The effectiveness of psychotherapies in reducing further suicide attempts: a systematic review with meta-analysis of randomized controlled trials

There is little evidence on the effectiveness of psychotherapeutic interventions in reducing new suicide attempts. This article aims to evaluate the effectiveness of psychotherapeutic interventions in reducing suicide attempts among patients with a history of previous attempts. We selected 17 articles from four databases: PubMed, Cochrane, APA PsycInfo and LILACS, in 2023. Six studies showed statistical differences that favored psychotherapeutic intervention at some point during the follow-up period. These psychotherapies addressed: problem-solving, hope induction, skills training. When comparing psychotherapy with usual care, a meta-analysis revealed an odds ratio of 0.41 (95 % CI, 0.17-0.99, p = .05) in the analysis up to 12 months of follow-up, and an odds ratio of 0.48 (95 % CI, 0.30-0.78, p < .001) after 12 months of follow-up. The results indicate the efficacy of these interventions in reducing additional suicide attempts, but they should be analyzed with caution, given the heterogeneity of the sample, treatments, and comparators. This review supports the development of prevention strategies indicated for patients who have attempted suicide.

Hay poca evidencia sobre la eficacia de las psicoterapias para reducir los nuevos intentos de suicidio. Este artículo tiene como objetivo evaluar la efectividad de las intervenciones psicoterapéuticas en la reducción de los intentos de suicidio entre pacientes con intentos previos. Se seleccionaron 17 artículos de cuatro bases de datos: PubMed, Cochrane, APA PsycInfo y LILACS. Seis estudios mostraron diferencias estadísticas que favorecieron la intervención psicoterapéutica en algún momento durante el período de seguimiento. Estas psicoterapias abordaron: resolución de problemas, inducción de esperanza y entrenamiento de habilidades. Al comparar la psicoterapia con el tratamiento habitual, el metanálisis reveló un odds ratio de 0.41 (IC del 95 %, 0.17 a 0.99, p = .05) en el análisis hasta los 12 meses de seguimiento, y un odds ratio de 0.48 (IC del 95 %, 0.30 a 0.78, p < .001) después de 12 meses de seguimiento. Los resultados apuntan a la eficacia de estas intervenciones para reducir los intentos de suicidio adicionales, pero deben analizarse con cautela, dada la heterogeneidad de la muestra, los tratamientos y los comparadores. Esta revisión apoya el desarrollo de estrategias de prevención indicadas para pacientes que han intentado suicidarse.

Citrus supplementation in subjective cognitive decline: results of a 36-week, randomized, placebo-controlled trial.

BACKGROUND: Developing interventions for older adults with subjective cognitive decline (SCD) has the potential to prevent dementia in this at-risk group. Preclinical models indicate that Citrus-derived phytochemicals could benefit cognition and inflammatory processes, but results from clinical trials are still preliminary. The aim of this study is to determine the effects of long-term supplementation with Citrus peel extract on cognitive performance and inflammation in individuals with SCD. METHODS: Eighty participants were randomly assigned to active treatment (400 mg of Citrus peel extract containing 3.0 mg of naringenin and 0.1 mg of auraptene) or placebo at 1:1 ratio for 36 weeks. The primary endpoint was the change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score across the 36-week trial period. Other cognitive outcomes included tests and scales evaluating verbal memory, attention, executive and visuospatial functions, and memory concerns. The secondary endpoint was the change of interleukin-8 (IL-8) levels over the 36-week trial period in a subsample of 60 consecutive participants. An Intention-to-treat approach with generalized linear mixed models was used for data analysis. RESULTS: The RBANS total score showed significant improvement in both Citrus peel extract and placebo groups at 36 weeks (p for time < .001, d = 0.36, p time x treatment = .910). Significant time effects were also found in cognitive domains of short- and long-term verbal memory (p < .001) and scales of subjective memory (p < .01), with no significant time x treatment interaction. The largest effect sizes were observed in verbal memory in the placebo group (d = 0.69 in short-term, and d = 0.78 in long-term verbal memory). Increased IL-8 levels were found at 36-week follow-up in both Citrus peel extract and placebo groups (p for time = .010, d = 0.21, p time x treatment = .772). Adverse events were balanced between groups. CONCLUSIONS: In this randomized clinical trial, long-term Citrus peel extract supplementation did not show cognitive benefits over placebo in participants with SCD, possibly due to high placebo response. These findings might have specific implications for designing future nutraceutical trials in individuals experiencing SCD. TRIAL REGISTRATION: The trial has been registered at the United States National Library of Medicine at the National Institutes of Health Registry of Clinical Trials under the code NCT04744922 on February 9th, 2021 ( https://www. CLINICALTRIALS: gov/ct2/show/NCT04744922 ).

