Nonrandomized Clinical Studies Research Articles

Clinical Impact of Preexisting Right Bundle Branch Block after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Introduction Transcatheter aortic valve replacement (TAVR) is now the treatment of choice for patients with severe aortic stenosis regardless of their surgical risk. Right bundle branch block (RBBB) can be a predictor for development of significant atrioventricular (AV) block after TAVR, requiring permanent pacemaker implantation (PPI). However, data related to the risk of PPI requirement with preexisting RBBB is scarce. Hence, this systematic review and meta-analysis aims to assess clinical outcomes of patients undergoing TAVR with RBBB on preexisting electrocardiogram. Methods We performed a systematic literature review to identify randomized and nonrandomized clinical studies that reported any clinical impact of patients undergoing TAVR with preexisting RBBB. A total of eight databases including PubMed (Medline), Embase, Cochrane Library, ACP Journal Club, Scopus, DARE, and Ovid containing articles from January 2000 to May 2020 were analyzed. Results We identified and screened 224 potential eligible publications through the databases and found 14 relevant clinical trials for a total of 15,319 participants. There was an increased 30-day pacemaker implantation rate of 38.1% in the RBBB group compared to 11.4% in the no RBBB group with a risk ratio of 3.56 (RR 3.56 (95% CI 3.21–3.93, p < 0.01)). There was an increased 30-day all-cause mortality in the RBBB group of 9.5% compared with 6.3% in the no RBBB group with an odds ratio of 1.60 (OR 1.60 (95% CI 1.14–2.25, p < 0.01)). Conclusion This study indicates that patients with preexisting RBBB have higher incidence of PPI and all-cause mortality after TAVR compared with patients without RBBB. Further trials are needed to compare the clinical outcomes based on TAVR valve types and assess the benefit of PPI in patients with new-onset RBBB after TAVR.

SHORT-WAVE DIATHERMY IN PATIENTS WITH CHRONIC LOW BACK PAIN: A SYSTEMATIC REVIEW

ABSTRACT The aim of this study was to evaluate the evidence of application of short-wave diathermy (SWD) in individuals with chronic low back pain (CLBP) and its prescription parameters. The data sources (MEDLINE, PubMed, LILACS, DARE, PsycINFO, AusportMed, SciELO, PEDro and the Cochrane Central Register of Controlled Trials) were systematically searched for articles published up to December 2017. Randomized and non-randomized clinical trial studies that investigated the effect of the application of SWD on CLBP were selected. Two independent reviewers assessed the risk of bias in studies using the Jadad and the Downs &amp; Black scales. Five studies (731 patients) were included, all of whom presented improvements in CLBP. The majority used continuous mode SWD, with only one using pulsed mode (82 and 200 Hz). SWD produced improvements in CLBP, but there is limited evidence for its application, and a lack of standardization of the parameters used. Furthermore, the results that address this topic should be interpreted with caution due to their low methodological quality and limited number. Level of evidence II; Systematic review.

Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis

To provide a comprehensive and contemporary overview of the long-term safety outcomes after aortic valve replacements (AVR) with conventional biological heart valve (stented or stentless). English databases (Medline, Embase, Web of Science, CENTRAL, and ClinicalTrial.gov) and Chinese databases (CNKI, VIP, WanFang, and SinoMed) were searched systemically from January 1, 2000 to January 26, 2019. Eligible randomized controlled trials, non-randomized clinical trials, cohort studies (retrospective or prospective), and unselected case series were included. Strict screening of the obtained literature was conducted to extract relevant data by two reviewers. Other inclusion criteria were studied reporting on outcomes of AVR with biological valves (stented or stentless), with or without coronary artery bypass grafting (CABG) or valve repair procedure, with mean follow-up length equal to or longer than 5 years. We excluded studies that reported only a specific patient group (e.g., patients with renal failure, or pregnancy), without the report of biological valve type, or with study population size less than 100. The meta-analysis was performed using Stata 14.0 software. In this study, 53 papers (in total 57 study groups) involving 47 803 patients were included. (1) The all-cause mortality was 6.33/100 patient-years (95%CI: 5.85-6.84). Subgroup analysis showed that the mortality rates of porcine and bovine valve prostheses were 5.69/100 patient-years (95%CI: 5.05-6.41) and 7.29/100 patient-years (95%CI: 6.53-8.13), respectively. The all-cause mortality rates for stented and stentless valve were 6.69/100 patient-years (95%CI: 6.12-7.30) and 5.21/100 patient-years (95%CI: 4.43-6.14), respectively. (2) The incidence rate of thromboembolism was 1.16/100 patient-years (95%CI: 0.96-1.40), the incidence rate of permanent pacemaker (PPM) implantation was 1.08/100 patient-years (95%CI: 0.75-1.54), the incidence rate of stroke was 0.74/100 patient-years (95%CI: 0.51-1.06), the incidence rate of structural valve dysfunction (SVD) was 0.73/100 patient-years (95%CI: 0.59-0.91), the incidence rate of major bleeding was 0.52/100 patient-years (95%CI: 0.41-0.65), the incidence rate of endocarditis was 0.38/100 patient-years (95%CI: 0.33-0.44), and the incidence rate of non-structural valve dysfunction (NSVD) was 0.20/100 patient-years (95%CI: 0.13-0.31). The total reoperation rate for biological aortic valve was 0.77/100 patient-years (95%CI: 0.65-0.91), and the SVD related reoperation rate was 0.46/100 patient-years (95%CI: 0.36-0.58). The all-cause mortality for conventional biological AVR was 6.33/100 patient-years. Thromboembolism, PPM implantation, reoperation, stroke, and SVD were major long term complications.

A Pharmacovigilance Study of Hydroxychloroquine Cardiac Safety Profile: Potential Implication in COVID-19 Mitigation.

In light of the favorable outcomes of few small, non-randomized clinical studies, the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Hydroxychloroquine (HCQ) for hospitalized coronavirus disease 2019 (COVID-19) patients. In fact, subsequent clinical studies with COVID-19 and HCQ have reported limited efficacy and poor clinical benefits. Unfortunately, a robust clinical trial for its effectiveness is not feasible at this emergency. Additionally, HCQ was suspected of causing cardiovascular adverse reactions (CV-AEs), but it has never been directly investigated. The objective of this pharmacovigilance analysis was to determine and characterize HCQ-associated cardiovascular adverse events (CV-AEs). We performed a disproportionality analysis of HCQ-associated CV-AEs using the FDA adverse event reporting system (FAERS) database. The FAERS database, comprising more than 11,901,836 datasets and 10,668,655 patient records with drug-adverse reactions, was analyzed. The disproportionality analysis was used to calculate the reporting odds ratios (ROR) with 95% confidence intervals (CI) to predict HCQ-associated CV-AEs. HCQ was associated with higher reporting of right ventricular hypertrophy (ROR: 6.68; 95% CI: 4.02 to 11.17), left ventricular hypertrophy (ROR: 3.81; 95% CI: 2.57 to 5.66), diastolic dysfunction (ROR: 3.54; 95% CI: 2.19 to 5.71), pericarditis (ROR: 3.09; 95% CI: 2.27 to 4.23), torsades de pointes (TdP) (ROR: 3.05; 95% CI: 2.30 to 4.10), congestive cardiomyopathy (ROR: 2.98; 95% CI: 2.01 to 4.42), ejection fraction decreased (ROR: 2.41; 95% CI: 1.80 to 3.22), right ventricular failure (ROR: 2.40; 95% CI: 1.64 to 3.50), atrioventricular block complete (ROR: 2.30; 95% CI: 1.55 to 3.41) and QT prolongation (ROR: 2.09; 95% CI: 1.74 to 2.52). QT prolongation and TdP are most relevant to the COVID-19 treatment regimen of high doses for a comparatively short period and represent the most common HCQ-associated AEs. The patients receiving HCQ are at higher risk of various cardiac AEs, including QT prolongation and TdP. These findings highlight the urgent need for prospective, randomized, controlled studies to assess the risk/benefit ratio of HCQ in the COVID-19 setting before its widespread adoption as therapy.

Three-dimensional analyses of short- and long-term effects of rapid maxillary expansion on nasal cavity and upper airway: A systematic review and meta-analysis.

