Effects of high-dilutions in behavioural models: a commentary on critical issues, from reproducibility to plausibility

As part of a rigorous investigation into the effects of Gelsemium sempervirens on laboratory mice, we performed two complete series of experiments and published three scientific papers. A recent commentary has, however, called into question the reproducibility and validity of these findings. In this article we discuss the major issues raised by this critique within the framework of methodological aspects and the interpretation of results of high-dilution and homeopathic research. The charge of non-reproducibility is shown to be unfounded, because a same homeopathic medicine displayed the same direction of effects in two well-validated models (light-dark and open-field), albeit with nonlinear patterns. The double-blind protocols and statistics by means of ANOVA were performed appropriately and the difference between dilutions of Gelsemium (5cH, 7cH, 9cH and 30cH with variations according to model) and placebo was statistically highly significant. Our investigations brought to light some problems related with the lack of activity of buspirone and diazepam (conventional anxiolytic drugs used as control) on some behavioural parameters, suggesting that Gelsemium may have broader action, and raising doubts as to the reliability of benzodiazepines as positive controls for homeopathic treatments. Concerning the plausibility of experiments in this field, disputed on the grounds of alleged lack of dose-response effect, we note that the latter is not at all uncommon, and can be accounted for by a host of possible reasons. In conclusion, our research line showed reproducible and consistent effects of Gelsemium in laboratory mice.

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The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

European Psychologist ◽

10.1027//1016-9040.6.1.15 ◽

2001 ◽

Vol 6 (1) ◽

pp. 15-25 ◽

Cited By ~ 18

Author(s):

Harald Walach ◽

Stefan Schmidt ◽

Yvonne-Michelle Bihr ◽

Susanne Wiesch

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

Cognitive Task ◽

Well Being ◽

Control Group ◽

Double Blind ◽

Main Effect ◽

The Difference ◽

Being There ◽

To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

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Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 Randomized Clinical Trial in the Russian Federation

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1649 ◽

2020 ◽

Author(s):

Elena V Esaulenko ◽

Aleksey A Yakovlev ◽

Genady A Volkov ◽

Anastasia A Sukhoruk ◽

Kirill G Surkov ◽

...

Keyword(s):

Hepatitis B ◽

Geometric Mean ◽

Serious Adverse Events ◽

Double Blind ◽

Antigen Vaccine ◽

Single Antigen ◽

Antibody Titers ◽

The Russian Federation ◽

The Difference ◽

Mean Concentration

Abstract Background This study compares the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia. Methods We conducted a randomized, double-blind, comparative study of 3-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18–45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at days 1, 28, 90, 180, and 210, adverse and serious adverse events (SAEs) to study day 210. The primary outcome was based on the difference in rates of seroconversion at day 210 (lower bound 95% confidence interval [CI]: > − 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs ≥10 mIU/mL and anti-HBs geometric mean concentration (GMC). Results Rate of seroconversion in 3AV (100%) was noninferior to 1AV (97.9%) at study day 210 (difference: 2.1%, 95% CI: −2.0, 6.3%]) but significantly higher at study day 28. SPR at study day 210 was >97% in both arms. Anti-HBs titers were significantly higher at study days 90 (P = .001) and 180 (P = .0001) with 3AV. Sex, age, and body mass index (BMI) had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, P = .15), second (20.0% vs 14.6%, P = .33), and third vaccination (14.9% vs 23.4%, P = .22). No SAEs were reported. Conclusions 3AV was noninferior to 1AV. 3AV induced high SPR, and there were no safety concerns. Clinical Trials Registration. NCT04209400.

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341 Acute effects of seltorexant, a selective orexin-2 antagonist (JNJ- 42847922), on driving after bedtime administration

SLEEP ◽

10.1093/sleep/zsab072.340 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A136-A136

Author(s):

S Brooks ◽

R G J A Zuiker ◽

G E Jacobs ◽

I Kezic ◽

A Savitz ◽

...