Prevention of occlusal caries using VanishTM XT: an 18-month follow-up randomized clinical trial.

AIM: To evaluate the effectiveness of a light curable resin-modified glass ionomer varnish (VanishTM XT) in the prevention of occlusal caries compared to topical fluoride varnish in newly erupted first permanent molars over 18 months. METHODS: A randomized controlled clinical trial was conducted using a split-mouth design. A total of 53 participants aged 6-9 years with 97 pairs of caries-free newly erupted first permanent molars were enrolled in the study. Each molar in the pair was randomly assigned either to the experimental group, which received the VanishTM XT Extended Contact Varnish, or to the control group, which received topical fluoride varnish (VanishTM 5% Sodium Fluoride White Varnish). Follow-ups were performed at 6, 12, and 18 months to evaluate dental caries development. RESULTS: At the 6-month follow-up, caries development was significantly higher in the control group (7.8%) than that in the experimental group (0%) (P = 0.031). At the 12-month follow-up, significantly (P = 0.012) more occlusal caries developed in the control group (12.2%) compared to the experimental group (1.2%). At the 18-month follow-up, significantly (P = 0.002) more occlusal caries developed in the control group (14.3%) compared to the experimental group (1.1%). CONCLUSION: Compared to fluoride varnish, VanishTM XT was significantly more effective in preventing caries on the occlusal surfaces of newly erupted first permanent molars at 6, 12, and 18 months. TRIAL REGISTRATION: Registration number at ClinicalTrials.gov: NCT04579536 on 08/10/ 2020, retrospectively registered.

Hydraulic sinus floor elevation using advanced platelet-rich fibrin: A randomized clinical trial with two-dimensional radiographic results.

PURPOSE: To assess the radiographic outcomes, complications, and implant survival rates of advanced platelet-rich fibrin versus xenografts in hydraulic sinus floor elevation. METHODS: In this randomized trial, 40 patients with 46 implants were divided into two groups: a test group (advanced platelet-rich fibrin alone) and a control group (xenograft alone). The key outcome measures included bone regeneration, implant survival, and complications. RESULTS: Both groups achieved 100% implant survival. One case of maxillary sinus infection occurred in the control group after surgery. There was no significant difference in bone regeneration between the two groups at 6 months post-surgery and 12 months post-load (P > 0.05). The residual bone height and sinus width at the apex of the implant were significant negative predictors of bone regeneration (P < 0.05), whereas the presence of adjacent teeth was a significant positive predictor (P < 0.05). CONCLUSIONS: Both advanced platelet-rich fibrin and xenografts effectively enhanced bone growth at sinus floor elevation, achieving high implant survival rates over one year. Advanced platelet-rich fibrin alone may be a viable xenograft alternative, necessitating further long-term studies to confirm its efficacy. The study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the registration number ChiCTR2100042060. This clinical trial was not registered before participant recruitment or randomization.

High-dose Omega-3 Alters Serum Magnesium and Calcium Levels and Affects Fibromyalgia Symptoms: A Randomized, Double-blind, Placebo-Control Study.

OBJECTIVE: The aim of this study is to investigate the effect of a high oral dose of omega- 3 on serum magnesium (Mg) and calcium (Ca) levels and their effects on clinical measures of pain threshold. METHODS: One hundred twenty patients were recruited and randomized 1:1 to omega-3 or placebo and blinded to their treatment group. At baseline and after 8 weeks of treatment, the Widespread Pain Index (WPI), the Symptom Severity Scale (SSS), the Visual Analogue Scale (VAS), and the FM Impact Questionnaire (FIQ) were completed. In addition, serum was taken for Ca and Mg analysis at the same time point. RESULTS: The WPI, SSS, VAS, and FIQ scores improved significantly in the omega-3 group compared to the placebo group (P < 0.001). Serum Ca levels correlated negatively with WPI (r = - 0.308), SSS (r = -0.28), VAS (r = -0.311), and FIQ (r= -0.348) scores (P < 0.001) after 8 weeks of treatment. Serum Mg levels were negatively correlated with SSS (r = -0.212) and VAS (r = -0.231) scores after 8 weeks of treatment. The difference between serum Ca levels before and after 8 weeks of omega-3 treatment and serum Mg levels increased significantly compared to 8 weeks of placebo treatment. CONCLUSION: The results of this study showed that a high dose of omega-3 could have a positive effect on the relief of FM pain, which could be due to an increase in serum Mg and Ca levels.

Comparative Study of Triamcinolone and Sumac for Treating Minor Aphthous Lesions - A Triple-Blind Study.

