Discrepancies in publications related to HMB-FA and ATP supplementation.
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ABSTRACT:
SUBMITTER: Gentles JA
PROVIDER: S-EPMC5496306 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
Publications
Discrepancies in publications related to HMB-FA and ATP supplementation.
Gentles Jeremy A JA Phillips Stuart M SM
Nutrition & metabolism 20170704
This letter addresses a number of discrepancies found in several publications related HMB-FA and ATP supplementation. ...[more]
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Project description:Gentles and Phillips have submitted questions regarding three recent papers investigating ATP, HMB and the combination. The questions pertaining to the homogeneity of subjects' characteristics between the three different published papers, and why there appears to be differences in the number of subjects in placebo groups across studies. This response addresses each of these issues and demonstrates that there are no discrepancies between papers but rather a misunderstanding of the papers previously published.
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Project description:ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication.Small sample that included earliest results posted to the database.Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.Agency for Healthcare Research and Quality.
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Project description:β-Hydroxy-β-methylbutyrate (HMB) supplementation increases muscle and strength mass in some muscle-wasting disorders. Malnutrition and sarcopenia are often present in liver cirrhosis. We aimed to investigate the effects of oral HMB supplementation on changes in body composition and liver status in patients with cirrhosis and malnutrition. In a randomized, controlled, double-blind trial, 43 individuals were randomized to receive twice a day and for 12 weeks an oral nutritional supplement (ONS) enriched with 1.5 g of calcium HMB per bottle or another supplement with similar composition devoid of HMB. Inclusion criteria were liver cirrhosis with at least one previous decompensation and clinical malnutrition. Liver function, plasma biochemistry analyses, and physical condition assessment were carried out at baseline, then after six and 12 weeks of supplementation. A total of 34 patients completed the clinical trial. An improvement in liver function and an increase in fat mass index were observed in both groups. None of the two ONS changed the fat-free mass. However, we observed an upward trend in handgrip strength and a downward trend in minimal hepatic encephalopathy in the HMB group. At the end of the trial and regardless of the supplement administered, fat mass content increased with no change in fat-free mass, while liver function scores and nutritional analytic markers also improved.
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Project description:ObjectivesProspectively registering study plans in a permanent time-stamped and publicly accessible document is becoming more common across disciplines and aims to reduce risk of bias and make risk of bias transparent. Selective reporting persists, however, when researchers deviate from their registered plans without disclosure. This systematic review aimed to estimate the prevalence of undisclosed discrepancies between prospectively registered study plans and their associated publication. We further aimed to identify the research disciplines where these discrepancies have been observed, whether interventions to reduce discrepancies have been conducted, and gaps in the literature.DesignSystematic review and meta-analyses.Data sourcesScopus and Web of Knowledge, published up to 15 December 2019.Eligibility criteriaArticles that included quantitative data about discrepancies between registrations or study protocols and their associated publications.Data extraction and synthesisEach included article was independently coded by two reviewers using a coding form designed for this review (osf.io/728ys). We used random-effects meta-analyses to synthesise the results.ResultsWe reviewed k=89 articles, which included k=70 that reported on primary outcome discrepancies from n=6314 studies and, k=22 that reported on secondary outcome discrepancies from n=1436 studies. Meta-analyses indicated that between 29% and 37% (95% CI) of studies contained at least one primary outcome discrepancy and between 50% and 75% (95% CI) contained at least one secondary outcome discrepancy. Almost all articles assessed clinical literature, and there was considerable heterogeneity. We identified only one article that attempted to correct discrepancies.ConclusionsMany articles did not include information on whether discrepancies were disclosed, which version of a registration they compared publications to and whether the registration was prospective. Thus, our estimates represent discrepancies broadly, rather than our target of undisclosed discrepancies between prospectively registered study plans and their associated publications. Discrepancies are common and reduce the trustworthiness of medical research. Interventions to reduce discrepancies could prove valuable.Registrationosf.io/ktmdg. Protocol amendments are listed in online supplemental material A.
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Project description:Undisclosed discrepancies often exist between study registrations and their associated publications. Discrepancies can increase risk of bias, and when undisclosed, they disguise this increased risk of bias from readers. To remedy this issue, we developed an intervention called discrepancy review. We provided journals with peer reviewers specifically assigned to check for undisclosed discrepancies between registrations and manuscripts submitted to journals. We performed discrepancy review on 18 manuscripts submitted to Nicotine and Tobacco Research and three manuscripts submitted to the European Journal of Personality. We iteratively refined the discrepancy review process based on feedback from discrepancy reviewers, editors and authors. Authors addressed the majority of discrepancy reviewer comments, and there was no opposition to running a trial from authors, editors or discrepancy reviewers. Outcome measures for a trial of discrepancy review could include the presence of primary or secondary outcome discrepancies, whether publications that are not the primary report from a clinical trial registration are clearly described as such, whether registrations are permanent, and an overarching subjective assessment of the impact of discrepancies in published articles. We found that discrepancy review could feasibly be introduced as a regular practice at some journals interested in this process. A full trial of discrepancy review would be needed to evaluate its impact on reducing undisclosed discrepancies.
