Complementary Therapies in Medicine (2015) 23, 626—632

Available online at www.sciencedirect.com

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Traditional herbal medicine as adjunctive

therapy for breast cancer:
A systematic review
Woojin Kim a, Won-Bock Lee a, Jung-Woo Lee a, Byung-Il Min a,b,
Sun Kyung Baek c, Hyang Sook Lee d, Seung-Hun Cho e,∗

a
Department of East-West Medicine, Graduate School, Kyung Hee University, Seoul 130-701, South Korea
b
Department of Physiology, College of Medicine, Kyung Hee University, Seoul 130-701, South Korea
c
Department of Internal Medicine, Kyung Hee University Hospital, Seoul 130-701, South Korea
d
Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University,
Seoul, South Korea
e
Hospital of Korean Medicine, Kyung Hee University Medical Center, #1 Heogi Dong, Dongdaemun-Gu,
Seoul 130-701, South Korea

Received 14 July 2014; received in revised form 22 March 2015; accepted 29 March 2015
Available online 16 April 2015

KEYWORDS Summary
Objectives: To assess the effectiveness of traditional herbal medicine (THM) as adjunctive
Breast cancer;
therapy for breast cancer as evidenced by randomized controlled trials (RCTs).
Alternative medicine;
Methods: Five electronic English and Chinese databases were systematically searched up to
QOL;
February, 2014. All RCTs involving THM in combination with conventional cancer therapy for
Traditional herbal
breast cancer were included.
medicine
Results: Eight RCTs involving 798 breast cancer patients were systematically reviewed. Three
studies reported a significant difference in the improvement of quality of life (QOL) compared
to the control group. Two studies reported an increase in the white blood cell count after treat-
ment. Data on hot flashes and sleep quality were evaluated. However, no significant differences
in immediate tumor response were observed.
Conclusion: THM combined with conventional therapy in the treatment of breast cancer is
efficacious in improving QOL and in decreasing the number of hot flashes per day. More research
and well-designed, rigorous, large clinical trials are necessary to further address these issues.
© 2015 Published by Elsevier Ltd.

∗ Corresponding author. Tel.: +82 2 958 9498; fax: +82 2 958 9185.
E-mail address: chosh@khu.ac.kr (S.-H. Cho).

http://dx.doi.org/10.1016/j.ctim.2015.03.011
0965-2299/© 2015 Published by Elsevier Ltd.