BACKGROUND: Recurrent aphthous stomatitis (RAS) is a common oral mucosal lesion. Herbal medicine has been explored to treat this condition. This study compared the effectiveness of two oral pastes containing Triamcinolone and Sumac, for the healing, size, and symptomatology of RAS. METHODS: This triple-blind randomized clinical trial included 60 patients with minor aphthous ulcers. Participants were informed about the study and provided consent. Exclusion criteria consisted of specific medical conditions and medication use. The patients were divided into three groups and received either Sumac adhesive gel, Triadent oral paste, or a placebo. Ulcer size was measured before and after treatment. The medication was prepared using carboxymethylcellulose-based gel and Sumac powder extract. The study was triple-blinded, and the groups were labelled as A, B, and C. Data analysis was performed using SPSS version 22, employing repeated measurement, student t test, Kolmogorov-Smirnoff, and one-way ANOVA for quantitative data. Statistical significance was set at P ≤ .05. RESULTS: A clinical trial involving 59 participants compared the Sumac, Triadent, and placebo groups. The Sumac group exhibited the shortest healing time, significantly reduced lesion size, and lower Visual Analog Scale scores. Triadent took the longest time to heal ulcers. ANOVA test indicated no significant difference in age and gender distribution. CONCLUSION: This clinical trial evaluated two oral pastes for treating aphthous ulcers and found that the Sumac group achieved faster healing and reduced lesion size compared to the Triadent and control groups. Sumac shows promise as a treatment option, but further studies are necessary to confirm its efficacy and safety. These favourable results support the use of herbal treatments and suggest their potential for broader utilization in managing diseases such as RAS.

Efficacy of Glycyrrhizin as an Intracanal Medicament on Bacterial Load Reduction in Primary Infected Root Canals: A Randomized Clinical Trial.

AIM: This study was done to clinically investigate the efficacy of glycyrrhizin-based intracanal medication (ICM) compared to calcium hydroxide Ca(OH)2 and Ledermix on the bacterial counts inside the root canals of necrotic teeth with chronic periapical periodontitis. METHODOLOGY: Thirty-six patients having single-rooted and single-canaled necrotic teeth with chronic periapical periodontitis were enrolled in this research. Aseptic control measures were taken before clinical steps. Access cavity preparation was done. First bacteriological samples (S1) were collected immediately after access cavity preparation and before cleaning and shaping inside the root canals. Cleaning and shaping were performed on the root canals. Patients were randomly allocated into 3 groups according to the type of intracanal medicament used [Ca(OH)2, Ledermix, Glycyrrhizin]. Second bacteriological samples (S2) were collected after 1 week from placing the ICMs. S1 and S2 were transferred to the lab of microbiology for culturing on blood agar dishes in anaerobic conditions, and the bacteria on the plates were enumerated as colony-forming units (CFUs) by the manual counting method. The anti-bacterial efficacy of the ICM was estimated by the percentage reduction in the bacterial colonies from S1 to S2. RESULTS: All tested ICM documented a significant reduction in the CFUs from S1 to S2 (p < 0.05). Regarding S1, there was no significant difference between the three tested materials (p > 0.05). Regarding S2, Glycyrrhizin and Ledermix showed significantly lower CFUs than Ca(OH)2. There was no significant difference between Glycyrrhizin and Ledermix. CONCLUSION: Under the conditions of the present study, Glycyrrhizin and Ledermix showed comparable antimicrobial effects that were better than the commonly used Ca(OH)2 ICM. Glycyrrhizin may be a promising ICM. CLINICAL SIGNIFICANCE: Herbal medicine can be considered as an alternative antimicrobial material for root canal disinfection because it has many benefits, like low toxicity, absence of microbial resistance, and favorable antimicrobial efficacy. This study highlights the clinical efficacy of Glycyrrhizin as a promising ICM. How to cite this article: Eltantawi AR, Abdel-Razik GM, Elhawary YM, et al. Efficacy of Glycyrrhizin as an Intracanal Medicament on Bacterial Load Reduction in Primary Infected Root Canals: A Randomized Clinical Trial. J Contemp Dent Pract 2024;25(6):540-546.

Comparative Evaluation of Platelet-rich Fibrin and Treated Dentin Matrix in Regenerative Endodontic Treatment of Nonvital Immature Permanent Teeth: A Randomized Clinical Trial.

