Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial.

OBJECTIVE: To assess the efficacy and safety of Bushen Huoxue Formula (BSHXF) for the treatment of discogenic low-back pain (DLBP). METHODS: This was a parallel, double-blind, randomized, clinical trial performed between May 2019 and June 2020. Seventy patients were assigned by computerized random number table to the treatment group (lumbar traction and BSHXF, 35 cases) or the control group (lumbar traction and placebo, 35 cases). The patients received intervention for 3 weeks. Assessment was conducted before treatment and at week 1, 2, 3 during treatment. Primary outcome was the self-reported score of Oswestry Disability Index (ODI). Secondary outcomes included Visual Analog Scale (VAS), clinical efficacy rate by minimal clinically important difference (MCID) as well as lumbar tenderness, muscle tone and lumbar spine mobility. Adverse reactions were recorded. Follow-up was performed at 1 and 3 months after the end of treatment. RESULTS: In the treatment group, ODI score was significantly decreased compared with baseline (P<0.05) and the control group at 2- and 3- week treatment. Similarly, VAS score decreased compared with the baseline (P<0.05) and was lower than that in the control group at 2- and 3- week treatment (P<0.05). The clinical efficacy rate of the treatment group was higher than that of the control group after treatment [32.35% (11/34) vs. 3.13% (1/32), P<0.05). Moreover, the tenderness, and muscle tone, as well as the back extension and left flexion in lumbar spine mobility in the treatment group at 3-week treatment were significantly improved compared with the control group (P<0.05). Follow-up showed that at 1-month after treatment, the treatment group had better outcomes than the control group with regard to a total score of ODI and VAS scores, as well as clinical efficacy rate (all P<0.05). Moreover, VAS score was still significantly lower than the control group at 3-month follow-up (P<0.05). No adverse reactions were reported during the study. CONCLUSION: BSXHF combined with lumbar traction can significantly improve the clinical symptoms including pain intensity, functionality, muscle tone, and lumbar spine mobility in DLBP patients. (Registration No. ChiCTR1900027777).

[Efficacy and safety of Shentong Zhuyu Decoction for lumbar disc herniation: systematic review and Meta-analysis].

To evaluate the clinical efficacy and safety of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation, in order to provide evidence for its clinical application. PubMed, Cochrane Library, EMbase, CNKI, WanFang, VIP, CBM and Clinical Trials.gov databases were sysmatically retrieved. Two researchers independently searched, screened and extracted data. Randomized controlled trials in line with the inclusion criteria were included in the study. The article quality was assessed with the bias risk tool in the Cochrane Handbook. Meta-analysis was performed using RevMan 5.3. A total of 604 articles were obtained from the retrieval, and 824 patients in 9 studies were finally selected through screening. The course of treatment was about 1 month, and all of the studies were completed in China. Meta-analysis showed that the efficacy of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation was better than that of the control group(RR=1.19, 95%CI[1.12, 1.26], P<0.000 01), including the comparison with Yaotongning Capsules(RR=1.10, 95%CI[1.02, 1.19], P=0.01) and diclofenac sodium tablets(RR=1.26, 95%CI[1.11, 1.44], P=0.000 4). In VAS pain score, Shentong Zhuyu Decoction had also obvious advantages(MD=-3.70, 95%CI[-6.31,-1.09], P=0.005). In addition, the number of adverse events in the Shentong Zhuyu Decoction group was lower than that in the control group. Shentong Zhuyu Decoction can effectively alleviate discomfort symptoms of patients with LDH. It has an obvious clinical efficacy and less adverse reactions. However, restricted by the quality of the included literatures, prospective, multi-center, large-sample-size randomized controlled trials are still needed to further improve the clinical evidence of the effect of Shentong Zhuyu Decoction in the treatment of LDH.

[Effect of serum of Bushen Huoxue prescription on rabbit with intervertebral disc motion segments in vitro culture].

