OBJECTIVES: To assess the effect of psychological interventions on psychological morbidities and quality of life among women with non-metastatic breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov up to 16 March 2021. We also scanned the reference lists of relevant articles.
SELECTION CRITERIA: Randomised controlled trials that assessed the effectiveness of psychological interventions for women with non-metastatic breast cancer.
DATA COLLECTION AND ANALYSIS: Two review authors independently appraised, extracted data from eligible trials, and assessed risk of bias and certainty of the evidence using the GRADE approach. Any disagreement was resolved by discussion. Extracted data included information about participants, methods, the intervention and outcomes.
MAIN RESULTS: We included 60 randomised controlled trials comprising 7998 participants. The most frequent reasons for exclusion were non-randomised trials and the inclusion of women with metastatic disease. The updated review included 7998 randomised women; the original review included 3940 women. A wide range of interventions was evaluated. Most interventions were cognitive- or mindfulness-based, supportive-expressive, and educational. The interventions were mainly delivered face-to-face (56 studies) and in groups (50 studies) rather than individually (10 studies). Most intervention sessions were delivered on a weekly basis with an average duration of 14 hours. Follow-up time ranged from two weeks to 24 months. Pooled standardised mean differences (SMD) from baseline indicated that the intervention may reduce depression (SMD -0.27, 95% confidence interval (CI) -0.52 to -0.02; P = 0.04; 27 studies, 3321 participants, I2 = 91%, low-certainty evidence); anxiety (SMD -0.43, 95% CI -0.68 to -0.17; P = 0.0009; 22 studies, 2702 participants, I2 = 89%, low-certainty evidence); mood disturbance in the intervention group (SMD -0.18, 95% CI -0.31 to -0.04; P = 0.009; 13 studies, 2276 participants, I2 = 56%, low-certainty evidence); and stress (SMD -0.34, 95% (CI) -0.55 to -0.12; P = 0.002; 8 studies, 564 participants, I2 = 31%, low-certainty evidence). The intervention is likely to improve quality of life in the intervention group (SMD 0.78, 95% (CI) 0.32 to 1.24; P = 0.0008; 20 studies, 1747 participants, I2 = 95%, low-certainty evidence). Adverse events were not reported in any of the included studies.
AUTHORS' CONCLUSIONS: Based on the available evidence, psychological intervention may have produced favourable effects on psychological outcomes, in particular depression, anxiety, mood disturbance and stress. There was also an improvement in quality of life in the psychological intervention group compared to control group. Overall, there was substantial variation across the studies in the range of psychological interventions used, control conditions, measures of the same outcome and timing of follow-up.
OBJECTIVE: This review aimed to assess the influence of tai chi on postural stability and quality of life in older adults with abnormal gait.
METHOD: According to the literature retrieval principles, the works published from the inception date to May 2023 were retrieved, including the following databases: PubMed, Scopus, Web of Science, China National Knowledge Infrastructure, EBSCOhost, and Google Scholar. Subsequently, literature screening and quality assessment were performed.
RESULTS: A total of 16 randomized controlled trials were included in this study, Tai Chi intervention can affect populations with Parkinson's disease (PD), no exercise, mild cognitive impairment (MCI), chronic stroke, sedentary, fear of falling, or history of falling. Postural instability is associated with balance, gait, the Unified Parkinson's Disease Rating Scale Motor Subscale 3 (UPDRS III), mobility, lower body strength, and falls. Only two articles looked at quality of life. The Yang style is the most commonly used in the intervention. Nonetheless, most studies were performed on female participants, hence, more research on older male populations is needed.
CONCLUSION: Tai Chi intervention benefits postural balance in patients with gait disorders. 12 weeks is the most common intervention period for patients with gait disorders. The frequency of intervention is seven articles twice a week, and the intervention time is about 60 minutes. The Tai Chi intervention methods in this study involve Yang Style, Sun Style, Taoist Tai Chi, and Health Qigong Tai Chi, but the Yang Style Tai Chi intervention is the most widely used.
MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit.
DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus.
TRIAL REGISTRATION NUMBER: NCT04829045.
AREAS COVERED: This systematic review identified and evaluated the potential of current drug treatments for long-COVID, examining both completed and ongoing RCTs.
EXPERT OPINION: We identified four completed and 22 ongoing RCTs, investigating 22 unique drugs. However, most drugs were deemed to not have high potential for treating long-COVID, according to three pre-specified domains, a testament to the ordeal of treating long-COVID. Given that long-COVID is highly multifaceted with several proposed subtypes, treatments likely need to be tailored accordingly. Currently, rintatolimod appears to have modest to high potential for treating the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) subtype, LTY-100 and Treamid for pulmonary fibrosis subtype, and metformin for general long-COVID prevention.
AIMS: This study aims to evaluate the effect of theory- and web-based health education intervention on mental health literacy among foundation students at a public university in Malaysia.
METHODS: A randomised controlled trial study will be conducted among foundation students. Participants will be recruited and randomly assigned to either the intervention or control group. The intervention will be conducted for two weeks with a one-month follow-up. The health education intervention will be developed according to the Information, Motivation, and Behavioural Skill Theory, and will be delivered via a website. The outcome will be measured using validated, self-administered questionnaires. at baseline, post-intervention, and one-month follow up. The data will be analysed using Generalised Estimating Equation (GEE). This study is registered to the Thai Clinical Trial Registry (TCTR) (reference number: TCTR20210705006), dated 4th July 2021.
CONCLUSIONS: The results from this study will be useful for relevant authorities to take further efforts in mental health promotion among young people.
METHODOLOGY: 88 university students with migraine symptoms are the target participants. 4 of 5 on the Migraine Screen Questionnaire, 5 of 7 on the International Classification of Headache Disorders 3rd edition (ICHD-3), and both genders aged 18-40 years will be included. The participants with a score of more than or equal to 5 on the visual aura rating scale, diagnosed with a secondary headache, pregnancy, medication for neurological and cardiorespiratory conditions, and unwilling to participate will be excluded. Based on the disability questionnaire, the participants will be randomly assigned to either of the three groups. The primary outcome is resting-state electroencephalography (EEG) brain, and the secondary outcomes are sleep quality, quality of life, and migraine pain level. The post-test assessments will be performed at week 6.
RESULT: After the primary EEG analysis using MATLAB, the amplitude, frequency, frequency band ratio, and power spectrum density will be analysed. Mixed design analysis and intention-to-treat analysis will be used to assess the efficacy of aerobic training.
DISCUSSION: Migraines can be unpredictable, sometimes occurring without symptoms. If underdiagnosed or over-looked, it encompasses a serious of long-term effects. Hence with appropriate intervention, the symptoms can be prevented from worsening. But there is an unmet need for evidence-based non-pharmacological approaches to complement pharmacotherapy in migraine prevention. Moreover, an exercise intervention may be more suitable for people with migraine considering their tendency toward inactivity. Although some studies developed exercise programs for untrained patients with migraine, the outcome was primarily in terms of exercise capacity rather than the primary characteristics and secondary brain wave/ sleep quality changes, indicating the need for this study.
METHODS: The electronic databases PubMed, Web of Science, SCOPUS, and SPORTDiscus were systematically searched up to June 2023 without placing any restrictions on the publication dates. The PICOS method was adopted to establish the inclusion criteria: (a) healthy athletes who participate in racket sports; (b) a PT program; (c) a control group; (d) assessment of physical fitness components pre- and post-PT; and (e) RCTs. The records' methodological quality was assessed utilizing the Physiotherapy Evidence Database (PEDro) scale. The certainty in the evidence related to each outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment. A random-effects model was used to calculate effect sizes (ES; Hedges' g) between experimental and control groups.
