Safety and efficacy of Yaobitong capsules for lumbar disc herniation: A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial.

BACKGROUND: Lumbar disc herniation (LDH) is one of the most common diseases and is a global medical and socioeconomic problem characterized by leg or back pain, weakness in the lower extremities and paresthesia. OBJECTIVES: A multicenter, randomized, double-blinded, parallel, positive-controlled clinical trial was conducted to evaluate the efficacy and safety of Yaobitong capsules (YBT) for LDH. MATERIAL AND METHODS: Patients (n = 479) were recruited and randomized into YBT and Jingyaokang capsule (JYK) groups (the positive control), and received YBT or JYK at a dose of 3 capsules 3 times per day after a meal for 30 days. The primary efficacy outcome was the Oswestry Disability Index (ODI), with the visual analogue scale (VAS) used as the secondary efficacy outcome. The adverse events and adverse reactions were also evaluated. RESULTS: There was no significant difference in baseline characteristics between YBT (n = 358) and JYK groups (n = 120), and no difference was observed between groups for mean ODI score at day 0 (p = 0.064) or day 7 (p = 0.196), but there were differences at days 14, 21 and 30 (p < 0.001). The YBT showed more decline from baseline, and the decreased ODI score was substantially different from JYK (p < 0.001). The differences in decreased VAS scores between YBT and JYK were also significant at each time point (days 7, 14, 21, and 30), with better scores in the YBT group than in the JYK group (p < 0.001). In terms of safety, there was no obvious disparity in adverse events or adverse reactions between the 2 groups (p > 0.05). CONCLUSIONS: Yaobitong was better than JYK for LDH treatment, with no significant difference in safety. The study suggests that YBT is a promising and effective treatment for LDH.

[Research on community promotion and application of single acupoint electroacupuncture therapy for lumbar intervertebral disc herniation].

OBJECTIVE: To observe the clinical effect of single acupoint [Yaotu (extra)] electroacupuncture (EA) therapy on lumbar intervertebral disc herniation (LIDH) and its promotion and application in community medical institutions. METHODS: This research adopted a three-level promotion model, and used multi-center collaboration topics as a platform. A total of 240 patients with LIDH were divided into a group A (top three hospital, 80 cases, 3 cases dropped off), a group B (secondary hospital, 80 cases, 8 cases dropped off), and a group C (community health center, 80 cases, 7 cases dropped off). All groups were treated with EA at a single acupoint [Yaotu (extra)] under the guidance of a unified experimental protocol. The EA was given 60 min each time and performed 3 times a week for a total of 2 weeks. The changes of visual analogue scale (VAS) scores of three groups before and after each treatment were compared, and the clinical efficacy was evaluated. RESULTS: Compared with before each treatment, the VAS scores of three groups after each treatment decreased (P<0.05). Except for the second and fifth treatments, the immediate effect in the group A was higher than that in the group B and C (P<0.05). The total effective rate of group A, group B, and group C respectively was 90.9% (70/77), 93.1% (67/72), 86.3% (63/73), and there was no statistically significant difference among the three groups (P>0.05). CONCLUSION: The single acupoint EA therapy has a significant effect in the treatment of LIDH, can quickly relieve the pain symptoms, and has the characteristics of simple operation and easy control, suitable for promotion and application in primary hospitals.

[Study on the clinical value of cervical spondylosis with articulatio atlantoepistrophica sublaxation].

