Review Of Randomized Controlled Trials Research Articles

A Systematic Review of Upper Extremity Outcome Measures Assessed in Randomized Controlled Trials of Post-Stroke Upper Extremity Rehabilitation in Low-to-Middle-Income and High-Income Countries.

To systematically review Randomized Controlled Trials (RCTs) of post-stroke upper extremity (UE) motor rehabilitation interventions to identify the outcome measures used in studies in low-to-middle-income countries (LMICs) and high-income countries (HICs) and describe the differences in the context of the International Classification of Functioning Disability and Health (ICF). Five databases "Embase, PubMed, CINAHL, Scopus and Web of Science" were searched from 1960 to April 1, 2021. Studies were included if they were: 1) RCTs or RCT crossovers in English; 2) with ≥50% participants affected by ischemic/hemorrhagic stroke; 3) participants ≥18 years old, 4) used an intervention for the hemiparetic UE as the primary objective of the study. Title and abstract screening and full-text studies were reviewed, and data for included studies were extracted by two independent investigators. The study quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. Data analyses were performed using SPSS (V29.0). Of 5,408 records, 1,276 RCTs were eligible, 298 RCTs were conducted in LMICs and 978 in HICs. A higher percentage of RCTs in LMICs employed body structure and function outcome measures for central nervous system (e.g. Fugl Meyer Assessment) and tone and range of motion (e. g. modified Ashworth Scale) as well as activity outcome measures for general activities of daily living (e.g. Barthel Index). In HICs, a higher percentage of RCTs utilized body structure and function outcome measures assessing strength (e.g. Motricity index), activity outcome measures examining motor specific activity (e. g. Action Research Arm Test, Wolf Motor Function Test) and dexterity (e.g. Box and Block Test), as well as participation outcome measures (e. g. Stroke Impact Scale). There were significant differences in the outcome measures chosen for assessing post stroke UE rehabilitation interventions by researchers in LMICs and HICs. This suggests that there might be potential resource and expertise as well as timing constraints that influences the choice of outcome measures in RCTs between HICs and LMICs and highlights the need for investigating the availability of resources, infrastructure, and expertise and their impact on the feasibility and practicality of employing different outcome measures in different countries.

When the attention control condition works: A systematic review of attention control training for posttraumatic stress disorder.

Attentional bias and deficits in attentional control are associated with posttraumatic stress disorder (PTSD) symptoms. Attention control training (ACT) may address these factors. We reviewed randomized controlled trials (RCTs) of ACT for PTSD to address unanswered questions about ACT's effectiveness, tolerability, and implementation. Studies were included if they were an RCT that used an adult sample, recruited participants with a PTSD diagnosis, and had ACT as at least one treatment arm. The PTSD Trials Standardized Data Repository (PTSD-Repository) and additional databases were searched to identify PTSD RCTs published through May 2024. Seven studies met the inclusion criteria (N = 407). The effect size for ACT versus a comparison condition on PTSD symptoms was large, but the confidence interval (CI) overlapped with 0, g = 0.75, 95% CI [-0.63, 2.12]. The same pattern was observed for attention bias variability, g = 1.04, 95% CI [-0.90, 2.98]. There was a significant within-group effect of ACT on self-reported PTSD symptoms, g = -1.43, 95% CI [-2.83, -0.03]. Risk of bias varied, with high risk of bias being primarily due to bias in the measurement of the outcome. These effects should be interpreted cautiously given the significant heterogeneity and wide confidence intervals observed. It remains unclear for whom and under what conditions ACT may be most effective. Future studies should move beyond response time measures, employ an inactive comparator, and examine the mechanism of action to determine whether ACT could be a viable intervention for PTSD.

