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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (4): 312-320.doi: 10.3736/jcim20100403

• Systematic Review • Previous Articles     Next Articles

Xiaochaihu Tang for treatment of chronic hepatitis B: A systematic review of randomized trials

 Xian-kui Qina, Ping Lia, Mei Hanb, Jian-ping Liub,c   

  1. a Outpatient Clinic of People’s Liberation Army Unit 96819,Beijing 100853,China;
    b Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    c National Research Center in Complementary and Alternative Medicine, University of Troms, Troms N-9037, Norway
  • Received:2009-12-02 Accepted:2010-03-09 Online:2010-04-20 Published:2010-04-15
  • Contact: Jian-ping Liu E-mail:jianping_l@hotmail.com

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Background

Xiaochaihu Tang was a compound traditional Chinese herbal medicine recorded in ancient Chinese medical book Shanghanlun, and has been widely used for chronic liver diseases especially in Japan.
Objective

To assess the beneficial effects and safety of Xiaochaihu Tang for chronic hepatitis B (CHB).Search strategy: Electronic and manual searches were conducted and the search ended in November 2009.Inclusion criteria: We included randomized clinical trials testing Xiaochaihu Tang against placebo, non-specific treatment, antivirals, or combined with antivirals against antivirals alone. Data extraction and analysis: Selection of trials for inclusion, assessment of methodological quality by Jadad score, data extraction and data syntheses were conducted according to the Cochrane Hepato-Biliary Group methods．
Results

Sixteen randomized trials (involving 1 601 CHB patients) with various methodological quality were included. One trial published in English had good quality, while other trials published in Chinese were of poor quality. The pooled results showed that Xiaochaihu Tang combined with antiviral drugs was more effective in serum loss of hepatitis B viral markers and in improving liver function compared with antiviral drugs alone. Xiaochaihu Tang was not different from placebo in terms of viral clearance or improving liver function. However, Xiaochaihu Tang was superior to non-specific treatment in liver function improvement. There were no adverse effects reported in the trials regarding Xiaochaihu Tang, but adverse effects were reported in patients treated by interferon, and severe adverse effects occurred in few cases.
Conclusion

Xiaochaihu Tang in this review appears to be effective in improving liver function and clearance of serum hepatitis B viral markers in patients with chronic hepatitis B. However, due to poor methodological quality in the majority of included trials the potential benefits need to be confirmed in rigorous clinical trials following international standards.

Key words: Xiaochaihu Tang, Chronic hepatitis B, Systematic review, Randomized controlled trials

Figure 1

Flow diagram of literature retrieval and selection"

Table 1

Characteristics and methodological quality of included studies"

Study Gender Diagnosis Age Methodology Interventions Control
(Male/Female) (Years) quality
Bo 2006[10] 76/20 Chronic hepatitis B 32.6 Low Xiaochaihu Tang plus interferon-α-2b Interferon-α-2b
Chen 2008[11] 78/42 Chronic hepatitis B fibrosis 38 Low Xiaochaihu Tang plus adefovir dipivoxil Adefovir dipivoxil
He 2008[12] 114/23 Chronic hepatitis B fibrosis 39.8 Low Xiaochaihu tablet plus interferon-α-2b Interferon-α-2b
Hirayama 1989[13] NA Chronic hepatitis B NA High Xiaochaihu Tang Placebo
Li 2001[14] 80/30 Chronic hepatitis B fibrosis 30—60 Low Xiaochaihu Tang plus interferon-γ Interferon-γ
Li 2009[15] 45/23 Chronic hepatitis B 32.1 Low Xiaochaihu Tang plus lamivudine Lamivudine
Miao 2001[16] 28/22 Chronic hepatitis B NA Low Xiaochaihu Tang plus Danshen Injection Essentiale forte
Shi 2006[17] 50/26 Chronic hepatitis B 15—40 Low Xiaochaihu Tang plus interferon Interferon
Sun 2003[18] 62/32 Chronic hepatitis B fibrosis 43.6 Low Xiaochaihu Tang plus oxymatrine injection Vitamins
Wang 1992[19] NA Chronic hepatitis B NA Low Xiaochaihu Tang plus autologous LAK cell infusion Autologous LAK cell infusion
Wu 1994[20] NA Chronic hepatitis B NA Low Xiaochaihu Tang plus autologous LAK cell infusion Autologous LAK cell infusion
Wu 2009[21] 85/56 Chronic hepatitis B cirrhosis 32—80 Low Xiaochaihu Tang Transaminase-lowering drug
Xiong 2003[22] 65/21 Chronic hepatitis B fibrosis 39.7 Low Xiaochaihu Tang plus interferon-α Interferon-α
Yu 2000[23] NA Chronic hepatitis B 15—65 Low Xiaochaihu Tang plus ribavirin Ribavirin
Zhang 1998[24] 56/21 Chronic hepatitis B 18—56 Low Xiaochaihu Tang Inosine, vitamins C
Zhang 2008[25] 58/16 Chronic hepatitis B 41 Low Xiaochaihu Tang plus interferon-α-2b Interferon-α-2b
Study Duration of Follow-up Outcome measures
treatment (weeks) (months)
Bo 2006[10] 24 0 Symptoms, HBsAg, HBeAg, HBV-DNA, liver function, side effects
Chen 2008[11] 52 0 HBeAg, HBV-DNA, liver function, side effects
He 2008[12] 24 0 Liver fibrosis, liver function
Hirayama 1989[13] 12 3 HBsAg, HBeAg, anti-HBe, liver function, side effects
Li 2001[14] 12 0 Liver function, liver fibrosis
Li 2009[15] 12 0 Liver function, HBeAg, HBV-DNA
Miao 2001[16] 12 0 Symptoms, liver function, HBeAg, HBV-DNA
Shi 2006[17] 16 0 Liver function, HBsAg, HBeAg , HBV-DNA
Sun 2003[18] 24 0 Liver function, liver fibrosis, side effects
Wang 1992[19] 6 6 Liver function, HBeAg, anti-HBe, HBV-DNA
Wu 1994[20] 6 0 HBsAg, HBeAg, HBV-DNA, side effects
Wu 2009[21] 24 36 Symptoms, liver function, side effects
Xiong 2003[22] 12 0 Symptoms, liver function, liver fibrosis
Yu 2000[23] 12 9 Symptoms, liver function, HBeAg, HBV-DNA, side effects
Zhang 1998[24] 16 12 Symptoms, liver function, side effects
Zhang 2008[25] 24 0 Symptoms, liver function, HBeAg, HBV-DNA, side effects

