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Asia-Pacific Psychiatry ISSN 1758-5864

ORIGINAL ARTICLE

Health-related quality of life and symptom severity in Chinese

patients with major depressive disorder
Yuping Cao1 MD PhD, Wen Li2 MD, Jingjin Shen1,3 MD, Robert T. Malison4 MD, Yalin Zhang1 MD PhD &
Xingguang Luo4 MD
1 Mental Health Institute, Second Xiangya Hospital, Central South University, Changsha, China
2 Department of Psychosomatics, Hunan Mental Hospital, Changsha, China
3 Department of Psychiatry, Shenzhen Sixth Hospital, Shenzhen, China
4 Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA

Keywords
Chinese, correlation, health-related quality of
life, major depressive disorder, symptom
severity
Correspondence
Yalin Zhang MD PhD, Mental Health Institute,
Second Xiangya Hospital, Central South
University, Changsha, Hunan 410011, China.
Tel: +86 731 85292159
Fax: +86 731 85362586
Email: zhangyl69@vip.sina.com
Received 5 March 2012
Accepted 4 December 2012
DOI:10.1111/appy.12059

Abstract
Introduction: Patients suffering from major depressive disorder (MDD)
have been reported to have substantial long-lasting limitations in multiple
domains of health-related quality of life (HRQoL). The thoughtful assessment of HRQoL and the impact of treatment response on HRQoL are
emerging as important issues in the care of patients with major depressive
disorder.
Methods: One hundred and three patients meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD took fluoxetine (20 mg/d) for 6 weeks and were assessed by the Short Form 36
Health Survey (SF-36), the 17-item Hamilton Depression Rating (HAMD17) and the Clinical Global Impression (CGI) scales. Relationships between
SF-36 scores and depressive symptom severity and early change of these
symptoms were tested.
Results: SF-36 component scores at week 6 were higher than those at
baseline (all P 0.0058). Scores for general health were significantly
higher in responders than non-responders (P = 0.0009). The overall
HAMD-17 and CGI scores at 2- and 6-week follow-up were significantly
lower than those at baseline (P 0.0001). Higher scores for anxiety/
somatization were significantly associated with poorer SF-36 scores at
baseline (P = 0.0001); role-physical scores at week 6 were positively correlated with reduction rate of anxiety/somatization in 2-week follow-up
(P = 0.0002).
Discussion: Depressive symptom severity was associated with HRQoL in
patients with MDD. HRQoL may vary with severity of depression and/or
anxiety-somatization at baseline.

Introduction
Depression is among the most prevalent of medical
illnesses, and has become the fourth leading cause of
global disability adjusted life years (DALYs), and the
leading cause in developed countries (Murray and
Lopez, 1997a). Depression is also projected to become
the second leading cause of global disability by 2020
according to the World Health Organization (WHO)
(Murray and Lopez, 1997b). Thus, many nations now
acknowledge the importance of recognizing and

276

treating depression both for the benefit of patients and

for society.
WHO defined health as a state of complete physical, mental, and social well-being and not merely the
absence of disease in 1948. This concept has resurfaced as an important touchstone for the evaluation of
both mental and physical health treatment outcomes
(Rapaport et al., 2005). Health-related quality of life,
referring to the perceptions of daily function and
well-being in physical, social, and psychological
domains, can help doctors better understand how an

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Y. Cao et al.