OBJECTIVE: To explore the effect of articulatio atlantoepistrophica sublaxation on the pathogenesis of cervical spondylosis, and provide a thread for diagnosis and treatment of cervical spondylosis with manipulation. METHODS: There were two groups in the study, which were non cervical spondylosis group and cervical spondylosis group. There were 333 patients in cervical spondylosis group, included 119 males and 214 females with the mean age of(48.11±12.21) years old. The patients were recruited from clinic service of orthopaedics in Shuguang Hospital between March 2006 and December 2008. There were 73 subjects in non cervical spondylosis group, included 18 males and 55 females with the mean of(45.99±11.47) years old. The subjects were recruited from undergraduate students, postgraduate, advanced study persons, and community personnel. The position relation of the atlanto axial joint was observed by cervical X rays with opening position, and the incidence rate of articulatio atlantoepistrophica sublaxation was compared between two groups, and their clinical characteristics were analyzed. RESULTS: The incidence of articulatio atlantoepistrophica sublaxation in cervical spondylosis group was 81.38%(271/333)and was more than non cervical spondylosis group(P<0.01). Furthermore, the pattern of the articulatio atlantoepistrophica sublaxation in cervical spondylosis group was complicated and diversified, which was 50.55% (137/271)with single moving sublaxation, 7.01%(19/271) with revolving sublaxation, 42.44%(115/271) with single moving and revolving sublaxation. CONCLUSIONS: The articulatio atlantoepistrophica sublaxation may be a X ray diagnostic indication to the cervical spondylosis, which should be grouping studied in clinic. It will provide guidance for the diagnosis and treatment of cervical spondylosis.

[Specific lumbocrural pain and the individual diagnosis of lumbar intervertebral disc herniation].

Pain is all lumbocrural pain cases very common clinical symptoms,but the etiology, pathology, site (range or area), intensity, nature, evolution situation and influence factors of pain usually has some certain characteristics and rules, these differences particularly are regarded as the primary and important basis or clue for the clinical diagnosis and differential diagnosis of related diseases. In addition, according to these differences can determine the individual diagnosis of lumbar intervertebral disc herniation as well, including typical and atypical, simple and compound, the general and special cases, these be- come the basis to determine the individualized therapeutic schedule of this disese.

[Ideas and methods of differential diagnosis of lumbar intervertebral disc herniation].

Pain is common clinical symptoms of lumbocrural, but the etiology, pathology, sites (range or area), intensity, nature, evolution situation and influence factors of pain has some certain characteristics and rules. These differences particularly were regarded as the primary and important basis or clues for the clinical diagnosis and differential diagnosis of related diseases. A series of exclusive diagnosis for similar symptoms is premise of diagnosis of lumbar intervertebral disc protrusion. Ideas and methods of differential diagnosis of lumbar intervertebral disc herniation can help the diagnosis and identification.

[Study on the correlation between "Gucuofeng and Jinchucao" and cervical spondylosis].

OBJECTIVE: To explore the relation between "Gucuofeng and Jinchucao" and cervical spondylosis. METHODS: From March 2006 to October 2011,333 patients with cervical spondylosis were collected in the study as cervical spondylosis group; 30 subjects of control group come from student of Shuguang Hospital and other health volunteer. There were 119 males and 214 females with a mean age of (48.11 +/- 12.21) years in cervical spondylosis group and there were 6 males and 24 females with a mean age of (45.27 +/- 10.12) years in control group. In aspect of the symptom and sign, dynamic palpation, X-ray examination wer performed to find the incidence rate of "Gucuofeng and Jinchucao" in two groups. RESULTS: There was significant difference in symptom and sign, dynamic palpation, X-ray examination between two groups (P<0.01). In cervical spondylosis group, "Gucuofeng and Jinchucao" occurred in 293 cases (87.99%),there was significant difference compared with control group (P<0.01). CONCLUSION: Cervical "Gucuofeng and Jinchucao" is one of pathological point of cervical spondylosis,and it can provide a guidance for the diagnosis and treatment of cervical spondylosis.

Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial.

Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3 : 1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, -16.62 points, P < 0.001 in VAS; -15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (-7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.

[Clinical significance of vertebral artery MRA to vertebral artery type of cervical spondylosis' diagnosis and treatment].

