Hindawi Publishing Corporation
Evidence-Based Complementary and Alternative Medicine
Volume 2012, Article ID 691258, 11 pages
AChineseHerbal Formulato Improve GeneralPsychological
Status inPosttraumatic Stress Disorder:A Randomized
Xian-ZeMeng,1Feng Wu,1Pin-KangWei,1Li-JuanXiu,1Jun Shi,1Bin Pang,1,2
1Department of Traditional Chinese Medicine, Shanghai Changzheng Hospital, Second Military Medical University,
Shanghai 200001, China
2Department of Internal Medicine, Air Force Sanatorium, Dujiangyan, Sichuan Province 611833, China
3Department of Mathematics and Statistics, University of Maryland Baltimore County, 1000 Hilltop Circle, Baltimore,
MD 21250, USA
4Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA
Correspondence should be addressed to Pin-Kang Wei, email@example.com
Received 14 May 2011; Revised 26 July 2011; Accepted 29 July 2011
Academic Editor: David Mischoulon
Copyright © 2012 Xian-Ze Meng et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Introduction. Posttraumatic stress disorder (PTSD) is accompanied by poor general psychological status (GPS). In the present
study, we investigated the effects of a Chinese herbal formula on GPS in earthquake survivors with PTSD. Methods. A randomized,
double-blind, placebo-controlled trial compared a Chinese herbal formula, Xiao-Tan-Jie-Yu-Fang (XTJYF), to placebo in 2008
SichuanearthquakesurvivorswithPTSD.PatientswererandomizedintoXTJYF(n = 123)andplacebo(n = 122)groups.Baseline-
to-end-point score changes in the three global indices of the Symptom Checklist-90-Revised (SCL-90-R) and rates of response in
the SCL global severity index (GSI) were the primary endpoints. A subanalysis of the nine SCL factors and the sleep quality score
were secondary endpoints. Results and Discussion. Compared to placebo, the XTJYF group was significantly improved in all three
SCL global indices (P = 0.001∼0.028). More patients in the XTJYF group reported “much improved” than the placebo group (P
= 0.001). The XTJYF group performed significantly better than control in five out of nine SCL factors (somatization, obsessive-
compulsivebehavior,depression,anxiety,andhostility(P =0.001∼0.036)),andinsleepqualityscore(P < 0.001).XTJYFproduced
no serious adverse events. These findings suggest that XTJYF may be an effective and safe treatment option for improving GPS in
patients with PTSD.
On May 12, 2008, an earthquake measuring 8.0 on the Rich-
ter scale hit Sichuan Province in southwestern China. Ac-
cording to the official data, more than 69,200 people were
confirmed dead, more than 374,600 were seriously injured
, and at least 5 million were left homeless . Recent liter-
ature shows that posttraumatic stress disorder (PTSD) and
other psychological disorders such as anxiety and depression
were fairly common and highly comorbid in 2008 Sichuan
earthquake survivors .
Posttraumatic stress disorder (PTSD) is a significant pu-
blic health problem . About 6.8% of adults develop PTSD
in their lifetimes; 3.5% have the condition in any given year
PTSD , which often persists for years if untreated [8–10].
The disorder is characterized by flashbacks and avoidance
or numbness as well as hyperarousal after experiencing, wit-
nessing, or confronting actual or potential death, serious phy
sical injury, or a threat to physical integrity . In addition
to these symptoms, co-morbid psychiatric disorders are ex-
tremely common. In the National Comorbidity Survey
(USA), approximately 80% of individuals with PTSD also
met criteria for at least one other disorder listed in the diag-
nostic and statistical manual of mental disorders-III (DSM-
2 Evidence-Based Complementary and Alternative Medicine
III) . Patients with PTSD often manifest other compli-
cations such as depression, anxiety, obsessive-compulsive
behavior, hostility, and paranoid ideation disorders [3, 12–
16]. Co-morbid psychiatric disorders and related subclinical
symptoms combined with core PTSD symptoms result in
poor general psychological status (GPS).
