The immediate effect of cervical rotation-traction manipulation on cervical paravertebral soft tissue: a study using soft tissue tension cloud chart technology.

BACKGROUND: To evaluate the reliability of the Soft Tissue Tension Cloud Chart (STTCC) technology, an original method combining multi-point Cervical Paravertebral Soft Tissue Test (CPSTT) with MATLAB software, we conducted a preliminary analysis on the immediate effects of Orthopaedic Manual Therapy (OMT) on cervical paravertebral soft tissue. METHODS: 30 patients with Cervical Spondylotic Radiculopathy (CSR) were included in this study. We analyzed the differences in CPSTT before and after treatment with Cervical Rotation-Traction Manipulation (CRTM), a representative OMT technique in Traditional Chinese Medicine, using the STTCC technology. RESULTS: The STTCC results demonstrated that post-treatment CPSTT levels in CSR patients were significantly lower than pre-treatment levels after application of CRTM, with a statistically significant difference (P < 0.001). Additionally, pre-treatment CPSTT levels on the symptomatic side (with radicular pain or numbness) were higher across the C5 to C7 vertebrae compared to the asymptomatic side (without symptoms) (P < 0.001). However, this difference disappeared after CRTM treatment (P = 0.231). CONCLUSIONS: The STTCC technology represents a reliable method for analyzing the immediate effects of OMT. CSR patients display uneven distribution of CPSTT characterized by higher tension on the symptomatic side. CRTM not only reduces overall cervical soft tissue tension in CSR patients, but can also balance the asymmetrical tension between the symptomatic and asymptomatic sides. TRIAL REGISTRATION: This study was approved by the Chinese Clinical Trials Registry (Website: . https://www.chictr.org.cn .) on 20/04/2021 and the Registration Number is ChiCTR2100045648.

Efficacy, Safety and Mechanism of Jinzhen Oral Liquid in the Treatment of Acute Bronchitis in Children: A Randomized, Double-Blind, Multicenter Clinical Trial Protocol.

Background: Acute bronchitis (AB) is a common disease in pediatrics. Prolonged AB may develop into chronic bronchitis. Bronchitis caused by the influenza virus can lead to severe hypoxia or insufficient ventilation, causing great harm to patients and increasing the burden on children and society. Presently, there is no specific treatment for AB except symptomatic supportive treatment. It is urgent to find an effective treatment for AB. Jinzhen Oral Liquid (JZOL) has been found to have a broad spectrum of anti-inflammatory and antiviral effects in previous clinical and basic studies and has a good effect on AB in children. However, the large-sample, randomized, double-blind, head-to-head, evidence-based studies are lacking. The purpose of this protocol is to evaluate the efficacy, safety, and mechanism of JZOL in the treatment of AB in children. Methods: This is a randomized, double-blind, parallel-controlled multi-center clinical trial. The sample size is 500 participants in the intervention group and the control group respectively, with a total of 1000 participants. They will be recruited by 10 hospitals in China. The Intervention group takes JZOL and Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution (AHCHOS) placebo, while the control group receives AHCHOS and JZOL placebo. The dosage of the two drugs varies according to age and weight. The medication lasts for 7 days. The disappearance time of cough is adopted as the primary outcome. Quality control will be carried out at every stage of data management and processing to ensure that all data are reliable and processed correctly. SAS is used for statistical analysis. Intention-to-treat analysis will be carried out in this trial. All statistical tests are conducted using a two-sided test, and p <0.05 would be considered statistically significant. Discussion: We hypothesized that children with AB could get good health benefits from JZOL. This study not only evaluates the clinical efficacy and safety of JZOL but also conducts metagenomics analysis and metabolomics analysis of feces and saliva of participants to study the mechanism of JZOL against AB. Therefore, this protocol evaluates the efficacy, safety, and mechanism of JZOL from a comprehensive perspective, so as to obtain a more solid evidence chain, which will enhance the credibility of the evidence. If successful, this study will provide a high-level evidence-based reference for the treatment of AB in children and future relevant studies.

Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients.

