Combining The Effect Of Invigorating Kidney And Strengthening Spleen As Well As Promoting Blood Circulation To Treat The Primary Osteoporosis: A Randomized Controlled Trial

Osteoporosis (OP) is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue. The clinical symptoms include bone pain, spinal deformity and with a consequent increase in bone fragility and susceptibility to fracture. Bone repairs itself by actively remodeling, bone resorption and bone formation. So the treatments and the drugs developing are based on these mechanism. To achieve ideal treatment effect, the combination of multiple drugs is in need, which may result in high cost and many other adverse reactions defects. Therefore, to take the key features of Traditional Chinese Medicine in treatment of osteoporosis into play, developing Chinese materia medica preparation for osteoporosis prevention and treatment has become one of the most important tasks for clinical doctors. Currently, the research of primary osteoporosis medicine has been started from single herb to preparation. However, due to the small sample size of clinical trial, unified evaluation standards of TCM syndromes differentiation and effect evaluation, research in this paper is a randomized controlled trial, which is based on the combining the effect of invigorating kidney and strengthening spleen as well as promoting blood circulation, providing ideas for Chinese medicine clinic treatment of osteoporosis.Patterns of the use of traditional Chinese medicines in the internal treatment of primary osteoporosisObjectiveTo explore the patterns of the use of traditional Chinese medicines in prevention and treatment of primary osteoporosis (POP).MethodsTo study the patterns of the use of traditional Chinese medicines in prevention and treatment of POP, correlative data between 1994 and June 2010 were collected, Their therapy, prescription and collocations were statistically analyzed with the aim to reveal their medical regularities.ResultsThe statistical analysis was performed on 165 documents and 177 prescriptions (totaling 152 kinds and 1847 counts of herbs) of confirmed efficacy, which were prescribed by experts. The warm, calm, cold of property of Chinese herbs take the most proportion; meanwhile the sweet, bitter, pungent of the flavours take the most proportion. In drug classifications, supplementing drug has 39 categories, accounted for 25.65%, wherein yang- supplementing drugs dominates in this classification compared with yin- supplementing.ConclusionKidney deficiency is the root of POP, spleen deficiency is the stimulation, and the blood stasis is the pathological base and produce. The therapy must invigorate kidney, strengthen spleen, and promote blood circulation for removing blood stasis as well. In addition, TCM emphasize the treatment in accordance with differentiation of syndromes and symptoms, which is more direction, and more efficient. Combining the effect of invigorating kidney and strengthening spleen as well as promoting blood circulation to treat the primary osteoporosis:A randomized controlled trialObjective(1) By means of different group therapy, to analyze the efficacy of each treatment of 3 groups, through the improvement of the core symptoms and TCM-type symptoms, and changes of the BMD and blood laboratories.(2) To explore the role of treatment in the process of the osteoporosis, which is combining the effect of invigorating kidney and strengthening spleen as well as promoting blood circulation.(3) To discusses the efficacy evaluation method of the treatment of osteoporosis.MethodThis study is a randomized -controlled trial. The 45-80 years old patients are object of study, who visit the Xiyuan Hospital of China Academy of Chinese Medical Sciences from march 2008 to February 2011.The patients who meet the inclusion criteria are divided into three groups, who treated Jingujian Granule, decoction and Caltrate D. The patients in Jingujian Granule and decoction group are divided into syndrome of kidney deficiency, syndrome of spleen and kidney deficiency, syndrome of spleen and kidney deficiency with blood stasis. The patients general information, the core symptoms and the TCM syndromes are learned by the Case Report Form, and collect the BMD and the laboratory examinations. There are 3 mouths as a course, and statistical analysis the data with SPSS 17.0.Result(1) Treatment efficacy of the symptoms:after the treatment, the clinical effect of Jingujian Granule group and the decoction group are both obviously better in core syndrome score and TCM syndrome score(P<0.01). The syndrome scores of these two groups are both have advantages over Caltrate D group (P<0.05). The effective rate of the decoction group is 84.44%, Jingujian Granule group is 79.55%, which are both have advantages over Caltrate D group (P<0.01).(2) Change of the BMD:after the treatment, the BMD of Jingujian Granule group and the decoction group are both increase slightly (P<0.05 or P<0.01), which are both have advantage over Caltrate D group (P<0.05). The amount of Jingujian Granule group (64.77%) and the decoction group(67.78%) in the BMD are both superior to Caltrate D group (P<0.05).(3) Changes of the laboratory examinations:for the tests relative to promotion bone formation, Jingujian Granule group and the decoction group can both increase the value of ALP and BGP, and both have advantages over Caltrate group in BALP (P<0.05 or P<0.01). The BMP-2 has no obvious changes after the treatments by Jingujian Granule and decoction, but has fall after the treatment by Caltrate D (P<0.05). For the tests relative to inhibitied bone resorption:Jingujian Granule group and the decoction group can both decrease the value of ACP, increase the value of CT and OGP (P<0.05 or P<0.01). For the tests relative to hormone levels, Jingujian Granule group and the decoction group can both increase the value of E2 of women patients (P<0.05), and are both superior to Caltrate D group (P<0.05).Conclusion(1) By means of treatment based on syndrome differentiation, it has true and certain effect in the process of treating primary osteoporosis by Jingujian prescription, and the decoction can reduce adverse reactions.(2) To cure the primary osteoporosis, Chinese medicine play the role of various approaches, multiple links and diversified targets, which can not only inhibit bone resorption and promote bone formation, but also participate in adjustment of hormone levels.(3) The therapeutic evaluation standards of the osteoporosis are based on the lumbar spine BMD. What is more, laboratory examinations must be as a reference to recognize the bone metabolism, in order to make a comprehensive evaluation.