A Review of Randomized Controlled Clinical Trials on the Effects of PC6 Stimulation on Blood Pressure - Focusing on Domestic Studies and PubMed

Objectives: This study reviewed randomized controlled trials (RCTs) investigating the effects of Neiguan (PC6) stimulation on blood pressure and suggests a better research process.Methods: We searched for RCTs for effects of Neiguan (PC6) stimulations on blood pressure published until July 2024 using six databases (PubMed, Oriental Medicine Advanced Searching Integrated System (OASIS), Korea Citation Index (KCI), Research Information Service System (RISS), Korean Studies Information Service System (KISS), and Science ON). In total, eight RCTs that met all the inclusion criteria were selected.Results: All the selected studies showed significant effects of Neiguan (PC6) stimulation on blood pressure. In most studies, Neiguan (PC6) stimulation was effective in stabilizing blood pressure and improving various indicators related to blood pressure.Conclusion: Neiguan (PC6) stimulation is an effective treatment for stabilizing blood pressure. However, the selected RCTs were short-term studies and had small number of subjects; so, long-term and large-scale studies are needed.

The additive value of platelet-rich plasma to topical Minoxidil in the treatment of androgenetic alopecia: A systematic review and meta-analysis.

It still needs to be determined if platelet-rich plasma (PRP) has any added advantage over Minoxidil in treating androgenetic alopecia. We reviewed randomized controlled trials (RCTs) comparing scalp injections of PRP plus Minoxidil vs Minoxidil alone for managing androgenetic alopecia. All RCTs published on Embase, Cochrane Library, and PubMed comparing PRP plus Minoxidil vs. Minoxidil alone were eligible. The literature search was completed on 5 March 2024. The review was registered on PROSPERO (CRD42024509826). Of five included RCTs, three had a high risk of bias, while one had some concerns. A systematic review of the studies showed that all trials reported better outcomes with PRP plus Minoxidil than with Minoxidil alone. Meta-analysis showed that hair density at one month (MD: 11.07 95% CI: 1.20, 20.94 I2 = 0%), three months (MD: 21.81 95% CI: 10.64, 33.00 I2 = 57%) and 5/6 months (MD: 17.80 95% CI: 7.91, 27.69 I2 = 80%) of follow-up was significantly better in the PRP plus Minoxidil vs the Minoxidil alone group. Meta-analysis of adverse events showed that the risk of adverse events was comparable in both groups (OR: 0.55 95% CI: 0.22, 1.36 I2 = 0%). The certainty of evidence on the GRADE assessment was "low to very low." Very low-quality evidence shows that the addition of injectable PRP to topical Minoxidil may improve outcomes in patients with androgenetic alopecia. The addition of PRP was found to improve hair density and patient satisfaction significantly. However, the small number of studies with a high risk of bias and heterogeneity in PRP preparation methods are significant limitations of current evidence. Further studies with larger sample sizes and uniform PRP preparation protocols are needed.

Safety and efficacy of intralesional bleomycin for keloids and hypertrophic scars: A systematic review and meta-analysis.

Bleomycin, originally an antitumor drug, was explored as a pathological scar treatment in the mid-1990s. However, its efficacy and safety profile varies among individuals. This study aimed to assess topical bleomycin's efficacy and safety in treating hypertrophic scars and keloids. We reviewed randomized controlled trials (RCTs) and controlled clinical trials (CCTs) published in English, comparing intralesional bleomycin to placebos or common intralesional scar treatments. Primary outcomes included percentage change in scar improvement, pigmentation, recurrence, atrophy, pain, telangiectasia, ulceration, patient self-assessment, and observer assessment (>50%). Six trials met the criteria. Bleomycin significantly improved scar reduction compared to triamcinolone (p < 0.05). There was no significant difference in pigmentation (p = 0.05) and recurrence (p = 0.21) compared to other treatments. In terms of safety, bleomycin caused less skin atrophy (p < 0.01) and telangiectasia (p < 0.01) but more pain (p = 0.03) than other treatments. Bleomycin was more effective than TAC, 5-FU, or TAC combined with 5-FU for treating keloids and hypertrophic scars with lower skin atrophy and telangiectasia risks. However, it may cause more pain than 5-FU or TAC. Further comprehensive studies, including RCTs, are required for objective analysis.

