Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Effects of Lycium barbarum polysaccharide on cytokines in adolescents with subthreshold depression:a randomized controlled study

Strong evidence has accumulated to show a correlation between depression symptoms and inflammatory responses.Moreover,anti-inflammatory treatment has shown partial effectiveness in alleviating depression symptoms.Lycium barbarum polysaccharide(LBP),derived from Goji berries,exhibits notable antioxidative and anti-inflammatory properties.In our recent double-blinded randomized placebo-controlled trial,we found that LBP significantly reduced depressive symptoms in adolescents with subthreshold depression.It is presumed that the antidepressant effect of LBP may be associated with its influence on inflammatory cytokines.In the double-blinded randomized controlled trial,we enrolled 29 adolescents with subthreshold depression and randomly divided them into an LBP group and a placebo group.In the LBP group,adolescents were given 300 mg/d LBP.A 6-week follow up was completed by 24 adolescents,comprising 14 adolescents from the LBP group(15.36±2.06 years,3 men and 11 women)and 10 adolescents from the placebo group(14.9±1.6 years,2 men and 8 women).Our results showed that after 6 weeks of treatment,the interleukin-17A level in the LBP group was lower than that in the placebo group.Network analysis showed that LBP reduced the correlations and connectivity between inflammatory factors,which were associated with the improvement in depressive symptoms.These findings suggest that 6-week administration of LBP suppresses the immune response by reducing interleukin-17A level,thereby exerting an antidepressant effect.

A Double-Blind, Randomized, Placebo-Controlled Nutritional Study Using an Insoluble Yeast Beta-Glucan to Improve the Immune Defense System

Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.

Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China:study protocol of a multicenter randomized controlled trial

BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.

Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy Subjects

In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group (p = 0.935). There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as “very good” or “good” by the investigators for 99% of the subjects and by 98% subjects in self-assessment with no statistical differences to placebo. CONCLUSION: The measured parameters as well as the evaluation of the tolerability by the investigators and the subjects demonstrate a very good tolerance profile of the proprietary arabinogalactan extract with no differences to placebo when taken for 12 weeks.

Stochastic resonance whole body vibration reduces musculoskeletal pain:A randomized controlled trial

AIM:To examined the effects of stochastic resonance whole-body vibration training on musculoskeletal pain in young healthy individuals.METHODS:Participants were 43 undergraduate students of a Swiss University.The study was designed as a randomized controlled trial(RCT)with randomized group allocation.The RCT consisted of two groups each given 12 training sessions during four weeks with either 5 Hz-Training frequency(training condition)or 1.5 Hz Training frequency(control condition).Outcome was current musculoskeletal pain assessed in the evening on each day during the four week training period.RESULTS:Multilevel regression analysis showed musculoskeletal pain was significantly decreased in the training condition whereas there was no change in the control condition(B=-0.023,SE=0.010,P=0.021).Decrease in current musculoskeletal pain over four weeks was linear.CONCLUSION:Stochastic resonance whole-body vibration reduced musculoskeletal pain in young healthy individuals.Stochastic resonance vibration and not any other exercise component within training caused pain reduction.

Hypothenar fat pad flap vs conventional open release in primary carpal tunnel syndrome:A randomized controlled trial

