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Placebo - Wiley Online Library

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Last Updated: 26 September 2022

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Low Intensity Vibration Protects the Weight Bearing Skeleton and Suppresses Fracture Incidence in Boys with Duchenne Muscular Dystrophy: A Prospective, Randomized, Double‐Blind Placebo Controlled Clinical Trial

In a random controlled trial, the ability of low intensity vibration to combat skeletal degeneration in Duchenne Muscular Dystrophy was investigated. Ten DMD boys were expected to stand for 10 minutes/d on an Active LIV platform, while ten boys were on a Placebo unit. With DXA and trabecular bone density of tibia with QCT, baselineline and 14 month BMC and BMD of spine, hip, and total body were determined, as well as bone, hip, and total body with DXA. Hip BMD and BMC in Placebo dropped 22% and 13% respectively, compared to no change from baseline in Active, with no change from baseline. Three incident fractures in three placebo patients were reported in three placebo patients, but no new fractures were found in Active subjects across the 14-month study. In summary, these findings show that non-u2010invasive LIV can help shield the skeleton of DMD children against disease progression, reduced load bearing, and chronic steroid use.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/jbm4.10685


An exploratory machine learning approach to identify placebo responders in pharmacological binge eating disorder trials

Short-u2010 placebo responses have been found in highly randomized, placebo-controlled studies for binge eating disorder, which have often increased, and often highly marked, rates of short-term placebo response. Several quantitative based studies in patients with BED have inconsistently identified which patient causes an increase in placebo response. This research intends to use machine learning algorithms to identify moderators of placebo response in patients with BED. Patients with a u226575% drop in binge eating frequency at the study's end point were classified as patients who were experiencing a u226575% decrease in binge eating frequency at the study end point. Patients with low baseline BEF and anxiety status, according to Shapley's review, are key influencers of placebo responses. This is the first use of ML to find moderators of placebo response in BED. The results of this report support previous findings of reduced baseline disease prevalence, although it does indicate that patients with no anxiety are more vulnerable to placebo responses.

Source link: https://onlinelibrary.wiley.com/doi/10.1111/cts.13406


EPO AND THE ATHLETE BIOLOGICAL PASSPORT: HEMATOLOGICAL RESULTS FROM A PLACEBO‐CONTROLLED, BOOSTING AND MICRODOSE EPO ADMINISTRATION IN MALE RECREATIONAL ATHLETES

The Athlete Biological Passport from a placebo-controlled EPO administration study is published here, as a result of a placebo-u2010controlled EPO administration study. Over the course of twenty days, twelve participants administered eight subcutaneous boosting doses of epoetin alfa. The blinded Placebo cohort followed the same dosing pattern, administering saline rather than EPO, rather than EPO. In 49 percent of the samples obtained during the boosting and initial washout phases, and 24% of the samples during the microdosing and final washing phases, according to ABP's perspective. From all samples collected from the Placebo cohort, only a single ATPF was identified. All volunteers in the study were interviewed in the study, giving an opportunity to clearly show variations in the magnitude and timing of the hematological changes caused by EPO on the individual level. These reports are expected to include useful information for Athlete Passport Management Units and ABP expert panels alike, and are likely to include valuable information for Athlete Passport Management Units and ABP expert panels alike.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/dta.3370


The effects of rutin flavonoid supplement on glycemic status, lipid profile, atherogenic index of plasma, brain‐derived neurotrophic factor (BDNF), some serum inflammatory, and oxidative stress factors in patients with type 2 diabetes mellitus: A double‐blind, placebo‐controlled trial

This research was conducted to determine the effects of rutin flavonoid in type 2 diabetes mellitus patients. For 3 u2010 months, 50 T2DM patients were randomly distributed and supplemented with 500 mg rutin or placebo per day. The mean changes of FBG, insulin, HbA1c, HOMOu2010c, LDL. HDL, ChOL, LDL, AIP, MDA, and IL20106 were much higher in the rutin group in comparison to the placebo group, but remarkably higher. In T2DM patients, it seems that rutin may have beneficial effects on improving metabolic function, BDNF, and inflammatory and oxidative stress factors.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/ptr.7611