OBJECTIVE: To compare effect of serum of Bushen Huoxue prescription on rabbit with intervertebral disc motion segments in vitro culture. METHODS: Twenty-four New Zealand white rabbits aged from 4 to 6 months and weighted from 2.5 to 3 kg were divided into medicated group and control group, 7 in each group. Rabbits were excuted under condition of asepsis, 28 spinal motion segments were taken out in each group, and segments were loaded in spinal motion segments in vitro and cultured in culture apparatus. Nutrient solution of medicated group contain 10% serum of Bushen Huoxue prescription, and 10% blank serum in control group. Seven discs between two groups were taken out and observed by histomorphology, proteoglycan PAS/AB stining, collagen II immunohistochemical staining, AGG, Col2aI by PCR test before culture and on the 3th, 7th and 14th day after culture. RESULTS: Histomorphology results showed the formation of medicated group was better than that of control group at 1 week after culture. PAB/AB test results showed content of poteoglycan between two groups were decreased. Imunohistochemical results showed content of collagen II in medicated group were obviously increased than that of control group at 3 days, but decreased obviously at 1 week than that of control group. PCR results showed expression of Agg in medicated group was obviously decreased than that of control group, but no statistical significance between two groups on the 7 th and 14 th day. Expression of Col2aI between two groups at 3 days were increased, and medicated group increased obviously more, while there were no significant difference between two groups. CONCLUSIONS: Serum of Bushen Huoxue prescription could delay intervertebral disc degeneration at short time for it is relate with improving circulation, inhibiting inflammatory, regulating extracellular matrix, so the prescription plays an important role in early prevention and treatment for intervertebral disc degeneration.

[Research on the stability of teaching robots of rotation-traction manipulation].

OBJECTIVE: To evaluate the stability of teaching robot of rotation-traction manipulation. METHODS: Operators were required to get the hang of rotation-traction manipulation and had clinical experience for over 5 years. The examination and data processing of the ten operators in our research were collected by the teaching robot of rotation-traction manipulation. Traction, pulling force, maximum force, pulling time, rotational amplitude and pitch range were recorded and compared for five times(G1, G2, G3, G4 and G5). The qualification rates were analyzed to evaluate the stability of teaching robot of rotation-traction manipulation. RESULTS: Nonconforming items were found in G1 and G2, for instance, pulling force(P=0.074), maximum force(P=0.264) and rotational amplitude (P=0.531). There was no statistically difference. None nonconforming item was found in G3, G4 and G5. All data were processed by SPSS and One-way ANOVA was used to analysis. Pulling force was found statistically different in G1, compared with G4 and G5(P=0.015, P=0.006). Maximum force was found statistically different in G1, compared with G4 and G5 (P=0.021, P=0.012). None differences were found in other comparisons (P>0.05). CONCLUSIONS: The teaching robot of rotation-traction manipulation used in our research could provide objective and quantitative indices and was considered to be an effective tool of assessing the rotation-traction manipulation.

[Comparison of paravertebral soft tissue tension changes in patients with chronic lower back pain treated by sliver needle and traditional Chinese medicine fumigation].