OBJECTIVE: In a substudy of a randomized controlled trial, we investigated the effects of the valsartan/amlodipine single-pill combination and nifedipine gastrointestinal therapeutic system (GITS) monotherapy on brachial pulse pressure (bPP) and radial augmentation index (rAI) in patients with previously uncontrolled hypertension. METHODS: We performed measurements of clinic blood pressure (BP) and pulse rate and rAI (n = 63) and ambulatory BP monitoring (n = 42) at baseline and 12-week of follow-up. Analysis of covariance was performed to calculate the least square mean change from baseline and between-group differences [95% confidence interval (CI)]. Correlation analysis was performed to study the interrelationship between the changes in bPP and rAI and in pulse rate. RESULTS: After 12-week treatment, clinic and ambulatory SBP/DBP and pulse rate were not differently changed between the valsartan/amlodipine (n = 29) and nifedipine GITS groups (n = 34, P ≥ 0.06) except daytime SBP (P = 0.01). The reductions in 24-h and daytime ambulatory bPP were significantly greater in the former than the latter group (P ≤ 0.04). rAI increased slightly by 3.5% (P = 0.20) and 5.2% (P = 0.06) in the valsartan/amlodipine and nifedipine groups, respectively, with a between-group difference of -1.7% (95% CI -9.6 to 6.1%, P = 0.66). In the two groups combined, the changes in clinic and ambulatory bPP were not or weakly associated with that in clinic or ambulatory pulse rate (r = -0.14 to 0.36, P = 0.02-0.95), while the changes in rAI were more strongly or significantly associated with that in clinic or ambulatory pulse rate (r = -0.39 to -0.23, P = 0.02-0.16). CONCLUSIONS: Antihypertensive drug-induced changes in rAI but not bPP were dependent on pulse rate.

The short-term efficacy of mud therapy for knee osteoarthritis: A meta-analysis.

The objective of this review is to systematically evaluate the short-term efficacy of mud therapy in the treatment of knee osteoarthritis (KOA).Randomized controlled trials, in which treatment of KOA is mud therapy, were included by systematically searching the PubMed, Embase, and the Cochrane Library databases.According to inclusion criteria and searching method, 11 articles, containing a total of 1106 patients, were included in the study. Our results showed significant differences in visual analog scale pain score and Western Ontario and McMaster Universities Osteoarthritis Index (pain, stiffness, function). In addition, the heterogeneity of study included is lower (I < 25%).According to the results of this meta-analysis, mud therapy can effectively alleviate the pain and improve joint function for KOA.

[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.

Huangqi Guizhi Wuwu Decoction for treating cervical radiculopathy: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Huangqi Guizhi Wuwu Decoction (HGWD) is a common prescription for the treatment of cervical radiculopathy (CR). And the effectiveness and safety of HGWD for CR were assessed in this study. METHODS: Seven databases were searched. Randomized controlled trials involving HGWD alone or HGWD combined with conventional treatment were enrolled. The authors in pairs independently assessed the risk of bias and extracted the data. RESULTS: Eight studies involving 783 participants with CR were included. Meta-analysis revealed that the efficacy of HGWD for CR was significantly superior compared with control treatment (risk ratio = 1.12, 95% confidence interval [CI]:1.06-1.19, Z = 3.71; P = .0002). Compare with control group, there is an increase in visual analog scale (mean difference [MD] = 0.99; 95% CI: 0.83-1.14; Z = 12.57; P < .00001). There was also an improvement of neck disability index (MD = 9.2; 95% CI: 8.28-10.11; Z = 19.75; P < .00001). Adverse events were not mentioned in the 8 trials. CONCLUSION: HGWD alone or HGWD plus other treatment may be helpful to patients with CR. However, the methodological quality of the randomized controlled trials was generally low. Larger and better-designed randomized controlled trials are recommended.

Safety of Shujinjianyao pill in clinical real world: A prospective, observational, multicenter, large-sample study Protocol.

