How completely are randomized controlled trials of non-pharmacological interventions following concussion reported? A systematic review

Purpose:The study aimed to examine the reporting completeness of randomized controlled trials(RCTs)of non-pharmacological interventions following concussion.Methods:We searched MEDLINE,Embase,PsycInfo,CINAHL,and Web of Science up to May 2022.Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication(TIDieR),Consensus on Exercise Reporting Template(CERT),and international Consensus on Therapeutic Exercise aNd Training(i-CONTENT)checklists.Additional information was sought my study authors where reporting was incomplete.Risk of bias(ROB)was assessed with the Cochrane ROB-2 Tool.RCTs examining non-pharmacological interventions following concussion.Results:We included 89 RCTs(n=53 high ROB)examining 11 different interventions for concussion:sub-symptom threshold aerobic exercise,cervicovestibular therapy,physical/cognitive rest,vision therapy,education,psychotherapy,hyperbaric oxygen therapy,transcranial magnetic stimulation,blue light therapy,osteopathic manipulation,and head/neck cooling.Median scores were:TIDieR 9/12(75%;interquartile range(IQR)=5;range:5-12),CERT 17/19(89%;IQR=2;range:10-19),and i-CONTENT 6/7(86%;IQR=1;range:5-7).Percentage of studies completely reporting all items was TIDieR 35%(31/89),CERT 24%(5/21),and i-CONTENT 10%(2/21).Studies were more completely reported after publication of TIDieR(t_(87)=2.08;p=0.04)and CERT(t_(19)=2.72;p=0.01).Reporting completeness was not strongly associated with journal impact factor(TIDieR:rs=0.27;p=0.01;CERT:r_(s)=-0.44;p=0.06;i-CONTENT:r_(s)=-0.17;p=0.48)or ROB(TIDieR:rs=0.11;p=0.31;CERT:rs=0.04;p=0.86;i-CONTENT:rs=0.12;p=0.60).Conclusion:RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness,but are often missing key components,particularly modifications,motivational strategies,and qualified supervisor.Reporting completeness improved after TIDieR and CERT publication,but publication in highly cited journals and low ROB do not guarantee reporting completeness.

Traditional Chinese medicine for acute mountain sickness prevention: A systematic review and meta-analysis of randomized controlled trials

Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.

Effect of Gum-Chewing after Cesarean Section on Gastrointestinal Function Recovery: A Systematic Review and Meta-Analysis of Randomized Trials

Objective: To evaluate the effect of chewing sugar-free gum on gastrointestinal function recovery after cesarean section. Methods: Randomized controlled trials comparing the use of chewing gum in postoperative recovery with a control group were retrieved from the databases including Pubmed, Cochrane Library, Science Direct, Web of Science, CBM, CNKI, Wanfang and VIP, et al. After screening literatures, evaluating the quality of studies, extracting data, the RevMan5.3 software was used for data analysis. Results: A total of 13 RCTs including 2233 patients were analyzed in the study. The results showed that chewing gum after cesarean delivery can effectively shorten the recovery time of bowel sounds, passage of flatus and first defecation (all P Conclusion: Chewing sugar-free gum after cesarean section can promote the early recovery of gastrointestinal function, but the side effects of chewing gum are still unclear, which needs more clinical, large sample and high-quality studies to further verify.

Establishing delivery route-dependent safety and efficacy of living biodrug mesenchymal stem cells in heart failure patients