Diagnostic value of soluble Interleukin-2 receptor in patients suffering neurosarcoidosis: A systematic review.

Neurosarcoidosis is an inflammatory granulomatous disease. Up to 25% of occult sarcoidosis affecting the nervous system are only detected by autopsy. In addition, in recent years the suspicion arose that the soluble Interleukin-2 Receptor (sIL-2R) might be useful in differentiating between neurosarcoidosis and neurosarcoidosis-like diseases such as neurotuberculosis, multiple sclerosis, or cerebral lymphoma. Therefore, we aimed to systematically review randomized controlled trials (RCT), observational studies, and case-control studies evaluating sIL-2R levels in neurosarcoidosis patients. For this systematic review, a comprehensive literature search of electronic databases including EMBASE, The Web Of Science, The Cochrane Library, MEDLINE, and Google Scholar was conducted. The search was limited to the English language and publication date up to January 08th, 2024. As part of the search strategy conducted, 6 articles met the inclusion criteria. Two independent reviewers extracted the relevant data from each article. In addition, 2 independent reviewers assessed the quality of each study using the Newcastle-Ottawa Scale (NOS). We included 6 studies comprising 98 patients suffering from neurosarcoidosis, 525 non-sarcoidosis patients, and 118 healthy controls. Included studies were published between 2010 and 2023. Cerebrospinal fluid (CSF) sIL-2R levels differed significantly between neurosarcoidosis patients and multiple sclerosis, vasculitis, and healthy controls whereas serum sIL-2R levels did not reveal sufficient discriminative power. sIL-2R index was able to discriminate neurosarcoidosis from neurotuberculosis, bacterial/viral meningitis, and healthy controls. In this systematic review, we found indications that sIL-2R may be a useful biomarker for the diagnosis of neurosarcoidosis. To determine an additional diagnostic value of sIL-2R, large prospective studies are needed that not only examine absolute sIL-2R levels in serum or CSF but also the dynamic changes as well as the implications of renal function on sIL-2R levels.

Efficacy and safety of levetiracetam for migraine prophylaxis in children: a systematic review and meta-analysis.

Levetiracetam (LEV), an antiepileptic drug, has been effective in adult migraine prevention but lacks extensive research in children. This study evaluates LEV's efficacy and safety for pediatric migraine prophylaxis. We reviewed randomized controlled trials (RCTs) and non-RCTs in major databases through 8 January 2024, focusing on four efficacy endpoints and adverse drug reactions (ADRs). Data synthesis involved pooled relative risks or odds ratios for dichotomous outcomes and mean differences for continuous outcomes, using fixed- or random-effects models as appropriate. Eight studies with 190 participants showed that after taking LEV, the mean headache frequency decreased 5.19 per month (MD: -5.19, 95% CI: -7.11 to -3.27, p < 0.00001) and improved headache-free rates to 28% (95% CI: 0.17-0.41). More than 83% experienced a >50% reduction in monthly headache frequency. The migraine disability score decreased by 33.51 points (MD: -33.51, 95% CI: -38.46 to -28.55, p < 0.00001). ADR incidence did not significantly differ between LEV and control groups (RR: 1.06, 95% CI: 0.39 to 2.85, p = 0.91), with an overall ADR rate of 18% (95% CI: 0.13-0.24). The most common ADR was irritability (12%), leading to treatment discontinuation in 13% of cases (95% CI: 0.05-0.30). LEV has shown good efficacy in preventing pediatric migraines. However, its safety requires further confirmation through more extensive and well-designed RCTs. Identifier PROSPERO CRD42024497643.

The Role of Lactobacillus plantarum in Reducing Obesity and Inflammation: A Meta-Analysis.