Selective serotonin reuptake inhibitors are the usual first
level pharmacological treatment for PTSD [17–22]. Other
lines of drugs, such as benzodiazepines and monoamine oxi-
dase inhibitors, are also commonly used . However, the
effects of these pharmaceuticals are not always satisfactory
[23–25], and undesirable side effects such as sleep distur-
bance, sexual dysfunction, and dizziness have been reported
For centuries, traditional Chinese medicine (TCM) has
been widely used in China and some other Asian countries
have been used to treat such maladies [30–38]. Xiao-Yao-
San is one of the most popular [30–36]. We developed a
modified, granulated form of Xiao-Yao-San, Xiao-Tan-Jie-
Yu-Fang (XTJYF), by adding additional herbs, mainly from
another classic TCM formula Er-Chen-Tang for treating de-
pression, and we studied the safety and effects of this modi-
fication in cancer patients with depression (see Table 1) .
Because we found the formula effective and observed no
serious side effects, we hypothesized that XTJYF would im-
prove GPS in PTSD patients.
study five months after the 2008 Sichuan earthquake, bet-
ween October 2008 and January 2009, through a commu-
nity-based epidemiological survey of four settlements of a
severely affected city, Dujiangyan. In the enrollment survey,
the relationship between exposure to the earthquake and
PTSD was assessed. Preliminary screening was performed in
to participate in a diagnostic face-to-face or telephone
interview with one of three experienced psychiatrists, each of
which has at least eight years of clinical experience. Patients
who met the inclusion and exclusion criteria were enrolled
(see Patient Flow Chart, Figure 1), and our psychologists
verified PTSD as the primary diagnosis of each enrollee.
Inclusion criteria were age 16 or older, meeting DSM III
criteria for PTSD with at least one of the nine Symptom
Check-List-90-Revised (SCL-90-R)  subscores above the
Chinese norm , and being willing to be randomly
assigned. Participants understood that those randomized
into the placebo control group could receive XTJYF after
completion of the whole trial if they wished. Exclusion cri-
teria were past history of bipolarism, schizophrenia, or other
psychotic disorders; current organic mental disorder, facti-
tious disorder, or malingering; any past history of alcohol
or substance dependence or abuse; evidence of clinically
significant hepatic or renal disease or any other acute or un-
stable medical condition that might interfere with safe
participation in the study; use of any medication with cli-
nically significant psychotropic activity within two weeks
of randomization; any cognitive-behavioral therapy during
the trial; psychotherapy initiated or ending during the trial.
For female patients of childbearing age, participation was
contingent on a negative serum pregnancy test and a medi-
cally accepted method of contraception.
Written informed consent was obtained from all patients
before participation. Patients were free to withdraw from the
study at any time. Clinical diagnoses, physicals, and labor-
atory examinations were mainly conducted in the outpatient
clinic at the Air Force Sanatorium in the city of Dujiangyan
by our psychologist and other investigators. The research
staff collected patients’ weekly feedback on their medical
conditions and delivered the XTJYF or placebo through in-
house visits. The trial protocol was approved by the Ethics
Committee of Shanghai Changzheng Hospital and the Air
Force Sanatorium in Dujiangyan.
A sociodemographic inventory and a medical history
were taken, and a routine physical and laboratory examina-
tion (i.e., blood pressure, ECG, clinical chemistry and hema-
tology tests, and urinalysis) was performed by the investiga-
tors as a baseline for future toxicology screening.
2.2. Randomization and Blinding. Eligible patients were ran-
domized to either XTJYF treatment or placebo control. Ran-
dom numbers were generated by computer software; treat-
ment codes were held by the chief investigator, who was iso-
lated from patients and outcome data. The chief investigator
was also responsible for distributing the XTJYF and placebo
with the assistance of our research staff. Patients, research
staff, and data entry clerks were blinded to treatment group
assignment. Treatment compliance was assessed by package
count and observation by the research staff. Treatment codes
were disclosed after the entire study was completed.
2.3. Study Interventions. All patients received 12g packages
of granulated XTJYF or placebo twice a day for eight weeks
 and were instructed to drink the contents dissolved in
warm, boiled water.