The purpose of this systematic review was to evaluate the three-dimensional (3D) changes occurring at short- and long-term follow-up after rapid maxillary expansion (RME) in nasal cavity (NC) and upper airway (UA) in growing patients. A literature search up to 1 July 2019 was performed. Randomized and non-randomized clinical trials and cohort studies comparing the effects of RME in a paediatric population using 3D analyses based on computed tomography (CT), cone-beam CT and MRI were included. The risks of bias of the included studies were assessed using the Cochrane Collaboration's risk of bias tool, the GRADE approach and a customized tool. The random-effects meta-analyses of the mean differences and 95% confidence intervals of NC and UA volume changes were carried out, followed by subgroup analyses. Twenty-seven studies were included, with 18 selected for quantitative synthesis. Immediately after expansion, the nasopharynx and oropharynx increased significantly. After 3months of retention, only the NC and nasopharynx showed a significant volume increase. Two studies mentioned the use of a sleep-disordered breathing questionnaire, and one study reported the difference before and after RME. None of the 27 articles included assessed the correlation between the skeletal widening and NC or UA volume changes after RME. The existing evidence confirmed only the short-term positive effect of RME on expanding the volume of the NC and the upper part of the UA. However, long-term stability could not be sustained.

Evaluation of Internal Medicine Physician or Multidisciplinary Team Comanagement of Surgical Patients and Clinical Outcomes

Older patients who undergo surgery may benefit from geriatrician comanagement. It is unclear whether other internal medicine (IM) physician involvement improves outcomes for adults who undergo surgery. To evaluate the association of IM physician involvement with clinical and health system outcomes compared with usual surgical care among adults who undergo surgery. MEDLINE, Embase, CINAHL, and CENTRAL databases were searched for studies published in English from database inception to April 2, 2019. Prospective randomized or nonrandomized clinical studies comparing IM physician consultation or comanagement with usual surgical care were selected by consensus of 2 reviewers. Data were extracted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline by 2 authors independently. Intervention characteristics were described using existing indicators. Risk of bias was assessed using Risk of Bias 2.0 and Risk of Bias in Nonrandomized Studies of Interventions tools. Studies were pooled when appropriate in meta-analysis using random-effects models. Prespecified subgroups included IM physician-only vs multidisciplinary team interventions and patients undergoing elective vs emergency procedures. The prespecified primary outcome was length of stay; other outcomes included 30-day readmissions, inpatient mortality, medical complications, functional outcomes, and costs. Of 6027 records screened, 14 studies (with 1 randomized clinical trial) involving 35 800 patients (13 142 [36.7%] in intervention groups) were eligible for inclusion. Interventions varied substantially among studies and settings; most interventions described comanagement by a hospitalist or internist; 7 (50%) included a multidisciplinary team, and 9 (64%) studied predominantly patients who had elective procedures. Risk of bias in 10 studies (71%) was serious. Meta-analysis showed no significant association with length of stay (mean difference, -1.02 days; 95% CI, -2.09 to 0.04 days; P = .06) or mortality (odds ratio, 0.79; 95% CI, 0.56 to 1.11; P = .18), but multidisciplinary team involvement was associated with significant reduction in length of stay (mean difference, -2.03 days; 95% CI, -4.05 to -0.01 days; P = .05) and mortality (odds ratio, 0.67; 95% CI, 0.51 to 0.88; P = .004). There was no difference in 30-day readmissions (odds ratio, 0.89; 95% CI, 0.68 to 1.16; P = .39). Data could not be pooled for complications or costs. Only 1 study (7%) reported functional outcomes. The findings of this study suggest that IM physician comanagement that includes multidisciplinary team involvement may be associated with reduced length of stay and mortality in adults undergoing surgery. Evidence was low quality, and well-designed prospective studies are still needed.

