A phase II randomized, double-blind, placebo-controlled study of Nuvastatic (C50SEW505OESA), a standardized rosmarinic acid-rich polymolecular botanical extract formulation to reduce cancer-related fatigue in patients with solid tumors.

AIM: We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA) in improving cancer-related fatigue (CRF) among cancer patients. METHODS: This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA). RESULTS: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen's d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%). CONCLUSION: Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials. TRIAL REGISTRATION: ClinicalTrial.gov ID: NCT04546607. Study registration date (first submitted): 11-05-2020.

Who are the patients who use non-pharmacological home remedies? Cross-sectional study in Switzerland and France.

BACKGROUND: Many patients may be tempted to use non-pharmacological home remedies (NPHRs) to relieve various complaints. To the best of our knowledge, there is little data on the characteristics of patients using NPHRs. In this cross-sectional study carried out between March 2020 and July 2021, we examined the socio-demographic factors underlying their use in patient populations in Switzerland and France. METHODS: Using official registries, we randomly selected 50 primary care physicians (PCPs) in Geneva (Switzerland) and Lyon/Grenoble (France). Seven research assistants consecutively recruited patients from PCP waiting rooms (20-25 patients per practice). Patients completed a paper-based questionnaire assessing the use [yes/no] of 304 NPHRs for 79 medical conditions. The NPHR list was developed by our team with input from 97 patients. We used univariable and multivariable logistic regressions, adjusting for intra-cluster correlations, to examine associations between NPHR use and patient characteristics (gender, age, practice location, nationality, education level, and self-rated health). RESULTS: Of the 1198 eligible patients, 1012 agreed to participate (85%). Overall, 635 patients (63%) reported using at least one of the remedies tested in the study. In multivariable analysis, women (OR = 1.7 [95%CI = 1.3-2.3], P-value < 0.001), younger patients (< 40 years: OR = 2.1 [95%CI = 1.6-2.9], P-value < 0.001), and French patients (OR = 1.6 [95%CI = 1.1-2.3], P-value < 0.001) tended to use NPHRs more often than other patients. CONCLUSIONS: Many patients, particularly women, young people, and French patients, reported using NPHRs. This survey's findings hold the potential to inform healthcare providers, policymakers, and researchers about the diverse preferences that shape patients' healthcare choices.

Efficacy of Exclusive Fat Grafting for Breast Reconstruction: An Updated Systematic Review and Meta-analysis.

BACKGROUND: Exclusive fat grafting is an alternative method to implant- or flap- based reconstruction techniques following mastectomies or breast conservation therapies. Its efficacy has been explored before but new data has come to light, resulting in previous results becoming outdated. Concerns have also been raised about the oncological safety of this procedure which must be evaluated alongside the efficacy to gain a comprehensive understanding of the merits of this alternative technique. METHODS: We queried the PubMed electronic database from its inception until August 2023 for studies evaluating the efficacy and oncological safety of exclusive fat grafting breast reconstruction following cancer-related mastectomy or breast conservation therapy. Results of the analysis were pooled and presented as means or valid proportions. Results of the analysis were pooled using a random-effects model and presented with 95% confidence intervals (95% CIs) where appropriate. RESULTS: 41 studies were included in our analysis. Pooled results show that on average, 1.7 sessions of exclusive fat grafting were required to complete reconstruction in Breast Conservation Therapy (BCT) patients, with an average volume of 114.2 ml being injected. For mastectomy patients with irradiated breasts, 4.7 sessions were needed on average with 556.8 ml being required to complete reconstruction, compared to their non-irradiated Counterparts requiring only 2.6 sessions and 207.2 ml to complete reconstruction. Oncological recurrence events were found in 29/583 non-irradiated mastectomy patients (p = 0.014) and in 41/517 BCT patients (p = 0.301) CONCLUSION: Exclusive fat grafting is an oncologically safe and reasonably efficacious alternative to more common methods of breast reconstruction. More data is needed to fully characterize the oncological safety of this procedure in irradiated and non-irradiated mastectomy patients. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Autograft Reoperation Following the Ross Procedure: Evolving Strategies and Future Perspectives.

Background: Pulmonary autograft failure remains a cause of reoperation following the Ross procedure. The aim of this study is to describe our evolving approach to autograft reoperations. Methods: Retrospective study of all patients who underwent a pulmonary autograft reoperation following a Ross procedure between June 1997 and July 2022. Results: Two-hundred and thirty-five Ross procedures were performed. Thirty-six patients (15%) plus one referral underwent an autograft reoperation at a median of 7.8 years (IQR 4.6-13.6). The main indication was: neoaortic root dilatation associated with mild/moderate (n = 12) or severe (n = 8) aortic regurgitation; isolated severe aortic regurgitation (n = 6); infective endocarditis (IE) (n = 8); and aortic root pseudoaneurysm with no history of IE (n = 3). The autograft was spared in 29 cases (78%): 9 patients (24%) underwent aortic valve repair or aortic root remodeling, 15 patients (40%) aortic root reimplantation, 5 patients neoaortic root stabilization with a Personalized External Aortic Root Support (PEARS) sleeve. There were no in-hospital deaths. At a median follow up of 37 months (IQR 8-105), all patients were alive, 30 (81%) were asymptomatic. Eight patients (22%) required nine further reoperations. Estimated freedom from further reoperation was 90%, 72%, and 72% at 12-, 36-, and 60-months. Conclusions: Autograft reoperations following the Ross procedure can be safely performed and do not affect overall survival in the early and mid-term. Valve-sparing autograft replacement is technically feasible but remains at risk of further interventions. Alternative strategies, such as the PEARS sleeve, are becoming increasingly available but requires validation in the long term.

RETRACTED: Alhakamy et al. Optimized Icariin Phytosomes Exhibit Enhanced Cytotoxicity and Apoptosis-Inducing Activities in Ovarian Cancer Cells. Pharmaceutics 2020, 12, 346.

The journal retracts the article, "Optimized Icariin Phytosomes Exhibit Enhanced Cytotoxicity and Apoptosis-Inducing Activities in Ovarian Cancer Cells" [...].

RETRACTED: Alhakamy et al. Chitosan-Based Microparticles Enhance Ellagic Acid's Colon Targeting and Proapoptotic Activity. Pharmaceutics 2020, 12, 652.

The journal retracts the article "Chitosan-Based Microparticles Enhance Ellagic Acid's Colon Targeting and Proapoptotic Activity" [...].

A Systematic Evaluation of the Quality of Health Information on Cleft Lip and Palate in the Arabic Language.

Background: The internet serves as a vital health information resource, yet the quality of data on specific health conditions, especially in Arabic, is often overlooked. This research assesses the quality of Arabic online information about cleft lip and palate (CLP) and proposes avenues for enhancement. Methods: From July to August 2022, a systematic evaluation of Arabic articles on CLP was performed using the DISCERN tool for quality assessment. Searches on Google and Bing resulted in 119 articles that met the study's criteria. Results: The quality of available Arabic information on CLP displayed substantial gaps. Commercial sources dominated (49.6%), followed by private (32.8%) and nonprofit entities (17.6%). The average DISCERN score was 2.26 of 5 (SD = 1.06), indicating the need for enhanced content, particularly concerning treatment risks. Conclusions: The study underscores the subpar quality of Arabic CLP information online, which might mislead patients and impede access to accurate advice. Nonprofit organizations should bolster their online footprint, offering refined health content. A deep dive into DISCERN scores reveals pinpointed improvement areas. Clinicians should direct patients and their families to reliable information sources. Addressing these gaps promises improved CLP knowledge in Arabic, fostering superior patient education and outcomes for those with this condition.