AIM To compared outcomes between the hypothenar fat pad flap(HTFPF) and conventional open carpal tunnel release(COR) in primary carpal tunnel syndrome(CTS). METHODS Forty-five patients(49 hands) were enrolled into the study from January 2014 to March 2016, 8 patients were excluded. Randomization was conducted in 37 patients(41 hands) by computer generated(Block of four randomization) into COR and HTFPF group. Nerve conduction study(NCS) included distal sensory latency(DSL), distal motor latency(DML), sensory amplitude (S-amp), motor amplitude(M-amp) and sensory nerve conduction velocity(SCV) were examined at 6 and 12 wk after CTR. Levine score, grip and pinch strength, pain [visual analog scale(VAS)], 2-point discrimination(2-PD), Semmes-Weinstein monofilament test(SWM), Phalen test and Tinel's sign were evaluated in order to compare treatment outcomes.RESULTS The COR group, 19 patients(20 hands) mean age 50.4 years. The HTFPF group, 20 patients(21 hands) mean age 53.3 years. Finally 33 patients(36 hands) were analysed, 5 patients were loss follow-up, 17 hands in COR and 19 hands in HTFPF group. NCS revealed significant difference of DSL in HTFPF group at 6 wk(P < 0.05) compared with the COR group. S-amp was significant improved postoperatively in both groups(P < 0.05) but not significant difference between two groups. No significant difference of DML, M-amp and SCV postoperatively in both groups and between two groups. Levine score, pain(VAS), grip and pinch strength, 2-PD, SWM, Phalen test and Tinel's sign were improved postoperatively in both groups, but there was no significant difference between two groups.CONCLUSION There is no advantage outcome in primary CTS for having additional HTFPF procedure in CTR. COR is still the standard treatment. Nevertheless, improvement of DSL and S-amp could be observed at 6 wk postoperatively.

Bias-Variation Dilemma Challenges Clinical Trials: Inherent Limitations of Randomized Controlled Trials and Meta-Analyses Comparing Hernia Therapies

Purpose:Evaluation of hernia therapies according to the current rules of Evidence Based Medicine is widely reduced to results of RCTs or meta-analyses. RCTs have been accepted as a most important tool to confirm a superior effect of an intervention. Unfortunately, in hernia surgery, comparisons of RCTs and correspondingly their use in meta-analyses, are not, surprisingly often, able to confirm any significant impact of a specific procedure due to intrinsic restrictions in a multi-causal setting with its web of influences. Methods:Based on our own experiences of clinical studies in surgery, the present article outlines several situations, with their respective reasons, which argue the severe limitations of RCTs and meta-analysis to define an optimum treatment. Results:Meta-analyses accumulate the variations of each trial, which then may cover any clear causal relationship. RCTs usually are dealing with subgroups of standard patients thus excluding the majority of our patients. Low statistical power of current cohort sizes restricts the analysis of subgroups or of effects with low incidences. Simple comparisons of means frequently are hampered by nonlinear relationships to outcome. The relevance of a specific variable is difficult to separate from other influences. The limited surveillance period of studies ignores a delayed change in outcome. Randomization cannot guarantee a standardized patient’s condition. All the arguments have to be considered as a crucial and fundamental consequence of the bias-variance dilemma or principle of uncertainty in medicine, and underline the many limitations of RCTs to evaluate any specific impact of hernia therapies on e.g. infection, pain or recurrence. Conclusions: Many surgical issues cannot be and should not be investigated by RCTs, in particular, if a marked patients’ heterogeneity has to be considered or the low incidences of the outcome readout cannot be addressed with sufficient statistical power without getting lost in the variation mire. Registries with their non-restricted data-acquisition should be regarded as reliable alternatives for postoperative outcome quality surveillance studies.

Effects of Depth of Needle Insertion with Risperidone Long-Acting Injectable in Persons with Schizophrenia: A Randomized Double-Blind Study

