Effect of Jianpi Bushen formula for colon cancer patients who underwent adjuvant chemotherapy:Statistical analysis plan for a multicenter trial

Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.

An overview of systematic reviews of clinical evidence for cupping therapy

Background:As a traditional treatment method,cupping therapy is widely used in Asian countries.This overview of systematic reviews (SRs) investigated the effectiveness and safety of cupping therapy through an evidence-based approach.Methods:SRs that assessed the effectiveness of cupping therapy for any type of disease were searched through 6 electronic databases.Target diseases,cupping methods,numbers and types of included studies,quality of included trials,main results (including meta-analysis re sults),and authors' conclusions of SRs were extracted.The Assessment of Multiple Systematic Reviews measurement was used to evaluate methodologic quality of the SRs.Results Eight SRs met the inclusion criteria and effectiveness and safety of cupping therapy for 11 diseases were assessed.All included SRs were of good methodologic quality.However,quality of trials included in the SRs was generally poor.Meta-analysis was performed in 4 studies.Results:showed cupping therapy (alone or combined with other interventions) was better than medications (or other interventions alone) for herpes zoster,acne,facial paralysis,low back pain,or cervical spondylosis.One review reported adverse events,including hematoma,increased pain and tingling following cupping treatment.Conclusions:Cupping therapy may be beneficial for pain-related conditions,acne,and facial paralysis.However,a firm conclusion could not be drawn due to the insufficient number of included reviews and the low quality of the original studies.

Cupping therapy for acute and chronic pain management:a systematic review of randomized clinical trials

Objective:Cupping as a traditional therapy is used to treat a myriad of health conditions,including pain.This systematic review assessed the effectiveness and safety of cupping for different types of pain.Methods:Thirteen databases and four trial registries were searched for randomized clinical trials.Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity(measured by I2 test)among trials.Results:Sixteen trials with 921 participants were eligible and included.Six trials were assessed as low risk of bias,another six trials were of unclear risk of bias,and the remaining four trials were of high risk of bias.Pain was related to three acute and seven chronic diseases.Metaanalysis showed a beneficial effect of cupping compared to wait-list control(visual analogue scale(VAS),MD
1.85 cm,95%CI
2.66 to
1.04)and heat therapy(numerical rating scale,MD
2.05 cm,95%CI
2.93 to
1.17).Cupping combined with acupuncture was superior to acupuncture alone on post-treatment pain intensity(VAS,MD
1.18 cm,95%CI
1.68 to
0.68),however,no difference was found between this comparison based on changes in pain intensity(difference of VAS,MD 0.16 cm,95%CI
0.54 to 0.87).Results from other single studies showed significant benefit of cupping compared with conventional drugs or usual care.Hematoma and pain at the treated site,increasing local pain or tingling were reported as mild adverse effects of cupping.Conclusion:This review suggests a potential positive short-term effect of cupping therapy on reducing pain intensity compared with no treatment,heat therapy,usual care,or conventional drugs.

Characteristics of DBD micro-discharge at different pressure and its effect on the performance of oxygen plasma reactor

The oxygen plasma reactor based on dielectric barrier discharge principle can produce a high concentration of reactive oxygen species,which can cooperate with hydraulic cavitation gas-liquid mixer to realize the application of advanced oxidation technology in water treatment.In this technology,the work pressure of the oxygen plasma reactor is decreased by the vacuum suction effect generated in the snap-back section of the gas-liquid mixed container.In this paper,the characteristics of single micro-discharge at different pressures were investigated with the methods of discharge image,electrical characteristics and spectral diagnosis,in order to analyze the electrical characteristics and reactive oxygen species generation efficiency of oxygen plasma reactor at the pressure range from 60 kPa to 100 kPa.The study indicated that,when the pressure decreases,the duty ratio of ionization in the discharge gap and number of electrons with high energy increases,leading to a rise in reactive oxygen species production.When the oxygen reaches the maximum ionization,the concentration of reactive oxygen species is the highest.Then,the discharge intensity continues to increase,producing more heat,which will decompose the ozone and lower the production of reactive oxygen species.The oxygen plasma reactor has an optimum working pressure at different input powers,which makes the oxygen plasma reactor the most efficient in generating reactive oxygen species.

Research on resonance parameters matching based on partitioned operation method of atmospheric pressure plasma reactor array

Matching optimization of resonant parameters among the high power inverters,low power transformers and plasma reactors have significant effects on the performance and output of the reactor array when applying the partitioned operation method.In this paper,the Matlab/Simulink electrical model was established based on the method of partitioned operation.The matching relation between resonant parameters is analyzed on the basis of experimental result.As a consequence,transformer leakage inductance and working frequency are the important parameters influencing the operational efficiency of system,leakage inductance of transformer should be adjusted based on the equivalent capacitance of plasma reactor to realize the matching optimization of resonant parameters.