Recent research has underscored the efficacy of Lactobacillus plantarum (L. plantarum) in managing obesity among healthy adults. This meta-analysis reviewed randomized controlled trials (RCTs) from major databases up to May 2024, focusing on the effects of L. plantarum on body weight, body mass index (BMI), and metabolic parameters. This study has been registered in PROSPERO (number: CRD 42024531611). The analysis of nine studies revealed significant weight reduction and BMI decreases with L. plantarum supplementation compared to a placebo. Notably, using more than two strains together enhanced these effects. Improvements were also observed in abdominal fat and inflammatory markers such as interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP). This meta-analysis synthesizes evidence from nine RCTs to test the hypothesis that L. plantarum supplementation effectively reduces body weight and BMI in healthy adults compared to a placebo. However, variations in study designs, probiotic strains, and intervention durations call for more robust trials to confirm these benefits.

Technology-Based Music Interventions to Reduce Anxiety and Pain Among Patients Undergoing Surgery or Procedures: Systematic Review of the Literature.

Hospitalized patients undergoing surgery or procedures may experience negative symptoms. Music is a nonpharmacological complementary approach and is used as an intervention to reduce anxiety, stress, and pain in these patients. Recently, music has been used conveniently in clinical situations with technology devices, and the mode of providing music is an important factor in technology-based music interventions. However, many reviews have focused only on the effectiveness of music interventions. We aimed to review randomized controlled trials (RCTs) of technology-based music interventions for reducing anxiety and pain among patients undergoing surgery or procedures. We examined the clinical situation, devices used, delivery methods, and effectiveness of technology-based music interventions in primary articles. The search was performed in the following 5 electronic databases: PubMed, MEDLINE (OvidSP), CINAHL complete, PSYCINFO, and Embase. This systematic review focused on technology-based music interventions. The following articles were included: (1) RCTs, (2) studies using interactive technology (eg, smartphones, mHealth, tablets, applications, and virtual reality), (3) empirical studies reporting pain and anxiety outcomes, and (4) English articles published from 2018 to 2023 (as of January 18, 2023). The risk of bias was assessed using the Cochrane Risk of Bias tool version 2. Among 292 studies identified, 21 met the inclusion criteria and were included. Of these studies, 9 reported that anxiety scores decreased after music interventions and 7 reported that pain could be decreased before, during, and after procedures. The methodology of the music intervention was important to the results on anxiety and pain in the clinical trials. More than 50% (13/21, 62%) of the studies included in this review allowed participants to select themes themselves. However, it was difficult to distinguish differences in effects depending on the device or software used for the music interventions. Technology-based music interventions could help reduce anxiety and pain among patients undergoing surgery or procedures. The findings of this review could help medical teams to choose a practical methodology for music interventions. Future studies should examine the effects of advanced technology-based music interventions using smart devices and software that promote interactions between medical staff and patients.

Survival Rates of Short Dental Implants (≤6 mm) Used as an Alternative to Longer (>6 mm) Implants for the Rehabilitation of Posterior Partial Edentulism: A Systematic Review of RCTs.