illness or its treatment affects a persons life

(Endicott et al., 1993).
Patients suffering from MDD have been reported to
have substantial long-lasting limitations in multiple
domains of health-related quality of life (HRQoL),
when compared to the general population (Pyne et al.,
1997) or to those who suffer from other common
chronic medical illnesses such as diabetes, arthritis or
cardiovascular diseases (Wells et al., 1989; Ormel et al.,
1994; Hays et al., 1995; Wells and Sherbourne, 1999;
Saarijarvi et al., 2002). Thus, the thoughtful assessment
of HRQoL and the impact of treatment response on
HRQoL are emerging as important issues in the care of
depressed patients. In fact, reports in the literature in
non-Chinese populations have suggested that depression severity is associated with health-related quality of
life (Rapaport et al., 2005; Aydemir et al., 2009;
Patten et al., 2009; ten Doesschate et al., 2010).
To our knowledge (by searching English[language], (severity OR early improvement), healthrelated quality of life, Chinese, depression in
PubMed), no literature in any international journal has
reported the relationship between the severity of
symptoms or their early improvement (in the first 2
weeks (Quitkin et al., 1984; Bech, 2001) ) and the
HRQoL improvement in Chinese MDD patients.
However, based on prior work in the non-Chinese
populations (Quitkin et al., 1984; Bech, 2001;
Rapaport et al., 2005; Aydemir et al., 2009; Patten et al.,
2009; ten Doesschate et al., 2010), we hypothesized
that such an association might also exist in the Chinese
population. The current study employed a fixed, openlabel trial of antidepressant medication (fluoxetine) for
6 weeks in Chinese MDD patients in order to explore
this hypothesis. We assessed health-related quality of
life (HRQoL) among Chinese patients with major
depressive disorder (MDD) using standardized measures and investigated its correlations with depressive
symptom severity and with early change of these
symptoms after antidepressant intervention. These correlations were investigated within the same subjects; in
other words, HRQoL and depressive symptom severity
were assessed under the same conditions. This study is
important for us to know if HRQoL can serve as a
potential supplemental outcome measurement in clinical treatment trials in Chinese MDD patients.

Methods
Subjects
The Mental Health Institute of Second Xiangya Hospital and the Hunan Mental Health Hospital are two

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Quality of life and severity of symptoms

province-run psychiatric institutes/hospitals in South

China. They are two of the top psychiatric institutes/
hospitals in China. Consecutive outpatients from
these two institutes/hospitals were invited to participate from January to July 2006. The inclusion criteria were as follows: (i) all participants aged between
1865 years; (ii) all participants met DSM-IV criteria
for MDD; (iii) Hamilton Depression Rating for
Depression 17-item (HAMD-17) total scores were no
less than 16; and (iv) all participants were free of any
antidepressant and antipsychotic within 1 month
before trial.
The exclusion criteria included (i) a history of
dysthymia, mania, hypomania, bipolar disorder or
depression secondary to a known substance or general
medical condition; (ii) a drug allergy or clinically significant laboratory abnormality; (iii) active suicidal
ideation, comorbid mental disorders, catatonic features, and/or severe psychomotor retardation that
made interview difficult; (iv) active substance abuse;
(v) history of brain injury or other severe medical
comorbidity, such as stroke, diabetes or cardiovascular
disease; (vi) current medication that might influence
mood or the central nervous system; (vii) pregnancy
or breastfeeding; or (viii) current use of other antidepressants or electroconvulsive therapy.
Subjects were diagnosed by two senior psychiatrists. These psychiatrists were trained before study to
assure they used the tools consistently. The inter-rater
reliability of the assessment of the measurements was
97% for assessing ten patients. Each patient was rated
by the same clinician each time. This study was
approved by the Medical Ethics Committee of Second
Xiangya Hospital of Central South University in
China. All patients provided written informed consent
prior to their participation in the study.

Measurements
Short Form 36 Health Survey Questionnaire
(SF-36) (Ware and Sherbourne, 1992)
The Chinese version of SF-36 (Fang and Hao, 2001),
developed by the Medical Outcomes Study (MOS),
was used to assess health-related quality of life. The
SF-36 is a self-rated instrument consisting of nine
domains: physical functioning, role-physical, bodily
pain, general health, vitality, social functioning, roleemotional, mental health and reported health transition. SF-36 has been claimed to have good reliability
and validity for assessment in major depressive
patients (Zhang et al., 2006). A higher score on the
SF-36 represents a better health-related quality of life.

