Rigorous Randomized Controlled Trials Research Articles

Effect of nutrition-based prehabilitation on the postoperative outcomes of patients with esophagogastric cancer undergoing surgery: A systematic review and meta-analysis.

Meta-analyses have primarily focused on the effects of exercise-based prehabilitation on postoperative outcomes and ignored the role of nutritional intervention. In this study, we filled this gap by investigating the effect of nutrition-based prehabilitation on the postoperative outcomes of patients who underwent esophagectomy and gastrectomy. Five electronic databases, namely, PubMed, the Web of Science, Embase, Cochrane Library, and CINAHL, were searched. Adults diagnosed with esophagogastric cancer who were scheduled to undergo surgery and had undergone uni- or multimodal prehabilitation, with at least a week of mandatory nutritional intervention, were included. Forest plots were used to extract and visualize the data from the included studies. The occurrence of any postoperative complication was considered the primary endpoint. Eight studies met the eligibility criteria, with five randomized controlled trials (RCTs) and three cohort studies. In total, 661 patients were included. Any prehabilitation, that is, unimodal (only nutrition) and multimodal prehabilitation, collectively decreased the risk of any postoperative complication by 23% (95% confidence interval [CI] = 0.66-0.90). A similar effect was exclusively observed for multimodal prehabilitation (risk ratio [RR] = 0.78, 95% CI = 0.66-0.93); however, it was not significant for unimodal prehabilitation. Any prehabilitation significantly decreased the length of hospital stay (LOS) (weighted mean difference = -0.77, 95% CI = -1.46 to -0.09). Nutrition-based prehabilitation, particularly multimodal prehabilitation, confers protective effects against postoperative complications after esophagectomy and gastrectomy. Our findings suggest that prehabilitation slightly decreases LOS; however, the finding is not clinically significant. Therefore, additional rigorous RCTs are warranted for further substantiation.

Meta-analysis and trial sequential analysis of Shenshao Capsules in treatment of angina pectoris in coronary heart disease

The efficacy and safety of Shenshao Capsules in combination with conventional western medicine for the treatment of angina pectoris in coronary heart disease were systematically evaluated. Computer search of seven databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library, was conducted to identify randomized controlled trial(RCT) on Shenshao Capsules for the treatment of angina pectoris in coronary heart disease up to December 2023. According to inclusion and exclusion criteria, articles were screened, and data was extracted. Cochrane bias risk assessment tool 2.0(RoB 2.0) was used to evaluate the quality of the included articles. Meta-analysis was performed by RevMan 5.4 and Stata/SE 15.1 software, and evidence quality was rated by the GRADE system. TSA 0.9.5.10 beta software was used for the trial sequential analysis(TSA). Twelve RCTs, with a total of 1 128 participants(567 in the experimental group and 561 in the control group), were included. Meta-analysis showed that Shenshao Capsules + conventional western medicine significantly improved clinical efficacy(RR=1.20, 95%CI[1.15, 1.26], P<0.000 01) and electrocardiogram efficacy(RR=1.16, 95%CI[1.04, 1.30], P=0.01), reduced the frequency of weekly angina pectoris attacks(MD=-2.85, 95%CI[-5.27,-0.43], P=0.02), daily angina pectoris attacks(MD=-0.30, 95%CI[-0.57,-0.03], P=0.03) and the duration of angina pectoris attacks(RR=-2.28, 95%CI[-3.44,-1.12], P=0.000 1). There was no statistically significant difference in adverse reactions between the two groups(RR=1.33, 95%CI[0.71, 2.51], P=0.37). TSA indicated that the cumulative evidence for clinical efficacy exceeded the traditional boundary but did not exceed the TSA boundary, suggesting a potential false positive result. According to GRADE assessment, except for clinical efficacy, which was rated as low-quality evidence, the remaining outcomes were rated as very low-quality evidence. The results indicate that Shenshao Capsules + conventional western medicine may have certain advantages in improving clinical efficacy and electrocardiographic efficacy, reducing the frequency and duration of angina pectoris attacks. However, due to the limitations of this study, more rigorous and high-quality RCT is needed to validate its efficacy and safety.

It's never too late to be financially literate: Evaluating a financial education intervention for adults in Italy

AbstractFinancial education represents a powerful tool for improving economic literacy of citizens. This paper presents results from an experiment providing a group of 136 workers in an Italian university (administrative staff) an online, synchronous course. Classes were organized in 5 sessions of 2h each and covered basic topics about personal finance. The effectiveness of the course is assessed through a rigorous randomized controlled trial (RCT). In addition to the analysis of improvements in financial knowledge, financial self‐efficacy and the role of prior attitudes and behaviors were explored. Participants obtained post‐test scores statistically higher than individuals in the control group, with an average effect size of 0.55 SD. The effect is particularly relevant for participants starting with low levels of financial knowledge. Moreover, two novel findings emerge: financial self‐efficacy increases (0.51 SD) after the course, and pre‐treatment individuals' financial attitudes and behaviors shed further light on the financial learning process.

