The document describes a study that investigated the effects of artificial tiger bone powder on fracture healing time, wrist function recovery, and quality of life in elderly patients with distal radius fractures. 76 elderly patients with distal radius fractures were randomly assigned to either a treatment group that received artificial tiger bone powder or a control group that received a placebo. Outcomes including fracture healing time, wrist range of motion, and quality of life scores were measured before and 6 and 12 months after treatment. The study found that the treatment group had significantly shorter fracture healing times and better wrist function and quality of life scores compared to the control group after 6 and 12 months.

1. ARTICLE
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Traditional Chinese Medicine
Artificial tiger bone powder for improving the quality of life in elderly
patients with fracture
Li-You Wei1
, Hong-Wei Zhang1*
, Jin-Zeng Zuo1
, Su-Miao Xu2
1
The Second Hospital of Tangshan (Orthopaedic Hospital Affiliated to North China University of Science and
Technology), Tangshan, 063000, China. 2
Tangjiazhuang Hospital of Kailuan (Group) Limited Liability Corporation,
Tangshan, 063000, China.
*Corresponding to: Hong-Wei Zhang. The Second Hospital of Tangshan (Orthopaedic Hospital Affiliated to North
China University of Science and Technology), No. 21 Jianshebei Road, Tangshan, 063000, China. E-mail:
zhanghw200087@163.com.
Highlights
The early administration of artificial tiger bone powder after distal radius fracture promotes the healing of
fracture, recovery of wrist joint function, and ultimately improve the quality of life in elderly patients.
Traditionality
Tiger bone has been used as a rare traditional medicinal product in ancient Chinese pharmacopoeia for
hundreds of years. The earliest record about the usage of tiger bones as a medicine is in the ancient book of
Chinese medicine Ming Yi Bie Lu published in Han Dynasty of China (184 C.E.- 220 C.E.). After that, there
were many traditional Chinese medicine ancient books recorded that tiger bone had the effect of analgesia,
eliminating wind to dispersing cold and strengthening bone. Presently, however, tiger bone use has been
banned internationally and in China as a protected species. The artificial tiger bone powder is extracted from
non-protected animal bones by modern bionic technology, and has almost the same composition as natural
tiger bone.

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Abstract
Objective: To investigate the application of artificial tiger bone powder on fracture healing time, wrist functional
recovery and quality of life (QOL) in elderly patients with distal radius fracture. Methods: The study was a
randomised controlled trials performed from January 2015 to December 2016 in a hospital. Elderly patients with
distal radius fracture were divided into the treatment and the control groups by the random sealed envelope method.
All patients were given splint or plaster fixation after manipulative reduction, and functional exercise, the treatment
group was also given artificial tiger bone powder orally (trade name: Jintiange capsule), the control group was
given an oral placebo in their appearance and usage identical with the treatment group. Prior to treatment and 6, 12
months after treatment, the wrist function was assessed by range of motion, including flexion-extension,
radial-ulnar and pronation-supination, and the QOL was assessed by the Mos 36-item Short Form Health Survey.
Each patient's fracture healing time was recorded. Results: Before treatment, there were no significant differences
in wrist function and QOL between the two groups. At 6 and 12 months after treatment, the wrist function and QOL
in the treatment group were better than those in the control group, the differences were statistically significant (P <
0.05). The fracture healing time in the treatment group was shorter than that of the control group, and the difference
was statistically significant (P < 0.05). Conclusion: The early usage of artificial tiger bone powder for elderly
patients with distal radius fracture can promote the healing of fracture, recovery of wrist joint function, and
ultimately improve the QOL for elderly patients.
Keywords: Artificial tiger bone powder, Elderly people, Distal radius fracture, Wrist function, Quality of life.
Acknowledgments:
This work was supported by Science and Technology Support Project of Hebei Traditional Chinese Medicine
Administration (No. 2019210).
Abbreviations:
ROM, Range of motion; QOL, Quality of life; SF-36, Mos 36-item Short Form Health Survey; PF, Physical
functioning; RP, Role limitations due to physical health problems; BP, Bodily pain; GH, General health; VT,
Vitality; SF, Social functioning; RE, Role limitations caused by emotional problems; MH, Mental health.
Competing interests:
The authors declare that there is no conflict of interests regarding the publication of this paper.