Key elements that determine the efficacy of cupping therapy:A bibliometric analysis and review of clinical studies

Objective:The aim of this review was to identify the possible mechanisms behind cupping therapy by employing an evidence-based approach,and to explore its possible regional and systemic effects in the human body.Methods:We searched six electronic databases and four online trial registries for articles published up to January 1,2020.Clinical studies on the mechanisms of retained cupping,flashing cupping,moving cupping,and vacuum cupping were considered for this review.The methodological qualities of controlled studies were assessed using the National Institute for Clinical Excellence methodology checklist,the Newcastle-Ottawa Scale,and the Cochrane risk of bias tool.Characteristic statistical description and qualitative summary of results were used for data analysis.Results:Thirty-eight studies(37 full texts and one abstract)were included in this study.Due to the clinical heterogeneity among the studies,we could not conduct a meta-analysis.The results showed that the key factors that contribute to the efficacy of cupping therapy are negative pressure and temperature.Cupping therapy mainly causes local and systemic changes in hemodynamics,immune regulation,metabolism,and pain relief.Conclusion:We identified negative pressure as the key element behind cupping therapy.Cupping therapy may cause redistribution of oxygen at the cupping site and in neighboring tissues,thereby inducing a therapeutic effect by increasing regional blood flow.It may also induce metabolic change,immunomodulation,and neuromodulation.However,additional rigorous clinical research needs to be conducted to further clarify the mechanism behind cupping therapy.

Anti-cancer activity of Tonglian decoction against esophageal cancer cell proliferation through regulation of the cell cycle and PI3K/Akt signaling pathway

Objective:The purpose of this study was to observe the anti-cancer activity of Tonglian decoction(TD)on esophageal cancer(EC)cells in vitro,and to elucidate the related molecular mechanisms in the cell cycle and PI3K/Akt signaling pathway.Methods:EC9706 cells were cultured in RPMI 1640 medium supplemented with 10%calf serum at 37
C in a 5%CO2 incubator.The cells were treated with rat serum containing TD or the serum of rats administered Xiaoaiping as a positive control drug.Cell proliferation was assessed by methylthiazolyldiphenyl-tetrazolium bromide assays.Cell morphology was observed under a microscope.The cell cycle was examined by flow cytometry.Protein expression in the PI3K/Akt signaling pathway was measured by western blotting.Results:TD mainly inhibited cell proliferation.Concentrations of 50%cell inhibition by rat serum containing TD or Xiaoaiping were 73.6 and 153.8 mL/mL,respectively.TD also influenced cell morphology characterized by small shrunken cells.Cell colonies became small and the cell proliferation rate was slower.In cell cycle analysis,the percentage of cells in S phase was decreased significantly by TD and Xiaoaiping compared with the blank control group(P<.05).Western blotting showed that serum containing TD strongly downregulated EGFR,PI3K,Akt,p-Akt,and mTOR expression compared with the blank control group(P<.05).Conclusion:TD could inhibit EC9706 carcinoma cell proliferation by blocking the cell cycle progression in S phase.The possible mechanism was inhibition of multiple targets in the PI3K/Akt signaling pathway by TD.

The Association between Expression of NK Cells and Prognosis of Patients with HBV Acute-on-Chronic Liver Failure in Advanced Phase

Acute-on-chronic liver failure (Acute-on-chronic liver failure, ACLF) is acute liver function decompensation on the basis of chronic liver disease. The progression of ACLF develops from advanced phase, plateau phase to remission phase. The pathophysiological basis of ACLF in different phases is various. In advanced phase, immune imbalance and systemic inflammatory reaction plays key roles. In this study, we try to assess the association between expression of NK cells and its receptors and prognosis of patients with ACLF in advanced phase. A total of 35 inpatients with HBV acute-on-chronic liver failure in advanced phase were recruited. They were divided into case group (n = 18) and control group (n = 17) according to whether the patients was dead in the 12 weeks. PBMC were detected for the frequency and expression of NK cell receptors by flow cytometric analysis. Our results demonstrated that patients who died had lower expression of NK cells and inhibitory receptor KIR3DL1, higher levels of FASL. During 12-week follow-up in those case alive, we found that NK cells increased, while expression of FASL decreased. High short-term mortality of ALCF was associated with NK cell, especially related to KIR3DL1 and FASL (PNK = 0.036, PKIR3DL1 = 0.0265, PFasL = 0.0008).