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 Traditional herbal medicine for breast cancer
Introduction
Breast cancer is the most common cancer and the major
cause of cancer-related deaths among women worldwide,
with an expected 1,383,500 newly diagnosed cases and
458,400 deaths in 2010. In the United States, excluding
skin cancer, breast cancer is the most common cancer in
women.1 The incidence of breast cancer varies by about
five-fold globally.2
The National Cancer Institute (NCI) recognizes six types
of standard treatment: surgery, sentinel lymph node biopsy
followed by surgery, radiation therapy, chemotherapy, hor-
mone therapy, and targeted therapy. Of these, radiation
therapy, chemotherapy, and hormone therapy are used pri-
marily to manage the cancer cell population after surgery
or in the absence of surgery. However, these methods
cause many short- and long-term adverse effects and often
decrease the quality of life (QOL).3 Short-term side effects
include fatigue, alopecia, and nausea/vomiting. These gen-
erally occur during the course of treatment but usually
resolve within 1 month following completion of therapy.
Long-term side effects include premature ovarian failure,
weight gain, and cardiac dysfunction. They generally have a
much longer duration, sometimes lasting for several years.
Systemic conventional therapy has been associated with
significantly poorer quality of life 5—10 years after diag-
nosis with breast cancer.4 Breast cancer survivors who did
not undergo chemotherapy are reported to have a higher
QOL than patients treated by chemotherapy.5 New com-
plementary methods that augment conventional treatment
modalities are being used to decrease the incidence of side
effects and increase the QOL of breast cancer patients.6
Increasingly, Americans are using complementary and alter-
native therapies. Data from the 2002 United States National
Health Interview Survey (NHIS) showed that during the
preceding 12 months, 62% of adults ≥18-years-of-age had
used some form of complementary and alternative medicine
(CAM), including prayer, for health reasons. When prayer was
excluded, 36% of adults used some form of CAM.7
Traditional herbal medicine (THM) has been reported to
alleviate chemotherapy-induced nausea and vomiting8 and
also peripheral neuropathy.9 THM is reported to possess
immunopharmaceutical effects evident as the modula-
tion of lymphocyte functions and immune effector cells.10
Anti-cancer effects of some traditional herbal components
have been reported to involve improved immune functions
in vitro and in vivo.11,12
Recently, several randomized controlled trials (RCTs) of
THM for the treatment of breast cancer have been pub-
lished. However, no systematic review of the effectiveness
of THM for breast cancer treatment has been performed.
We undertook a systematic review to evaluate the efficiency
of adjunctive orally administered THM in the treatment of
breast cancer patients.
Materials and methods
Search strategy
Sources used for the literature review until February
2014 were The Cochrane Central Register of Controlled
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627
Trials, MEDLINE, EMBASE, Allied and Complementary
Medicine Database (AMED), and the Cumulative Index to
Nursing and Allied Health Literature (CINAHL). The refer-
ence lists of articles were searched for the most recent
relevant publications. A manual search of relevant jour-
nals, symposia, and conference proceedings was conducted.
All identified publications were cross-referenced. Personal
contact was made with the authors of published stud-
ies, if necessary, to request additional data. The search
terms used were Breast Neoplasms [MeSh] OR ((Breast
(TIAB)) OR Mammary (TIAB) AND Neoplasms[MeSH] OR Neo-
plasms*[TI] OR Cancer*[TI] OR Tumor*[TI] OR Tumor*[TI]
OR Carcinoma[MeSH] OR Carcinoma*[TI] OR Adenocarci-
noma[MeSH] OR Adenocarcinoma*[TI] OR adenomatous[TI]
OR Sarcoma[MeSH] OR Sarcoma *[TI] OR Antineoplastic
agents [MeSH] OR antineoplas *[TI] OR (adenoma *[TI] OR
adenopath*[TI]) AND malignant *[TI]). Since the various
databases searched for this review possessed their own sub-
ject headings, each database was searched independently.
No language restrictions were imposed.
Study selection
Only RCT articles were selected. Quasi-randomized or non-
randomized trials were excluded. Articles involving in vivo
and in vitro studies and articles with parenteral THM were
also excluded. Studies of THM combined with conven-
tional cancer therapy as the treatment group were included
(Fig. 1). For the control group, the selected patients were
undergoing conventional treatment with chemotherapy,
hormone therapy, chemo-hormone therapy, and/or radiation
therapy (Table 1).
Quality assessment
The quality of all studies was assessed following the descrip-
tion of these categories in the Cochrane Handbook for