AIM: Clinical and radiographic evaluation of the efficacy of platelet-rich fibrin (PRF) and treated dentin matrix (TDM) in regenerative endodontic treatment and periapical healing of nonvital immature permanent teeth with chronic apical periodontitis. MATERIALS AND METHODS: Twenty-four children aged between 7 and 11 years, each presenting with a nonvital immature permanent upper central incisor, were selected. They were randomly allocated into two groups (n = 12), group I (PRF) and group II (TDM). Baseline clinical findings were recorded, and preoperative cone-beam computed tomography (CBCT) was taken. Follow-up was done clinically for 15 months at 3-month intervals (3, 6, 9, 12, and 15 months), and CBCT was taken at the end of the 15-month follow-up. Root length, apical diameter, radiographic root area (RRA), and size of the periapical lesion were quantitively assessed at the end of follow-up period and compared to the preoperative CBCT. RESULTS: Clinical success was 100% in both groups by the end of the follow-up period. Radiographically, after a 15-month follow-up, there was a significant increase in root length and RRA, and there was also a significant reduction in apical diameter and lesion size within each group (p < 0.05). However, there was no statistically significant difference between both groups regarding the mean percentage of increase in root length and mean percentage of reduction of apical diameter (p > 0.05). On the other hand, PRF showed more increase in RRA and more reduction in lesion size, with a statistically significant difference between both groups (p < 0.05). CONCLUSION: Both PRF and TDM were clinically successful. Platelet-rich fibrin showed better radiographic outcomes and periapical healing. CLINICAL SIGNIFICANCE: Platelet-rich fibrin is a viable scaffold to aid further root development and resolution of periapical lesions of nonvital immature permanent teeth. Further studies with different forms of TDM are needed to assess the efficacy of TDM in regenerative endodontic treatment of nonvital immature permanent teeth. How to cite this article: Asal MA, Elkalla IH, Awad SM, et al. Comparative Evaluation of Platelet-rich Fibrin and Treated Dentin Matrix in Regenerative Endodontic Treatment of Nonvital Immature Permanent Teeth: A Randomized Clinical Trial. J Contemp Dent Pract 2024;25(6):563-574.

Prospective Human Validation of Artificial Intelligence Interventions in Cardiology: A Scoping Review.

Background: Despite the potential of artificial intelligence (AI) in enhancing cardiovascular care, its integration into clinical practice is limited by a lack of evidence on its effectiveness with respect to human experts or gold standard practices in real-world settings. Objectives: The purpose of this study was to identify AI interventions in cardiology that have been prospectively validated against human expert benchmarks or gold standard practices, assessing their effectiveness, and identifying future research areas. Methods: We systematically reviewed Scopus and MEDLINE to identify peer-reviewed publications that involved prospective human validation of AI-based interventions in cardiology from January 2015 to December 2023. Results: Of 2,351 initial records, 64 studies were included. Among these studies, 59 (92.2%) were published after 2020. A total of 11 (17.2%) randomized controlled trials were published. AI interventions in 44 articles (68.75%) reported definite clinical or operational improvements over human experts. These interventions were mostly used in imaging (n = 14, 21.9%), ejection fraction (n = 10, 15.6%), arrhythmia (n = 9, 14.1%), and coronary artery disease (n = 12, 18.8%) application areas. Convolutional neural networks were the most common predictive model (n = 44, 69%), and images were the most used data type (n = 38, 54.3%). Only 22 (34.4%) studies made their models or data accessible. Conclusions: This review identifies the potential of AI in cardiology, with models often performing equally well as human counterparts for specific and clearly scoped tasks suitable for such models. Nonetheless, the limited number of randomized controlled trials emphasizes the need for continued validation, especially in real-world settings that closely examine joint human AI decision-making.

A comparative effectiveness study of usual care, simple Chuna manual therapy, and complex Chuna manual therapy for the treatment of pelvic biomechanical lesions in patients with non-acute low back pain: a protocol for multicenter, randomized controlled trial.

BACKGROUND: Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care. METHODS: This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments. DISCUSSION: This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.

Short-Term Powered Mobility Intervention is Associated With Improvements in Development and Participation for Young Children with Cerebral Palsy: A Randomized Clinical Trial.