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Quality of life and severity of symptoms

Y. Cao et al.

17-Item Hamilton Depression Rating Scale

(HAMD-17) (Hamilton, 1967)
The Chinese version of the HAMD-17 (Zhu and
Zhang, 1998), which is the most widely employed
instrument for assessing MDD, was applied to assess
severity of depressive symptoms. It consists of 17
items that evaluate functioning in five areas (subscales): cognitive impairment, retardation, anxiety/
somatization, sleep disturbance, and weight change.
Higher scores indicate more severe depression. The
reliability of the Chinese version of the HAMD-17 is
0.880.99.
Clinical global impression (CGI)
The Chinese version of the CGI (Wu, 1998) was used
to assess severity of depressive symptoms. Higher
scores represent more severe symptoms.

(1.6%) patients were unable to tolerate side-effects,

such as severe nausea, vomiting, anxiety, insomnia or
weakness; 5 (3.9%) patients were non-compliant with
research procedures. 15 of the 103 (14.6%) patients
had ever taken estazolam or nitrodiazepam to alleviate
severe insomnia.
Statistical analysis
SPSS version 15.0 was used for analyses. Paired t-tests
were used for within subject comparisons between
baseline and either 2-week or 6-week follow-up
assessments. Two-sample (unpaired) t-tests were used
for comparisons of responders and non-responders.
Pearson correlation test was used to assess the relationships between HRQoL and depressive symptoms
and between HRQoL and symptom severity change.
Multiple testing was accounted for by Bonferroni
correction.

Procedures
All patients met DSM-IV criteria for major depressive
disorder. They were assessed by SF-36 at baseline and
at the end of the 6th week after taking antidepressant.
HAMD and CGI for these patients were evaluated at
baseline, 2-week and 6-week follow-up. Symptom
severity change was measured by a change in total
HAMD-17 score. Responders were defined as patients
with a 75% or greater improvement in symptoms and
non-responders as those with less than 75% improvement in symptoms.
One hundred and twenty-eight patients were
enrolled in this study. All patients were given a fixed
dosage of 20 mg/d of fluoxetine hydrochloride for 6
weeks. One hundred and three patients completed
both the 2-week and 6-week follow-up evaluations.
Eighteen (14.1%) patients withdrew from the study
due to travel/inconvenience, lack of time/availability
or being unsatisfied with antidepressant response; 2

Results
Demographic characteristics
A total of 103 patients completed the 6-week
follow-up and were included for statistical analyses,
including 45 men (43.7%) and 58 women (56.3%).
The mean age was (34.4 12.7) years (ranging from
18 to 63 years). The duration of illness ranged from 2
to 77 weeks, with an average of 12.0 weeks. The
average education level was (11.1 3.1) years. The
response rate of antidepressant intervention was 34%
(threshold for improvement: 75%).
Comparisons of scores for the SF-36 at baseline
and week 6
As shown in Table 1, scores for all domains of the
SF-36 were nominally higher at week six as compared

Table 1. Six-week follow-up and baseline comparisons of scores of SF-36 (M SD)

SF-36

Baseline

6-week follow-up

P-value

Physical function
Role-physical
Bodily pain
General health
Vitality
Social functioning
Role-emotional
Mental health
Reported health transition

80.73 18.92
25.97 38.50
70.54 22.95
30.79 18.45
22.18 18.40
32.28 25.03
4.53 13.24
27.53 15.89
3.00 0.90

92.86 8.90
58.98 41.55
77.00 18.35
48.51 20.40
53.45 20.16
64.56 28.07
31.07 40.22
56.93 18.02
3.9 1.22

-7.226
-6.680
-2.809
-8.722
-11.253
-10.797
-6.737
-12.129
6.972

<0.0001
<0.0001
0.0058
<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
<0.0001

a = 0.05/9 = 0.0044.

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Quality of life and severity of symptoms

Table 2. Two- and six-week follow-ups and baseline comparisons of scores of HAMD and CGI (M SD)
2-week follow-up

HAMD total score

Cognitive disturbance
Retardation
Anxiety/somatization
Sleep disturbance
Weight change
CGI score

