Additional file 1. Details of characteristics and methodological quality of the included studies.
Total No. of
Study ID
Patients
(Intervention/
Intervention Group
Control Group
Duration
Primary Outcomes
Secondary Outcomes
Follow
up
Quality
Control)
49 (28/21)
Chen 2005
[21]
Chen 2006
[30]
‘Fufang
Biejia
Tablets’
Ruangan IFN-γ 1MU (IM).
(standardized
prescription; oral 4 tablets,
6 months HA: intervention group better
2006_2 [20]
None
Good
than control group (P < 0.05).
(Modified
NS in LN, PC-III & IV-C.
Cochrane
TID) and access to IFN-γ
risk of
1MU (IM).
bias 9/16)
116 (58/58) Kang Xian Decoction
IFN-α 3MU.
6 months HA, LN & PC-III: intervention
ALT & improvement of
None
Poor
(standardized prescription;
group better than control group
related clinical symptoms:
(Modified
oral, one dose per day) and
( P < 0.05).
intervention group better
Cochrane
than control group (P <
risk of
0.01).
bias 5/16)
access to IFN-α 3MU.
Chen
NS in ALT & AST.
138 (68/70) ‘Qianggan Capsule’
Placebo (shape
6 months HA, LN, PC-III & IV-C:
ALT, improvement of
None
Good
(standardized prescription; consistent with
intervention group better than
related clinical symptoms:
(Modified
oral, 4 g/d) plus
intervention group)
control group ( P < 0.05).
intervention group better
Cochrane
conventional care.
plus conventional
than control group (P <
risk of
care.
0.05).
bias
Adverse events: 4 cases in
10/16)
intervention group and 5 in
control group- nausea,
vomiting and abdominal
discomfort.
Chen 2007
[31]
164 (54/58/52) Group I: Bie Jia Jian Pills
IFN 3MU (IM) plus 9 months HA: intervention group better
Adverse events: In the use
None
Good
(standardized prescription; conventional care.
than control group at 6 & 9
of IFN therapy, 80%
(Modified
oral, 6 g/d) plus
months (P < 0.01).
patients had cold or
Cochrane
conventional care.
LN & PC-III: Group II better
“flu-like” symptoms; some
risk of
Chen 2010
96 (46/50)
[22]
Group II: Group I plus
than control group at 6 & 9
control group.
months (P < 0.01), NS compared leucopenia and
‘Fufang Biejia Ruangan
Entecavir 0.5 mg
Tablets’ (standardized
(oral, QD).
1 year
prescription; oral 2 g, TID)
Dai 2011
68 (34/34)
[23]
patients with mild
Group I with control group.
thrombocytopenia.
HA, LN, PC-III & IV-C:
NS in ALT & AST.
bias
10/16)
None
Poor
intervention group better than
(Modified
control group (P < 0.05).
Cochrane
and access to Entecavir 0.5
risk of
mg (oral, QD).
bias 7/16)
‘Fufang Biejia Ruangan
Entecavir 0.5 mg
Tablets’ (standardized
(oral, QD).
1 year
HA, LN, PC-III & IV-C:
NS in ALT & AST.
intervention group better than
Improvement of related
(Modified
control group (P < 0.05).
clinical symptoms:
Cochrane
and access to Entecavir 0.5
intervention group better
risk of
mg (oral, QD).
than control group (just
bias 8/16)
prescription; oral 2 g, TID)
None
Good
description).
Gao 2000
120 (60/60) ‘HB-Granule-3’
[32]
IFN-α 3MU (SC,
HA & IV-C: intervention group ALT (P < 0.01) &
3
(standardized prescription; three times per
better than control group
improvement of related
months (Modified
oral 10 g, TID).
(p<0.05).
clinical symptoms:
Cochrane
NS in LN.
intervention group better
risk of
than control group (just
bias 3/16)
week).
90 days
Poor
description).
Huang 2007
[24]
99 (50/49)
‘Decoction of Radix
Salviae Milltorrhizae,
Radix Astragali and
Rhubarb’ (standardized
prescription; oral 100
mL, BID).
IFN-α 5MU (IM,
3 months HA & PC-III: intervention group ALT: intervention group
6
Good
once every two
better than control group (P <
better than control group (P months (Modified
days).
