Traditional Chinese Medicine is effective for COVID-19: A systematic review and meta-analysis.

Traditional Chinese Medicine (TCM) has played crucial roles in treating COVID-19 in China. But its effectiveness has not yet been widely realized/recognized over the world. We performed a systematic review and meta-analysis to investigate the clinical efficacy of TCM medicine in the treatment for COVID-19. We obtained the data of COVID-19 and traditional Chinese medicine from PubMed, MEDLINE, Web of Science and other databases, and searched from January 1, 2020 to January 26, 2022 to determine the randomized controlled trials (RCTs) without language restrictions. The review includes 26 randomized clinical trials including 2981 patients. The treatment of COVID-19 by TCM combined with conventional treatment is more effective than by pure conventional treatment in many aspects, including increasing of the effective rate [OR â€‹= â€‹2.47, 95%CI (1.85, 3.30), P â€‹< â€‹0.00001], fever disappearance rate [OR â€‹= â€‹3.68, 95%CI (1.95, 6.96), P â€‹< â€‹0.0001], fatigue disappearance rate [OR â€‹= â€‹3.15, 95%CI (1.60, 6.21), P â€‹= â€‹0.0009], cough disappearance rate [OR â€‹= â€‹2.89, 95%CI (1.84, 4.54), P â€‹< â€‹0.00001], expectoration disappearance rate [OR â€‹= â€‹5.94, 95%CI (1.98, 17.84), P â€‹= â€‹0.001], disappearance rate of shortness of breath [OR â€‹= â€‹2.57, 95%CI (1.13, 5.80), P â€‹= â€‹0.02], improvement rate of CT image [OR â€‹= â€‹2.43, 95%CI (1.86, 3.16), P â€‹< â€‹0.00001], and reduction of the hospitalization time [MD â€‹= â€‹-3.16, 95%CI (-3.75, -2.56), P â€‹< â€‹0.00001], and deterioration rate [OR â€‹= â€‹0.49, 95%CI (0.29, 0.83), P â€‹= â€‹0.007]. The findings of this meta-analysis suggest that TCM can effectively relieve symptoms, boosted patients' recovery, cut the rate of patients developing into severe conditions, and reduce the deterioration rate.

Comparison of postoperative pancreatic fistula between open and laparoscopic surgery in patients with gastric cancer: A meta-analysis.

Background: Open gastrectomy"OG" compared with laparoscopic gastrectomy"LG" in patients with gastric cancer"GC" has been widely discussed over the past years. However, the lack of comparative analysis in postoperative pancreatic fistula "POPF" hinders its severity as surgical procedures developed rapidly. Therefore, there are still moot on whether one of these surgical options is superior in POPF. Objective: To compare the incidence of POPF in patients undergoing OG and LG for gastric cancer "GC". Methods: Articles from January 2011 to August 2021 that compared LG and OG for GC were reviewed. Cohort studies were included in our study. The quality of enrolled studies was evaluated. Outcomes regarding POPF complication and relative operation results were analyzed. Statistical analysis portrayed the Weighted mean difference"WMD"and the odds ratio"OR"with a 95% confidence interval "CI". The curative effect was analyzed using RevMan 5.4.1 software. Results: Totally 7 articles met the inclusion criteria, including 3194 patients with treatment of gastrectomy surgeries for gastric cancer "GC". There was no significant difference observed in POPF incidence (OR, 95% CI = 1.04 [0.74,1.46], P = 0.81) between OG group and LG group in patients undergoing GC gastrectomy. Conclusion: We stringently explored the current incidence of POPF after GC gastrectomy, comparing its incidence during LG and OG, there was no significant difference between OG and LG in the incidence of POPF, and surgeons should give more concern for improvement in surgical techniques. Further research is still needed to explore the risk of causes and surgical techniques should be considered cautiously in a clinical procedure.

Antiviral effect of mouthwashes against SARS-COV-2: A systematic review.