6-week follow-up

Baseline

Mean SD

P-value

Mean SD

P-value

26.42 6.16
4.88 1.87
9.55 2.67
7.61 2.99
3.58 1.77
0.64 0.76
5.25 1.03

16.66 6.80
2.84 1.70
6.88 3.08
5.09 2.95
1.66 1.48
0.63 0.36
3.92 1.09

<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
>0.05
<0.0001

8.81 6.04
1.24 1.43
3.71 2.55
2.67 2.40
1.17 1.83
0.37 0.23
2.26 1.17

<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
>0.05
<0.0001

Comparing HAMD and CGI scores in 2-week and 6-week follow-up with baseline, respectively. a = 0.05/(7 2) = 0.0036.

to baseline (all P 0.0058). After Bonferroni correction (i.e. with a set at 0.0044 = 0.05/9 in which 9
refers to the number of domains on the SF-36), these
differences remained marginally (P = 0.0058 for bodily
pain) or highly significant (P < a for others).
Comparisons of scores for the HAMD-17 and CGI
at 2- and 6-week follow-up relative to baseline
As shown in Table 2, the total HAMD-17 and all subscale scores (except for weight change) were significantly lower at both week 2 and week 6 as compared
to baseline (all corrected for P < a; with a set at
0.0036 = 0.05/(2 7) in which 2 was the number of
comparisons between baseline and each of 2- and
6-week follow-ups, and 7 was the number of
HAMD-17 total, HAMD-17 subscales, and CGI scores).
Similarly, scores for the CGI were also significantly
lower at week 2 and week 6 relative to those at baseline (all P < a).
Comparisons of scores for the SF-36 between
responders and non-responders, and between
week 6 and baseline within responders
or non-responders
As shown in Table 3, scores for various domains of the
SF-36 were not significantly different at baseline
between responders and non-responders (P > 0.05)
(although a nominally higher score for the roleemotional domain was found for non-responders as
compared responders that did not survive correction
for multiple comparisons [P = 0.001]). At the end of
the sixth week after taking antidepressant, the scores
for general health, vitality, social functioning and
mental health transition in responders were nominally higher than those in non-responders
(0.0009 P 0.014). After Bonferroni correction
(i.e. with a set at 0.0014 = 0.05/(9 4) where 9 was
the number of domains of SF-36 and 4 was the

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number of comparisons between groups), only scores

for general health remained significantly different
between groups.
Between baseline and 6-week follow-up, all
domains of the SF-36 (except for body pain) significantly increased in both responders and nonresponders (all P 0.0002; a = 0.0014).
Correlation between SF-36 and HAMD/CGI scores
We analyzed correlations between scores for the SF-36
(total plus nine subscales) and scores for the HAMD
(total and five domains) and the CGI (total) at different time points. A total of maximal 210 correlations
were tested (=[(1 + 9) (1 + 5) + (1 + 9) 1] 3 in
which 3 corresponded to the specific correlations
described below and other numbers to total/subscales
ratings employed). Thus, a was set at 0.0002 (=0.05/
210) for each test.
Correlations between SF-36 and HAMD/CGI
scores at baseline
The total SF-36 score was negatively correlated with
the total HAMD score (r = -0.273, P = 0.0053) as well
as domain scores for cognitive impairment
(r = -0.237, P = 0.0166) and anxiety/somatization
(r = -0.367, P = 0.0001), and the CGI (r = -0.338,
P = 0.0005). However, after Bonferroni correction,
only results between the SF-36 and anxiety/
somatization domain remained significant.
Correlations between baseline HAMD and
week 6 SF-36 scores
SF-36 scores for reported health transition and sleep
disturbance at the end of the 6th week were negatively
correlated with HAMD at baseline (r = -0.338,
P = 0.0005 and r = 0.285, P = 0.0037, respectively);
the scores for general health perception and

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Y. Cao et al.

P > 0.05
P > 0.05
P > 0.05
0.0009
0.0023
0.0140
P > 0.05
0.0093
P > 0.05

role-emotional were negatively correlated with

HAMD measures of anxiety/somatization (r = -0.227,
P = 0.0224 and r = -0.238, P = 0.0154, respectively).
However, after Bonferroni correction, only the results
for reported health transition remained marginally
significant.
Correlations between the change in HAMD
scores within the first 2 weeks and the SF-36
scores at week 6

0.0002
<0.0001
0.0110
<0.0001
<0.0001
<0.0001
0.0001
<0.0001
<0.0001

The score for the role-physical subscale at week 6 was

positively correlated with changes in ratings of
anxiety/somatization (r = 0.358, P = 0.0002) and sleep
disturbance (r = 0.305, P = 0.0021) on the HAMD
within the first 2 weeks; the scores for body pain at
week 6 were positively correlated with the 2-week
change of sleep disturbance (r = 0.211, P = 0.0347).
However, only the correlation between role-physical
and anxiety/somatization survived Bonferroni
correction.