Keyword(s):

Postural Stability ◽

Driving Simulator ◽

Motor Vehicle ◽

Subjective Effects ◽

Driving Ability ◽

Post Dose ◽

Double Blind ◽

Increased Risk ◽

Subjective Sleepiness ◽

The Difference

Abstract Introduction Seltorexant (JNJ-42847922), a potent and selective antagonist of the human orexin-2 receptor, is being developed for the treatment of major depressive disorder. Seltorexant also has sleep-promoting properties. Investigating the effects of sleep-promoting medications on driving is important because some of these agents (e.g. GABAA receptor agonists) may be associated with increased risk of motor vehicle accidents. We evaluated the effect of seltorexant on driving after forced awakening at night, using a validated driving simulator. Methods This double-blind, placebo and active-controlled, randomized, 3-way cross-over study was conducted in 18 male and 18 female healthy subjects. All subjects received seltorexant 40 mg, zolpidem 10 mg, or placebo 15 minutes before bedtime. Eighteen subjects were awakened at 2- and 6-hours post-dose, and the other 18 at 4- and 8-hours post-dose. At those timepoints, pharmacokinetics, objective (standard deviation of the lateral position [SDLP]) and subjective effects (using Perceived Driving Quality and Effort Scales) on driving ability, postural stability and subjective sleepiness were assessed. Results For seltorexant, the SDLP difference from placebo (95% confidence interval) at 2-, 4-, 6- and 8-hours post-dose was 3.9 cm (1.26, 6.60), 0.9 cm (-1.08, 2.92), 1.1 cm (-0.42, 2.63), and 0.6 cm (-2.75, 1.55), respectively vs. 9.6 cm (6.97, 12.38), 6.6 cm (3.53, 9.60), 4.7 cm (1.46, 7.85), and 1.3cm (-1.16, 3.80), respectively for zolpidem. The difference from placebo was significant at 2-hours after taking seltorexant, while the difference from placebo was significant at 2, 4 and 6-hours after zolpidem. Subjective driving quality was decreased for both drugs at all time points and driving effort was increased up to 4-hours post-dose for both medications. Subjective sleepiness showed a significant increase compared to placebo 2- and 4-hours after administration of either drug. Postural stability was decreased up to 2-hours after administration of seltorexant, and up to 4-hours after administration of zolpidem. Conclusion Compared to zolpidem, objective effects on driving performance were more transient after seltorexant administration and largely normalized by 4–6 hours post-dose. Support (if any) This work was sponsored by Janssen R&D.

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A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate and Linezolid for Treatment of Ventilated Gram-Positive Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

Clinical Infectious Diseases ◽

10.1093/cid/ciab032 ◽

2021 ◽

Author(s):

Richard G Wunderink ◽

Antoine Roquilly ◽

Martin Croce ◽

Daniel Rodriguez Gonzalez ◽

Satoshi Fujimi ◽

...

Keyword(s):

Clinical Response ◽

Bacterial Pneumonia ◽

Double Blind Study ◽

Phase 3 ◽

Gram Positive ◽

Double Blind ◽

Intention To Treat ◽

The Difference ◽

Hospital Acquired ◽

Noninferiority Margin

Abstract Background Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are associated with high mortality rates. We evaluated the efficacy and safety of tedizolid (administered as tedizolid phosphate) for treatment of gram-positive ventilated HABP/VABP. Methods In this randomized, noninferiority, double-blind, double-dummy, global phase 3 trial, patients were randomized 1:1 to receive intravenous tedizolid phosphate 200 mg once daily for 7 days or intravenous linezolid 600 mg every 12 hours for 10 days. Treatment was 14 days in patients with concurrent gram-positive bacteremia. The primary efficacy end points were day 28 all-cause mortality (ACM; noninferiority margin, 10%) and investigator-assessed clinical response at test of cure (TOC; noninferiority margin, 12.5%) in the intention-to-treat population. Results Overall, 726 patients were randomized (tedizolid, n = 366; linezolid, n = 360). Baseline characteristics, including incidence of methicillin-resistant Staphylococcus aureus (31.3% overall), were well balanced. Tedizolid was noninferior to linezolid for day 28 ACM rate: 28.1% and 26.4%, respectively (difference, –1.8%; 95% confidence interval [CI]: –8.2 to 4.7). Noninferiority of tedizolid was not demonstrated for investigator-assessed clinical cure at TOC (tedizolid, 56.3% vs linezolid, 63.9%; difference, –7.6%; 97.5% CI: –15.7 to 0.5). In post hoc analyses, no single factor accounted for the difference in clinical response between treatment groups. Drug-related adverse events occurred in 8.1% and 11.9% of patients who received tedizolid and linezolid, respectively. Conclusions Tedizolid was noninferior to linezolid for day 28 ACM in the treatment of gram-positive ventilated HABP/VABP. Noninferiority of tedizolid for investigator-assessed clinical response at TOC was not demonstrated. Both drugs were well tolerated. Clinical Trials Registration NCT02019420.