OBJECTIVE: To study clinical significance of vertebral artery magnetic resonance angiography (MRA) to vertebral artery type of cervical spondylosis' diagnosis and treatment. METHODS: There were two groups in the study, which were observation group and control group. There were 53 patients in observation group,including 19 males and 34 females,with a mean age of (52.51 +/- 11.29) years. There were 30 subjects in control group,including 10 males and 20 females,with a mean age of (48.11 +/- 12.21) years. Based on the vertebral artery MRA picture,the course and caliber of vertebral artery were compared between two groups. RESULTS: The abnormal incidence of course and caliber of vertebral artery in observation group was higher than that of control group, which had statistic difference (P=0.000). Furthermore, the patterns of abnormal course and caliber of vertebral artery in observation group were complicated and diverse, but the regional circuity and stegnosis was the most common pattern,about 47.18%(25/53). The cause of circuity and stegnosis was vertebra Gu-Cuofeng,about 43.41% (23/53). CONCLUSION: The vertebral artery MRA provides a guidance for the diagnosis of abnormal course and caliber of vertebral artery in vertebral artery cervical spondylosis.

[Clinical significance of specific lumbocrural pain for the diagnosis of lumbar intervertebral disc herniation].

Lumbar intervertebral disc herniation clinical symptoms and signs are very complicated, lumbocrural pain is the most characteristic clinical symptoms,and show the site (range or area), intensity, nature, evolution, influence factors and adjoint symptoms and so on has certain characteristics and rules. Among them, the dermatomal pain, kinesthetic dysesthesia, dynamic changing pain and lesions segment vertebral side deep tenderness are the most impotent characteristics and rules of pain, therefore, can be regarded as the main basis of clinical diagnosis of the disease, and also the core content of this article.

[Individual stratification diagnosis of lumbar intervetebral disc herniation].

Lumbar intervertebral disc herniation is one of the most common causes of lumbocrural pain with its uncertain causes and varied clinical manifestations which marked by the specific symptoms and signs. Effective individualized therapy scheme depends on the correct and timely multi-level diagnosis of this disease. The paper systematically proposed the multilevel diagnosis, including qualitative diagnosis, level diagnosis, diagnosis by exclusion,combined diagnosis, classification diagnosis, syndrome differentitation in different stages, and disease severity grading diagnosis etc. The content and methods of the multi-level diagnosis on each individual case has great significance to formulate the individualized therapy scheme and to promote the clinical research of LIDH.

[Diagnostic ideas and programs of lumbar intervetebral disc herniation].

Lumbar intervertebral disc herniation (LIDH) is one of the most common causes of lumbocrural pain with its uncertain causes, varied clinical manifestations and featuring on each individual case. Effective individualized therapy scheme depends on the correct and timely diagnosis of this disease. Many evidence indicated that the nervous symptoms and signs have higher specificity and sensitivity, has great significance to the diagnosis of LIDH but usually has polytropy among different patients or different period and conditioning of the same patient to some degree. This article systematically reviewed and analyzed the diagnostic value of specific symptoms and signs, selected physical and photographical examination methods of LIDH, and proposed that LIDH can be accurately and timely evaluated by using these diagnostic factors and ways comprehensively and systematically, this will be the helpful ideas and program to the diagnosis of this disease.

[Study on the effect of vertebrae semi-dislocation on the stress distribution in facet joint and interuertebral disc of patients with cervical syndrome based on the three dimensional finite element model].

OBJECTIVE: To study the effect of vertebrae semi-dislocation on the stress distribution in facet joint and interuertebral disc of patients with cervical syndrome using three dimensional finite element model. METHODS: A patient with cervical spondylosis was randomly chosen, who was male, 28 years old, and diagnosed as cervical vertebra semidislocation by dynamic and static palpation and X-ray, and scanned from C(1) to C(7) by 0.75 mm slice thickness of CT. Based on the CT data, the software was used to construct the three dimensional finite element model of cervical vertebra semidislocation (C(4)-C(6)). Based on the model,virtual manipulation was used to correct the vertebra semidislocation by the software, and the stress distribution was analyzed. RESULTS: The result of finite element analysis showed that the stress distribution of C(5-6) facet joint and intervertebral disc changed after virtual manipulation. CONCLUSION: The vertebra semidislocation leads to the abnormal stress distribution of facet joint and intervertebral disc.