Discussion

a = 0.05/(9 4) = 0.0014.

94.06 8.08
64.84 36.40
81.75 17.98
58.67 19.41
62.34 18.75
74.61 25.69
36.46 43.47
63.75 17.77
4.03 1.17
81.34 18.69
28.87 40.23
71.10 23.06
29.98 19.42
21.27 19.23
31.34 26.12
5.63 14.89
27.72 16.58
3.01 0.93
79.38 19.66
19.53 34.04
69.31 23.02
32.53 16.01
24.22 16.52
34.38 22.67
2.08 8.20
27.12 14.50
2.94 0.84
Physical function
Role physical
Bodily pain
General health
Vitality
Social function
Role emotional
Mental health
Reported health transition

92.32 9.25
56.34 43.65
74.86 18.24
44.23 19.38
49.44 19.59
60.03 28.08
28.64 38.75
53.86 17.39
3.80 1.25

<0.0001
<0.0001
P > 0.05
<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
<0.0001

Responders versus
non-responders
6-week versus
baseline
6-week versus
baseline
Non-responders
(n = 68)
Responders
(n = 35)
Non-responders
(n = 68)
Responders
(n = 35)
SF-36

Responders
6-week follow-up
Baseline

Scores

Table 3. Responders and non-responders comparisons of scores of SF-36 (M SD)

P-value

Non-responders

6-week follow-up

Quality of life and severity of symptoms

The scope of the present study was to investigate the

correlations between HRQoL and depressive symptom
severity and between HRQoL and early change of
these symptoms after antidepressant intervention
within the same subjects. To assess that the efficacy of
antidepressants was not within the scope of this study;
a placebo-controlled design was not necessary and
thus was not set, which did not substantially affect our
study scope because both HRQoL and depressive
symptoms during 6-week follow-up were assessed
under the same conditions within same subjects.
As literature shows, it has been found that the
more severe the depressive symptom is, the worse the
HRQoL would be (Pyne et al., 1997; Rapaport et al.,
2005; Aydemir et al., 2009; Patten et al., 2009). The
severity of depression mainly influences patients
vitality and social function. The more severe the cognitive impairment is, the worse the social function and
the subjective perception would be. Retardation and
anxiety/somatization mainly impact patients health
status and assessment of their health. Patients with
depressive disorders often manifest multiple complaints. At least 60% of these complaints are painrelated (Hollifield et al., 1994; Kroenke et al., 1994;
Bair et al., 2004). As bodily pain is the predominant
complaint when evaluating anxiety/somatization
symptoms, it is harmful to patients social function
(Kroenke et al., 1994), which has been reported by

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Y. Cao et al.