Factor Xa inhibitors versus low-molecular-weight heparin for preventing coagulopathy following COVID-19: a systematic review and meta-analysis of randomized controlled trials.

Hospitalized patients with COVID-19 have shown a significant occurrence of thromboembolism and a heightened risk of death. It remains unclear whether factor Xa inhibitors are superior to enoxaparin in this context. Hence, there is a need for a direct comparison to assess the preventive effects and safety of factor Xa inhibitors versus enoxaparin in hospitalized COVID-19 patients. MEDLINE, Embase, and Cochrane Central databases were searched for randomized controlled trials (RCTs) or retrospective studies that compared the effectiveness or safety of factor Xa inhibitors and enoxaparin in preventing thromboembolism in hospitalized patients with COVID-19. Embolic incidence, incidence of bleeding, and all-cause mortality were among the outcomes of interest. Mantel-Haenszel weighted random-effects model was used to calculate relative risks (RRs) with 95 percent CIs. The analysis included six RCTs and two retrospective studies containing 4048 patients. Meta-analysis showed a statistically significant reduction among patients on factor Xa inhibitors compared with low-molecular-weight heparin (LMWH) in the embolic incidence [risk ratio (RR) 0.64 (95%, CI 0.42, 0.98); P=0.04, I2=12%]. Upon subgroup analysis by type of study design, no significant reductions were noted in patients on factor Xa inhibitors in RCTs (RR: 0.62; 95% CI: 0.33-1.17; P=0.14) or observational studies (RR: 0.53; 95% CI: 0.23-1.26; P=0.15) when compared with enoxaparin Factor Xa inhibitors were not significantly associated with incidence of bleeding [RR 0.76 (95% CI 0.36, 1.61); P=0.47, I2=0%] or all-cause mortality (RR: 0.81; 95% CI: 0.48-1.36; P=0.43). Consistent results were obtained upon subgroup analysis by the type of study design. Factor Xa inhibitors are more effective than enoxaparin in preventing thromboembolism among patients with COVID-19 who are not acutely ill and are hospitalized. Additional rigorous RCTs comparing factor Xa inhibitors with enoxaparin are warranted.

Effects of Hyperbaric Oxygen Therapy on Long COVID: A Systematic Review.

The coronavirus disease (COVID-19) pandemic has resulted in an increasing population that is experiencing a wide range of long-lasting symptoms after recovery from the acute infection. Long COVID refers to this specific condition and is associated with diverse symptoms, such as fatigue, myalgias, dyspnea, headache, cognitive impairment, neurodegenerative symptoms, anxiety, depression, and a sense of despair. The potential of hyperbaric oxygen therapy (HBOT) to improve chronic fatigue, cognitive impairments, and neurological disorders has been established; therefore, the use of HBOT to treat long COVID has also been studied. We conducted a literature search between 1 January 2019 and 30 October 2023, focusing on the clinical efficacy and utility of HBOT for treating long COVID and found ten clinical studies that fit the review topic, including one case report, five one-group pretest-posttest design studies, one safety report from a randomized controlled trial (RCT), and three complete reports of RCTs. Most studies found that HBOT can improve quality of life, fatigue, cognition, neuropsychiatric symptoms, and cardiopulmonary function. Although HBOT has shown some benefits for long COVID symptoms, further rigorous large-scale RCTs are required to establish precise indications, protocols, and post-treatment evaluations.

Comparison of the Effects of Lidocaine and Amiodarone on Patients With Cardiac Arrest: A Systematic Review and Meta-Analysis.

The objective of this study was to compare the impact of amiodarone and lidocaine on survival and neurological outcomes following cardiac arrest.A systematic review of randomized controlled trials (RCTs) as well as cohort and cross-sectional trials was undertaken, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Potential relevant studies were searched in databases, including PubMed, Embase, Cochrane Library, and Web of Science, from the beginning of databases to February 15, 2024.Outcomes assessed in this study were survival to hospital discharge, survival to hospital admission or 24 hours, favorable neurological outcomes, and return of spontaneous circulation (ROSC). A total of seven studies (five observational and two RCTs) were included in this meta-analysis encompassing 19,081 patients with cardiac arrest. Pooled analysis showed no difference between amiodarone and lidocaine in terms of survival to hospital discharge(odds ratio (OR): 0.88, 95% confidence interval (CI): 0.75 to 1.04), ROSC (OR: 0.94, 95% CI: 0.84 to 1.05, p-value: 0.25), favorable neurological outcomes(OR: 0.88, 95% CI: 0.66 to 1.17, p-value: 0.38), and survival to 24 hours(OR: 0.82, 95% CI: 0.55 to 1.21, p-value: 0.31).While lidocaine demonstrated a slight survival advantage, the differences were statistically insignificant. Similarly, no significant variations were observed in ROSC incidence, neurological outcomes, or survival at 24 hours. These findings align with current guidelines but underscore the necessity for further rigorous RCTs to provide conclusive recommendations.