OBJECTIVE: The objective of this study was to evaluate the effects of 2 short-term powered mobility interventions across developmental domains, participation, and perceptions of intervention implementation for young children with cerebral palsy and their families. METHODS: This randomized, crossover clinical trial compared 2 powered mobility interventions: the Explorer Mini (Permobil AB, Timra, Sweden) and an adapted ride-on toy car. Analyses included 24 children aged 12 to 36 months, recruited from 3 sites. Each device was trialed in the home for an 8-week period for a total of 16 weeks. Three in-person study visits took place at baseline, crossover, and study completion, and 2 additional virtual check-ins were conducted for each device trial period. Outcome measures included all domains of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4); Child Engagement in Daily Life (CEDL) participation questionnaire; and t3 perceptual implementation measures: Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure. Analyses included descriptive statistics, 2 by 3 group × time analysis of variance, and post hoc t tests as warranted. RESULTS: Statistically significant mean improvements were observed in all domains of the Bayley-4 and in the self-care subscale of the CEDL regardless of device order. Caregivers ranked both devices as acceptable and feasible to implement, although the Explorer Mini was ranked slightly more favorably than the adapted ride-on toy car, with a device order effect being observed. CONCLUSION: Short-term powered mobility intervention may advance multiple domains of development and participation for young children with cerebral palsy. Caregivers rated 2 different powered mobility devices favorably as part of their child's early intervention strategies. IMPACT: This study enhances the quality of evidence available to clinicians and families to support decision-making about powered mobility intervention for young children with motor disabilities, especially those who may be reluctant to begin powered mobility due to stigma or concern for motor skill development.

In this study, children with cerebral palsy used 2 different powered mobility devices over 16 weeks. The goal of the study was to understand how powered mobility device use affected the children's movement, communication, learning, and social interactions. The goal was also to understand how caregivers felt about the intervention and device options.

Influence of occlusal surface reduction on post endodontic pain following instrumentation and obturation: A randomized double blinded clinical study.

Objective: The purpose of this randomized clinical study was to investigate the influence of occlusal surface reduction on postendodontic pain. Methodology: Sixty patients were included with a diagnosis of acute irreversible pulpitis and acute apical periodontitis and divided randomly into two groups. In the intervention group, occlusal surfaces were reduced and left intact in the control group. Postoperative pain was evaluated at the 6th, 12th, 24th, and 48th h after the root canal instrumentation and 6th and 12th h following obturation using visual analog scale. Data were evaluated using the Chi-square test, t-test, Friedman test, Mann-Whitney U-test, and Wilcoxon rank test. Results: Postoperative pain levels in both groups were reduced significantly over the time period evaluated, however, between the two groups, there was no difference evident. Conclusion: Occlusal surface reduction did not influence the pain following root canal instrumentation and obturation.

Impact of Topical Fluocinonide on Oral Lichen Planus Evolution: Randomized Controlled Clinical Trial.

OBJECTIVE: To examine the impact of fluocinonide 0.05% gel formulation for the topical treatment of oral lichen planus (OLP). METHODS: Through an RCT design, 47 patients with OLP were randomly allocated for topical OLP treatment with fluocinonide 0.05% (n = 23) or placebo (n = 24). Patients were examined for OLP symptoms, signs, disease severity, and extension score changes over 6-month follow-up. RESULTS: After 6 months, in comparison with placebo, patients treated with fluocinonide experienced a significant reduction of OLP symptoms (p = 0.024), signs (p = 0.014), and OLP extension score (p = 0.028). The two-way ANOVA estimation models revealed that treatment with fluocinonide determined, at 6 months, a positive significant effect on the reduced OLP signs (p = 0.017), OLP symptoms (p = 0.026), and OLP extension score (p = 0.028). The multivariate regression analysis highlighted that anxiety, stress, and depression were significant predictors of every analyzed OLP outcome (p < 0.05 for each parameter) and that patients who had baseline anxiety, depression, and stress gained more benefits from fluocinonide at 6-month follow-up. CONCLUSIONS: Topical fluocinonide 0.05% was more efficacious compared to placebo in reducing OLP outcomes at 6-month follow-up. Anxiety, depression, and stress were significant predictors of OLP outcomes and positively impacted the treatment with fluocinonide at 6 months.

Altmetric and impact analysis of randomized clinical trials in dentistry.

OBJECTIVES: This study investigated altmetrics, citations, and field-normalized impact of dental articles reporting randomized clinical trials (RCTs) published within a one-year period. METHODS: Data were collected in 2024 from PubMed-indexed RCTs published in 2019. Dependent variables included Altmetric Attention Scores (AAS), PlumX citations, and Field-Weighted Citation Impact (FWCI). Independent variables encompassed article-, author-, and journal-related variables. Adjusted quasi-Poisson regression models were used to assess associations. Point-biserial correlation evaluated the relationship between Journal Impact Factor (JIF) and selected reporting variables. RESULTS: A total of 653 RCTs were included, with periodontology, implantology, and oral and maxillofacial surgery comprising 50.4 % of the sample. Only 28.6 % of the articles reported CONSORT use, 49.6 % pre-registered their protocol, and 68.8 % reported a sample size calculation. Most articles (63.6 %) reported no conflicts of interest, with unclear sponsorship being the most frequent (34.6 %). Regression analyses revealed significant associations for AAS, PlumX citations, and FWCI with various factors. JIF increased AAS by 17 % per unit, PlumX citations by 13 %, and FWCI by 6 %. Protocol pre-registration boosted AAS by 132 %, while mixed or no sponsorship increased PlumX citations by up to 47 %. First author H-index increased PlumX citations and FWCI by 1 % per unit, while first author continent impacted AAS, citations, and FWCI. Weak positive correlations between JIF and both protocol pre-registration and CONSORT use were observed. No significant differences were observed across different dental fields for any metric. CONCLUSION: An interplay among article-, author-, and journal-related variables collectively influenced the online attention, citations, and impact of dental RCT articles. CLINICAL SIGNIFICANCE: Understanding the factors that influence the visibility and impact of dental RCTs can guide researchers in improving the design, reporting, and dissemination of their studies, ultimately enhancing the quality and reach of dental research.

