Unveiling the hidden world of gut health:Exploring cutting-edge research through visualizing randomized controlled trials on the gut microbiota

BACKGROUND The gut microbiota plays a crucial role in gastrointestinal and overall health.Randomized clinical trials(RCTs)play a crucial role in advancing our knowledge and evaluating the efficacy of therapeutic interventions targeting the gut microbiota.AIM To conduct a comprehensive bibliometric analysis of the literature on RCTs involving the gut microbiota.METHODS Using bibliometric tools,a descriptive cross-sectional investigation was conducted on scholarly publications concentrated on RCTs related to gut microbiota,spanning the years 2003 to 2022.The study used VOSviewer version 1.6.9 to examine collaboration networks between different countries and evaluate the frequently employed terms in the titles and abstracts of the retrieved publications.The primary objective of this analysis was to identify key research areas and focal points associated with RCTs involving the gut microbiota.RESULTS A total of 1061 relevant articles were identified from the 24758 research articles published between 2003 and 2022.The number of publications showed a notable increase over time,with a positive correlation(R2=0.978,P<0.001).China(n=276,26.01%),the United States(n=254,23.94%),and the United Kingdom(n=97,9.14%)were the leading contributing countries.Københavns Universitet(n=38,3.58%)and Dankook University(n=35,3.30%)were the top active institutions.The co-occurrence analysis shows current gut microbiota research trends and important topics,such as obesity interventions targeting the gut microbiota,the efficacy and safety of fecal microbiota transplantation,and the effects of dietary interventions on humans.CONCLUSION The study highlights the rapid growth and importance of research on RCTs that involve the gut microbiota.This study provides valuable insight into research trends,identifies key players,and outlines potential future directions in this field.Additionally,the co-occurrence analysis identified important topics that play a critical role in the advancement of science and provided insights into future research directions in this field.

Efficacy and safety of Di-Tan Decoction for treating post-stroke neurological disorders:a systematic review and Meta-analysis of randomized clinical trials

The management of post-stroke complications plays an important role in the quality of life.Di-Tan Decoction(DTD;涤痰汤)is a widely used traditional Chinese medicine.This study incorporated systematic review and meta-analysis to evaluate the efficacy of DTD in post-stroke neurological disorders.Randomized clinical trials(RCTs)were searched from English,Chinese and Korean electronic medical databases,by including the keywords"Di-Tan Tang","Di-Tan Decoction","Scour Phlegm Decoction","stroke",and"RCT.Each RCT included control(placebo,conventional therapy,or Western medicine)and experimental(DTD treatment)groups.For patients inflicted with stroke for 1-6 weeks,the outcomes of post-stroke neurological disorders were measured by scales for post-stroke symptoms and were classified as"completely healed","markedly effective","effective"and"ineffective".Totally,11 RCTs(n=490 controls and n=502 DTD subjects)were selected from 210 articles identified in the initial search.A metaanalysis of evaluation criteria in post-stroke symptoms revealed that the overall odds ratio(ORs)for alleviating post-stroke neurological disorders were 0.30-fold lower(95%CI=0.21-0.43)in the DTD group than the control(Western medicine)group(P<0.00001).Moreover,regardless of the type of stroke diagnostic scale applied(including NFA,HDS,and NIHSS),the overall post-stroke symptoms determined were less severe in the DTD group(n=219)than the control group(n=217).No adverse effects of DTD were observed in the 11 RCTs reviewed.All 11 studies used an appropriate method for randomization of subjects to evaluate the risk of bias(ROB),and 7 studies included allocation concealment as well as blinding of patients and practitioners.High-risk ROB was included in6 RCTs.No significant publication bias was derived from the funnel plot.Our results indicate that the administration of DTD alone,and DTD in combination with Western medicine,exert greater efficacy for post-stroke complication therapy,than Western medicine administered alone.More rigorous and regulated studies are required to confirm the therapeutic efficacy of DTD for post-stroke neurological disorders.disorders.