In some cases, if the insertion depth is shallower than expected, intramuscular (IM) injection of risperidone long-acting injectable (RLAI) may not penetrate the muscle fascia. However, if needle insertion depth is deeper than anticipated, needle penetration may cause damage to nerves, arteries and veins. Few clinical studies were done to evaluate the depth of needle length insertion reaching the intended gluteal muscle. The aim of this study was to evaluate the suitable depth of injecting RLAI. Twenty-six patients with schizophrenia were treated with RLAI, and randomly divided into two groups: 50 mm needle inserted group (Group-D, deep insertion, n = 13) and 20 mm needle insertion group (Group-S, shallow insertion, n = 13). For Group-S, the needle length was marked with a spacer at exactly 20 mm. Injections were performed by the psychiatrist or nurse, alternating between the two gluteal sites by double-cross method every two weeks. Clinical psychotic symptoms and injection site reactions were recorded throughout the study period. Experienced psychologists who were blinded from the needle-length experimental variable evaluated patients’ psychotic symptoms using the Positive and Negative Syndrome Scale (PANSS) every two weeks. The plasma 9-hydroxyrisperidone (9-OH-RIS) concentrations were measured every two weeks;comparison data were determined on the 8th week and the 14th week. No significant difference was observed in 9-OH-RIS concentrations, psychotic symptoms, injection site skin reactions of subjects in both groups. However, in Group-D, injection site adverse reactions were confirmed in two subjects (15%). In Group-S, injection site reactions were confirmed in six subjects (46%). Although effective 9-OH-RIS concentrations were obtained with the insertion using both depth, it was concluded that the 50 mm insertion length was more suitable for dorsogluteal IM injections in adult patients with schizophrenia as demonstrated by the incidence of local adverse skin reactions.

Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study

Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.

Effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸)in the treatment of premenstrual syndrome(liver depression,spleen deficiency,and blood-heat syndrome):a multi-center,randomized,placebo-controlled trial

OBJECTIVE:To investigate the effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸,JXP)in the treatment of symptoms associated with premenstrual syndrome(PMS).METHODS:A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018,and randomized to receive either a JXP or a matching placebo(12 g/d,6 g twice a day)for 3 menstrual cycles.The primary indicator was the reduced Daily Record of Severity of Problems(DRSP)scores in the luteal phase after 3 months of treatment.The safety outcomes included clinical adverse events(AEs),adverse reactions(ARs),changes in vital signs,and laboratory tests.RESULTS:JXP surpassed the placebo in reducing DRSP scores(psychological/somatic dysfunction)in the luteal phase over 3 menstrual cycles of treatment(PFAS=0.002,PPPS=0.001).Additionally,there were no significant differences in the incidence of AEs,severe AEs,withdrawal due to AEs and ARs between the two groups(all P>0.05),and no clinically significant adverse medical events related to the test drug observed.CONCLUSIONS:JXP was superior to the placebo in relieving the symptoms associated with PMS,which signified that JXP may be effective,safe,and welltolerated as an alternative therapy.

Study design in evidence-based surgery:What is the role of case-control studies?

Randomized controlled trials(RCTs) are the gold standard in terms of study design, however, in the surgical setting conducting RCTs can often be unethical or logistically impossible. Case-control studies should become the major study design used in surgical research when RCTs are unable to be conducted and definitely replacing case series which offer little insight into surgical outcomes and disease processes.

Efficiency and safety of acupuncture for women with premature ovarian insufficiency:study protocol for a randomized controlled trial

Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI.Seventy-six patients with POI will be randomly assigned to two groups.The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week HRT.The whole study will consist of a 12-week treatment plan and a 12-week follow-up session.The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and 24.Secondary outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual condition.This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.

Botulinum toxin type A for treating chronic low back pain:A double blinded randomized control study

BACKGROUND Low back pain(LBP)is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting.LBP can arise from various causes,with stiffness in the paraspinal muscles being a notable contributor.The administration of Botulinum toxin type A(BoNT-A)has been found to alleviate back pain by relaxing these stiff muscles.While BoNT-A is approved for use in numerous conditions,a limited number of randomized clinical trials(RCTs)validate its efficacy specifically for treating LBP.AIM To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP(CLBP).METHODS In this RCT,adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled.Participants were allocated to either the Drug group,receiving 200 Ipsen Units(2 mL)of BoNT-A,or the Control group,which received a 2 mL placebo.Over a 2-month follow-up period,both groups were assessed using the Visual Analog Scale(VAS)for pain intensity and the Oswestry Disability Index(ODI)for disability at the start and conclusion of the study.A decrease in pain by 50%was deemed clinically significant.RESULTS The study followed 40 patients for two months,with 20 in each group.A clinically significant reduction in pain was observed in 36 participants.There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months.Nonetheless,when comparing the mean score changes,only the reduction in ODI scores(15 in the placebo group vs 16.5 in the drug group,clinically insignificant)was statistically significant(P=0.012),whereas the change in mean VAS scores was not significant(P=0.45).CONCLUSION The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients.