Validation of a New Sham Acupuncture Needle for Double-Blind Trials: A Study Protocol

Background: To establish efficacy in acupuncture treatment, rigorous randomized controlled trials (RCT) are needed. Non-invasive sham acupuncture needles are an effective tool for practitioner/participant blinding. This study presents a protocol for the validation of a newly developed sham acupuncture needle.Methods: A double-blind RCT will be conducted on 66 healthy adults who will be randomly assigned (using computer-generated random numbers) to either the verum (<i>n</i> = 33) or sham (<i>n</i> = 33) acupuncture needle group. The needles will be inserted at 2 acupuncture points: LI4 (upper limb) and ST36 (lower limb). The primary outcome measure is the practitioner/participants belief that they received verum or sham acupuncture. The secondary outcome measures are participant-rated sensations (penetration, pain, and de qi). Adverse events will be recorded with detailed explanations, categorizing occurrences according to related or unrelated to acupuncture. As the newly developed sham acupuncture has not been studied before, an exploratory approach has been adopted. Descriptive statistics, t test, and χ² test will be applied appropriately.Results: This study is intended to provide a protocol for the validation of a sham acupuncture needle by using a double-blind RCT setting, and the results will hopefully contribute to the standardization of the needles used for sham acupuncture. The outcomes aim to determine the reliability of practitioner/participant blinding, participant experience of sensations, and lay groundwork for a standardized control group for clinical trials in the future. The newly developed non-invasive sham acupuncture needle may reduce bias and improve reliability in the size effect of acupuncture treatment.

Efficacy and safety of the Valsalva maneuver in relieving venipuncture pain in children and adults: A systematic review and meta-analysis.

Venipuncture is a common invasive clinical procedure, and pain management during puncture has been of interest to healthcare professionals. The purpose of this systematic review and meta-analysis was to evaluate the efficacy and safety of the Valsalva maneuver (VM) for the relief of venipuncture pain in children and adults. PubMed, Embase, Web of Science, Cochrane Library, CNKI, Wanfang, VIP database, and CBM were searched from inception to December 2023 for all available randomized controlled trials (RCTs) that evaluated the impact of VM on venipuncture. Two reviewers independently performed study selection, data extraction, and risk of bias assessment. Continuous variables were analyzed by mean differences (MD) or standardized mean differences (SMD), whereas dichotomous variables were analyzed by risk ratios (RR). A total of 22 studies involving 1740 participants were included. The pooled results showed that VM relieved pain intensity during venipuncture in children (SMD = -0.89, 95% CI = -1.47 to -0.30, p = 0.003) and adults (SMD = -1.11, 95% CI = -1.46 to -0.77, p < 0.00001), reduced anxiety intensity (SMD = -1.07, 95% CI = -1.68 to -0.47, p = 0.0005), and shortened puncture time (MD = -13.52, 95% CI = -21.14 to -5.90, p = 0.0005). There was no significant difference in the success rate of venous cannulation, MAP, HR, or incidence of adverse events in subjects who performed VM compared to controls. VM was an effective and safe method of pain management that reduced pain intensity during venipuncture in children and adults without significant adverse effects. The results of this meta-analysis need to be further validated by more rigorous and larger RCTs.

Efficacy of physical exercise intervention on children with acute lymphoblastic leukemia during treatment and rehabilitation: a systematic review and meta-analysis.