BACKGROUND Mesenchymal stem cells(MSCs)as living biopharmaceuticals with unique properties,i.e.,stemness,viability,phenotypes,paracrine activity,etc.,need to be administered such that they reach the target site,maintaining these properties unchanged and are retained at the injury site to participate in the repair process.Route of delivery(RoD)remains one of the critical determinants of safety and efficacy.This study elucidates the safety and effectiveness of different RoDs of MSC treatment in heart failure(HF)based on phase II randomized clinical trials(RCTs).We hypothesize that the RoD modulates the safety and efficacy of MSCbased therapy and determines the outcome of the intervention.AIM To investigate the effect of RoD of MSCs on safety and efficacy in HF patients.METHODS RCTs were retrieved from six databases.Safety endpoints included mortality and serious adverse events(SAEs),while efficacy outcomes encompassed changes in left ventricular ejection fraction(LVEF),6-minute walk distance(6MWD),and pro-B-type natriuretic peptide(pro-BNP).Subgroup analyses on RoD were performed for all study endpoints.RESULTS Twelve RCTs were included.Overall,MSC therapy demonstrated a significant decrease in mortality[relative risk(RR):0.55,95%confidence interval(95%CI):0.33-0.92,P=0.02]compared to control,while SAE outcomes showed no significant difference(RR:0.84,95%CI:0.66-1.05,P=0.11).RoD subgroup analysis revealed a significant difference in SAE among the transendocardial(TESI)injection subgroup(RR=0.71,95%CI:0.54-0.95,P=0.04).The pooled weighted mean difference(WMD)demonstrated an overall significant improvement of LVEF by 2.44%(WMD:2.44%,95%CI:0.80-4.29,P value≤0.001),with only intracoronary(IC)subgroup showing significant improvement(WMD:7.26%,95%CI:5.61-8.92,P≤0.001).Furthermore,the IC delivery route significantly improved 6MWD by 115 m(WMD=114.99 m,95%CI:91.48-138.50),respectively.In biochemical efficacy outcomes,only the IC subgroup showed a significant reduction in pro-BNP by-860.64 pg/mL(WMD:-860.64 pg/Ml,95%CI:-944.02 to-777.26,P=0.001).CONCLUSION Our study concluded that all delivery methods of MSC-based therapy are safe.Despite the overall benefits in efficacy,the TESI and IC routes provided better outcomes than other methods.Larger-scale trials are warranted before implementing MSC-based therapy in routine clinical practice.

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.

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.

Clinical research on Tai Chi:a review of health benefits

Tai Chi,a traditional Chinese martial art and health exercise,has gained significant global attention and recognition.The clinical benefits of Tai Chi have been studied extensively in recent decades.We conducted a systematic search of PubMed,Web of Science,EMBASE databases,and the China National Knowledge Infrastructure,identifying and reviewing 241 clinical trials on the benefits of Tai Chi from their inception to June 1,2023.Most of these studies have consistently demonstrated the positive impact of Tai Chi on balance,cognitive function,mood regulation,sleep quality,pain relief,cardiorespiratory function,and overall health.In the future,the key to fostering the ongoing development of this field lies in comprehensive research on standardized study designs and reporting,the scope of Tai Chi applications,and the core factors influencing its efficacy.

Systematic Evaluation and Meta-analysis of Efficacy and Safety of Zhichuanling Oral Liquid (止喘灵口服液) in the Treatment of Bronchial Asthma

Objective:To systematically evaluate the effectiveness and safety of Zhichuanling Oral Liquid(止喘灵口服液)in the treatment of bronchitis asthma.Methods:A systematic search of CNKI,Wanfang Data,VIP,CBM,Cochrane Library,PubMed,Embase and Web of Science was conducted to screen out randomized controlled trials of Zhichuanling Oral Liquid in the treatment of bronchial asthma.Meta-analysis and systematic evaluation of the included studies were conducted to finally included researches using the Cochrane Handbook 5.1 evaluation standard tool and RevMan 5.3 software.Results:Five studies were included,with a total sample size of 354 cases,176 in experimental group and 178 in control group.Meta-analysis showed that the total effective rate of Zhichuanling Oral Liquid combined with conventional treatment was better than that of conventional treatment alone(RR=1.27,95%CI[1.13-1.42],P<0.0001).Conclusion:Based on the existing data and methods,Zhichuanling Oral Liquid combined with conventional Western medicine in the treatment of bronchial asthma can improve the total effective rate.However,the quality of the included studies is not high and the number is small,so it is necessary to adopt clinical trial protocols with large samples,rigorous design and in line with international standards to improve the quality of evidence in the future.

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Xianling Gubao Capsule as Adjuvant Treatment of Osteoporotic Fracture