Systematic Reviews of Interventions.13 Each included study
was evaluated against the inclusion criteria by one of the
reviewers. Where there was uncertainty regarding eligi-
bility, a second reviewer also assessed the study and a
decision was reached through discussion and consensus.
Both reviewers independently assessed whether the studies
met the inclusion criteria and discussed any disagreements.
Further information was sought from the authors when
papers contained insufficient information to make a decision
about eligibility. The following questions were assessed and
answered by the reviewers: (a) Was the allocation sequence
adequately generated? (b) Was allocation adequately con-
cealed? (c) Was knowledge of the allocated interventions
adequately prevented during the study? (d) Was the blinding
of the outcome assessment adequate? (e) Were incomplete
outcome data adequately addressed? (f) Were the results of
the study free of the suggestion of selective outcome report-
ing? and (g) Was the study apparently free of other problems
that could put it at risk of bias? This review used ‘Y, U, N’
as keys for the judgments for each question assessed. An
answer of ‘Yes’ indicated a low risk of bias (Y), ‘Unclear’
indicated an uncertain risk of bias (U), and ‘No’ indicated a
high risk of bias (N).
 628
Figure 1 Flow diagram showing the number of studies included and excluded from the systematic review and meta-analysis. RCT,
randomized controlled trial.
Statistical analysis
The study data were summarized using basic statistics by
simple counts and means. The main purpose of the anal-
ysis was to quantify and compare the effect of RCTs of
breast cancer patients who received THM with conven-
tional cancer therapy (treatment group) vs. the group that
received only conventional cancer therapy (control group).
Statistical analysis was conducted using Review Manager 5.1
for Windows (The Nordic Cochrane Center). In four stud-
ies with continuous data, one study of QOL, two of white
blood cell (WBC) counts, and one of nuclear transcriptional
factor-kappa B(NF-␬B) scores were evaluated using Stanford
Microarray Database (SMD).14—17 The remaining four stud-
ies reported dichotomous data on the immediate tumor
response, hot flashes, and sleep parameters. These were
evaluated by calculating odds ratios (ORs) and reduction
with 95% confidence intervals (CIs), and are presented indi-
vidually for each trial. An OR <1 indicates a lower risk in the
treatment group than the control group. An OR >1 indicates
a greater risk in the treatment group than the control group.
Results
Eight RCTs involving 798 breast cancer patients were sys-
tematically reviewed. Three studies reported a significant
difference in the improvement of QOL compared to the con-
trol group. Two studies reported an increase in the WBC
count after treatment. Data on hot flashes and sleep qual-
ity were also evaluated. The ‘risk of bias’ assessment tool
of the Cochrane collaboration was used to assess the qual-
ity. However, the quality of the studies was not highly
assessed.
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W. Kim et al.
QOL of breast cancer patients after treatment
Three studies16,18,19 involving 388 patients examined QOL
after treatment for breast cancer. In the study by Liu et al.18
the improvement and stabilization rate of QOL for the treat-
ment group was 95% (38/40), compared with 80% (69/86) for
the control group (P < 0.05). Zhang et al.19 reported a signif-
icant difference in the improvement and stabilization rate
of QOL in the treatment group of 85% (60/71) vs. the con-
trol group (69% (49/71)) (P < 0.05). In these two results, THM
therapy significantly affected QOL in favor of the treatment
group (OR 2.97, 95% CI = 1.68—5.24). Situ et al.16 using the
EuroQLQ-BR23 questionnaire also reported a significant dif-
ference in the total QOL score before and after treatment
between the two groups using continuous data (SMD 2.86,
95% CI = 2.35—3.38). The questionnaire has five functional
scales (physical, role, cognitive, emotional, and social) and
eight symptom scales (fatigue, pain, nausea and vomiting,
dyspnea, sleep disturbance, appetite loss, constipation, and
diarrhea). The treatment group displayed a significant dif-
ference comparing the before and after treatment scores in
12 of 13 functional and symptom criteria, with the category
or role being the exception. In the control group there were
no significant difference in all 13 scales.
Hot flashes and sleep disturbance
One study20 evaluated the number of hot flashes per day and
the sleep quality of 73 breast cancer patients. The number of
hot flashes per day was significantly different between the
two groups, with 57% (19/33) of the treatment group and
30% (10/33) of the control group patients showing reduced
or absent symptoms (OR 3.12, 95% CI = 1.13—8.60). With
 Traditional herbal medicine for breast cancer 629

