Artificial tiger bone powder for improving the quality of life in elderly patients with fracture

Li-You Wei,Hong-Wei Zhang*,Jin-Zeng Zuo,Su-Miao Xu

1The Second Hospital of Tangshan (Orthopaedic Hospital Affiliated to North China University of Science and Technology),Tangshan,063000,China.2Tangjiazhuang Hospital of Kailuan(Group)Limited Liability Corporation,Tangshan,063000,China.

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 medicineMing Yi Bie Lupublished 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 theDirectory of Animal Medicinal Productsby 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 theDutch 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 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.Thex2test 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=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.

Figure 1 Flow diagram of this randomized controlled trials

Table 1 Baseline demographics and fracture healing time

Discussion

Figure 2 Comparison of wrist ROM

Figure 3 Comparison of SF-36

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 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 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 theAnnals 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.