Citation:
Li-You Wei, Hong-Wei Zhang, Jin-Zeng Zuo, et al. Artificial tiger bone powder for improving the quality of life
in elderly patients with fracture. Traditional Medicine Research, 2019, 4 (4): 213-221.
Executive Editor: Pan Shao, Nuo-Xi Pi.
Submitted: 31 May 2019, Accepted: 22 June 2019, Online: 29 June 2019.

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Background
Distal radius fracture is a common form of fracture,
this kind of fracture is common among the elderly, the
incidence of distal radius fracture is about 17 % of
emergency fractures [1-3]. Within increasing aging
society, the incidence of distal radius fracture resulted
from injury in the elderly is gradually increasing. The
injury mechanism of distal radius fracture is when the
palm or back of the hand strikes the ground when the
elderly fall, and the transmission of force to the distal
radius causes a fracture [4-8]. In elderly patients with
varying degrees of osteoporosis and reduction of bone
strength, once their distal radius bear external force,
they are very easy to fracture. Therefore the distal
radius fracture in most elderly patients is a low
invasive fracture, which is referred to as brittle fracture.
Whether receiving surgery or conservative treatment,
the elderly patients are unable to perform normal
activity for a period of time following the fracture
reduction and fixation, which usually can aggravate
osteoporosis, and then the healing of the radius fracture
is disturbed. Consequently, early effective medicine
intervention is important for improving the elderly
patient’s quality of life (QOL).
Tiger bone has been used as a rare traditional
medicinal product in ancient Chinese pharmacopoeia
for hundreds of years. The earliest record about the
usage of tiger bones as a medicine is in the ancient
book of Chinese medicine Ming Yi Bie Lu published in
Han Dynasty of China (184 C.E.- 220 C.E.). After that,
there were many traditional Chinese medicine ancient
books recorded that tiger bone had the effect of
analgesia, eliminating wind to dispersing cold and
strengthening bone. Presently, however, tiger bone use
has been banned internationally and in China as a
protected species. The artificial tiger bone powder is
extracted from non-protected animal bones by modern
bionic technology, and has almost the same
composition as natural tiger bone [9]. The
pharmacological studies have proven that the effective
ingredients in artificial tiger bone powder have
considerable effects on enhancing bone metabolism
and promoting fracture healing [10]. Jintiange capsules
are a type of Chinese patent medicine made of artificial
tiger bone powder. Likewise Jiantiange capsules are
included in the Directory of Animal Medicinal
Products by Food and Drug Administration of China.
Its effectiveness for treating osteoporosis fractures has
been confirmed by a large number of clinical studies
[11, 12]. In this study, we used artificial tiger bone
powder plus conventional therapy for treating distal
radius fractures in elderly patients, then subsequently
observed the effects in fracture healing, functional
recovery and improving the patient’s QOL. This report
is set out as follows.
Materials and methods
Participants
Commencing from January 2015 and concluding
December 2016, eighty elderly patients with distal
radius fracture and closed unilateral fracture confirmed
on radiograph were selected. Closed unilateral fracture
was defined according to the Dutch National
Guidelines [13]. The classification of distal radius
fracture was aligned to Arbeitsgemeinschaft für
Osteosynthesefragen (AO)/Association for the study of
internal fixation [14].
Inclusion criteria
Adult patients older than 60 years of age diagnosed
with distal radius fracture and closed unilateral fracture
confirmed on radiograph; the patients with primary
causes of injury of falls and traffic accidents and other
miscellaneous accidents; the patients were provided
conservative treatment of distal radius fracture and
given splint or plaster fixation after manipulative
reduction and functional exercise.
Exclusion criteria
Patients excluded from this study were those with prior
history of injury to either wrist; those with pathological
fractures from osteomyelitis, bone tuberculosis, bone
tumors, open fractures or bilateral fracture; those
suffering from severe liver, kidney and other organ
dysfunctions or mental disorders.
Ethical standards
Patients signed agreements outlining their voluntarily
participation in the program and were informed of the
relevant treatment conditions. This study was approved
by Second Hospital of Tangshan Ethics Committee
(Tangshan, China).
Trial design
This study is a randomized control trial, the number of
patients in the treatment and the control group was 1:1.
