scholarly journals Neuroprotective effect of vitamin B6 and vitamin B12 against vincristine- induced peripheral neuropathy: A randomized, double- blind, placebo controlled, multicenter trial

2021 ◽  
Author(s):  
Fatiha Tasmin Jeenia ◽  
Ferdaush Ahmed Sojib ◽  
Md Sayedur Rahman ◽  
Tasneem Ara ◽  
Rafiquzzaman Khan ◽  
...  
Keyword(s):  
Relative Risk ◽  
Peripheral Neuropathy ◽  
Vitamin B12 ◽  
Risk Reduction ◽  
Vitamin B6 ◽  
Absolute Risk ◽  
Neuroprotective Effect ◽  
Induction Phase ◽  
Double Blind ◽  
Significant Difference

Background: Vincristine leads to development of debilitating neuropathy in 40-45% patients with resultant compromised efficacy of chemotherapy, suboptimal treatment and worse prognostic outcome. Vitamin B6 and vitamin B12 improves non- oncological neuropathies. Therefore, this study investigated vitamin B6 and vitamin B12 to prevent vincristine- induced peripheral neuropathy (VIPN) by reducing incidence, absolute risk, relative risk, severity as well as delaying the onset. Methods: Patients with ALL undergoing induction phase were randomly assigned into intervention or placebo arm in a double- blind manner. Vitamin B6 (25 mg Pyridoxine) two tablets were given three times daily for 5 weeks. Vitamin B12 (500 μg/ml Methylcobalamin) was administered intravenously on day 1, 3 and 5 of every week for 5 weeks during induction period. Placebo arm received oral and intravenous placebo for same duration. Patients were evaluated on the outset of every week by FACT/GOG-NTX questionnaire. Severity was assessed per NCI-CTCAE grading scale. Results: 102 patients were enrolled. Among them 81 completed the study, where 42 received vitamin B6 and B12 and 39 received placebo. There was significant difference in incidence of neuropathy between arms (26.19% intervention arm, 56.41% placebo; P-0.01). Relative risk of neuropathy was significantly (RR-0.46) lower in intervention arm. Besides, absolute risk reduction (ARR) was 30% and relative risk reduction (RRR) was 54%. NNT was 3.33. Significant trend was observed in difference of severity of VIPN between groups (P-0.03). No significant difference observed in between arms for time to onset of neuropathy. Conclusion: Vitamin B6 and vitamin B12 significantly reduced the incidence, relative risk and severity of VIPN. NNT was encouraging too. Henceforth, the status of vitamin B6 and vitamin B12 as neuroprotective agent against VIPN can be recommended as a promising one.

scholarly journals Relationship between Vitamin B9 (Folic Acid), Vitamin B12 (Cobalamin), and Peripheral Neuropathy in Children with Beta-Thalassemia Major

2021 ◽  
Vol 9 (2) ◽  
Author(s):  
Uni Gamayani ◽  
Titin Junaidi ◽  
Nushrotul Lailiyya ◽  
Nur Suryawan ◽  
Nanan Sekarwana
Keyword(s):  
Folic Acid ◽  
Peripheral Neuropathy ◽  
Vitamin B12 ◽  
Thalassemia Major ◽  
Beta Thalassemia ◽  
Control Group ◽  
Case Group ◽  
Beta Thalassemia Major ◽  
Vitamin B9 ◽  
Significant Difference

