Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial.

Background: Transcutaneous Electrical Acupoint Stimulation (TEAS) therapy opens up the possibility for individuals with Cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. The aim of this study is designed to evaluate the efficacy of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC). Methods/Design: This is a study protocol for a prospective, triple-blind, randomized controlled trial. We anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The true group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this investigation is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, quality of life scale, mood scales, and routine blood counts on the assessment days. Any adverse events will be promptly addressed and reported if they occur. We will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight. Discussion: PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture and to explore a safe and effective integrative medicine scheme for CIBP. Trial Registration: ClinicalTrials.gov NCT05730972, registered February 16, 2023.

A meta-analysis for the diagnostic accuracy of SelectMDx in prostate cancer.

To overview the diagnostic accuracy of SelectMDx for the detection of clinically significant prostate cancer and to review sources of methodologic variability. Four electronic databases, including PubMed, Embase, Web of Science, and Cochrane Library were searched for eligible studies investigating the diagnostic value of SelectMDx compared with the gold standard. The pooled sensitivity, specificity, and positive and negative predictive values were calculated. Included studies were assessed according to the Standards for Quality Assessment of Diagnostic Accuracy Studies 2 tool. The review identified 14 relevant publications with 2579 patients. All reports constituted phase 1 biomarker studies. Pooled analysis of findings found an area under the receiver operating characteristic analysis curve of 70% [95% CI, 66%-74%], a sensitivity of 81% [95% CI, 69%-89%], and a specificity of 52% [95% CI, 41%-63%]. The positive likelihood ratio was 1.68, and the negative predictive value is 0.37. Factors that may influence variability in test results included the breath collection method, the patient's physiologic condition, the test environment, and the method of analysis. Considerable heterogeneity was observed among the studies owing to the difference in the sample size. SelectMDx appears to have moderate to good diagnostic accuracy in differentiating patients with clinically significant prostate cancer from people at high risk of developing prostate cancer. Higher-quality clinical studies assessing the diagnostic accuracy of SelectMDx for clinically significant cancer are still needed.

Several laboratory variables indicate severity and prognosis of COVID-19.

OBJECTIVE: While several laboratory variables have been used to assess COVID-19 disease, to our knowledge, no attempt has previously been made to compare differences across different patient groups. We attempted to evaluate the relationship between laboratory variables and severity of the disease as well as on prognosis. METHOD: We searched BioLINCC database and identified three studies which had separately included outpatients, inpatients, and ICU patients. For this re-analysis, we extracted data on general demography, laboratory variables and outcome. RESULT: In total, 2454 participants (496 outpatients [Study 1], 478 inpatients [Study 2], and 1480 ICU patients [Study 3]) were included in the analysis. We found three laboratory variables (i.e., creatinine, aspartate transferase, and albumin) were not only prognostic factors for outcome of inpatients with COVID-19, but also reflected disease severity as they were significantly different between inpatients and ICU patients. These three laboratory variables are an indication of kidney function, liver function, and nutritional status. CONCLUSION: For patients with COVID-19, in addition to monitoring infectious disease indicators, we need to pay attention to liver function, renal function, and take timely measures to correct them to improve prognosis.

Transcutaneous electrical acupoint stimulation for cancer-related pain management in patients receiving chronic opioid therapy: a randomized clinical trial.

