Objective: Lunasin, a soy peptide that reportedly alters histone acetylation in vitro, was associated with a single ALS reversal in the media. Following an ALSUntangled report, we sought to determine whether Lunasin altered histone acetylation and improved progression in people with ALS, and whether patient-centric trial design features might improve enrollment and retention. Methods: This single-center, year-long trial (NCT02709330) featured broad inclusion criteria, historical controls, primarily virtual data collection, and real-time results. Participants measured their own ALSFRS-R score, weight and perceived efficacy, and recorded these monthly on PatientsLikeMe. Blood tests at screening and month 1 assessed alterations in histone H3 and H4 acetylation. The protocol was published online, empowering patients outside the study to self-experiment. Results: Fifty participants enrolled in 5.5 months. Although this population had more advanced disease compared to other trials, retention and adherence were very high. There was no significant effect of Lunasin treatment on histone acetylation or disease progression. A cohort following our protocol outside the trial reported similar side effects and perceived effectiveness; however, their compliance with data entry was markedly lower. Conclusions: While Lunasin's lack of efficacy is disappointing, our novel trial design had the highest ALS trial enrollment rate ever recorded, with excellent retention and adherence. Low data density from patients who are selfexperimenting outside a formal protocol casts doubt on the possibility of gathering useful information from unsupervised expanded access programs or "right to try" initiatives.
(1) Background: Several studies investigating the clinical outcomes of potentially premalignant oral epithelial lesions treated with CO2 lasers have been published over the last decades. (2) Methods: A systematic research review was performed for studies published between 2011 and 2021 in the PubMed, Science Direct, and Google Scholar databases. (3) Results: Initially, the search identified 52 relevant articles. The primary analysis of the titles and abstracts eliminated 22 articles, leaving 30 articles whose full texts were examined. A total of 22 articles met the inclusion criteria. The studies were classified into 3 categories. (4) Conclusions: After evaluating the results of all the studies included in this review, an initial general statement can be made, namely that CO2 lasers are a treatment option worth taking into consideration when approaching oral mucosal lesions. When compared to other types of lasers used in dental practice, the CO2 laser stands out due to its many advantages.
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