2.4. Outcome Measures. Each patient completed the SCL-90-
R questionnaires twice, at baseline prior to randomization
and in the eighth week after the randomization, that is, at
the end of this clinical trial. The SCL-90-R is a questionnaire
for self-reporting psychological distress. It is widely used in
patients suffering from mental diseases and for psychological
evaluation of healthy individuals. The instrument is well ac-
cepted for its good internal consistency, dimensional struc-
ture, reliability, and validity [43–45]. The Chinese SCL-90,
translated and validated by Wang from the English version of
the SCL-90-R, was used [46, 47].
The SCL-90-R consists of 90 symptoms of distress. Pa-
tients were instructed to indicate the degree to which they
had been troubled by each symptom during the preceding
week by ranking the symptom from 0 to 4, with 0 being “not
into nine dimensions, or factors (F), that reflect various
Evidence-Based Complementary and Alternative Medicine3
2344 did not meet inclusion criteria
178 did not meet inclusion criteria
25 met exclusion criteria
Placebo control group:
6 AEs (e.g diarrhea, nausea)
6 protocol violation
4 lack of efficacy
3 other (e.g bad flavor of drug)
5 AEs (e.g malaise, diarrhea)
4 protocol violation
8 lack of efficacy
3 other (e.g bad flavor of drug)
Completed study: n = 102
Completed study: n = 99
2 lost to
3 lost to
372 lost to follow-up or
XTJYF treatment group: N = 123
Figure 1: Flow chart of the study sample.
Table 1: Ingredients of Xiao-Tan-Jie-Yu-Fang.
Radix Angelicae sinensis
Rhizoma Atractylodis macrocephalae (parched)
Radix Paeonia alba (parched)
Radix Glycyrrhizae preparatae
Rhizoma Pinelliae preparatae
Pericarpium Citri reticulatae
Os Draconis (calcined)
Concha Ostreae (calcined)
Radix et Rhizoma Rhei preparatae
Rhizoma Acori graminei
4 Evidence-Based Complementary and Alternative Medicine
types of psychopathology: (F1) somatization, (F2) obsessive-
compulsive behavior, (F3) interpersonal sensitivity, (F4)
depression, (F5) anxiety, (F6) hostility, (F7) phobic anxiety,
(F8) paranoid ideation, and (F9) psychoticism. Three sup-
plementary global indices reflect the degree of symptoma-
tology. The global severity index (GSI) registers the average
depth of impairment based on the severity recorded for each
symptom; the positive symptom total index (PST) indicates
the total number of symptoms experienced; the Positive
Symptom Distress Index (PSDI) reflects the level of distress
by correlating the reported symptoms . In addition, on
the SCL-90-R, there are seven items not included in any of
the nine factors, among which, three reflect sleep quality.
Individual SCL-90-R factors have been used to evaluate the
psychological condition of PTSD patients, and there is suf-
ficient evidence to support the correlation of higher global
SCL-90-R scores with the severity of a patient’s core PTSD
symptoms [12, 48–57].
During the trial, patients were closely monitored for
adverse events (AEs) and worsening of symptoms. The time
of onset of any observed or spontaneously reported AE, its
duration and severity, any action taken, and the outcome
2.5. Herbal Preparation and Dispensing. The original for-
mula, Xiao-Yao-San, contains eight herbs: Chai-Hu (Radix
Bupleuri), Dang-Gui (Radix Angelicae sinensis), Fu-Ling
(Poria), Bai-Zhu (Rhizoma Atractylodis macrocephalae), Bai-
Shao (Radix Paeoniae alba), Bo-He (Herba Menthae), Zhi
Gan-Cao (Radix Glycyrrhizae preparata), and Sheng-Jiang
(Rhizoma Zingiberis recens). Our modification, XTJYF, con-
tains all the herbs of the original formula, except Sheng-
Jiang, plus additional seven herbs, including Fa Ban-Xia
(RhizomaPinelliae preparatae)and Chen-Pi (PericarpiumCi-
tri reticulatae), that are commonly used for psychological
disorders (see Table 1).
All herbal substances used in this trial are listed with the
Pharmacopoeia Commission of China, 2005, and are accept-
ed as suitable for human consumption when administered
within standard dosage levels. None of these herbs is a con-
trolled substance or an endangered species. Raw herbs were
(Shanghai, China). The herbs were extracted with water, and
the resulting granules were packaged by the Chinese Drug
Preparation Department of Shanghai Changzheng Hospital.
Levels of heavy metals and microbial and pesticide residues
were carefully assessed, and all fell well within the normal
The placebo granules, purchased from Jiangsu Tianjiang
Pharmaceutical Company, Ltd., were designed to resemble
the XTJYF granules in taste, smell, and appearance. The
placebo was composed of dextrin, sunset yellow fcf, and a
sweetener; the proportion was 1200:1:7. After being tested
on five independent volunteers, the placebo was deemed in-
distinguishable from XTJYF. XTJYF and the placebo were
dispensed in identical opaque packages.
2.6. Statistical Analysis. Quantitative data was summarized
using mean, standard deviation (SD), or 95% confidence
interval (95% CI). Qualitative data was described using pro-
portion, as percentages. Baseline characteristics of the two
groups were compared using the two-sided chi-square test
or t-test at a significance level of 0.05.
Since this was a randomized, blind clinical trial, the sta-
tistical analyses for treatment effect evaluation of the pri-
mary and secondary outcomes are relatively straightforward.
Baseline-to-end-point score changes in the three global SCL-
90-R indices and rates of response in the GSI were computed
as the primary endpoints. For defining rate of response,
patients with a reduction of at least 30% from the baseline
GSI score were classified as “much improved”; at least 50%,
as “very much improved.” Subanalyses of the baseline-to-
end-point score changes of the nine SCL factors and sleep
quality score (the average of the scores of the three SCl-90-R
items on sleep quality) were secondary endpoints. Statistical
analysis on both primary and secondary outcomes was done
using intention-to-treat analysis (ITT) with statistical soft-
ware SPSS. Missing values in the SCL-90-R questionnaire
for the patients who withdrew from the study before the
eighth week were imputed using the last-observation-car-
three global indices) and number needed to treat (NNT, for
rate of response in the GSI), as well as the P values from two
sample t-tests and chi-square tests, are reported in the treat-
ment effect assessment. The same analytic approaches were
applied to the secondary outcomes. Additionally, Fisher’s
exact test was used to compare the difference in dropout rate
and AEs between the two treatment groups.
A total of 3478 individuals were screened, of whom 820 pass-
ed the preliminary screening and 245 were finally enrolled
into the study; 575 were excluded. Of these, 372 were lost
to follow-up or refused enrollment; 178 did not meet the
inclusion criteria; 25 met the exclusion criteria. Enrolled
patients were randomly assigned to XTJYF (n = 123) or
placebo (n = 122) treatment. Of these, 102 (83%) of the
XTJYF group and 99 (81%) of the control group completed
the whole study. Reasons for withdrawal from the study are
listed separately for each treatment group in Figure 1, and a
detailed discussion on treatment tolerability is provided in
3.1. Baseline Characteristics and GPS Assessment. Table 2
shows that randomization was effective and that there were
no significant differences between the two groups in baseline
demographics, core clinical PTSD symptoms, or baseline
SCL-90-R global indices. Even though individual SCL-90-
R factor scores and sleep quality scores at baseline are not
shown here, we checked all of them and founded no signi-
ficant differences between the two groups. Notice that
women constituted 72% of XTJYF-treated and 71% of place-
bo-treated patients. Ages ranged from 16 to 85; 64% were
Table 3 shows the urgency of the public health needs
of these earthquake-affected PTSD patients and indicates
Evidence-Based Complementary and Alternative Medicine5
Table 2: Baseline characteristics, earthquake-affected PTSD patient treatment groups.
(N = 123)
(N = 122)
Sex, n (%)
Age, mean (SD)
Marital status, n (%)
Married or living together
Others (unmarried, divorced, etc.)
