Abstract
Objective
To evaluate the efficacy and safety of oral oxymatrine preparation for the treatment of chronic hepatitis B (CHB).
Methods
Randomized controlled trials (RCTs) on oral oxymatrine preparation in treating patients with CHB were retrieved until October 2013 by searching PubMed, the Cochrane Library, Embase and four Chinese databases, irrespective of language and publication status. Data extraction and data analyses were conducted according to the Cochrane standards. The risk of bias for each included trials and the quality of evidence on pre-specified outcomes were assessed. The RevMan software was used for statistical analyses.
Results
Totally 52 RCTs enrolling 5,227 participants were included, of which 51 RCTs were included in meta-analyses. Oral oxymatrine preparation including oxymatrine capsule and oxymatrine tablet were associated with statistically significant effect on the clearance of hepatitis B virus (HBV) DNA, HBV surface antigen and HBV e antigen, and were beneficial to the normalization of serum alanine aminotransferase and aspartate aminotransferase. Nevertheless, the overall methodological quality and the quality of evidence in the included trials were poor. In addition, safety of oral oxymatrine preparation was not confirmed.
Conclusions
Oral oxymatrine preparation showed some potential benefits for patients with CHB. However, the overall quality of evidence was limited and the safety of oral oxymatrine preparation for CHB patients was still unproven. More high quality evidence from rigorously designed RCTs is warranted to support the clinical use of oral oxymatrine preparation for patients with CHB.
Similar content being viewed by others
References
World Health Organization. Hepatitis B. Available: http:// www.who.int/mediacentre/factsheets/fs204/en/. [Accessed 16 October, 2013].
Song P, Feng X, Zhang K, Song T, Ma K, Kokudo N, et al. Screening for and surveillance of high-risk patients with HBVrelated chronic liver disease: promoting the early detection of hepatocellular carcinoma in China. Biosci Trends 2013;7:16.
Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009;50:661–662.
American Association for the Study of Liver Diseases. Viral hepatitis prevention, screening, and treatment. Available: http://www.aasld.org/patients/Pages/ ViralHepatitisPrevention.aspx. [Accessed 16 October, 2013].
Blumberg BS. Hepatitis B virus: search for plant-derived antiviral. In: Tomlinson TR and Akerele D, ed. Medical plants-their role in health and biodiversity. Philadelphia: University of Pennsylvania Press; 1998:7.
Wang BE. Treatment of chronic liver diseases with traditional Chinese medicine. J Gastroenterol Hepatol 2000;15 Suppl:E67–E70.
Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, et al. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res 2011;89:227–231.
Chen XS, Wang GJ, Cai X, Yu HY, Hu YP. Inhibition of hepatitis B virus by oxymatrine in vivo. World J Gastroenterol 2001;7:49–52.
Lu LG, Zeng MD, Mao YM, Li JQ, Wan MB, Li CZ, et al. Oxymatrine therapy for chronic hepatitis B: a randomized double-blind and placebo-controlled multi-center trial. World J Gastroenterol 2003;9:2480–2483.
Liu J, Zhu M, Shi R, Yang M. Radix Sophorae fl avescentis for chronic hepatitis B: a systematic review of randomized trials. Am J Chin Med 2003;31:337–354.
Wu XN, Wang GJ. Experimental studies of oxymatrine and its mechanisms of action in hepatitis B and C viral infections. Chin J Dig Dis (Chin) 2004; 5:12–16.
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and metaanalyses: the PRISMA statement. BMJ 2009;339:b2535.
Song WJ, Luo J, Wu T, Yao SK. Oral oxymatrine preparation for chronic hepatitis B: a systematic review of randomized clinical trials. PROSPERO 2013:CRD42013005997. Available at: http://www.crd.york.ac.uk/PROSPERO_ REBRANDING/display_record.asp?ID=CRD42013005997.
Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions, version 5.1.0. The Cochrane Collaboration, 2011. Available at: http://www.cochranehandbook. org/.
Brozek J, Oxman A, Schünemann H. GRADEpro. [Computer program]. Version 3.6 for Windows, 2011. Available at: http:// ims.cochrane.org/revman/other-resources/gradepro.
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327:557–560.
Zhao WL, Hu QM, Yang ZM, Zhang W. Effectiveness of alpha interferon combined with oxymatrine on the treatment of chronic hepatitis B. J Yangtze Univ (Nat Sci ed, Med V Chin) 2007;4:161–162.
Chen DY, Mo CH, Xie YX, Xie YF. Clinical study of interferon α-2b combined with oxymatrine capsules in the treatment of chronic viral hepatitis B. J Tropical Med (Chin) 2012;12:987–989.
Duan XX, Li Y, Song YQ. Clinical observation of adefovir dipivoxil and lamivudine combined with Oxymatrine Capsule for chronic hepatitis B. Chin J Modern Drug Applic (Chin) 2013;7:121–122.
Zhu WP, An LM, Xie CF. The affect of adefovir dipivoxil combined with oxymatrine on liver fibrosis and virus mutation of the patients with chronic hepatitis B. Modern Hospital (Chin) 2010;10 Suppl:19–22.