According to formula N = Z2
× [P × (1-P)]/E2
, N is the
sample size, Z is the confidence interval, P is the
probability value, E is the error value. The confidence
is 90%, Z = 1.64. A minimum of 30 patients in each
group would be needed, because of some subjects may
fall off in the course of experiment, so the final sample
size was N = 80.
Randomization
These selected subjects were divided into the treatment
and the control groups via applying the random sealed
envelope method, 40 patients in each group. A
computer-generated randomization list with
1:1 allocation (artificial tiger bone powder : placebo)
was used. The treatment allocation was placed in

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a sealed, opaque, envelope and picked up
sequentially. Once a patient has consented to enter a
trial, an envelope was opened and the patient was then
offered the allocated treatment regimen.
Blinding
Both patients and intervenors were blinded, patients
were not aware of if they were selected for the
treatment or the control group and likewise the
intervenors were also not aware of what medicine they
assigned. Placebo capsules consisted of starch giving it
the same appearance as the Jintiange capsules
(artificial tiger bone powder).
Intervention
All patients were provided conventional treatment.
Splint or plaster fixation after manipulative reduction
for 4 to 6 weeks, functional training included flexion
and extension of fingers during flexion of splint or
plaster, rehabilitation exercise adding flexion and
extension of wrist after removal of plaster or splint
flexion and hot compresses on the wrist.
The treatment group was also given artificial tiger
bone powder orally, with trade name of Jintiange
capsule (Jinhua Enterprise Limited by Share Ltd. Xi'an
Jinhua Pharmaceutical Factory, China), 3 times daily,
1.2g for each time, 3 months for a course. The control
group was given a placebo of starch in their capsule
and usage identical with Jintiange capsules. No other
substance or medicine was permitted during the
treatment and follow-up period.
Effectiveness evaluation
Before treatment, and 6, 12 months after treatment,
outcomes including wrist range of motion (ROM),
QOL and fracture healing time were recorded.
The wrist ROM recommended by the American
Orthopaedic Associatio includes flexion-extension,
radial-ulnar and pronation-supination. The determined
score of ROM is expressed as percentage of the
affected side / healthy side [15].
QOL is assessed by the Mos 36-item Short Form
Health Survey (SF-36). The SF-36 consists of 36
questions organized into eight sub-categories including
physical functioning (PF), role limitations due to
physical health problems (RP), bodily pain (BP),
general health (GH), vitality (VT), social functioning
(SF), role limitations caused by emotional problems
(RE) and lastly mental health (MH). Each project
consists of 2 to 10 problems, converted score = [(actual
score － the project may be the lowest score) / (the
project may be the highest score － the project may
be the lowest score)] × 100. The score ranges from 0 to
100 points, higher scores indicate better health status
[16-18]. SF-36 is a general purpose medical survey for
assessing the QOL. Elderly patients with distal radius
fracture and who simultaneously suffer from
osteoporosis have a QOL which is generally at a low
level. SF-36 can indicate changes of QOL from
multiple perspectives, so we choose SF-36 for
evaluating QOL in this study.
The fracture healing time is determined according to
the formation of the callus and local examination of
fracture. The standard of fracture healing is that there
is no local tenderness and longitudinal percussion pain,
nor abnormal activity. X-rays show the fracture line
blurred with continuous callus formation. After
removing the external fixation, arms horizontally raise
1 kg weight up to 1 min [19].
Statistical analysis
All data was analyzed using statistical software
SPSS17.0 (SPSS software Inc., USA). Measurement
data was presented as mean ± standard deviation. The
variance of the sample is homogeneous and accords
with the normal distribution. T-test was used for
comparing between the two groups, including of the
age, fracture healing time, wrist ROM and SF-36. The
x2
test was used to analyze numerical data, including of
the gender, side, flexion and cause. Mann-Whitney test
was used to analyze rank data, including of the
AO-type. Lastly, P < 0.05 was regarded as the
difference has statistical significance.
Results
Comparison of basic situation
Eighty elderly patients with distal radius fracture were
elected, four selected patients were excluded, of which
three patients dropped out and changed to surgical
treatment because of fracture displacement, and one
patients ended the experiment for complaining the
curative effect of the medicine. Finally, 76 patients
entered the statistical analysis and each group had 38
patients. The flow diagram of this study design was
depicted in Figure 1.