PURPOSE: The opioid crisis resulting from its use disorder and overdose poses additional challenges for cancer pain management. The American Society of Clinical Oncology Practice Guideline recommends acupuncture therapy for the management of adult cancer-related pain (CRP), but the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on CRP remains uncertain. METHODS: This 5-week prospective randomized clinical trial was conducted at 2 hospitals in China, and participants with CRP receiving chronic opioid therapy were randomized 1:1 into two groups between December 2014 and June 2018. The true TEAS group underwent 15 sessions of TEAS treatments over 3 consecutive weeks, while the control group received sham stimulation. The primary outcome was the numerical rating scale (NRS) score in the past 24h at week 3. The secondary outcomes included morphine equivalent daily dose, quality of life and adverse events. RESULTS: A total of 159 participants were included in the modified intention-to-treat population. The baseline characteristics were similar in both groups. The mean NRS scores were 0.98 points at week 3 in the true TEAS group and 1.41 points in the sham group, with the mean difference between groups of -0.43 points (P < 0.001; OR = 0.68, P < 0.05). The proportion of patients with NRS reduction more than thirty percentage at week 3 was 50.00% in the true TEAS group and 35.44% in the sham group (RD = 0.15, P > 0.05; RR = 1.41, P > 0.05). No significant difference in pain intensity between the two groups was observed during the follow-up period without TEAS intervention (week 4, OR = 0.83, P > 0.05; week 5, OR = 0.83, P > 0.05). The Karnofsky Performance Status value suggested that patients in the true TEAS group experienced an improved quality of life (Between-group differences: week 3, 3.5%, P < 0.05; week 4, 4.6%, P < 0.001; week 5, 5.6%, P < 0.001). CONCLUSIONS: The 3-week application of TEAS in patients with CRP receiving chronic opioid therapy resulted in a statistically significant reduction in pain scores, but the observed reduction was of uncertain clinical significance. The prolonged analgesic effect of TEAS was not confirmed in this trial. CLINICALTRIAL: GOV: ChiCTR-TRC-13003803.

Treatment of multiple myeloma based on autologous stem cell transplant: An overview of systematic reviews.

BACKGROUND: Multiple myeloma (MM) is a malignant plasma cell disease. In recent years, several systematic reviews, and meta-analyses have been published on treatment protocols, including autologous stem cell transplantation for MM. METHODS: Web of Science, PubMed, Embase, and Cochrane Library were searched to systematically summarize the quality of the methodology and evidence of meta-analyses regarding treatment of MM including autologous stem cell transplantation. RESULTS: Total 11 meta-analyses were included. The preferred reporting items for systematic reviews and meta-analyses evaluation revealed that the quality of included reviews was affected by possible unevaluated bias between studies and the lack of protocol and registration. The AMSTAR2 scale indicated that the quality of the methodology of included reviews ranged from very low to moderate. The grading, assessment, development, and evaluation of recommendations evaluation showed that among the included outcome indicators, most of them are of low quality. CONCLUSION: This overview suggested that the combination of drugs has improved patient survival rates, efficacy and safety compared with the standard regimen. However, the strength of the evidence is uneven and due to methodological errors, the results should be interpreted with caution in order to provide a reference for further improvement of the study design. The methodological quality of the relevant meta-analysis needs to be further improved.

Early diagnosis for pulmonary embolism: A systematic review and meta-analysis.

BACKGROUND: The incidence of acute pulmonary embolism (APE) (especially early diagnosis) has increased annually in recent years, but the diagnosis of APE is a great challenge for every clinician. However, few studies have evaluated multiple diagnostic indicators simultaneously. METHODS: A systematic search was performed using CNKI, Wan fang data, VIP, PubMed and Web of Science for studies on the diagnosis of pulmonary embolism published up to October 31, 2022. Using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2), we evaluated the risk of bias in included studies, and used a random-effects meta-analysis to obtain the summary sensitivity and specificity. The data that were extracted and calculated for this study included the first author, year of publication, country, study type, sample size, disease type, gold standard, diagnostic indicators and 4-compartment table data. We strictly followed the Preferred Reporting Items for Systematics reviews and Meta-Analysis (PRISMA) guidelines in this review. RESULTS: This study included 30 articles with a total sample size of 8947 cases, involving 4 detection methods: D-dimer, Geneva rules, Wells rules, and lung imaging. The combined effect size showed that lung imaging had the highest diagnostic value (SEN = 0.95, SPE = 0.89), followed by D-dimer (SEN = 0.92, SPE = 0.60), Geneva rules (SEN = 0.78, SPE = 0.68), and Wells rules (SEN = 0.77, SPE = 0.67). The area of lung imaging was largest under the Summary Receiver Operator Characteristic (SROC) curve (AUC = 0.97), followed by Geneva rules (AUC = 0.80), Wells rules (AUC = 0.79), and D-dimer (AUC = 0.74). CONCLUSION: All 4 detection methods showed good ability to diagnose PE, and lung imaging was the best. Clinical trials are recommended to build an early decision-making model for the diagnosis of pulmonary embolism in order to increase the detection rate and improve prognosis.

Investigation of bacterial and fungal population structure on environmental surfaces of three medical institutions during the COVID-19 pandemic.

