A Rumsfeld Matrix test for acupuncture clinical trials

This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.

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.

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.

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.

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 transcutaneous auricular vagus nerve stimulation combined with conventional rehabilitation training in acute stroke patients: a randomized controlled trial conducted for 1 year involving 60 patients

Transcutaneous auricular vagus nerve stimulation(ta-VNS)is a novel noninvasive treat-ment for stroke that directly stimulates the peripheral auricular branch of the vagus nerve.There have been recent reports that ta-VNS combined with conventional rehabilitation training promotes the recovery of neurological function of patients with acute stroke.However,these were small-sample-sized studies on the recovery of neurological function in patients after percutaneous vagus nerve stimulation in the subacute and chronic phases after stroke.This double-blinded randomized controlled trial involved 60 acute ischemic or hemorrhagic stroke patients aged 18-80 years who received treatment in the Second Affiliated Hospital of Chongqing Medical University.The subjects were randomly assigned to receive ta-VNS or sham ta-VNS combined with conventional rehabilitation training.The follow-up results over 1 year revealed that ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses compared with sham ta-VNS combined with conventional rehabilitation training.There were no obvious side effects.These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or hemorrhagic stroke patients is safe and effective.

Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial(THERESA-3)

AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease.

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.

Study protocol of the Asian XELIRI ProjecT(AXEPT):a multinational,randomized,non-inferiority,phase Ⅲ trial of second-line chemotherapy for metastatic colorectal cancer, comparing the eicacy and safety of XELIRI with or without bevacizumab versus FOLFIRI w

Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German Cancer Society(AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan(200 mg/m^2 on day 1) and capecitabine(1600 mg/m^2 on days 1–14), repeated every 3 weeks, has shown favorable tolerability and eicacy which were comparable to those of capecitabine and oxaliplatin(XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab(BIX) as second?line chemotherapy was well tolerated and had promising eicacy in Japanese patients.Methods: The Asian XELIRI Projec T(AXEPT) is an East Asian collaborative, open?labelled, randomized, phase Ⅲ clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI(5?fluorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with m CRC. Patients with 20 years of age or older, histologically conirmed m CRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the irst?line regimen will be eligible. Patients will be randomized(1:1) to receive standard FOLFIRI with or with?out bevacizumab(5 mg/kg on day 1), repeated every 2 weeks(FOLIRI arm) or XELIRI with or without bevacizumab(7.5 mg/kg on day 1), repeated every 3 weeks(XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conidence interval(CI) upper limit of the hazard ratio was pre?speciied as less than 1.3.Conclusion: The Asian XELIRI Projec T is a multinational phase III trial being conducted to provide evidence for XELIRI with or without bevacizumab as a second?line treatment option of mCRC.

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.

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.

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.

Based on the process management of traditional Chinese medicine comprehensive intervention method on outcomes in patients with mild/moderate chronic obstructive pulmonary disease:study protocol for a practical randomized controlled trial

Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.

A randomized placebo-controlled trial of Chinese medicine acupoint application on gastrointestinal dysfunction after appendectomy

Background:Gastrointestinal dysfunction is one of the common complications of appendectomy,which seriously affects the postoperative recovery and clinical prognosis.Through traditional Chinese medicine acupoint application is suggested for managing postoperative gastrointestinal dysfunction,supporting evidence is weak.Here,the prospective randomized placebo-controlled study was designed to provide high-level evidence regarding whether traditional Chinese medicine acupoint application is effective on the gastrointestinal dysfunction after appendectomy.Methods:A total of 60 patients who underwent appendectomy in Dongfang Hospital Beijing University of Chinese Medicine(Beijing,China)from November 2016 to December 2017 were selected as study objects and randomly divided into control group(n=30)and observation group(n=30).Based on routine postoperative care,the acupoints Zusanli(ST36)and Yongquan(KI1)were selected.The control group was given acupoint application of traditional Chinese medicine placebo and the observation group was given acupoint application of clinical empirical Chinese medicine called Wentongliqi prescription.The course of treatment was performed on the 1st,2nd,and 3rd days after appendectomy,once a day and 4 hours each time.The primary outcome includes the time until the recovery time of bowel sounds(h),the first postoperative flatus(h)and first bowel movement time(h)on the 1st,2nd,and 3rd days after appendectomy.The secondary outcome includes clinical symptom score,life ability score and adverse reactions were observed and recorded on the 1st,2nd,and 3rd days after appendectomy.Results:After treatment,the recovery time of intestinal sound in the observation group was earlier than that in the control group(P<0.05).However,there were no significant difference between the two groups in first anal exhaust time and first bowel movement time,clinical symptom scores and life ability scores between the two groups before and after treatment(P>0.05).Conclusion:Acupoint application therapy has limited effect on the recovery of gastrointestinal dysfunction after appendectomy.Further study with large sample size is needed to confirm its therapeutic effects.

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.

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.

Status of Clinical Application of Yufeng Ningxin Preparations and the Meta-Analysis of Its Efficacy and Safety in the Treatment of Cardiovascular and Cerebrovascular Diseases

Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin(YFNX)preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular and cerebrovascular diseases.Methods Through searching databases of China National Knowledge Infrastructure,Wanfang,SinoMed,VIP,PubMed,Embase,and the Cochrane Library,the literature of clinical research on YFNX preparations in treating malignant tumors of cardiovascular and cerebrovascular diseases from the establishment of the databases to February 2021 was collected.The clinical randomized controlled trials and case-control studies of cardiovascular and cerebrovascular diseases treated with these preparations were analyzed.Two reviewers independently screened literature,extracted data,and assessed the risk of bias in the included studies,and meta analysis was performed by using ReMan 5.3 software to analyze the eficacy and safety of YFNX preparations in the treatment of cardiovascular and cerebrovascular diseases.Results A total of 29 clinical studies were finally included.The dosage forms were dropping plls,tablets,capsules,and granules.The preparations were used for the treatment of coronary heart disease,hypertension,neuropathic headache,etc.This study systematically evaluated the efficacy and safety of YFNX preparations in the treatment of coronary heart disease,hypertension,and nervous headache.A total of 1,162 cases were included in 13 studies,582 cases of the YFNX preparation group and 580 cases of the Western medicine group.The results of meta-analysis showed that the clinical efficacy of YFNX preparations combined with the Western medicine group in the treatment of coronary heart disease and hypertension,improving electrocardiogram and reducing the frequency and duration of angina attacks,was better than that of the simple Western medicine group,and the difference was statistically significant.Conclusion YFNX preparations are effective for coronary heart disease,hypertension,and neuropathic headache,and the adverse reactions are few.