OBJECTIVE: To assess the effectiveness and safety of Xianling Gubao(XLGB) Capsule in the treatment of osteoporotic fracture(OF). METHODS: Published articles from eight Chinese and English databases were searched from inception to August 2017. Clinical trials were selected according to inclusion criteria and exclusion criteria. Risk evaluation tool was used to assess the quality of studies. Data was extracted and meta-analysis was performed by RevMan5.3 software. RESULTS: A total of 229 articles were searched, and 27 were included for study with 2292 samples,including 1152 cases in the experiment group and 1140 cases in the control group. For patients with four limbs OF,XLGB Capsule combined with manipulation reposition with plaster external fixation can shorten healing time of fracture[MD=–0.77, 95% CI(–1.25, –0.30)], increase bone mineral density(BMD) [MD=0.17, 95% CI(0.10, 0.25)], blood calcium content [MD=0.52, 95% CI(0.38, 0.64)], phosphorous content in serum [MD=0.28, 95% CI(0.21, 0.35)], and alkaline phosphatase content [SMD=–5.24, 95% CI(–3.45, –2.42)]. In the treatment of spine OF, XLGB Capsule had no significant effects on reducing re-fracture rate of non-surgical vertebral body, but it could postpone the interval time of refracture of non-surgical vertebral bodies [RR=0.71, 95% CI(0.23, 2.18)]. Combined treatment with XLGB Capsule could improve clinical effective rate [RR=1.17, 95% CI(1.11, 1.23)]. Both alone and combined application of XLGB Capsule could increase BMD and calcitonin content of patients with spine OF. Combined application of calcium or medicine that regulating calcium metabolism was faster in reducing Cobb angle of centrum kyphosis than application alone [MD=–2.68,95% CI(–3.72, –2.12)]. Alone or combined application showed no significant effects on osteoporotic pain. The adverse reactions reported in the study were mainly the digestive system damage. CONCLUSIONS: XLGB Capsule alone or combine with other western medicine had better efficacy in treating OF than western medicine treatment alone. However,there was potential bias in the included studies, so the conclusion still needed further high quality randomized controlled trials to improve the evidence level.

Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

AIM: To evaluate published trials examining oral postoperative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results.METHODS: Database searches(MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: "oral'' or "enteral'' and "postoperative care'' or "post-surgical'' and "proteins' ' or "milk proteins' ' or "dietary proteins' ' or "dietary supplements' ' or "nutritional supplements' '. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted.RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements(discrete from other nutritionalcomponents) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage.CONCLUSION: The optimal level of protein supplementation required to maximise recovery in gastrointestinal surgery patients is effectively unknown, and may warrant further study.

Effects of Tai Chi in diabetes patients: Insights from recent research

Tai Chi,a practice that combines elements of both exercise and mindfulness,offers a wide range of health benefits.The body of evidence concerning the impact of Tai Chi on diabetes has recently been growing.This editorial aims to provide a concise summary of the current state of evidence for Tai Chi's effects on individuals with type 2 diabetes(T2D).The review includes 3 randomized controlled trials(RCTs)and 5 systematic reviews and meta-analyses,all of which investigate the effectiveness of Tai Chi on various health outcomes in individuals with T2D.Tai Chi demonstrates a significant effect to enhance glycemic control,lower blood pressure,improve serum lipid profiles,reduce insulin resistance,positively influence obesity-related indices,and improve overall quality of life in individuals with T2D.However,it is noteworthy that recent RCTs have reported inconsistent findings regarding the effects of Tai Chi on glycemic control and insulin resistance.The author also delves into potential mechanisms by which Tai Chi may exert its influence on the human body.Finally,the editorial highlights the critical issues that warrant further exploration in the future.

Essentials of Nursing Care in Randomized Controlled Trials of Nurse-Led Interventions in Somatic Care: A Systematic Review

Background: Nursing practice has to contribute to evidence pointing out why there is a need for more nurse-designed randomized control trials (RCTs) focusing on evidence-based practice (EBP). How far this EBP has progressed in different health aspects is usually established by systematic reviews of RCTs. Nurse-led RCTs exist but no study has addressed the essentials of nursing care. Aim: The aim was therefore to determine the essentials of nurses’ interventions by means of nurse-led RCTs in somatic care focusing on the stated context, goals, content, strategies as well as the nurse’s role related to effectiveness. Methods: A systematic review was realized according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data extraction process (n = 55) from PubMed and CINAHL. Results: Of the RCTs in somatic care, 71% showed a positive effectiveness of nurse-led interventions, of which the nurse had a significant role with regard to being the main responsible in 67% of the studies. Also, 47% of the RCTs presented a theoretical standpoint related to the nurse-led interventions and most prominent were international evidence-based guidelines. Goals were found to have either a patient-centered or a professional-centered ambition. Strategies were based on patient-directed initiatives, nurse-patient-directed initiatives or nurse-directed initiatives, while contents were built upon either a patient-nurse interaction or a nursing management plan. Conclusions: This review underlines the necessity of a holistic view of a person, as nurse-led RCTs comprising a patient-centered ambition, patient-directed initiative and patient-nurse interaction plan showed beneficial nursing care effectiveness, particularly if theory-based. In a nurse-led RCT, a basic theoretical perspective is advantageous as well as to elucidate the role of the nurse in relation to the estimated effects.