To systematically evaluate the impact of physical exercise intervention on children with acute lymphoblastic leukemia (ALL) during the treatment and rehabilitation consolidation periods. Randomized controlled trials (RCTs) were retrieved from PubMed, Scopus, Web of Science, CNKI, and Cochrane databases, with a search time range from database establishment to September 1, 2023. The quality of the included RCTs was evaluated using the Cochrane risk assessment tool, and a systematic evaluation was conducted using RevMan 5.4. The study has been registered with INPLASY (registration number: 202390100). A total of 12 RCTs including 423 subjects was included. The meta-analysis results showed that long-term exercise intervention can effectively improve the endurance performance (SMD = 1.37, 95% CI 0.45 to 2.29, p = 0.004), functional mobility (MD = - 1.17, 95% CI - 1.85 to - 0.49, p = 0.0008), cancer-related fatigue (CRF) (MD = - 1.25, 95% CI - 1.69 to - 0.80, p < 0.00001), and quality of life (QOL) (MD = 4.93, 95% CI 1.80 to 8.05, p = 0.002) of ALL children during the treatment and rehabilitation consolidation periods. Its promoting effect on the muscle strength (SMD = 0.53, 95% CI - 0.33 to 1.39, p = 0.23) and bone mineral density (BMD) (SMD = 0.48, 95% CI 0.20 to 0.77, p = 0.05) of the subjects was not significant. Further meta-analysis showed that exercise intervention with a duration of less than 1year (SMD = 0.91, 95% CI 0.55 to 1.28, p < 0.00001) rather than more than 1year (SMD = - 0.16, 95% CI - 0.61 to 0.29, p = 0.49) can effectively reduce subject BMD, while in terms of strength, exercise intervention can effectively improve strength during the treatment period (SMD = 0.97, 95% CI 0.40 to 1.54, p = 0.0008) rather than the consolidation period (SMD = - 0.27, 95% CI - 1.08 to 0.53, p = 0.51). Long-term regular exercise can effectively improve the endurance, functional mobility, CRF, and QOL of children with ALL in the rehabilitation and treatment consolidation stages. Their strength and BMD may be influenced by the timing of treatment and the intervention cycle, respectively. Considering the limited number of included literature and the instability of some outcome indicators, it is necessary to design more comprehensive and rigorous high-quality RCTs in the future to test the exercise efficacy of ALL children.

Comparative efficacy of different growth hormone supplementation protocols in improving clinical outcomes in women with poor ovarian response undergoing assisted reproductive therapy: a network meta-analysis

Growth hormone (GH) has a long-standing history of use as an adjunctive therapy in the treatment of poor ovarian response (POR), but the optimal dosage and timing remains unclear. The aim of this study was to evaluate and compare the efficacy of different GH supplementation protocols through a network meta-analysis (NMA) and determine the optimal treatment protocol. This study was reported based on the Preferred Reporting Items for Systematic Reviews for Network Meta-Analysis (PRISMA-NMA) statement. Databases including PubMed, Web of Science, Cochrane Library and Embase were searched until June 2023. A total of 524 records were retrieved in our search, and 23 clinical studies comprising 4889 cycles were involved. Seven different GH protocols were identified. Results showed that compared to the control group, daily administration of 4–8 IU of GH during the follicular phase of the stimulation cycle had the best comprehensive therapeutic effects on improving the number of retrieved oocytes, mature oocytes, endometrial thickness, and reducing gonadotropin requirements in POR patients undergoing assisted reproductive therapy, with a relatively brief treatment duration and a moderate total GH dose. Subgroup analysis demonstrated that this protocol could significantly improve the clinical pregnancy rate of POR patients in the randomized controlled trials (RCT) subgroup and the African subgroup. Therefore, its clinical application is suggested. Besides, the potential advantages of long-term GH supplementation protocol (using GH for at least 2 weeks before oocyte retrieval) has merit for further research. Rigorous and well-designed multi-arm RCTs are needed in the future to confirm the conclusions drawn from this study.

Effects of mHealth-Based Lifestyle Interventions on Gestational Diabetes Mellitus in Pregnant Women With Overweight and Obesity: Systematic Review and Meta-Analysis.