Objectives: To evaluate the population structure of environmental bacteria and fungi in three different types of medical institutions and the potential risks due to antibiotic resistance during the coronavirus disease 2019 (COVID-19) pandemic. Methods: One hundred twenty-six environmental surface samples were collected from three medical institutions during the COVID-19 pandemic. A total of 6,093 and 13,514 representative sequences of 16S and ITS ribosomal RNA (rRNA) were obtained by amplicon sequencing analysis. The functional prediction was performed using the Phylogenetic Investigation of Communities by Reconstruction of Unobserved States tool based on the Greengenes database and the FAPROTAX database. Results: On environmental surfaces in three medical institutions during the COVID-19 pandemic, Firmicutes (51.6%) and Bacteroidetes (25%) were the dominant bacteria, while Ascomycota (39.4%) and Basidiomycota (14.2%) were the dominant fungi. A number of potential bacterial and fungal pathogens were successfully identified by the metagenomic approach. Furthermore, compared with the bacterial results, the fungi showed a generally closer Bray Curtis distance between samples. The overall ratio of Gram-negative bacteria to Gram-positive bacteria was about 3:7. The proportion of stress-tolerant bacteria in medical institutions A, B and C reached 88.9, 93.0 and 93.8%, respectively. Anaerobic bacteria accounted for 39.6% in outdoor environments, 77.7% in public areas, 87.9% in inpatient areas and 79.6% in restricted areas. Finally, the ß-Lactam resistance pathway and polymyxin resistance pathway were revealed through functional prediction. Conclusion: We described the microbial population structure changes in three different types of medical institutions using the metagenomic approach during the COVID-19 pandemic. We found that the disinfection measures performed by three healthcare facilities may be effective on the "ESKAPE" pathogens, but less effective on fungal pathogens. Moreover, emphasis should be given to the prevention and control of ß-lactam and polymyxin antibiotics resistance bacteria during the COVID-19 pandemic.

Long-Term Clinical and Imaging Results of Oblique Lateral Interbody Fusion for Degenerative Lumbar Spondylolisthesis: A Systematic Review and Meta-Analysis.

The efficacies and safety of oblique lateral interbody fusion (OLIF) for degenerative lumbar spondylolisthesis (DLS) remains controversial, and long-term clinical efficacies in particular need to be explored. This study is designed accordingly, therefore, we searched PubMed, Embase, Scopus, Web of Science, Cochrane Library, ProQuest, OVID, and SinoMed for literature, regardless of publication date or language. Taking 12 months after operation as the shortest limit, the outcome measures were extracted, including visual analog scale (VAS), Oswetry dysfunction index (ODI), Japanese Orthopaedic Association (JOA) score, intervertebral disk height (IDH), foraminal height (FH), lumbar lordosis (LL), segment lordosis (SL), slip ratio, and incidence of surgical complications. Meta-analysis was performed by RevMan 5.4 and Stata 16.0, and results were expressed with MD and 95% CI, and two-sided p-values with p < 0.05 being statistically significant. In total, 17 clinical studies (n = 689 patients) were screened, with an average patient age of 63.4 years. Our study revealed that VAS decreased by 4.55 (low back pain) and 5.46 (leg pain) points, respectively. And ODI score decreased by an average of 33.82% while JOA score increased by an average of 11.56 points. In terms of imaging indicators, mean IDH and FH increased by 4.18 and 4.91 mm, mean LL and SL improved by 9.22° and 2.46°, respectively. Besides, mean slip ratio decreased by 10.45%. The incidence of complications was statistically analyzed in 18 studies, with a rate of 4%-54% and an overall incidence of 19%. To sum up, our study was the first to focus on the long-term efficacies of OLIF treatment for DLS, and to provide further clinical evidence. However, long-term follow-up multicenter randomized controlled trials are still needed for further evaluation.

Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia: An Overview of Systematic Reviews.