RESULTS: There were 14 eligible studies of moderate-to-high-quality, involving 746 athletes in total. The results revealed small-to-moderate effects (p < 0.05) of PT on muscle power (ES = 0.46), muscle strength (ES = 0.50), sprint speed (ES = 0.45), change of direction ability (ES = 0.76), and reaction time (ES = 0.67), while no clear evidence was found on balance and flexibility. The training-induced changes in muscle power showed no significant difference (p > 0.05) between youth (ES = 0.72) and adults (ES = 0.40). There were also similar muscle power improvements (ES = 0.36-0.54 vs 0.38-0.56, all p > 0.05) for a length of ≤7 weeks with ≤14 total PT sessions vs >7 weeks with >14 total PT sessions, and ≤2 weekly sessions vs >2 sessions. No adverse effects were reported in the included studies regarding the PT intervention. The certainty of evidence varied from very low to moderate. Conclusions: Our findings demonstrated that PT has positive effects on important indices of physical fitness among athletes participating in racket sports. Future studies are required to clarify the optimal doses and examine interactions among training variables to further promote the physical fitness of this specific population.
METHODS AND ANALYSIS: Initially, during Phase I of the study, the serum level of IL-1β, IL-6 and TNF-α; ERP changes in the EEG and fecal microbiota content will be compared between 120 AUD patients and 120 healthy controls. Subsequently in Phase II of the study, 120 AUD patients will be randomized by stratified permuted block randomization into the probiotic, ACT and placebo groups in a 1:1:1 ratio. Participants in the probiotic and placebo groups will be administered one sachet per day of Lactobacillus spp. probiotic and placebo, respectively for 12 weeks. While those in the ACT group will receive one session per week of ACT for 8 weeks. Outcome measures will be administered at four timepoints, such as t0 = baseline assessment prior to intervention, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention and t3 = 24 weeks after intervention. Primary outcomes are the degrees of alcohol craving, alcohol withdrawal during abstinence and AUD. Secondary outcomes to be assessed are the severity of co-morbid depression and anxiety symptoms; the serum levels of IL-1β, IL-6 and TNF-α; changes in ERP and fecal microbiota content.
TRIAL REGISTRATION NUMBER: NCT05830708 (ClinicalTrials.gov). Registered on April 25, 2023.
DESIGN: The search was conducted in PubMed, Ebscohost, ProQuest, and Scopus databases till June 2021. Children undergoing pulpotomy therapy in primary molars treated with ferric sulfate (FS) and bioactive endodontic materials were evaluated for clinical and radiographic success. Meta-analysis was performed on a random-effects model to assess the success at 6,12,18, and 24 months. The quality of studies was evaluated using the Cochrane risk of bias tool for randomized trials RESULTS: No significant difference was observed between Mineral trioxide aggregate (MTA) and FS at 24 months for both clinical [RR0.98 (95%CI 0.15,6.34), I2 = 0%] and radiographic [RR0.74 (95%CI: 0.23,2.43), I2 = 0%] success. At 6 months [RR1.36 (95%CI: 0.10,19.34), I2 = 33%], no difference was observed in the clinical [RR1.00 (95%CI: 0.95,1.05), I2 = 0%] and radiographic success [RR0.99 (95%CI: 0.88,1.11), I2 = 51%] between Biodentine (BD), FS and radiographic success of calcium enriched cement and FS [RR0.25 (95%CI: 0.03, 2.22), I2 = 0%].
CONCLUSION: Amongst bioactive materials, MTA and FS demonstrated equal success rates in both clinical and radiographic outcomes with follow-up periods of up to 24 months. Future, high-quality trials are required to verify the result of the current review.
DESIGN: A systematic review, meta-analysis, and trial sequential analysis (TSA).
SETTING: In the operating room, postoperative anesthesia care units (PACU), and ward.
PARTICIPANTS: Elderly patients (>60 years old) undergoing surgery.
INTERVENTIONS: The EMBASE, MEDLINE, and CENTRAL databases were searched systematically from their inception until December 2020 for randomized controlled trials comparing BIS and usual care or blinded BIS.