The increasing incidence of gestational diabetes mellitus (GDM) is a global health problem that is more likely to occur in pregnant women with overweight or obesity. Adhering to a healthy lifestyle is associated with a reduced risk of GDM. With the development of IT, mobile health (mHealth) interventions have become widely available in health care. However, there are no definitive conclusions on the effectiveness of mHealth-based lifestyle interventions in preventing GDM. This study aims to evaluate the impact of mHealth-based lifestyle interventions on GDM and other pregnancy outcomes in pregnant women with overweight or obesity. A systematic literature search was conducted in 5 English databases (MEDLINE, Embase, Web of Science, CENTRAL, and CINAHL) and 4 Chinese databases (CBM, CNKI, Vip, and Wanfang) to identify randomized controlled trials (RCTs) on the effectiveness of mHealth-based interventions for GDM from inception to January 10, 2023. In total, 2 authors independently screened the studies and extracted the data. The quality of the included studies was examined using the Cochrane risk-of-bias tool. Data synthesis was conducted using Review Manager (version 5.4; The Cochrane Collaboration). A total of 16 RCTs with 7351 participants were included in this study. The included studies were published between 2014 and 2021 and were conducted in China, the United States, Australia, New Zealand, the United Kingdom, Ireland, and Norway. The sample sizes of the studies ranged from 75 to 2202, and the duration of the mHealth-based lifestyle interventions ranged from 4 to 28 weeks. Compared with usual care, mHealth-based lifestyle interventions significantly reduced the incidence of GDM (odds ratio [OR] 0.74, 95% CI 0.56-0.96; P=.03; I2=65%), preterm birth (OR 0.65, 95% CI 0.48-0.87; P=.004; I2=25%), macrosomia (OR 0.59, 95% CI 0.40-0.87; P=.008; I2=59%), and gestational weight gain (mean difference=-1.12 kg, 95% CI -1.44 to -0.80; P<.001; I2=43%). The subgroup analysis showed that interventions delivered via apps (OR 0.55, 95% CI 0.37-0.83; P=.004; I2=44%), provided by obstetricians (OR 0.69, 95% CI 0.51-0.93; P=.02; I2=60%), and targeted at Asian populations (OR 0.44, 95% CI 0.34-0.58; P<.001; I2=0%) and that used the International Association of Diabetes and Pregnancy Study Groups diagnostic criteria (OR 0.58, 95% CI 0.39-0.86; P=.007; I2=69%) showed a statistically significant reduction in the risk of GDM. mHealth-based lifestyle interventions had a favorable impact on the prevention of GDM in pregnant women with overweight and obesity. Future studies need to further explore the potential of mHealth-based interventions for GDM through better design and more rigorous large-scale RCTs. PROSPERO International Prospective Register of Systematic Reviews CRD42021286995; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286995.

Effectiveness and Safety of Chinese Herbal Injections Combined with SOX Chemotherapy Regimens for Advanced Gastric Cancer: a Bayesian Network Meta-Analysis.

Background: Randomized controlled trials (RCTs) have demonstrated that combining Chinese herbal injections (CHIs) with oxaliplatin plus tegafur (SOX) chemotherapy regimens improves clinical effectiveness and reduces adverse reactions in patients with advanced gastric cancer (AGC). These RCTs highlight the potential applications of CHIs and their impact on AGC patient prognosis. However, there is insufficient comparative evidence on the clinical effectiveness and safety of different CHIs when combined with SOX. Therefore, we performed a network meta-analysis to rank the clinical effectiveness and safety of different CHIs when combined with SOX chemotherapy regimens. This study aimed to provide evidence for selecting appropriate CHIs in the treatment of patients with AGC. Methods: We searched eight databases from their inception until March 2023. Surface Under the Cumulative Ranking Curve (SUCRA) probability values were used to rank the treatment measures, and the Confidence in Network Meta-Analysis (CINeMA) software assessed the grading of evidence. Results: A total of 51 RCTs involving 3,703 AGC patients were identified. Huachansu injections + SOX demonstrated the highest clinical effectiveness (SUCRA: 78.17%), significantly reducing the incidence of leukopenia (93.35%), thrombocytopenia (80.19%), and nausea and vomiting (95.15%). Shenfu injections + SOX improved Karnofsky's Performance Status (75.59%) and showed a significant reduction in peripheral neurotoxicity incidence (88.26%). Aidi injections + SOX were most effective in reducing the incidence of liver function damage (75.16%). According to CINeMA, most confidence rating results were classified as "low". Conclusion: The combination of CHIs and SOX shows promising effects in the treatment of AGC compared to SOX alone. Huachansu and Shenfu injections offer the greatest overall advantage among the CHIs, while Aidi injections are optimal for reducing the incidence of liver damage. However, further rigorous RCTs with larger sample sizes and additional pharmacological studies are necessary to reinforce these findings.

The effectiveness of Baduanjin on metabolic syndrome: An overview of systematic reviews and meta‐analyses