BACKGROUND: Low back pain is a common health problem worldwide, which also is a leading cause of long-term disability and has an important effect on the global economy and society. Usually, conservative therapies are used to treat low back pain. As a kind of Chinese patent medicine, Shujinjianyao pill (SJJYP) has a great curative effect on low back pain. However, its safety has not been studied yet. Therefore, we carried out this clinical trial to observe the safety of SJJYP in the real world. METHODS: First, participants need to meet the medication standards according to inclusion and exclusion criteria. Then, participants are conducted safety examination before taking SJJYP. After qualified screening, participants can be enrolled into the group. Second, all enrolled participants will receive SJJJYP for a period of 4 weeks. During the observation period, participants need to return to the hospital for a subsequent visit after 2 weeks of medication, and come to the hospital for safety check after 4 weeks of medication. Third, telephone follow-up is used to investigate any participants' physical discomfort after 6 to 8 weeks (2-4 weeks after medication withdrawal). After all these steps are completed, clinical observation is finished. If any adverse events occur during this process, we will record them in time. When serious adverse events occur, we will use nested case-control study to explore the causes and mechanisms. DISCUSSION: This study will obtain the safety results of SJJYP in clinical real world, which will offer a scientific basis for clinicians in the treatment of low back pain, and also provide a methodological basis for the safety study of other medicines. TRIAL REGISTRATION: ClinicalTrial.gov registration number is NCT03598153. This study was approved by the ethics committee of Wangjing hospital, China Academy of Chinese Medical Sciences (WJEC-KT-2018-012-P002).

Is the Wedged Insole an Effective Treatment Option When Compared with a Flat (Placebo) Insole: A Systematic Review and Meta-Analysis.

BACKGROUND: Using the lateral wedge insole is a conservative management strategy for knee osteoarthritis. The theoretical basis for this intervention is to correct femorotibial angle, thereby reducing pain and optimising function. OBJECTIVE: This systematic review evaluates the evidence on the effectiveness of wedge insole compared with flat insole for the treatment of knee osteoarthritis. METHODS: A systematic review was performed, searching published (MEDLINE, EMBASE, CNKI, Cochrane Library, and Web of Science) and unpublished literature from their inception to April 2018. Randomized controlled trials (RCTs) that compared the use of wedge insole with a flat insole were included. Risk of bias and clinical relevance were assessed, and outcomes were analysed through meta-analysis. RESULT: From a total of 413 citations, 8 studies adhered to the a priori eligibility criteria. The WOMAC pain was shown to be statistically nonsignificant change with the use of wedge insole (SMD=0.07), and low heterogeneity (I2=22%) and a 95% CI that crossed zero (95% CI: -0.09 to 0.24). The 5 independent trials were not significant in improving pain score (SMD = -0.02, 95% CI: -0.19 to 0.16). This review also revealed no significance in improving Lequesne index (SMD = -0.27, 95% CI: -0.72 to 0.19). The meta-analysis from the 2 independent trials was significant in improving femorotibial angle (SMD = -0.41, 95% CI: -0.73 to -0.09). In conclusion, this meta-analysis suggested that lateral wedge insoles can improve femorotibial angle but are of no benefit with pain and functions in knee osteoarthritis.

[Effect of Osthole on Adrenocortical Function in Y1 Mouse Adrenocortical Tumor Cells].