Overcoming resistance to endocrine therapy in hormone receptorpositive human epidermal growth factor receptor 2-negative(HR^(+)/HER2^(-))advanced breast cancer:a meta-analysis and systemic review of randomized clinical trials

New targeted therapies have been developed to overcome resistance to endocrine therapy(ET)and improve the outcome of HR^(+)/HER2^(-)advanced breast cancer(ABC).We conducted a meta-analysis and systemic review on randomized controlled trials evaluating various targeted therapies in combination with ET in HR^(+)/HER2^(-)ABC.PUBMED and EMBASE databases were searched for eligible trials.Hazard ratios(HRs)for progression-free survival(PFS),odds ratios(ORs)for objective response rate(ORR),clinical benefit rate(CBR),and toxicity were meta-analyzed.Twenty-six studies with data on 10347 patients were included and pooled.The addition of cyclin-dependent kinase 4/6 inhibitors to ET significantly improved median PFS(pooled HR=0.547,P<0.001),overall survival(pooled HR=0.755,P<0.001),and tumor response rates(ORR,pooled OR=1.478,P<0.001;CBR,pooled OR=1.201,P<0.001)with manageable toxicities(pooled OR=3.280,P<0.001).The mammalian targets of rapamycin inhibitors and exemestane were not clinically beneficial for this pooled population including ET-naïve and ET-resistant patients.Moderate improvement in PFS(pooled HR=0.686,P<0.001)yet pronounced toxicities(pooled OR=2.154,P<0.001)were noted in the combination of phosphatidylinositol-4,5-bisphosphate 3-kinase inhibitors with fulvestrant.Future studies are warranted to optimize the population and the dosing sequence of these available options.

Postrandomization Confounding Challenges the Applicability of Randomized Clinical Trials in Comparative Effectiveness Research

Different from trials for regulatory approvals of new interventions aimed to test the efficacy, comparative effectiveness research （CER） is the direct comparison of existing health-care interventions （compared with active controls） to examine which treatment works best, for whom,

Design flaws in randomized, placebo controlled, double blind clinical trials

The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. Placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. Placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. Placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.

Probiotics supplementation for management of type Ⅱ diabetes risk factors in adults with polycystic ovarian syndrome: a meta-analysis of randomized clinical trial

This meta-analysis of randomized controlled trials aimed to evaluate the effects of probiotic supplementation on glucose homeostasis in patients with polycystic ovary syndrome(PCOS).The meta-analysis was performed in accordance with the Cochrane Handbook guidelines and relevant the preferred reporting items for systematic reviews and meta-analyses(PRISMA)statement criteria.Of 825 identified reports,11 randomized clinical trials were included in the meta-analysis.An analysis of pooled extracted data revealed that supplementation with probiotics significantly decreased fasting blood glucose(FBG,n=7;standardized mean difference(SMD)=−0.40;95%confidence interval(CI):−2.02,−0.02;P=0.04)and insulin levels(n=6;SMD=−0.57;95%CI:−0.89,−0.25;P=0.0004)and the homeostatic model assessment of insulin resistance(n=7;SMD=−0.64;95%CI:−0.96,−0.31;P=0.0001)while increasing the quantitative insulin sensitivity check index(QUICKI,n=5;SMD=0.58;95%CI:0.08,1.09;P=0.02)in patients with PCOS.The FBG-reducing effect decreased as the baseline body mass index(BMI)and mean age of the participants increased.Indeed,a greater number of bacterial species and a higher bacterial dose were shown to reduce QUICKI effectively.The systematic review indicated that probiotic supplementation may help to control glucose homeostasis in adults with polycystic ovarian syndrome.

Randomized Clinical Trials on Eastern-Western Integrative Medicine for Health Care in Korean Literature:A Systematic Review

Objective：To summarize and critically evaluate the evidence for and against the effectiveness of Eastern-Western integrative medicine（EWIM） for health care compared to Eastern medicine（EM） or Western medicine（WM） alone.Methods：Systematic searches were conducted on five Korean medical databases.Manual searches were also conducted through nine major Korean medical journals.Prospective randomized clinical trials （RCTs） were included if EWIM was tested for any type of conditions compared to EM or WM.Results：There were one hundred forty-one possibly relevant studies were identified,and seven RCTs were included.The risk of bias was high in most studies.The EWIM methods were compared with EM or WM in patients with pain conditions in four studies.These studies showed favorable effects of EWIM on pain reduction in patients with shoulder pain and chronic headache compared with EM,while the other RCTs failed to do so in traffic injury patients.Two studies tested EWIM in patients with Bell＇s palsy compared with EM and found acute functional improvement.An RCT comparing EWIM with WM in patients with acne showed a significant difference.Conclusion：The results of our systematic review suggest that there is limited evidence for the superiority of EWIM over EM or WM in the treatment of pain and acute symptom improvement in patients with Bell＇s palsy.The evidence from our analysis was limited from the low number of RCTs included and the high risk of bias.Future RCTs appear to be warranted.

Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis:A Scoping Review

Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.

Chinese herbal medicine for incomplete immune reconstruction in patients with AIDS undergoing antiretroviral treatment: A systematic review of randomized trials

Objective:To evaluate the effectiveness and safety of Chinese herbal medicines(CHMs)for incomplete immune reconstruction in patients with HIV/AIDS.Methods:Eight electronic databases were searched for randomized controlled trials(RCTs)on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction.Outcomes included CD4þcell count,quality of life,and adverse events/effects.The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.Results:We identified 13 eligible RCTs,with an overall high risk of bias,on 10 different CHMs.There was a significant increase in CD4þcell count after the use of Jianpi Yiqi medicinal paste for 3 months;tripterygium glycosides tablets(TGTs)for 3 months(mean difference[MD]52.63 cells/mL,95%confidence interval[CI,46.98,58.28]),6,9,and 12 months;Wenshen Jianpi granules for 6 months;Shenling Fuzheng capsules for 6 months(MD 49.53 cells/mL,95%CI[8.45,90.61])and 12 months;Aikeqing granules for 9 months(MD 61.51 cells/mL,95%CI[16.25,106.77])and 12 months;Guipi decoction for 12 months;Mianyi No.2 granules(JT)for 12 and 18 months;and Chinese medicine granules for 18 months.The increase in the mean difference of CD4þcell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules(JT).Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score.Four RCTs reported the outcome of adverse events/effects,while four cases of minor adverse effects were reported in the TGTs group.Conclusion:Jianpi Yiqi medicinal paste,Wenshen Jianpi granules,Shenling Fuzheng capsules,Aikeqing granules,Guipi decoction,and TGTs may be effective in increasing CD4þwithin 12 months,and Mianyi No.2 granules(JT)and Chinese medicine granules may show long-term effects.High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.

Transcranial direct current stimulation for auditory verbal hallucinations:a systematic review of clinical trials

Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallucination(AVH).This study aims to review the effects of tDCS on AVH in patients with schizophrenia through combining the evidence from randomized clinical trials(RCTs).The databases of PsycINFO(2000–2019),PubMed(2000–2019),EMBASE(2000–2019),CINAHL(2000–2019),Web of Science(2000–2019),and Scopus(2000–2019)were systematically searched.The clinical trials with RCT design were selected for final analysis.A total of nine RCTs were eligible and included in the review.Nine RCTs were included in the final analysis.Among them,six RCTs reported a significant reduction of AVH after repeated sessions of tDCS,whereas three RCTs did not show any advantage of active tDCS over sham tDCS.The current studies showed an overall decrease of approximately 28%of AVH after active tDCS and 10%after sham tDCS.The tDCS protocols targeting the sensorimotor frontal-parietal network showed greater treatment effects compared with the protocols targeting other regions.In this regard,cathodal tDCS over the left temporoparietal area showed inhibitory effects on AVHs.The most effective tDCS protocol on AVHs was twice-daily sessions(2 mA,20-minute duration)over 5 consecutive days(10 sessions)with the anode over the left dorsolateral prefrontal cortex and the cathode over the left temporal area.Some patient-specific and diseasespecific factors such as young age,nonsmoking status,and higher frequencies of AVHs seemed to be the predictors of treatment response.Taken together,the results of tDCS as an alternative treatment option for AVH show controversy among current literatures,since not all studies were positive.However,the studies targeting the same site of the brain showed that the tDCS could be a promising treatment option to reduce AVH.Further RCTs,with larger sample sizes,should be conducted to reach a conclusion on the efficacy of tDCS for AVH and to develop an effective therapeutic protocol for clinical setting.