A Systematic Review of the Effect of Aromatherapy and Storytelling on Anxiety in Children during Dentistry

Background There is limited study and a lack of systematic review in the field of aromatherapy with orange, and storytelling and their positive effects as a safe, simple and low-cost. The present study is aimed to provide a comprehensive review of the alleviating effects of aromatherapy with orange and therapeutic storytelling on anxiety during dentistry. Materials and Methods: Systemic search of online databases (Medline, Web of Science, Cochrane, EMBASE and Scopus), for randomized control trial and non-randomized prospective or retrospective clinical studies without time and language limitation, using related keyword combinations were searched up to Mar 2019. Two reviewers did study selection and the evaluation of studies was conducted by Jadad scale. Results: Finally,three studies were included in a systematic review. In the first study, salivary cortisol and pulse rate improved significantly in both aromatherapies with and without orange aroma. In the second study, there was no significant difference in the mean of blood pressure, oxygen saturation, and pulse rate between groups (orange essential oil and without aroma) of children during dental treatment; anxiety level was assessed with Venham’s picture scale. Comparison between groups regarding Venham’s picture test was significant. In the third study, there was significant decrease of anxiety, pain and anger in the storytelling psychotherapy group compared with, the placebo and control groups of children receiving treatment by the dentist. Conclusion Both methods, orange odor and storytelling, were effectiveness in decreasing the anxiety level of children receiving dental treatment.

EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) IN CHRONIC LOW BACK PAIN: A SYSTEMATIC REVIEW OF RANDOMIZED CLINICAL TRIALS

Background: Extracorporeal Shock Wave Therapy (ESWT) has become a popular tool to treat musculoskeletal disorders and chronic low back pain. Aim of the study: To review the current scientific literature and assess the utility of ESWT in treating chronic low back pain. Methods: This systematic review was conducted from November 2019 to January 2020. Its purpose was to determine what the effectiveness is of the various forms of ESWT for the treatment of chronic low back pain. The critical review of the literature on the use of ESWT in chronic low back was made using the scientifically recognized medical databases PubMed, MEDLINE, Physiotherapy Evidence Database (PEDro) and Web of Science Core Collection. There was no restriction by date. Exclusion criteria were experimental, in vitro, animal, review, case reports, non-randomized clinical trials or studies with healthy participants. All articles written in languages other than English have also been excluded. Results: Six studies were included in the final analysis. According to the applied PEDro classification, the average scoring for the studies was 4.83, which indicates overall low quality of the presented reports. However, this result appeared closer to the moderate (acceptable) quality range (6-8 points) than to the unacceptable range (0-2 points). Conclusion: Based on the findings in the analyzed articles, ESWT promises to be an efficient and useful procedure in chronic low back pain treatment. Unfortunately, the level of evidence is relatively weak because there are a limited number of published studies related to ESWT and the final score in the PEDro classification was low. Together, these results indicate the need for further high quality randomized clinical trials.

Testosterone replacement therapy.

The aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anaemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range. TRT has been used in the last 70years, and overtime, numerous preparations and formulations have been developed to improve pharmacokinetics (PKs) and patient compliance. The routes of delivery approved for use in the Western world include buccal, nasal, subdermal, transdermal and intramuscular (IM). The aim of this narrative review was to describe and compare all available and approved testosterone preparations according to pharmacology, PKs and adverse effects. We have performed an extensive PubMed review of the literature on TRT in clinical practice. Contraindications and monitoring of TRT were analyzed by comparing available guidelines released in the last five years. We provide a review of advantages and disadvantages of different modalities of TRT and how to monitor treatment to minimize the risks. TRT is associated with multiple benefits highly relevant to the patient. However, the recommendations given in different guidelines on TRT are based on data from a limited number of randomized controlled trials (RCTs), as well as non-randomized clinical studies and observational studies. This is the case for the safety of a long-term TRT in late-onset hypogonadism (LOH). No evidence is provided indeed on the effects of TRT on endpoints such as deterioration of heart failure suggesting a cautious approach to T replacement in older men with a history of heart failure. Clinicians must consider the unique characteristics of each patient and make the necessary adjustments in the management of LOH in order to provide the safest and most beneficial results.