AbstractObjectiveThis meta‐analysis evaluated the effects of Baduanjin on the metabolic status of individuals with metabolic syndrome (MetS). The aim was to identify effective interventions for MetS prevention and treatment.MethodsWe conducted a comprehensive search of English (PubMed, Embase, Web of Science, and Cochrane Library) and Chinese (CNKI, Wanfang, Chinese Biomedical Database, VIP) databases till August 19, 2022. Randomized controlled trials (RCTs) focusing on Baduanjin for MetS patients were included. Data were pooled and assessed using the Cochrane risk‐of‐bias tool. The Grades of Recommendation, Assessment, Development, and Evaluation for Systematic Reviews was used to evaluate literature quality.ResultsEight RCTs involving 435 participants were included. Baduanjin showed significant improvements in fasting blood glucose (mean difference [MD] = −0.41, 95% confidence interval [CI] [−0.22, −0.61], p &lt; 0.0001) and glycated hemoglobin levels (MD = −0.99, 95% CI [−0.38, −1.60], p &lt; 0.00001). Waist‐to‐hip ratio (MD = −0.04, 95% CI [−0.03, −0.06], p = 0.002), body mass index (MD = −1.60, 95% CI [−0.10, −3.10], p = 0.04), fasting insulin (MD = −4.82, 95% CI [−0.15, −8.59], p = 0.01), systolic blood pressure (MD = −7.16, 95% CI [−5.16, −9.17], p &lt; 0.00001), diastolic blood pressure (MD = −3.43, 95% CI [−0.62, −6.24], p = 0.02), total cholesterol (MD = −0.48, 95% CI [−0.10, −0.85], p = 0.01), triglycerides (MD = −0.39, 95% CI [−0.14, −0.64], p = 0.003), and low‐density lipoprotein cholesterol (MD = −0.52, 95% CI [−0.10, −0.94], p = 0.01) also significantly improved. No adverse events were reported. Literature quality ranged from very low to moderate.ConclusionsBaduanjin effectively improves metabolic status in individuals with MetS, including blood glucose, lipid profile, obesity‐related indicators, insulin levels, and blood pressure. However, the overall literature quality is moderate to low. Further rigorous RCTs are needed to explore Baduanjin's effects on MetS, considering intervention methods, content, and research methodologies.

The effect of traditional Chinese medicine rehabilitation exercise (pulmonary Daoyin) in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis

Objective: Previous research has demonstrated that pulmonary Daoyin could be an efficacious way to ameliorate the physical and psychological state of sufferers with chronic obstructive pulmonary disease (COPD) and bolster the quality of life. However, the results are not consistent. Thus, the objective of this research is to assess the impacts of pulmonary Daoyin in individuals with COPD. Methods: Relevant articles were searched in Web of Science, Cochrane Library, PubMed, EMBASE, SinoMed, CNKI, Wanfang, and VIP from database inception to January 2024. Results: There were a total of 15 randomized controlled trials (RCTs) included in this meta-analysis involving 1732 patients, of which 864 participated in the intervention group and 868 in the control group. When comparing with the control group, the COPD patients practicing pulmonary Daoyin demonstrated a significant improvement in 6 min walking distance (mean difference [MD] = 24.53, 95% confidence interval [CI] [18.55, 30.52], P &lt;0.00001), forced expiratory volume in the 1 s (FEV1) (MD = 0.39, 95% CI [0.18, 0.59], P = 0.0002), percentage of FEV1 to the predicted value (FEV1%) (MD = 5.35, 95% CI [3.22, 7.48], P &lt; 0.0001), the forced vital capacity (FVC) (MD = 0.39, 95% CI [0.06, 0.73], P = 0.02), percentage of FVC to the predicted value (FVC%) (MD = 7.52, 95% CI [4.91, 10.13], P &lt; 0.00001), the ratio of FEV1/FVC (MD = 4.95, 95% CI [0.91, 8.99], P = 0.02), peak expiratory flow rate (standardized MD = 0.98, 95% CI [0.74, 1.22], P &lt; 0.00001), modified Medical Research Council (mMRC) scale (MD= −0.47, 95% CI [−0.89, −0.04], P=0.03), and Borg scale (MD =−0.65, 95% CI [−0.75, −0.55], P &lt; 0.00001). Conclusions: Our findings may illuminate the influence of pulmonary Daoyin on exercise ability, breathlessness, and pulmonary function in COPD patients. More rigorous RCTs with larger samples and longer-term interventions will be required moving forward.

Mechanism of traditional Chinese medicine in elderly diabetes mellitus and a systematic review of its clinical application.

Objective: Affected by aging, the elderly diabetes patients have many pathological characteristics different from the young people, including more complications, vascular aging, cognitive impairment, osteoporosis, and sarcopenia. This article will explore their pathogenesis and the mechanism of Traditional Chinese medicine (TCM) intervention, and use the method of systematic review to evaluate the clinical application of TCM in elderly diabetes. Method: Searching for randomized controlled trials (RCTs) published from January 2000 to November 2023 in the following databases: Web of Science, Pubmed, Embase, Cochrane Library, Sinomed, China National Knowledge Internet, Wanfang and VIP. They were evaluated by three subgroups of Traditional Chinese Prescription, Traditional Chinese patent medicines and Traditional Chinese medicine extracts for their common prescriptions, drugs, adverse reactions and the quality of them. Results and Conclusion: TCM has the advantages of multi-target and synergistic treatment in the treatment of elderly diabetes. However, current clinical researches have shortcomings including the inclusion of age criteria and diagnosis of subjects are unclear, imprecise research design, non-standard intervention measures, and its safety needs further exploration. In the future, the diagnosis of elderly people with diabetes needs to be further clarified. Traditional Chinese patent medicines included in the pharmacopoeia can be used to conduct more rigorous RCTs, and then gradually standardize the traditional Chinese medicine prescriptions and traditional Chinese medicine extracts, providing higher level evidence for the treatment of elderly diabetes with traditional Chinese medicine.