Short dental implants have been proposed as an alternative treatment option to bone regeneration procedures for the rehabilitation of resorbed alveolar ridges. The aim of this paper was to systematically review randomized controlled trials (RCTs) comparing short implants (≤6 mm) and longer implants (>6 mm) in atrophic alveolar ridges in terms of implant survival rates, peri-implant marginal bone loss (MBL), prevalence of peri-implantitis and technical complications. A thorough electronic search was performed until September 2023. RCTs with follow-up of at least 1-year post-loading comparing short implants with rough surfaces to longer implants in the posterior jaws of systemically and periodontally healthy, partially edentulous adults were considered. Studies with incomplete information on the number of patients, follow-up or definition of "short implants" were excluded. The revised Cochrane risk-of-bias tool for randomized trials was used for Risk of bias assessment. Fixed-effects meta-analysis of the selected studies was applied to compare the outcome variables. Random-effect meta-analysis was performed, on the basis of within-study comparisons. In total, 16 articles were selected for meta-analysis and incorporated 408 short implants and 475 longer implants inserted in 317 and 388 patients, respectively. The survival rates of longer implants in pristine or augmented bone were significantly increased compared to short implants (95%CI: 2-5%, p < 0.001). Standard-length implants displayed increased, although non-statistically significant MBL (95%CI: -0.17-0.04, p > 0.05), and prevalence of peri-implantitis (95%CI: 0-5%, p > 0.05). No statistically significant differences were observed between short and long implants in terms of technical complications (implant-level 95%CI: -4-6%, p > 0.05). Short implants represent a promising alternative treatment option for the rehabilitation of posterior jaws to avoid additional bone augmentation procedures. Nonetheless, they should be selected cautiously due to a potentially limited survival rate compared to longer implants. A major limitation of this study is the variability in the included studies regarding sample size, patient profile, type of bone, loading protocol, definition of peri-implantitis, among others. This study received no external funding. The study protocol was registered in PROSPERO (CRD42023485514).

Comparative effectiveness of peroneus longus tendon (PLT) autografts versus hamstring tendon (HT) autografts in anterior cruciate ligament reconstruction: a comprehensive systematic review and meta analysis

The hamstring tendon (HT) autograft is currently the most widely utilised autograft option for anterior cruciate ligament (ACL) reconstruction. However, recent studies endorse the peroneus longus tendon (PLT) autograft as a viable alternative. To evaluate this, we systematically reviewed randomised controlled trials (RCTs) to compare the efficacy of PLT against HT autografts. Our search encompassed Cochrane, Embase, OVID, PubMed, and Scopus databases for RCTs comparing outcomes of PLT and HT autografts in ACL reconstruction. Primary outcomes included Lysholm and International Knee Documentation Committee (IKDC) scores, while secondary outcomes involved American Orthopaedic Foot and Ankle Society (AOFAS) scores, graft diameters and donor-site complications. Statistical analysis was performed using Review Manager 5.4 (Cochrane Collaboration) and heterogeneity was assessed with I2 statistics. 683 patients from 6 RCTs were included, with 338 (49.5%) patients treated with PLT autografts. Follow-up ranged from 12 to 30 months. Despite lower preoperative Lysholm scores in the PLT group, no significant differences were observed at 6 and 12 months. Although preoperative and 6-month IKDC scores were lower in the PLT group, no significant differences were found at 12 and 24 months. AOFAS scores showed no significant preoperative difference, but slightly lower scores were noted in the PLT group at 12 or 24 months. There was no significant difference in graft diameter, while donor-site complications were fewer in the PLT group. In summary, the PLT autograft is a promising and non-inferior alternative to the HT autograft, demonstrating equivalent outcomes in patient-reported knee and ankle metrics, comparable graft diameters and fewer donor-site complications.

The Safety and Feasibility of Contraception Care by Midwives and Other Nonphysician Providers: A Scoping Review of Randomized Control Trials

Background: Although midwives in most Canadian provinces and other high-income countries have contraceptive prescribing ability, it is not within the Ontario midwifery scope of practice.Aim: To outline the contraceptive-related scope of practice of midwives in Canada and other high-income countries and to review the outcomes of contraceptive provision by physician versus nonphysician providers.Methods: We conducted an environmental scan through a search of grey literature to summarize contraception-related scopes of practice of midwives in provinces across Canada and in other high-income countries. We then conducted a scoping review of randomized controlled trials (RCTs) that examined the outcomes of physicians compared with nonphysician providers for the provision of contraception care, and summarized that evidence.Findings: Our environmental scan revealed that Quebec and Ontario are the only provinces in Canada in which midwives cannot prescribe contraception. In the following industrialized countries, midwives with education similar to that of Ontario midwives are able to prescribe contraception: New Zealand, Australia, United States, Sweden, Norway, Netherlands, Finland, and France. Our review of RCTs indicates that for most measures of competency, the outcomes of physician and nonphysical providers are similar when providing contraception care. This article has been peer reviewed.

