A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented. Results The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P&lt;0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns. Conclusion Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>31919749</pmid><doi>10.1007/s11655-020-3250-0</doi><tpages>9</tpages></addata></record>
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Medicine & Public Health
Original Article
title Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial
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