Education, n (%)
Primary school or less
More than primary school
Occupation, n (%)
Farmer or unemployed
Other employment or retired
Clinical PTSD symptom data, n (%)
Uncontrollable recall of earthquake experiences
Repeated nightmares of earthquake
Heart racing, sweating, pallor when viewing earthquake ruins or victims
Tense or easily agitated
Lack of concentration
Avoids recalling anything related to the earthquake
Avoids activities related to earthquake
Avoids contact with others, indifferent to relatives
Loss of interest and motivation
Loss of hope for the future
Lost relatives in the earthquake, n (%)
Baseline outcome measures from SCL-90-R, mean (SD)
Global severity index
Positive symptom total index
Positive symptom distress index
that baseline scores of the patients in our clinical trial are
significantly higher in all nine SCL-90-R factors and all three
supplementary global indices than those seen in Chinese and
American norms [41, 42].
3.2. Treatment Effect on Primary Outcomes. Table 4 shows
tary global index scores compared to the placebo group.
Based on the reported effect sizes, XTJYF treatment has a
moderate effect on GSI and PSDI indices and a small effect
on the PST index. Our findings on the rate of response,
defin-ed based on GSI score improvement, are displayed in
Figure 2; 50% of the XTJYF patients versus 28% of those
in the placebo group were “much improved,” providing
statistically significant evidence supporting the advantage of
XTJYF over placebo at the level of 0.05 (P value = 0.001).
The NNT is 4.55. Additionally, as Figure 2 shows, 20% of
the XTJYF patients versus 12% of those in the placebo group
were “very much improved,” but this result is not statistically
significant (P value = 0.12).
3.3. Treatment Effect on Secondary Outcomes. The second
part of Table 4 displays the treatment effects of XTJYF and
placebo on the nine SCL factors and sleep quality score. The
results indicate that, in comparison to placebo, the XTJYF
group experienced statistically significant improvement after
treatment in five of the nine SCL factors, somatization (P =
0.003), obsessive-compulsive behavior (P = 0.036), de-
pression (P = 0.001), anxiety (P < 0.001), and hostility
6 Evidence-Based Complementary and Alternative Medicine
Table 3: SCL-90-R Factor scores, Chinese and American norms compared to earthquake-affected PTSD patients at baseline.
N = 1388
Mean (95% CI)
N = 974
Mean (95% CI)
N = 245
Mean (95% CI)
Global severity index
Positive symptom total index
Positive symptom distress index
?The original data was obtained from Jin et al. . We recalculated the original data from “mean (sd)” to “mean (95% CI)” in order to make these data
comparable.•The original data was obtained from Derogatis . We recalculated the original data from “mean (sd)” to “mean (95% CI)” in order to make
these data comparable.∗Compared to the Chinese and American norms, P < 0.05.?Compared to the American norms, P < 0.05.
Table 4: XTJYF treatment effect on primary and secondary outcomes.(1)
SCL-90-R factor XTJYF (N = 123)
Mean (95% CI)
Placebo (N = 122)
Mean (95% CI)
Global severity index
Positive symptom total index
Positive symptom distress index
(1)Statistical analysis was done using intent-to-treat analysis (ITT) with SPSS.(2)Cohen’s d effect size measure, in which an effect size of 0.2 to 0.3 is considered
a “small” effect, around 0.5, a “medium” effect, and 0.8 to infinity, a “large” effect, is used here.(3)The P values come from the two sample t-tests.
(P = 0.019). Based on the reported effect sizes, XTJYF
treatment has a moderate effect on somatization, depression,
anxiety, and hostility, as well as a small effect on obsessive-
compulsive behavior, interpersonal sensitivity, and phobic
anxiety. Table 4 also shows that XTJYF treatment yielded
statistically significant improvement in sleep quality at the
end of the study, with a P value of less than 0.001 and a mo-
derate effect size.
3.4. Treatment Tolerability. Overall, XTJYF was well toler-
ated. Compliance rate, 83% for the XTJYF and 81% for the
placebo group, was reasonably high. Six in the XTJYF and
five in the control group withdrew due to adverse effects,
so reported AEs were similar in the two groups. The most
0.24), diarrhea (10.6% versus 6.5%; P = 0.36), and malaise
(10.6% versus 12.3%; P = 0.69). All AEs were minor and
were determined to be unrelated to the ingestion of XTJYF.