Neoadjuvant chemoradiotherapy for resectable esophageal cancer:an in-depth study of randomized controlled trials and literature review

Surgery following neoadjuvant chemoradiotherapy(NCRT) is a common multidisciplinary treatment for resectable esophageal cancer(EC). After analyzing 12 randomized controlled trials(RCTs), we discuss the key issues of surgery in the management of resectable EC. Along with chemoradiotherapy, NCRT is recommended for patients with squamous cell carcinoma(SCC) and adenocarcinoma(AC), and most chemotherapy regimens are based on cisplatin, fluorouracil(FU), or both(CF). However, taxane-based schedules or additional studies, together with newer chemotherapies, are warranted. In nine clinical trials, post-operative complications were similar without significant differences between two treatment groups. In-hospital mortality was significantly different in only 1 out of 10 trials. Half of the randomized trials that compare NCRT with surgery in EC demonstrate an increase in overall survival or disease-free survival. NCRT offers a great opportunity for margin negative resection, decreased disease stage, and improved loco-regional control. However, NCRT does not affect the quality of life when combined with esophagectomy. Future trials should focus on the identification of optimum regimens and selection of patients who are most likely to benefit from specific treatment options.

Lavender aromatherapy on anxiety and depression in patients with Acute Coronary Syndrome: a single-blind randomized clinical trial

Objective:In cardiovascular disease,a patient’s anxiety and depression can increase cardiac rehabilitation duration and recovery.Lavender aromatherapy as a non-pharmacological intervention effective in other contexts may be an efficient intervention to alleviating anxiety and depression in patients with Acute Coronary Syndrome(ACS).Methods:In this study,110 ACS patients were randomly assigned to two intervention and control groups.Inhalation of the lavender fragrance was prescribed for the intervention group and the drop of aromatic almond for the control group for 3 days.Results:The first-day anxiety and depression were significantly different in the two groups at 1 h and 9 h after the intervention.The’morning’s difference before the intervention was not significant,but it was substantial 1 h after the intervention.On the third morning of the intervention,this difference was confirmed.Conclusions:This study confirmed the effectiveness of lavender aromatherapy in reducing anxiety and depression in ACS patients.This’study’s results enable intensive care nurses to use aromatherapy with lavender oil as a non-pharmacological and cost-effective intervention to reduce their psychological tensions and increase patient satisfaction during hospitalization in the cardiac care units(CCU).

Immunomodulatory Activities of a Concentrated Fruit and Vegetable Juice Tested in a Randomized,Placebo-Controlled,Double-Blind Clinical Trial in Healthy Volunteers

22 healthy volunteers were included in a randomized, placebo-controlled pilot study in order to investigate immunomodulatory effects of a concentrated juice, containing the ingredients of a total of 80 different fruits, vegetables, herbs, mushrooms, oils, and others (Cellagon aurum?, “CA”). 11 subjects received the concentrated juice while 11 were allocated to the placebo group. Stimulated whole-blood cultures were used to assess any treatment-related changes in the response of leukocytes towards experimental immune cell activation. For each of the individuals, 5 cultures were performed either immediately before, during, or 3 days after termination of the 7 weeks treatment. Leukocyte activities were determined by measuring cytokine levels in the supernatants at the end of the 48 h of stimulation (induced by the addition of LPS + SE-B + anti-CD28 antibodies). Despite the relatively small number of volunteers, multiplexed cytokine assays revealed a typical T-cell signature of cytokines that were increased significantly in the course of CA treatment compared to placebo (GM-CSF, IFNγ, IL-4, IL-10, IL-17, TNFβ, all p 0.05). These preliminary results suggest that CA is able to support leukocyte activation, in particular that of T-lymphocytes.