OBJECTIVE: This systematic review aimed to evaluate the antiviral effect of mouthwashes against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MATERIAL AND METHODS: An electronic search was performed on PubMed, Scopus, Web of Science, Cochrane Library, LILACS, ProQuest, and Google Scholar, and was complemented by a manual search. Both clinical and in vitro studies that focused on the antiviral effect of mouthwashes against SARS-CoV-2 were included. Risk of bias assessment was performed only on the clinical studies using the RoB-2 and ROBINS-I tools. RESULTS: A total of 907 records were found; after initial selection by title and abstract, 33 full-text articles were selected to be evaluated for eligibility. Finally, a total of 27 studies were included for the qualitative synthesis, including 16 in vitro studies and 11 clinical trials. Antiviral effects were evaluated separately for the in vitro and clinical studies. In vitro studies included mouthwashes containing hydrogen peroxide, chlorhexidine digluconate, povidone-iodine, essential oils, cetylpyridinium chloride, and other compounds; in vivo studies included mouthwashes containing hydrogen peroxide, chlorhexidine digluconate, povidone-iodine, cetylpyridinium chloride, essential oils, chlorine dioxide, ß-cyclodextrin-citrox, and sorbitol with xylitol. Povidone-iodine, cetylpyridinium chloride, and essential oils were effective in vitro, while hydrogen peroxide, chlorhexidine digluconate, povidone-iodine, cetylpyridinium chloride, ß-cyclodextrin-citrox, and sorbitol with xylitol were effective in vivo. Unclear or high risk of bias was found for almost all clinical studies, and only one study presented with a low risk of bias. No further quantitative analysis was performed. CONCLUSION: Although povidone-iodine, cetylpyridinium chloride, and essential oils may be an alternative to reduce the viral load in vitro and in vivo, more studies are needed to determine the real antiviral effect of these different mouthwashes against SARS-CoV-2.This work was not funded. The protocol was registered in PROSPERO (identification number: CRD42021236134).

Comparing clinical and radiographic outcomes of robotic-assisted, computer-navigated and conventional unicompartmental knee arthroplasty: A network meta-analysis of randomized controlled trials.

INTRODUCTION: The purpose was to compare robotic assisted (RA), computer navigated (CN), and conventional UKA techniques. METHODS: Databases were queried for data on study characteristics, UKA systems, complications, and tibiofemoral alignment. RESULTS: Four RA and six CN RCTs were identified. No significant differences were found in operative time, tibiofemoral alignment, and reoperation rates when comparing RA or CN to conventional UKA. RA UKA resulted in a significantly lower risk of complications compared to conventional UKA. CONCLUSIONS: RA UKA results in fewer complications than conventional UKA with a clinically significant increase in operative time. All groups were similar in remaining evaluated parameters.

Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation.

BACKGROUND: A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. METHODS: Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis. RESULTS: The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. CONCLUSIONS: RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02338869. Registered on October 4, 2014.

Antibiotic prescription monitoring and feedback in primary care in Switzerland: Design and rationale of a nationwide pragmatic randomized controlled trial.

INTRODUCTION: Antibiotic consumption is highest in primary care, and antibiotic overuse furthers antimicrobial resistance. In our recently published pilot-RCT, we used monthly aggregated claims data to provide personalized antibiotic prescription feedback to general practitioners (GPs). The pilot-RCT has shown that personalized prescription feedback is a feasible and promising low-cost intervention to reduce antibiotic prescribing. Here, we describe the rationale and design of the follow-up RCT with 3426 GPs in Switzerland. We now have access to pseudonymized patient-level data from routinely collected health insurance data of the three largest health insurers in Switzerland. METHODS AND ANALYSIS: 1713 GPs randomized to the intervention group received once evidence-based treatment guidelines at the beginning, including region-specific antibiotic resistance information from the community and personalized feedback of their antibiotic prescribing, followed by quarterly personalized prescription feedback for two years. The first and the last mailings were sent out in December 2017 and September 2019, respectively. The 1713 GPs randomized to the control group were not notified about the study and they received no guidelines and no prescription feedback. The personalized prescription feedbacks and the analyses of the primary and secondary outcomes are entirely based on pseudonymized patient-level data from routinely collected health insurance data. The primary outcome is prescribed antibiotics per 100 patient consultations during the second year of intervention. The secondary outcomes include antibiotic use during the entire two-year trial period, use of broad-spectrum antibiotics, hospitalization rates (all-cause and infection-related), and antibiotic use in different age groups. If the feedback intervention proves to be efficacious, the intervention could be continued systemwide. ETHICS AND DISSEMINATION: The trial is publicly funded by the Swiss National Science Foundation (SNSF, grant number 407240_167066). The trial was approved by the ethics committee "Ethikkommission Nordwest-und Zentralschweiz" (EKNZ Project-ID 2017-00888). Results will be disseminated in peer-reviewed journals and international conferences.