Table 1 Randomized control trials of traditional herbal medicine for the treatment of breast cancer.

Study Subjects Type of conventional Main results Quality

therapy (THM + conventional therapy vs. assessment*
conventional therapy alone)

Adachi et al., 119 subjects with Chemo-endocrine No significant difference in Y-Y-U-U-Y-U-Y

198921 advanced breast therapy immediate tumor response (48.2%
cancer vs. 50.8%).
Fang, 199514 67 subjects with Chemotherapy alone Significant difference in response U-U-N-N-Y-Y-Y
breast cancer at rate (53.3% vs. 42.1%, P < 0.05);
stages I and II by TNM No significant change in white
criteria blood cell count after treatment
(−0.7 ± 1.11 vs. −3.4 ± 1.32,
P > 0.05).
Liu et al., 126 subjects with SrCl2 (Strontium No significant difference in relief U-U-N-N-Y-Y-Y
200318 breast cancer Chloride) of ostalgia (95.0% vs. 83.72%,
P > 0.05);
Significant difference in quality of
life (95% vs. 80.23, P < 0.05)
(based on Karnofsky performance
status);
No significant difference in
toxicity (30% vs. 28%, P > 0.05)
Zhao et al., 55 subjects with Chemotherapy alone Significant difference in NF-␬B U-U-N-N-Y-Y-Y
200317 breast cancer at expression (34.74 ± 7.62 vs.
stages I to III 4.43 ± 1.92, P < 0.01)
Hong et al., 92 subjects with Chemotherapy alone Significant difference in white U-U-N-N-Y-Y-Y
200515 breast cancer at blood cell count after treatment
stages I to III (1.04 ± 2.05 vs. 0.19 ± 2.03,
P < 0.01)
Situ et al., 120 subjects with a Chemotherapy alone Significant difference in the U-U-N-N-Y-Y-Y
200516 breast cancer increase in quality of life score
diagnosis (five functional scales; physical,
role, cognitive, emotional, and
social) between the treatment and
control groups (40.69 ± 7.58 vs.
18.98 ± 7.48, P < 0.01) (based on
the Euro QLQ-BR23 questionnaire)
Five functional scale: physiology
(2.69 ± 0.83 vs. 1.90 ± 0.88), role
(0.62 ± 0.55 vs.0.44 ± 0.50),
cognitive (1.00 ± 0.63 vs.
0.25 ± 0.64), emotional
(2.64 ± 1.20 vs. 1.19 ± 1.12),
society (2.26 ± 0.87 vs.
1.22 ± 0.91). Eight symptom scale:
fatigue (3.71 ± 1.07 vs.
2.68 ± 0.82), pain (2.44 ± 0.87 vs.
1.53 ± 1.02), nausea and vomiting
(0.87 ± 1.15 vs. −0.27 ± 1.35),
dyspnea, sleep disturbance,
appetite loss, constipation,
diarrhea.
Zhang et al., 142 subjects with Endocrinotherapy and No significant difference in U-U-N-N-Y-Y-Y
200519 late-stage mammary chemotherapy immediate tumor response (49.2%
cancer vs. 49.2%);
Significant difference in quality of
life (84.5% vs. 69%) (based on
Karnofsky performance status)