Huang XM, Zhu YJ. Adefovir dipivoxil combined with oxymatrine capsule in chronic hepatitis B treatment. Acta Med Sinica (Chin) 2012;25:510–512.
Tu YH, Ma Y, Li SS. Effects of adefovir dipivoxil in combination with Marine Capsules on HBV replication and T lymphocyte subsets in patients with chronic hepatitis B. World Chin J Digestol (Chin) 2009;34:3547–3549.
Yan ZW, Li SH, Chen JH. Adefovir dipivoxil and oxymatrine combination therapy in treatment of patients with HBeAgpositive chronic hepatitis B. Chin J Pract Med (Chin) 2011;38:31–33.
Zhang HB. Therapeutic effect of adefovir dipivoxil combined with oxymatrine for HBeAg-positive chronic hepatitis B. J Clin Hepatol (Chin) 2012;15:440–441.
Wei JS, Zhang L, Deng TH, Li CY. Adefovir dipivoxil in combination with oxymatrine for chronic hepatitis B in 33 cases. J Pract Tradit Chin Intern Med (Chin) 2008;22:38–40.
Zhang DP. Adefovir dipivoxil in combination with oxymatrine for chronic hepatitis B in 40 cases. Herald Med (Chin) 2009;28 Suppl:9.
Liu Q, Zhang XF, Liu H, Gao Y. Clinical study of adefovir dipivoxil combined with matrine soft capsule in the treatment of chronic hepatitis B patients with liver fibrosis. Med Innovat China (Chin) 2010;7:45–46.
Xu ZG, Liang Y. Clinical study of adefovir dipivoxil combined with oxymatrine for patients with chronic hepatitis B. Chin Foreign Med Res (Chin) 2013;11:22–23.
Yu JG. Clinical observation of adefovir dipivoxil combined with oxymatrine for chronic hepatitis B. J Clin Hepatol (Chin) 2011;14:442–443.
Shen SH. Clinical observation of adefovir dipivoxil in combination with oxymatrine for chronic hepatitis B. China Pract Med (Chin) 2013;8:141–142.
Gong YQ, Sheng GG. Clinical study of entecavir combined with Oxymatrine Tablet for HBeAg positive chronic hepatitis B in 52 cases. Chin J Integr Tradit West Med Liver Dis (Chin) 2013;23:25–26.
Zhang TX, Peng FJ. Clinical study of entecavir combined with Oxymatrine Tablet for chronic hepatitis B in 41 cases. J New Chin Med (Chin) 2012;44:67–68.
Yang YD, Hou W. Effect analysis of entecavir combined with oxymatrine on patients with HBeAg positive chronic hepatitis B. China Modern Doctor (Chin) 2012;50:64–65.
Zhang C, Shen A, Wu ZJ. Efficacy of entecavir combined with matrine in the treatment of HBeAg-positive related chronic hepatitis B. J Chongqing Med Univ (Chin) 2013;38:294–296.
Yin WH, Ni HH. Clinical observation of entecavir in combination with oxymatrine for HBeAg positive chronic hepatitis B. J Clin Ration Drug Use (Chin) 2011;4:60–61.
Shao ZL, Zhang BH. Clinical effect of entecavir combined with oxymatrine on patients with HBeAg positive chronic hepatitis B. Chin J Integr Tradit Wester Med Digest (Chin) 2010;18:92–94.
Xu DX. Clinical effect of diammonium glycyrrhizinate combined with oxymatrine for chronic hepatitis B. Chin J Misdiagn (Chin) 2009;9:42–43.
Yu JG. Clinical observation of interferona-2a combined with Oxymatrine Capsule for chronic hepatitis B. Chin Hepatol (Chin) 2013;18:205–209.
Huang YQ, Lin ZH, Ji SM, Xu ZJ, Wang CG. Clinical study ofthe interferon α-2b combined with kurorinone in the treatment of chronic hepatitis B. Chin J Infect Dis (Chin) 2004;22:42–45.
Huang SS. Interferon in combination with Oxymatrine Capsule for chronic hepatitis B. Chin J Pract Med (Chin) 2008;35:72–73.
Ding YH. Investigation the effects of entecavir plus Kurorinone Capsule for chronic hepatitis B. Chin J Clin Pharmacol (Chin) 2011;27:566–567.
Wang L, Zhang JC, Shen GH, Li CT, Li YP. Therapeutic effect of Oxymatrine Capsule on the clearance of HBV DNA for patients with HBeAg negative and HBV DNA positive chronic hepatitis B. Chin J Integr Tradit West Med Liver Dise (Chin) 2005;15:238–239.
Wang L, Zhang JC, Li CT, Li YP, Shen GH. Therapeutic effect of Oxymatrine Capsule combined with lamivudine for chronic hepatitis B. Zhejiang J Integr Tradit Chin West Med (Chin) 2006;16:412–414.