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Does Consumption of Nitrate Containing Beetroot Juice Affect Indoor Rowing Performance in Males and Females?

Current Developments in Nutrition ◽

10.1093/cdn/nzaa066_009 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 1754-1754

Author(s):

Giselle Greisman ◽

June Kloubec ◽

Alexandra Kazaks ◽

Kelly Morrow ◽

Cristen Harris

Keyword(s):

P Value ◽

Beetroot Juice ◽

Double Blind ◽

Male Athletes ◽

Funding Sources ◽

Beverage Type ◽

Rowing Performance ◽

Males And Females ◽

The Difference ◽

Research Grant

Abstract Objectives The nitrates found in beetroot juice (BR) are known to be a precursor of nitric oxide (NO). NO is a known vasodilator which allows more oxygen to travel in the blood and may improve muscle efficiency. This study aims to measure the effect of BR supplementation on performance on 500-meter row time for trained CrossFit athletes. Many past studies have analyzed the effect of BR on male athletes, this study aimed to include both males and females. Methods This study used a randomized, cross-over, double-blind, placebo-controlled design to measure 500-meter row time. Thirty athletes age 18–60 consumed either a 2.7 oz shot of BR (6.5 mmol nitrate) or a placebo nitrate-free beetroot juice (PL). Two hours later, they rowed 500 meters. After at least a seven-day washout period, athletes repeated the 500-meter row with either BR or PL for comparison. This study was performed from July 2019 – January 2020 and was conducted in Mercer Island, Washington. Results Ten males age 18.0 to 60.3 (median 47.7) and twenty females age 26.7 to 58.3 (median 43.8), participated in this study. Row times for the 500-meter row ranged from 88.2 seconds to 150.7 seconds. Data indicate that although 60% of all participants rowed faster with BR (mean 112.83 seconds), compared to PL (mean 113.40 seconds), the difference in the means of row times (−0.563) was not significant overall (P = 0.29). However, for the 10 males, row times were significantly faster (1.02 second difference, P = 0.04) on average with BR compared to PL. For the 20 females, the difference in mean row time (−0.335 seconds) was not significant (P = 0.66). Competitive rowers were defined as those who rowed under 110 seconds (N = 15). For competitive rowers (10 males, 5 females), row times were significantly faster with BR compared to PL (difference in means −0.94, P = 0.009). However, for those rowers, the P-value of drink * group was 0.015. Conclusions Dietary nitrate improved indoor rowing performance in males but not in females. In addition, competitive rowers were also significantly faster with BR, however, there may be an order bias, since there was significant interaction between beverage type and testing order. Food based nitrate supplements may increase rowing performance with male rowers. Funding Sources Supported by Bastyr Faculty Student Research Grant.

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A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

Alzheimer s Research & Therapy ◽

10.1186/s13195-021-00795-7 ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

Shifu Xiao ◽

Piu Chan ◽

Tao Wang ◽

Zhen Hong ◽

Shuzhen Wang ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trial ◽

Controlled Trial ◽

Drug Effects ◽

Disease Assessment ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

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Neurofeedback, Where Are We and Where Are We Going? Three Critical Issues for Consideration: Perspective from 25 Years of Practice

Biofeedback ◽

10.5298/1081-5937-49.3.04 ◽

2021 ◽

Vol 49 (3) ◽

pp. 59-70

Author(s):

Mari K. Swingle

Keyword(s):