Background: Hematopoietic stem cell transplantation (HSCT) has become the main treatment for acute myeloid leukemia (AML) and has been studied in many systematic reviews (SRs), but strong conclusions have not been drawn yet. Objective: This study aimed to summarize and critically evaluate the methodological and evidence quality of SRs and meta-analysis on this topic. Methods: PubMed, Embase, the Cochrane Library, and Web of Science were searched for SRs/meta-analyses regarding HSCT for AML. Two reviewers assessed the quality of SRs/meta-analyses in line with AMSTAR-2 and evaluated the strength of evidence quality with the grading of the evaluation system (GRADE) for concerned outcomes independently. Results: 12 SR/Meta articles were included, and the AMSTAR-2 scale showed that the quality grade of all articles was low or very low. GRADE results showed 29 outcomes, 2 of which were high, 12 were moderate, and 15 were low. Limitations and inconsistency were the most important factors leading to degradation, followed by imprecision and publication bias. Allo-SCT had better OS and DFS benefits than auto-SCT and significantly reduced the relapse in intermediate-risk AML/CR1 patients. Auto-SCT was associated with lower TRM than allo-SCT but generally had higher relapse. The results should be confirmed further for the low or moderate evidence quality. Conclusion: Current SRs show that allo-SCT in the treatment of AML might improve the OS, RFS, and DFS. Auto-SCT has significantly lower TRM but higher RR. Whether bone marrow transplantation is superior to nonmyeloablative chemotherapy remains to be evaluated. Meanwhile, the quality of methodology needs to be further improved. The intensity of evidence was uneven, and the high-quality evidence of outcomes was lacking. Considering the limitations of our overview, more rigorous and scientific studies are needed to fully explore the efficacy of different interventions of HSCT in AML, and clinicians should be more cautious in the treatment.

Value of digital PCR in the early diagnosis of sepsis: A systematic review and meta-analysis.

BACKGROUND: We systematically assessed whether a digital polymerase chain reaction (PCR) could detect pathogenic microorganisms in patients with sepsis early and accurately. METHODS: We searched the Cochrane Library, MEDLINE, Embase, CNKI, CBM, and Wanfang Data databases for eligible studies to compare the detection of pathogenic microorganisms in blood samples by digital PCR with the gold standard. The Quality Assessment of Diagnostic Accuracy Studies 2 was used to evaluate bias risk, and a random-effects meta-analysis approach was used for sensitivity and specificity calculations. RESULTS: Among the eight articles, there were eight identified studies with a total of 1278 subjects. The pooled sensitivity of digital PCR was 94% (95% confidence interval [CI], 85%-98%), the specificity was 87% (95% CI, 76%-94%), the positive likelihood ratio was 7.3 (95% CI, 3.8-14.2), the negative likelihood ratio was 0.07 (95% CI, 0.03-0.17), the positive predictive value was 84.7%, the negative predictive value was 89.2%, the diagnostic odds ratio was 105 (95% CI, 37-303), and the area under the receiver operating characteristic curve was 0.97 (95% CI, 0.95-1.00). Digital PCR can shorten the detection time of pathogenic microorganisms in patients with sepsis. CONCLUSIONS: Digital PCR can detect pathogenic microorganisms in patients with sepsis earlier than blood culture. Therefore, digital PCR can be used as a potential strategy for the detection of pathogenic microorganisms in patients with sepsis.

Traditional Chinese medicine treatment for COVID-19: An overview of systematic reviews and meta-analyses.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a rapidly spreading disease that has caused an extensive burden to the world. Consequently, a large number of clinical trials have examined the efficacy of traditional Chinese medicine (TCM) for treating and preventing COVID-19, with coinciding proliferation of reviews summarizing these studies. OBJECTIVE: This study aimed to evaluate the methodological quality and evidence quality of systematic reviews and meta-analyses on the efficacy of TCM. SEARCH STRATEGY: Seven electronic databases, including PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data and SinoMed, were searched for systematic reviews and meta-analyses in October 2021. Search terms such as "Chinese medicine," "Lianhua Qingwen" and "COVID-19" were used. INCLUSION CRITERIA: Systematic reviews and meta-analyses of randomized controlled trials that evaluated the efficacy of TCM treatment of COVID-19 were included. DATA EXTRACTION AND ANALYSIS: A Measurement Tool to Assess Systematic Reviews Version 2.0 (AMSTAR 2) was used to evaluate the methodological quality. The quality of evidence was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Data extraction and analysis were performed by two reviewers independently. RESULTS: There were 17 meta-analyses included in our overview. The intervention group was defined as TCM combined with Western medicine, while the control group was Western medicine alone. The methodological quality of all the included studies was moderate to poor. A total of 89 outcome indicators were evaluated, of which, 8 were rated as moderate quality, 39 as low quality, and 41 as very low quality. Only one outcome measure was graded as being of high quality. The moderate quality of evidence indicated that, for the treatment of COVID-19, the clinical efficacy of TCM in combination with Western medicine was better, in terms of lung recovery, rate of conversion to severe/critical cases, symptom scores, duration of symptoms, mortality, and length of hospital stay. CONCLUSION: Evidence from the included studies shows that, compared with conventional Western medical therapy alone, the addition of TCM to COVID-19 treatment may improve clinical outcomes. Overall, the quality of evidence of TCM for COVID-19 was moderate to poor. Meta-analyses of the use of TCM in the treatment of COVID-19 can be used for clinical decision making by accounting for the experiences of clinical experts, medical policies, and other factors.