A Randomized Controlled Clinical Trial on Efficacy and Safety of Electroacupuncture on Oral Oxycodone Hydrochloride Prolonged-Release Tablets Related Constipation

Objective:To observe the efficacy and safety of electroacupuncture on oral oxycodone hydrochloride prolonged-release tablets related constipation in Qi(气)deficiency syndrome.Methods:A randomized control trial was conducted in 44 participants,who were divided into the treatment group(electroacupuncture group)and the control group(western medicine group).Two groups were treated by electroacupuncture at Zusanli(ST36),Tianshu(ST25),Zhigou(SJ6)and Shangjuxu(ST37)acupoints every day for 20 mins for 14 consecutive days and lactulose oral solution 30 ml every day for 14 consecutive days respectively.The constipation symptoms,traditional Chinese medicine(TCM)symptoms,quality of life,physical condition before and after the treatments were observed,and the safety indicators were monitored.Results:The treatment group was better than the control group in improving constipation symptom score,improving TCM symptom score and improving quality of life score,and the difference was statistically significant.There was no significant difference between the two groups in improving physical condition score.No acupuncture related adverse events were observed in the treatment group.Two patients in the control group withdrew from the study due to taking emergency defecation therapy and mild diarrhea respectively.Conclusion:Electroacupuncture is better than lactulose in the treatment of Qi deficiency constipation related to oxycodone hydrochloride prolonged-release tablets.It can significantly improve the symptoms of constipation,improve the symptoms of TCM,improve the quality of life.It is safe and effective.

Xi-Feng-Hua-Shi granules for diarrhea-predominant irritable bowel syndrome:protocol for a randomized,double-blind,placebo-controlled multi-center clinical trial

Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.

Efficacy and safety of fecal microbiota transplantation for treatment of ulcerative colitis:A post-consensus systematic review and metaanalysis

BACKGROUND Numerous studies have assessed the efficacy and safety of fecal microbiota transplantation(FMT)as a therapy for ulcerative colitis(UC).However,the treatment processes and outcomes of these studies vary.AIM To evaluate the efficacy and safety of FMT for treating UC by conducting a systematic meta-analysis.METHODS The inclusion criteria involved reports of adult patients with UC treated with FMT,while studies that did not report clinical outcomes or that included patients with infection were excluded.Clinical remission(CR)and endoscopic remission(ER)were the primary and secondary outcomes,respectively.RESULTS We included nine studies retrieved from five electronic databases.The FMT group had better CR than the control group[relative risk(RR)=1.53;95%confidence interval(CI):1.19-1.94;P<0.0008].ER was statistically significantly different between the two groups(RR=2.80;95%CI:1.93-4.05;P<0.00001).Adverse events did not differ significantly between the two groups.CONCLUSION FMT demonstrates favorable performance and safety;however,well-designed randomized clinical trials are still needed before the widespread use of FMT can be recommended.Furthermore,standardizing the FMT process is urgently needed for improved safety and efficacy.

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.

Yiwei Xiaoyu granules for treatment of chronic atrophic gastritis with deficiency syndrome of the spleen and stomach

BACKGROUND The Correa sequence,initiated by Helicobacter pylori(H.pylori),commonly progresses to gastric cancer through the stage of chronic atrophic gastritis(CAG).Although eradication of H.pylori only reduces the risk of gastric cancer,it does not eliminate the risk for neoplastic progression.Yiwei Xiaoyu granules(YWXY)are a commonly used composite preparation in Chinese clinics.However,the pursuit of excellence in clinical trials and the establishment of standardized animal experiments are still needed to contribute to full understanding and application of traditional Chinese medicine in the treatment of CAG.AIM To demonstrate the effectiveness of YWXY in patients with CAG and spleenstomach deficiency syndrome(DSSS),by alleviating histological scores,improving response rates for pathological lesions,and achieving clinical efficacy in relieving DSSS symptoms.METHODS We designed a double-blind,randomized,controlled trial.The study enrolled seventy-two H.pylori-negative patients(mean age,52.3 years;38 men)who were randomly allocated to either the treatment group or control group in a 1:1 ratio,and treated with 15 g YWXY or 0.36 g Weifuchun(WFC)tablet combined with the respective dummy for 24 wk.The pre-randomization phase resulted in the exclusion of 72 patients:50 participants did not meet the inclusion criteria,12 participants declined to participate,and 10 participants were excluded for various other reasons.Seven visits were conducted during the study,and histopathological examination with target endoscopic biopsy of narrow-band imaging was requested before the first and seventh visits.We also evaluated endoscopic performance scores,total symptom scores,serum pepsinogen and gastrin-17.RESULTS Six patients did not complete the trial procedures.Treatment with YWXY improved the Operative Link on Gastric Intestinal Metaplasia Assessment(OLGIM)stage,compared with WFC(P<0.05).YWXY provided better relief from symptoms of DSSS and better improvement in serum gastric function,compared with WFC(P<0.05).CONCLUSION YWXY compared with WFC significantly reduced the risk of mild or moderate atrophic disease,according to OLGIM stage,significantly relieved symptoms of DSSS,and improved serum gastric function.

