Over the last week, I have privately been in contact with several friends and collaborators over the *SINGLE* study that was cited by the FDA in supporting the label extension of leucovorin for autism spectrum disorders. https://lnkd.in/dHpfCt_9 https://lnkd.in/dYWbHXyY Given the enormous importance of this study, and the fact that the results look too good to be true and there are various signals I would have thought would have raised a sleuth eyebrow (for example, Table 1 where all categorical values in each group except for 1 differ by exactly one unit), I am very surprised that until now the only Pubpeer comments are by two MDs and by myself, pointing to some inconsistencies between tables and figures. https://lnkd.in/duFQDccr I have also formally asked the authors for the individual participant data. Perhaps given this is not some random wacky study about how much food can one eat in a fast-food or some obscure paper citing another obscure retracted paper, but the SINGLE study that now underpins the retrospective post-marketing approval of an entire treatment, the very large community of people who want to correct science ASAP particularly when findings have huge policy implications could join me in scrutinizing this study to make sure findings are reliable and that the data are correct and analyzed correctly. | 13 comments on LinkedIn
RETRACTED ARTICLE: Efficacy of oral folinicacid supplementation in children with autism spectrum disorder: a randomizeddouble-blind, placebo-controlled trial
Oral folinic acid has shown potential to improve symptoms in childrenwith autism spectrum disorder (ASD). However, randomized controlled trials (RCTs)are limited. This double-blind, placebo-controlled RCT aimed to compare changes inChildhood Autism Rating Scale (CARS) scores in children with ASD aged 2–10 years,among folinic acid (2 mg/kg/day, maximum of 50 mg/day) and placebo groups at24 weeks, in comparison with baseline. Both the groups received standard care (ABAand sensory integration therapy). Secondary objectives included changes inbehavioral problems measured by the Child Behavior Checklist (CBCL) and serum levelsof anti-folate receptor autoantibodies and folic acid, correlated with changes inautism symptom severity. Out of the 40 participants recruited in each group, 39 and38 participants completed the 24-week follow-up in the folinic acid and placebogroups, respectively. The change in CARS score was higher in the folinic acid group(3.6 ± 0.8) compared to the placebo group (2.4 ± 0.7, p < 0.001). Changes in CBCL total score and CBCL internalizingscore were also better in the folinic acid group (19.7 ± 9.5 vs. 12.6 ± 8.4 and15.4 ± 7.8 vs. 8.5 ± 5.7, p < 0.001 for both).High-titer anti-folate receptor autoantibodies were positive in 32/40 and 33/40cases in the folinic acid and placebo groups, respectively (p = 0.78). In the placebo group, improvement in CARS score wascomparable regardless of autoantibody status (p = 0.11), but in the folinic acid group, improvement was morepronounced in the high-titer autoantibody group (p = 0.03). No adverse reactions were reported in either group.
Annual Reports | CAA
For archived content, please refer to the National Diet Library's Web Archiving Project (WARP).
Nut intake and hyperuricemia risk in young adults
Objective:The relationship between dietary nut intake and hyperuricemia risk remains unclear. The aim of this study was to investigate the relationship between different nut intake and hyperuricemia risk with a cross-sectional study.Design:A semi-quantitative FFQ was adopted to collect dietary information. Biochemical and anthropometric parameters were measured by standard methods. Multivariate-adjusted logistic regression models were implemented to analyse the relationship between individual nut intake and hyperuricemia risk.Setting:Qingdao University in Shandong Province, China.Participants:During 2018–2019, a total of 14 056 undergraduates (6862 males and 7194 females) aged 15–25 years participated in the study.Results:After adjusting for multiple confounding factors, compared with the lowest quartile, the highest quartile intakes of pine nut (95 % CI (0·51, 0·98)) was significantly associated with 29 % reduction in hyperuricemia risk, the highest quartile intake of walnut (OR = 0·78; 95 % CI (0·58, 1·05)) was marginally negatively associated with hyperuricemia risk.Conclusions:The present study showed that the relationships between intakes of different nuts and hyperuricemia risk were different. Increased dietary intakes of walnut and pine nut are negatively associated with the hyperuricemia.
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Nikhil Krishnan on Twitter / X
yeah there used to be a company called Eureka that powered these types of observational, more lifestyle style studies (here's an example looking at coffee's effect on different biomarkers/conditions)https://t.co/urQRvTVTb7I think it can work if you have enough people in…— Nikhil Krishnan (@nikillinit) September 14, 2025
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Genetic Determinants of Macronutrient Intake Are Associated With Specific Food Intake in Youth: A Cohort Study Across Childhood and Adolescence
OBJECTIVE. We examined associations of polygenic scores (PS) for macronutrient intake with food intake and cardiometabolic outcomes during childhood and ad
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“Statistical Significance” and Statistical Reporting: Moving Beyond Binary
Null hypothesis significance testing (NHST) is the default approach to statistical analysis and reporting in marketing and the biomedical and social sciences more broadly. Despite its default role, NHST has long been criticized by both statisticians and applied researchers, including those within marketing. Therefore, the authors propose a major transition in statistical analysis and reporting. Specifically, they propose moving beyond binary: abandoning NHST as the default approach to statistical analysis and reporting. To facilitate this, they briefly review some of the principal problems associated with NHST. They next discuss some principles that they believe should underlie statistical analysis and reporting. They then use these principles to motivate some guidelines for statistical analysis and reporting. They next provide some examples that illustrate statistical analysis and reporting that adheres to their principles and guidelines. They conclude with a brief discussion.
so I just commented on that paper in Cell Host and Microbe that is cited as evidence that the autism/microbiome link is solid: pubpeer.com/publications/9A4B5695950D3396… (not sure what the word “precision” is supposed to mean in the title) tldr; looks p-hacked 🫤 and I couldn’t find the ethics approval 🤔
PubPeer - Precision microbial intervention improves social behavior bu...
pubpeer.com
Kevin Mitchell
Criticism of Autism-Gut Microbiome Research Sparks Pushback the-scientist.com/criticism-of-autism-gut-micro…
This is crazy! The data from the study show patterns that make it nearly impossible for it to be legit. But we can learn a lot from the tone of the comments. "We have concerns about [x], please clarify." Out in the wild, this would be THESE IDIOTS FAKED THEIR STUDY!!
Health Nerd
This is one of the most remarkable academic debacles I've ever seen. A large RCT got published in BMJ. There are currently 44 Pubpeer comments, mostly about the data, including...well. Read for yourself. pubpeer.com/publications/C08779C45DB6E407…
New Ketamine study 🧪. Abstract: ✅Ketamine "tablets were effective, safe & well tolerated" Actual results: ❌At primary endpoint of 13 weeks, 0 of 4 ketamine groups outperformed placebo /re remission ❌At 13 weeks, only 1 of 4 outperformed placebo /re response, with a beautiful p-value of 0.046 🤪
Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial - Nature Medicine
www.nature.com@bmj.com Please look at PubPeer comments on an article you published last week. pubpeer.com/publications/C08779C45DB6E407… I think your research integrity dept shld act swiftly on this one, given clinical significance. I'm aware of even more evidence of problems so let me know if this is not sufficient.
PubPeer - Prevention of acute myocardial infarction induced heart fail...
pubpeer.com