Quality evaluation of systematic reviews of the effects of Baduanjin on diabete

Objective:Recently,the effects of Baduanjin(a traditional Chinese mind-body exercise)on diabetes have attracted increasing attention,and relevant systematic reviews(SRs)have emerged.However,the qualities of these SRs vary markedly,and their conclusions are inconsistent,which is not conducive to guiding decision-making.We sought to assess the quality of these SRs and provide more evidence for diabetes treatment.Methods:A literature search was conducted in 7 databases from inception to December 1st,2021.SRs of randomized controlled trials investigating the effects of Baduanjin were identified.A Measurement Tool to Assess Systematic Reviews 2(AMSTAR-2)checklist,Preferred Reporting Items for Systematic Review and Meta-analysis(PRISMA)statement,and Grading of Recommendations Assessment,Development and Evaluation(GRADE)system were applied to evaluate the quality of the SRs.Results:Ten SRs were identified.All SRs were judged as critically low methodological quality by the AMSTAR-2 checklist.The total PRISMA score of the included SRs ranged from 15 to 21,and the mean score was 18.60(1.90),indicating that all SRs had partial reporting deficits.Sixty outcomes were reported in the included studies,of which 25(41.67%)were judged as low quality,and 34(56.67%)as very low quality according to the GRADE system,indicating that the overall evidence quality of outcomes was not high.Conclusion:Baduanjin seems to be an effective therapy for diabetes in improving glucose and lipid metabolism,mental health,quality of life,and waist-hip ratio(WHR).The overall quality of the SRs was less than optimal.This conclusion should be treated with caution,and researchers should conduct higher-quality clinical studies following AMSTAR-2checklist,PRISMA statement,and GRADE system in the future.

Acupoint injection for asthma:Systematic review of randomized controlled trials

Objective:To assess the effectiveness and safety of acupoint injection for the treatment of asthma.Methods:Six electronic databases were searched for randomized controlled trials(RCTs)of acupoint injection for asthma.Two authors extracted data and assessed methodological quality independently using the Cochrane Collaboration Risk of Bias tool.Data were evaluated using RevMan v5.2.Results:Eighteen RCTs involving 1913 participants with asthma were identified.Overall methodological quality of the RCTs was classified as unclear risk of bias.Western medicine(12 RCTs)was injected most frequently into acupoints,followed by Chinese herbal medicine(four RCTs),vitamins(one RCT),and Chinese herbal medicine combined with Western medicine(one RCT).Four RCTs used only one acupoint[ST36(two RCTs),BL13,CV22],whereas the other RCTs selected multiple acupoints(among which BL13 was used most frequently).One RCT reported mortality,no RCT reported quality of life,15 RCTs reported the symptom improvement rate,one RCT reported asthma control test(ACT)data,one RCT reported the duration of asthma,three RCTs reported the mean time that asthma was controlled(MTAC),and 13 RCTs reported lung-function tests(LFTs).Some RCTs showed acupoint injection may improve the attack time of asthma,MTAC,and LFTs.Five RCTs reported the outcome of adverse events and showed no significant differences between the acupoint injection group and control group.Conclusions:The findings suggest that acupoint injection may be effective for improving ACT data,duration of asthma,MTAC and LFTs.However,the evidence is insufficient owing to the poor methodological quality of the RCTs.