Analysis of the Characteristics of Dominant Diseases in Traditional Chinese Medicine: Based on 95 Diseases.

Background: Traditional Chinese medicine (TCM) has been widely used all over the world and has shown its superiority in some diseases. However, there are no clear evaluation criteria for TCM. In 2019, a list of TCM dominant diseases was published by the Chinese National Administration of Traditional Chinese Medicine. This study aimed to systematically summarize the characteristics of 95 TCM dominant diseases and provide a reference for the establishment of evaluation criteria for TCM dominant diseases. Methods: The diagnosis and treatment protocols of all the 95 TCM dominant diseases were screened. The data of disease classification, diseases' code of TCM, length of hospital stay, treatment protocols, and clinical pathways were reviewed and summarized. Results: The diseases of the genitourinary and nervous systems accounted for 14.74% and 12.73% of the TCM dominant diseases, respectively. The length of hospital stay for 55 (57.89%) diseases was no more than less than 14 days. Each disease had its specific Chinese herbal decoction pieces and Chinese patent drugs. Chinese medical injections were not widely used. TCM external treatments for these diseases are abundant, with hundreds optional. Conclusion: Some potentially promising TCM dominant diseases remain to be identified and deserve further research to establish the evaluation criteria of TCM dominant diseases.

Efficacy and Safety of Chinese Medicine for COVID-19: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of traditional Chinese medicine for COVID-19 treatment with a focus on the benefits of symptomatic relief and time-related indexes. Seven electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Chongqing VIP, Wanfang Data, and Chinese Clinical Trial Registry) were systematically searched from their beginning to April 2021. Only randomized controlled trials (RCTs) comparing patients using Western therapy (WT) alone and those using additional Chinese medicine (WT [Formula: see text] CM) were included. Primary outcomes included overall efficacy, lung recovery, and time to viral assay conversion. Secondary outcomes included time and rate of individual symptom recovery, laboratory indicators, and adverse events. Overall, 15 RCTs, including 1469 participants, were included in this review. WT [Formula: see text] CM significantly improved overall efficacy (risk ratio, RR [Formula: see text] 1.21; 95% CI: 1.12 to 1.30; [Formula: see text] [Formula: see text] 0.01) and lung recovery (RR [Formula: see text] 1.30; 95% CI:1.19 to 1.42; [Formula: see text] [Formula: see text] 0.01) and shortened the time to viral assay conversion (weighted mean differences, WMD [Formula: see text]1.38; 95% CI: -1.98 to -0.78; [Formula: see text] [Formula: see text] 0.01) and duration of chest distress (WMD [Formula: see text] 2.41; 95% CI: -2.99 to -1.83; [Formula: see text] [Formula: see text] 0.01) compared to WT alone. There was no difference in safety between the WT [Formula: see text] CM and WT groups (RR [Formula: see text] 0.94; 95% CI: 0.64 to 1.39; [Formula: see text] 0.76). In conclusion, the synthesized evidence from 15 RCTs showed that additional Chinese medication may improve treatment efficacy, relieve symptoms, promote lung recovery, and reduce the inflammatory response against COVID-19, while not increasing the risk of adverse events compared with conventional Western medication alone.

Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov.