Effectiveness of direct patient outreach with a narrative naloxone and overdose prevention video to patients prescribed long-term opioid therapy in the USA: the Naloxone Navigator randomised clinical trial.

INTRODUCTION: Public health efforts to reduce opioid overdose fatalities include educating people at risk and expanding access to naloxone, a medication that reverses opioid-induced respiratory depression. People receiving long-term opioid therapy (LTOT) are at increased risk for overdose, yet naloxone uptake in this population remains low. The objective of this study was to determine if a targeted, digital health intervention changed patient risk behavior, increased naloxone uptake, and increased knowledge about opioid overdose prevention and naloxone. METHODS: We conducted a pragmatic randomized clinical trial among patients prescribed LTOT in a health care delivery system in Colorado. Participants were randomly assigned to receive an animated overdose prevention and naloxone educational video (intervention arm) or usual care (control arm). The 6-minute video was designed to educate patients about opioid overdose and naloxone, increase overdose risk perception, and prompt them to purchase naloxone from the pharmacy. Over an 8-month follow-up, opioid risk behavior was assessed with the Opioid-Related Behaviors in Treatment survey instrument, and overdose and naloxone knowledge was measured with the Prescription Opioid Overdose Knowledge Scale after viewing the video at baseline. Naloxone dispensations were evaluated using pharmacy data over a 12-month period. Data were analyzed with generalized linear mixed effects and log-binomial regression models. RESULTS: There were 519 participants in the intervention arm and 485 participants in the usual care arm. Opioid risk behavior did not differ between the study arms over time (study arm by time interaction P=0.93). There was no difference in naloxone uptake between the arms (RR = 1.13, 95% CI: 0.77-1.66). Knowledge was significantly greater in the intervention arm compared to usual care (P<0.001). CONCLUSIONS: A targeted, digital health intervention video effectively increased opioid overdose and naloxone knowledge, without increasing opioid risk behavior. Naloxone uptake did not differ between the intervention and usual care arms. TRIAL REGISTRATION: ClinicalTrials.gov number NCT03337009.

Effect of Tenofovir Alafenamide Fumarate on the outcomes of hospitalized COVID-19 patients: a prospective, block-balanced, open-label, randomized controlled trial.

BACKGROUND: The global effort to cure COVID-19 is still ongoing. Thus, a prospective, block-balanced, open-label, randomized controlled trial was conducted to evaluate how Tenofovir Alafenamide Fumarate affects hospitalized COVID-19 patients' outcomes. METHODS: The intervention and control groups of 60 hospitalized COVID-19 patients were randomly allocated. Along with normal medication, the intervention group received 25 mg of tenofovir orally daily for seven days. The control group got normal therapy, including remdesivir and corticosteroids. ICU hospitalization duration, laboratory data, fever, dyspnea, arterial blood oxygen saturation with and without an oxygen face mask, mechanical ventilation, and mortality were the outcomes. RESULTS: Sixty of 236 eligible patients between September 2020 and February 2021 were enrolled. The intervention group had a mean age (±SD) of 61.33 (±13.09) years and the control group 60.03 (±18.03). Sixteen (53.3%) intervention patients and 15 (50.0%) control patients were males. The intervention group had fewer mechanical ventilation and ICU days. Tenofovir Alafenamide Fumarate did not improve fever, dyspnea, oxygen saturation with or without a face mask or nasal cannula, or laboratory data including WBC, ESR, CRP, AST, ALT, AlkP, total and direct bilirubin, in COVID-19 patients. CONCLUSION: According to this pilot trial, Tenofovir Alafenamide Fumarate, along with conventional treatment, significantly reduced mechanical ventilation and ICU stay in COVID-19 patients. Further thorough research is necessary to verify this conclusion.