Vitamin B9 (folic acid) and B12 (cobalamin) are essential vitamins that play roles in the process of hematopoiesis and maintaining the function of peripheral nerves. Therefore, these deficiencies may create a risk for peripheral neuropathy in beta-thalassemia major patients. The purpose of this study is to determine the relationship between vitamin B9 level, vitamin B12 level, and peripheral neuropathy in beta-thalassemia major children. It was an observational analytical study with a case-control design has been conducted at Dr. Hasan Sadikin General Hospital Bandung, Indonesia, in May–July 2019. There were 47 beta-thalassemia major children with peripheral neuropathy (case) and 41 healthy children (control). All subjects completed a general demographic questionnaire, underwent neurological examination, and were tested for vitamin B9 and B12 serum levels. Data were then analyzed using the unpaired t test to compare the vitamin levels between both groups and Spearman’s rank correlation test to investigate the correlation between vitamin levels and the number of affected nerves in the case group. Comparison of folic acid levels in the case group (21.52±6.22 ng/mL) and the control group (23.81±7.51 ng/mL) showed no significant difference (p=0.19). In contrast, cobalamin in the case group (288.57±168.61 ng/mL) and the control group (385.95±197.48 ng/mL) showed a significant difference (p=0.01). In addition, there was a moderate correlation (p=0.004, r=0.41) between folic acid level and the number of motoric nerves affected in the case group. In conclusion, cobalamin level correlates with peripheral neuropathy in beta-thalassemia major patients, and folic acid level correlates with the number of affected nerves, especially motoric nerves. HUBUNGAN ANTARA VITAMIN B9 (ASAM FOLAT), VITAMIN B12 (KOBALAMIN), DAN NEUROPATI PERIFER PADA ANAK DENGAN TALASEMIA BETA MAYORVitamin B9 (asam folat) dan B12 (kobalamin) merupakan vitamin esensial yang berperan dalam proses hematopoiesis dan menjaga fungsi saraf tepi. Defisiensi vitamin ini dapat menimbulkan risiko neuropati perifer pada pasien talasemia beta mayor. Tujuan penelitian ini mengetahui hubungan antara kadar vitamin B9, vitamin B12, dan neuropati perifer pada anak talasemia beta mayor. Metode penelitian ini adalah analitik observasional dengan rancangan studi kasus kontrol yang dilakukan di RSUP Dr. Hasan Sadikin Bandung, Indonesia pada Mei–Juli 2019. Terdapat 47 anak talasemia beta mayor dengan neuropati perifer (kelompok kasus) dan 41 anak sehat (kelompok kontrol). Seluruh subjek penelitian mengisi kuesioner demografi umum, menjalani pemeriksaan fisis neurologis, serta dilakukan tes kadar vitamin B9 dan B12 serum. Uji t test tidak berpasangan digunakan untuk membandingkan kadar vitamin pada kedua kelompok dan uji korelasi Spearman untuk membandingkan kadar kedua vitamin tersebut dengan jumlah saraf yang terkena pada kelompok kasus. Perbandingan kadar asam folat kelompok kasus (21,52±6,22 ng/mL) dan kelompok kontrol (23,81±7,51 ng/mL) menunjukkan perbedaan yang tidak bermakna (p=0,19), sedangkan perbandingan kadar kobalamin kelompok kasus (288,57±168,61 ng/mL) dan kelompok kontrol (385,95±197,48 ng/mL) menunjukkan perbedaan yang bermakna (p=0,01). Selain itu, terdapat korelasi sedang (p=0,004; r=0,41) antara kadar asam folat dam jumlah saraf motorik yang terkena pada kelompok kasus. Kesimpulan, kadar kobalamin berhubungan dengan neuropati perifer pada penderita talasemia beta mayor dan kadar asam folat berhubungan dengan jumlah saraf yang terkena, terutama saraf motorik.

THE APPLICATION OF STATISTICAL METHODS IN EVALUATING THE RESULTS OF CLINICAL FINDINGS OF THE DRUG BOVHUALONIDASE AZOXIMER IN CATS WITH UROLOGICAL DISEASES

2020 ◽  
pp. 212-218
Author(s):  
А. V. Nazarova ◽  
◽  
B. S. Semenov ◽  
Т. Sh. Kuznetsova ◽  
◽  
...  
Keyword(s):  
Relative Risk ◽  
Side Effects ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Control Group ◽  
Control Groups ◽  
Saint Petersburg ◽  
Number Of Patients ◽  
And Control ◽  
Experimental Group

In the period from November 2018 to August 2020, we conducted a randomized blind placebo-controlled confirmatory clinical trial in parallel groups on the basis of network of veterinary clinics in Saint Petersburg and Saint Petersburg state university of veterinary medicine. The purpose of the study: to evaluate the effectiveness of Bovhualonidaze azoximer(BA) in patients subjected to surgical intervention on the urethra and bladder, to prevent postoperative complications and relapses of the underlying disease. The frequency of complications was taken as an indicator of effectiveness. 80 cats were evaluated according to the criteria for inclusion in the study, after evaluation and randomization, 53 patients (24 and 29 cats in the experimental and control groups, respectively) who had indications for surgery on the urethra and/or bladder were included in the study. After the withdrawal of some patients, 38 cats were analyzed (17 and 23 cats in the experimental and control groups, respectively). Animals in the experimental group received BA drugs in addition to conventional therapy, and animals in the control group received placebo. The rate of complications in the experimental group was 11.8 %, in the control group-61.9 %. The relative risk was 19.0 %, and the relative risk reduction was 80.9 %. The chance of developing complications in the animals of the experimental group is 12.2 times lower than in animals of the control group.. Absolute risk reduction — 50.1 %, and the number of patients to be treated — 2 patients. The confidence interval for the risk of side effects of BA drugs in cats was 0.0-10.1 %. Based on the results of our clinical study, we proved that the use of BA drugs is effective for preventing complications during surgical interventions on the urethra and bladder, and the risk of side effects when using BA drugs in cats is insignificant