Systematic review and meta-analysis of text messaging interventions to support tobacco cessation

ObjectiveTo review randomised controlled trials (RCTs) investigating the effectiveness of text message-based interventions for smoking cessation, including the effects of dose (number of text messages) and concomitant use of behavioural...

The effect of antioxidant supplementation on dysmenorrhea and endometriosis-associated painful symptoms: a systematic review and meta-analysis of randomized clinical trials.

This study aimed to review randomized controlled trials (RCTs) investigating the effects of dietary antioxidant supplements on the severity of endometriosis-related pain symptoms. The PubMed/Medline, Scopus, and Web of Science databases were searched until April 2022. Additionally, we manually searched the reference lists. Endpoints were summarized as standardized mean difference (SMD) with 95% confidence intervals (CIs) in a random-effects model. The I2 statistic was used to assess heterogeneity. Ten RCTs were included in this meta-analysis. Overall, 10 studies were related to dysmenorrhea, four to dyspareunia, and four to pelvic pain. Antioxidants significantly reduced dysmenorrhea (SMD, -0.48; 95% CI, -0.82 to -0.13; I2=75.14%). In a subgroup analysis, a significant reduction of dysmenorrhea was observed only in a subset of trials that administered vitamin D (SMD, -0.59; 95% CI, -1.13 to -0.06; I2=69.59%) and melatonin (SMD, -1.40; 95% CI, -2.47 to -0.32; I2=79.15%). Meta-analysis results also suggested that antioxidant supplementation significantly improved pelvic pain (SMD, -1.51; 95% CI, -2.74 to -0.29; I2=93.96%), although they seem not to have a significant beneficial impact on the severity of dyspareunia. Dietary antioxidant supplementation seems to beneficially impact the severity of endometriosis-related dysmenorrhea (with an emphasis on vitamin D and melatonin) and pelvic pain. However, due to the relatively small sample size and high heterogeneity, the findings should be interpreted cautiously, and the importance of further well-designed clinical studies cannot be overstated.

A systematic literature review of randomised controlled trials evaluating colchicine for cardiovascular prevention: There is an elephant in the room

ObjectivesTo review randomised controlled trials (RCT) investigating colchicine (COL) for cardiovascular (CV) prevention in patients at high to very high CV risk aiming to extract data that could be useful in rheumatology practice. MethodsA systematic search of multiple databases according to the PICO framework was performed from inception to April 3, 2023. Three researchers independently screened abstracts/titles and reviewed full texts reviewed. Data extraction was performed using a pilot‐tested data extraction form. ResultsA total of 14,096 references were retrieved by the search and 30 articles, describing 28 RCTs, were included in the review (Total number of patients 16,795, of which 8,463 randomised to COL; dose 0.5–2 mg/day, treatment duration 1day-29 months). Only one of the 28 RCTs provided clear information on whether patients with rheumatic diseases (more specifically gout) were enrolled in the study cohorts and previous use of COL was an exclusion criterion only in 14 (50 %) RCTs. Previous therapy with glucocorticoids and/or non-steroidal anti-inflammatory drugs and/or immune suppressive therapies was an exclusion criterion only in 9 (32 %) RCTs. ConclusionOur results highlight the need to redefine the eligibility criteria as well as the reporting of results in future RCTs in order to minimise bias or previous exposure to COL and also obtain data that could be useful in rheumatology practice.

Direct Oral Anticoagulants for Treating Acute Venous Thromboembolism in Children: Meta-Analysis of Randomized Controlled Trials.