Adding Chinese herbal medicine to probiotics for irritable bowel syndrome-diarrhea:A systematic review and meta-analysis of randomized controlled trials

Objective:This study assessed whether Chinese herbal medicine(CHM)combined with probiotics/synbiotics for irritable bowel syndrome-diarrhea(IBS-D)was more effective and safer than probiotics/synbiotics alone.Methods:Ten databases were searched for randomized control trials(RCTs)of IBS-D as diagnosed by Manning or Rome criteria.Trials comparing probiotics and probiotics with CHM were included.The Cochrane risk of bias(ROB)was evaluated for each trial.RevMan 5.3 was used to conduct a meta-analysis.Results:Twenty-six RCTs were included(25 Chinese,1 English),involving 2045 participants.Metaanalysis was conducted on two outcomes:overall symptom improvement and relapse.CHM combined with live Bifidobacterium and Lactobacillus preparations reduced relapse rate(RR 0.28,95%CI 0.15e0.52,3 trials,n?205)compared with probiotics alone.The subgroup analysis showed the benefit of CHM prescriptions based on soothing liver and invigorating spleen(1.28,1.14e1.44,3,244),invigorating spleen and resolving dampness(1.20,1.03e1.41,2,128),or warming and invigorating spleen and kidney formulae(1.27,1.09e1.46,2,210)combined with triple Bifidobacterium preparations than the same probiotics alone which improved overall symptoms for IBS-D.There was unclear bias in almost domains of ROB.Most studies had a high risk of bias due to lack of blinding of investigator and participants,and selective reporting.Conclusions:This study showed that CHM combined with probiotics may reduce relapse rate by 72%,and improve overall symptoms of IBS-D(as diagnosed by Rome II and III)compared to probiotics alone.From the limited subgroup analysis,only soothing liver and invigorating spleen formulae,represented by Tongxie Yaofang,added to triple Bifidobacterium preparations may be superior to the single preparations in terms of overall symptoms.However,due to the poor methodological quality and small sample size of the trials,these findings must be interpreted with caution.

Reports of clinical trial protocols of coronavirus disease 2019: a systematic review

Background:To examine the outcomes heterogeneity of clinical trial protocols of coronavirus disease 2019(COVID-19)to prioritize the establishment of a core outcome set.Methods:Databases of the International Committee of Medical Journal Editors–accepted clinical trial registry platforms were searched on February 14,2020 and May 31,2020.Randomized controlled trials and non-randomized controlled trials of COVID-19 were considered.Patient condition was classified as common,severe,or critical.Interventions included traditional Chinese medicine and Western medicine.We excluded trials that involved discharged patients,psychological intervention,and complications of COVID-19.The general information and outcomes,outcome measurement instruments,and measurement times were extracted.The results were analyzed by descriptive analysis.Results:In all,19 registry platforms were searched.A total of 97 protocols were selected from among 160 protocols for the first search.For protocols of traditional Chinese medicine clinical trials,76 outcomes from 16 outcome domains were reported,and almost half(34/76,44.74%)of the outcomes were reported only once;the most frequently reported outcome was time taken for severe acute respiratory syndrome coronavirus 2 RNA to become negative.Twenty-seven(27/76,35.53%)outcomes provided one or more outcome measurement instruments.Ten outcomes provided one or more measurement time frame.For protocols of Western medicine clinical trials,126 outcomes from 17 outcome domains were reported;almost half(62/126,49.21%)of the outcomes were reported only once;the most frequently reported outcome was proportion of patients with negative severe acute respiratory syndrome coronavirus 2.Twenty-seven outcomes provided one or more outcome measurement instruments.Forty(40/126,31.75%)outcomes provided one or more measurement time frame.There were>40 duplicated outcomes between the clinical trials protocols of traditional Chinese medicine and western medicine protocols.All of them were included in the Delphi survey when developing core outcome set for COVID-19.A total of 1,027 protocols were selected from 2,741 protocols for the second search.Forty-two new outcomes and 47 new outcome measurement instruments were reported.Conclusion:Outcome reporting in clinical trial protocols of COVID-19 is inconsistent.Thus,establishing a core outcome set is necessary for diagnosis and management.

Essentials of Teamcare in Randomized Controlled Trials of Multidisciplinary or Interdisciplinary Interventions in Somatic Care:A Systematic Review

