| Primary osteoporosis is a metabolic bone disease characterized by decreased bone mass,increased bone fragility and increased risk of fracture,and is frequently appeared in the elderly and postmenopausal women.The symptom of pain caused by the primary osteoporosis has seriously affected the quality of the life of the elderly.The greater risk of fractures caused by the primary osteoporosis even directly threatens the lives of the elderly.The Chinese medicine circle believes that osteoporosis belongs to the category of kidney deficiency and bone atrophy.Symptoms include deficiency of kidney essence,lumbar spinal pain,weakness of the lower extremities,etc.Kidney-reinforcing and bone-strengthening are classic theories of traditional Chinese medicine.The Chinese traditional medicine strong bone capsule consisted of the active ingredient of polygonum multiflorum,epimedium,prepared rehmannia root,tortoise shell,morinda root,eucommia bark,dipsacus root,drynaria rhizome,Chinese angelica,Chinese yam under special processing with the analgesic and sedative effect can treat the primary osteoporosis with syndrome of deficiency of kidney yang and deficiency of kidney yang by supplementing liver and kidney,invigorating essence and blood,regulating yin and yang,nourishing the blood and promoting blood circulation,expelling wind and removing damness,strengthening tendons and bones based on the theory of the kidney generating marrow and dominating bone.The randomized,single-blind,positive drug parallel control,multicenter clinical study design method is adopted.It planned to enroll 300 subjects,but the actual enrollment was 158 cases.The test group and the control group receive the subjects with the stratified group randomization method according to the proportion of 1:1.A total of 25 cases were lost during the test,while 12 cases belong to the experimental group,and 13 cases belong to the control group.The random number will be sent to each test center,and the researcher or research nurse randomly distributes the drug numbers and distributes the corresponding drug according to the sequence of each subject in ascending order.They can not randomly or purposely select the drugs.The drug number remained unchanged throughout the test of the subject.The Chinese medicine strong bone capsule(No.1 medicine)was distributed to the experimental group,4 grains one time,3 times a day,taken 30 minutes after the meal.The Xianlinggubao capsule(No.2 medicine)was distributed to the control group,3 grains once.2 times a day,taken 30 minutes after the meal.The course of treatment is 12 weeks.The test analyzed baseline characteristics of the tested population and the demographic characteristics of the subjects(including age,height,weight,history of past illness,family history),etc.The data were roughly balanced between the two groups,suggesting that there is a comparability between the two groups.The validity indexes include the analysis of measured bone mineral density,the analysis of SF-3 6 scoring scale,pain score analysis,analysis of height change and the analysis of fracture condition during test.The TCM syndromes include the analysis of TCM syndrome scale scoring.The experiment reevaluated the effectiveness of Chinese medicine strong bone capsule from the perspectivs of effectiveness index and TCM syndrome scoring.The test drug,strong bone capsule,is used to treat primary osteoporosis(deficiency of kidney-essence),and it has the similar effect of the control drug,Xianling Gubao capsule.Both of them slow down or even stagnate the loss of bone mineral density.Besides,the group taking strong bone capsule showed an increasing trend in the measurement of bone density of the femoral neck and femur great trochanter.The group taking Xianlinggubao capsule showed a significant increase in L2～L4 average and femoral neck.In addition,both of them have a good effect on improving the pain symptoms of lower back and lower extremities of subjects,and they showd good improvement on the physical health,physical function,social function,somatic pain and other iems of the SF-36 scoring,clearly reducing the TCM syndrome quantitative score.It shows that the curative effect of Chinese medicine strong bone capsule on primary osteoporosis(deficiency of kidney-essence)is not inferior to the Xianling Gubao capsule. |
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