scholarly journals Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Mansoor Husain ◽  
Stephen C. Bain ◽  
Anders Gaarsdal Holst ◽  
Thomas Mark ◽  
Søren Rasmussen ◽  
...  
Keyword(s):  
Relative Risk ◽  
High Risk ◽  
Prediction Model ◽  
Risk Reduction ◽  
Risk Prediction ◽  
Risk Score ◽  
Relative Risk Reduction ◽  
Absolute Risk ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract Background Semaglutide is a glucagon-like peptide-1 (GLP-1) analog treatment for type 2 diabetes (T2D) available in subcutaneous (s.c.) and oral formulations. Two cardiovascular (CV) outcomes trials showed that in subjects with T2D at high risk of CV events there were fewer major adverse CV events (MACE; defined as CV death, non-fatal stroke, non-fatal myocardial infarction) with semaglutide than with placebo (hazard ratio [95% CI]: 0.74 [0.58;0.95] for once-weekly s.c. semaglutide and 0.79 [0.57;1.11] for once-daily oral semaglutide). However, there is little evidence for an effect of semaglutide on MACE in subjects not at high risk of CV events. This post hoc analysis examined CV effects of semaglutide in subjects across a continuum of baseline CV risk. Methods Data from the s.c. (SUSTAIN) and oral (PIONEER) semaglutide phase 3a clinical trial programs were combined according to randomized treatment (semaglutide or comparators) and analyzed to assess time to first MACE and its individual components. A CV risk model was developed with independent data from the LEADER trial (liraglutide vs placebo), considering baseline variables common to all datasets. Semaglutide data were analyzed to assess effects of treatment as a function of CV risk predicted using the CV risk prediction model. Results The CV risk prediction model performed satisfactorily when applied to the semaglutide data set (area under the curve: 0.77). There was a reduced relative and absolute risk of MACE for semaglutide vs comparators across the entire continuum of CV risk. While the relative risk reduction tended to be largest with low CV risk score, the largest absolute risk reduction was for intermediate to high CV risk score. Similar results were seen for relative risk reduction of the individual MACE components and also when only placebo comparator data were included. Conclusion Semaglutide reduced the risk of MACE vs comparators across the continuum of baseline CV risk in a broad T2D population. Trial registrations ClinicalTrials.gov identifiers: NCT02054897, NCT01930188, NCT01885208, NCT02128932, NCT02305381, NCT01720446, NCT02207374, NCT02254291, NCT02906930, NCT02863328, NCT02607865, NCT02863419, NCT02827708, NCT02692716, NCT02849080, NCT03021187, NCT03018028, NCT03015220.

scholarly journals Efficacy and safety parameters of a novel COVID-19 vaccine

2021 ◽  
Vol 2 (1) ◽  
pp. 13-15
Author(s):  
Bozena Riedel-Baima ◽  
◽  
Roman Zielinski ◽  
Kornelia Polok ◽  
◽  
...  
Keyword(s):  
Relative Risk ◽  
Risk Reduction ◽  
Health Care Providers ◽  
Absolute Risk ◽  
Real Life ◽  
Published Data ◽  
Number Needed To Treat ◽  
Care Providers ◽  
Efficacy And Safety ◽  
Safety Parameters

Considering the fact that vaccine efficacy may be a difficult concept for physicians and health officials alike, we decided to explain it using data from the first publication on the efficacy and safety of a COVID-19 vaccine produced by Pfizer/BioNTech. We examined the published data and calculated common epidemiological parameters such as RRR (relative risk reduction), RR (relative risk), ARR (absolute risk reduction) and NNT (number needed to treat) for 3 groups of patients as described in the original paper. Further, we calculated safety parameters for the vaccine as NNH (number needed to harm) for any, related and severe side effects as mentioned by the investigators. We argue that both NNT and NNH are necessary estimates of how a vaccine might perform in real life and that a robust understanding of efficacy is vital for patients and health care providers as well as health officials in order to make responsible and balanced policy decisions regarding vaccination.

scholarly journals Clinical Assessment of Rosemary-based Toothpaste (Rosmarinus officinalis Linn.): A Randomized Controlled Double-blind Study