Lv ML, Liu Q, Jia QL. Therapeutic effect of HBeAg positive chronic hepatitis B treated by Kurorinone Capsule combined with Adefovir Dipivoxil Capsule. China Med Herald (Chin) 2010;8:62–64.
Huang MG, Chen SH. Clinical study of Oxymatrine Capsule combined with interferon for chronic hepatitis B in 48 cases. Jilin Med J (Chin) 2010;31:3080–3081.
Wang HR. Kushenin combing with lamivudine in treating chronic type B hepatitis. Public Med Forum Magaz (Chin) 2009;13:21–22.
Li MH. Therapeutic effect of Oxymatrine Capsule for chronic hepatitis B. Contemp Med (Chin) 2010;16:142–143.
Zhang JC, Hu J. Clinical study of adefovir dipivoxil combined with oxymatrine for chronic hepatitis B. Chin Hepatol (Chin) 2010;15:34–35.
Zhao WL, Cheng H, Yang ZM, Liu HP. Therapeutic effect of marine combined with adefovir dipivoxil on patients with chronic hepatitis B. China Pharmac (Chin) 2009;12:1789–1791.
He LL, Chen F, Wang S, Bao RL. Clinical observation of matrine in combination with lamivudine, adefovir dipivoxil for the treatment of chronic hepatitis B virus. China Health Indust (Chin) 2013;12:11–13.
Wang WW, Zhao YG, Zhong WZ. Therapeutic effect of oxymatrine in combination with lamivudine for chronic hepatitis B virus. J Pract Med (Chin) 2006;22:1061–1062.
Zhou XQ. Clinical observation of oxymatrine for chronic hepatitis B. Chin Commun Doctors (Chin) 2008;10:30.
Chen Q, Yang HF. Clinical study of lamivudine combined with oxymatrine for chronic hepatitis B in 70 cases. Chin J Integr Tradit West Med Digest (Chin) 2010;18:117–118.
Hu M. Therapeutic effect of lamivudine combined with oxymatrine for HBeAg-positive chronic hepatitis B. J Commun Med (Chin) 2009;7:13–14.
Li MY, Wang DT, Zhou LX. Clinical study of lamivudine combined with oxymatrine for HBeAg negative chronic hepatitis B. J Datong Med Coll (Chin) 2006;26:24–27.
Chen WG. Clinical study of lamivudine combined with oxymatrine for chronic hepatitis B in 38 cases. China Modern Med (Chin) 2009;16:62–63.
Wang WQ, Cheng YQ. Clinical study of lamivudine combined with kurorinone in the treatment of chronic hepatitis B. J Clin Hepatol (Chin) 2005;8:83–84.
Tu YY. Observation of the effect on treatment of treatment of chronic hepatitis B by lamivudine combination with oxymatrine. J Guangxi Med Univ (Chin) 2005;22:516–518.
Yan N. Clinical observation of lamivudine combined with oxymatrine for chronic hepatitis B. Modern Med J (Chin) 2004;32:257–258.
Gong YQ, Sheng GG. Changes of peripheral blood T lymphocyte subsets and serum cytokine levels in patients with chronic hepatitis B receiving lamivudine and kurorinone treatment. J Clin Hepatol (Chin) 2013;16:229–231.
Hao MY. Therapeutic effect of lamivudine combined with oxymatrine for chronic hepatitis B. China Foreign Med Treatm (Chin) 2008;27:63.
Lian CP. Clinical study of lamivudine combined with oxymatrine for chronic hepatitis B. Med Inform (Chin) 2011;24: 3519-3520.
Yang XR, Wang W. Therapeutic observation of combination of telbivudine and oxymatrine in patients with HBeAg positive chronic hepatitis B. China Tropic Med (Chin) 2012;12:1375–1377.
Yang J, Zeng FH. Therapeutic effect of telbivudine combined with oxymatrine for HBeAg positive chronic hepatitis B in 43 cases. Chin J Integr Tradit West Med Liver Dis (Chin) 2013;23:114–115.
Ding PP. The clinical effect of telbivudine combined with oxymatrine for patients with HBeAg positive chronic hepatitis B. J Clin Hepatol (Chin) 2009;12:424–426.
Lu LG, Zeng MD, Mao YM, Wan MB, Li CZ, Chen CW, et al. Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebocontrolled trial. Chin J Hepatol (Chin) 2004;12:597–600.
Chen JX. Therapeutic effect of magnesium isoglycyrrhizinate in combination with oxymatrine for chronic hepatitis B. Chin J Misdiagn (Chin) 2011;11:4593.
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726–732.
Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006;144:364–367.
Author information
Authors and Affiliations
Corresponding author
Additional information
Supported by the National Key Scientific Project for New Drug Discovery and Development of China (No. 2012zx09103201)
Electronic supplementary material
Rights and permissions
About this article
Cite this article
Song, Wj., Luo, J., Wu, T. et al. Oral oxymatrine preparation for chronic hepatitis B: A systematic review of randomized controlled trials. Chin. J. Integr. Med. 22, 141–149 (2016). https://doi.org/10.1007/s11655-015-2143-0
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11655-015-2143-0