Background: Teamcare should, like all patient care, also contribute to evidence-based practice (EBP). Randomized controlled trials (RCTs) focusing on teamcare have been performed but no study has addressed its essentials. How far this EBP has progressed in different health aspects is generally established in systematic reviews of RCTs. Aim: The aim is to determine the essentials of teamcare including the nurse profession in RCTs of multi- or interdisciplinary interventions in somatic care focusing on the stated context, goals, strategies, content as well as effectiveness of quality of care. Methods: A systematic review was performed according to Cochrane review assumptions to identify, appraise and synthesize all empirical evidence meeting pre-specified eligibility criteria. The PRISMA statement guided the data selection process of 27 articles from PubMed and CINAHL. Results: Eighty-five percent of RCTs in somatic care showed a positive effectiveness of teamcare interventions, of which interdisciplinary ones showed a greater effectiveness compared with the multidisciplinary approach (100% vs 76%). Also theory-based RCTs presented higher positive effectiveness (85%) compared with non-theory-based RCTs (79%). The RCTs with positive effectiveness showed greater levels for professional-centered ambition in terms of goals and for team-directed initiatives in terms of strategy, and a significantly higher level for patient-team interaction plans in terms of content was shown. Conclusions: Teamcare RCTs are still grounded in the multidisciplinary approach having a professional-centered ambition while interdisciplinary approaches especially those that are theory-based appear to be essential with regard to positive effectiveness and preferable when person-centered careis applied.

A systematic review of effi cacy and tolerability of mebeverine in irritable bowel syndrome

We evaluated the eff icacy and tolerability of mebeverine, a musculotropic antispasmodic agent, in irritable bowel syndrome (IBS) and compared its usual dosages by meta-analysis. Medical databases and all relevant literature were searched from 1965 to June 2009 for any placebo-controlled clinical trials of mebeverine, using search terms such as mebeverine, clinical trials, and IBS. Eight randomized trials met our criteria, including six trials that compared mebeverine with placebo and two that compared mebeverine tablets with capsules. These eight trials included 555 patients randomized to receive either mebeverine or placebo with 352 (63%)women and 203 (37%) men in all subtypes of IBS. The pooled relative risk (RR) for clinical improvement of mebeverine was 1.13 (95% CI: 0.59-2.16, P = 0.7056) and 1.33 (95% CI: 0.92-1.93, P = 0.129) for relief of abdominal pain. The efficacy of mebeverine 200 mg compared to mebeverine 135 mg indicated RRs of 1.12 (95% CI: 0.96-1.3, P = 0.168) for clinical or global improvement and 1.08 (95% CI: 0.87-1.34, P = 0.463) for relief of abdominal pain. Thus, mebeverine is mostly well tolerated with no signif icant adverse effects; however, its eff icacy in global improvement of IBS is not statistically signif icant.

Efficacy and safety of local anaesthetics for prematurejaculation： a systematic review and meta-analysis

To assess the efficacy and safety of local anaesthetics for premature ejaculation （PE）, a systematic review of the literature was performed using the Cochrane Library, PUBMED and EMBASE. We screened and retrieved the randomized controlled trials on the treatment of PE with local anaesthetics. End points included intravaginal ejaculation latency time （IELT）, patient-reported outcome assessments and adverse events. Meta-analyses were conducted with Stata 11.0. In total, seven publications involving 566 patients with local anaesthetics and 388 with placebos strictly met our eligibility criteria. Meta-analyses showed that after the patients were treated with the local anaesthetics, the value of the standardized mean difference of the changes in IELT was 5.02 （95% Ch 3.03- 7.00）. A higher rate of adverse events occurred compared with placebos （odds ratio： 3.30, 95% Ch 1.71-6.36）, but these events were restricted to local side effects. In addition, significantly greater improvement was observed in patient-reported outcomes. In summary, local anaesthetics can prolong IELT and improve ejaculatory control and sexual satisfaction.

Systematic review of long-term Xingnao Kaiqiao needling efficacy in ischemic stroke treatment

OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials that used theXingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July 2014. SeLeCTION CRITeRIA： Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers’ Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOMe MeASUReS： Mortality rate, recurrence rate, and disability rate were observed. ReSULTS：Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no sig-niifcant differences in mortality reduction （risk ratio （RR） = 0.58, 95% conifdence interval （CI）： 0.17–1.93,Z = 0.89,P = 0.37） or recurrence rate （RR = 0.55, 95%CI： 0.18–1.70,Z = 1.04,P = 0.30） of ischemic stroke patients between theXingnao Kaiqiao needling and control treatment groups. However, theXingnao Kaiqiao needling method had a tendency towards higher efifcacy in mor-tality reduction and recurrence rates. TheXingnao Kaiqiao needling method was signiifcantly better than that of the control treatment in reducing disability rate （RR = 0.51, 95%CI： 0.27–0.98, Z = 2.03,P 〈 0.05）. CONCLUSION：TheXingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect ofXingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions aboutXingnao Kaiqiao needling.