Internet-based cognitive behavioral therapy for psychological distress in older adults without cognitive impairment living in nursing homes during the COVID-19 pandemic: A feasibility study.

BACKGROUND: The COVID-19 pandemic has had a detrimental effect on the mental health of older adults living in nursing homes. Very few studies have examined the effects of Internet-based Cognitive Behavioral Therapy (ICBT) on older adults living in nursing homes during the pandemic. We conducted a feasibility study using a single-group design, to explore the effectiveness of ICBT on psychological distress in 137 older adults (without cognitive impairment) from 8 nursing homes in 4 southeast cities in China, between January and March 2020. METHODS: Symptoms of depression, anxiety, general psychological distress, and functional disability were measured at baseline, post-treatment (5 weeks) and at a 1-month follow-up. Mixed-effects model was used to assess the effects of ICBT. RESULTS: Statistically significant changes with large effect sizes were observed from pre- to post-treatment on the PHQ-9 (p < .001, Cohen's d = 1.74), GAD-7 (p < .001, d = 1.71), GDS (p < .001, d = 1.30), K-10 (p < .001, d = 1.93), and SDS (p < .001, d = 2.03). Furthermore, improvements in treatment outcomes were sustained at 1-month follow-up, and high levels of adherence and satisfaction were indicated. CONCLUSION: ICBT was effective in reducing psychological distress in older adults without cognitive impairments living in nursing homes during the COVID-19 pandemic. Thus, it could be applied in improving the mental health of this vulnerable group during the pandemic.

Effects of Febuxostat on Mortality and Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVE: To investigate the association between using febuxostat and cardiovascular events. METHODS: Systematic search of randomized controlled trials was performed using PubMed/MEDLINE, Cochrane review, and EMBASE databases through April 17, 2019. Meta-analysis was performed using random effect model and estimates were reported as risk difference (RD) with 95% CIs. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. The main outcomes of interest were cardiovascular mortality and all-cause mortality. RESULTS: A total of 15 randomized controlled trials (16,070 participants) were included. The mean ± SD age was 58.1±11.7 years. At the median follow-up of 6.4 months, use of febuxostat was not associated with statistically significant risk of cardiovascular mortality (RD, 0.12%; 95% CI, -0.25% to 0.49%; I 2 =48%; low certainty evidence), all-cause mortality (RD, 0.20%; 95% CI, -0.28% to 0.68%; I 2  =60%; very low certainty evidence), major adverse cardiovascular events (RD, 0.40%; 95% CI, -0.34% to 1.13%; I 2 =26%; low certainty evidence), myocardial infarction (RD, -0.06%; 95% CI, -0.29% to 0.17%; I 2  =0%; moderate certainty evidence), stroke (RD, 0.10%; 95% CI, -0.15% to 0.35%; I 2 =0%; moderate certainty evidence), or new-onset hypertension (RD, 1.58%; 95% CI, -0.63% to 3.78%; I 2 =58%; very low certainty evidence). These findings were consistent in patients with existing cardiovascular disease. CONCLUSION: This meta-analysis suggested that use of febuxostat was not associated with higher risk of mortality or adverse cardiovascular outcomes in patients with gout and hyperuricemia. The results were limited by low to moderate certainty of evidence.

The efficacy of honey and a Thai Herbal Oil preparation in the treatment of pressure ulcers based on Thai traditional medicine wound diagnosis versus standard practice: An open-label randomized controlled trial.

BACKGROUND: Scientific support for Thai traditional medicine (TTM) practice is warranted for reintroduction into modern healthcare systems. A promising TTM practice for treatment of pressure ulcers was selected to conduct a clinical trial. This study aimed to evaluate the efficacy of the TTM practice for the treatment of pressure ulcers using honey or a Thai Herbal Oil preparation (THO) based on the TTM wound diagnosis comparing with the standard practice. METHODS: The study design was an open-label randomized controlled trial. Sixty-six participants, with pressure ulcers at least stage II-IV or unstageable, were allocated to two groups via minimization. A TTM practice group received honey or THO depending on the TTM diagnosis via the Thai Traditional Medicine Pressure Ulcer Assessment Tool (TTM-PUAT). A standard practice group received advanced dressings, including hydrogel, alginate, silver-impregnated, or hydrocolloid dressings. The primary outcome was the Pressure Ulcer Scale for Healing (PUSH). RESULTS: Both TTM practice and standard practice showed a significant reduction in PUSH scores after treatments. However, there was no significant difference in PUSH score reduction between the groups. The mean PUSH score reduction over the 6-week period was 2.58 ± 3.38 (95% CI 1.34-3.82) in the TTM practice group and 3.24 ± 3.49 (95% CI 1.91-4.57) in the standard practice group (p = 0.284). The TTM practice and standard practice accelerated pressure ulcer healing without statistically significant difference between the practices, during 6 weeks in a home-based care setting. This finding supported the TTM practice as an alternative treatment for pressure ulcer.