2019 ◽  
Vol 30 (2) ◽  
pp. 146-151
Author(s):  
Marcela A. A. Valones ◽  
Ingrid Carla Guedes Silva ◽  
Luiz Alcino Monteiro Gueiros ◽  
Jair Carneiro Leão ◽  
Arnaldo F. Caldas Jr ◽  
...  
Keyword(s):  
Relative Risk ◽  
Risk Reduction ◽  
Rosmarinus Officinalis ◽  
Double Blind Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Gingival Bleeding ◽  
Group A ◽  
Group B ◽  
Bacterial Plaque

Abstract The present study was to investigate the action of a toothpaste made from the extract of Rosmarinus officinalis Linn. (rosemary) in a clinical randomized, controlled, open and double-blind trial. One hundred and ten volunteers fulfilled the inclusion criteria and were randomly separated into two groups according to the toothpastes used: Group A (experimental) and Group B (control). They were assessed at baseline and 30 days after the study using the gingival bleeding index (GBI) and the plaque index (PI). Data analysis was conducted to calculate the effects of the two toothpastes on gingival bleeding and plaque, using measurements such as the excess relative risk (ERR), the Relative Risk Reduction (RRR), the Absolute Risk Reduction (ARR) and the Number Needed for Treatment (NNT). The two toothpastes provided similar results in terms of the reduction in the risk of gingival bleeding (relative and absolute): a reduction of 38% in Group A, ERR=0.38; a reduction of 29.3% in Group B, ERR=0.293; A and B reduced by 18% ARR=0.18). The reductions in bacterial plaque were also similar (22.7% reduction in Group A, RRR=0.227; 28% reduction in Group B, RRR= 0.28). The number needed for treatment values for bleeding and plaque were A and B NNT=5 and A and B NNT=7, respectively. The rosemary-based toothpaste effectively treated gingival bleeding and reduced bacterial plaque, when compared with conventional toothpaste.

Association of Plasma Homocysteine and Macular Edema in Type 2 Diabetes Mellitus

2008 ◽  
Vol 18 (2) ◽  
pp. 226-232 ◽  
Author(s):  
E. Aydin ◽  
H.D. Demir ◽  
H. Ozyurt ◽  
I. Etikan
Keyword(s):  
Type 2 Diabetes ◽  
Diabetic Retinopathy ◽  
Folic Acid ◽  
Vitamin B12 ◽  
Macular Edema ◽  
Vitamin B6 ◽  
Serum Vitamin ◽  
Plasma Homocysteine ◽  
Significant Difference

Purpose The aim of this study was to assess the association of macular edema (ME) with plasma homocysteine, vitamin B6, vitamin B12, and folic acid levels in patients with Type 2 diabetes. Methods Sixty-five diabetic subjects with no retinopathy and nonproliferative diabetic retinopathy (NPDR) (no DR, without ME, with ME: 16, 25, 24, respectively), 28 with proliferative diabetic retinopathy (PDR) (with and without ME: 14, 14, respectively), and 19 healthy subjects as control were recruited in this cross-sectional study Plasma homocysteine, vitamin B12, vitamin B6, and folate levels were determined after 8-hour of fasting for all subjects. The levels of serum homocysteine and vitamin B6 were measured using high performance liquid chromatography (HPLC) with fluorescence detection, and the levels of serum vitamin B12 and folic acid were measured by electrochemiluminescence immunoassay. Results When diabetic groups with ME were compared with diabetic groups without ME for homocysteine, vitamin B12, vitamin B6, and folic acid, the only significant difference was detected in homocysteine levels (p=0.001). There was no significant difference between NPDR with ME group compared with NPDR without ME group and no DR group for plasma homocysteine, vitamin B12, vitamin B6, and folic acid (p=0.200, p=0.660; p=0.999, p=0.678; p=1.0, p=0.248; p=1.0, p=0.982, respectively). On the other hand, when PDR with ME group was compared with PDR without ME group, there was only significant difference in homocysteine levels (p=0.023). Conclusions Mild to moderate elevation of homocysteine may explain the role of vascular dysregulation and endothelial dysfunction in patients with DR. The present study suggests hyperhomocysteinemia may be one of the crucial risk factors for development of ME.