0.01) at 3-month, NS at 6-month < 0.05) at 3-month, but NS
Cochrane
follow-up.
observed at 6-month
risk of
LN & IV-C: intervention group
follow-up.
bias 8/16)
better than control group at
NS in AST.
3-month (P < 0.01) and 6-month Adverse events: 15 cases
follow-up (P < 0.05).
“flu-like” symptoms in
control group; 3 cases
severe diarrhea in
intervention group (1 stop
treatment).
Huang 2009
83 (43/40)
[25]
‘Fufang Biejia Ruangan
Adefovir dipivoxil 1 year
Tablets’ (standardized
10 mg (oral, QD).
NS in ALT & AST.
None
Poor
(Modified
prescription; oral 4 tablets,
Cochrane
TID) and access to Adefovir
risk of
dipivoxil 10 mg (oral,
bias 6/16)
QD).
Kuang 2005
53 (27/26)
[26]
Bie Jia Jian Decoction
LVD 100 mg (QD). 60 days
HA: intervention group better
Improvement of related
None
Good
(standardized prescription;
than control group (P < 0.05).
clinical symptoms:
(Modified
oral, one dose per day).
NS in PC-III & IV-C.
intervention group better
Cochrane
than control group (P <
risk of
0.05).
bias 8/16)
NS in ALT & AST.
Li 2006 [27]
60 (30/30)
‘Xiexian Oral Liquid’
Placebo
4 months HA, LN & IV-C: intervention
AST & improvement of
6
Good
months (Modified
(standardized prescription; (physiological
group better than control group
related clinical symptoms:
oral 30 mL, QD), plus
saline plus food
(P < 0.01).
intervention group better
Cochrane
conventional care.
coloring), plus
than control group (P <
risk of
conventional care.
0.01).
bias 8/16)
NS in ALT.
Adverse events: 4 cases in
intervention group (1
allergic, 3 diarrhea).
Li 2011 [28]
88 (44/44)
‘Anluo Huaxian Pills’
Adefovir dipivoxil 9 months HA, LN, PC-III & IV-C:
(standardized prescription; 10 mg (oral, QD).
intervention group better than
oral 6g, BID) and access to
control group (P < 0.05).
NS in ALT & AST.
Adverse events: none.
None
Poor
(Modified
Cochrane
Adefovir dipivoxil 10 mg
risk of
(oral, QD).
bias 5/16)
Lu 2010
82 (42/40)
[29]
Shen 2003
68 (31/37)
[33]
‘Fufang Biejia Ruangan
Adefovir dipivoxil 1 year
HA & LN: intervention group
ALT, AST & Improvement None
Good
Tablets’ (standardized
10 mg (oral, QD).
better than control group (P <
of related clinical
(Modified
prescription; oral 4 tablets,
0.01).
symptoms: intervention
Cochrane
TID) and access to Adefovir
NS in PC-III & IV-C.
group better than control
risk of
dipivoxil 10 mg (oral,
group (P < 0.05).
bias 8/16)
QD).
Adverse events: none.
‘Ganxian Prescription’
LVD 100 mg (oral, 1 year
HA: intervention group better
ALT: intervention group
(semi-standardized
QD).
than control group (P < 0.05).
better than control (P <
(Modified
NS in LN & IV-C.
0.05).
Cochrane
day) and access to LVD 100
NS in AST.
risk of
mg (oral, QD).
Adverse events: none.
bias 8/16)
prescription, one dose per
Shen 2005
120 (40/40/40) Group I: ‘Ganxian Recipe’ LVD 100 mg (oral, 2 years
[34]
(semi-standardized
QD).
HA, LN & IV-C: Group II better ALT: Group II better than
None
None
Good
Poor
than control group (P < 0.05).
control group (P < 0.05),
(Modified
prescription, one dose per
NS in HA, LN & IV-C
NS comparing Group I with
Cochrane
day).
comparing Group I with control control group.
risk of
Group II: ‘Ganxian Recipe’
group.
bias 7/16)
NS in AST.
(same as Group I) and
Adverse events: 8 cases
access to LVD 100 mg
diarrhea (3 in Control
(oral, QD).
group, 5 in Group I), 2
cases dizziness in Group II,
3 cases upper respiratory
infection-like symptoms in
control group.
Sun 2010
[35]
55 (30/25)
‘Anluo Huaxian Pills’
Adefovir dipivoxil 48 weeks HA: intervention group better
ALT, AST & Improvement None
Poor
(standardized prescription; 10 mg (oral, QD).
than control group (P < 0.05).
of related clinical
(Modified
oral 6g, TID) and access to
NS in LN, PC-III & IV-C.
symptoms: intervention
Cochrane
Adefovir dipivoxil 10 mg
group better than control
risk of
(oral, QD).
group (P < 0.05).
bias 7/16)
Wang 2006 160 (50/60/50) Group I: experienced
LVD 100 mg (oral, 6 months HA, LN, PC-III & IV-C: Group
None
Good
[36]
clinical decoction
QD).
II better than control group at 3
(Modified
(semi-standardized
and 6 months (P < 0.01); Group
Cochrane
prescription, one dose per
I better than control group in HA
risk of
day).
at 3 and 6 months (P < 0.01).
bias
Group II: Group I plus
10/16)
control group.
Wang 2010
98 (49/49)
[37]
‘Fufang Biejia Ruangan
Adefovir dipivoxil 1 year
HA, LN, PC-III & IV-C:
ALT: intervention group
Tablets’ (standardized
10 mg (oral, QD).
intervention group better than
better than control group (P
(Modified
control group (P < 0.05).
< 0.05).
Cochrane
prescription; oral 4 tablets,
None
Poor
TID) and access to Adefovir
risk of
dipivoxil 10 mg (oral,
bias 6/16)
QD).
Wei 2010
44 (22/22)
[38]
‘Fufang Biejia Ruangan
Adefovir dipivoxil 1 year
HA, LN, PC-III & IV-C:
Tablets’ (standardized
10 mg (oral, QD).
intervention group better than
(Modified
control group (P < 0.05).
Cochrane
prescription; oral 4 tablets,
NS in ALT & AST.
None
Good
TID) and access to Adefovir
risk of
dipivoxil 10 mg (oral,
bias 9/16)
QD).
Xie 2009
[39]
Yang 2009
[40]
62 (32/30)
Conventional care. 6 months HA, LN, PC-III & IV-C:
‘Huaxian Fugan
intervention group better than
Prescription’ (standardized
ALT, AST & Improvement None
Good
of related clinical
(Modified
prescription; oral 100 mL,
symptoms: intervention
Cochrane
BID), plus conventional
group better than control
risk of
care.
group (P < 0.01).
bias 8/16)
120 (60/60) ‘Fufang Biejia Ruangan
Tablets’ (standardized
control group (P < 0.05).
LVD 100 mg (oral, 6 months HA, LN, PC-III & IV-C:
QD) plus
prescription; oral 4 tablets, conventional care.
NS in ALT & AST.
None
Good
intervention group better than
(Modified
control group (P < 0.05).
Cochrane
TID), and access to LVD
risk of
100 mg (oral, QD) plus
bias 9/16)
conventional care.
Yin 2004
102 (52/50) ‘Herbal Compound 861’
[41]
Placebo (shape
(standardized prescription; consistent with
oral 7 capsules, TID).
24 weeks PC-III, MMP9, TIMP1 &
ALT & AST: intervention
None
Good
TIMP2: intervention group
group better than control
(Modified
‘Herbal Compound
better than control group (P <
group (P < 0.05).
Cochrane
861’; oral 7
0.05).
NS in Improvement of
risk of
capsules, TID).
NS in HA, LN, IV-C, MMP1 & related clinical symptoms.
MMP2.
bias 8/16)
Adverse events: dry throat,
nausea, abdominal
discomfort, constipation in
both groups (the number of
patients not mentioned).
Zhang 2000
[42]
78 (39/39)
‘Kanggan Xianfang’
Conventional care. 6 months HA, PC-III & TGF-β1:
ALT & Improvement of
None
Good
(standardized prescription;
intervention group better than
related clinical symptoms:
(Modified
oral 8g, TID) plus
control group (P < 0.05).
intervention group better
Cochrane
than control group (P <
risk of
0.05).
bias 8/16)
conventional care.