Regulation of Zishen Qinggan( Shuangyi) Prescription to Insulin Resistance of GK Rats

[Objective] To study the effects of Zishen Qinggan( Shuangyi) Prescription on blood glucose,Hb A1c( glycosylated hemoglobin A1c),C-peptide( C-P),glucagon-like peptide( GLP-1),and α-glucosidase activity in GK( Goto-Kakizaki) rats. [Methods]Selected fasting blood glucose( FBG) > 11. 1mmol/L GK rats and randomly divided into groups: model group,Zishen Qinggan( Shuangyi) Prescription low dosage( ig,400 mg/kg/d),medium dosage( ig,800 mg/kg/d),and high dosage groups( ig,1600 mg/kg/d),and metformin group(ig,85 mg/kg/d). After continuous administration for 28 d,fasting blood glucose(FBG),oral glucose tolerance test(OGTT),Hb A1 c,C-P,GLP-1 and α-glucosidase activity were detected. [Results] Compared with the control group,FBG and Hb A1 c of the model group was significantly higher( P < 0. 01); compared with the model group,Zishen Qinggan( Shuangyi) Prescription could significantly reduce the levels of blood glucose,Hb A1 c,and the elevated blood glucose levels after 120 min of glucose loading in OGTT( P < 0. 05,P < 0. 01),and also can significantly improve the level of C-P,GLP-1( P < 0. 05,P < 0. 01),reduce Homa-IR,and inhibit α-glucosidase activity. [Conclusions]Zishen Qinggan( Shuangyi) Prescription can effectively reduce the blood glucose of GK rats,the action mechanism of which is possibly that it can improve insulin resistance,increase GLP-1 content and inhibit α-glucosidase activity.

Do major customers promote firms’ innovation?

This study examines whether and how a concentrated supply chain relationship affects a firm’s innovation decisions. Using data from Chinese listed firms in the manufacturing industry, we find that a concentrated customer base constrains a firm’s R&D investment, where a 1% increase in customer concentration is associated with a 0.011% decrease in R&D investment. To establish causality, we use the instrumental variable method, the reverse causality model, and the Granger causality test to re-examine the relationship and arrive at a consistent conclusion. Results from mechanism analysis suggest that a concentrated customer base constrains the internal fund availability and that the negative relationship between customer concentration and firms’ innovation is less pronounced for firms with more external financial support. Additional analysis reveals that the negative effect of customer concentration mainly affects R&D investment expenditure and that customer concentration also constrains innovation output in China. Overall, our paper reveals the dark side of close customer-supplier relationships and provides new insights into how supply chain relationships affect firms’ innovation decisions.

Board secretary and market information efficiency:Evidence from corporate site visits

Using the setting of corporate site visits,this study examines the information interpretation role of board secretaries on market information efficiency.We find that the presence of the board secretary during corporate site visits can significantly improve the information content of such visits.From the perspective of information interpretation ability,when the board secretary has a dual role,receives high relative compensation,and has a high level of education,his or her participation in site visits has a greater effect on improving the informativeness of such visits.From the perspective of information asymmetry,the information interpretation role of the board secretary is more pronounced when the level of information asymmetry between the firm and its investors is high.Further analysis shows that when the board secretary attends more site visits,the level of analyst forecast error is lower.In summary,we confirm the information interpretation role of board secretaries,which is useful for opening the‘‘black box"of their participation in the information assimilation process and for better understanding of how to improve market information efficiency.

Efficacy and safety of low-dose rifampicin in patients with benign intrahepatic cholestasis

Background and aim:Some previous studies supported that rifampicin was an effective treatment for benign intrahepatic cholestasis.However,the efficacy and safety of rifampicin remain unclear.Therefore,this study aimed to evaluate its efficacy and safety on benign intrahepatic cholestasis.Methods:A retrospective,single-center,observational study was conducted on patients diagnosed with benign intrahepatic cholestasis between 2019 and 2021,who were administered 150 mg of rifampicin orally once a day.We collected and analyzed the data at baseline and post-treatment,including total bilirubin(TBIL),direct bilirubin(DBIL),total bile acid(TBA),gamma-glutamyl transferase(GGT),alkaline phosphatase,aspartate aminotransferase,and alanine aminotransferase levels.Statistical analysis was performed using appropriate tests.Results:A total of 17 rifampicin-treated patients were enrolled in the study from January 2019 to January 2021.Among them,14 patients(82%)improved,with significantly decreased TBIL,DBIL,and TBA levels after 3 weeks of treatment(all P<0.05),whereas the remaining 3 had no improvement.Moreover,GGT levels of the former were significantly lower than those of the latter(34(12-227)U/L vs.244(76-293)U/L,P=0.023)at baseline.No severe adverse effect was observed during treatment.Conclusions:Low-dose rifampicin(150 mg per day)was an effective and safe treatment for benign intrahepatic cholestasis.Low GGT level at baseline and a significant decrease of TBIL,DBIL,and TBA levels within the first 3 weeks of treatment may lead to the good curative effect.