Effects of respiratory muscle therapy on obstructive sleep apnea: a systematic review and meta-analysis

The purpose of this study is to conduct a systematic review and meta-analysis evaluating the effects of respiratory muscle therapy (ie, oropharyngeal exercises, speech therapy, breathing exercises, wind musical instruments) compared with control therapy or no treatment in improving apnea-hypopnea index ([AHI] primary outcome), sleepiness, and other polysomnographic outcomes for patients diagnosed with obstructive sleep apnea (OSA). Only randomized controlled trials with a placebo therapy or no treatment searched using PubMed, EMBASE, Cochrane, and Web of Science up to November 2018 were included, and assessment of risk of bias was completed using the Cochrane Handbook. Nine studies with 394 adults and children diagnosed with mild to severe OSA were included, all assessed at high risk of bias. Eight of the 9 studies measured AHI and showed a weighted average overall AHI improvement of 39.5% versus baselines after respiratory muscle therapy. Based on our meta-analyses in adult studies, respiratory muscle therapy yielded an improvement in AHI of -7.6 events/h (95% confidence interval [CI] = -11.7 to -3.5; P ≤ .001), apnea index of -4.2 events/h (95% CI = -7.7 to -0.8; P ≤ .016), Epworth Sleepiness Scale of -2.5 of 24 (95% CI= -5.1 to -0.1; P ≤ .066), Pittsburgh Sleep Quality Index of -1.3 of 21 (95% CI= -2.4 to -0.2; P ≤ .026), snoring frequency (P = .044) in intervention groups compared with controls. This systematic review highlights respiratory muscle therapy as an adjunct management for OSA but further studies are needed due to limitations including the nature and small number of studies, heterogeneity of the interventions, and high risk of bias with low quality of evidence.

Evaluation of Non-Pharmacological Strategies, Therapeutic and Cognitive-Behavioral Interventions in the Treatment of Premenstrual Syndrome: A Review Study

Background Premenstrual syndrome (PMS) is one of the most common problems in women of childbearing age that often interferes with their work and social relationships. The aim of the present study was to evaluate the pharmacological and non-pharmacological strategies in the treatment of PMS. Materials and Methods Medline, Scopus, Cochrane, EMBASE, and Google Scholar were searched along with SID, Magiran and Irandoc for randomized control trail and non-randomized prospective or retrospective clinical studies published to Dec. 2019 that use Pharmacological and Nonpharmacological treatment for the treatment of PMS in reproductive-age women with PMS. Study selection was done by two reviews. Results Findings of the present study revealed that pharmacological treatment of PMS include lithium and fluoxetine and non-pharmacological treatment include herbal remedies: ginger, fennel, chamomile, lavender, dietary supplements: omega-3 capsules, turmeric, citrus sinensis essential oil, carbohydrate-rich foods, soy, behavioral-psychological therapies, exercise activities such as walking and yoga, and minerals (vitamin E, B6, and calcium). Conclusion PMS treatment includes pharmacological and non-pharmacological strategies. Considering its popularity and fewer complications, non-pharmacological drugs are suggested to improve the symptoms of PMS.

Clinical Efficacy of Photobiomodulation on Dental Implant Osseointegration: A Systematic Review.

Background:Photobiomodulation (PBM) has been shown to have a positive effect on dental implant osseointegration and stability in in vitro and animal studies; however, its usefulness in dental implant clinical practice is yet unclear.Objective:The objective was to assess the clinical effectiveness of PBM on dental implants’ osseointegration.Methods:Two reviewers independently conducted a comprehensive electronic search of articles published from inception up to January 10, 2020, in PubMed, Cochrane Library and Embase databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Randomized clinical trials (RCTs) and nonrandomized clinical studies that compared the effect of PBM on dental implant stability with control groups were included. Animals and in vitro studies studies as well as studies with confounders such as application of orthodontic were excluded. Risk of bias (using Cochrane Risk of Bias tool for RCTs and Risk of Bias in Non-Randomized Studies of Interventions tool for nonrandomized studies) was assessed by both authors. Owing to substantial heterogeneity, only a narrative synthesis of the included studies is presented.Results:Seven relevant clinical studies were included, and they used a variety of PBM parameters and devices. The posterior region of the jaw was found to be more frequently evaluated. For assessing the effect of PBM on implant stability, five studies used resonance frequency analysis and two used periotest; three studies additionally used biomarkers for assessment. Four studies found that PBM has a potential positive effect on the outcome of dental implant stability, whereas three studies reported that PBM has no effect on implant stability.Conclusion:The findings of this systematic review suggest that postoperative application of PBM may potentially have some positive effect on dental implant’s osseointegration and stability. However, additional studies are required with uniformity in methods to provide a more robust assessment of this effect.

Feasibility of a Brazilian samba protocol for patients with Parkinson's disease: a clinical non-randomized study.