Acute venous thromboembolism (VTE) in children presents unique challenges due to the limitations of standard anticoagulation therapies. Herein, we aimed to systematically review randomized controlled trials (RCTs) evaluating the efficacy and safety of direct oral anticoagulants (DOACs) in pediatric patients with acute VTE. PubMed and Embase databases were searched for RCTs comparing DOACs to standard anticoagulation in pediatric VTE patients. Efficacy outcomes included VTE recurrence and all-cause mortality, while safety outcomes comprised major bleeding and other adverse events. Three RCTs with 790 participants were included. When compared with standard anticoagulation, DOACs demonstrated a reduced risk of VTE recurrence (risk difference[RD] = -3%, 95% confidence interval[CI]: -6% to 0%, P = 0.04) and an increased risk of any adverse event (RD = 8%, 95% CI: 1% to 14%, P = 0.02). No significant differences were found in all-cause mortality, major bleeding, clinically relevant non-major bleeding, or total bleeding between the DOAC and control groups. DOACs, primarily dabigatran and rivaroxaban, are non-inferior to standard anticoagulants in reducing VTE recurrence in pediatric patients, with comparable safety profiles. Further research is essential to confirm these findings.

The Role of Digital Health Technology Interventions in the Prevention of Type 2 Diabetes Mellitus: A Systematic Review.

Diabetes in the 21st century presents one of the greatest burdens of disease on the global population. Digitally mediated interventions have become imperative in alleviating this disease epidemic. We aimed to systematically review randomized controlled trials (RCTs) on different health technologies for preventing Type 2 diabetes mellitus, and their efficacy in decreasing diabetes risk-related outcomes in at-risk patients in comparison to standard care. Five electronic databases were searched between October 2021 and December 2022. Studies including digital health technology interventions used for preventing diabetes development by reducing diabetes risk-related outcomes in at-risk adults (⩾18 years) were identified. Data on glycemic levels, incidence of T2DM, weight, and intervention descriptions were extracted, and the risk of bias (ROB) was assessed. Nine studies met the inclusion criteria and 5 studies (56%) achieved clinically significant outcomes in at least one of the following: decreased weight (22%), glycemic levels (22%), or incidence of T2DM (11%). Two of the 3 (67%) computer-based interventions effectively reduced the HbA1c levels and mean weight of their study population, and 3 of 6 (50%) mobile based interventions (text messages, mobile app, and telehealth) decreased the incidence of T2DM and HbA1c levels. Four studies each had an overall low ROB and one had a high ROB due to attrition. Preliminary evidence identified in our review demonstrated that health technologies for diabetes prevention are effective for improving diabetes risk-related outcomes. Future research into digital technology protocol and studies of longer duration and more diverse populations are needed for clinical feasibility.

Efficacy of Herbal Medicine on Sleep Disorders in Parkinson’s Disease: A Review of Randomized Controlled Trials

Objectives: This study reviewed randomized controlled trials (RCTs) investigating the efficacy of herbal medicine on sleep disorders associated with Parkinson’s disease and suggests a better research process.Methods: We searched for RCTs for herbal medicine treatments for sleep disorders related to Parkinson’s disease on July 31, 2023 using eight databases (PubMed, Embase, the Cochrane library, China National Knowledge Infrastructure [CNKI], the Research Information Service System [RISS], Science ON, the Oriental Medicine Advanced Searching Integrated System [OASIS], and the Korea Citation Index [KCI]). Cochrane’s risk of bias tool was used to assess the quality of the RCTs.Results: A total of 16 RCTs met all the inclusion criteria, and in most reports, the treatment group showed a significant improvement in sleep disorders compared to the control group. Total effective rate (TER), Pittsburgh Sleep Quality Index (PSQI), Unified Parkinson’s Disease Rating Scale (UPDRS), TCM Symptom Score (TSS), Parkinson’s Disease Sleep Scale (PDSS), etc., were used as evaluation indicators.Conclusion: Herbal medicine is a potential treatment for sleep disorders associated with Parkinson’s disease. However, the selected RCTs were of poor quality, and it is necessary to perform more systematic studies.