BACKGROUND AND OBJECTIVE: The novel coronavirus disease (COVID-19) outbreak is currently ravaging populations worldwide. Many studies were registered and conducted in rapid response to the epidemic, but how to choose the proper design for clinical trials remains the main concern. This study aimed to determine the fundamental characteristics of study design during the COVID-19 pandemic and provide references for other emerging infectious diseases. METHODS: We searched the database of ClinicalTrials.gov with the keyword "COVID-19" and compared the results with the design features of other conventional studies except for COVID-19. RESULTS: From January 1, 2020 to September 30, 2021, 55,334 trials were registered at ClinicalTrials.gov. Of all the registered trials, 6,408 were related to COVID-19 (11.58%). There were significant differences in the proportion of observational studies between COVID-19 (43.48%) and others (23.27%). The completion rate of observational trials and interventional trials in COVID-19 was 29.04% and 25.84%, respectively. COVID-19 trials showed a higher rate of completion than others (P<0.01). The time distribution and trend of observational studies and interventional studies varied considerably. CONCLUSION: Appropriately designed trials can help to improve research efficiency and reduce the possibility of research failure. In addition to randomized controlled trials, observational and single-armed studies are also worth considering.

Characteristics of Depression Clinical Trials Registered on ClinicalTrials.gov.

Background: Mental disorders are among the leading causes of the global health-related burden, and depression is one of the most disabling mental disorders. The emergence of the COVID-19 pandemic has created an environment where many determinants of mental health are exacerbated. Many studies have been registered and conducted over the past 16 years, but how to choose the proper design for depression clinical trials remains the main concern. This study aimed to characterize the current status of global depression clinical trials registered on ClinicalTrials.gov. Methods: We examined all the trials registered on ClinicalTrials.gov from 2007 to 2021. Results: Overall, 7623 depression clinical trials were identified for analysis. Of those trials, 6402 (83.98%) were intervention trials and 1212 (15.90%) were observational trials. The majority of intervention types were behavioral (35.2%) and drug (28.55%), with very few procedures, dietary supplements, and diagnostic test studies. In addition, 55.53% of trials enrolled <100 participants. The proportions of trials registered in North America were higher than on other continents. Furthermore, the trials that involved only females (12.6%) were more than only males (0.87%) from 2019 to 2021. Conclusion: Depression clinical trials registered on ClinicalTrials.gov were dominated by small sample size trials, and there is a lack of trials related to COVID-19. The choice of study design is crucial, and properly designed trials can help improve study efficiency and reduce the likelihood of study failure. Given the increased number of RCT trials, the trial quality is gradually improving over the years. In addition, depression trials concentrating on children and older adults need more scientific attention. Further studies related to COVID-19 are needed, given the great damage that causes to people's physical and mental health.

A systematic review and meta-analysis of indoor bioaerosols in hospitals: The influence of heating, ventilation, and air conditioning.

OBJECTIVES: To evaluate (1) the relationship between heating, ventilation, and air conditioning (HVAC) systems and bioaerosol concentrations in hospital rooms, and (2) the effectiveness of laminar air flow (LAF) and high efficiency particulate air (HEPA) according to the indoor bioaerosol concentrations. METHODS: Databases of Embase, PubMed, Cochrane Library, MEDLINE, and Web of Science were searched from 1st January 2000 to 31st December 2020. Two reviewers independently extracted data and assessed the quality of the studies. The samples obtained from different areas of hospitals were grouped and described statistically. Furthermore, the meta-analysis of LAF and HEPA were performed using random-effects models. The methodological quality of the studies included in the meta-analysis was assessed using the checklist recommended by the Agency for Healthcare Research and Quality. RESULTS: The mean CFU/m3 of the conventional HVAC rooms and enhanced HVAC rooms was lower than that of rooms without HVAC systems. Furthermore, the use of the HEPA filter reduced bacteria by 113.13 (95% CI: -197.89, -28.38) CFU/m3 and fungi by 6.53 (95% CI: -10.50, -2.55) CFU/m3. Meanwhile, the indoor bacterial concentration of LAF systems decreased by 40.05 (95% CI: -55.52, -24.58) CFU/m3 compared to that of conventional HVAC systems. CONCLUSIONS: The HVAC systems in hospitals can effectively remove bioaerosols. Further, the use of HEPA filters is an effective option for areas that are under-ventilated and require additional protection. However, other components of the LAF system other than the HEPA filter are not conducive to removing airborne bacteria and fungi. LIMITATION OF STUDY: Although our study analysed the overall trend of indoor bioaerosols, the conclusions cannot be extrapolated to rare, hard-to-culture, and highly pathogenic species, as well as species complexes. These species require specific culture conditions or different sampling requirements. Investigating the effects of HVAC systems on these species via conventional culture counting methods is challenging and further analysis that includes combining molecular identification methods is necessary. STRENGTH OF THE STUDY: Our study was the first meta-analysis to evaluate the effect of HVAC systems on indoor bioaerosols through microbial incubation count. Our study demonstrated that HVAC systems could effectively reduce overall bioaerosol concentrations to maintain better indoor air quality. Moreover, our study provided further evidence that other components of the LAF system other than the HEPA filter are not conducive to removing airborne bacteria and fungi. PRACTICAL IMPLICATION: Our research showed that HEPA filters are more effective at removing bioaerosols in HVAC systems than the current LAF system. Therefore, instead of opting for the more costly LAF system, a filter with a higher filtration rate would be a better choice for indoor environments that require higher air quality; this is valuable for operating room construction and maintenance budget allocation.