MEASUREMENTS AND MAIN RESULTS: Ten trials (N = 3,891) were included for quantitative meta-analysis. In comparison to the control group, there was no significant difference in the incidence of POD in elderly patients randomized to BIS-guided anesthesia (odds ratio [OR] 0.71, 95% CI 0.47-1.08, I2 = 76%, p = 0.11, level of evidence = very low, TSA = inconclusive). The authors' review demonstrated that elderly patients with BIS-guided anesthesia were significantly associated with a lower incidence of postoperative cognitive dysfunction (POCD) (OR 0.64, 95% CI 0.46-0.88, p = 0.006), extubation time (mean difference [MD] -3.38 minutes, 95% CI -4.38 to -2.39, p < 0.00001), time to eye opening (MD -2.17 minutes, 95% CI -4.21 to -0.14, p = 0.04), and time to discharge from the PACU (MD -10.77 minutes, 95% CI -11.31 to - 10.23, p < 0.00001).
CONCLUSION: The authors' meta-analysis demonstrated that BIS-guided anesthesia was not associated with a reduced incidence of POD, but it was associated with a reduced incidence of POCD and improved recovery parameters.
METHODS: This is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.
DISCUSSION: The intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.
TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772 . Registered on 20 November 2019.
METHODS: We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924).
FINDINGS: Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95-1·24; I2=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91-1·58; I2=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71-1·04; I2=0%). The composite adverse perinatal outcome was lower in women who were allocated to balloon catheters than in those allocated to vaginal prostaglandins (ten trials, 4452 neonates, crude incidence 13·6%; aOR 0·80, 95% CI 0·70-0·92; I2=0%). There was no significant difference in the composite adverse maternal outcome (ten trials, 4326 women, crude incidence 22·7%; aOR 1·02, 95% CI 0·89-1·18; I2=0%).
INTERPRETATION: In induction of labour, balloon catheters and vaginal prostaglandins have comparable caesarean delivery rates and maternal safety profiles, but balloon catheters lead to fewer adverse perinatal events.
FUNDING: Australian National Health and Medical Research Council and Monash Health Emerging Researcher Fellowship.
METHOD: We searched PubMed, Embase, EBSCOhost and ClinicalTrials.gov for the eligible RCTs which compared the efficacy and safety of combined atezolizumab and nab-paclitaxel with nab-paclitaxel alone. The outcomes analyzed included overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and treatment-related adverse effects (AEs).
RESULTS: A total of six RCTs were included in this MA. For efficacy, although OS was not significantly prolonged with combined atezolizumab and nab-paclitaxel (HR 0.90, 95% CI [0.79, 1.01], p=0.08), this combination therapy significantly improved PFS (HR 0.72, 95% CI [0.59, 0.87], p=0.0006) and ORR (RR 1.25, 95% CI [0.79, 1.01] p<0.00001). For safety, any AEs, haematological, gastrointestinal, and liver AEs showed no statistically significant differences between the atezolizumab and nab-paclitaxel combination group and nab-paclitaxel alone group. However, serious AEs, high grade, dermatological, pulmonary, endocrine, and neurological AEs were significantly lower with nab-paclitaxel alone compared to atezolizumab and nab-paclitaxel combined (p-value range from <0.00001 to 0,02).
CONCLUSION: Atezolizumab combined with nab-paclitaxel was associated with improved outcomes in the treatment of TNBC; however, this combination resulted in more toxicity compared to nab-paclitaxel alone. While nab-paclitaxel alone produced chemotherapy-related AEs, the combination of atezolizumab with nab-paclitaxel produced AEs, especially immune-related AEs such as haematological, pulmonary, endocrine, and neurological AEs.
TRIAL REGISTRATION: This research work of systematic review has been registered on PROSPERO (Registration number: CRD42022297952).
METHODS AND RESULTS: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients.
CONCLUSION: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.