Safety,immunogenicity,and preliminary efficacy of a randomized clinical trial ofomicron XBB.1.5-containing bivalent mRNA vaccine

Periodically updating coronavirus disease 19(COVID-19)vaccines that offer broad-spectrum protection is needed giventhe strong immune evasion by the circulating omicron sublineages.The effectiveness of prototype and BA.4/5-containing bivalent mRNA vaccines is reduced when XBB subvariants predominate.We initiated an observer-blinded,threearms study in 376 patients in Chinese individuals aged from 18 to 55 years old who had previously received three dosesCOVID-19 vaccine.Immunogenicity in terms of neutralizing antibodies elicited by a 30-mg dose of XBB.1.5-containingbivalent vaccine(RQ3027),a 30-mg dose of BA.2/BA.5-Alpha/Beta bivalent vaccine(RQ3025)and their precedent 30-mg Alpha/Beta(combined mutations)monovalent mRNA vaccine(RQ3013)and safety are primary and secondary endpoints,respectively.We recorded prescribed COVID-19 cases to explore the preliminary efficacy of three vaccines.RQ3027 and RQ3025 boosters elicited superior neutralizing antibodies(NAbs)against XBB.1.5,XBB.1.16,XBB.1.9.1,and JN.1 compared to RQ3013 at day 14 in participants without SARS-CoV-2 infection.All study vaccines were welltolerated without serious adverse reactions identified.The incidence rates per 1000 person-years of COVID-19 casesduring the 2nd-19th week after randomization were lowest in RQ3027.Overall,our data show that XBB.1.5-containingbivalent booster generated superior immunogenicity and better protection against newer severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)variants compared to BA.2/BA.5-containing bivalent and Alpha/Beta monovalentwith no new safety concerns.

Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study

Subthreshold depression is a highly prevalent condition in adolescents who are at high risk for developing major depressive disorder.In preclinical models of neurological and psychiatric diseases,Lycium barbarum polysaccharide(LBP)extracted from Goji berries had antidepressant effects including but not limited to anti-oxidative and anti-inflammatory properties.However,the effect of LBP on subthreshold depression is unclear.To investigate the clinical efficacy and safety of LBP for treating subthreshold depression in adolescents,we conducted a randomized,double-blind,placebo-controlled trial(RCT)with 29 adolescents with subthreshold depression recruited at The Fifth Affiliated Hospital of Guangzhou Medical University.The participants were randomly assigned to groups where they received either 300 mg LBP(LBP group,n=15,3 boys and 12 girls aged 15.13±2.17 years)or a placebo(placebo group,n=14,2 boys and 12 girls aged 15±1.71 years)for 6 successive weeks.Interim analyses revealed that the LBP group exhibited a greater change in Hamilton Depression Scale(HAMD-24)scores relative to the baseline and a higher remission rate(HAMD-24 total score≤7)at 6 weeks compared with the placebo group.Scores on the Beck Depression Inventory-II(BDI-II),Pittsburgh Sleep Quality Index(PSQI),Kessler Psychological Distress Scale(Kessler),and Screen for Child Anxiety-Related Emotional Disorders(SCARED)were similar between the LBP and placebo groups.No side effects related to the intervention were reported in either group.These results indicate that LBP administration reduced depressive symptoms in adolescents with subthreshold depression.Furthermore,LBP was well tolerated with no treatment-limiting adverse events.Clinical trials involving a larger sample size are needed to further confirm the anti-depressive effects of LBP in adolescents with subthreshold depression.This study was approved by the Medical Ethics Committee of the Fifth Affiliated Hospital of Guangzhou Medical University(Guangzhou,China;approval No.L2019-08)on April 4,2019 and was registered on ClinicalTrials.gov(identifier:NCT04032795)on July 25,2019.