Placebo Effect ◽

First Generation ◽

Double Blind ◽

Left Behind ◽

Road Map ◽

Critical Issues ◽

Division 2 ◽

Over Time

For those of you who do not recognize the Swingle name, I am a neuro-brat, generation 2.0. I did not find the field, the field found me, or rather was just there … I grew up with the clicking and flipping of switches and amusing myself soldering in my father's university lab, mostly wire sculptures, bracelets, and such (my mother was an artist, after all), but also the odd connection or two on what were then wall-to-wall computers. Being a neuro-brat also meant I matured professionally in the frenetic energy of innovative minds. It took 25 years or so, and some digressions into other fields, namely, art, fashion, and education, but I was eventually drawn in fully at a Winterbrain conference in the 1990s. These were fascinating years wherein I mostly observed and listened to the great minds that rooted us, great minds that clashed (as titans do) as much as they drove the profession forward. In these cerebral jousting matches, however, I fear many were left behind. Over time I have witnessed fewer and fewer people pick up the excitement of research and exploration and more wanting a road map, finding the paths of their forefathers and foremothers (our pioneers) harder than expected to follow. As this brilliant first generation slowly leaves us to retirement and beyond (the Budzynskis, Tooman, Judith Lubar, Michael Thompson, Stu Donaldson, Larry Klein, Joe Kamiya, and a few more), their legacies should be accessible and foundations strong for us to continue to build upon. It might also be time to put down the swords, to address conflicts that no longer push us forward before we fracture further, not through loss of persons, but loss of standards, knowledge, and skill. To preserve and move neurotherapy forward, three things are critical for our discipline to address: (1) conflict and division, (2) the red herring of the double-blind imperative and its little cousin the placebo effect, and (3) perhaps most important, practice and equipment standards.

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MO258SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF VIS649, AN APRIL-NEUTRALIZING IGG2 MONOCLONAL ANTIBODY, IN HEALTHY VOLUNTEERS: PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab104.0016 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

Yusuke Suzuki ◽

Mohit Mathur ◽

Jonathan Barratt ◽

Frank Engler ◽

Jill Yarbrough ◽

...

Keyword(s):

Phase 1 ◽

Study Drug ◽

Dependent Manner ◽

Double Blind ◽

Serum Iga ◽

Dose Study ◽

Dose Response Effect ◽

Japanese Descent ◽

Dose Dependent ◽

Single Ascending Dose Study

Abstract Background and Aims Immunoglobulin A (IgA) nephropathy (IgAN) is a glomerulonephritis characterized by the presence of circulating and glomerular immune complexes containing galactose-deficient (Gd) IgA1. A proliferation-inducing ligand (APRIL), a member of the tumor necrosis factor superfamily of ligands, is thought to play a key role in the pathogenesis of IgAN by virtue of its role in class-switching to IgA production. VIS649, a humanized immunoglobulin G (IgG2) monoclonal antibody that binds to and blocks the biological actions of APRIL, is in clinical development as a potential treatment for IgAN. The primary objective of this first-in-human study was to evaluate the safety and tolerability of VIS649 in healthy volunteers. Secondary objectives included characterization of the pharmacokinetics (PK) and pharmacodynamics (PD) of VIS649. Method This was a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study of VIS649 in healthy adult male and female volunteers (ClinicalTrials.gov identifier: NCT03719443). The study was conducted in sequential dosing cohorts. The first four cohorts (0.5, 2.0, 6.0, and 12.0 mg/kg, respectively) each enrolled 9 participants (4 of Japanese descent and 5 of non-Japanese descent) who were randomized to VIS649 or placebo in a ratio of 7:2. In addition, a fifth cohort enrolled 15 adults randomized to receive VIS649 6.0 mg/kg or placebo (10:5), followed by tetanus/diphtheria vaccine challenge after 28 days (TENIVAC®, Sanofi Pasteur Limited; the effect of APRIL inhibition on vaccine response is described in a companion abstract). Participants received intravenous administration of study drug on Day 1, were discharged from the institution on Day 2, and were followed for 16–24 weeks on an outpatient basis. Standard safety assessments and blood sampling for PK and PD were performed at regular intervals. Results 51 participants were randomized and dosed with study drug, of whom 47 (92.2%) completed the study. VIS649 was well tolerated, with no serious adverse events (AEs) or AEs that led to study discontinuation. Most treatment-emergent AEs (TEAEs) were mild; the incidence and severity of TEAEs were not dose dependent. One participant in the 2.0 mg/kg group experienced a severe TEAE of syncope following phlebotomy that the investigator considered unlikely to be related to study drug. There was no clinically relevant effect of treatment on laboratory tests, vital signs, electrocardiogram parameters, or physical examinations. VIS649 had non-linear PK: half-life (t½) increased with dose, while drug exposure (AUC) increased in a greater than dose proportional manner. Serum IgA, Gd-IgA1, IgG, and IgM were reversibly suppressed in a dose-dependent manner following VIS649 administration. The maximum mean percentage reductions from baseline occurred at Week 12 for the 12.0 mg/kg dose: IgA, -57.2% (Figure); Gd-IgA1, -71.6% (Figure); IgG, -33.6%; and IgM, -67.2%. These reductions were reversible and showed a dose-response effect with respect to time-to-recovery. Mean free (non-VIS649 bound) serum APRIL levels decreased to the lower limit of quantification (50 pg/mL) for all VIS649 doses at Week 1, and also showed a dose-response effect with respect to time-to-recovery. No depletions in circulating lymphocyte populations were observed. There were no significant PK or PD differences between Japanese and non-Japanese participants. Conclusion A single dose of VIS649, up to 12.0 mg/kg, was safe and well tolerated in healthy adults and was able to suppress free serum APRIL to the lower level of quantification. Serum Gd-IgA1 decreased in parallel with total serum IgA and recovered in a dose-dependent manner following reappearance of free APRIL in serum. These data support the further clinical development of VIS649 as a potential treatment for IgAN.