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial.

BACKGROUND: Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. METHODS/DESIGN: This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks - 4-0), a 4-week-long treatment period (weeks 1-4) and a 12-week-long follow-up period (weeks 5-16). Twelve treatment sessions will be performed over a 4-week period (weeks 1-4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. DISCUSSION: The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-1800017259 . Registered on 20 July 2018.

Circulating Irisin Levels in Patients with Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Previous studies have revealed the close relation of irisin with the occurrence and development of nonalcoholic fatty liver disease (NAFLD). A systematic review and meta-analysis were conducted to evaluate the association of circulating irisin levels and NAFLD. METHODS: A systematic literature search of PubMed, Embase, Cochrane Library, Clinicaltrials.gov, WANFANG, CNKI, and CBM databases was performed for relevant articles till August 2020. The weighted mean difference (WMD) values and 95% confidence intervals (CIs) were estimated to compare the case-control studies and pooled results using meta-analysis. RESULTS: The meta-analysis included 5 case-control studies with a total of 1087 people. The results revealed that the circulating irisin levels showed no significant difference between NAFLD and healthy groups (WMD = 7.51 (-12.53, 27.56) ng/ml, P > 0.05). Subgroup analysis based on races showed that the average irisin levels were higher in the NAFLD group than in the healthy group (WMD = 13.53 (0.71, 26.34) ng/ml, P < 0.05) in 4 Asian studies. Subgroup analysis based on disease severity from 3 Asian studies revealed that the average irisin levels were higher in the NAFLD group than in the healthy group (WMD = 25.1 (22.85, 27.51) ng/ml, P < 0.05 and WMD = 13.52 (22.85, 27.51) ng/ml, P < 0.05, respectively). Subgroup analysis including 3 studies from Asia suggested that the irisin levels were higher in mild NAFLD than in moderate-severe NAFLD (WMD = 11.68 (9.03, 14.32) ng/ml, P < 0.05). CONCLUSION: The average irisin levels might be higher in the NAFLD group than in the healthy group in Asians. The irisin levels in the mild NAFLD group might be higher than those in the moderate-severe group in Asians. It is important to monitor the changing trend of irisin levels in predicting the course of NAFLD disease and its changes.

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial.

BACKGROUND: Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-related pain. Opioid drugs are strongly recommended for treating cancer-related pain, but opioid-induced immunosuppression is still the most intractable drug-induced medical problem. Evaluating the efficacy and potential advantage of TEAS combined with opioid drugs in moderate and severe cancer-related pain in China is important because such studies are lacking. METHODS/DESIGN: This trial is a multicenter, prospective randomized controlled clinical trial. In total, 160 patients who were enrolled from two hospitals in the Zhejiang Province (China) will be randomly allocated into two groups: a TEAS group and sham TEAS group without acupoint electrical stimulation. Both groups will receive a 21-day interval of chemotherapy and conventional cancer pain therapy. Fifteen treatment sessions will be performed over a three-week period. The primary outcomes will be measured by changes in the Numerical Rating Scale (NRS) scores and equivalent dosage of morphine at baseline, three weeks of treatment and one two-week follow-up. The secondary outcome measures include cellular immunity function, life quality assessment, opioids side effects assessment, and safety and compliance evaluation. DISCUSSION: This trial is expected to clarify whether TEAS is effective for cancer-related pain. These results demonstrate the advantage of TEAS combined with opioid drugs on improving immune function and decreasing opioid induced side effects. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-13003803 . Registered on 27 August 2013.