OBJECTIVE: To study the effect of osthole (Ost) on adrenocortical function in Y1 mouse adrenocortical tumor cells. METHODS: Y1 mouse adrenocortical tumor cells were taken as subjects in this experiment. In 10.0%, 1.0%, and 0.1% serum DMEM-F12 medium, Y1 cells were treated with 1, 10, 25, 50, 100, and 200 micromol/L Ost for 24 and 48 h. 0.1% Dimethyl Sulfoxide (DMSO) was taken as negative control group and 1 mmol/L (Bu) 2cAMP as positive control group. Cell growth morphology was observed under inverted microscope. Contents of corticosterone were tested by ELISA. Expression levels of steroids synthase such as Star, Cyp11a1, Cyp21a1, Hsd3b2, Cyp11b1, Cyp11b2, Cyp17a1, and Hsd17b3 mRNA were detected by Real time quantitative PCR (RT-qPCR). RESULTS: Y1 cell proliferation was obviously inhibited by 100 and 200 micromol/L Ost, and its inhibitory effect was more significant in 0.1% serum medium. Compared with the negative control group, gene expressions of Star, Cyp11a1 , Cyp21a1, Hsd3b2, Cyp11b1, Cyp17a1, and Hsd17b3 were significantly enhanced in the posi- tive control group (P < 0.05). Y1 cell corticosterone levels significantly increased in 50 micromol/L Ost treatment group after 24-and 48-h intervention (P < 0.05). Contents of corticosterone increased more obviously in 25 and 50 +/- mol/L Ost treatment groups after 48-h intervention, as compared with 24-h intervention (P < 0.01). After 24-h intervention, expression levels of Star, Cyp21a1, and Hsd3b2 genes were significantly up-regulated in 25 and 50 lLmol/L Ost groups (P < 0.05). Star gene expression was further enhanced after 48-h intervention (P < 0.05). However, Ost showed no effect on Cyp11a1 (P > 0.05). Additionally, gene expressions of Cyp11b1 and Cyp17a1 were significantly enhanced by 10, 25, and 50 pLmolIL Ost after treatment for 24 and 48 h (P < 0.05). Ost showed no obvious effect on Cyp11b2 and Hsd17b3 expressions. CONCLUSION: Ost could regulate adrenal cortex function and promote corticosterone synthesis and secretion through strengthening gene expressions of steroidogenic enzymes.

Mitigative effect of micribial degradation on autotoxicity of Panax ginseng / 中国中药杂志

Continuously cropping obstacle restricts ginseng production and rational use of land resource severely, and autotoxicity is one of the most important factors. In our previous work, ginseng autotoxin degrading bacteria were isolated, in the present re- search, plate culturing method and traditional physiological and biochemical method were used to analyze biological indices and protective enzyme activities, in order to elucidate the mitigative effect of autotoxin degrading bacteria on autotoxicity of P. ginseng. Results indicated that, except for palmitic acid, autotoxicity of benzonic acid, diisobutyl phthalate, diisobutyl succinate, and 2,2-bis (4- hydroxyphenyl) propane on the growth of ginseng seeds was significantly alleviated after autotoxins degrading bacteria was inoculated, and which have no evident difference with control. Except for benzoic acid, enzyme activity of SOD, POD and CAT in other autotoxin degrading treatments decreased significantly. The present research showed that, microbial degradation could alleviate the autotoxicity of autotoxins on ginseng seeds effectively, and which will be helpful for the resolution of ginseng continuously cropping obstacle problem.

Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy.

INTRODUCTION: Current hypertension guidelines recommend single-pill combinations because they not only improve convenience and compliance to therapy and thus blood pressure (BP) control, but also reduce health-care costs. This study compared the efficacy and safety of valsartan/amlodipine single-pill combination with nifedipine gastrointestinal therapeutic system (GITS) in Chinese patients with hypertension who were inadequately controlled with monotherapy. METHODS: In this multicenter, open-label, active-controlled, parallel-group study, 564 patients with hypertension not adequately controlled by prior monotherapy were randomized to receive valsartan/amlodipine 80/5 mg or nifedipine GITS 30 mg once daily for 12 weeks. RESULTS: In the intention-to-treat analysis (n = 540), valsartan/amlodipine (n = 272) showed a least-square mean reduction of -16.6 versus -10.8 mmHg by nifedipine GITS (n = 268; mean between-treatment difference: -5.8 mmHg; P < 0.0001) from baseline to week 12. The corresponding results for mean sitting diastolic BP were -8.6 and -4.6 mmHg, respectively (difference: -4.0 mmHg; P < 0.0001). The percentage of patients achieving the BP target (<140/90 or <130/80 mmHg in the absence or presence of diabetes mellitus, respectively) was significantly higher with valsartan/amlodipine (79.0%) versus nifedipine GITS (57.4%; P < 0.0001). The overall incidence rate of adverse events was lower with valsartan/amlodipine (19.2%) than with nifedipine GITS (29.4%; P = 0.004). CONCLUSION: The valsartan/amlodipine 80/5 mg single-pill combination is well tolerated and more effective than nifedipine GITS 30 mg for BP control in Chinese patients with hypertension.