In the XTJYF group, 21 subjects dropped out (17.1%); in
the placebo group, 23 did (18.9%, P = 0.74). The primary
reasons cited for dropout in the XTJYF and placebo groups,
respectively, were AE (4.9% versus 4.1%; P = 1); lost to
Evidence-Based Complementary and Alternative Medicine7
Response rates (%)
Much improved Very much improved
Figure 2: Treatment response rates of XTJYF versus placebo. Pa-
tients with a score reduction of at least 30% from the baseline SCL-
90-R GSI score were classified as “much improved,” and 50%, as
“very much improved.”∗XTJYF versus placebo, P < 0.05.
follow-up (1.6% versus 2.5%; P = 0.68); protocol violation
(4.9% versus 3.3%; P = 0.75); lack of efficacy (3.3% versus
6.6%; P = 0.25); miscellaneous reasons, for example, disliked
the taste of the herbs (2.4% versus 2.5%; P = 1). Subjects’
laboratory values and vital signs were similar in the two
groups. Changes in these values were minor, infrequent, and
not considered clinically meaningful.
In the present study, we compared our data to the Chinese
norm calculated by Jin et al.  and to the USA norm pub-
lished by Derogatis . (see Table 3). At baseline, the nine
SCL factors and three global indices were higher than the
norm in these earthquake-related PTSD subjects, suggesting
that earthquake-related PTSD is accompanied by poor GPS.
vestigators [3, 59–63].
Hypothesizing that it would improve poor GPS in earth-
quake-related PTSD, we investigated a Chinese herbal for-
and found that, compared to placebo, XTJYF significantly
improved all of the three global indices of SCl-90-R, and a
significantly greater proportion of patients were “much im-
proved” according to changes in GSI score. (See Table 4 and
Figure 2). A subanalysis provided a more detailed look at
specific XTJYF effects on poor GPS, showing that five of
the nine SCL factors and sleep quality score improved. (see
These findings suggest that XTJYF may globally improve
GPS in earthquake-related PTSD patients, specifically in
somatization, obsessive-compulsive behavior, depression,
anxiety, and hostility. In addition, the formula may improve
the sleep quality of the patients and appears to be safe.
Although a few subjects reported gastrointestinal complaints
such as nausea and diarrhea during treatment, these were
probably due to the poor diet available after the earthquake;
these symptoms were also frequently reported in the placebo
control group. Our findings are consistent with those of our
previous study on XTJYF for cancer patients with depression
The results are meaningful because all five of the psycho-
logical disorders mentioned above are associated with high
levels of functional and psychosocial disability in chronic
PTSD patients [3, 4, 6, 12–16, 64–69], and most are report-
ed to predict greater refractoriness to routine therapy in
individuals diagnosed with PTSD [17, 70–73]. For example,
PTSD patients who report somatic symptoms also report
higher overall PTSD symptoms [15, 64] and a higher freq-
uency of depression [64, 74]. Patients with co-morbid PTSD
and obsessive-compulsive behavior have been found to have
a poorer response to cognitive behavioral therapy than those
diagnosed with PTSD alone . Co-morbid PTSD/depres-
sion appears to predict greater refractoriness to pharmaco-
therapy, greater symptom severity, lower levels of function-
ing and rates of recovery, and increased disability and poten-
tial of suicide [4, 6, 65–67]. Like depression, anxiety sym-
ptoms are associated with lower quality-of-life estimates and
greater refractoriness to routine pharmacotherapy in PTSD
patients [3, 68]. Hostility, which according to a meta-anal-
ysis of 39 studies is significantly elevated in individuals with
PTSD , is linked to adverse health outcomes, including
cardiac death . In the present study, XTJYF also appears
of PTSD . All of these symptoms are likely to contribute
to alcohol and drug abuse [76, 77] as well as suicidal ideation
The psychological mechanisms of action of Xiao-Yao-
San and its modifications have been investigated. It has been
reported that the formula may act on psychological sym-
ptoms by upregulating central neurotransmitters such as
serotonin. Bao et al.  reported that Xiao-Yao-San pro-
duced antidepressant effects in a mouse model of depression
by ameliorating brain cortex 5-HT and 5-HIAA content.