The Cancer Patient Empowerment Program: A Comprehensive Approach to Reducing Psychological Distress in Cancer Survivors, with Insights from a Mixed-Model Analysis, Including Implications for Breast Cancer Patients.

BACKGROUND/OBJECTIVES: Psychological distress is a significant concern among cancer patients, negatively affecting their quality of life and adherence to treatment. The Cancer Patient Empowerment Program (CancerPEP) was developed as a comprehensive, home-based intervention aimed at reducing psychological distress by incorporating physical activity, dietary guidance, and social support. This study aimed to evaluate the feasibility, accrual and attrition rates, safety, and effectiveness of the CancerPEP intervention, with and without the biofeedback device, on psychological distress from baseline to 6 months, specifically focusing on the effects of group randomization and the difference between pre- and post-intervention results. METHODS: This single-site, crossover randomized clinical trial included 104 cancer patients who were randomized to receive the CancerPEP intervention, with or without a Heart Rate Variability (HRV) biofeedback monitor. At 6 months, participants who did not receive the device were allowed to use one until the end of the year, while those who did receive the device were followed up to 12 months. Randomization was stratified by the presence or absence of clinically significant psychological distress and metastatic status. Psychological distress was assessed using the Kessler Psychological Distress Scale (K10) at baseline, 6 months, and 12 months. The primary endpoint was the presence of nonspecific psychological distress, as measured by the K10 scale at 6 months from the trial start, based on group randomization. A secondary exploratory analysis assessed psychological distress at baseline, 6 months, and 12 months for both groups, while controlling for group randomization and prognostic covariates. Prognostic covariates included age; comorbidities; time between diagnosis and randomization; treatment modality; relationship status; and use of prescribed medications for anxiety, depression, or both. An exploratory sub-analysis was conducted for the breast cancer subgroup, based on the sample size available after recruitment. The trial is registered at ClinicalTrials.gov (NCT05508412). RESULTS: The provision of the HRV biofeedback monitor in conjunction with the CancerPEP intervention did not significantly affect the primary outcome in either the full sample or the breast cancer subgroup, indicating that the HRV biofeedback provision was not beneficial in this trial. No self-reported or otherwise discovered adverse events at the 6-month mark were observed. About 10% of participants were lost to follow-up in both the early and late HRV monitor provision groups. Participation in the CancerPEP program led to a significant reduction in psychological distress over time. The odds of psychological distress were significantly higher at the start of the trial than at the end of the intervention (aOR = 2.64, 95% CI: 1.53-4.56) or 6 months after the intervention (aOR = 2.94, 95% CI: 1.62-5.30). Similarly, in the breast cancer subgroup, distress was higher at the trial's start than at 6 months, i.e., after the intervention (aOR = 2.25, 95% CI: 1.24-4.08), or at the end of the trial at 12 months (aOR = 2.73, 95% CI: 1.35-5.52). CONCLUSIONS: CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer types and stages, including benefits specifically for breast cancer patients. These findings build upon the success of the Prostate Cancer Patient Empowerment Program (PC-PEP), indicating that a similar comprehensive intervention can be advantageous for all cancer patients and may be further tailored to address specific needs. With its holistic approach-encompassing physical, dietary, and psychosocial support-CancerPEP shows promise as a vital component of survivorship care. Ongoing 24-month evaluations will yield critical data on its long-term benefits. Additionally, a randomized trial with a control group (usual care without intervention) for breast cancer patients is currently under way and could potentially guide the integration of CancerPEP into standard oncology care to enhance patient outcomes and quality of life.

Influence of Peanut Consumption on the Gut Microbiome: A Randomized Clinical Trial.