many research studies considering homologous cause

and symptom between pain and depression (Breslau
et al., 2000; Lipton et al., 2000; Reed et al., 2009).
Depressive patients with bodily pain have worse
HRQoL and treatment response (Bair et al., 2004;
Kroenke et al., 2008).
To avoid the potentially confounding effects that
different antidepressants might have (Tylee et al.,
1999; Kroenke et al., 2001; Ruhe et al., 2006), we
employed the same type and dose of medication in our
assessment of HRQoL and intervention response.
After 6 weeks of antidepressant intervention with
20 mg/d fluoxetine, changes in depressive symptoms
(except for weight) were evident on the HAMD,
consistent with parallel changes in the CGI. Healthrelated quality of life in both responders and nonresponders enhanced significantly too, although
current evidence, without a placebo control, was
insufficient to assert that these changes were completely attributable to antidepressant effects. As an
exception, bodily pain was not significantly changed
after 6-week intervention, which was consistent with
the report by Reed et al. (2009) (Reed et al., 2009).
Patients (even the responders) who failed to experience complete remission after antidepressant treatment were more likely to suffer residual pain
symptoms (Paykel et al., 1995). Painful physical symptoms are prevalent in MDD patients, highlighting the
importance of addressing both the physical and emotional symptoms of depression (Duenas et al., 2007).
This study also showed that the severity of symptoms was associated with lower perception of mental
health status after 6-week intervention. Patients with
severe anxiety and somatic symptoms at baseline
had a worse evaluation of their health tendency.
Reed et al. (2009) also reported that the severity of
self-rated depression was strongly associated with
poorer outcomes on the mental component of SF-36
(Reed et al., 2009).
There was little difference in HRQoL at baseline
except for a non-significant trend in role-emotional
between responders and non-responders, which suggested that symptom severity change after intervention might not be strongly associated with HRQoL
at baseline. After 6-week antidepressant intervention,
general health perception was changed in responders
more significantly than non-responders, which suggested that this domain of SF-36 was changed in
accordance with the change of the depressive
symptoms. On the other hand, although the severity
of symptoms was significantly different between
responders and non-responders, the domains of
HRQoL on physical functioning, bodily pain,

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Quality of life and severity of symptoms

role-emotional and reported health transition, vitality,

social function and mental health were not different
(after Bonferroni correction). ten Doesschate et al.
(2010) reported that HRQoL in remitted MDD
patients was lower than in the general population
(ten Doesschate et al., 2010). This might imply that
HRQoL enhancement therapies were also needed
even though the clinical symptoms were remitted.
One of the interesting findings was that the score for
role-emotional of non-responders was in a higher
trend than that of responders at baseline, but became
lower than that of responders in week 6, which might
suggest that there was a more significant change in
symptom severity for Chinese MDD patients who had
a lower score of emotional role at baseline.
There was an early change of symptom in this
study (i.e. the total score of HAMD declined significantly in the first 2 weeks [although it needs to be
examined whether this change was actually attributable to antidepressant invention using a placebocontrolled design]). We found that early change of
anxiety/somatization during antidepressant intervention could be a positive factor to ameliorate the
patients physical role (i.e. a physical component that
reflects physical health).
In conclusion, this study showed that HRQoL in
Chinese MDD patients had a negative correlation with
the symptom severity. Various aspects of symptoms
and early symptom change might be correlated with
various domains of HRQoL. We thus suggest that
HRQoL enhancement therapies, such as psychotherapy, could also be employed even after the clinical
symptoms were remitted. Our findings regarding the
HRQoL in Chinese population may reflect the Chinese
peoples perception of their position in life that is
related to their specific culture and value systems.
Replication of these findings in other populations is
warranted before generalization.
This study has several limitations. First, it only
analyzed the relationship between HRQoL and the
depressive symptoms. Many studies have shown that
quality of life is associated with other factors besides
severity of symptoms, such as education, occupation,
some clinical variance (the number of previous episodes of depression and the duration of the current
depressive episode) and/or any drug adverse effect
(Berlim et al., 2008; Reed et al., 2009). Second, we
only examined a single measure of heath-related
quality of life. To assess multiple measures of quality of
life, as well as measures of functional impairment, will
help us better understand the relationship between
HRQoL and severity of depression. Furthermore, it
would be better to observe symptom changes for a

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Quality of life and severity of symptoms

longer time in order to find out the treatment effects

in restoring psychosocial functioning and improving
the HRQoL in MDD during the continuation and
maintenance phases. Finally, this was not a casecontrol study, so we do not know if there would be a
difference of HRQoL between the responders and a
group of matched healthy controls. Further studies to
address these issues are warranted.

Acknowledgments
This work was supported by Nature Science Foundation
in China. We thank all clinicians and nurses in Second
Xiangya Hospital in assisting in the research work and
thank for Dr Daniel K. Winsteads helpful comments.
This work is secondary to a previous study by Cao et al.
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2011; 36:1438
(in Chinese).

Conflict of interest

Y. Cao et al.

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The authors have declared that no competing interests

exist.

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