Table 2

Analysis of antiviral response"

Antiviral response Intervention
(n/N)		 Control
(n/N）		 RR
[95% CI]		 P value
Loss of serum HBsAg
Xiaochaihu Tang compared with placebo
Xiaochaihu Tang vs placebo 1 52/116 47/106 1.01 [0.75, 1.36] 0.94
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 1 7/50 4/46 1.61 [0.50, 5.14] 0.42
Xiaochaihu Tang plus interferon vs interferon 1 1/46 0/30 1.98 [0.08, 47.03] 0.67
Meta-analysis 2 8/96 4/76 1.66 [0.56, 4.94] 0.36
Loss of serum HBeAg
Xiaochaihu Tang compared with placebo
Xiaochaihu Tang vs placebo 1 33/116 32/106 0.94 [0.63, 1.42] 0.78
Xiaochaihu Tang compared with non-specific treatment
Xiaochaihu Tang plus Danshen Injection vs essentiale forte 1 16/30 2/20 5.33 [1.37, 20.71] 0.02
Xiaochaihu Tang plus immunotherapy compared with immunotherapy
Xiaochaihu Tang plus autologous LAK cell infusion vs autologous
LAK cell infusion		 2 43/65 38/75 1.29 [0.97, 1.71] 0.08
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 1 29/50 17/46 1.57 [1.01, 2.45] 0.05
Xiaochaihu Tang plus adefovir dipivoxil vs adefovir dipivoxil 1 18/60 12/60 1.50 [0.79, 2.84] 0.21
Xiaochaihu Tang plus lamivudine vs lamivudine 1 19/34 10/34 1.90 [1.04, 3.46] 0.04
Xiaochaihu Tang plus interferon vs interferon 1 18/46 9/30 1.30 [0.68, 2.51] 0.43
Xiaochaihu Tang plus ribavirin vs ribavirin 1 31/57 46/55 0.65 [0.50, 0.85] 0.001
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 1 21/40 14/45 1.69 [1.00, 2.85] 0.05
Meta-analysis 6 136/287 71/270 1.74 [1.38, 2.19] <0.000 0
Loss of serum HBV-DNA
Xiaochaihu Tang compared with non-specific treatment
Xiaochaihu Tang plus Danshen Injection vs essentiale forte 1 8/18 2/11 2.44 [0.63, 9.48] 0.20
Xiaochaihu Tang plus immunotherapy compared with immunotherapy
Xiaochaihu Tang plus autologous LAK cell infusion vs autologous
LAK cell infusion		 2 43/65 36/75 1.36 [1.01, 1.82] 0.04
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 2 52/90 35/91 1.49 [1.09, 2.04] 0.01
Xiaochaihu Tang plus adefovir dipivoxil vs adefovir dipivoxil 1 23/60 18/60 1.28 [0.77, 2.11] 0.34
Xiaochaihu Tang plus interferon vs interferon 1 17/46 7/30 1.58 [0.75, 3.35] 0.23
Xiaochaihu Tang plus ribavirin vs ribavirin 1 16/57 4/55 3.86 [1.38, 10.82] 0.01
Xiaochaihu Tang plus lamivudine vs lamivudine 1 29/34 26/34 1.12 [0.88, 1.41] 0.36
Meta-analysis 6 137/287 90/270 1.46 [1.20, 1.77] 0.000 1