There are no significant differences between these
two groups in the terms of gender, age, AO type,
trauma, cause of injury, etc. (P > 0.05). The healing
time for the fracture treatment group is shorter than
that of the control group, and this difference is
statistically significant (P < 0.05) (Table 1). There
were no adverse reactions to the medicine in these two
groups, and there were no obvious abnormalities when
examining their blood, urine and stool (Data not
shown).
Comparison of wrist function
Before treatment (0-month), there are no statistically
differences in terms of wrist ROM between these two
groups (t0 = 1.432, t0 = 0.123, t0 = 1.145, P > 0.05). At
6 and 12 months after treatment, the wrist ROM in
treatment group are higher than those of control group,
and the differences are statistically significant (t6 =
4.308, t6 = 3.65, t6 = 7.141, t12 = 2.258, t12 = 5.249, t12
= 2.595, P6 < 0.001, P6 < 0.001, P6 < 0.001, P12 =

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0.027, P12 < 0.001, P12 = 0.011). The outcomes are
measured at three time points: baseline, at six months,
and at twelve months. The higher the score, the better
the function. As shown in Figure 2.
Comparison of quality of life
Before treatment (0-month), there are no statistically
differences in projects of SF-36 between the two
groups (t0 = 1.112, t0 = 1.208, t0 = 0.852, t0 = 0.786, t0
= 0.700, t0 = 0.912, t0 = 0.345, t0 = 0.694, P > 0.05). At
6 and 12 months after treatment, the scores of SF-36 in
treatment group are higher than those of control group,
and the differences are statistically significant (t6 =
4.159, t6 = 3.611, t6 = 3.418, t6 = 3.219, t6 = 2.536, t6 =
2.506, t6 = 2.535, t6 = 4.053, t12 = 3.310, t12 = 2.039, t12
=4.88, t12 = 3.998, t12 = 4.252, t12 = 2.179 , t12 = 2.437,
t12 = 3.014, P6 < 0.001, P6 < 0.001, P6 = 0.001, P6 =
0.002, P6 = 0.014, P6 = 0.014, P6 = 0.013, P6 < 0.001,
P12 = 0.001, P12 = 0.045, P12 < 0.001, P12 < 0.001, P12
< 0.001, P12 = 0.032, P12 = 0.018, P12 = 0.004). The
higher the score, the better the QOL. As shown in
Figure 3.
Assessed for eligibility (n = 80 )
Excluded (n = 0)
Not meeting inclusion criteria (n = 0)
Declined to participate (n = 0)
Randomized (n = 80)
Allocated to the treatment group (n = 40).
Received artificial tiger bone powder orally.
Allocated to the control group (n = 40).
Received an oral placebo.
Discontinued intervention (n = 2)
Changed to surgical treatment (n = 2)
Discontinued intervention (n = 2)
Feeling ineffective (n = 1)
Changed to surgical treatment (n = 1)
Analysed (n = 38)
Analysed (n = 38)
Figure 1 Flow diagram of this randomized controlled trials
Table 1 Baseline demographics and fracture healing time
Group
Gender
(cases)
Age
(years)
Side
(cases)
AO-type
(cases)
Flexion
(cases)
Cause
(cases)
Fracture healing time
(weeks)
M/F L/R A/B/C Plaster/splint Fall/traffic/other
Control (n = 38) 12/26 69.16 ± 4.56 17/21 6/13/19 11/27 32/4/2 12.82 ± 1.51
Treatment (n = 38) 15/23 68.64 ± 4.52 20/18 7/15/16 13/25 34/3/1 11.47 ± 1.68
x2
/t/ Z, P value
x2
= 0.517 t = 0.425 x2
= 0.474 Z = -0.649 x2
= 0.244 x2
= 0.537 t = 3.473
P = 0.472 P = 0.673 P = 0.491 P = 0.516 P = 0.622 P = 0.765 P < 0.001

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Note: M/F: Male/Female; L/R: Left/Right; AO-type: Arbeitsgemeinschaft für Osteosynthesefragen type; A: Extra
articular fractures; B: Partial intra-articular fractures; C: Complete intra-articular fracture.
Discussion
It is generally agreed that the distal radius fracture
occurs inside 3 cm of the distal radius, at the junction
of cancellous bone and compact bones, and the
collapse of cancellous bone is easy to occur when
under force. Since many elderly have osteoporosis and
bone mass reduction, they are vulnerable to suffer from
comminuted bone fractures and distal radius fractures.