Long‐Term Selenium‐Yeast supplementation does not affect bone turnover markers: A Randomised‐Placebo controlled trial

In epidemiological studies, a higher selenium status has been correlated with lower bone turnover measurements. In the short and long run, we investigated the effects of selenium supplementation on BTMs, including osteocalcin, procollagen type I, Nau2010terminal propeptide, collagen type I, and bone alkaline phosphatase. The randomisation of placebos vs. 100, 200, or 300,000, or 300 selenium as selenium selenium, enriched yeast, daily for five years was randomly distributed among 481 Danish men and women. In non-fasted samples at baseline, 6 months, and 5 years, plasma selenium concentration was determined using inductivelyu2010plasma mass spectrometry and BTMs. After 6 months and stayed high at 5 years, plasma selenium concentrations soared dramatically with increasing selenium supplementation to 152. 6, 209. 1 and 253. 7 u03bcg/L. In the placebo group, there was no change in plasma selenium levels. Testing in more disadvantaged populations may provide further insight into the effects of selenium supplementation on bone health.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/jbmr.4703


Savor the flavor: A randomized double‐blind study assessing taste‐enhanced placebo analgesia in healthy volunteers

Placebo effects play a significant role in analgesic disease management and may be able to develop goldu2010standard treatments. Participants were exposed to experimental tonic cold water pain before, or after receiving taste buds of taste-u2010neutral, bitter, sweet, or no placebo drops. The primary result, however, revealed that placebo therapy produced a small analgesic effect compared to no treatment. Sweet over bitter placebo was not apparent, but no convincing advantage was shown by the sweet over bitter placebo. An increase in peak HRu2010response to cold water was linked to an increase in peak HRu2010response to cold water, according to an analysis of heart rate recordings, but placebo analgesia was not related to individual level. Addition taste may be a fast-u2010implement, cost-effective, and safe way to ensure treatment outcomes, as well as reducing placebou2010 related outcome variation in clinical trials, according to these results.

Source link: https://onlinelibrary.wiley.com/doi/10.1111/cts.13397


Informed Consent for Placebo‐Controlled Trials: Do Ethics and Science Conflict?

The use of a placebo has been deemed the most reliable measure of medical effectiveness in assessing a medical therapy in a prospective randomized clinical trial. However, placebo trials, determining the sample size, seeking permission, or analyzing clinical trial findings are often ignored when designing a scientific trial, determining the sample size, obtaining consent, or reporting clinical trial findings are often overlooked.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/eahr.500142


Safety and immunogenicity of a recombinant receptor‐binding domain‐based protein subunit vaccine (Noora vaccine™) against COVID‐19 in adults: A randomized, double‐blind, placebo‐controlled, Phase 1 trial

In adults, we have evaluated the effectiveness and immunogenicity of a recombinant receptor-u2010 binding domain u2010binding domain u2010-19 protein subunit vaccine against COVIDu201019. In healthy adult volunteers, this Phase 1 trial is a double-blind, placebo-controlled experiment to determine the effectiveness and immunogenicity of the recombinant RBD–u2010b-u2010 immunoglobinant subunit vaccine against COVIDu201019. Secondary outcomes including the humoral and cellular immunity were determined on days 0, 21, 28, 35, 42, and 49 by using the ELISA kit and the Virus Neutralization Test was carried out on day 49. In 80% of the vaccinated volunteers, there was local pain at the vaccination site. The anti-u2010RBD IgG antibody and neutralizing antibody test showed significant seroconversion in comparison to the placebo group. The cellular immunity panel also demonstrated moderate to moderate induction of TH1 responses, and the VNT showed 78% of seroprotection, with mild to moderate induction.

Source link: https://onlinelibrary.wiley.com/doi/10.1002/jmv.28097

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions