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Chinese herbal medicines for threatened miscarriage (Review)
Li L, Dou L, Leung PC, Wang CC
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2012, Issue 5
http://www.thecochranelibrary.com
Chinese herbal medicines for threatened miscarriage (Review)
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T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
71DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specific
secondary outcome), Outcome 1 Effectiveness of intervention (primary outcome). . . . . . . . . . . 73
Analysis 1.2. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specific
secondary outcome), Outcome 2 No relief of clinical signs. . . . . . . . . . . . . . . . . . . 74
Analysis 1.12. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specificsecondary outcome), Outcome 12 Effectiveness of intervention (non-prespecified secondary outcome). . . . 75
Analysis 3.1. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary
outcome), Outcome 1 Effectiveness of intervention (primary outcome). . . . . . . . . . . . . . . 76
Analysis 3.2. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary
outcome), Outcome 2 No relief of clinical signs. . . . . . . . . . . . . . . . . . . . . . . 77
Analysis 3.12. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary
outcome), Outcome 12 Effectiveness of intervention (non-prespecified secondary outcome). . . . . . . . 78
79 ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
81 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
84HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
85CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
85DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
85SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
85INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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[Intervention Review]
Chinese herbal medicines for threatened miscarriage
Lu Li1 , Lixia Dou2 , Ping Chung Leung 3 , Chi Chiu Wang 1
1Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong. 2 Cochrane Pregnancy and
Childbirth Group, Department of Women’s and Children’s Health, The University of Liverpool, Liverpool, UK. 3 Institute of Chinese
Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Contact address: Chi Chiu Wang, Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Prince of Wales
Hospital, Shatin, New Terrorities, Hong Kong. [email protected] .
Editorial group: Cochrane Pregnancy and Childbirth Group.
Publication status and date: New, published in Issue 5, 2012.
Review content assessed as up-to-date: 2 April 2012.
Citation: Li L, Dou L, Leung PC, Wang CC. Chinese herbal medicines for threatened miscarriage. Cochrane Database of Systematic Reviews 2012, Issue 5. Art. No.: CD008510. DOI: 10.1002/14651858.CD008510.pub2.
Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
Threatened miscarriage occurs in 10% to 15% of all pregnancies. Vaginal spotting or bleeding during early gestation is common,
with nearly half of those pregnancies resulting in pregnancy loss. To date, there is no effective preventive treatment for threatened
miscarriage. Chinese herbal medicines have been widely used in Asian countries for centuries and have become a popular alternative
to Western medicines in recent years. Many studies claim to show that they can prevent miscarriage. However, there has been nosystematic evaluation of the effectiveness of Chinese herbal medicines for threatened miscarriage.
Objectives
To review the therapeutic effects of Chinese herbal medicines for the treatment of threatened miscarriage.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 January 2012), Chinese Biomedical Database (1978 to
31 January 2012), China Journal Net (1915 to 31 January 2012), China National Knowledge Infrastructure (1915 to 31 January 2012),
WanFang Database (1980 to 31 January 2012), Chinese Clinical Trial Registry (31 January 2012), EMBASE (1980 to 31 January
2012), CINAHL (31 January 2012), PubMed (1980 to 31 January 2012), Wiley InterScience (1966 to 31 January 2012), International
Clinical Trials Registry Platform (31 January 2012) and reference lists of retrieved studies. We also contacted organisations, individual
experts working in the field, and medicinal herb manufacturers.
Selection criteria
Randomised or quasi-randomised controlled trials that compared Chinese herbal medicines (alone or combined with other pharma-
ceuticals) with placebo, no treatment (including bed rest), or other pharmaceuticals as treatments for threatened miscarriage.
Data collection and analysis
Two review authors independently assessed all the studies for inclusion in the review, assessed risk of bias and extracted the data. Data
were checked for accuracy.
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Main results
In total, we included 44 randomised clinical trials with 5100 participants in the review.
We did not identify any trials which used placebo or no treatment (including bed rest) as a control.
The rate of effectiveness (continuation of pregnancy after 28 weeks of gestation) was not significantly different between the Chinese
herbal medicines alone group compared with the group of women receiving Western medicines alone (average risk ratio (RR) 1.23;
95% confidence interval (CI) 0.96 to 1.57; one trial, 60 women).
Chinese herbal medicines combined with Western medicines were more effective than Western medicines alone to continue the
pregnancy beyond 28 weeks of gestation (average RR 1.28; 95% CI 1.18 to 1.38; five trials, 550 women).
Authors’ conclusions
There was insufficient evidence to assess the effectiveness of Chinese herbal medicines alone for treating threatened miscarriage.
A combination of Chinese herbal and Western medicines was more effective than Western medicines alone for treating threatened
miscarriage. However, the quality of the included studies was poor. More high quality studies are necessary to further evaluate the
effectiveness of Chinese herbal medicines for threatened miscarriage.
P L A I N L A N G U A G E S U M M A R Y
Chinese herbal medicines for threatened miscarriage
Miscarriage or spontaneous abortion is the loss of a pregnancy without medical or mechanical means before completion of the 20th week
of gestation. The fetus is not sufficiently developed to have been able to survive outside the mother’s womb. Threatened miscarriage
is a very common in early pregnancy. Most threatened miscarriages occur in the first 12 weeks of pregnancy and become evident as
vaginal bleeding, abdominal and low back pain that persist for days or weeks. So far, therapies have limited effectiveness in preventing
early pregnancy loss due to threatened miscarriage. Chinese herbal medicines are a part of Traditional Chinese Medicines and are made
up of products from plants and some animal and mineral substances. They have become very popular and are commonly used as an
alternative treatment for threatened miscarriage.
This review compared the therapeutic effects of Chinese herbal medicines with other pharmaceutical agents. Among the 44 includedrandomised trials involving 5100 participants, all from China, no trial used placebo or bed rest as a control intervention. Twenty
trials used a common prescription of Shou Tai Pill as a basic formula, while the other 24 trials used other formulae. The Western
medicines included tocolytic drugs such as salbutamol and magnesium sulfate, hormonal supplementation with human chorionic
gonadotrophin or progesterone and supportive supplements including vitamin E and folic acid. Five trials followed 550 women until
after 28 weeks of gestation and delivery and showed that combined Chinese herbal and Western medicines were more effective than
Western medicines alone in the treatment of threatened miscarriage. The remaining studies looked at the immediate effects of treatment.
Combined treatment was more effective than Western medicines in preventing inevitable miscarriage so that the pregnancy continued.
Many of the trials did not report on side effects during treatment or throughout continuing pregnancy and birth. Chinese medicine
practitioners slightly modify the classical prescriptions depending on the individual women’s clinical presentations. All the trials had
poor methodological quality. In conclusion, there is a lack of evidence from randomised controlled trials on the effectiveness of Chinese
herbal medicines for the treatment of threatened miscarriage and to determine if Chinese herbal medicines alone are more beneficial
than Western medicines alone for threatened miscarriage.
B A C K G R O U N D
Description of the condition
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Miscarriage
Miscarriage is defined as spontaneous abortion occurring with-
out medical or mechanical means before completion of the 20th
week of gestation so that the fetus is not sufficiently developed to
survive (Cunningham 2005). It denotes pregnancy loss prior to
completion of the 20th
gestational week, or 139 days, counting from the first day of the last normal menses (DeCherney 2007).
The incidence of miscarriage is commonly stated as 10% to 15%
of all pregnancies, and is the most common complication during
pregnancy (Petrozza 2006). However, the incidence is difficult to
determine precisely, since as many as 30% may go unrecognised,
and these can occur very early during a pregnancy.
Threatened miscarriage
Threatened miscarriage presents with vaginal bleeding or any
bloody vaginal discharge during early pregnancy, and although the
bleeding is frequently slight, it may persist for days or weeks with-
out cervical dilatation and fetal loss (Cunningham 2005). Threat-ened miscarriage will become inevitable when gross rupture of
fetal membranes occurs along with severe vaginal bleeding and
cervical dilatation; imminent fetal loss is almost certain in these
cases (Cunningham 2005). Vaginal bleeding during early gesta-
tion occurs in 20% to 25% pregnancies and may last for days or
weeks; nearly half of these pregnancies will result in pregnancy loss
(Cunningham 2005). If the miscarriage is avoided, there is still a
high risk of preterm labour (Batzofin 1984), and low birthweight
(Funderburk 1980), and perinatal death ( Weiss 2004).
Major causes of miscarriage
More than 80% of miscarriages occur in the first 12 weeks of preg-nancy (Loue 2004). There are many factors that put a pregnancy
at a high risk of miscarriage.
Genetic defects
Chromosomal anomalies contribute to at least half of miscarriages
at the early stage of pregnancy, and it could depend on paternal,
maternal or fetal factors (Cunningham 2005). Chromosomal ab-
normalities from either parent can be inherited by their offspring.
Numerical abnormality, such as haploid and triploid, and struc-
tural abnormality, such as deletion and translocation, are two clas-
sical types of chromosomal anomalies for miscarriage. Fetal factors
include abnormal zygotic development and aneuploidy (numeri-cal chromosomal abnormality).
Immunological dysfunction
Miscarriage, caused by immunological dysfunction, is also related
to the parents. The paternal factor includes human leukocyte anti-
gens (HLA) (Kano 2007) and antisperm antibodies (Choudhury
2010). For the mother, a pregnancy is like an allograft, the mater-
nal body may have a rejection reaction to the fetus. Maternal fetal
incompatibility occurs because of ABO and Rhesus (Rh) blood
group antigens (Bandyopadhyay 2010) and excess antiphospho-
lipid antibodies (Suzumori 2010).
Other maternal factors
The risk of miscarriage appears to increase with parity as well as
with maternal and paternal age (Gracia 2005). A variety of ma-
ternal diseases and developmental abnormalities have been impli-
cated, including chronic infection, anatomic defects, endocrine
deficiencies, toxin exposure, immunologic disorders, and physical
or emotionaltrauma,which may leadto recurrent miscarriagesand
threatened miscarriages (DeCherney 2007). Some isolated events
such as laparotomy, chronic debilitating disease, nutrition, high
fever, tobacco, drug abuse, or alcoholism, are also considered to
be causes of threatened miscarriage (Lyttleton 2004).
Environmental factors
Over orlastingexposure tosome chemicalsand metalssuchas lead,
cadmium, and arsenic, could also cause harm to the pregnancy
and lead to pregnancy loss (Tabacova 1994).
Clinical management
In current clinical practice, surgical and non-surgical interven-
tions are used in the management of miscarriage. However, in
threatened miscarriage, non-surgical interventions, which prevent
the inevitable consequence of pregnancy loss, are rather empirical
(Tien 2007). Most cases will progress to the next stage no matter
what is done. Bed rest and avoidance of sexual intercourse, thoughcommonly advised, are without sufficient proven benefit ( Aleman
2005). Supportive care may reduce inevitable miscarriage (Tien
2007). Progesterone support hasbeen used to reducethe incidence
of miscarriage (El-Zibdeh 2009), but the conclusion is still very
limited (Haas 2008). Hence, to date, no therapy has been con-
firmed as efficacious for threatened miscarriage.
Description of the intervention
Traditional Chinese medicine (TCM) has been used for more than
3000 years in China (Ma 2006). Chinese herbal medicine, one
of the commonly therapeutic approaches of TCM, mainly refersto products made of, or from, plants, or parts of plants, and also
includes animal and mineral substances.
How the intervention might work
Unlike mainstream Westernmedicine, TCMhas a unifiedmedical
theory for clinical diagnosis and treatment which focuses on ’Qi’
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and ’blood’ as the two basic elements of human physiology. ’Qi’ is
equivalent to vital energy. There is an overall or essential ’Qi’ for
each organ (such as kidney ’Qi’, liver ’Qi’, etc). ’Qi deficiency’ (or
Qi vacuity) can lead to aging and weakness, whereas ’Qi’ stagnant
can cause pain. ’Blood’ is the sustenance of the body; ’Blood defi-
ciency’ (or Blood vacuity) can lead to pallor and dizziness, whereas’Blood stasis’ can result in bleeding tendency.
TCM practitioners use ’inquiry, inspection, hearing, and palpa-
tion’ to makediagnosesand prescribe Chinese herbal medicinesac-
cordingto the’Jun, Chen,Zuo, Shi’ principle(which standsfor the
charactersas Monarch, Minister, Assistant and Guide) (Li 2005b).
As each of the herbal medicines has its own properties and poten-
tial interactivity, the application of this principle will decrease or
avoid the side effects of the other herbs, enhance the therapeutical
actions of some herbs and collaborate with all the herbs to create
a more harmonious effect on the human body resulting in a more
enhanced and direct impact on treatments. Among allthe systems,
deficiency in the ’kidney’ and ’liver’ functions are particularly im-
portant in the pathology and mechanism of miscarriage. ’Kidney’stores the essential ’Qi’ that warms up and activates all the other
systems in the body. It is responsible for growth, development,and
reproduction (Li 2005b). ’Liver’ stores the ’blood’ that regulates
the flow of ’Qi’ and maintains reproductivity (Li 2005b). The
main causes of miscarriage include ’Qi’ deficiency, ’blood’ heat,
’blood’ deficiency and ’kidney’ deficiency (Ma 2006). Amongst
all of these, ’kidney deficiency’ is the most frequent clinical type
in miscarriage (Lyttleton 2004); women with ’kidney deficiency’
tend to miscarry earlier in the pregnancy (Lyttleton 2004). Chi-
nese herbal medicines such as Radix rehmanniae (Rehmania root),
Fructus lycii (Lycium fruit) and Semen cuscutae (Cuscuta fruit), are
commonly used to correct ’kidney deficiency’ through nourishing
the “Kidney” and benefiting the fetus in preventing miscarriage(Liu 2002).
Why it is important to do this review
Chinese medicines and other herbal medicines or botanicals are
principally used in China and South East Asia, but these are in-
creasingly becoming accepted worldwide as an alternative to West-
ern medicines to promote the health of both mothers and fetuses
and to relieve medical problems during pregnancy. Based on our
preliminary literature search, miscarriage, in particular threatened
miscarriage, is one of the most common clinical indications for
Chinese herbal medicines during pregnancy (Li 2011b).
Despite the wide use of Chinese herbal medicines for preventing
pregnancy loss, the therapeuticeffects of Chinese herbalmedicines
for threatened miscarriage in early pregnancy has not been eval-
uated systematically. Similarly, medication exposures during early
pregnancy are known to result in birth defects, but currently there
is insufficient information on the risks and safetyof Chinese herbal
medicines.
O B J E C T I V E S
To review the therapeutic effects of Chinese herbal medicines for
the treatment of threatened miscarriage.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised or quasi-randomised controlled trials, as well as clus-
ter-randomised trials, comparing Chinese herbal medicines (alone
or combined with other pharmaceuticals) with placebo, no treat-
ment (including bed rest), or other pharmaceuticals as treatments
for threatened miscarriage.
Trials were included regardless of publication status, with or with-out full text. We only identified studies that compared Chinese
herbal medicines with other pharmaceuticals (mainly Western
medicines). We did not identify any trials which used placebo or
bed rest as a control.
We did not apply any language restrictions, and most of the papers
were in Chinese or English, which was the mother language or
second language for all the authors, who fully understood the
papers as well as the design and intervention of the trials.
Types of participants
All pregnant women with a viable pregnancy diagnosed with
threatened miscarriage, regardless of underlying causes. No treat-ment wasgivenbefore the trial interventions. Fetal viability wasas-
sessed by ultrasound to ensure exclusion from the study of women
with inevitable, incomplete, or missed miscarriage. Women with
vaginal bleeding after the 20th week of pregnancy were also ex-
cluded. We included women regardless of whether the pregnancy
was singleton or multiple, and irrespective of thematernal age and
parity.
Types of interventions
All types of Chinese herbal medicines in either standard or com-
binedformulaefor the treatmentof threatenedmiscarriage, regard-
lessof the dose or duration of administration, were compared with
other pharmaceuticals. The pharmaceuticals were mostly Western
medicines. We planned the following comparisons.
• Chinese herbal medicines versus placebo.
• Chinese herbal medicines versus no treatment (including
bed rest).
• Chinese herbal medicines alone versus other
pharmaceuticals.
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• Combined Chinese herbal medicines and other
pharmaceuticals versus other pharmaceuticals.
Types of outcome measures
Primary outcomes
(1) Effectiveness of intervention: continuation of pregnancy after
28 weeks of gestation.
Pregnancy after 28 weeks of gestation is generally considered vi-
able, and pregnancy loss before 28 weeks is considered to be non
viable due to extreme low birthweight and underdeveloped struc-
tures. In this review, only viable pregnancy at 28 weeks was con-
sidered as the primary outcome.
Secondary outcomes
Mother
During treatment
(2) No relief of clinical signs (vaginal bleeding and abdominal
pain).
(3) No improvement in laboratory investigations (urinary and
serum beta human chorionic gonadotropin (ß-HCG) titre).
After treatment
(4) Repeated threatened miscarriage before 28th week of the same
pregnancy (current miscarriage signs and symptoms remitted after
intervention but relapsed in the same pregnancy).
(5) Preterm labour.
(6) Any other adverse pregnancy outcomes reported, including
side effects, toxicity, etc.
Fetus(7) Live birth (non-prespecified outcomes).
(8) Preterm birth.
(9) Stillbirth.
(10) Neonatal death.
(11) Fetal structural malformations.
(12) Any other adverse perinatal outcomes reported, including
side effects, toxicity, etc.
Search methods for identification of studies
Electronic searches
We searched the Cochrane Pregnancy and Childbirth Group’s Tri-als Register by contacting the Trials Search Co-ordinator (31 Jan-
uary 2012).
The Cochrane Pregnancy and Childbirth Group’s Trials Register
is maintained by the Trials Search Co-ordinator and contains trials
identified from:
1. monthly searches of the Cochrane Central Register of
Controlled Trials (CENTRAL);
2. weekly searches of MEDLINE;
3. weekly searches of EMBASE;
4. handsearches of 30 journals and the proceedings of major
conferences;
5. weekly current awareness alerts for a further 44 journals
plus monthly BioMed Central email alerts.Guidelines of the search strategiesfor CENTRAL, MEDLINEand
EMBASE, the handsearched journals and conference proceedings
and the journals reviewed via the current awareness service were
followed according to the ’Specialized Register’ section from the
Cochrane Pregnancy and Childbirth Group.
In addition, we searched:
1. EMBASE (1980 to 31 January 2012) ( Appendix 1)
2. Cumulative Index to Nursing and Allied Health Literature
(CINAHL) (31 January 2012) ( Appendix 2)
3. PubMed (1980 to 31 January 2012) ( Appendix 3)
4. China Journal Net (CJN) (1915 to 31 January 2012)
( Appendix 4)
5. China National Knowledge Infrastructure (CNKI) (1915to 31 January 2012) ( Appendix 4)
6. WanFang Database (Chinese Ministry of Science &
Technology) (1980 to 31 January 2012) ( Appendix 5)
7. Chinese Biomedical Database (CBM) (1978 to 31 January
2012) ( Appendix 6)
8. Wiley Inter Science (1966 to 31 January 2012) ( Appendix
6)
9. Chinese Clinical Trial Registry (31 January 2012)
( Appendix 7)
10. International Clinical Trials Registry Platform (ICTRP) (31
January 2012) ( Appendix 7)
Searching other resources
Handsearching
We searched 64 Chinese language journals ( Appendix 8).
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References from published studies
We searched the reference lists of relevant trials and reviews iden-
tified.
Unpublished literature
As some of the trials showed that there would be on-going stud-
ies, we tried to contact the authors for more details if the stud-
ies were completed and results were available. We contacted the
pharmaceutical companies for more information of the relevant
medicines/products.
Personal communications
We contacted organisations, individual experts working in the
field, and medicinal herb manufacturers in order to obtain addi-
tional references.
We did not apply any language restrictions.
Data collection and analysis
Selection of studies
To determine which clinical trials to include, we screened the
titles, abstracts, and keywords of the trials identified by the search.
Two review authors (LL and LD) independently assessed each
trial for inclusion and any disagreements were discussed. If thedisagreementscould not be resolved, we contactedthe trial authors
forclarification. We did notblindthe reviewauthors to thejournal
of origin or institution.
Data extraction and management
We designed a form to extract data, and two review authors (LL)
and (LD) extracted the data using the agreed form for study eligi-
bility. We resolved discrepancies through discussion or consulted
the third review author (CCW). We entered data into Review
Manager software (RevMan 2011), and checked for accuracy. We
assessed the abstracts in the same way as full papers, then included
them in the analyses. We excluded trials that did not meet our
eligibility criteria (or as a result of the study authors’ replies to our
queries) and noted the reasons for exclusion in the Characteristics
of excluded studies table. Studies awaiting classification are those
for which the authors of the original reports have not yet provided
information. However, we will reconsider these trials for inclusion
if the authors provide more information or once the full publica-
tions become available to confirm our queries.
Assessment of risk of bias in included studies
Two review authors (LL and LD) independently assessed the risk
of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
It includes seven parts as follows. Any disagreements were resolved
by discussion or by involving the third assessor (CCW).
(1) Random sequence generation (checking for possible
selection bias)
We describe for each included study the method used to generate
the allocation sequence in sufficient detail to allow an assessment
of whether it should produce comparable groups.
We assessed the method as:
• low risk of bias (any truly random process, e.g. random
number table; computer random number generator);
• high risk of bias (any non-random process, e.g. odd or even
date of birth; hospital or clinic record number);
• unclear risk of bias.
(2) Allocation concealment (checking for possible selection
bias)
We describe for each included study the method used to conceal
allocation to interventions prior to assignment and assess whether
intervention allocation could have been foreseen in advance of, or
during recruitment, or changed after assignment.
We assessed the methods as:
• low risk of bias (e.g. telephone or central randomisation;
consecutively numbered sealed opaque envelopes);
• high risk of bias (open random allocation; unsealed or non-
opaque envelopes, alternation; date of birth);• unclear risk of bias.
(3) Blinding (checking for possible performance bias)
We describe for each included study the methods used to blind
study participants and personnel from knowledge of which inter-
vention a participant received. We assessed blinding separately for
different outcomes or classes of outcomes. We judged studies at
low risk of bias if they were blinded. Trials with no blinding or
blinding of participants only were considered at high risk of bias
which may affect the results.
We assessed the methods as:
• low, high or unclear risk of bias for participants;• low, high or unclear risk of bias for personnel;
• low, high or unclear risk of bias for outcome assessors.
(4) Incomplete outcome data (checking for possible attrition
bias due to the amount, nature and handling of incomplete
outcome data)
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We describe for each included study, and for each outcome or class
of outcomes, the completeness of data including attrition and ex-
clusions from the analysis. We state whether attrition and exclu-
sions were reported and the numbers included in the analysis at
each stage (compared with the total randomised participants), rea-
sons for attrition or exclusion where reported, and whether miss-ing data were balanced across groups or were related to outcomes.
Where sufficient information was reported, or was supplied by
the trial authors, we re-included the missing data in the analyses
which we undertook.
We assessed methods as:
• low risk of bias (e.g. no missing outcome data; missing
outcome data balanced across groups);
• high risk of bias (e.g. numbers or reasons for missing data
imbalanced across groups; ‘as treated’ analysis done with
substantial departure of intervention received from that assigned
at randomisation);
• unclear risk of bias.
If data for more than 20% of participants were missing, we ex-cluded the outcome or study from the analysis.
(5) Selective reporting (checking for reporting bias)
We describe for each included study how we investigated the pos-
sibility of selective outcome reporting bias and what we found.
We assessed the methods as:
• low risk of bias (where it is clear that all of the study’s pre-
specified outcomes and all expected outcomes of interest to the
review have been reported);
• high risk of bias (where not all the study’s pre-specified
outcomes have been reported; one or more reported primary
outcomes were not pre-specified; outcomes of interest arereported incompletely and so cannot be used; study fails to
include results of a key outcome that would have been expected
to have been reported);
• unclear risk of bias.
(6) Other sources of bias (compliance and baseline
similarity)
We describe for each included study any important concerns we
had about other possible sources of bias. For example, if the trial
stopped early, or if there was a baseline imbalance (e.g. severeblood
loss before intervention) or differential diagnosis (e.g. pattern/
syndrome differentiation for individualised treatment) between
the comparing groups.
We assessed whether each study was free of other problems that
could put it at risk of bias as follows.
Compliance
• Good: more than 95% participants received the treatment
exactly following the physicians’ instructions.
• Fair: 95% to 90%.
• Poor: 90% to 80%.
• Failed: less than 80%.
Baseline similarity
• Yes: all participants were inpatients or outpatients, with the
symptoms, signs, examinations or diagnosis related to threatened
miscarriage and suitable for each study, then were randomly
selected for different study groups.
• No.
• Unclear.
(7) Overall risk of bias
We made explicit judgements about whether the studies were at
high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
With reference to (1) to (6) above, we assessed the likely magnitude
and direction of the bias and whether we considered it was likely
to impact on the findings. We planned to explore the impact of
the level of bias through undertaking sensitivity analyses - see Sensitivity analysis.
Measures of treatment effect
Statistical analysis was performed using (RevMan 2011).
Continuous data
Not applicable in this review.
Dichotomous data
We presented results as summary risk ratio with 95% confidence
intervals for dichotomous data.
Unit of analysis issues
Trials with three arms (Chinese herbal medicines alone, West-
ern medicines alone, combined Chinese herbal and Western
medicines) were included and are described in the Characteristics
of included studies. We input the data separately for the respective
meta-analysis for a better understanding on the effectiveness of
each intervention.
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Dealing with missing data
For included studies, we noted levels of attrition, and explored the
impact of included studies with high levels of missing data for the
overall assessment of treatment effect by using sensitivity analysis.
For all outcomes, we carried out analyses, on an intention-to-treat
basis; we attempted to include all participants randomised to eachgroup in the analyses. The denominator for each outcome in each
trial was the total number of participants randomised minus any
participants whose outcomes were known to be missing.
Assessment of heterogeneity
We assessed statistical heterogeneity in each meta-analysis using
the T², I² and Chi² statistics. We regarded heterogeneity as sub-
stantial if T² was greater than zero and either I² was greater than
30% or there was a low P value (less than 0.10) in the Chi² test
for heterogeneity.
Data synthesis
We carried out statistical analysis using RevMan 2011 and used
fixed-effect inverse variance meta-analysis for combining data
when the studies were estimating the same underlying treatment
effect and the populations and methods of the trials were judged
sufficiently similar. For clinical heterogeneity sufficient to expect
that the underlying treatment effects differed between trials, or if
substantial statistical heterogeneity was detected, we used random-
effects meta-analysis to produce an overall summary if an average
treatment effect across trials was considered clinically meaningful.
We treated the random-effects summary as the average range of
possible treatment effects and we discussed the clinical implica-
tions of treatment effects differing between trials. Where the av-erage treatment effect was not clinically meaningful, we did not
combine trials. For random-effects analyses, we presented the re-
sults as the average treatment effect with its 95% confidence in-
terval, and the estimates of T² and I².
Subgroup analysis and investigation of heterogeneity
Due to lack of data we were unable to carry out anyof theprespec-
ified subgroup analysis. In future updates of this review, if more
data become available, we will carry out the following prespecified
subgroup analyses:
1. maternal age below 35 versus 35 and above;
2. primipara versus multipara;
3. threatened miscarriage in first trimester versus second
trimester;
4. referred herbal medicines versus non-referred herbal
medicines, according to the formulary stated in the Chinese
Pharmacopeia;
5. short-term treatment (one course only) versus long-term
treatment (more than one course);
6. quasi-randomised clinical trials versus randomised clinical
trials.
In future updates of this review, we will use the following outcome
in subgroup analysis:
• continuation of pregnancy after 28 weeks of gestation.
For fixed-effect meta-analyses, we will conduct planned subgroup
analyses classifying whole trials by interaction tests as described by
Deeks 2001. For random-effects meta-analyses, we will assess dif-
ferences between subgroups by inspection of the subgroups’ con-
fidence intervals; non-overlapping confidence intervals indicating
a statistically significant difference in treatment effect between the
subgroups.
Sensitivity analysis
It was not necessary to carry out the planned sensitivity analyses
in this review. In future updates, we will carry out the following
prespecified sensitivity analyses, wherenecessary. We will carry outsensitivity analysis to explore the effect of trial quality for impor-
tant outcomes in the review. Sensitivity analyses will be performed
to examine the effect of:
1. high risk of bias in the allocation of participants to groups
associated with a particular study (Schulz 1995); or
2. high levels of missing data (Higgins 2011).
R E S U L T S
Description of studies
See: Characteristicsof included studies; Characteristicsof excluded
studies; Characteristics of studies awaiting classification.
From the169 clinical trialsof Chinese herbal medicines for threat-
ened miscarriage identified by the search, we assessed 63 poten-
tially eligible trials for inclusion in this review. We included 44
trials, excluded 17 trials, and two trials are still awaiting classifica-
tion, see Characteristics of studies awaiting classification.
Included studies
Forty-four trials (5100 women) were included for assessment and
meta-analysis in this review. All the participants were pregnant
Chinese women, and the studies were carried out in different
provinces of mainland China (middle-income country), mainly in
municipal hospitals and provincial level hospitals. For full details,
see Characteristics of included studies and Table 1 which is a qual-
ity assessment of selected randomised clinical trials.
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Types of studies
All of the included studies were declared as randomised controlled
trials, although only a few of them (11 trials) did report the details
of randomisation methods.
Types of participants
All of the included trials recruited women with threatened miscar-
riages before 20 gestational weeks and who had not received any
treatment before the study commenced.
Types of interventions
Five trials compared Chinese herbal medicines with Western
medicinestreatments, while39 trials comparedcombinedChinese
herbal medicines and Western medicines with Western medicines
alone. We did not identify any trials comparing Chinese herbal
medicines with placebo or no treatment (including bed rest).
Follow-up
All the included trials followed up the participants until the end
of the treatments. Four of the included trials followed up the
participants until delivery, two of which reported the development
of the infants.
Excluded studies
Seventeen trials were excluded because the control group included
normal pregnant women; different Westernmedicines in the com-
bined medicines group and Western medicines group; Chinese
medicines versus Chinese medicines; Kampoo medicines versus Western medicines; low quality of the methodology; unqualified
gestational age. See Characteristics of excluded studies.
Risk of bias in included studies
All the included trials reported that they use randomisation meth-
ods when they recruited participants for different intervention
groups, and no missing data were reported. We double checked
each included study and found that the number of participants
were consistent with the numbers reported for outcomes and fol-
low-up. As there were no reports of drop-outs, and no evidence of
reporting biases on the number of participants, the interventions
and the outcomes in the 44 included studies, no subgroup analysis
was carried out.
Allocation
All the included clinical trials reported that the participants were
randomised, allocated and grouped. However, only 11 studies re-
ported detailed randomisation and allocation methods, including
’visiting sequence’, ’visiting date’, ’layered method’, ’randomised
number table’ and ’2:1 ratio randomisation’. See Characteristics of
included studies.
BlindingTwo studies reported that single blinding was applied but without
further details; we considered that no blinding was applied in the
other studies. Blinding was not feasible in this kind of clinical
study, especially to the participants and clinicians.
Incomplete outcome data
No incomplete data were reported in the included studies. After
double checking the total number of participants and the patients
included in each intervention group, there were no missing data
in all the studies.
Selective reporting
All the studies clearly reported the prespecified outcomes and all
expected outcomes of interest, and no incomplete outcomes were
recorded.
Other potential sources of bias
All included studies followed up the patients until the end of treat-
ment (which were prespecified in their studies), some studies con-
tinually followed up thehealthconditions of mothersafterdelivery
and the development of the newborn. Thirty-fourstudies reported
that there was no significant difference amongst the groups before
treatment, and were considered to have good baseline similarity.
Effects of interventions
We did not find any comparisons of Chinese herbal medicines
with placebo or no treatment in the 44 included studies. All in-
cluded studies compared Chinese herbal medicines with active in-
terventions (pharmaceuticals, mostly Western medicines). So only
two comparisons were included.
• Chinese herbal medicines alone versus Western medicines
alone.• Combined Chinese herbal and Western medicines versus
Western medicines alone.
Western medicines included tocolytic drugs (e.g. salbutamol and
magnesium sulfate), hormonal supplementations (e.g. HCG and
progesterone), immunotherapy (e.g. IgG immunisation and anti-
phospholipid antibodies) and supportive supplements (e.g. vita-
min E and folic acid).
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Chinese herbal medicines alone versus Western
medicines alone
Primary outcomes
1. Effectiveness of the intervention: continuation of
pregnancy after 28 weeks of gestation
The rateof effectiveness (continuationof pregnancy after28 weeks
of gestation) appeared tobe higherin theChinese herbalmedicines
group (90.0%) compared with the group of women receiving
Western medicines (73.3%) but this difference was not statisti-
cally significant (risk ratio (RR) 1.23; 95% confidence interval
(CI) 0.96 to 1.57) ( Analysis 1.1). Only one trial (Zhong 2002)
was included in the analysis, with 60 participants, half of whom
were treated with Chinese herbal medicines while the other half
received with Western medicines.
2. Subgroup analysis
No data were available for subgroup analyses of maternal age be-
low 35 versus 35 and above, primipara versus multipara, threat-
ened miscarriage in first trimester versus second trimester, referred
herbal medicines versus non-referred herbal medicines, short-term
treatment (one course only) versus long-term treatment (more
than one course), or quasi-randomised clinical trials versus ran-
domised clinical trials.
Secondary outcomes
3. No relief of clinical signs (vaginal bleeding and abdominal
pain)
The incidence of no relief of clinical signs was lower in the women
in the Chinese herbal medicines group than those in the Western
medicines group, 10% versus 26.7%, respectively, however, the
difference was not statistically significant (RR 0.38; 95% CI 0.11
to 1.28) ( Analysis 1.2). Only one trial (Zhong 2002), involving
60 women, was included in this analysis.
4. Other prespecified outcomes
No data were available from the included studies for the follow-
ing prespecified outcomes: no improvement in laboratory inves-
tigations; repeated threatened miscarriage; preterm labor; adverse
pregnancy outcomes; livebirth; preterm birth; stillbirth; neonatal
death; fetal structural malformations; and other adverse perinatal
outcomes.
Non-prespecified outcomes
5. Effectiveness of intervention: continuation of pregnancy
after treatment
Fifteen studies with 1807 participants assessed the outcomes im-mediately after the course of treatment, instead of long-term ob-
servations after 28 weeks of gestation. Therefore, as a supplement
to the primary and secondary outcomes, we have included these
clinical trials and analysed the data as non-prespecified outcomes,
i.e., ’continuation of pregnancy after treatment’.
Chinese herbal medicine alone was, on average, significantly more
effective than Western medicines in preventing inevitable miscar-
riage and continuing the pregnancy, 87.7% versus 71.0%, respec-
tively (average RR 1.22; 95% CI 1.12 to 1.32) ( Analysis 1.12).
Substantial heterogeneity was observed (T² = 0.02; I² = 68%; Chi2 = 43.10, df = 14 (P less than 0.0001)), so we used a random-
effects model for this analysis.
Combined Chinese herbal medicines and Western
medicines versus Western medicines alone
Primary outcomes
1. Effectiveness of intervention: continuation of pregnancy
after 28 weeks of gestation
A combination of Chinese herbal medicines and Western
medicines was more effective than Western medicines alone to
continue the pregnancy after 28 weeks of gestation, 94.4% ver-sus 73.6%, respectively (average RR 1.28; 95% CI 1.18 to 1.38)
( Analysis 3.1). In total, five clinical trials with 550 participants
were included (Chen 2002; Feng 1997; Lu 2011; Lv 2007; Zhong
2002).
2. Subgroup analysis
Due to a lack of detailed information, it was not possible to carry
out the planned subgroup analyses. Only the mean values and/or
ranges of maternal age in each group were reported in all the tri-
als, however, a comparison of women below 35 years and women
above 35 years old was not possible. All the clinical trials reported
the parity of the participants but did not provide details about
the parity in each group, so further comparisons of primipara and
multipara were not possible. Data on gestational age at threat-
ened miscarriage were only available in one study (Lu 2011), so a
comparison between first trimester and second trimester was not
possible. All of the Chinese herbal medicines and the supplements
were standard formulae as stated in Chinese Pharmacopeia, so no
subgroup analysis of referred and non-referred herbal medicines
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was carried out. As to the treatment course, Chen’s study (Chen
2002) stopped the treatments around 12 weeks to five months of
gestation, Feng’s (Feng 1997) and Lu’s (Lu 2011) studies did not
report the termination of treatment but evaluated the effectiveness
after the relief of clinical signs. Lv’s study (Lv 2007) reported one
week as one course but did not give details on the total numberof the courses for the treatment. Zhong’s study (Zhong 2002) re-
ported that the treatment was stopped at two weeks after clinical
signs were relieved. Therefore, it is difficult to extract the data
and carry out subgroup analysis. There were no quasi-randomised
clinical trials in the included studies.
Secondary outcomes
3. No relief of clinical signs (vaginal bleeding and abdominal
pain)
The result showed that combined medicines treatment was moreeffective in the reliefof clinical signs than Westernmedicines treat-
ment, the incidence rates were 5.6% versus 26.4%, respectively,
(RR 0.21; 95% CI 0.13 to 0.36) ( Analysis 3.2). In total, five clin-
ical trials with 550 participants were included (Chen 2002; Feng
1997; Lu 2011; Lv 2007; Zhong 2002).
4. No improvement in laboratory investigations (urinary and
serum 08-HCG titre)
Only one trial (Lv 2007) measured serum ß-HCG and proges-
terone levels during the treatments. However, the author did not
report the results, so we could not include any data for further
analysis.
5. Other prespecified events
No data were available from the included studies for the following
prespecified outcomes: repeated threatened miscarriage; preterm
labour; adverse pregnancy outcomes; livebirth; preterm birth;still-
birth; neonatal death; fetal structural malformations; and other
adverse perinatal outcomes.
Non-prespecified outcomes
6. Effectiveness of intervention: continuation of pregnancy
after treatment
Combined Chinese herbal and Western medicines was signifi-
cantly more effective than Western medicines alone for preventing
inevitable miscarriage (continuation of pregnancy), than Western
medicines alone 92.4% versus 72.8%, respectively (average RR
1.24; 95% CI 1.18 to 1.30;) ( Analysis 3.12). In total, 26 clinical
trials (involving 2809 women) were included in the analysis. Sub-
stantial heterogeneity was observed (T² = 0.00; I² = 37%; Chi²
= 39.91, df = 25 (P equal to 0.03)), so we used a random-effects
model in our analysis.
D I S C U S S I O N
Effectiveness
Chinese herbalmedicines claim to be effective, and are accepted as
an alternative treatment for threatened miscarriage in most Asian
countries. This review aimed to evaluate the therapeutic effects of
Chinese herbal medicines for threatened miscarriage. The most
valuable and important comparison to evaluate the intervention
is for Chinese herbal medicines to be compared with placebo.
However, no such trials were identified.
We identified five randomised clinical trials comparing Chineseherbal medicines with Western medicines. Meta-analysis indicates
that a combination of Chinese herbal and Western medicines
are more effective than other pharmaceuticals (Chinese herbal
medicines or Western medicines alone) for treating threatened
miscarriage, to prevent inevitable miscarriage and to continue the
pregnancy beyond 28 weeks’ gestation. However, we have no evi-
dence to assess whether Chinese herbal medicines alone are more
effective because no controlled trials of placebo versus no treat-
ment (including bed rest) were identified. As a non-prespecified
outcome, we examined the 39 studies that assessed effectiveness
immediately after the course of treatment (rather than long-term
observations after 28 weeks of pregnancy). These studies indi-
catedthat Chinese herbal medicinesalone weremore effectivethan Western medicines alone in treating threatened miscarriage. Chi-
nese herbal medicines alone or combined with Western medicines
were more effective than Western medicines alone in relieving the
clinical signs of threatened miscarriage, including vaginal bleed-
ing, low back pain and abdominal pain.
However, it should be emphasized that the use of Western
medicines, such as human chorionic gonadotropin (HCG) which
maintains the luteotrophic effects in supporting continued secre-
tion of placental oestrogen, and progesterone and progesterone,
are also not supported by evidence proving them to be beneficial
(Devaseelan 2010; Haas 2008), yet they are considered as classical
therapies for threatened miscarriage (Devaseelan 2010; Wahabi
2011). Most cases will progress to the next stage no matter what is
done. Even bed rest has no significant effects in altering the course
and progress of miscarriage ( Aleman 2005). So any conclusion on
the effectiveness of Chinese medicines for threatened miscarriage
is very tentative.
This review favoured Chinese herbal medicines for threatened
miscarriage. Most Chinese medicine practitioners have slightly
modified the classical prescriptions depending on the individual
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clinical presentations. In the 44 included clinical trials, 20 trials
used a common prescription of Shou Tai Pill as a basic formula,
while the other 24 trials used other referred formulae. Some herbal
medicines have been added to, or removed from the standard for-
mula during treatment.
Adverse effects and follow-up
Chinese herbal medicines have been commonly used to treat
threatened miscarriage in attempts to promote maternal health
and embryo-fetal development. However, confirmation of safety
claims is still pending, so it is important to study the potential
adverse effects of Chinese medicines on mothers and fetuses. Most
of the clinical trials did not report whether there were side effects
of Chinese herbal medicines during treatment or afterwards. Very
few clinical trials followed up the pregnancy until, and after birth.
So we are unable to draw any conclusions about the safety of Chi-
nese herbal medicines for mothers and fetuses. Xiao’s study ( Xiao
2008), mentioned that all the participants were followed up after
one month of delivery, but didnot report anyfurther information.
Zhang’s study (Zhang 2008b), reported that no complications oc-
curred during the deliveries andthat all the infants developed well,
both mentally and physically, in the half-year follow-up. Song’s
study (Song 2007), reported that there were no congenital mal-
formations of the newborns and that no adverse effects occurred
during the treatment, but did not provide any detailed data. Li’s
study (Li 2006), reported detailed information and data on the
percentage of follow-up, termdelivery and preterm delivery, Apgar
scores of newborns and average newborn weight. Thus, only one
in four trials was available but no further analysis could be carried
out.
Study design
With regard to the design of the clinical trials of Chinese herbal
medicines, there are still many limitations. Firstly, well-conducted
randomised controlled trials are important for meta-analysis. All
the selected trials in this review had inadequate methodological
quality, compared with foreign literature. For the five trials in-
cluded for the primary outcome analysis, the authors reported
that the women were randomised in the control and intervention
groups, but none of them reported the detailed methods used for
randomisation. For the other 39 trials, only seven trials reported
adequate sequence generation, “layered method” (Li 2004), “ran-
domised number table” (Li 2006; Wang 2011; Xiao 2008; Zhang
2008a ) and “2:1 ratio randomisation” (Hou 2010; Yang 2006);
while four trials reported inadequate sequence generation, “visit-
ing sequence” (Chen 2003) and “visiting date” (Liu 2008; Song
2007; Sun 2003). None of the 44 trials reported the method of
blinding, but from the descriptions of methods reported in each
trial, we believe that all studies were open to both the doctors and
the women. In line with other reports ( Wu 2007; Wu 2009; Zhuo
2008), it is not surprising that many problems in the study designs
and methodologies of clinical trials of Chinese herbal medicines
were identified. Trial quality would be greatly improved if the tri-
alists were adequately trained to carry out and report such clini-
cal trials according to the international standard, including suffi-cient details of randomisation method and having adequate allo-
cation concealment, double-blinded participants, researchers and
outcome assessors, participants classifications, and effects assess-
ments.
Secondly, a good clinical trial should also provide some essential
information, such as the average days or weeks of the treatments,
the changes in medicine dosage and compositions, the number
of women with a successful pregnancy until 28 weeks or after-
wards, and the mortality and follow-up of newborns, which would
be helpful to examine the effects of Chinese herbal medicines
in the treatment of this condition. Thirdly, there is a potential
risk that the interventions were delivered in a way that automat-
ically favoured the group receiving Chinese medicines. Detailedinformation on the standardisation of the treatment in the con-
trol groups is lacking, so there is no way of knowing whether the
treatment periods in the two groups were similar. This leads to
concerns about whether the two groups were treated equivalently.
Finally, the small numbers of qualified clinical trials and insuffi-
cient information in this review prevented us from carrying out
planned subgroup analysis which could inform this review on the
effectiveness and safety of Chinese herbal medicines.
In summary, comparisons made between different treatments
of threatened miscarriage suggest that combined Chinese herbal
and Western medicines were more effective than Chinese herbal
medicines alone or Western medicines alone for treatment of
threatened miscarriage.
A U T H O R S ’ C O N C L U S I O N S
Implications for practice
No placebo controlled trials were available for comparison.
Paucity of evidence supported the effectiveness of Chinese herbal
medicines alone for the treatment of threatened miscarriage for
preventing pregnancy loss and continuing the pregnancy after 28
weeks. However, combined treatments were significantly more ef-
fective than Western medicines alone for preventing miscarriage.
Systematic information regarding the potential harm and long-term effects to the mother or child, or both, with the use of Chi-
nese herbal medicines in the treatment of threatened miscarriage
was lacking.
Implications for research
It is both interesting and important to identify the active com-
poundsin theChinese herbalmedicines that are beneficialin treat-
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ingthreatenedmiscarriage.Thiswill involve studyingpharmacoki-
netics as well as the mechanismand the interactions of these active
compounds with Western medicines. In addition, lack of quali-
fied placebo controlled trials, adequate randomisation methods,
potential bias in intervention limit the conclusions of the system-
atic reviews in Chinese herbal medicines. We strongly recommendstandardisation of clinical trials on the efficacy of Chinese herbal
medicines during pregnancy.
A C K N O W L E D G E M E N T S
We appreciate the help given by the Managing Editor (Sonja Hen-
derson), and other associates (Denise Atherton, Frances J Kellie,
Jill Hampson, Lynn Hampson and Therese Dowswell) in the ed-
itorial office of the Cochrane Pregnancy and Childbirth Group.
As part of the pre-publication editorial process, this review has
been commented on by three peers (an editor and two referees
who are external to the editorial team), a member of the Pregnancy
and Childbirth Group’s international panel of consumers and the
Group’s Statistical Adviser.
The preparation of this review was partially supported by the
Health and Health Service Research Grant from Food and HealthBureau, Hong Kong Special Administration Region (HHSRF
06070511 & 09100031) to CCW and PCL.
LL received the Hop Wai Scholarship and Zi Ying Scholarship
from the Institute of Chinese Culture and Postgraduate Stu-
dent Grants for Overseas Academic Activities from the Graduate
School, The Chinese University of Hong Kongto attend Cochrane
training workshops in Oxford and Freiburg and to visit the Edi-
torial Base of the Cochrane Pregnancy and Childbirth Group at
University of Liverpool in order to receive one to one training and
support; LL received a Yu To Sang Memorial Scholarship 2008/
2009 and 2009/2010 from The Chinese University of Hong Kong
to pursue her PhD study.
R E F E R E N C E S
References to studies included in this review
Chen 2002 {published data only}
Chen JH, Wang J, Shang L. Integrated medicines for 51
cases of threatened miscarriage. Ning Xia Medicine Journal
2002;24(8):506.
Chen 2003 {published data only}
Chen LZ. Combined TCM and west medicine to treating
45 cases of threatened miscarriage. Hunan Guiding Journal of TCMP 2003;9(3):29.
Cui 2002 {published data only}
Cui XP, Yang JB, Deng YC. Tai Er An decoction for
threatened miscarriage. Shan Xi Traditional Chinese
Medicine 2002;23(5):387–8.
Deng 2009 {published data only}
Deng WH. Integrated treatment for 100 cases of threatened
miscarriage during early pregnancy. Zhe Jiang Journal of
Traditional Chinese Medicine 2009;44(2):117.
Feng 1997 {published data only}
Feng ZR. Integrated medicines for 61 cases of threatened
miscarriage. Jiang Su Journal of Traditional Chinese Medicine
1997;18(9):23.Feng 2010a {published data only}
Feng YQ. The effects on ß-HCG and CA125 of Bu Shen
An Tai method for threatened miscarriage. Shan Xi Journal
of Chinese Medicine 2010;31(7):790–1.
Feng 2010b {published data only}
Feng YQ, Wang L. Clinical observational study of Bu Shen
An Tai method for threatened miscarriage. He Bei Journal of
Chinese Medicine 2010;32(1):52–3.
Fu 2006 {published data only}
Fu XX. Integrated medicines for threatened miscarriage.
Forum on Traditional Chinese Medicine 2006;21(3):40–1.
Hou 2010 {published data only}
Hou LL, Shen WW. Chinese medicines for threatened
miscarriage. Si Chuang Journal of Chinese Medicine 2010;28
(11):96–7.
Hu 2010 {published data only}Hu HJ, Xie YH. San Huang An Tai decoction for early
threatened miscarriage. Journal of Emergency Traditional
Chinese Medicine 2010;19(4):669–70.
Huang 2011 {published data only}
Huang P, Zhang L, Wei YH, Ma BM. Combined Chinese
medicines and western medicines for early threatened
miscarriage. Chinese Journal of Modern Drug Application
2011;5(7):90–1.
Kuang 2007 {published data only}
Kuang LJ, Kuang JL. Integrated treatment for threatened
miscarriage during early pregnancy. Chinese Archives of
Traditional Chinese Medicine 2007;25(7):1527–8.
Li 2004 {published data only}
Li WL, Li DJ, Lu Y, Zhou J, Liu CL. Bu Shen An Tai Yin
for threatened miscarriages. Clinical Journal of Traditional
Chinese Medicine 2004;16(3):232–3.
Li 2005 {published data only}
Li SX, Chen HY. Integrated medicines for threatened
miscarriage. He Bei Journal of Traditional Chinese Medicine
2005;27(3):216–7.
13Chinese herbal medicines for threatened miscarriage (Review)
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Li 2006 {published data only}
Li L, Zhou CX, Liu JY. Bu Shen Gu Tai Decoction with
Hermone Therapy for Threatened Miscarriage. Guang Xi
Traditional Chinese Medicine 2006;29(4):17–8.
Li 2009a {published data only}
Li YM, Yang Y. Integrated medicines for threatened
miscarriages during early pregnancy. Journal of ChangchunUniversity of Traditional Chinese Medicine 2009;25(2):
255–6.
Li 2009b {published data only}
Li Z, Nong YS. Integrated medicines for 91 cases of
threatened miscarriage in early pregnancy. He Bei Journal of
Traditional Chinese Medicine 2009;15(7):807.
Li 2010 {published data only}
Li GR, Zhang N. An Tai decoction for threatened
miscarriage. Shan Xi Journal of Chinese Medicine 2010;31
(11):1447–9.
Liu 2008 {published data only}
Liu SM. Integrated medicines for threatened miscarriages.
Family Nurse 2006;6(5c):1370.Liu 2009 {published data only}
Liu F, Meng QC, Yao J, Jiang LP. Bu Shen Jian Pi formula
for 30 cases of threatened miscarriage. Journal of New
Chinese Medicine 2009;41(6):30–2.
Liu 2011a {published data only}
Liu SL. Bao Chang decoction for early threatened
miscarriage. Guang Ming Journal of Chinese Medicine 2011;
26(10):2023–4.
Liu 2011b {published data only}
Liu XM. Bao Tai decoction for threatened miscarriage.
Chinese Journal of Misdiagnosis 2011;11(13):3111.
Lu 2011 {published data only}
Lu YJ. Chinese medicines for threatened miscarriage: 104cases. Shan Dong Journal of Chinese Medicine 2011;30(3):
176.
Lv 2007 {published data only}
Lv XH, Han YP, Luo Y. Integrated medicines for 58 cases
of threatened miscarriages. Yun Nan Journal of Traditional
Chinese Medicine 2007;28(12):11.
She 2008 {published data only}
She XH, Tang JQ. Integrated medicines for threatened
miscarriages. Guang Xi Journal of Traditional Chinese
Medicine 2008;31(3):43.
Shen 2010 {published data only}
Shen YQ, Wu XH, Wei JM. Combined Chinese and
western medicines for early threatened miscarriage. Jiang Su
Journal of Chinese Medicine 2010;2:11.
Song 2005 {published data only}
Song YL, Zhao YQ, Zhang XY. Clinical observations on
126 cases of early threatened miscarriage treated by Zhi Xue
Bao Tai Yin. Journal of Traditional Chinese Medicine 2005;
46(2):116–8.
Song 2007 {published data only}
Song YL, Zhu LP. The fetus protection effects of Zhi Xue
Bao Tai decoction on women of early threatened miscarriage
with dark area surrounding pregnancy sac. Chinese Journal
of Integrated Traditional and Western Medicine 2007;27(11):
1025–8.
Sun 2003 {published data only}
Sun GY, Yin XH. Clinical efficacy on the sex hormone of
combination of Chinese medicine and west medicine for
the treatment of threatened miscarriage. Hunan Guiding Journal of TCM 2003;9(11):33–4.
Wang 2005 {published data only}
Wang XF, OuYang XB. Intergrated medicines for threatened
miscarriages. Fujian Journal of Traditional Chinese Medicine
2005;36(1):43–4.
Wang 2007 {published data only}
Wang YB, Li XH. Bu Shen Gu Chong decoction for 48
cases of threatened miscarriages. Liao Ning Journal of
Traditional Chinese Medicine 2007;34(1):54.
Wang 2010 {published data only}
Wang ZM, Ji QY. Integrated medicines for early threatened
miscarriage. Traditional Chinese Medicine Research 2010;23
(9):46–7. Wang 2011 {published data only}
Wang F, Liu XH. Clinical efficacy of Gushen Antai pill for
early threatened abortion. Evaluation and Analysis of Drug-
use in Hospitals of China 2011;11(12):1121–3.
Xiao 2008 {published data only}
Xiao ZX. Integrated medicines for 30 cases of threatened
miscarriage. Cuiding Journal of Traditional Chinese Medicine
and Pharmacy 2008;14(6):59–60.
Xu 2005 {published data only}
Xu H, Hu YJ. Integrated medicines for 32 cases of
threatened miscarriages, with progesterone as control. Zhe
Jiang Journal of Traditional Chinese Medicine 2005;9:383.
Xun 2008 {published data only} Xun AH, Xia QH. Integrated medicines for threatened
miscarriages. Modern Traditional Chinese Medicine 2008;5
(16):7.
Yang 2001 {published data only}
Yang LF. Integrated medicines for threatened miscarriage
(42 cases). Jiang Xi Journal of Traditional Chinese Medicine
2001;32(2):57.
Yang 2006 {published data only}
Yang MQ. Integrated medicines for 100 cases of threatened
miscarriage in early pregnancy. Guangxi Medical Journal
2006;28(12):1984–5.
Zeng 2011 {published data only}
Zeng JT. Clinical observation of integrated medicines for
threatened miscarriage. Guide of Chinese Medicine 2011;9(17):295–6.
Zhang 2007 {published data only}
Zhang XF, Li X, Wang XR. Integrated medicines for
threatened miscarriages. Hu Bei Journal of Traditional
Chinese Medicine 2007;29(6):40.
Zhang 2008a {published data only}
Zhang XM. Integrated medicines for 50 cases of threatened
miscarriage in early pregnancy. Cuiding Journal of
14Chinese herbal medicines for threatened miscarriage (Review)
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Traditional Chinese Medicine and Pharmacy 2008;14(10):
38–9.
Zhang 2008b {published data only}
Zhang H. Integrated treatment to threatened miscarriage
and the effects on estrogen levels. Journal of Sichuan of
Traditional Chinese Medicine 2008;26(1):88–9.
Zhong 2002 {published data only}
Zhong DM, Jiang HZ. Jian Pi Gu Shen therapy for 90 cases
of threatened miscarriage. Traditional Chinese Medicine
Research 2002;15(4):24–6.
Zhou 2010 {published data only}
Zhou BQ. An Tai decoction for threatened miscarriage.
Chinese Journal of Ethnomedicine and Ethnopharmacy 2010;
16:168.
References to studies excluded from this review
Bi 2010 {published data only}
Bi LM. Outcomes of integreated medicines for threatened
miscarriage. Chinese Community Physician 2010;17:99.
Chan 2010 {published data only}Chen M. Integrated medicines for theatened miscarriage.
Chinese journal of ethnomedicine and ethnopharmacy 2010;
15:196–8.
Gao 2011 {published data only}
Gao J, Luo SP. Clinical observation of Shoutai pills for
treatment of early threatened abortion. Journal of New
Chinese Medicine 2011;43(8):81–3.
Guo 2010 {published data only}
Guo YQ, Jiao LM. Integrated medicines for early threatened
miscarriage. He Nan Journal of Traditional Chinese Medicine
2010;30(2):176–7.
Hu 2010b {published data only}
Hu YF, Zhang JM. Yun Kang decoction for threatened
miscarriage. Shan Xi Journal of Chinese Medicine 2010;41(330):49.
Li 2011 {published data only}
Li W. Integrated medicines for threatened miscarriage.
Chinese Journal of Coal Industry Medicine 2011;14(6):
885–6.
Lin 2010 {published data only}
Lin GQ. An Tai decoction for early threatened miscarriage.
Family Medicine 2010;9:665–6.
Lu 2007 {published data only}
Lu Z, Jin S, Chen H. Clinical observation on Chinese
integrative medicine in the treatment of threatened
abortion. China Medical Herald 2007;4(32):73–4.
Lu 2011b {published data only}Lu QB, Ren QL, Haung MH, Lu Y, Ni YY, Xu JY. Clinical
evaluation of An Zi mixture’s effects on treating threatened
abortion. Journal of Nan Jing Traditional Chinese Medicine
2011;27(5):414–7.
Lu 2011c {published data only}
Lu QY, Shen JH. Chinese medicines for threatened
miscarriage: 30 cases. Hu Nan Journal of Traditional Chinese
Medicine 2011;27(1):63–110.
Luo 2010 {published data only}
Luo LH, Gui P, Zhou AL. Shoutai pill combined with
western medicines for threatened miscarriage. Shen Zhen
Journal of Integrated Medicines 2010;20(1):51–2.
Qin 2010 {published data only}
Qin XR. Chinese medicines for early threatened miscarriage:
150 cases. Si Chuan Journal of Traditional Chinese Medicine
2010;28(12):88–90.
Ushiroyama 2006 {published data only}
Ushiroyama T, Araki R, Sakuma K, Nosaka S, Yamashita Y,
Kamegai H. Efficacy of the kampo medicine Xiong-Gui-
Jiao-Ai-Tang, a traditional herbal medicine, in the treatment
of threatened abortion in early pregnancy. American Journal
of Chinese Medicine 2006;34(5):731–40.
Wu 2010 {published data only}
Wu JF, Zhao HY. Integrated medicines for threatened
miscarriage. China Naturopathy 2010;8(1):44.
Zhang 2000 {published data only}
Zhang JF, Zhang YF, Liu GZ, Feng QJ. Clinical and
experimental study on Yun’an granule in treating threatened
abortion. Chinese Journal of Integrative Medicine. 2000;20
(4):251–4.
Zhang 2006 {published data only}
Zhang TT, Huang CM, Qin BF, Su LD, Dai DY. Treatment
to 140 cases of threatened miscarriage (kidney deficiency).
Shan Dong Journal of Chinese Medicine 2006;25(4):235–7.
Zhang 2011 {published data only}
Zhang Y. Hu tai decoction combined with western
medicines for threatened miscarriage. Shan Xi Journal of
Chinese Medicine 2011;32(11):1455–6.
References to studies awaiting assessment
Chen 1999 {published data only}
Chen SQ. Clinical observations on integrative medicines
for 480 cases of threatened miscarriage. Hu Nan Journal of
Traditional Chinese Medicine Mar. 1999;15(2):15.
Guan 2008 {published data only}
Guan HF. Combined Chinese medicines and Western
medicines for 50 cases of threatened miscarriages. Modern
Traditional Chinese Medicine Jul. 2008;28(4):26–7.
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17Chinese herbal medicines for threatened miscarriage (Review)
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C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Chen 2002
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 84 inpatients or outpatients from People’s Hospital of Ning Xia were recruited. Partici-
pants were all diagnosed as threatened miscarriage due to vaginal bleeding and abdomi-
nal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, including Chinese Dodder Seed 30
g; Himalayan Teasel Root, Chinese Taxillus Twig 20 g, and Donkey-hide Glue 15 g
2) Formula changes• Qi deficiency: Pilose Asiabell Root, Mongolian Milkcetch Root 15 g each; and
Liquorice Root 6 g were added.
• Blood deficiency: Chinese Angelica, and White Paeony Root 10 g were added.
• Blood heat: Baical Skullcap Root 10 g was added.
• Yin deficiency: Rehmannia Root 15 g, Glossy privet fruit 10 g, and Yerbadetajo
Herb 10 were added.
• Severe vomiting: tangerine peel 10 g, Villous Amomrum Fruit 10 g, and Perilla
Stem 10 g were added.
• Spleen deficiency: Largehead Atractylodes Rhizome 10 g was added.
• Severe bleeding: Hairyvein Agrimonia 15 g, Chinese Arborvitae Twig 12 g,
Dragon Bone 30 g, and Fortune Windmillpalm 10 g were added.
3) Decoction: po, BID until 12 weeks or 5 months of pregnancy
4) Western medicines were received at the same time, including HCG 2000 U, im, qd;progesterone 20~40 mg, im, bid; vitamin E 100 mg, po, qd; folic acid 5 mg, po, tid;
Salbutamol sulfate 2 pills, po, tid; 25% magnesium sulfate 60 ml ivgtt
Control group was treated with Western medicines alone.
Same as above, HCG 2000U, im, qd; progesterone 20~40 mg, im, bid; vitamin E 100
mg, po, qd; folic acid 5 mg, po, tid; Salbutamol Sulfate 2 pills, po, tid; 25% magnesium
sulfate 60 mL ivgtt
Outcomes Symptoms subsided and pregnancy maintained until del ivery were considered as effec-
tive. The effectiveness rate of combined medicines group was 96.07%, and Western
medicines group was 69.69% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
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Chen 2002 (Continued)
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detectionbias)
All outcomes
High risk Blinding of participants and clinicians wasnot feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Chen 2003
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 83inpatientsfromAffiliatedHospitalofHengDongNurse School wererecruited(1999-
2002). Participants were all diagnosed as threatened miscarriage due to vaginal bleeding
and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Tai Shan Pan Shi Yin, including Pilose Asiabell
Root 12 g, Mongolian Milkcetch Root 10 g, Largehead Atractylodes Rhizome 10 g,
Liquorice Root 5 g, Chinese Angelica 12 g, Szechuan Lovage Rhizome 3 g, White Paeony
Root 9 g, Steamed Rehmannia Root 12 g, Himalayan Teasel Root 10 g, Baical SkullcapRoot 8 g, and Villous Amomrum Fruit 3 g
2) Formula changes
• Heat excess: Villous Amomrum Fruit was removed and Baical Skullcap Root was
increased to 16 g.
3) Decoction: po, bid.
4) Western medicines were received at the same time, including HCG 1000 U, im, qd
till bleeding stopped; vitamin E 20 mg, po, tid
Control group was treated with Western medicines alone. Same as above, HCG 1000U,
im, qd till bleeding stopped; vitamin E 20 mg, po, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 93.33%, and Western medicines group was 76.
32% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
19Chinese herbal medicines for threatened miscarriage (Review)
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Chen 2003 (Continued)
Random sequence generation (selection
bias)
High risk “Randomised into two groups by visiting
sequence.”
Allocation concealment (selection bias) High risk “Randomised into two groups by visiting
sequence.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported (but the participants were allo-
cated according to attending sequence and
therewas a gap betweenthe numbers of the
2 groups). It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Cui 2002
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 70 inpatients or outpatients from Affiliated Hospital of Shan Xi Chinese MedicineCollege were recruited (1995 March-2000 December). Participants were all diagnosed
as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) Tai Er An decoction: mainly used Chinese Taxillus Twig, Chinese Dodder Seed,
Himalayan Teasel Root, 15 g each; Cattail Pollen, Trogopterus Dung 9 g each; Danshen
Root, Villous Amomrum Fruit, Perilla Stem, Donkey-hide Glue, White Paeony Root
10 g each; and Liquorice Root 6 g
2) Decoction: po, TID.
The Western medicines group used progesterone 20 mg, im, qd; 3 days as a course,
usually 5 courses
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 98%, and Western medicines group was 65% (P < 0.
05)
Notes RCT with 2 arms.
Risk of bias
20Chinese herbal medicines for threatened miscarriage (Review)
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Cui 2002 (Continued)
Bias Authors’ judgement Support for judgement
Random sequence generation (selectionbias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
Low risk Single blinding was reported in this study,
but the review authors doubt if it was a real
single-blinding, as the study author did not
report the detailed method of blinding of
participant
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Deng 2009
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 200 participants at the Department of Obstetrcis and Gynaecology, Chinese Medicine
Hospital of Foshan (Guangzhou, China) were recruited. Participants were all diagnosed
as threatenedmiscarriageby HCGand ultrasound examination, and suffered withvaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula: included Donkey-hide Glue, Pilose Asiabell Root,
White Paeony Root, Himalayan Teasel Root 15 g each; Prepared Rhizome of Adhesive
Rehmannia, Chinese Taxillus Twig, 20 g each; Chinese Dodder Seed 30 g; and Chinese
Mugwort leaf and Liquorice Root 10 g each
2) Formula changes
• Significant low back pain: Eucommia Bark 15 g was added, Chinese Taxillus Twig
was increased to 30 g.• Hard stool: Desertliving Cistanche 10 g was added.
• Combined with habitual miscarriage: Lotus Seed, and Ramie Root 10 g were
added.
3) Decoction: po, qd
4) Western medicines were received at the same time, including HCG 1000U, im, qd
for 10 days then decline the dosage; vitamin E 100 mg, po, tid; folic acid 0.4 mg, qd
Control group was treated with Western medicines alone. Same as above, HCG 1000U,
21Chinese herbal medicines for threatened miscarriage (Review)
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Deng 2009 (Continued)
im, qd for 10 days then decline the dosage; vitamin E 100 mg, po, tid; folic acid 0.4 mg,
qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided and pregnancy main-
tained were considered as effective. The effectiveness rate of combined medicines group
was 95% while Western medicines group was 72% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Feng 1997
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 108 outpatients from Second Affiliated Hospital of Hunan University of Chinese
Medicine were recruited (1995 January-1996 Novenber). Participants were all diagnosed
as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed 30
g, Himalayan Teasel Root 20 g, Chinese Taxillus Twig 20 g, Donkey-hide Glue 10 g;
Pilose Asiabell Root, White Paeony Root, Himalayan Teasel Root 15 g each; Prepared
Rhizome of Adhesive Rehmannia, Chinese Taxillus Twig 20 g each; Chinese Dodder
Seed 30 g; and Chinese mugwort leaf and Liquorice Root 10 g each
2) Formula changes
22Chinese herbal medicines for threatened miscarriage (Review)
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Feng 1997 (Continued)
• Qi deficiency: Pilose Asiabell Root 15 g, Mongolian Milkcetch Root 15 g, and
Liquorice Root 6 g were added.
• Blood deficiency: Chinese Angelica 10 g and White Paeony Root 10 g were added.
• Blood heat: Baical Skullcap Root 10 g was added.
• Yin deficiency: Rehmannia Root 15 g, Glossy Privet Fruit 10 g, and Yerbadetajo
Herb 10 g were added.
• Increased vomiting: Tangerine Peel 10 g, Villous Amomrum Fruit 10 g, and
Perilla Stem 10 g were added.
• Spleen deficiency: Largehead Atractylodes Rhizome 10 g was added.
• Increased bleeding: Herb of Hairyvein Agrimonia 15 g, Chinese Arborvitae Twig
10 g, Dragon Bone 30 g were added.
3) Decoction: po, QOD.
4) Western medicines were received at the same time, including vitamin E, folic acid,
progesterone (regular dosage but not listed in the study)
Control group was treated with Western medicines alone. Same as above, vitamin E,
folic acid, progesterone (regular dosage but not listed in the study)
Outcomes Symptoms subsided and pregnancy maintained till delivery were considered as effective.
The effectiveness rateof combined medicinesgroup was 95.08%, and Westernmedicines
group was 70.21% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
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Feng 2010a
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 202 outpatients from Chinese Medicine Hospital of Shi Jia Zhuang were recruited.Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Chinese herbal medicine group:
1) Bu Shen An Tai decoction: mainly used Chinese Taxillus Twig, Chinese Dodder Seed,
Himalayan Teasel Root, Milkvetch Root, Pilose Asiabell Root, Eucommia Bark, 15 g
each; Medicinal Cornel Fruit, Yerbadetajo Herb, 12 g each; Donkey-hide Glue, Glossy
Privet Fruit, 10 g each; Morinda Root 9 g
2) Decoction: po, BID.
The Western medicines group used dydrogesterone 4 pills, po, once, then 1 pill, po,
TID; till 3 days after bleeding stopped
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 87.5%, and Western medicines group was 77% (P < 0.
01). ?-HCG significantly increased (P < 0.01) while CA-125 significantly decreased (P
< 0.01)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selectionbias) Unclear risk “the patients were randomized divided into2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
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Feng 2010b
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 78 outpatients from Chinese Medicine Hospital of Shi Jia Zhuang were recruited. Par-ticipants were all diagnosed as threatened miscarriage due to vaginal bleeding and ab-
dominal pains
Interventions Chinese herbal medicine group:
1) Bu Shen An Tai decoction: mainly used Chinese Taxillus Twig, Chinese Dodder Seed,
Himalayan Teasel Root, Milkvetch Root, Pilose Asiabell Root, Eucommia Bark, 15 g
each; Medicinal Cornel Fruit, Yerbadetajo Herb, 12 g each; Donkey-hide Glue, Glossy
Privet Fruit, 10 g each; Morinda Root 9 g
2) Decoction: po, BID.
The Western medicines group used dydrogesterone 4 pills, po, once, then 1 pill, po,
TID; till 3 days after bleeding stopped
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 87.5%, and Western medicines group was 76.3% (P <
0.01). CA-125 significantly decreased (P < 0.01)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
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Fu 2006
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 87 inpatients from First Affiliated Hospital of Zhong Shan University were recruited(2004 May-2006 May). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Si Wu soup, included Steamed Rehmannia Root
12 g, Chinese Angelica 9 g, White Paeony Root 9 g, Szechuan Lovage Rhizome 6 g;
Donkey-hide Glue, Pilose Asiabell Root, White Paeony Root, Himalayan Teasel Root
15 g each; Prepared Rhizome of Adhesive Rehmannia, Chinese Taxillus Twig 20 g each;
Chinese Dodder Seed 30 g; and Chinese Mugwort Leaf and Liquorice Root 10 g each
2) Formula changes
• Kidney deficiency: Chinese Dodder Seed 15 g, Chinese Taxillus Twig 15 g,
Himalayan Teasel Root 15 g, and Donkey-hide Glue 10 g were added; Szechuan
Lovage Rhizome was decreased (no information on the dosage).
• Qi deficiency: Pilose Asiabell Root 30 g, Mongolian Milkcetch Root 15 g,
Donkey-hide Glue 10 g, and Villous Amomrum Fruit 6 g were added.
• Blood deficiency: Chinese Angelica was increased to 18 g, Szechuan Lovage
Rhizome was removed, Donkey-hide Glue 15 g, Himalayan Teasel Root 15 g, and
Chinese Taxillus Twig 15 g were added.
• Blood heat: Szechuan Lovage Rhizome removed, Rehmannia Root 15 g replaced
Steamed Rehmannia Root, Dwarf Lilyturf Tuber, and Cochinchinese Asparagus Root
15 g, Donkey-hide Glue 10 g, and Ramie Root 20 g were added.
3) Decoction: po, QD.
4) Western medicines were received at the same time, including progesterone 10 mg,
im, qd; HCG 2000 U, im, qd; Allylestrenol 5 mg, Ritodrine 10 mg, po, tid; vitamin C
100 mg, po, qd; folic acid 0.4 mg, tid
Control group wastreated withWesternmedicines alone. Same as above, progesterone 10
mg, im, qd; HCG 2000U, im, qd; Allylestrenol 5mg, Ritodrine 10mg, po, tid; vitamin
C 100 mg, po, qd; folic acid 0.4 mg, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 97.87%, and Western medicines group was 87.50%
(P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
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Fu 2006 (Continued)
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Hou 2010
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 75 inpatients from Women’s Hospital of Nan Jing were recruited (2008 Sep-2010 Feb)
. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
The Chinese medicine formula was Jianpi Huoxue Bushen Antai decoction, including
Milkvetch Root, Hairyvein Agrimonia Herb and Bud, 30 g each; White Paeony Root,
Ramie Root, Chinese Dodder Seed, 20 g each; Largehead Atractylodes Rhizome, Don-
key-hide Glue, Chinese Taxillus Twig, 15 g each; Himalayan Teasel Root, 10 g; Largetri-
foliolious Bugbane Rhizome, Chinese Angelica, Bitter Orange, Liquoric Root, 6 g each.?
Decoction: po, dosing was not listed in the study.
Western medicines were received at the same time, including HCG and progesterone;
vitamin K and P-aminomethyl Benzoic Acid (PAMBA) if necessary. Dosage and dosing
were not listed in the study
Control group was treated with Western medicines alone. Same as above, HCG and
progesterone; vitaminK and P-aminomethyl BenzoicAcid (PAMBA) if necessary. Dosage
and dosing were not listed in the study
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 94.1%, and Western medicines group was 62.
5% (P < 0.01)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
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Hou 2010 (Continued)
Random sequence generation (selection
bias)
Low risk “2:1 ratio randomization.”
Allocation concealment (selection bias) Low risk “2:1 ratio randomization.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-tween groups”
Hu 2010
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 68 inpatients and outpatients from Integrated Medicines Hospital of Wen Zhou were
recruited. Participants were all diagnosed as threatened miscarriage due to vaginal bleed-
ing and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicinesThe Chinese medicine formula was San Haung An Tai Yin, including Hairyvein Agri-
monia Herb and Bud, White Paeony Root, 30 g each; Milkvetch Root, Ramie Root,
Chinese Taxillus Twig, Chinese Dodder Seed, Himalayan Teasel Root, Szechwon Tang-
shen Root, 15 g each; Honeysuckle Flower, 12 g; Largehead Atractylodes Rhizome 10
g; Dock Root, 9 g; Liquoric Root, 5 g; Figwortflower Picrorhiza Rhizome, SanChi, 3 g
each
Decoction: po, bid, 15 days as a course.
4) Western medicines were received at the same time, including HCG 40 mg, im, qd,
15 days as a course
Control group was treated with Western medicines alone. Same as above, HCG 40 mg,
im, qd. 15 days as a course
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 88.24%, and Western medicines group was 64.
71% (P < 0.05). The dark area around gestational sac was significantly reduced (P < 0.
05)
Notes RCT with 2 arms.
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Hu 2010 (Continued)
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
Low risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
High risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Huang 2011
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 100 inpatients or outpatients from Integrated Medicines Hospital of Gui Zhou were
recruited (2008 Jul-2010 Dec). Participants were all diagnosed as threatened miscarriage
due to vaginal bleeding and abdominal pains (Luteal Phase Defect)
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, including Chinese Dodder Seed 30
g; Chinese Taxillus Twig, 20 g; Himalayan Teasel Root, 15 g; Largehead Atractylodes
Rhizome, Donkey-hide Glue, 10 g each; Liquoric Root, 6 g
2) Formula changes
• Abdominal pain: White Paeony Root 20 g; Eucommia Bark 15 g; Szechwon
Tangshen Root, 30 g were added.
• Blood deficiency: Medicinal Cornel Fruit, 20 g was added.• Vaginal bleeding: Garden Burnet Root, 30 g was added.
3) Decoction: po, bid, 10 days as a course.
4) Western medicines were received at the same time, including HCG 2000 U, im, qd,
progesterone 20 mg, im, qd, vitamin E, 100 mg, po, qd, folic acid, 0.4 mg, po, qd
Control group was treated with Western medicines alone. Same as above, HCG 2000
U, im, qd, progesterone 20 mg, im, qd, vitamin E, 100 mg, po, qd, folic acid, 0.4 mg,
po, qd
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Huang 2011 (Continued)
Both groups had standard care for pregnancy (prohibit sexual activity, bed rest, and
psychotherapy)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 96%, and Western medicines group was 80% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Kuang 2007
Methods Randomised c ontrolled t rial of comparisonsa mong c ombined medicines, C hineseherbal
medicines alone, and Western medicines alone
Participants 180 inpatients or outpatients from Second Affiliated Hospital of Hunan University of
Chinese Medicine were recruited (2004 May-2006 May). Participants were all diagnosed
as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) mainly used Pilose Asiabell Root 10 g, Mongolian Milkcetch Root, White Paeony
Root,IndianBueadand TuberFleeceflower Root10 g each;Prepared rhizome of Adhesive
Rehmannia, Chinese Dodder Seed, Himalayan Teasel Root and Chinese Taxillus Twig
15 g each; and Liquorice Root 5 g
2) Formula changes
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Kuang 2007 (Continued)
• vaginal bleeding: Cuttlefish bone 30 g, Dark Plum Fruit 15 g and Tuber of
Hyacinth Bletilla 10 g were added, and prepared Himalayan Teasel Root before add
into the formula.
• dry mouth and hard stool: White Paeony Root was increased to 30 g, Liquorice
Root was increased to 10 g, and Chinese Thorowax Root, Baical Skullcap Root, Dwarf
Lilyturf Tuber and Root of Lobed Kudzuvine 10 g each were added.
3) 7-day as a course, and usually took 1-3 courses. (Details of administration were not
available.)
The Western medicines group used vitamin E capsules 0.1 g, po, BID; HCG 1000 U,
im, QD, then alternative injection after vaginal bleeding stopped
All 3 groups had standard care for pregnancy (prohibit sexual activity, psychotherapy,
and regulate ultrasound tests)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 68.3%, Western medicines group was 63.3%, and com-bined medicine group was 91.7%. Significant difference was found between combined
medicine and Chinese medicines or Western medicines alone (P < 0.05). No statistic
difference was found between Chinese herbal medicines and Western medicines groups
(P > 0.05)
Notes RCT with 3 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,“no significant difference wasfoundamong
groups”
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Li 2004
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 50 inpatients or outpatients from Affiliated Hospital of An Hui University of ChineseMedicine were recruited (1999 June-2003 December). Participants were all diagnosed
as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Bu Shen An Tai Yin, included Chinese Dodder
Seed, Eucommia Bark, Chinese Taxillus Twig, Himalayan Teasel Root, Heterophylly
FalsestarwortRoot, Mongolian MilkcetchRoot, LargeheadAtractylodes Rhizome, Baical
Skullcap Root, White Paeony Root, Steamed Rehmannia Root and Ramie Root, each
10 g
2) Formula changes (no information on the dosage)
• Blood heat: Baical Skullcap Root was increased.
• Kidney deficiency: Chinese Dodder Seed was increased.
3) Decoction: po, bid, 10 days as a course.
4) Western medicines were received at the same time, including progesterone 10 mg,
im, qd; vitamin E 100 mg, po, qd; folic acid 5 mg, tid
Control group was treated with Western medicines alone. Same as above, progesterone
10 mg, im, qd; vitamin E 100 mg, po, qd; folic acid 5 mg, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 96%, and Western medicines group was 80% (P < 0.
05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “Layered method”, but no further informa-
tion was available.
Allocation concealment (selection bias) Low risk “Layered method”, but no further informa-
tion was available.
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
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Li 2004 (Continued)
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Li 2005
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 90 inpatients from First Affiliated Hospital of Guang Zhou University of Chinese
Medicine were recruited (2003 April-2004 June). Participants were all diagnosed as
threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed15 g, Chinese Taxillus Twig 15 g, Himalayan Teasel Root 15 g, Donkey-hide Glue 10
g, Pilose Asiabell Root 15 g, Mongolian Milkcetch Root 15 g, Largehead Atractylodes
Rhizome 10 g, White Paeony Root 15 g, and Liquorice Root 5 g
2) Formula changes
• Increased bleeding: Baical Skullcap Root, Lotus Rhizome Node and Garden
Burnet Root, each 10 g were added.
• Low back pain: Eucommia Bark and Palmleaf Raspberry Fruit, each 10 g were
added.
• Stool dehydration: Desertliving Cistanche and Mulberry Fruit, each 10 g were
added.
3) Decoction: po, BID.
4) Western medicines were received at the same time, including vitamin E 50 mg, po,
bid; folic acid 0.4 mg, po, qd; HCG 2000 U, im, qd; Allylestrenol, 5 mg, po, tid, if witha history of over twice habitual miscarriage
Control group was treated with Western medicines alone. Same as above, vitamin E 50
mg, po, bid; folic acid 0.4 mg, po, qd; HCG 2000 U, im, qd; Allylestrenol, 5 mg, po,
tid, if with a history of over twice habitual miscarriage
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 95%, and Western medicines group was 76.67% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
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Li 2005 (Continued)
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Li 2006
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 89 inpatients or outpatients from Affiliated Hospital of Guang Xi College of Chinese
Medicine wererecruited(2003 January-2005September). Participantswere all diagnosed
as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Bu Shen Gu Tai soup, included Chinese Dodder
Seed 30 g, Barbary Wolfberry Fruit 30 g, Chinese Taxillus Twig 20 g, Himalayan Teasel
Root 20 g; Pilose Asiabell Root 30 g; Common Yam Rhizome 15 g, Eucommia Bark 20
g, White Paeony Root 20 g, and Liquorice Root 5 g
2) Formula changes• Dry mouth: Glossy privet fruit 15 g and Yerbadetajo Herb 20 g were added.
3) Decoction: po, BID, for 10 days.
4) Western medicines were received at the same time, including HCG 2000 U and
progesterone 20 mg, im, qod for 10 days
Control group was treated with Western medicines alone. Same as above, HCG 2000U
and progesterone 20 mg, im, qod for 10 days
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 77.78%, and Western medicines group was 70.50%
(P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk Randomised number table.
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Li 2006 (Continued)
Allocation concealment (selection bias) Low risk Randomised number table.
Blinding (performance bias and detectionbias)
All outcomes
High risk Blinding of participants and clinicians wasnot feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported . No losses were
reported forthe main outcomes, butfor the
secondary outcomes of this trial the level of
losses to follow up was high and the data
for these outcomes would not be included
in the review. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,“no significant difference was found be-
tween groups”
Li 2009a
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 138 inpatients or outpatients from Zhao Qing People’s Hospital were recruited (2004
May-2006 May). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed 20
g, Himalayan Teasel Root 15 g, Chinese Taxillus Twig 15 g, Pilose Asiabell Root 15 g,
Donkey-hide Glue 10 g, Largehead Atractylodes Rhizome 12 g, Steamed Rehmannia
Root 12 g, Common Macrocarpium Fruit 10 g, White Paeony Root 15 g, Eucommia
Bark 15 g, and Liquorice Root 6 g
2) Formula changes
• Bleeding: Fineleaf Schizonepeta Herb 10 g, Garden Burnet Root 10 g were added.
• Yin deficiency: Pilose Asiabell Root replaced by Heterophylly Falsestarwort Root,
Baical Skullcap Root were added.
• Qi deficiency: Pilose Asiabell Root 30 g was added.
• Vomiting: Villous Amomrum Fruit, Pinellia Tuber and Bamboo Shavings were
added.• Stool dehydration: Desertliving Cistanche and Hemp Fruit were added.
3) Decoction: po, BID, 7 days as a course.
4) Western medicines were received at the same time, including HCG 2000 U, im, qod,
progesterone 20 mg, im, qd
Control group was treated with Western medicines alone. Same as above, HCG 2000U,
im, qod, progesterone 20 mg, im, qd
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Li 2009a (Continued)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 93.1%, and Western medicines group was 80.3% (P< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Li 2009b
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 189 inpatients from Wu Yi Chinese Medicine Hospital were recruited (2005 September-
2007September). Participants wereall diagnosedas threatened miscarriagedue to vaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed 15g, Himalayan Teasel Root 10 g, Chinese Taxillus Twig 15 g, Donkey-hide Glue10 g,
Baical Skullcap Root 6 g, Pilose Asiabell Root 15 g, Largehead Atractylodes Rhizome 12
g, White Paeony Root 15 g, and Liquorice Root 6 g
2) Formula changes
• Vomiting: Bamboo Shavings 6 g, Villous Amomrum Fruit 6 g and Perilla Stem 6
g were added.
• Bleeding: Ramie Root 15 g and Hairyvein Agrimonia 15 g were added.
• Low back pain: Eucommia Bark 10 g and Barbary Wolfberry Fruit 15 g were
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Li 2009b (Continued)
added.
• Stool dehydration: Hemp Fruit 15 g and Desertliving Cistanche 10 g were added.
3) Decoction: details not provided.
4) Western medicines were received at the same time, including vitamin E 50 mg, po,
bid; folic acid, 0.4 mg, po, qd; HCG 2000 IU, im, qd
Control group was treated with Western medicines alone. Same as above, vitamin E 50
mg, po, bid; folic acid, 0.4 mg, po, qd; HCG 2000 IU,im, qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 91.75%, and Western medicines group was 75% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
(In its English abstract, it reported with
“randomly divided”. But in Chinese ver-
sion no information regarding this was pro-
vided.)
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
(In its English abstract, it reported with
“randomly divided”. But in Chinese ver-
sion no information regarding this was pro-vided.)
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-tween groups”
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Li 2010
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 268 inpatients and outpatients from Chinese Medicines Hospital of An Yang were re-cruited. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding
and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula included Chinese Dodder Seed, Chinese Taxillus
Twig, 15 g each; Himalayan Teasel Root, Largehead Atractylodes Rhizome, Donkey-
hide Glue, Szechwon Tangshen Root, Villous Amomum Fruit, 10 g each
2) Formula changes
• Abdominal pain: White Paeony Root 15~30 g; Liquoric Root 6 g were added.
• Low back pain: Eucommia Bark 10 g was added.
• Dry mouth: Baical Skullcap Root 15 g, Cape Jasmine Fruit 10 g were added.
3) Decoction: po, bid for 2 weeks.
4) Western medicines were received at the same time, including HCG 2000 U, im, qod,
progesterone, 20 mg, im, qod for 2 weeks
Control group was treated with Western medicines alone. Same as above, HCG 2000
U, im, qod, progesterone, 20 mg, im, qod for 2 weeks
Both groups had standard care for pregnancy (prohibit sexual activity and bed rest)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 92.14%, and Western medicines group was 72.
66% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
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Li 2010 (Continued)
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Liu 2008
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 90 outpatients from Shan Xi Service Centre for Pregnancy were recruited (2006 June-
2007 October). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines.
1) The Chinese medicine formula was given according to different subtype of diagnosisof threatened miscarriage
i. Kidney deficiency subtype: used Shou Tai Pill, included Chinese Dodder Seed 12 g,
Chinese Taxillus Twig 12 g, Himalayan Teasel Root 12 g, Donkey-hide Glue 9 g, Pilose
Asiabell Root 9 g, and Mongolian Milkcetch Root 9 g
ii. Qi deficiencysubtype: usedTaiYuan Yin,includedPilose Asiabell Root9 g, Mongolian
Milkcetch Root 9 g, Largehead Atractylodes Rhizome 9 g, Chinese Angelica 6 g, White
Paeony Root 12 g, Chinese Taxillus Twig 12 g, and Villous Amomrum Fruit 6 g
iii. Trauma subtype: used Sheng Yu Soup, included Chinese Angelica 6 g, Szechuan
Lovage Rhizome 3 g, White Paeony Root 12 g, Rehmannia Root 9 g, Pilose Asiabell
Root 9 g, and Mongolian Milkcetch Root 9 g
iv. Blood heat: used Bao Yin Jian, included Rehmannia Root 9 g, Mongolian Milkcetch
Root 12 g, Bark of Chinese Corktree 9 g, and White Paeony Root 9 g
2) Decoction: po, QD.3) Western medicines were received at the same time, including progesterone 20 mg,
im, and vitamin E 100 mg, po, tid
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, and vitamin E 100 mg, po, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained at 12 weeks were considered as effective. The ef-
fectiveness rate of combined medicines group was 91.4%, and Western medicines group
was 75.5% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
High risk “Randomization according to visiting date.
”
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Liu 2008 (Continued)
Allocation concealment (selection bias) High risk “Randomization according to visiting date.
”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Liu 2009
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 45 outpatients from Shen Zhen Women’s Hospital were recruited (2006 August-2007
September). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) mainly used Chinese Dodder Seed, Chinese Taxillus Twig, Pilose Asiabell Root each
20 g; Himalayan Teasel Root, Donkey-hide Glue, Largehead Atractylodes Rhizome,Herb of Hairyvein Agrimonia each 15 g; Villous Amomrum Fruit, Rhizome of East
Asian Tree Fern each 10 g, and Liquorice Root 5 g
2) Decoction: po, BID for 2 weeks.
The Western medicines group used progesterone 20 mg, im, qd; HCG 2000 U, im, qod
for 2 weeks
Both groups had standard care for pregnancy (prohibit sexual activity, psychotherapy,
and regulate ultrasound tests)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of combined medicines group was 90%, and Western medicines group was 66.7% (P <
0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
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Liu 2009 (Continued)
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Liu 2011a
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 155 outpatients from Chinese Medicine Institute of Shan Xi were recruited (2008 Jun-
2010 Dec). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) Bao Tai decoction: mainly used Szechwon Tangshen Root, Milkvetch Root, 15 g;Chinese Dodder Seed,Chinese Taxillus Twig, WhitePaeony Root, 12 g each; Himalayan
Teasel Root, Donkey-hide Glue, Largehead Atractylodes Rhizome, India Mustard Seed,
10 g each
2) Decoction: po, BID for 2 weeks.
The Western medicines group used progesterone 100 mg, po, qd for 2 weeks
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 93.5%, and Western medicines group was 83.3% (P <
0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
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Liu 2011a (Continued)
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Liu 2011b
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 100 inpatients and outpatients from People’s Hospital of Xing Tai were recruited (2009
Jan-2012 Jan). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) Bao Tai decoction: mainly used Milkvetch Root, Ramie Root, 30 g; Hairyvein Agri-
monia Herb and Bud, Chinese Taxillus Twig, 24 g; Glossy Privet Fruit, 18 g; Himalayan
Teasel Root, Chinese Dodder Seed, Eucommia Bark, Giant St.John’swort Herb, Medici-nal Cornel Fruit, Fortune Windmillpalm Petiole, Gordon Euryale Seed, 15 g; Largehead
Atractylodes Rhizome, Largetrifoliolious Bugbane Rhizome , 10 g each
2) Decoction: po, BID, 7 days as a course till symptoms subsided
The Western medicines group used progesterone 20 mg, im, qd; vitamin E, 100 mg, po,
TID, 7 days as a course till symptoms subsided
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 80%, and Western medicines group was 72% (P < 0.
05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
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Liu 2011b (Continued)
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Lu 2011
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 200 inpatients from Chinese MedicinesHospital of Ning Bo were recruited. Participants
were all diagnosed as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula included Chinese Dodder Seed, Eucommia Bark,
Glossy Privet Fruit, Chinese Taxillus Twig, 100 g each; Medicinal Cornel Fruit, 50 g
2) Decoction: external use at Yong Quan acu-point, qd.3) Western medicines (hormone treatment) were received at the same time, details were
not listed in this study
Control group was treated with Western medicines alone. Same as above, hormone
treatment but details were not listed in this study
Outcomes Symptoms subsided and pregnancy maintained till delivery were considered as effective.
The effectiveness rate of combined medicines group was 95.2%, and Western medicines
group was 78.2% (P < 0.01)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
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Lu 2011 (Continued)
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
Low risk Single blinding was reported in this study,
but the review authors doubt if it was a real
single-blinding, as the study author did not
report the detailed method of blinding of
participant
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Lv 2007
Methods Randomised controlledtrials of combined medicines(Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 98 inpatients from Tian Jin Chinese Medicine University were recruited (2004 May-
2006 May). Participants were all diagnosed as threatened miscarriage due to vaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula: included Chinese Dodder Seed 20 g, Himalayan
TeaselRoot, Chinese Taxillus Twig,PiloseAsiabell Root, Common Yam Rhizome each15
g, Largehead Atractylodes Rhizome 12 g, Common Macrocarpium Fruit 10 g, Steamed
Rehmannia Root 10 g, and Liquorice Root 6 g
2) Formula changes
• Bleeding: Donkey-hide Glue, Baical Skullcap Root and Ramie Root were added.
• Abdomen pain: White Paeony Root was added.
• Blood Hhat: Baical Skullcap Root was added.
• Insomnia: Spina Date Seed was added.
• Low back pain: Eucommia Bark was added.
• Vomiting: Villous Amomrum Fruit was added.
3) Decoction: po, QD.4) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; vitamin E 100 mg, po, tid
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; vitamin E 100 mg, po, tid
Outcomes Symptoms subsided and pregnancy maintained till delivery were considered as effective.
The effectiveness rateof combined medicinesgroup was 91.38%, and Westernmedicines
group was 70% (P < 0.05)
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Lv 2007 (Continued)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
She 2008
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-ern medicines) compared with Western medicines alone
Participants 100 inpatients oroutpatients from ChineseMedicine Hospital of Gui Lin wererecruited.
Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed 15
g, Chinese Taxillus Twig 10 g, Himalayan Teasel Root 10 g, Donkey-hide Glue 10 g,
Pilose Asiabell Root 20 g, and Largehead Atractylodes Rhizome 15 g
2) Formula changes
• Qi and blood deficiency: Mongolian Milkcetch Root 15 g, Steamed Rehmannia
Root 10 g and White Paeony Root 10 g were added.
• Blood heat: Rehmannia Root 15 g, Baical Skullcap Root 12 g and Bark of
Chinese Corktree 6 g were added.
3) Decoction: po, BID, 10 days as a course.
4) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; HCG 2000 U, im, qod; vitamin E 100 mg, po, qd; folic acid 0.4 mg, qd
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; HCG 2000U, im, qod; vitamin E 100 mg, po, qd; folic acid 0.4 mg, qd
45Chinese herbal medicines for threatened miscarriage (Review)
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She 2008 (Continued)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 93.3%, and Western medicines group was 70%(P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Shen 2010
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 120 inpatients or outpatients from Chinese Medicines Hospital of Dong Tai were re-
cruited. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding
and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill and Bu Shen Jian Pi Gu Chong decoction, including Chinese Dodder Seed, 20 g; ?Chinese Taxillus Twig, Himalayan
Teasel Root, 15 g each; Largehead Atractylodes Rhizome, Szechwon Tangshen Root,
Donkey-hide Glue, Wingde Yan Rhizome, 10 g each; Liquorice Root 6 g
2) Formula changes
• Bleeding: Ramie Root 15 g, Garden Burnet Root 10 g were added.
• Low back pain: Eucommia Bark, Palmleaf Raspberry Fruit, 10 g each were added.
3) Decoction: po, bid.
4) Western medicines were received at the same time, including HCG 10 mg, im, qd;
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Shen 2010 (Continued)
vitamin E 100 mg, po, qd; 7 days as a course
Control group was treated with Western medicines alone. Same as above, HCG 10 mg,
im, qd; vitamin E 100 mg, po, qd; 7 days as a course
Both groups had standard care for pregnancy (bed rest and regulate ?-HCG and ultra-
sound tests)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 91%, and Western medicines group was 80% (P
< 0.01)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Song 2005
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 243 outpatients fromNing Xia Women’s Hospital were recruited(2001 May-2003 May)
. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Chinese herbal medicine group:
1) Zhi Xue An Tai Yin: mainly used Himalayan Teasel Root, Chinese Dodder Seed,
Chinese Taxillus Twig, Perilla Stem, Villous Amomrum Fruit, White Paeony Root,
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Song 2005 (Continued)
Largehead Atractylodes Rhizome, Common Macrocarpium Fruit, Sharpleaf Galangal
Fruit, Mongolian Milkcetch Root, Heterophylly Falsestarwort Root, Chinese Arborvitae
Twig, Garden Burnet Root, India Madder Root, and Donkey-hide Glue 10 g each
2) Formula changes
• Heat sign: Baical Skullcap Root was added.
• Cold sign: Chinese Mugwort Leaf and Ginger each 6 g were added.
• Vomiting: Pinellia Tuber, Clove, Persimmon Calyx and Receptacle each 10 g, and
Ginger 6 g were added.
3) po, TID, for 7 days.
The Western medicines group used progesterone 20mg, im, qd; vitamin E 100 mg, po,
tid; vitamin K 8 mg, tid; An Luo Xue, 5 mg, po, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained (HCG normal and LH > 200 mLU/ml) were
considered as effective. The effectiveness rate of combined medicines group was76.98%,
and Western medicines group was 43.59% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detectionbias)
All outcomes
High risk Blinding of participants and clinicians wasnot feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Song 2007
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
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Song 2007 (Continued)
Participants 105 outpatients from Ning Xia Women’s Hospital were recruited (2005 October-2006
August). Participants were all diagnosed as threatened miscarriagedue to vaginal bleeding
and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Zhi Xue Bao Tai Yin, included Himalayan Teasel
Root, Chinese Dodder Seed, Chinese Taxillus Twig, Perilla Stem, Villous Amomrum
Fruit, White Paeony Root, Largehead Atractylodes Rhizome, Common Macrocarpium
Fruit, Sharpleaf Galangal Fruit, Mongolian Milkcetch Root, Heterophylly Falsestarwort
Root, Chinese Arborvitae Twig, Garden Burnet Root, India Madder Root, and Donkey-
hide Glue, 10 g each
2) Formula changes
• Heat sign: Baical Skullcap Root was added.
• Cold sign: Chinese Mugwort Leaf and Ginger each 6 g were added.
• Vomiting: Pinellia Tuber, Clove, Persimmon Calyx and Receptacle 10 g each, and
ginger 6 g were added.3) Decoction: po, TID, for 7 days.
4) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; vitamin E 100 mg, po, tid; vitamin K 8 mg, tid; An Luo Xue, 5 mg, po, tid
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; vitamin E 100 mg, po, tid; vitamin K 8 mg, tid; An Luo Xue, 5 mg, po,
tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations showed pregnancy maintained (HCG normal and LH increased) were consid-
ered as effective. The effectiveness rate of combined medicines group was 81.5%, and
Western medicines group was 43.1% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
High risk “Randomization according to first visit
date.”
Allocation concealment (selection bias) High risk “Randomization according to first visit
date.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
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Song 2007 (Continued)
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Sun 2003
Methods Randomised c ontrolled t rial of comparisonsa mong c ombined medicines, C hineseherbal
medicines alone, and Western medicines alone
Participants 105 inpatients or outpatients from Xiang Tan Chinese Medicine Hospital were recruited
(2004 May-2006 May). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) mainly used Heterophylly Falsestarwort Root 15 g, Mongolian Milkcetch Root 12g, Largehead Atractylodes Rhizome 10 g, White Paeony Root 15 g, Barbary Wolfberry
Fruit 15 g, Chinese Taxillus Twig 15 g, Himalayan Teasel Root 15 g, Chinese Dodder
Seed 15 g, Common Yam Rhizome 15 g, and Liquorice Root 6 g
2) Formula changes
• Severe bleeding: Garden Burnet Root 10 g and Yerbadetajo Herb 10 g were added.
• Blood heat: Mongolian Milkcetch Root removed, Baical Skullcap Root 6 g were
added.
• Abdomen pain: White Paeony Root 20-30 g and Largetrifoliolious Bugbane
Rhizmome 10 g were added.
• Vomiting: Perilla Stem 10 g, Bamboo Shavings 10 g and Tangerine Pee 16 g were
added.
3) po, BID, 5-day as a course, and usually 1-3 courses.
The Western medicines group used vitamin E 100 mg, po, tid; folic acid 0.4 mg, po,qd; HCG 1000 U, im, qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical examina-
tionsshowed pregnancy maintained wereconsidered as effective.The effectiveness rate of
Chinese medicines group was 94%, Western medicines group was 71%, and combined
medicine group was 98%. Significant difference was found between combined medicine
or Chinese medicines and Western medicines alone (P < 0.05). No statistic difference
was found between Chinese herbal medicines and combined medicines groups (P > 0.
05)
Notes RCT with 3 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
High risk “Randomization according to visit date.”
Allocation concealment (selection bias) High risk “Randomization according to visit date.”
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Sun 2003 (Continued)
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias High risk No information was provided on the bal-
ance of baseline.
Wang 2005
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-ern medicines) compared with Western medicines alone
Participants 140 outpatients fromHui An Chinese Medicine Hospital were recruited(2002 October-
2004September). Participants wereall diagnosedas threatened miscarriagedue to vaginal
bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Zhu Ma An Tai soup, included Ramie Root 30
g, Chinese Taxillus Twig 20 g, Himalayan Teasel Root 20 g, Chinese Dodder Seed 20 g,
Largehead Atractylodes Rhizome 10 g, Baical Skullcap Root 10 g, White Paeony Root
12 g, Rehmannia Root 15 g, Yerbadetajo Herb 30 g, and Liquorice Root 3 g
2) Formula changes
• Severe bleeding: Chinese Arborvitae Twig and root of Common Euscaphis wereadded.
• Severe vomiting: Bamboo Shavings and Villous Amomrum Fruit were added.
• Stool dehydration: Desertliving Cistanche and Platycladi Seed were added.
3) Decoction: po, QD.
4) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; HCG 2000 U, im, qod; vitamin E 100 mg, po, qd; folic acid 0.4 mg, qd, (add
Zhi Xue Min if bleeding hardly)
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; HCG 2000U, im, qod; vitamin E 100 mg, po, qd; folic acid 0.4 mg, qd,
(add Zhi Xue Min if bleeding hardly)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 95%, and Western medicines group was 50% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
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Wang 2005 (Continued)
Bias Authors’ judgement Support for judgement
Random sequence generation (selectionbias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Wang 2007
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 96 inpatients or outpatients from Nan Yang Chinese Medicine College were recruited
(2003 March-2006 March). Participants were all diagnosed as threatened miscarriage
due to vaginal bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) Bu Shen Gu Chong soup: mainly used Chinese Dodder Seed 30 g, Himalayan Teasel
Root 15 g, Chinese Taxillus Twig 30 g, Largehead Atractylodes Rhizome 18 g, Donkey-
hide Glue 10 g, Eucommia Bark 15 g, White Paeony Root 15 g, Pilose Asiabell Root 30
g, Fineleaf Schizonepeta Herb 9 g, and Liquorice Root 6 g
2) Formula changes
• QI deficiency: Pilose Asiabell Root removed, Heterophylly Falsestarwort Root
and Mongolian Milkcetch Root, each 30 g were added.
• Severe bleeding: Herb of Hairyvein Agrimonia 30 g, Male Fern Rhizome 15 g and
Garden Burnet Root 30 g were added.
• Vomiting: Villous Amomrum Fruit 8 g and Perilla Stem 9 g were added.
• Heat sign: Baical Skullcap Root 9 g and Ramie Root 30 g were added.
• Abdomen pain: White Paeony Root 30 g was added.
3) po, BID, 7-day as a course.
The Western medicines group used HCG 1000U, im, qd, 7 day as a course
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 95.8%, and Western medicines group was 89.
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Wang 2007 (Continued)
5% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Wang 2010
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-ern medicines) compared with Western medicines alone
Participants 110 outpatients from He Nan Population Institute were recruited (2007 Jan-2009 Dec)
. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Chinese herbal medicine group:
1) Yi Shen An Tai decoction: mainly used Chinese Dodder Seed, Chinese Taxillus Twig,
15 g each; Largehead Atractylodes Rhizome, Himalayan Teasel Root, Baical Skullcap
Root, Donkey-hide Glue, Szechwon Tangshen Root, 10 g each; Liquoric Root, 6 g
2) Formula changes
• Bleeding: Garden Burnet Root 12 g, Argy Wormwood Leaf 6 g were added.
• Abdominal pain: White Paeony Root 15g was added.• Vomiting: Bamboo Shavings 10 g, Pinellia Tuber 6 g, Villous Amomum Fruit 6 g
were added.
• Low back pain: Eucommia Bark 12 g was added.
• Vexation: Lancelesf Lily Bulb 15 g was added.
3) Decoction: po, BID till the 12th week of gestation.
The Western medicines group used HCG 2000 U, im, qod, progesterone 20 mg, im,
qd, vitamin E, 100 mg, po, bid, folic acid, 0.4 mg, po, qd; till the 12th week of gestation.
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Wang 2010 (Continued)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 81.82%, and Western medicines group was 58.18% (P< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-tween groups”
Wang 2011
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 225 outpatients from Xi Dian Company Hospital of Shan Xi were recruited (2010 Jan-
Dec). Participants were all diagnosed as threatened miscarriage due to vaginal bleeding
and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines1) TheChinese medicine formula was Gu Shen An Tai Pill, includingLargehead Atracty-
lodes Rhizome, Chinese Dodder Seed, Chinese Taxillus Twig, White Paeony Root,
Rehmannia Root, Himalayan Teasel Root, Tuber Fleeceflower Root, Baical Skullcap
Root, Gambir Plant, Desertliving Cistanche. Details of dosage were not listed in this
study
2) Decoction: po, tid, 2 weeks as a course.
3) Western medicines were received at the same time, including progesterone, 100mg,
po,qd; vitamin E 200 mg, po, tid; 2 weeks as a course
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Wang 2011 (Continued)
Control group was treated with Western medicines alone. Same as above, progesterone,
100mg, po,qd; vitamin E 200 mg, po, tid; 2 weeks as a course
Both groups had standard care for pregnancy (prohibit sexual activity, psychotherapy,
and regulate ultrasound tests)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 93.04%, and Western medicines group was 88.
18% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “Randomized number method”
Allocation concealment (selection bias) Low risk “Randomized number method”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Xiao 2008
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 60 inpatients from Xin Shao People’s Hospital were recruited (2005 October-2007 Oc-
tober). Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Yan Xue Yi Shen soup, included Chinese Dodder
Seed 10 g, Chinese Taxillus Twig 15 g, Himalayan Teasel Root 10 g, Eucommia Bark
15 g, Mongolian Milkcetch Root 20 g, Ginseng 10 g, Common Yam Rhizome 15 g,
White Paeony Root 15 g, Donkey-hide Glue 15 g, Steamed Rehmannia Root 10 g and
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Xiao 2008 (Continued)
Tangerine Peel l5 g
2) Decoction: po, BID
3) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; HCG 2000 U, im, qd for 10 days then decline the dosage; vitamin E 50 mg,
Ritodrine 10 mg, po, tid; folic acid 0.4 mg, QD, An Luo Xue, vitamin K, vitamin C if
bleeding hardly (no detailed administration)
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; HCG 2000U, im, qd for 10 days then decline the dosage; vitamin E 50
mg, Ritodrine 10 mg, po, tid; folic acid 0.4 mg, QD, An Luo Xue, vitamin K, vitamin
C if bleeding hardly (no detailed administration)
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 90%, and Western medicines group was 66.7%
(P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “Randomized number method.”
Allocation concealment (selection bias) Low risk “Randomized number method.”
Blinding (performance bias and detection
bias) All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Xu 2005
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 62 inpatients or outpatients from Affiliated Hospital of Zhe Jiang University were re-
cruited. Participants were all diagnosed as threatened miscarriage due to vaginal bleeding
and abdominal pains
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Xu 2005 (Continued)
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Yun Kang decoction. (Further information of
herbs and dosages were not available.)2) Decoction: 20 ml, po, BID, for 14 days.
3) Western medicines were received at the same time, including progesterone 40 mg,
im, qd; vitamin E 1 pill, po, qd
Control group was treated with Western medicines alone. Same as above, progesterone
40 mg, im, qd; vitamin E 1 pill, po, qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 90.6%, and Western medicines group was 86.
6% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Xun 2008
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 75 inpatients or outpatients from Jiang Su East West Medicine Hospital were recruited
(2004 May-2006 May). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
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Xun 2008 (Continued)
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula, included Pilose Asiabell Root 10 g, Mongolian
Milkcetch Root 10 g, Largehead Atractylodes Rhizome 10 g, White Paeony Root 10 g,Steamed Rehmannia Root 10 g, Chinese Taxillus Twig 12 g, Donkey-hide Glue 10 g,
and Tangerine Peel 10 g
2) Decoction: po, BID.
3) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; HCG 2000 U, im, qd, qod if vaginal bleeding stopped
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; HCG 2000U, im, qd, qod if vaginal bleeding stopped
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 93.3%, and Western medicines group was 80%
(P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detectionbias)
All outcomes
High risk Blinding of participants and clinicians wasnot feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Yang 2001
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 55 inpatients or outpatients from Jiang Xi Ning Dou Chinese Medicine Hospital were
recruited. Participants were all diagnosed as threatened miscarriage due to vaginal bleed-
ing and abdominal pains
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Yang 2001 (Continued)
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) TheChinese medicine formula wasShou Tai Pill, included Chinese Dodder Seed 30 g,
Chinese Taxillus Twig 12 g, Himalayan Teasel Root 12 g, Donkey-hide Glue 15 g, Pilose Asiabell Root 30 g, Largehead Atractylodes Rhizome 10 g, Common Yam Rhizome 15
g, and Liquorice Root 6 g
2) Decoction: po, QD.
3) Western medicines were received at the same time, including progesterone 20 mg,
im, qd; vitamin K 3 4 mg, po, bid.
Control group was treated with Western medicines alone. Same as above, progesterone
20 mg, im, qd; vitamin K 3 4 mg, po, bid.
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 90.5%, and Western medicines group was 61.
5% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detectionbias)
All outcomes
High risk Blinding of participants and clinicians wasnot feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
Yang 2006
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 150 inpatients or outpatients from Guang Zhou Qin Zhou Chinese Medicine Hospital
were recruited (2004 January-2006 May). Participants were all diagnosed as threatened
miscarriage due to vaginal bleeding and abdominal pains
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Yang 2006 (Continued)
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Jiao Ai soup, included Donkey-hide Glue 15 g,
Chinese Mugwort Leaf 12 g, Steamed Rehmannia Root 20 g, Szechuan Lovage Rhizome5 g, White Paeony Root 10 g, Chinese Angelica 10 g, and Liquorice Root 6 g
2) Formula changes
• Qi and blood deficiency: Mongolian Milkcetch Root 30 g and Pilose Asiabell
Root 20 g were added.
• Kidney deficiency: Chinese Taxillus Twig 15 g, Eucommia Bark 15 g, Himalayan
Teasel Root 15 g and Chinese Dodder Seed 15 g were added.
• Blood heat: Baical Skullcap Root 10 g was added.
• Adominal distension: Villous Amomrum Fruit 3 g and Tangerine Peel 6 g were
added.
3) Decoction: po, QD.
4) Western medicines were received at the same time, including HCG 1000 U, im, qd
for 10 days then decline the dosage; vitamin E 100 mg, po, tid; folic acid 0.4 mg, qd
Control group was treated with Western medicines alone. Same as above, HCG 1000U,im, qd for 10 days then decline the dosage; vitamin E 100 mg, po, tid; folic acid 0.4 mg,
qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 95%, and Western medicines group was 72% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “2:1 ratio randomization.”
Allocation concealment (selection bias) Low risk “2:1 ratio randomization.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Unclear risk No information was provided on the bal-
ance of baseline.
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Zeng 2011
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 118 inpatients and outpatients from Dong Keng Hospital of Dong Wan were recruited
(2009 Jun-2011 Feb). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Bu Shen Yang Xue Gu Qi decoction, including
Chinese Taxillus Twig, Eucommia Bark, White Paeony Root, Wingde Yan Rhizome,
Donkey-hide Glue, 15 g each; Chinese Dodder Seed, Steamed Rehmannia Root, Hi-
malayan Teasel Root, 10 g each; Milkcetch Root 20 g; Tangerine Peel, 5 g
2) Decoction: po, bid till 7 days after symptoms subsided.