[Case control study on the association between abnormality curvature of cervical spine and pathogenesy of cervical spondylosis].

OBJECTIVE: To explore the relationship between the abnormality curvature of cervical spine and pathogenesy of cervical spondylosis, in order to provide a new way in diagnosis of cervical spondylosis. METHODS: There were two groups in the study, which were non-cervical spondylosis group (with heath adults) and cervical spondylosis group. From March 2006 to December 2008, 333 patients (out-patients in department of orthopaedics of Shuguang hospital) in cervical spondylosis group, which were 119 males, 214 females with an average age of (48.11 +/- 12.21) years. There were 73 subjects in non-cervical spondylosis group, which was 18 males, 55 females with an average age of (45.99 +/- 11.47) years. Based on the lateral view X-ray pictures of cervical spine, the abnormality curvature and character of cervical spine were studied in two groups. RESULTS: The incidence rate in abnormality curvature of cervical spine in cervical spondylosis group (achieved to 95.50%) was more than that of non-cervical spondylosis group, there was significant difference between two groups (P = 0.000 < 0.01). Furthermore, the patterns of the abnormality curvature of cervical spine in cervical spondylosis group was complicated and variegated, of which physiological curvature diminished had 23.12% (77 cases), turn straight had 40.84% (136 cases), increased had 0.60% (2 cases), recurved had 12.01% (40 cases), S shape had 4.20%(14 cases), contra-S shape had 2.70% (9 cases), upper flex and lower straight had 4.50% (15 cases), upper straight and lower flex had 7.51% (25 cases). CONCLUSION: The abnormality curvature of cervical spine may be an X-ray diagnostic indication to the cervical spondylosis, which is complicated and variegated. It will provide the guidance for the diagnosis and treatment of cervical spondylosis.

[Study on the method of construct the three-dimensional finite element model of cervical vertebrae semidislocation].

OBJECTIVE: Cervical vertebra semidislocation was one of major pathological aspects of cervical spondylosis, and it was also the target of manipulation to treat cervical spondylosis. The aim of this study was to combine the technology of three dimensional finite element analysis to investigate the method to construct the cervical vertebra semidislocation model. METHODS: A cervical spondylosis patient (male, 28 years old,176 cm tall, weight 69 kg) was randomly chosen, who was diagnosed cervical vertebra semidislocation by dynamic and static palpation and X-ray,and CT scanned from C1 to C7 by 0.75 mm slice thickness. Based on the CT data, the software was used to construct the three dimensional finite element model of cervical vertebra semidislocation (C4-C6). RESULTS: The model showed the three dimensional changes of vertebra semidislocation clearly. C5 had a three-dimensional abnormal position, which was downward translation for 0.9 mm and clockwise rotation for 4.5 degrees around X-axis. So C5 was diagnosed as hypokinesis-type semidislocation. CONCLUSION: The method to construct the three dimensional finite element model of cervical vertebra semidislocation is reliable, which provide a base study to analyse the mechanism of manipulation to treat vertebra semidislocation.

[Diagnosis and treatment of intervertebral disc disease based on the theory of "Gucuofeng and Jinchucao"].

It has previously been reported that the incidence rate of intervertebral disc disease including cervical and lumbar vertebra is at the 8th position among the chronic and difficult treated diseases in China. There are great challenges on the improving diagnosis and treatment as well as reducing recrudescence of this degenerative disease. It was well known that the degeneration and bulge or herniatation of intervertebral discs are the main reasons for it, and the treatment for it always focuses on the disc recovery. However, the discrepancy of the effect and expectation indicated that there were other reasons for it. Based on the clinical knowledge of intervertebral discs disease and combined with the cognition of Traditional Chinese Medicine,we proposed that the pathogenesis of intervertebral disc disease was Gucuofeng and Jinchucao, which meant that the improper location of diapophysis and the declined of muscle strength may cause the unstable of spine, unstable spine thus aggravated the semiluxation of diapophysis.