Point-of-care testing of (N-terminal pro) B-type natriuretic peptide for heart disease patients in home care and ambulatory care settings.

OBJECTIVES: The role of point-of-care testing (POCT) out of hospital, especially in home care and ambulatory care settings, is an issue meriting further research. We reviewed studies reporting cardiovascular events as a result of the implementation of B-type natriuretic peptide or N-terminal pro B-type natriuretic peptide POCT (BNP/NT-proBNP POCT) for heart disease patients in the settings. DESIGN: Articles were searched via a PubMed engine until May 30, 2020. RESULTS: In total, six studies were selected. Three studies involving ambulatory care used the POCT to refer patients with suspected heart diseases to a specialist. The other three used the tests in home care to monitor patients with heart failure. In ambulatory care, the randomized controlled trials, in which referrals were made to a specialist, showed that the group using POCT had significantly fewer cardiovascular outcomes, such as hospitalizations and deaths, than the non-use group. In home care, adverse outcomes were predicted from changes in BNP levels. CONCLUSIONS: In most studies, the use of BNP/NT-proBNP POCT in home care and ambulatory care settings demonstrated favorable results regarding the cardiovascular outcomes. The utility of POCT in the settings is suggested, while more investigations are required.

Consensus on DEfinition of Food Allergy SEverity (DEFASE): Protocol for a systematic review.

BACKGROUND AND AIMS: The term "Food Allergy" refers to a complex global health problem with a wide spectrum of severity. However, a uniform definition of severe food allergy is currently missing. This systematic review is the preliminary step towards a state-of-the-art synopsis of the current evidence relating to the severity of IgE-mediated food allergy; it will inform attempts to develop a consensus to define food allergy severity by clinicians and other stakeholders. METHODS: We will undertake a systematic review, which will involve searching international biomedical databases for published studies. Studies will be independently screened against pre-defined eligibility criteria and critically appraised by established instruments. Data will be descriptively and, if possible and applicable, quantitatively synthesised. ETHICS AND DISSEMINATION: This study does not require any specific ethical approval since it is a systematic review. We plan to report results from this systematic review in a peer reviewed journal. These results will be used to inform the development of an international consensus to define severe food allergy. Author's potential conflicts of interest are clearly stated. PROSPERO REGISTRATION NUMBER: CRD42020183103.

Limb-salvage surgery offers better five-year survival rate than amputation in patients with limb osteosarcoma treated with neoadjuvant chemotherapy. A systematic review and meta-analysis.

BACKGROUND: Osteosarcoma is the most common primary bone sarcoma. Currently, the main treatment option for high-grade osteosarcomas is neoadjuvant chemotherapy, followed by surgical resection of the lesion and adjuvant chemotherapy. Limb salvage surgery (LSS) and amputation are the main surgical techniques; however, controversy still exists concerning the best surgical method. Our meta-analysis compared the effectiveness of LSS and amputation combined with neoadjuvant chemotherapy in patients with limb osteosarcoma, in terms of 5-year overall survival (OS), 5-year disease-free survival (DFS) and local recurrence rate. METHODS: Following the established methodology of PRISMA guidelines, a literature search was conducted in PubMed, Cochrane, Google Scholar from 1975 until January 2020. Two independent reviewers evaluated the study quality based on the Newcastle-Ottawa scale. Odds ratio and 95% confidence interval of the OS, DFS and local recurrence rate were calculated. RESULTS: Thirteen studies were finally included with a total of 2884 patients; 1986 patients undergone LSS and 898 amputations. Five-year overall survival was almost 2-fold in patients treated with LSS than those treated with amputation (OR: 1.99; 95% CI: 1.35-2.93; I2 = 74%, p < 0.001). No difference was found in 5-year DFS between LSS patients and amputees (OR: 1.24; 95% CI: 0.55-2.79; I2 = 67%, p = 0.01). The odds of local recurrence was numerically higher in LSS compared to amputation but not statistically significant (OR: 2.29; 95% CI: 0.95-5.53; I2 = 47%, p = 0.05). However, the included studies did not clearly define differences in the stages of patients of the two groups. CONCLUSION: Our study demonstrated that in patients with limb osteosarcoma treated with neoadjuvant chemotherapy, LSS is associated with a higher 5-year overall survival and the odds of local recurrence may be increased but these results should be interpreted with caution due to high heterogeneity.