Table 3

Analysis of liver function parameters"

Liver function parameter MD [95% CI] P value
Lower ALT level (U/L)
Xiaochaihu Tang compared with placebo
Xiaochaihu Tang vs placebo 1 –2.00 [–41.34, 37.34] 0.92
Xiaochaihu Tang compared with non-specific treatment
Xiaochaihu Tang plus Danshen Injection vs essentiale forte 1 –1.04 [–11.26, 9.18] 0.84
Xiaochaihu Tang plus oxymatrine injection vs vitamins 1 –21.32 [–40.87, –1.77] 0.03
Meta-analysis [FEM] 2 –5.40 [–14.46, 3.66] 0.33
Meta-analysis [REM] 2 –9.40 [–28.96, 10.17] 0.35
Xiaochaihu Tang compared with transaminase-lowering drug
Xiaochaihu Tang vs transaminase-lowering drug 1 –12.60 [–13.31, –11.89] < 0.000 01
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 2 –23.66 [–33.85, –13.47] <0.000 01
Xiaochaihu Tang plus adefovir dipivoxil vs adefovir dipivoxil 1 –32.00 [–40.00, –24.00] <0.000 01
Xiaochaihu tables plus interferon-α-2b vs interferon-α-2b 1 –3.85 [–12.24, 4.54] 0.37
Xiaochaihu Tang plus interferon-γ vs interferon-γ 1 –19.68 [–38.04, –1.32] 0.04
Xiaochaihu Tang plus lamivudine vs lamivudine 1 –1.10 [–9.68, 7.48] 0.80
Xiaochaihu Tang plus interferon vs interferon 1 –46.00 [–68.73, –23.27] <0.000 1
Xiaochaihu Tang plus interferon-α vs interferon-α 1 –91.75 [–111.69, –71.81] <0.000 01
Meta-analysis [FEM] 8 –19.45 [–23.51, 15.38] <0.000 01
Meta-analysis [REM] 8 –29.18 [–45.30, –13.07] 0.000 4
Lower AST level (U/L)
Xiaochaihu Tang compared with placebo
Xiaochaihu Tang vs placebo 1 –5.00 [–27.64, 17.64] 0.67
Xiaochaihu Tang compared with non-specific treatment
Xiaochaihu Tang plus Danshen Injection vs essentiale forte 1 0.99 [–7.30, 9.28] 0.81
Xiaochaihu Tang plus oxymatrine injection vs vitamins 1 –25.58 [–47.67, –3.49] 0.02
Meta-analysis [FEM] 2 –2.29 [–10.05,5.47] 0.56
Meta-analysis [REM] 2 –10.24 [–35.79,15.48] 0.44
Xiaochaihu Tang compared with transaminase-lowering drug
Xiaochaihu Tang vs transaminase-lowering drug 1 –10.30 [–11.09,–9.51] <0.000 01
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus adefovir dipivoxil vs adefovir dipivoxil 1 –28.00 [–35.79, –20.21] <0.000 01
Xiaochaihu Tablets plus interferon-α-2b vs interferon-α-2b 1 7.09 [–0.29, 14.47] 0.06
Xiaochaihu Tang plus lamivudine vs lamivudine 1 –33.80 [–44.98, –22.62] <0.000 01
Xiaochaihu Tang plus interferon vs interferon 1 –45.60 [–64.99, –26.21] <0.000 01
Xiaochaihu Tang plus interferon-α vs interferon-α 1 –25.01 [–45.26, –4.76] 0.02
Xiaochaihu Tang plus interferon-α-2b vs interferon-α-2b 1 –53.90 [–68.23, –39.57] <0.000 01
Meta-analysis [FEM] 6 –19.81 [–24.16,–15.46] <0.000 01
Meta-analysis [REM] 6 –29.34 [–49.17, –9.52] 0.004
Lower TBIL level (U/L)
Xiaochaihu Tang compared with non-specific treatment
Xiaochaihu Tang plus oxymatrine injection vs vitamins 1 –6.28 [–12.62, 0.06] 0.05
Xiaochaihu Tang plus antivirals compared with antivirals
Xiaochaihu Tang plus adefovir dipivoxil vs adefovir dipivoxil 1 –5.00 [–8.80, –1.20] 0.010
Xiaochaihu Tang plus interferon-γ vs interferon-γ 1 –3.25 [–4.20, –2.30] <0.000 01
Xiaochaihu Tang plus lamivudine vs lamivudine 1 –0.50 [–3.81, 2.81] 0.77
Xiaochaihu Tang plus interferon-α vs interferon-α 1 –4.32 [–10.38, 1.74] 0.16
Meta-analysis 4 –3.17 [–4.05, –2.30] <0.000 01
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