Nonvitamin-K-antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and previous stroke or transient ischemic attack: An updated systematic review and meta-analysis of randomized controlled trials

2017 ◽  
Vol 12 (6) ◽  
pp. 589-596 ◽  
Author(s):  
George Ntaios ◽  
Vasileios Papavasileiou ◽  
Hans-Chris Diener ◽  
Konstantinos Makaritsis ◽  
Patrik Michel
Keyword(s):  
Atrial Fibrillation ◽  
Relative Risk ◽  
Risk Reduction ◽  
Relative Risk Reduction ◽  
Absolute Risk ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Absolute Risk Reduction ◽  
Number Needed To Treat ◽  
Ischemic Attack

Background In a previous systematic review and meta-analysis, we assessed the efficacy and safety of nonvitamin-K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and stroke or transient ischemic attack. Since then, new information became available. Aim The aim of the present work was to update the results of the previous systematic review and meta-analysis. Methods We searched PubMed until 24 August 2016 for randomized controlled trials using the following search items: “atrial fibrillation” and “anticoagulation” and “warfarin” and “previous stroke or transient ischemic attack.” Eligible studies had to be phase III trials in patients with atrial fibrillation comparing warfarin with nonvitamin-K antagonist oral anticoagulants currently on the market or with the intention to be brought to the market in North America or Europe. The outcomes assessed in the efficacy analysis included stroke or systemic embolism, stroke, ischemic or unknown stroke, disabling or fatal stroke, hemorrhagic stroke, cardiovascular death, death from any cause, and myocardial infarction. The outcomes assessed in the safety analysis included major bleeding, intracranial bleeding, and major gastrointestinal bleeding. We performed fixed effects analyses on intention-to-treat basis. Results Among 183 potentially eligible articles, four were included in the meta-analysis. In 20,500 patients, compared to warfarin, nonvitamin-K antagonist oral anticoagulants were associated with a significant reduction of stroke/systemic embolism (relative risk reduction: 13.7%, absolute risk reduction: 0.78%, number needed to treat to prevent one event: 127), hemorrhagic stroke (relative risk reduction: 50.0%, absolute risk reduction: 0.63%, number needed to treat: 157), any stroke (relative risk reduction: 13.1%, absolute risk reduction: 0.7%, number needed to treat: 142), and intracranial hemorrhage (relative risk reduction: 46.1%, absolute risk reduction: 0.88%, number needed to treat: 113) over 1.8–2.8 years. Conclusions This updated meta-analysis in 20,500 atrial fibrillation patients with previous stroke or transient ischemic attack shows that compared to warfarin non-vitamin-K antagonist oral anticoagulants are associated with a significant reduction of stroke, stroke or systemic embolism, hemorrhagic stroke, and intracranial bleeding.

Adjuvant Chemotherapy for Breast Cancer: How Presentation of Recurrence Risk Influences Decision-Making

2003 ◽  
Vol 21 (23) ◽  
pp. 4299-4305 ◽  
Author(s):  
Celia Chao ◽  
Jamie L. Studts ◽  
Troy Abell ◽  
Terence Hadley ◽  
Lynne Roetzer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Relative Risk ◽  
Risk Reduction ◽  
Survival Benefit ◽  
Relative Risk Reduction ◽  
Absolute Risk ◽  
Treatment Decision ◽  
Absolute Risk Reduction ◽  
Number Needed To Treat ◽  
The Impact

Purpose: The purpose of this study was to examine the impact of four methods of communicating survival benefits on chemotherapy decisions. We hypothesized that the four methods of communicating mathematically equivalent risk information would lead to different chemotherapy decisions. Methods: Each participant received two hypothetical scenarios regarding their mother (a postmenopausal woman with an invasive, lymph node-negative, hormone receptor-positive breast cancer) and was asked to decide whether they would encourage their mother to take chemotherapy in addition to surgery and tamoxifen. In the part 1, participants received one of four methods of describing the chemotherapy survival benefit: (1) relative risk reduction, (2) absolute risk reduction, (3) absolute survival benefit, or (4) number needed to treat. In part 2, each participant received all four methods. Following each decision, participants were asked to rate their confidence and confusion regarding their decision. Results: Participants included 203 preclinical medical students. In part 1, participants who received relative risk reduction information were significantly more likely to endorse chemotherapy. In part 2, there were no treatment decision differences when participants received all four methods of communicating survival benefits of chemotherapy. However, receiving all four methods led to significantly higher ratings of confusion. In deciding on endorsing chemotherapy, participants understood the information best when presented with data in the absolute survival benefit format. Conclusion: These results support the hypothesis that the method used to present information about chemotherapy influences treatment decisions. Absolute survival benefit is the most easily understood method of conveying the information regarding benefit of treatment.

scholarly journals Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 199
Author(s):  
Ronald B. Brown
Keyword(s):  
Clinical Trials ◽  
Relative Risk ◽  
Risk Reduction ◽  
Relative Risk Reduction ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Reporting Bias ◽  
Outcome Reporting Bias ◽  
Outcome Reporting ◽  
Risk Reduction Measures

Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.

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