Efficacy and safety of mesenchymal and haematopoietic stem cells in secondary progressive multiple sclerosis: a systematic review and meta-analysis

Abstract Introduction Multiple sclerosis (MS) is a devastating, immune-mediated disease of the central nervous system (CNS)1. Despite extensive research, there is still no known definitive cure for MS1. Disease modifying therapies (DMTs) currently available are primarily approved for relapsing remitting multiple sclerosis (RRMS) and show limited evidence of efficacy in secondary progressive multiple sclerosis (SPMS). Moreover, DMTs do not halt disease progression or promote CNS repair2. In contrast, mesenchymal stem cells (MSCs) and haematopoietic stem cells (HSCs) have emerged as potential therapeutic approaches and have exhibited promising outcomes in MS clinical trials3. Aim The aim of this systematic review and meta-analysis was to assess the effectiveness and safety of MSCs and HSCs in the treatment of the SPMS sub-type. Methods A systematic search of PubMed, Web of Science, and Cochrane Library databases was conducted to identify eligible studies published from 1971 to 2022. Included studies focused specifically on SPMS and investigated MSC or HSC therapies. The systematic search identified 854 studies, following screening, fifteen studies (systematic review n = 15, meta-analysis n = 14) met the inclusion criteria, comprising 8 MSC studies and 7 HSC studies. The primary outcome measure was the expanded disability status scale (EDSS). Ethics approval was not deemed necessary for this research, as it falls within the scope of systematic reviews and meta-analyses. Results The study revealed a significant difference between baseline and final follow-up disability scores (EDSS) in the included studies [random-effects, MD = -0.17, 95%CI (-0.28, -0.06), P = 0.002, I2 = 29%]. The experimental groups showed a significant improvement in EDSS scores compared to the control group [random-effects, MD = -0.38, 95%CI (-0.66, -0.09), P = 0.01, I2 = 59%]. No statistically significant difference in efficacy was observed between MSCs and HSCs (unequal variance t-test, P = 0.73). Moderate adverse events were predominantly associated with MSC studies, while HSC studies reported more hospitalizations and three deaths. Discussion/Conclusion MSC and HSC transplantation demonstrated efficacy in improving the clinical course of SPMS. MSCs were found to have a moderate safety profile, while HSCs raised concerns due to the higher incidence of hospitalizations and fatalities. Additional investigations are necessary to further consolidate and establish the safety profile of HSCs. Despite the positive outcomes observed in the clinical trials, larger and more rigorous randomized controlled trials (RCTs) are needed to draw definitive conclusions regarding the therapeutic efficacy of these therapies. The limited number of RCTs represents a significant limitation of this study.

How to Conduct a Randomized Controlled Trial.

Randomized controlled trials (RCTs) are considered to produce the highest level of evidence in the original studies that informs the practice of evidence-based medicine (EBM). By manipulating an independent variable to study its impact on the outcome, RCTs establish causal relationships and provide valuable insights into clinical treatment. To improve patient outcomes and optimize the use of clinical resources, the practice of EBM plays a crucial role in designing and conducting RCTs to evaluate the effectiveness of clinical interventions. This review aims to explore the essential steps involved in conducting a rigorous and reliable RCT, ensuring the generation of high-quality evidence.

Effect of Tai-chi on balance, mood, cognition, and quality of life in women with multiple sclerosis: A one-year prospective study

IntroductionOne of the most debilitating problems encountered by people with multiple sclerosis (MS) is the loss of balance and coordination. Our study aimed to comprehensively evaluate the effectiveness of one year of Tai-chi exercise in patients with MS using both subjective and objective methods, including posturography. MethodsThis was a single-group longitudinal one-year study performed from the 1st of January 2019 to the 1st of January 2020. The primary outcomes of interest were the Mini-Balance Evaluation Systems Test (Mini-BESTest) and static posturography measures as objective methods to detect subtle changes associated with postural control/balance impairment. Secondary outcomes were measures of depression, anxiety, cognitive performance, and quality of life. All objective and subjective parameters were assessed four times: at baseline, and after three, six and 12 months of regular Tai-chi training. The difference was calculated as a subtraction of baseline values from every timepoint value for each measurement. If the normality test was passed, parametric one-sample t-test was used, if failed, Wilcoxon signed ranks test was used to test the difference between the baseline and each timepoint. Alpha was set to 0.017 using Bonferroni correction for multiple comparisons. ResultsOut of 25 patients with MS enrolled, 15 women with MS (mean age 44.27 years) were included for statistical analyses after completing the 12-month program. After 12 months, significant improvements were found in all objective balance and gait tests: Mini-BESTest (p<0.001), static posturography measures (total area of the centre of foot pressure – TA; p = 0.015), 25 Feet Walk Test (25FWT; p = 0.001), anxiety (Beck Anxiety Inventory – BAI; p = 0.005) and cognition tests (Paced Auditory Serial Addition Test – PASAT; p = 0.003). Measures of depression (Beck Depression Inventory – BDI; p = 0.071), cognition (Symbol Digit Modalities Test – SDMT; p = 0.079), and health-related quality of life (European Quality of Life 5-Dimensions Questionnaire – EQ-5D-5L; p = 0.095) showed a trend of improvement but were not significant, which could be the result of a small sample and increased bias due the type II error. ConclusionAccording to these preliminary results, this study indicates the possible beneficial effects of long-term Tai-chi training on patients with MS. Although these findings need to be confirmed by further studies with a larger sample of participants of both genders and require more rigorous randomized controlled trials (RCT) design, our findings support the recommendation of regular and long-term Tai-chi exercise in patients with MS. ClinicalTrials.gov Identifier (retrospectively registered): NCT05474209