Vitamin D in the Middle East and North Africa.

PURPOSE: The Middle East and North Africa (MENA) region registers some of the lowest serum 25­hydroxyvitamin D [25(OH)D] concentrations, worldwide. We describe the prevalence and the risk factors for hypovitaminosis D, completed and ongoing clinical trials, and available guidelines for vitamin D supplementation in this region. METHODS: This review is an update of previous reviews published by our group in 2013 for observational studies, and in 2015 for randomized controlled trials (RCTs) from the region. We conducted a comprehensive search in Medline, PubMed, and Embase, and the Cochrane Library, using MeSH terms and keywords relevant to vitamin D, vitamin D deficiency, and the MENA region, for the period 2012-2017 for observational studies, and 2015-2017 for RCTs. We included large cross-sectional studies with at least 100 subjects/study, and RCTs with at least 50 participants per arm. RESULTS: We identified 41 observational studies. The prevalence of hypovitaminosis D, defined as a 25­hydroxyvitamin D [25(OH)D] level below the desirable level of 20 ng/ml, ranged between 12-96% in children and adolescents, and 54-90% in pregnant women. In adults, it ranged between 44 and 96%, and the mean 25(OH)D varied between 11 and 20 ng/ml. In general, significant predictors of low 25(OH)D levels were female gender, increasing age and body mass index, veiling, winter season, use of sun screens, lower socioeconomic status, and higher latitude.We retrieved 14 RCTs comparing supplementation to control or placebo, published during the period 2015-2017: 2 in children, 8 in adults, and 4 in pregnant women. In children and adolescents, a vitamin D dose of 1000-2000 IU/d was needed to maintain serum 25(OH)D level at target. In adults and pregnant women, the increment in 25(OH)D level was inversely proportional to the dose, ranging between 0.9 and 3 ng/ml per 100 IU/d for doses ≤2000 IU/d, and between 0.1 and 0.6 ng/ml per 100 IU/d for doses ≥3000 IU/d. While the effect of vitamin D supplementation on glycemic indices is still controversial in adults, vitamin D supplementation may be protective against gestational diabetes mellitus in pregnant women. In the only identified study in the elderly, there was no significant difference between 600 IU/day and 3750 IU/day doses on bone mineral density. We did not identify any fracture studies.The available vitamin D guidelines in the region are based on expert opinion, with recommended doses between 400 and 2000 IU/d, depending on the age category, and country. CONCLUSION: Hypovitaminosis D is prevalent in the MENA region, and doses of 1000-2000 IU/d may be necessary to reach a desirable 25(OH)D level of 20 ng/ml. Studies assessing the effect of such doses of vitamin D on major outcomes, and confirming their long term safety, are needed.

Probiotics supplementation and length of hospital stay in neonates with gastrointestinal surgery.

Any manipulation on open bowel causes interventional impact on gut microbiome, and surgical stress triggers bacterial translocation; thus, it will be fundamental to determine gut microbiome after surgery. Monitoring dynamic changes in microbiome of post-surgical infants who received probiotics and placebo could provide with important information about gut colonization and potential bacterial overgrowth. The purpose of this study is to assess the effect of probiotics supplementation on length of hospital stay, duration of parenteral nutrition, and feed tolerance in neonates after gastrointestinal surgery.

Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics: Beyond EROOM's Law.

Eroom's law (Moore's law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades. Therapeutics for cardiovascular diseases (CVD) appear to have been particularly sensitive to these trends. Thirty-three percent fewer CVD therapeutics were approved between 2000 and 2009 compared to the previous decade, and the number of CVD drugs starting all clinical trial stages declined in both absolute and relative numbers between 1990 and 2012. In the last 5 years, drugs to treat CVD disease comprised just 6% of all new drug launches. This review discusses the decline in CVD therapeutics, the reasons behind it, and ways in which this trend is being or might be addressed.