Whether elderly patients with distal radius fractures are
treated only with surgery is remain controversial
in the medical academic field. The majority of
Medical authorities recommend surgical treatment of
Figure 2 Comparison of wrist ROM
A: Flexion-extension; B: Radial-ulnar; C: Pronation-supination. Unit of wrist ROM is showed as percentage (%).

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Figure 3 Comparison of SF-36
Unit of project of SF-36 is score. PF: Physical functioning; RP: Role limitations due to physical health problems;
BP: Bodily pain; GH: General health; VT: Vitality; SF: Social functioning; RE: Role limitations caused by
emotional problems; MH: Mental health.
intra-articular distal radius fractures as their first
choice [20, 21]. The greatest advantage for surgical
treatment is that it can provide good fracture reduction
[22, 23]. However, because many elderly patients with
fractures usually have associated with other organ
diseases, surgical treatment has its definite
shortcomings of high cost and high risk [24, 25].
Therefore the majority of elderly patients choose a
conservative treatment. No matter what kind of
treatment mode is selected, it is still difficult to provide

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the best conditions for fracture healing and its
subsequent recovery of wrist action. Having a certain
period of braking the bones and being immobilized
causes stress and bone loss and subsequently the
adverse effects of osteoporosis in wrist. Therefore,
traditional medicine with its effectiveness in limiting
the effects of osteoporosis and promoting fracture
healing is supplemented in the treatment in elderly
patients with distal radius fractures. This would
maximize the recovery of wrist function and improve
the elderly patient’s QOL.
Tiger bone has the pharmacological function of
strengthening bones, analgesia and curing rheumatism,
which was recorded in the Annals of Traditional
Ancient Pharmacopoeia. Tiger bones have been used
as a rare traditional medicinal product for hundreds of
years. Recently, in order to protect the endangered wild
species, the tiger and its bones are not allowed for
medicinal purposes. However, there are ready
substitutes for tiger bones and non-protected animals
such as cattle and deer that provide an ample supply of
tiger bone substitute. Such artificial tiger bone powder
contains a variety of organic compositions such as
collagen, bone morphogenetic protein, bone growth
factors and polysaccharides. These ingredients can
promote bone formation, increase bone density, and
lastly inhibit bone resorption [10]. Animal experiments
show that artificial tiger bone powder can raise level of
alkaline phosphatase, increase bone
gamma-carboxyglutamic acid-containing proteins,
raise bone mineral content, accelerate bone metabolism,
and enhance bone repair [26]. Alternative studies
suggest that artificial tiger bone powder can activate
osteoblasts, inhibit osteoclasts and promote the
formation of cartilage callus during the early stages of
fracture. Likewise it accelerates the mineralization of
callus during the latter stages of bone fracture and this
promotes a fracture’s healing [27]. The effectiveness of
artificial tiger bone powder in treating osteoporosis and
fractures has been consistently affirmative [10-12] and
the application of this medicine has been incorporated
into China’s guidelines for treatment of osteoporosis
fractures.
SF-36 can accurately evaluate the QOL for patients
suffering from fractures. The higher range scores
illustrate the better recovery of fracture and the higher
QOL [16-18, 28, 29]. In this study, the QOL and wrist
function in the treatment group were higher than those
in control group. Fracture healing time in treatment
group was shorter than that in the control group. These
results have demonstrated that the early application of
artificial tiger bone powder plus conventional
treatment can promote fracture healing in elderly
patients. Additionally artificial tiger bone application
can improve the wrist joint functioning, and ultimately
improve the elderly’s QOL. Lastly, elderly patients
afflicted with distal radius fractures can be assisted by
avoiding local osteoporosis, and it further promotes
fracture healing.
Conclusion
Distal radius fracture is one of the most common
fracture form among the elderly. After exposure of
surgery or conservative treatment, the majority of the
elderly patients are unable to perform normal wrist
function for a period of time and achieve excellent
QOL. Since ancient time of China, Chinese medicine
tiger bone has been considered have the effect of
analgesia, eliminating wind to dispersing cold and
strengthening bone. The present clinical research
demonstrated the early application of artificial tiger
bone powder for elderly patients with distal radius
fracture can promote the healing of fracture, recovery
of wrist joint function, and ultimately improve the
QOL.
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