Toll-like receptor 9 interaction with CpG ODN--an in silico analysis approach.

BACKGROUND: Toll-like receptor 9 (TLR9) recognises unmethylated CpG DNA and activates a signalling cascade, leading to the production of inflammatory cytokines such as TNF-α, IL-1, IL-6 and IL-12 via the adaptor protein MyD88. However, the specific sequence and structural requirements of the CpG DNA for the recognition of and binding to TLR9 are unknown. Moreover, the 3D structures of TLR9 and the TLR9-ODN complex have not been determined. In this study, we propose a reliable model of the interaction of the TLR9 ECD with CpG ODN using bioinformatics tools. RESULTS: The three-dimensional structures of two TLR9 ECD-CpG ODN complexes were constructed using a homology modelling and docking strategy. Based on the models of these complexes, the TLR9 ECD-CpG ODN interaction patterns were calculated. The results showed that the interface between the human TLR9 and the CpG ODN molecule is geometrically complementary. The computed molecular interactions indicated that LRR11 is the main region of TLR9 that binds to CpG ODN and that five positively charged residues within LRR11 are involved in the binding of the TLR9 ECD to the CpG ODN. Observations in the close-up view of these interactions indicated that these five positively charged residues contribute differently to the binding region within the TLR9 ECD-CpG ODN complex. 337Arg and 338Lys reside in the binding sites of ODN, forming hydrogen bonds and direct contacts with the CpG ODN, whereas 347Lys, 348Arg, and 353His do not directly contact the CpG ODN. These results are in agreement with previously reported experimental data. CONCLUSION: In this study, we present two structural models for the human and mouse TLR9 ECD in a complex with CpG ODN. Some features predicted by this model are consistent with previously reported experimental data. This complex model may lead to a better understanding of the function of TLR9 and its interaction with CpG ODN and will improve our understanding of TLR9-ligand interaction in general.

[Preparation of self-microemusifying drug delivery system for volatile oil from rhizome of ligusticum Chuanxiong].

OBJECTIVE: To search on the optimum formula for the seif-microemulsifying drug delivery system of volatile oil from rhizome of ligusticum Chuanxiong. METHODS: Through solubility experiment, orthogonal screen and drawing phase diagram, taking the degree of emulsifying, the volume of the rest oil and emulsion particle size as parameters, the appropriate proportion composed of Chuanxiong oil, nonionic surfactant and flux was screened for the optimum formulation of self-microemulsifying drug delivery system. RESULTS: In the formulation of self-microemulsifying drug delivery system for volatile oil from rhizome of ligusticum Chuanxiong, taking S1 as the nonionic surfactant and C1 as the co-surfactant could get the best effect of emulsifying. CONCLUSION: The optimum formula for seif-microemulsification of volatile oil from rhizome of ligusticum Chuanxiong is volatile oil from rhizome of ligusticum Chuanxiong, S1 and C1, with their proportion being 10 : 9 : 1.

[In vitro evaluation of self-emulsifying drug delivery system of volatile oil from rhizome of Ligusticum chuanxiong].

OBJECTIVE: To investigate the evaluation method for self-emulsifying drug delivery system of volatile oil from rhizome of Ligusticum chuanxiong (VOC SEDDS). METHOD: The self-emulsifying ability, the efficiency of self-emulsification, the properties of emulsion, the dissolution of volatile oil from Rhizome of Ligusticum Chuanxiong and the stability of the emulsion were determined. RESULT: The optimized formulation can fully emulsify in 5 min and the particle sizes were around 102 nm. Zeta potential was about -30 mV. The O/W emulsions were stable through centrifugation with high reproducibility. In vitro dissolution test indicated that over 80% of drug dissolved in 30 min and VOC SEDDS was stable under light and high temperature in 10 d. CONCLUSION: VOC SEDDS has strong self-emulsifying ability, fine stability and high dissolution rate in vitro.