Background: Peanut consumption could impact cardiometabolic health through gut microbiota, a hypothesis that remains to be investigated. A randomized clinical trial in Vietnam evaluated whether peanut consumption alters gut microbiome communities. Methods: One hundred individuals were included and randomly assigned to the peanut intervention and control groups. A total of 51 participants were provided with and asked to consume 50 g of peanuts daily, while 49 controls maintained their usual dietary intake for 16 weeks. Stool samples were collected before and on the last day of the trial. After excluding 22 non-compliant participants and those who received antibiotic treatment, 35 participants from the intervention and 43 from the control were included in the analysis. Gut microbiota composition was measured by shotgun metagenomic sequencing. Associations of changes in gut microbial diversity with peanut intervention were evaluated via linear regression analysis. Linear mixed-effects models were used to analyze associations of composition, sub-community structure, and microbial metabolic pathways with peanut intervention. We also performed beta regression analysis to examine the impact of peanut intervention on the overall and individual stability of microbial taxa and metabolic pathways. All associations with false discovery rate (FDR)-corrected p-values of <0.1 were considered statistically significant. Results: No significant changes were found in α- and ß-diversities and overall gut microbial stability after peanut intervention. However, the peanut intervention led to lower enrichment of five phyla, five classes, two orders, twenty-four metabolic pathways, and six species-level sub-communities, with a dominant representation of Bifidobacterium pseudocatenulatum, Escherichia coli D, Holdemanella biformis, Ruminococcus D bicirculans, Roseburia inulinivorans, and MGYG-HGUT-00200 (p < 0.05 and FDR < 0.1). The peanut intervention led to the short-term stability of several species, such as Faecalibacterium prausnitzii F and H, and a metabolic pathway involved in nitrate reduction V (p < 0.05; FDR < 0.1), known for their potential roles in human health, especially cardiovascular health. Conclusions: In summary, a 16-week peanut intervention led to significant changes in gut microbial composition, species-level sub-communities, and the short-term stability of several bacteria, but not overall gut microbial diversity and stability. Further research with a larger sample size and a longer intervention period is needed to confirm these findings and investigate the direct impact of gut-microbiome-mediated health effects of peanut consumption. Trial registration: The International Traditional Medicine Clinical Trial Registry (ITMCTR). Registration number: ITMCTR2024000050. Retrospectively Registered 24 April 2024.

Transcutaneous Tibial Nerve Stimulation for Quality-of-Life Improvement and Sleep Deficiency in Women with Primary Dysmenorrhea: A Randomized Clinical Trial.

Background: Primary dysmenorrhea is a leading cause of chronic cyclic pelvic pain, contributing to a reduced quality of life and sleep disturbances in women. The objective of this study was to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving the quality of life, sleep, and overall health perceptions of participants compared to a control group of women with dysmenorrhea over short-term, medium-term, and long-term periods. Methods: A single-blind, controlled clinical trial was conducted, with participants randomly assigned to an experimental group (receiving TTNS) or a control group (receiving sham TTNS). Both groups underwent 12, weekly 30 min sessions using the NeuroTrac™ PelviTone electrostimulation device. Outcomes related to quality of life, sleep deficiency, and overall improvement were evaluated at three time points: short-term (post-treatment), medium-term (1-3 months), and long-term (6 months). Results: Of the 61 participants initially randomized (31 in the experimental group and 30 in the control group), 55 completed the study and were included in the final analysis. A statistically significant improvement was observed in the experimental group in both physical and mental health components, as measured by the SF-36v2® questionnaire, following 12 weeks of intervention, compared to the control group, persisting 6 months after the intervention. Additionally, statistically significant differences in overall improvement were noted between the two groups, as measured by the PGIC questionnaire at the end of treatment (p = 0.0103) and 6 months post-treatment (p = 0.0432). Conclusions: TTNS appears to be a safe and effective strategy for enhancing quality of life and overall health in women with PD, potentially reducing the reliance on pharmacological treatments or more invasive methods.

Effect of Xuefu zhuyu oral liquid on tension-type headache: A randomized clinical trial.

BACKGROUND: Tension-type headache (TTH) is the most common neurological disorder worldwide, incurring immense social and economic costs and affecting quality of life. However, due to adverse reactions and inadequate effectiveness, there is still an unmet need for treatment. Xuefu zhuyu oral liquid (XZOL) is a Chinese patent medicine widely used for TTH in China, but evidence of its efficacy remains scant. PURPOSE: The aim of this study was to assess the efficacy and safety of XZOL for TTH patients. METHODS: This multicenter, double-blind, randomized placebo-controlled trial enrolled 174 patients with TTH in six centers in China from March 2020 to October 2021. Patients were randomly assigned to receive XZOL or a matched placebo for 4weeks. The primary outcome was the change in the mean headache intensity as measured by a visual analogue scale (VAS) from baseline to the end of treatment (Week 4). Secondary outcomes were the change in VAS from baseline to Week 12, the area-under-the-headache curve (AUC), response rate, number of headache days, average headache duration, rescue medication use proportion, etc. RESULTS: Of the 174 patients who were randomized, 160 completed the study. There was no significant difference in the mean change in VAS from baseline to the end of treatment between the XZOL group and the placebo group (-0.29; (95 % CI:0.81 to 0.23; p = 0.279) in the full analysis set (FAS), while there were statistically significant results (-0.9; 95 % CI:1.47 to -0.33; p = 0.002) in the per-protocol set (PPS). There were no significant differences in any of the secondary outcomes. The incidence of adverse events was similar in the two groups. CONCLUSION: XZOL may be an alternative option to relieve pain for TTH patients with high compliance in clinical practice. However, XZOL did not improve headache measurements in the FAS population.