Other mechanisms of the formula have also been reported.
stress in a rat model by up-regulating GluR2/3, the AMPA
receptor subunit 2/3, which mediates the postsynaptic de-
polarization that initiates neuronal firing , and by down-
regulating PICK1, a protein that interacts with C-kinase 1,
which may lead to AMPA receptor anchorage  in hip-
pocampal regions CA1 and CA3. Similar findings, that Xiao-
Yao-San upregulates AMPA receptor subunit mRNA expres-
sion in hippocampal region CA1 and the amygdala, were
reported . Furthermore, Xiao-Yao-San and its modifi-
ing the stability of hippocampal neurons , inhibiting hy-
pothalamic-pituitary-adrenocortical axis negative feedback
regulation , and counteracting increase of Ca2+concen-
tration in hippocampal synaptosomes . Based on TCM
theory, seven drugs were added in our modification, mainly
from another classic TCM formula, Er-Chen-Tang. Accord-
ing to our previous preclinical study, this modification may
8Evidence-Based Complementary and Alternative Medicine
suppress depression by up-regulating the 5-HT1A receptor
in the hippocampus in a rat model of chronic stress .
However, because Xiao-Yao-San and its modifications con-
tain multiple ingredients, specific active ingredients have not
been identified, and the herbal interactions within the for-
mula have not been systematically investigated. Further in-
vestigation to elucidate the mechanisms of action of this for-
mula is warranted.
Several limitations to this study should be noted. First,
our trial lacked a long follow-up assessment. This was large-
ly due to the difficulties in following up this particular pop-
ulation, which consisted of earthquake survivors living in
shelters with no specific address. In the patient recruitment
stage, more than 45% (372 of 820) of those preliminarily
screened for PTSD were lost to follow-up. Secondly, we did
not include a questionnaire measuring specific PTSD core
symptoms, mainly because of the low level of education in
this mountain population. In our patient population, 43%
had an elementary education or less and found it difficult
to complete a single 90-question SCL-90-R questionnaire.
However, although we did not include a specific question-
naire such as the Clinician-Administered PTSD Scale 
or the Clinician-Rated Treatment Outcome PTSD Scale 
to measure core PTSD symptoms, the widely used SCL-90-
R captures a broader patient psychological profile than a
specific PTSD questionnaire would do. Thirdly, only one
dosage of XTJYF was used in this study, that used in our
standard clinical practice. A higher dosage might benefit the
nonresponders. Finally, more detailed information on types
of trauma and the percentages of patients who suffered them
should be gathered and analyzed.
Despite the limitations, our findings provide preliminary
support for the use of TCM in treating GPS in earthquake
survivors with PTSD. TCM has been used extensively in
China to treat people suffering from various diseases after
herbal products is quick and cost effective in China. Tradi-
tional Chinese herbal medicine may provide an adjuvant
therapy that is safe, effective, and timely for affected popula-
tions in natural disasters such as earthquakes.
X.-Z. Meng and F. Wu made equal contributions.
Conflict of Interests
XTJYF is a modified formula of a classic Chinese herbal
formula, Xiao-Yao-San, made by adding herbs, mainly from
another classic TCM formula, Er-Chen-Tang. The modifica-
tion was compounded by one of the authors, Dr. P.-K. Wei.
XTJYF is a nonbrand, nongeneric name.
The work was supported by a Modernization of Chinese
Medicine Grant supported by the Shanghai Committee of
from the China National Science and Technology Foun-
dation (no. 2008ZXJ09004-021). The authors acknowledge
the assistance of the Air Force Sanatorium in Dujiangyan
for the use of their research assistants and study facilities.
This project could not have been completed without the on-
going support of the Psychology Department of the Second
Military Medical University. Particular thanks are given to
the psychologists Wei-Zhi Liu, Wen Dong, and Jun-Ling
Wang and to all the patients who contributed their time
to this study. They would like to thank Dr. Lyn Lowry of
the Center for Integrative Medicine, University of Maryland
School of Medicine, for her editorial support.
 State Council Information Office of the People’s Republic
of China: Latest Developments of Wenchuan Earthquake
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China: 845.1 billion yuan were lost in Sichuan earthquake.
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