OBJECTIVE: To evaluate clinical significance of waist soft tissue tension detection in treating chronic nonspecific low back pain. METHODS: From August 2011 to March 2012,60 patients with chronic nonspecific low back pain were divided into two groups (sliver needle group and TCM fumigation group) according to propotion of 1:1. In sliver needle group, there were 17 males and 13 females aged from 28 to 55 years old with an average age of (45.70 +/- 4.15), treated with sliver needle; In TCM fumigation group,there were 19 males and 11 females aged from 27 to 55 years old with an average age of (43.03 +/- 5.86), treated with TCM fumigation. Changes of force-displacement distance (FDD), specific absorption rate (S) of two groups were observed before treatment, 1 week and 3 months after treatment respectively, VAS scoring and Roland-Morris disability questionnaire (RMDQ) were used to access clinical effects. RESULTS: (1) VAS score of silver needle group was 4.77 +/- 0.78, 1.99 +/- 1.08 and 2.55 +/- 0.94, respectively before treatment, at 1 week and 3 months after treatment,while VAS score in TCM fumigation group were 4.43 +/- 0.61, 2.48 +/- 0.71 and 3.05 +/- 0.86, respectively. VAS score of two groups after treatment were sigificant decrease than that of before treatment (P < 0.05). There was no sigificant differences between two groups before treatment, but sliver needle group performed well in analgesia than TCM fumigation group, and had obvious differences (P < 0.05). RMDQ score of silver needle group was 13.63 +/- 1.96, 5.87 +/- 2.33 and 6.53 +/- 2.89, respectively before treatment, at 1 week and 3 months after treatment, while RMDQ score in TCM fumigation group were 13.40 +/- 2.01, 6.90 +/- 2.31, 9.23 +/- 2.87, respectively. There was no significant differences between two groups before treatment and 1 week after treatment (P > 0.05), and had obvious differences between two groups at 3 months after treatment (P < 0.01). Both groups could obvious improve dysfunction caused by chronic low back pain, and curative effect of sliver needle groups was more endurable. (2) Following-up at 3 months after treatment, FDD of multifidus, erector spinae of effected side and multifidus of healthy in sliver needle group were obvious increased (P < 0.05); In TCM fumigation group, FDD of multifidus and erector spinae on both side were increased at 1 week after treatment (P < 0.05), but had no significant meaning at 3 months after treatment on health side (P>0.05). There was no significant meaning before treatment (P > 0.05), FDD of multifidus, erector spinae of effected side in sliver needle group were obvious increased at 1 week after treatment (P < 0.05); but no obvious meaning on health side. FDD of both side in sliver needle group were obvious increased at 3 months after treatment. (3) There was correlation among differences of FDD in multifidus and erector spinae, VAS score and differences of RMDQ, and Spearman correlation coefficient R was 0.517, 0.811, 0.746 and 0.625; There was correlation between items of soft tissue tension and sympotoms, function and life quality. Conclusion:Soft tissue tension detection can effectively manifest degree of pain and dysfunction of low back, and improve objectivity of therapeutic evaluation for chronic low back pain.

[Effect of removing dampness and promoting diuresis method on IgG, IgM and IL-1beta, IL-8 in serum of rats with autoimmunity induced by nucleus pulposus].

OBJECTIVE: To explore the effects of removing dampness and promoting diuresis method on autoimmune and immuno-inflammatory response caused by nucleus pulposus of rats, in order to provide the basis for the treatment of lumbar disc herniation with Chinese medical immunotherapy. METHODS: Forty male Wistar rats were divided into 4 groups randomly according to body weight layer:sham operation group (group A), model contrast group (group B), colchicine tablets group (group C), modified Qingyao decoction group (group D). There were 10 rats in each group. Nucleus pulposus of coccygeal vertebra was transplanted to the gluteal muscle by operation in groups B, C, D, which can lead to autoimmune and immuno-inflammatory response of rats; the rats of group A were only treated with sham operation. At the 3rd day after operation, the rats were fed through intragastric administration, the group A and B with distilled water (10 ml/kg), the group C and D respectively with suspension of colchicine tablets (10 ml/kg, 0.01 mg/ml) and water-decocted liquid of modified Qingyao decoction (10 ml/kg,1.035 g/ml), once a day and continuous medication for 18 days. All rats were killed at the 21th day after operation. The immunoglobulin G (IgG), immunoglobulin M (IgM) and interleukin-1beta (IL-1beta), interleukin-8 (IL-8) level in serum of different groups were detected by ELISA method. At the same time, surrounding tissues of the transplanted nucleus pulposus were observed by pathological section. RESULTS: The level of IgG, IgM, IL-1beta, IL-8 in serum of group B was significantly higher than that of group A (P < 0.01), while the level of IgG, IgM, IL-1beta, IL-8 in serum of group C, D was significantly lower than that of group B (P < 0.05 or P < 0.01). Moreover, pathological section indicated that immuno-inflammatory response was hardly found in surgical site of group A, while local immuno-inflammatory response of surrounding tissues of the transplanted nucleus pulposus of group C and D was much lighter than that of group B. CONCLUSION: Removing dampness and promoting diuresis method could inhibit autoimmune and immuno-inflammatory response caused by nucleus pulposus of rats.