3) Western medicines were received at the same time, including progesterone, 2 pills,
po, bid till 7 days after symptoms subsided
Control group was treated with Western medicines alone. Same as above, progesterone,2 pills, po, bid till 7 days after symptoms subsided
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 93.6%, and Western medicines group was 82.
0% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “the patients were randomized divided into
2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
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Zhang 2007
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 102 inpatients from Shan Dong Ji Nan Hospital were recruited (2004 May-2006 May). Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Chinese herbal medicine group:
1) Shou Tai Pill: mainly used Chinese Dodder Seed 10 g, Himalayan Teasel Root 15
g, Chinese Taxillus Twig 15 g, Donkey-hide Glue 10 g, Deer Horn 10 g, and Morinda
Root 10 g
2) Formula changes
• Low back pain: Eucommia Bark was added.
• Abdominal distension: Mongolian Milkcetch Root and Largetrifoliolious
Bugbane Rhizmome were added.
• Bleeding: Herb of Hairyvein Agrimonia, Garden Burnet Root and Lotus Seed Pot
were added.
3) Decoction: po, qd.
The Western medicines group used vitamin E 0.1g, po, qd; progesterone 20~40 mg, im,
qd; folic acid 5 mg, po, qd; HCG, 2000 IU, im, qod
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 97.1%, and Western medicines group was 84.
85% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias) All outcomes
Low risk No exclusion was reported. No losses werereported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
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Zhang 2008a
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 96 inpatients or outpatients from Liu Yang Central Hospital were recruited (2006 Oc-
tober-2008 January). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Shou Tai Pill, included Chinese Dodder Seed
20 g, Chinese Taxillus Twig 25 g, Donkey-hide Glue, Himalayan Teasel Root, Steamed
Rehmannia Root, Pilose Asiabell Root and Largehead Atractylodes Rhizome, each 15 g;
and Liquorice Root 10 g
2) Formula changes
• Qi deficiency: Mongolian Milkcetch Root 30 g was added.
• Severe bleeding: Herb of Hairyvein Agrimonia 30 g, Male Fern Rhizome 15 g,
Garden Burnet Root 30 g were added.• Vomiting: Villous Amomrum Fruit 8 g and Perilla Stem 9 g were added.
• Heat sign: Baical Skullcap Root 9 g and Ramie Root 30 g were added.
• Abdomen pain: White Paeony Root 30 g was added.
• Insomnia: Spina Date Seed 8 g was added.
3) Decoction: po, BID, 7-day as a course.
4) Western medicines were received at the same time, including HCG 2000 U, im, qod;
vitamin E 100 mg, po, qd; folic acid 2.5 mg, po, qd
Control group was treated with Western medicines alone. Same as above, HCG 2000U,
im, qod; vitamin E 100 mg, po, qd; folic acid 2.5 mg, po, qd
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 90.0%, and Western medicines group was 87.1% (P < 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Low risk “Randomized number table.”
Allocation concealment (selection bias) Low risk “Randomized number table.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
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Zhang 2008a (Continued)
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,“no significant difference was found be-
tween groups”
Zhang 2008b
Methods Randomised controlled trial of combined medicines (Chinese herbal medicines + West-
ern medicines) compared with Western medicines alone
Participants 100 inpatients or outpatients from Second Affiliated Hospital of Hunan University of
Chinese Medicine were recruited (2004 January-2006 December). Participants were all
diagnosed as threatened miscarriage due to vaginal bleeding and abdominal pains
Interventions Treatment group received Chinese herbal medicines combined with Western medicines
1) The Chinese medicine formula was Bao Tai Yin, included Steamed Rehmannia Root
20 g, Common Macrocarpium Fruit 15 g, Donkey-hide Glue 15 g, Himalayan Teasel
Root 15 g, White Paeony Root 10 g, Chinese Dodder Seed 15 g, Chinese Taxillus Twig
15 g, Eucommia Bark15 g, Largehead Atractylodes Rhizome 15 g, Mongolian Milkcetch
Root 20 g, Pilose Asiabell Root 10 g, and Liquorice Root 6 g
2) Formula changes
• Blood heat: Bamboo Shavings, Mulberry Leaf and Towel Gourd Vegetable Sponge
each 10 g were added.
• Abdominal distension: Villous Amomrum Fruit 3 g and Tangerine Pee 16 g were
added.
3) Decoction: po, tid, 1 or 2 weeks.
4) Western medicines were received at the same time, including progesterone, 20 mg,
qd; vitamin E 100 mg, po, tid
Control group was treated with Western medicines alone. Same as above, progesterone,
20 mg, qd; vitamin E 100 mg, po, tid
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exam-
inations showed pregnancy maintained were considered as effective. The effectiveness
rate of combined medicines group was 92%, and Western medicines group was 78% (P
< 0.05)
Notes RCT with 2 arms.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
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Zhang 2008b (Continued)
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Zhong 2002
Methods Randomised c ontrolled t rial of comparisonsa mong c ombined medicines, C hineseherbal
medicines alone, and Western medicines alone
Participants 90 inpatients or outpatients from Guang Zhou Second People’s Hospital were recruited
(2004 May-2006 May). Participants were all diagnosed as threatened miscarriage due to
vaginal bleeding and abdominal pains
Interventions Chinese herbal medicine group:
1) mainly used Pilose Asiabell Root, Largehead Atractylodes Rhizome, Common Yam
Rhizome, Chinese Taxillus Twig, Chinese Dodder Seed, Himalayan Teasel Root and
Baical Skullcap Root (no information on the dosage)
2) Formula changes (no information on the dosage)
• Blood deficiency: Donkey-hide Glue was added.• Cold sign: Chinese Mugwort Leaf was added.
• Blood heat: Garden Burnet Root was added.
• Abdomen pain: White Paeony Root, Nutgrass Galingale Rhizome and Perilla
Stem were added.
• Vomiting: Bamboo Shavings, Villous Amomrum Fruit and Tangerine Peel were
added.
• Dry mouth: Rehmannia Root, Glossy Privet Fruit and Yerbadetajo Herb were
added.
3) Decoction: po, QD.
The Western medicines group used HCG 2000 U, im, qod, then decline the dosage
after 12 weeks of pregnancy
Outcomes Symptoms subsided and pregnancy maintained till delivery were considered as effective.
The effectiveness rate of Chinese medicines group was 90%, Western medicines group
was 73.3%, and combined medicine group was 93.3%. Significant difference was found
between Chinese herbal medicines and Western medicines alone (P < 0.05). No statistic
difference was found between Chinese herbal medicines and combined medicines (P >
0.05)
Notes RCT with 2 arms.
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Zhong 2002 (Continued)
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk “patients were randomly allocated.”
Allocation concealment (selection bias) Unclear risk “patients were randomly allocated.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Zhou 2010
Methods Randomised controlled trial of Chinese herbal medicines compared with Western
medicines
Participants 87 outpatients from Central Hospital of Jia Ling were recruited (2005 May-2010 May). Participants were all diagnosed as threatened miscarriage due to vaginal bleeding and
abdominal pains
Interventions Chinese herbal medicine group:
1) An Tai Yin: mainly used White Paeony Root 30 g; Chinese Dodder Seed, Eucommia
Bark, Steamed Rehmannia Root, 25 g each; Chinese Taxillus Twig, Szechwon Tang-
shen Root, Largehead Atractylodes Rhizome, Donkey-hide Glue, Chinese Angelica, Hi-
malayan Teasel Root, Liquorice Root, 15 g each
2) Decoction: po, TID till 7 days after vaginal bleeding stopped
The Western medicines group used progesterone 20 mg, im, qd; vitamin E, 100 mg, po,
qd; folic acid, 5 mg, po, tid; till 7 days after vaginal bleeding stopped
Outcomes Symptoms such as vaginal bleeding and abdominal pains subsided, and clinical exami-
nations shows pregnancy maintained were considered as effective. The effectiveness rate
of Chinese medicines group was 91.1%, and Western medicines group was 73.8% (P <
0.05)
Notes RCT with 2 arms.
Risk of bias
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Zhou 2010 (Continued)
Bias Authors’ judgement Support for judgement
Random sequence generation (selectionbias)
Unclear risk “the patients were randomized divided into2 groups.”
Allocation concealment (selection bias) Unclear risk “the patients were randomized divided into
2 groups.”
Blinding (performance bias and detection
bias)
All outcomes
High risk Blinding of participants and clinicians was
not feasible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No exclusion was reported. No losses were
reported. It was an ITT
Selective reporting (reporting bias) Unclear risk The protocol of the trial was not available.
Other bias Low risk The intervention groups were comparable,
“no significant difference was found be-
tween groups”
Po (per os): by mouth; Im: (intramuscular); iv: (intravascular); ivgtt: (intravenously guttae, or IVdrop ) referred to different adminis-
tration methods; QOD: (every other day); QD: (once per day); BID: (twice per day); TID: (3 times per day); PIN: (taken when
necessary) referredto different dosing; HCG: human chorionic gonadotropin; ITT (intention-to-treat); RCT: randomised controlled
trial.
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Bi 2010 Comparisons were made between patients with threatened miscarriage and normal pregnant women. No out-
comes were reported on the effectiveness of treatments. So the review authors decided to exclude this trial
Chan 2010 This study included some participants with longer than 20 weeks of gestation, which did not meet our inclusion
criteria. So the review authors decided to exclude this paper
Gao 2011 This study did not mention the randomisation methods. Also, the number of participants in each group couldindicate randomisation was not applied to the allocation and intervention. So the review authors decided to
exclude this paper
Guo 2010 Comparison was between combined medicine and Westernmedicines. However, the women in2 groups received
different Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines.
We decided to exclude this paper
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(Continued)
Hu 2010b Comparison was between combined medicine and Westernmedicines. However, the women in2 groups received
different Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines. We decided to exclude this paper
Li 2011 Comparison was between combined medicine and Westernmedicines. However, the women in2 groups received
different Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines.
We decided to exclude this paper
Lin 2010 This study did not mention the randomisation methods. And the number of participants in each group could
indicate randomisation was not applied to the allocation and intervention. So the review authors decided to
exclude this paper
Lu 2007 Comparison was between combined medicine and Westernmedicines. However, the women in2 groups received
different Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines.
We decided to exclude this paper
Lu 2011b This study did not mention the randomisation methods. And the number of participants in each group could
indicate randomisation was not applied to the allocation and intervention. So the review authors decided to
exclude this paper
Lu 2011c Both treatment group and control group received a second Chinese medicine intervention, so the review authors
considered that these 2 groups were not comparable and doubt if the trial author could reach his conclusion that
the test Chinese medicine was effective. We decided to exclude this paper
Luo 2010 Comparison was between combined medicine and Westernmedicines. However, the women in2 groups receiveddifferent Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines.
We decided to exclude this paper
Qin 2010 Comparison was between one Chinese medicine and another Chinese medicine. The review authors considered
that the trial author could not reach his conclusion on the benefits of Chinese medicines as treatments. So this
paper was excluded
Ushiroyama 2006 Comparisons were made between a Kampo medicine and Western medicines. Kampo medicine is Japanese
traditional medicine, which may originate from China. To avoid the confusion of readers on the topic of our
review, which is about Chinese herbal medicines, we decided to exclude this trial
Wu 2010 This study did not mention the randomisation methods. And the number of participants in each group couldindicate randomisation was not applied to the allocation and intervention. So the review authors decided to
exclude this paper
Zhang 2000 This study included some participants with longer than 20 weeks of gestation, which did not meet our inclusion
criteria. Furthermore, the amount of participants in each group differed greatly. There were 580 participants in 1
Chinese medicine group, but 50 participants in another Chinese medicine group and 50 participants in Western
medicines group. Therefore, the review authors considered the participants were not randomly allocated, and
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(Continued)
decision was made to exclude this paper
Zhang 2006 Data were collected from 1995 to 2005, using 10 years. So the review authors doubt if this is a real RCT.
Also, the number of participants in each group differed. There were 140 participants in the combined medicine
group, but 128 participants in Western medicines group, and the author did not give further information on
the randomisation method. Thus, we decided to exclude this paper
Zhang 2011 Comparison wasbetween combined medicine and Westernmedicines. However, the women in 2 groupsreceived
different Western medicines. So the review authors considered that these 2 groups were not comparable and
doubt if the trial author could reach his conclusion that combined medicine was better than Western medicines.
We decided to exclude this paper
RCT: randomised controlled trial
Characteristics of studies awaiting assessment [ordered by study ID]
Chen 1999
Methods RCT of Chinese herbal medicines combined with Western medicines compared with Western medicines alone
Participants 720 participants diagnosed with threatened miscarriage were 2:1 divided into 2 groups. (480 for combined medicine
group, and 240 for Western medicines group)
Interventions Comparison between combined medicines and Western medicines was made
Outcomes The effectiveness of combined medicine is higher than Western medicines. Chinese herbal medicine could help andimprove the treatment of Western medicines alone
Notes Dates of data collection started from 1991, and the result was published in 1999, without mentioning the duration
that the 720 patients were involved in the treatments. So the review authors doubt if this was a real RCT, and have
been awaiting response from authors for further information
Guan 2008
Methods RCT of Chinese herbal medicines combined with Western medicines compared with Western medicines alone
Participants 100 participants diagnosed with threatened miscarriage were divided into 2 groups
Interventions Comparison between combined medicines and Western medicines was made
Outcomes The effectiveness of combined medicines is higher than Western medicines. Chinese herbal medicines could help
and improve the treatment of Western medicines alone
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Guan 2008 (Continued)
Notes Dates of data collection were from March 1999 to March 2006, using 7 years. So the review authors doubt if this
was a real RCT, and have been awaiting response from authors for further information
RCT: randomised controlled trial
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D A T A A N D A N A L Y S E S
Comparison 1. Chinese herbal medicines versus Western medicines (primary outcome and non-specific secondary
outcome)
Outcome or subgroup titleNo. of
studies
No. of
participants Statistical method Effect size
1 Effectiveness of intervention
(primary outcome)
1 60 Risk Ratio (M-H, Random, 95% CI) 1.23 [0.96, 1.57]
2 No relief of clinical signs 1 60 Risk Ratio (M-H, Random, 95% CI) 0.38 [0.11, 1.28]
3 No improvement of laboratory
investigations
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Repeated threatened miscarriage 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Preterm labour 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Adverse pregnancy outcomes 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
7 Preterm birth 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]8 Stillbirth 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
9 Neonatal death 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
10 Fetal structural malformations 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
11 Adverse neonatal outcomes 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
12 Effectiveness of intervention
(non-prespecified secondary
outcome)
15 1807 Risk Ratio (M-H, Random, 95% CI) 1.22 [1.12, 1.32]
Comparison 2. Chinese herbal medicines versus Western medicines (subgroup analysis)
Outcome or subgroup titleNo. of
studies
No. of
participants Statistical method Effect size
1 Effectiveness of intervention
(maternal age)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.1 Maternal age below 35 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.2 35 and above 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2 Effectiveness of intervention
(parity)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2.1 Primipara 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2.2 Multipara 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3 Effectiveness of intervention(gestational stage) 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.1 First trimester 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.2 Second trimester 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Effectiveness of intervention
(reference)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4.1 Referred herbal medicines 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4.2 Non-referred herbal
medicines
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
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5 Effectiveness of intervention
(treatment course)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.1 Short-term treatment 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.2 Long-term treatment 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Effectiveness of intervention
(randomisation)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.1 Quasi-RCTs 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.2 RCTs 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
Comparison 3. Combined medicines versus Western medicines (primary outcome and non-specific secondary
outcome)
Outcome or subgroup titleNo. of
studies
No. of
participants Statistical method Effect size
1 Effectiveness of intervention
(primary outcome)
5 550 Risk Ratio (M-H, Random, 95% CI) 1.28 [1.18, 1.38]
2 No relief of clinical signs 5 550 Risk Ratio (M-H, Random, 95% CI) 0.21 [0.13, 0.36]
3 No improvement of laboratory
investigations
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Repeated threatened miscarriage 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Preterm labour 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Adverse pregnancy outcomes 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
7 Preterm birth 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
8 Stillbirth 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
9 Neonatal death 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
10 Fetal structural malformations 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
11 Adverse neonatal outcomes 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
12 Effectiveness of intervention(non-prespecified secondary
outcome)
26 2809 Risk Ratio (M-H, Random, 95% CI) 1.24 [1.18, 1.30]
Comparison 4. Combined medicines versus Western medicines (subgroup analysis)
Outcome or subgroup titleNo. of
studies
No. of
participants Statistical method Effect size
1 Effectiveness of intervention
(maternal age)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.1 Maternal age below 35 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.2 Versus 35 and above 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2 Effectiveness of intervention
(parity)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2.1 Primipara 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
2.2 Multipara 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3 Effectiveness of intervention
(gestational stage)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
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3.1 First trimester 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.2 Second trimester 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Effectiveness of intervention
(reference)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4.1 Referred herbal medicines 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4.2 Non-referred herbalmedicines
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Effectiveness of intervention
(treatment course)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.1 Short-term treatment 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.2 Long-term treatment 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Effectiveness of intervention
(randomisation)
0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.1 Quasi-RCTs 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.2 RCTs 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
Analysis 1.1. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and
non-specific secondary outcome), Outcome 1 Effectiveness of intervention (primary outcome).
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 1 Effectiveness of intervention (primary outcome)
Study or subgroup
Chineseherbal
medicines Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Zhong 2002 27/30 22/30 100.0 % 1.23 [ 0.96, 1.57 ]
Total (95% CI) 30 30 100.0 % 1.23 [ 0.96, 1.57 ]
Total events: 27 (Chinese herbal medicines), 22 (Western medicines)
Heterogeneity: not applicable
Test for overall effect: Z = 1.63 (P = 0.10)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours Western medicines Favours Chinese herbal
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Analysis 1.2. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and
non-specific secondary outcome), Outcome 2 No relief of clinical signs.
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 2 No relief of clinical signs
Study or subgroup
Chineseherbal
medicines Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Zhong 2002 3/30 8/30 100.0 % 0.38 [ 0.11, 1.28 ]
Total (95% CI) 30 30 100.0 % 0.38 [ 0.11, 1.28 ]
Total events: 3 (Chinese herbal medicines), 8 (Western medicines)
Heterogeneity: not applicable
Test for overall effect: Z = 1.57 (P = 0.12)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours experimental Favours control
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Analysis 1.12. Comparison 1 Chinese herbal medicines versus Western medicines (primary outcome and
non-specific secondary outcome), Outcome 12 Effectiveness of intervention (non-prespecified secondary
outcome).
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 1 Chinese herbal medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 12 Effectiveness of intervention (non-prespecified secondary outcome)
Study or subgroup
Chineseherbal
medicines Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Cui 2002 49/50 13/20 4.1 % 1.51 [ 1.09, 2.08 ]
Feng 2010a 89/102 77/100 8.8 % 1.13 [ 0.99, 1.29 ]
Feng 2010b 35/40 29/38 6.4 % 1.15 [ 0.93, 1.42 ]
Kuang 2007 41/60 38/60 5.3 % 1.08 [ 0.83, 1.40 ]
Liu 2008 53/58 37/49 7.3 % 1.21 [ 1.01, 1.45 ]
Liu 2009 27/30 10/15 3.3 % 1.35 [ 0.93, 1.97 ]
Liu 2011a 72/77 65/78 9.2 % 1.12 [ 1.00, 1.26 ]
Liu 2011b 40/50 36/50 6.2 % 1.11 [ 0.89, 1.39 ]
Song 2005 97/126 51/117 6.0 % 1.77 [ 1.41, 2.22 ]
Song 2007 44/54 22/51 3.8 % 1.89 [ 1.34, 2.65 ]
Sun 2003 34/36 25/36 5.9 % 1.36 [ 1.08, 1.71 ]
Wang 2007 46/48 43/48 9.3 % 1.07 [ 0.96, 1.20 ]
Wang 2011 107/115 97/110 10.1 % 1.06 [ 0.97, 1.15 ]
Zhang 2007 67/69 27/33 7.7 % 1.19 [ 1.01, 1.40 ]
Zhou 2010 41/45 31/42 6.7 % 1.23 [ 1.01, 1.51 ]
Total (95% CI) 960 847 100.0 % 1.22 [ 1.12, 1.32 ]
Total events: 842 (Chinese herbal medicines), 601 (Western medicines)
Heterogeneity: Tau?? = 0.02; Chi?? = 43.10, df = 14 (P = 0.00008); I?? =68%
Test for overall effect: Z = 4.74 (P < 0.00001)
Test for subgroup differences: Not applicable
0.02 0.1 1 10 50
Favours experimental Favours control
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Analysis 3.1. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-
specific secondary outcome), Outcome 1 Effectiveness of intervention (primary outcome).
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 1 Effectiveness of intervention (primary outcome)
Study or subgroup
CombinedChi-
nese/Western Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Chen 2002 49/51 23/33 11.6 % 1.38 [ 1.09, 1.74 ]
Feng 1997 58/61 33/47 16.4 % 1.35 [ 1.11, 1.65 ]
Lu 2011 99/104 75/96 47.7 % 1.22 [ 1.09, 1.37 ]
Lv 2007 53/58 28/40 13.1 % 1.31 [ 1.05, 1.62 ]
Zhong 2002 28/30 22/30 11.2 % 1.27 [ 1.01, 1.61 ]
Total (95% CI) 304 246 100.0 % 1.28 [ 1.18, 1.38 ]
Total events: 287 (Combined Chinese/Western), 181 (Western medicines)
Heterogeneity: Tau?? = 0.0; Chi?? = 1.51, df = 4 (P = 0.83); I?? =0.0%
Test for overall effect: Z = 6.04 (P < 0.00001)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours Western medicines Favours Combined
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Analysis 3.2. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-
specific secondary outcome), Outcome 2 No relief of clinical signs.
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 2 No relief of clinical signs
Study or subgroup Combined medicines Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Chen 2002 2/51 10/33 12.2 % 0.13 [ 0.03, 0.55 ]
Feng 1997 3/61 14/47 18.3 % 0.17 [ 0.05, 0.54 ]
Lu 2011 5/104 21/96 29.5 % 0.22 [ 0.09, 0.56 ]
Lv 2007 5/58 12/40 27.9 % 0.29 [ 0.11, 0.75 ]
Zhong 2002 2/30 8/30 12.0 % 0.25 [ 0.06, 1.08 ]
Total (95% CI) 304 246 100.0 % 0.21 [ 0.13, 0.36 ]
Total events: 17 (Combined medicines), 65 (Western medicines)
Heterogeneity: Tau?? = 0.0; Chi?? = 1.06, df = 4 (P = 0.90); I?? =0.0%
Test for overall effect: Z = 5.95 (P < 0.00001)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Favours Combined Favours Western
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Analysis 3.12. Comparison 3 Combined medicines versus Western medicines (primary outcome and non-
specific secondary outcome), Outcome 12 Effectiveness of intervention (non-prespecified secondary
outcome).
Review: Chinese herbal medicines for threatened miscarriage
Comparison: 3 Combined medicines versus Western medicines (primary outcome and non-specific secondary outcome)
Outcome: 12 Effectiveness of intervention (non-prespecified secondary outcome)
Study or subgroup Combined medicines Western medicines Risk Ratio Weight Risk Ratio
n/N n/N
M-H,Random,95%
CI
M-H,Random,95%
CI
Chen 2003 39/45 24/38 2.3 % 1.37 [ 1.05, 1.79 ]
Deng 2009 95/100 72/100 5.8 % 1.32 [ 1.16, 1.50 ]
Fu 2006 46/47 35/40 6.1 % 1.12 [ 0.99, 1.27 ]
Hou 2010 48/51 15/24 1.7 % 1.51 [ 1.10, 2.07 ]
Hu 2010 30/34 22/34 2.2 % 1.36 [ 1.03, 1.80 ]
Huang 2011 48/50 40/50 5.0 % 1.20 [ 1.03, 1.39 ]
Kuang 2007 55/60 38/60 3.4 % 1.45 [ 1.18, 1.78 ]
Li 2004 24/25 20/25 3.3 % 1.20 [ 0.97, 1.48 ]
Li 2005 57/60 23/30 3.4 % 1.24 [ 1.01, 1.52 ]
Li 2006 35/45 31/44 2.6 % 1.10 [ 0.86, 1.41 ]
Li 2009a 67/72 53/66 5.6 % 1.16 [ 1.01, 1.33 ]
Li 2009b 91/97 69/92 5.9 % 1.25 [ 1.10, 1.42 ]
Li 2010 129/140 93/128 6.4 % 1.27 [ 1.13, 1.43 ]
She 2008 56/60 29/40 3.5 % 1.29 [ 1.05, 1.58 ]
Shen 2010 53/58 45/56 5.0 % 1.14 [ 0.98, 1.32 ]
Sun 2003 35/36 25/36 3.0 % 1.40 [ 1.12, 1.75 ]
Wang 2005 76/80 30/60 2.4 % 1.90 [ 1.47, 2.46 ]
Wang 2010 45/55 32/55 2.5 % 1.41 [ 1.09, 1.82 ]
Xiao 2008 27/30 20/30 2.1 % 1.35 [ 1.02, 1.79 ]
Xu 2005 29/32 26/30 4.1 % 1.05 [ 0.87, 1.25 ]
Xun 2008 42/45 24/30 3.7 % 1.17 [ 0.96, 1.42 ]
Yang 2001 38/42 8/13 1.0 % 1.47 [ 0.95, 2.28 ]
Yang 2006 95/100 36/50 4.1 % 1.32 [ 1.10, 1.58 ]
Zeng 2011 65/68 41/50 5.4 % 1.17 [ 1.01, 1.34 ]
0.01 0.1 1 10 100
Favours experimental Favours control
(Continued . . . )
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12. 1 AND 10 AND 11
Appendix 2. Search strategy for CINAHL
1. exp PREGNANCY/
2. (spontaneous adj2 abortion*).af 3. (threat* adj3 (pregnancy ADJ loss)).af
4. (abortion* adj3 threat*).af
5. (spontaneous adj3 (pregnancy ADJ loss)).af
6. miscarriage*.af
7. (chin* adj6 herb*).af
8. ((china OR chinese) AND (tradition* adj4 medicine*)).af
9. DRUGS, CHINESE HERBAL/
10. 2 OR 3 OR 4 OR 5 OR 6
11. 7 OR 8 OR 9
12. 1 AND 10 AND 11
Appendix 3. Search strategy for PUBMED
1. ((“Chin Med”[Journal] OR (“chinese”[All Fields] AND “medicine”[All Fields]) OR “chinese medicine”[All Fields]) OR (“medicine,
traditional”[MeSH Terms] OR (“medicine”[All Fields] AND “traditional”[All Fields]) OR “traditional medicine”[All Fields] OR
(“traditional”[All Fields] AND “medicine”[All Fields]))) OR (“Trends Cardiovasc Med”[Journal] OR “Case Manager”[Journal] OR
“tcm”[All Fields])
2. (((“therapy”[Subheading] OR “therapy”[All Fields] OR “treatment”[All Fields] OR “therapeutics”[MeSH Terms] OR “therapeu-
tics”[All Fields])OR (“therapy”[Subheading] OR “therapy”[All Fields] OR “therapeutics”[MeSH Terms] OR “therapeutics”[All Fields]))
OR clinical[All Fields]) OR application[All Fields]
3. 1 AND 2
4. (“abortion, spontaneous”[MeSH Terms]OR (“abortion”[AllFields]AND “spontaneous”[AllFields]) OR “spontaneous abortion”[All
Fields] OR “miscarriage”[All Fields]) OR (“abortion, induced”[MeSH Terms] OR (“abortion”[All Fields] AND “induced”[All Fields])
OR “induced abortion”[All Fields] OR “abortion”[All Fields])
5. threatened/abrupt[All Fields] OR threatened/actual[All Fields] OR threatened/actually[All Fields] OR threatened/endangered[AllFields] OR threatened/exposed[All Fields] OR threatened/forced[All Fields] OR threatened/injured[All Fields] OR threatened/in-
volved[All Fields] OR threatened’[All Fields]
6. (“therapeutics”[MeSH Terms] OR “therapeutics”[All Fields] OR “therapeutic”[All Fields]) OR (“recurrence”[MeSH Terms] OR
“recurrence”[All Fields] OR “recurrent”[All Fields]) OR complete[All Fields] OR incomplete[All Fields] OR missed[All Fields] OR
inevitable[All Fields]
7. 4 AND 5 NOT 6
8. 3 AND 7
Appendix 4. Search strategy for CNKI and CJN (Chinese)
1. (subject =miscarriage) OR (subject =abortion)
2. (subject= threatened)
3. (subject =therapeutic) OR (subject = recurrent) OR (subject = recurrent) OR (subject = complete) OR (subject= incomplete) OR (subject= inevitable) OR (subject = missed)
4. 1 AND 2 NOT 3
5. (subject= Chinese medicine*(therapy application+ clinical use)) OR (subject= traditional medicine) OR (subject=TCM)
6. 4 AND 5
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Appendix 5. Search strategy for WanFang Database (Chinese)
1. TCM OR (traditional medicine) OR (Chinese medicine)
2. application OR (clinical use) OR therapy
3. 1 AND 2
4. miscarriage OR abortion
5. (threatened abortion) OR (threatened miscarriage)6. 4 AND 5
7. 3 AND 6
Appendix 6. Search Strategies for CBM and Wiley InterScience
Searched by subject heading/keyword/abstract with:
• Traditional Chinese Medicines
• threatened miscarriage treatment
• western medicines
• comparisons studies
• randomized controlled trials
•
meta-analysis• Or could be included or replaced by similar words:
• herbal medicines
• pharmaceuticals
• miscarriage
• spontaneous abortion
• therapy
Medical Subject Headings (MeSH)Miscarriage, Abortion, Threatened [*drug therapy]; Traditional Chinese Medicines, Herbal medicines, [*therapeutic use]; Randomised
Controlled Trials [*methods/topic]; Meta analysis [*method/topic]
Appendix 7. Search Strategy for ICTRP and Chinese Clinical Trials RegistryKeywords of “Threatened”, “Threatened miscarriage”, “Threatened abortion”, “abortion”, “Chinese medicine”, “herbal medicine” were
searched in the title list of registered clinical trials in the databases.
Appendix 8. List of handsearched journals
The following journals were specifically searched for this review.
1. Acta Chinese Medicine and Pharmacology (1980 to Jan 2012)
2. Beijing Journal of Traditional Chinese Medicine (1980 to Jan 2012)
3. Central Plains Medical Journal (1980 to Jan 2012)
4. China Medical Herald (1980 to Jan 2012)
5. China’s Naturopathy (1980 to Jan 2012)
6. Chinese Archives of Traditional Chinese Medicine (1980 to Jan 2012)7. Chinese Journal of Information On Tcm (1980 to Jan 2012)
8. Chinese Journal of Medicine (1980 to Jan 2012)
9. Chinese Journal of Obstetrics and Gynecology (1953 to Jan 2012)
10. Chinese Journal of Perinatal Medicine (1999 to Jan 2012)
11. Chinese Journal of Practical Gynecology and Obstetrics (1986 to Jan 2012)
12. Chinese Medicine and Materia Medica (1980 to Jan 2012)
13. Clinical Journal of Anhui Traditional Chinese Medicine (1980 to Jan 2012)
14. Clinical Journal of Traditional Chinese Medicine (1980 to Jan 2012)
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15. Forum On Traditional Chinese Medicine (1980 to Jan 2012)
16. Gansu Journal of Traditional Chinese Medicine (1980 to Jan 2012)
17. Guizhou Medical Journal (1980 to Jan 2012)
18. Hebei Journal of Traditional Chinese Medicine (1980 to Jan 2012)
19. Heilongjiang Medicine and Pharmacy (1980 to Jan 2012)
20. Henan Medical Information (1980 to Jan 2012)21. Henan Traditional Chinese Medicine (1980 to Jan 2012)
22. Hubei Journal of Traditional Chinese Medicine (1980 to Jan 2012)
23. Hunan Guiding Journal of Traditional Chinese Medicine and Pharmacology (1980 to Jan 2012)
24. Hunan Journal of Traditional Chinese Medicine (1980 to Jan 2012)
25. Jiangsu Journal of Traditional Chinese Medicine (1980 to Jan 2012)
26. Jiangxi Journal of Traditional Chinese Medicine (1980 to Jan 2012)
27. Jounal of Hubei College of Traditional Chinese Medicine (1980 to Jan 2012)
28. Jouranl of Guangzhou University of Traditional Chinese Medicine (1980 to Jan 2012)
29. Journal of Anhui Traditional Chinese Medical College (1980 to Jan 2012)
30. Journal of Changzhi Medical College (1980 to Jan 2012)
31. Journal of Chinese Medicinal Materials (1980 to Jan 2012)
32. Journal of Chinese Rural Physician (1980 to Jan 2012)
33. Journal of Guangzhou University of Traditional Chinese Medicine (1980 to Jan 2012)34. Journal of Guiyang College of Traditional Chinese Medicine (1980 to Jan 2012)
35. Journal of Handan Medical College (1980 to Jan 2012)
36. Journal of Jinzhou Medical College (1980 to Jan 2012)
37. Journal of Nanjing University of Traditional Chinese Medicine (1980 to Jan 2012)
38. Journal of New Chinese Medicine (1980 to Jan 2012)
39. Journals of Practical Obstetrics and Gynecology (1986 to Jan 2012)
40. Journal of Practical Traditional Chinese Medicine (1980 to Jan 2012)
41. Journal of Tianjin College of Traditional Chinese Medicine (1980 to Jan 2012)
42. Journal of Traditional Chinese Medicine (1980 to Jan 2012)
43. Journal of Traditional Chinese Medicine and Chinese Materia Medica of Jilin (1980 to Jan 2012)
44. Journal of Youjiang Medical College For Nationalities (1980 to Jan 2012)
45. Liaoning Journal of Traditional Chinese Medicine (1980 to Jan 2012)
46. Maternal and Child Health Care of China (1980 to Jan 2012)47. Modern Journal of Integrated Traditional Chinese and Western medicine (1980 to Jan 2012)
48. Modern Traditional Chinese Medicine (1980 to Jan 2012)
49. Nei Mongol Journal of Traditional Chinese Medicine (1980 to Jan 2012)
50. New Journal of Traditional Chinese medicine (1971 to Jan 2012)
51. Ningxia Medical Journal (1980 to Jan 2012)
52. Practical Clinical Medicine (1980 to Jan 2012)
53. Primary Journal of Chinese Materia Medica (1980 to Jan 2012)
54. Progress in Obstetrics and Gynecology (1994 to Jan 2012)
55. Qinghai Medical Journal (1980 to Jan 2012)
56. Shaanxi Journal of Traditional Chinese Medicine (1980 to Jan 2012)
57. Shanghai Journal of Traditional Chinese Medicine (1980 to Jan 2012)
58. Shanxi Journal of Traditional Chinese Medicine (1980 to Jan 2012)
59. Sichuan Journal of Traditional Chinese Medicine (1980 to Jan 2012)60. Sponsored By Gubei College of Traditional Chinese Medicine (1980 to Jan 2012)
61. The Practical Journal of Integrating Chinese With Modern Medicine (1980 to Jan 2012)
62. Tianjin Journal of Traditional Chinese Medicine (1980 to Jan 2012)
63. Traditional Chinese Medicinal Research (1980 to Jan 2012)
64. Zhejiang Journal of Traditional Chinese Medicine (1964 to Jan 2012)
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H I S T O R Y
Protocol first published: Issue 5, 2010
Review first published: Issue 5, 2012
C O N T R I B U T I O N S O F A U T H O R S
Dr Li Lu and Prof Wang Chi Chiu both wrote the initial and final versions of the review. Dr Dou Li Xia and Prof Leung Ping Chung
commented on the final version of the review.
D E C L A R A T I O N S O F I N T E R E S T
None known.
S O U R C E S O F S U P P O R T
Internal sources
• Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong Kong.
• Institute of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong.
• Hop Wai Scholarship 2009. Institute of Chinese Culture,The Chinese University of Hong Kong, Hong Kong.
to support attending Cochrane training and workshops in United Kingdom (27 July-23 August 2009)
• Zi Ying Scholarship 2010. Institute of Chinese Culture,The Chinese University of Hong Kong, Hong Kong.
to support attending Cochrane workshop in Germany (18-20 Mar 2010)
• CUHK Postgraduate Student Grants for Oversea Academic Activities. The Chinese University of Hong Kong, Hong Kong.
to support the study trips in United Kingdom and Germany.
External sources
• Health and Health Services Research Fund (HHSRF) from Food and Health Bureau, Hong Kong Special Administration
Region, Hong Kong.
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
In the protocol, we planned to include studies with only abstracts available. After working on the review, we found that there are two
papers with abstract only and related to our topic, however, no detailed information is provided for our further inclusion for meta-
analysis study. Therefore, we excluded these trials and all the included papers had full texts. Additionally, we included 44 trials at first
and after having carefully read all the included studies and input data to the extraction forms, we found that 39 of the studies concluded
the outcomes immediately after the courses of treatment, instead of long-term observations until term delivery. Therefore, we still listed
the characteristics of these trials but reported the related data as non-prespecified secondary outcome (continuation of pregnancy after
treatment) to supplement the primary outcome. We have added ’livebirth’ as a secondary outcome.
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I N D E X T E R M S
Medical Subject Headings (MeSH)
Abortion, Threatened [∗drug therapy]; Drugs, Chinese Herbal [∗therapeutic use]; Phytotherapy [∗methods]; Randomized Controlled
Trials as Topic
MeSH check words
Female; Humans; Pregnancy
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