To investigate the feasibility of a Brazilian samba protocol in individuals with Parkinson's disease. Twenty participants, mean age of 66.4±10.7 years, diagnosed with idiopathic Parkinson 's disease, divided into: experimental group that received the intervention of Brazilian samba dance classes (10 individuals); and control group that maintained their routine activities (10 individuals). For data collection, a divided questionnaire was used: General Information; Disability stages scale; Balance and Quality of Life. During class implementation, there were no falls, as all dance activities adhered to the details of the protocol steps without any changes. On average, patients completed 82.7% of activities. After 12 weeks, the experimental group had improvements in the UPDRS global score, in daily activities, and on motor examination. There was also improvement in balance scores and in the mobility domain of the quality of life in the experimental group. The samba protocol seems to be feasible and safe for patients with PD. Moreover, it has pleasant characteristics and offers sufficient physical benefits for combination with drug treatment. There were also benefits in social relationships and as a possible rehabilitation tool in individuals with Parkinson's disease.

A Systematic Review of the Efficacy of Aromatherapy on Reducing the Duration of Hospitalization of Preterm Infants

Background: Advances in medical science and nursing care today have led to the survival of preterm infants. Therefore, it is important to address methods to reduce the duration of hospitalization of preterm infants. Aim of the systematic review on the efficacy of aromatherapy on reducing the duration of hospitalization of preterm infants. Materials and Methods: Systemic search of online databases (Medline (via PubMed), Web of Science, Cochrane, International Registry Platform for ongoing trials and clinical trails.gov, and EMBASE complete for randomized control trial and non-randomized prospective or retrospective clinical studies published with no time limit till Feb 2019. Study selection was done by two reviewers. Results: Five studies were included into systematic review. In the first study, 50 infants were divided into odorless and odor-stimulated (by anise or cinnamon) groups. The mean duration of discharge in the olfactory stimulation group was 3.4 days earlier than the odorless group (p=0.12). In the second study, the time spent in the hospital was significantly shorter in the milk-odor (43 days) than control group (55.5 days). In the second study, length of stay in hospital was shorter in premature infants in neonatal intensive care units exposing impregnated pad than control in the fourth study, the result of their study showed olfactory stimulation with vanilla but not rose decreased length of stay in hospital than control group. In the last study, duration of hospitalization was shorter in the Odor of breast milk group in comparison with control group. Conclusion: According to the results of the present study, the olfactory stimulation of preterm infants can be effective in reducing the duration of hospitalization.

Characteristic of Clinical Studies on Baduanjin during 2000-2019: A Comprehensive Review.

To date, a growing number of clinical studies have demonstrated the safety and health benefits from Baduanjin intervention. Based on this, our objective is to systematically retrieve and summarize the clinical studies on Baduanjin, with a view to providing more evidence-based evidence in support of the application of Baduanjin for healthcare, and to identify the shortcomings of existing research and provide feasibility suggest for further clinical research. Both four English language and four Chinese language electronic databases were used to search articles related to Baduanjin during 2000–2019. SPSS 22.0 software was used to analyze the data, and the risk of bias tool in the RevMan 5.3.5 software was used to evaluate the methodological quality of randomized controlled trials. A total of 810 publications were identified, including 43 (5.3%) systematic reviews, 614 (75.8%) randomized controlled trials, 66 (8.1%) nonrandomized controlled clinical studies, 84 (10.4%) case series, and 3 (0.4%) case reports. The top 10 diseases/conditions included diabetes, chronic obstructive pulmonary disease, hypertension, low back pain, neck pain, stroke, coronary heart disease, cognitive impairment, insomnia, and osteoporosis or osteopenia. The style of State General Administration of Sport of China in 2003 was the most commonly used version of Baduanjin, and Baduanjin was practiced with an average of 35 minutes, 1 or 2 times a day, 3–5 days per week, and a 18-week average duration. It is also worth noting that there were no serious adverse events related to Baduanjin intervention. Most studies were small sample size research, and the methodological quality of randomized controlled trials is generally low. The clinical studies of Baduanjin have a substantial quantity and evidence base. However, there are significant differences among different studies in the specific intervention measures such as style, intensity, duration, learning, and practice methods, which need to be further standardized and unified. Further high-quality designed and reporting studies are recommended to further validate the clinical benefits of Baduanjin.