Saturated fat, the estimated absolute risk and certainty of risk for mortality and major cancer and cardiometabolic outcomes: an overview of systematic reviews

ObjectiveTo assess the impact of reducing saturated fat or fatty foods, or replacing saturated fat with unsaturated fat, carbohydrate or protein, on the risk of mortality and major cancer and cardiometabolic outcomes in adults.MethodsWe searched MEDLINE, EMBASE, CINAHL, and references of included studies for systematic reviews and meta-analyses (SRMAs) of randomized controlled trials (RCTs) and observational studies in adults published in the past 10 years. Eligible reviews investigated reducing saturated fat or fatty foods or replacing saturated fat with unsaturated fat, carbohydrate or protein, on the risk of cancer and cardiometabolic outcomes and assessed the certainty of evidence for each outcome using, for example, the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. We assessed the quality of SRMAs using a modified version of AMSTAR-2. Results were summarized as absolute estimates of effect together with the certainty of effects using a narrative synthesis approach.ResultsWe included 17 SRMAs (13 reviews of observational studies with follow-up 1 to 34 years; 4 reviews of RCTs with follow-up 1 to 17 years). The quality of two-thirds of the SRMAs was critically low to moderate; the main limitations included deficient reporting of study selection, absolute effect estimates, sources of funding, and a priori subgroups to explore heterogeneity. Our included reviews reported > 100 estimates of effect across 11 critically important cancer and cardiometabolic outcomes. High quality SRMAs consistently and predominantly reported low to very low certainty evidence that reducing or replacing saturated fat was associated with a very small risk reduction in cancer and cardiometabolic endpoints. The risk reductions where approximately divided, some being statistically significant and some being not statistically significant. However, based on 2 moderate to high quality reviews, we found moderate certainty evidence for a small but important effect that was statistically significant for two outcomes (total mortality events [20 fewer events per 1000 followed] and combined cardiovascular events [16 fewer per 1000 followed]). Conversely, 4 moderate to high quality reviews showed very small effects on total mortality, with 3 of these reviews showing non-statistically significant mortality effects.ConclusionSystematic reviews investigating the impact of SFA on mortality and major cancer and cardiometabolic outcomes almost universally suggest very small absolute changes in risk, and the data is based primarily on low and very low certainty evidence.Systematic review registrationPROSPERO CRD42020172141

Omega-3 polyunsaturated fatty acids in sarcopenia management: A network meta-analysis of randomized controlled trials.

Sarcopenia frequently occurs with aging and leads to major adverse impacts on activities of daily living and quality of life in elderly individuals. Omega-3 polyunsaturated fatty acid (omega-3 PUFAs) supplements are considered promising therapeutic agents for sarcopenia management; however, the evidence remains inconsistent. We reviewed randomized controlled trials (RCTs) about omega-3 PUFA supplementation in patients with sarcopenia or in those at high risk for sarcopenia. Network meta-analysis (NMA) procedures were conducted using a frequentist model. The primary outcomes were (1) upper-extremity muscle strength and (2) lower-extremity physical function. The NMA of 16 RCTs showed that the high-dose (more than 2.5g/day omega-3 PUFAs) group yielded the greatest improvement in both upper-extremity muscle strength and lower-extremity physical function [compared to placebo/standard care groups, standardized mean difference (SMD)=1.68, 95% confidence interval (95%CI)=0.03-3.33, and SMD=0.73, 95%CI=0.16-1.30, respectively], and the effects were reaffirmed in subgroup analyses of placebo-controlled RCTs or those excluding concurrent resistance training programs. None of the investigated omega-3 PUFAs supplementation was associated with significantly increased skeletal muscle mass, fat mass, or overall body weight. Our findings provide a basis for future large-scale RCTs to investigate the dose effects and clinical application of omega-3 PUFA supplementation in sarcopenia management. TRIAL REGISTRATION: The current study was approved by the Institutional Review Board of the Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan (TSGHIRB No. B-109-29) and registered in PROSPERO (CRD42022347161).