Efficacy and safety of acupuncture combined with rehabilitation training for poststroke cognitive impairment: A systematic review and meta-analysis

BackgroundAccumulated evidence has proven that both acupuncture and rehabilitation therapy are beneficial for stroke sequelae. However, there is no systematic review to identify the efficacy and safety of acupuncture combined with rehabilitation training for poststroke cognitive impairment (PSCI). Therefore, the aim of this study was to assess the efficacy and safety of acupuncture combined with rehabilitation therapy for patients with PSCI. MethodsWe searched nine databases, including PubMed, Embase, Scopus, Web of Science, EBSCO, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), and Wan Fang, from their inception to September 2022. Randomized controlled trials (RCTs) examining the effect of acupuncture combined with rehabilitation on PSCI were included. The primary outcomes were the Mini-Mental State Examination (MMSE) score, Montreal Cognitive Assessment (MoCA) score, Modified Barthel Index (MBI) score, and Fugl-Meyer Assessment (FMA) score. The quality of the methodology was evaluated by Cochrane's risk of bias tool. Meta-analyses were performed by Revman 5.3 software. ResultsA total of 18 RCTs involving 1654 patients were included. The overall methodological quality of the included studies was low. Pooled results demonstrated that acupuncture combined with rehabilitation could significantly improve the clinical efficacy of PSCI (OR=3.23, 95% CI: 2.13 to 4.89), MMSE score (MD= 2.85, 95% CI: 2.56 to 3.15), MoCA score (MD= 2.18, 95% CI: 1.38 to 2.97), MBI score (MD= 9.23, 95% CI: 5.62 to 12.84), and FMA score (MD=5.72, 95% CI: 3.48 to 7.96). ConclusionsAcupuncture combined with rehabilitation may produce better outcomes than rehabilitation alone in the treatment of PSCI. However, the safety of combined interventions is still unclear. Therefore, research with more rigorous study designs and RCTs with larger sample sizes is still needed.

Aspiration and sclerotherapy versus hydrocelectomy for treating hydroceles: a systematic review and meta-analyses.

In this meta-analysis, we aimed to compare the hydrocelectomy versus aspiration and sclerotherapy for treating primary hydrocele. We included randomized controlled trials (RCTs) and quasi-RCTs that compared aspiration and sclerotherapy with any type of sclerosants versus hydrocelectomy for primary hydrocele. Studies were identified via a systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and ClinicalTrials.gov. Citation tracking of related articles was performed. Data extraction and quality assessment were performed independently by two authors. The primary and secondary outcome measures were compared and analyzed using the Review Manager 5.3.5 software. Five small RCTs were included in the present study. These 5 RCTs included 335 patients with 342 hydroceles, randomized to aspiration and sclerotherapy (185 patients; 189 hydroceles) and surgery (150 patients; 153 hydroceles). There was no significant difference in clinical cure between sclerotherapy and hydrocelectomy (RR 0.45, 95% CI 0.18 to 1.10). Meta-analysis revealed a significant increase in recurrence in the sclerotherapy group compared with the surgical group (RR 9.43, 95% CI 1.82 to 48.77). There were no significant differences between the two groups in assessing fever, infection, and hematoma. Aspiration and sclerotherapy is an efficient technique with a higher recurrent rate; therefore, we recommend aspiration and sclerotherapy for patients at high risk for surgery or avoiding surgery. In addition, included RCTs had low methodological quality, low sample size, and invalidated instrumentsfor outcome assessment. Therefore, there is a great need for further methodologically rigorous RCTs with the registered protocol.