A systematic review and meta-analysis on Bolton's ratios: Normal occlusion and malocclusion.

The purpose of this study was to seek and summarise the Bolton overall index (OI) and anterior index (AI) regarding normal occlusion and Angle's malocclusion according to gender, and to assess if these indices support Bolton's standards as general references. PubMed, LILACS, Embase, CENTRAL and Google Scholar databases were searched up to June 2019 (CRD42018088438). Non-randomised clinical studies, published in English and assessing Bolton's OI and/or AI in normal occlusion and Angle's malocclusion groups, were included. OI and AI means, sample size and SDs were collected. The National Heart, Lung, and Blood Institute's Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was used to assess the risk of bias. Pairwise random-effects and multilevel Bayesian network meta-analyses were used to synthesise available data. Fifty-three observational studies were included (11,411 participants; 3746 men, 4430 women; 15 studies lacked gender information). For normal occlusion, pooled estimates for OI and AI means were 91.78% (95% confidence interval [CI] = 91.42-92.14; I2 = 92.87%) and 78.25% (95% CI = 77.87-78.62; I2 = 90.67%), respectively. We could identify in Angle's Class III patients meaningful OI and AI mean deviations from normal occlusion (0.76, 95% credible interval [CrI] = 0.55-0.98 and 0.61, 95% CrI = 0.35-0.87, respectively), while in Class II patients we found a meaningful mean deviation from normal occlusion only for OI (-0.28, 95% CrI = -0.52--0.05). Concerning gender impact, male patients presented higher OI (0.30, 95% CI = 0.00-0.59) and AI (0.41, 95% CI = 0.00-0.83) mean values than female patients in Class I. Normal occlusion OI and AI mean values differ from Bolton's original values. Class II division 2, for OI mean values, and Class III, for both OI and AI, are proportionally larger than normal occlusion patients. Gender had almost no impact on teeth mesiodistal proportion.

Is Roux-en-Y or Billroth-II reconstruction the preferred choice for gastric cancer patients undergoing distal gastrectomy when Billroth I reconstruction is not applicable? A meta-analysis.

Background:Although Billroth II and Roux-en-Y procedures are the two most commonly performed types of reconstruction techniques following distal stomach resection, there is yet no consensus on which reconstruction is the best choice. This meta-analysis aims to compare the perioperative safety and long-term complications of Billroth-II and Roux-en-Y reconstruction.Method:We searched the databases of the PubMed, the Cochrane Library, Web of Science, EMBASE, and the Chinese Biomedicine Database from January 2000 to January 2018 and included studies that compared Roux-en-Y with Billroth-II reconstruction after distal gastrectomy for gastric cancer. The meta-analyses were performed using RevMan 5.0 software.Result:Four randomized controlled trials (RCTs) and eight non-randomized observational clinical studies (OCS) were included. Billroth-II anastomosis was more beneficial than Roux-en-Y in reducing the operation time (OR = 34.14, 95%CI = 24.19-44.08, P < .00001, I2 = 54%) and intraoperative blood loss (OR = 54.32, 95%CI = 50.29-58.36, P < .00001, I2 = 36%). However, Roux-en-Y anastomosis was more beneficial than Billroth-II in reducing the incidence of remnant gastritis (OR = 0.12; 95% CI = 0.08-0.17; P < .00001; I2 = 8%), reflux esophagitis (OR = 0.26; 95%CI = 0.15-0.44; P < .00001; I2 = 0%), dumping symptoms (OR = 0.31; 95%CI = 0.13-0.73; P = .008; I2 = 0%), reflux symptoms (OR = 0.20; 95% CI = 0.10-0.42; P < .0001; I2 = 0%). No differences were found between the two groups with respect to anastomotic leakage (OR = 1.56, 95%CI = 0.66-3.64, P = .59, I2 = 0%); postoperative mortality (OR = 1.15, 95%CI = 0.38-3.51, P = .80, I2 = 0%); overall postoperative morbidity (OR = 0.92, 95%CI = 0.6-1.42, P = .72, I2 = 0%); and delayed gastric emptying (OR = 0.84, 95%CI = 0.40-1.77, P = .65, I2 = 0%).Conclusion:Roux-en-Y reconstruction does not carry greater postoperative complications than the Billroth II reconstruction. Additionally, it can improve the postoperative quality of life owing to less remnant gastritis, reflux esophagitis, dumping symptoms, and reflux symptoms. Considering the long-term postoperative outcomes, Roux-en-Y reconstruction appears to be a better choice following distal stomach resection.