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Project description:Creatine monohydrate (CrM) and ?-hydroxy ?-methylbutyrate (HMB) are common ergogenic aids in the field of sports and are frequently used in an isolated way. However, there are a few studies that have investigated the effect of combining both supplements on different variables related to performance, with controversial results. Therefore, the main purpose of this study was to determine the efficacy and the degree of potentiation of 10 weeks of CrM plus HMB supplementation on sports performance, which was measured by an incremental test to exhaustion in elite male traditional rowers. In this placebo-controlled, double-blind trial, 10-week study, participants (n = 28) were randomized to a placebo group (PLG; n = 7), CrM group (0.04 g/kg/day of CrM; n = 7), HMB group (3 g/day of HMB; n = 7) and CrM-HMB group (0.04 g/kg/day of CrM plus 3 g/day of HMB; n = 7). Before and after 10 weeks of different treatments, an incremental test was performed on a rowing ergometer to calculate the power that each rower obtained at the anaerobic threshold (WAT), and at 4 mmol (W4) and 8 mmol (W8) of blood lactate concentration. There were no significant differences in WAT and W4 among groups or in body composition. However, it was observed that the aerobic power achieved at W8 was significantly higher in the CrM-HMB group than in the PLG, CrM and HMB groups (p < 0.001; ?2p = 0.766). Likewise, a synergistic effect of combined supplementation was found for the sum of the two supplements separately at WAT (CrM-HMBG = 403.19% vs. CrMG+HMBG = 337.52%), W4 (CrM-HMBG = 2736.17% vs. CrMG+HMBG = 1705.32%) and W8 (CrM-HMBG = 1293.4% vs. CrMG+HMBG = 877.56%). In summary, CrM plus HMB supplementation over 10 weeks showed a synergistic effect on aerobic power (measured as WAT, W4, and W8) during an incremental test but had no influence muscle mass.
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Project description:ObjectiveTo compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications.DesignCross-sectional study.SettingInternational medical literature.ParticipantsPreprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020.Main outcome measuresStudy characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably).ResultsOf 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study.ConclusionsThe COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.
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Project description:There is growing evidence that severe decline of skeletal muscle mass and function with age may be mitigated by exercise and dietary supplementation with protein and amino acid ingredient technologies. The purposes of this study were to examine the effects of the leucine catabolite, beta-hydroxy-beta-methylbutyrate (HMB), in C2C12 myoblasts and myotubes, and to investigate the effects of dietary supplementation with HMB, the amino acid β-alanine and the combination thereof, on muscle contractility in a preclinical model of pre-sarcopenia. In C2C12 myotubes, HMB enhanced sarcoplasmic reticulum (SR) calcium release beyond vehicle control in the presence of all SR agonists tested (KCl, P<0.01; caffeine, P = 0.03; ionomycin, P = 0.03). HMB also improved C2C12 myoblast viability (25 μM HMB, P = 0.03) and increased proliferation (25 μM HMB, P = 0.04; 125 μM HMB, P<0.01). Furthermore, an ex vivo muscle contractility study was performed on EDL and soleus muscle from 19 month old, male C57BL/6nTac mice. For 8 weeks, mice were fed control AIN-93M diet, diet with HMB, diet with β-alanine, or diet with HMB and β-alanine. In β-alanine fed mice, EDL muscle showed a 7% increase in maximum absolute force compared to the control diet (202 ± 3vs. 188± 5 mN, P = 0.02). At submaximal frequency of stimulation (20 Hz), EDL from mice fed HMB plus β-alanine showed an 11% increase in absolute force (88.6 ± 2.2 vs. 79.8 ± 2.4 mN, P = 0.025) and a 13% increase in specific force (12.2 ± 0.4 vs. 10.8 ± 0.4 N/cm2, P = 0.021). Also in EDL muscle, β-alanine increased the rate of force development at all frequencies tested (P<0.025), while HMB reduced the time to reach peak contractile force (TTP), with a significant effect at 80 Hz (P = 0.0156). In soleus muscle, all experimental diets were associated with a decrease in TTP, compared to control diet. Our findings highlight beneficial effects of HMB and β-alanine supplementation on skeletal muscle function in aging mice.
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Project description:Low muscle mass is prevalent among patients with cancer and a predictor of adverse clinical outcomes. To counteract muscle loss, β-hydroxy β-methylbutyrate (HMB) supplementation has been proposed as a potential therapy for older adults and various diseases states. This systematic review aimed to investigate the effects and safety of HMB supplementation in relation to muscle mass and function and other clinical outcomes in patients with cancer. A systematic search of MEDLINE, CINAHL, Embase, Cochrane Central Register of Controlled Trials, Scopus, ProQuest, and grey literature for reports published from inception to December 2021 was conducted. Included studies provided supplements containing any dose of HMB to adult patients with active cancer. A synthesis without meta-analysis was conducted using a vote-counting approach based solely on the direction of the effect (i.e. regardless of statistical significance). Risk of bias was assessed for each outcome domain, and evidence from higher-quality studies (i.e. those with either low or moderate risk of bias) was examined. Safety was evaluated using both lower-quality and higher-quality studies. Fifteen studies were included, in which six were randomized controlled trials in patients with various cancer types and treatments. Studies prescribed HMB combined with amino acids (73.3%), HMB in oral nutritional supplements (20.0%), or both supplement types (6.7%); Ca-HMB doses of 3.0 g/day were provided in 80.0% of the studies. Four studies had high risk of bias across all outcome domains. Considering the higher-quality studies, evidence of a beneficial effect of HMB supplementation was found in four of four studies for muscle mass, two of two for muscle function, three of three for hospitalization, and five of seven for survival. In contrast, no beneficial effects of HMB on quality of life or body weight was found in two of four and three of five studies, respectively. A limited number of higher-quality studies evaluating the impact of HMB on cancer therapy-related toxicity, inflammation, and tumour response were observed. No serious adverse effects directly related to the nutrition intervention were reported. Although limited, current evidence suggests that HMB supplementation has a beneficial effect on muscle mass and function in patients with cancer. Well-designed trials are needed to further explore the clinical benefit of HMB supplementation in this patient population.
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