[Pilot study on the standardization of non-operative treatment of lumbar disc herniation].

Lumbar disc herniation (LDH) is one of the most common causes of sciatica. Many non-operative treatment strategies have acquired satisfied effects and have been recommended in many countries. The effectiveness and advantages of non-operative treatment may depend on how they are being used. Based on analysis of the current clinical condition,the positive attitude to the treatment of both patients and doctors, appropriate therapeutic scheme and sufficient time, as well as the systematically combined optimum procedure in stepladder-like ways may be feasible principles for the treatment of LDH.

[Re-recognition of single-point electroacupuncture therapy for treatment of lumbar intervertebral disc herniation].

OBJECTIVE: To study on the characteristics and clinical application of single-point electroacupuncture therapy for treatment of lumbar intervertebral disc herniation. METHODS: Expound single-point electroacupuncture therapy from acupoint selection, acupuncture methods, clinical indications and the mechanism of this therapy. CONCLUSION: The single-point electroacupuncture therapy has the characteristic of "fewer but better" in acupoint selection, with a better analgesic effect on lumbocrural pain induced by lumbar intervertebral disc herniation, but the exact analgesic mechanisms have been incompletely known yet.

[Study on the needling depth of point Yaotu with CT scanning].

OBJECTIVE: To probe the safe depth and angle of needling the point Yaotu for treatment of prolapse of intervertebral disc. METHODS: CT technique was used for scanning investigation of the depth and angle of needling the point Yaotu. RESULTS: When the acupuncture needle was inserted vertically to the external space of intervertebral foramen of human body with arrival of qi, the tip of needle could reach to 73 mm deep, which is the best needling depth and angle. CONCLUSION: The needle vertically inserting to the external space of intervertebral foramen at the point Yaotu is proper in treatment of prolapse of intervertebral disc.

[Control study on analgesic effect of single-point electroacupuncture on prolapse of lumbar intervertebral disc].

OBJECTIVE: To explore an effective method for electroacupuncture treatment of pain in waist and lower extremities due to prolapse of lumbar intervertebral disc. METHODS: All 98 cases of such disease were randomly divided into a treatment group (n = 53) and a control group (n = 45). The treatment group were treated with local single-point electroacupuncture stimulation, and the control group with routine electroacupuncture stimulation for 8 sessions. The pain in waist and lower extremities in the two groups were continuously evaluated with short-form of McGill pain questionnaire (SF-MPQ). RESULTS: After first treatment, SF-MPQ scores in the two groups were significantly different from those before treatment (P < 0.001), and there were significant differences between the two groups respectively (P < 0.001) at the each time points. CONCLUSION: Local singly-point electroacupuncture has a better analgesic effect on pain in waist and lower extremities due to prolapse of lumbar intervertebral disc.

[Pathogenic factors of blood circulation disturbance in lumbar intervertebral disc herniation and mechanism of Tuina manipulation in promoting circulation].

Tuina manipulation has long been used in the treatment of lumbar intervertebral disc herniation, although its therapeutic mechanisms remain uncertain. The specific characteristic syndrome of this disease is lumbocrural pain in varying degrees, which is due to mechanical compression, aseptic inflammation, blood circulation disturbance and dystrophy. These factors can act on the involved nerve roots and give rise to nerve conduction disturbance. Since the blood circulation disturbance and nerve roots dystrophy are the most important pathogenic aspects of this disease, the therapeutic effect of Tuina manipulation on lumbar intervertebral disc herniation is related to them directly or indirectly.