P4392A systematic review and meta-analysis of the cardiovascular effects of e-cigarette

Abstract Background Electronic cigarette (EC) is marketed as a safe alternative to tobacco smoking, but EC cardiovascular effects remains largely unknown. Purpose To systematically review and meta-analyse published literature to investigate the cardiovascular effects and associated risk from EC use. Methods We searched PubMed from January 2000 until November 2017 for published studies assessing the cardiovascular effects of EC. For each eligible study we used the mean difference (MD) with 95% confidence intervals (CIs) for SBP, DBP and HR. The pooled MDs for each outcome of interest were calculated by using a fixed effects model. The presence of heterogeneity among studies was evaluated by the I2 statistic. Results We report conflicting evidence on the effects of EC on heart rate and blood pressure, which is mainly based on non-randomized clinical studies of moderate quality. In a meta-analysis of 14 studies (n=441 participants), that despite the negative effects of EC on heart rate (pooled MD=2.27, 95% CI: 1.64 to 2.89, p&lt;0.001), diastolic (DBP, pooled MD=2.01mmHg, 95% CI: 0.62 to 3.39, p=0.004) and systolic blood pressure (SBP, pooled MD=2.02mmHg, 95% CI: 0.07 to 3.97, p=0.042), benefits may be observed in terms of blood pressure regulation when switching from tobacco smoking to EC (SBP pooled MD=−7.00, 95% CI: −9.63 to −4.37, p&lt;0.001; DBP pooled MD=−3.65, 95% CI: −5.71 to −1.59, p=0.001). Evidence suggests that EC negatively affects endothelial function, arterial stiffness and the long-term risk for coronary events, but these findings are derived from single study reports and have not been confirmed in additional studies. Conclusions We report adverse effects of EC use on heart rate and blood pressure. Unless supported by stronger evidence, EC should not be labelled as cardiovascular safe products. Future studies should delineate whether EC use is less hazardous to cardiovascular health than conventional cigarette smoking.

Propensity Score Analysis and Its Applications

This review considers casual inference in observational studies which can prove medical treatment. The main aim of this study is to describe about its application in non-randomized clinical studies and in persons who support regulatory applications for marketing medical product. Propensity score makes an easy study about the large number of groups which cannot be randomized. By measuring the covariates, the methods which are used to measure the propensity score mimic the covariates. This study shows an illustration of the steps in the study and construction of propensity scores verses normal treatment of seriously ill individuals. Propensity score has the major advantage over alternate approaches when the treatment methods of illness do not overlap.

A systematic review: Current trends and take rates of cultured epithelial autografts in the treatment of patients with burn injuries.

Several issues persist in clinical translation and application of cultured epithelial autografts during treatment of patients with massive burn injuries. The aim of this systematic review is to determine (1) current practice and trends in clinical application and (2) clinical efficacy of cultured epithelial autografts. A structured literature search was performed in Ovid MEDLINE from 1946 and Ovid EMBASE from 1974 until present. All published peer-reviewed randomized or non-randomized clinical studies, cohort studies, prospective, or retrospective series involving human application of cultured epithelial autografts in the setting of burn injury were included. From 7,267 studies initially identified, 77 studies were included in the analysis. In 96% (74/77) of these series, the sample size was less than 100 patients. In 76.6% (59/77) publications, average burn treated exceeded 40% total body surface area. Overall, cultured epithelial autograft take rates reported in the literature were inconsistent and varied significantly from 0 to 100%. There was a recent trend for co-application of cultured grafts with autologous skin grafts, achieving relatively high and consistent take rates of 73-96%. Results from cultured epithelial autograft application remained unpredictable. This technology remains an adjunct or biological dressing, and not an alternative to conventional split skin graft. However, it has contributed to wound closure and it has been life saving in selected circumstances. Skin tissue engineering should continue as the clinical need for skin replacement is foreseeable into the future.