Double-blinded,randomized clinical trial of Gegen Qinlian decoction pinpoints Faecalibacterium as key gut bacteria in alleviating hyperglycemia

Background:Accumulating evidence suggests that metabolic disorders,including type 2 diabetes mellitus(T2DM),can be treated with traditional Chinese medicine formulas,such as the Gegen Qinlian decoction(GQD).This study elucidates the mechanisms by which gut microbes mediate the anti-diabetic effects of GQD.Methods:We conducted a double-blind randomized clinical trial involving 120 untreated participants with T2DM.During the 12-week intervention,anthropometric measurements and diabetic traits were recorded every 4 weeks.Fecal microbiota and serum metabolites were measured before and after the intervention using 16S rDNA sequencing,liquid chromatography-mass spectrometry,and Bio-Plex panels.Results:Anti-diabetic effects were observed in the GQD group in the human trial.Specifically,glycated hemoglobin,fasting plasma glucose,and two-hour postprandial blood glucose levels were significantly lower in the GQD group than in the placebo group.Additionally,Faecalibacterium was significantly enriched in the GQD group,and the short-chain fatty acid levels were higher and the serum inflammation-associated marker levels were lower in the GQD group compared to the placebo group.Moreover,Faecalibacterium abundance negatively correlated with the levels of serum hemoglobin,fasting plasma glucose,and pro-inflammatory cytokines.Finally,the diabetes-alleviating effect of Faecalibacterium was confirmed by oral administration of Faecalibacterium prausnitzi(DSMZ 17677)in T2DMmousemodel.Conclusions:GQD improved type 2 diabetes primarily by modulating the abundance of Faecalibacterium in the gut microbiota,alleviating metabolic disorders and the inflammatory state.

A Randomized Double-blind Placebo-controlled Study of Pu'er Tea(普洱茶) Extract on the Regulation of Metabolic Syndrome

Objective：To explore the regulative efficacy of Pu＇er tea（普洱茶）extract on metabolic syndrome. Methods：Ninety patients with metabolic syndrome were randomly divided into two groups,the intervention group administered with Pu＇er tea extract,and the placebo group with placebo capsules.After 3 months＇ treatment, body mass index,waist hip ratio,blood lipids,blood sugar,immune and inflammatory index,and oxidation index of the patients with metabolic syndrome were tested and analyzed.Results：In the intervention group,the body mass index,waist-hip ratio,fasting and 2 h postprandial blood glucose,serum total cholesterol,triglycerides, low density lipoprotein and apolipoprotein B-100 all decreased in the patients with metabolic syndrome,and also the high-density lipoprotein level increased and apolipoprotein A-1 showed the tendency to increase. Serum C-reactive protein,tumor necrosis factor-α,and interleukin-6 were decreased in the intervention group. lnterleukin-10 level was increased,MDA was decreased and superoxide dismutase was increased.Compared with before treatment and the placebo group,there were significant differences（P0.05,P0.01）.Conclusions： Pu＇er tea demonstrated excellent potential in improving central obesity,adjusting blood lipid,lowering blood sugar,regulating immunity and resisting oxidation.It can adjust the metabolic syndrome of different clinical phenotypes to different degrees,and is ideally fit for early prevention of metabolic syndrome.

Experimental Design of Observational Studies in Real-World Study

Objective To introduce the design of observational trials under real-world study(RWS),and to provide guidance for clinical development of new research trials and reference for real-world researchers.Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed,and then the design of observational studies was summarized under RWS.Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial(RCT)in clinical practice,but also objectively reflect the real situation in the process of clinical research and application.

Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial

Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.