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Polyamine-mediated regulation of mouse ornithine decarboxylase is posttranslational

Molecular and Cellular Biology ◽

10.1128/mcb.9.12.5484-5490.1989 ◽

1989 ◽

Vol 9 (12) ◽

pp. 5484-5490

Author(s):

T van Daalen Wetters ◽

M Macrae ◽

M Brabant ◽

A Sittler ◽

P Coffino

Keyword(s):

Ornithine Decarboxylase ◽

Translational Regulation ◽

Feedback Inhibition ◽

Chimeric Protein ◽

Sequence Information ◽

Pulse Label ◽

Protein Coding ◽

Coding Sequence ◽

Series Of Experiments ◽

The Difference

The activity of ornithine decarboxylase (ODC) is negatively regulated by intracellular polyamines, which thereby mediate a form of feedback inhibition of the initial enzyme in the pathway of their synthesis. This phenomenon has been believed to result, at least in part, from translational regulation. To investigate this further, we performed four series of experiments. First, we found that a chimeric protein encoded by an mRNA containing the ODC 5' leader sequence did not exhibit polyamine-dependent regulation. Second, we showed that transcripts containing the protein-coding sequence of ODC, but no other ODC-derived sequence information, exhibited regulation. Third, we found that the association of ODC mRNA with ribosomes was not altered when intracellular polyamine levels were modulated under conditions previously deemed to cause translational regulation. Last, we carried out experiments to measure the incorporation of [35S]methionine into ODC in polyamine-starved and polyamine-replete cells. Differential incorporation diminished progressively as pulse-label times were shortened; at the shortest labeling time used (4 min), the difference in favor of ODC in polyamine-starved cells was less than twofold. These findings suggest that it is necessary to reevaluate the question of whether polyamines cause alterations of translation of ODC mRNA.

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IMPACT OF ADOPTING IFRS STANDARD ON THE EQUITY COST OF BRAZILIAN OPEN CAPITAL COMPANIES

RAM Revista de Administração Mackenzie ◽

10.1590/1678-69712016/administracao.v17n4p84-107 ◽

2016 ◽

Vol 17 (4) ◽

pp. 85-108 ◽

Cited By ~ 3

Author(s):

RAFAEL CONFETTI GATSIOS ◽

JOSÉ MARCOS DA SILVA ◽

MARCELO AUGUSTO AMBROZINI ◽

ALEXANDRE ASSAF NETO ◽

FABIANO GUASTI LIMA

Keyword(s):

Financial Reporting ◽

Accounting Standard ◽

Financial Reporting Standards ◽

Quality Of Accounting Information ◽

Information Studies ◽

Equity Cost ◽

Mandatory Adoption ◽

The Difference ◽

Methodological Aspects ◽

The Impact

ABSTRACT Purpose: This study aims to assess the impact of adopting IFRS standard on the equity cost of Brazilian open capital companies in the period of 2004-2013. Originality/gap/relevance/implications: The adoption of International Financial Reporting Standards aims to increase the quality of accounting information. Studies performed in Europe suggest that, after the adoption of the IFRS standard, there was a reduction in the equity cost of companies due to the reduction of information asymmetry and risk. Key methodological aspects: The equity cost was calculated using the capital asset pricing model (CAPM) adapted to the Brazilian case. The empirical strategy was the difference analysis in differences, comparing the results of companies that voluntarily adopted the IFRS with companies that adopted IFRS after the mandatory adoption period. Summary of key results: The results indicate that the adoption of the IFRS standard does not contribute to reduce the equity cost in Brazil. Key considerations/conclusions: Suggesting that the process of adopting the international accounting standard may take more time to impact the equity cost of Brazilian open capital companies, since the impact of IFRS is not related only with the adoption, but also with its use by companies and users.

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