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 630
Table 1 (Continued )
Study Subjects
Sun et al., 73 subjects with
200920 breast cancer taking
tamoxifen
Abbreviation: THM, traditional herbal medicine.
* (a) Was the allocation sequence adequately generated? (b) Was allocation adequately concealed? (c) Was knowledge of the allocated
interventions adequately prevented during the study? (d) Was the blinding of outcome assessment adequate? (e) Were incomplete
outcome data adequately addressed? (f) Were the results of the study free of suggestion of selective outcome reporting? (g) Was the
study apparently free of other problems that could put it at a risk of bias?
Key: (Y) ‘‘Yes’’; (U) ‘‘Unclear’’; (N) ‘‘No’’.
regard to sleep disturbance, there was a significant differ-
ence between the two groups, with 63% (21/33) showing
reduced sleep disturbances in the treatment group com-
pared to 39% (13/33) in the control group (OR 2.69, 95%
CI = 1.00—7.28).
WBC counts after treatment
In two studies14,15 of 160 patients, the WBC counts before
and after treatment were determined. Fang14 reported that
the WBC count decreased in both the treatment and con-
trol groups, but was decreased more significantly in the
control group, with an SMD of 2.17 (95% CI = 1.56—2.77).
Hong et al.15 reported an increase in the WBC count in both
the treatment and control groups. However the increase
was non-significant, as indicated by an SMD of 0.41 (95%
CI = −0.03 to 0.85).
Immediate tumor response
Two studies19,21 investigated the immediate tumor response
of 261 patients. These reported that 48% (63/129) of the
treatment group and 50% (66/132) of the control group
exhibited a complete or partial response.19,21 There was no
significant difference between the treatment and control
groups (OR 0.95, 95% CI = 0.59—1.55).
Adverse events
Among the eight articles reviewed in this study, one21
reported adverse events in two patients who experienced
edema and minor urticaria for 2 weeks after administration
of THM. One subject chose to discontinue treatment.
Discussion
To the best of our knowledge, this is the first systematic
review of the efficacy of THM in breast cancer patients
when used complementary to more standard therapies. Only
articles involving RCT sand orally administered THM were
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W. Kim et al.
Type of conventional Main results Quality
therapy (THM + conventional therapy vs. assessment*
conventional therapy alone)
Hormone therapy Significant difference in hot Y-U-Y-Y-Y-Y-Y
flashes (57.5% vs. 30.3%,
P = 0.012);
Significant difference in condition
of sleep (63.6% vs. 39.4%,
P = 0.002)
included in this review. No restrictions were placed on
the language used in the articles and a number of litera-
ture databases were searched using a comprehensive search
strategy.
In 2007, Zhang et al.22 reviewed the effect of Chinese
herbal medicine on chemotherapy side-effects in breast can-
cer patients. However, we reviewed the efficacy of THM with
regard to chemotherapy side-effects as well as various other
breast cancer treatment modalities including hormone and
radiation therapy, since some articles have been reported
that QOL and other side effects are related to chemotherapy
and hormone and radiation therapy.4,23
This study had several limitations. First, the number of
trials was too few to draw firm conclusions, and the reviewed
studies included from 55 to 140 patients, which may have
resulted in false negatives and positives.
Second, the quality of the studies was not highly
assessed. To assess the quality of the reviews included in
this study, we used the ‘risk of bias’ assessment tool of the
Cochrane collaboration.13 As with the quality rating scale
method, it is difficult to justify the subtle differences among
the items in the scale,24 and we attempted to assess each
trial in terms of seven critical domains; i.e., randomization,
allocation concealment, blinding of participants and person-
nel, blinding of outcome assessment, incomplete outcome
data reporting, selective outcome reporting, and other bias.
Yet the ‘risk of bias’ assessment tool may not be entirely
free from subjectivity.25 The allocation sequence generation
and concealment were found to be unclear in most studies,
with the exception of two.20,21 The blinding of the partic-
ipants and personnel, and outcome assessment were not
mentioned or were not performed properly in all studies,
with the exception of that by Adachi et al.21
Third, none of the eight articles were in English. All arti-
cles were written in Chinese with the exception of that by
Adachi et al.,21 which was written in Japanese. Researchers
may have difficulty continuing the research of reports in
Chinese due to the language barrier.
Finally, the QOL measurements used differed among stud-
ies. All three studies that examined the QOL found an
increase in QOL scores in the treatment group compared
with the control group. However, two studies18,19 used the
 Traditional herbal medicine for breast cancer
Karnofsky Performance Status(KPS), while another study16
used the EuroQLQ-BR23 questionnaire to assess QOL. Also,
in the article of Adachi et al.21 QOL was assessed with 24
questionnaire and it was reported to be higher in the treat-
ment group than the control group. However, the data is not
shown in the paper. QOL in breast cancer patient is reported
to decrease, especially in patients who undergo chemother-
apy. It is interesting that THM could increase the QOL of
patients.
In eight articles Radix astragalus with Radix aneliacae
sinensis, Paeonia japonica and Astractylodes ovate were the
herbs most often used in breast cancer. Radix astragalus
has been reported to have anti-tumor, immunomodulat-
ing and immunorestorative effects in vivo and in vitro.11,12
Most of the articles used a combination of several herbs as
the THM group. The action of multiple active compounds
on cancer has not been established yet. However, Eisen-
berg et al.26 reported that a single active compound does
not reflect the diverse and complex effects of THM, where
patients are mostly prescribed multiple compounds rather
than a single herb. Also, some evidence suggests single
components extracted from plants are less potent than
complete extracts,27 and that the multi-targeted approach
can be more effective than the single-target approach.
Although the difference in mechanism and effects between
oral administered and intravenously injected THM has not
been clarified yet, in this review only orally prescribed
THM were included, as in clinic it is mostly administered
parenterally.28,29
Among eight articles, only one21 reported adverse events
of THM. Two patients suffered minor edema and urticaria
for2 weeks. The THM was discontinued in one patient.
More research should be conducted on the efficacy of
THM as adjunctive therapy in cases of distant metastasis
in breast cancer patients. Breast tumors most frequently
metastasize to the bone, and metastatic bone disease is
not only incurable but also causes significant medical com-
plications including fractures, pain and hypercalcemia.30
In this review, one article21 included data on bone metas-
tasis, but the results were insufficient to draw a firm
conclusion. Therefore, further well-designed research into
the effectiveness of THM with conventional treatment in
cases of bone metastases should be conducted. Also, since
lymphedema decreases the QOL in breast cancer surgery
patient31 and THM have been reported to reduce the
edema effectively further investigation should be concen-
trated in this field to increase the QOL of breast cancer
patient.
Conclusions
The results of this systematic review suggest that THM as
adjunctive therapy in breast cancer patients improves the
QOL and decreases the mean number of hot flashes per day.
Additionally, THM may also be beneficial to breast cancer
patients in terms of increasing WBC count and decreasing
sleep disturbances. However, the limited number of trials
and poor methodological quality of the included articles
prevents any firm conclusions about the effectiveness of
THM in these areas. More well-designed, large RCTs, that
incorporate rigorous methods of randomization, blinding,
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631
and adequately concealed allocations, as well as validated
outcome measures, are necessary.
Conflicts of interest
There are no conflicts of interest to declare.
Acknowledgments
This work was supported by the National Research Founda-
tion of Korea (NRF) funded by the Ministry of Education,
Science and Technology of the Korean government [MEST]
(No. 2012-0005755) and by a grant from the Kyung Hee Uni-
versity in 2010 (KHU-20100750).
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