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PloS One 2018Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a previously reported superiority trial of doxylamine-pyridoxine for the treatment of nausea and vomiting during pregnancy using the clinical study report obtained from Health Canada.
METHODS AND FINDINGS
We re-analysed individual level data for a parallel arm randomized controlled trial that was conducted in six outpatient obstetrical practices in the United States. Pregnant women between 7 and 14 weeks of gestation with moderate nausea and vomiting of pregnancy symptoms. The active treatment was a tablet containing both doxylamine 10 mg and pyridoxine 10 mg taken between 2 and 4 times per day for 14 days depending on symptoms. The control was an identical placebo tablet taken using the same instructions. The primary outcome measure was improvement in nausea and vomiting of symptoms scores using the 13-point pregnancy unique quantification of emesis scale between baseline and 14 days using an ANCOVA. 140 participants were randomized into each group. Data for 131 active treatment participants and 125 control participants were analysed. On the final day of the trial, 101 active treatment participants and 86 control participants provided primary outcome measures. There was greater improvement in symptoms scores with doxylamine-pyridoxine compared with placebo (0.73 points; 95% CI 0.21 to 1.25) when last observation carried forward imputation was used for missing data but the difference is not statistically significant using other approaches to missing data (e.g. 0.38; 95% CI -0.08 to 0.84 using complete data).
CONCLUSIONS
There is a trend towards efficacy for nausea and vomiting symptoms with doxylamine-pyridoxine compared with placebo but the statistical significance of the difference depends on the method of handling missing data and the magnitude of the difference suggests that there is no clinically important benefit employing the prespecified minimal clinically important difference or "expected difference" of 3 points.
TRIAL REGISTRATION
Clinical Trial NCT00614445.
Topics: Doxylamine; Drug Therapy, Combination; Female; Humans; Morning Sickness; Placebos; Pregnancy; Pyridoxine
PubMed: 29342163
DOI: 10.1371/journal.pone.0189978 -
MedEdPORTAL : the Journal of Teaching... Sep 2018Treatment of seizures in the neonatal patient is urgent and time sensitive. Effective and timely treatment of this life-threatening condition is vital in preventing...
INTRODUCTION
Treatment of seizures in the neonatal patient is urgent and time sensitive. Effective and timely treatment of this life-threatening condition is vital in preventing mortality and long-term morbidity. This simulation-based curriculum involves the identification and management of a seizure in a 4-day-old neonate with pyridoxine-dependent epilepsy. The target audience is emergency medicine and pediatric residents, pediatric emergency medicine fellows, and medical students.
METHODS
The primary objectives for this simulation are to (1) rapidly initiate stabilization techniques for a seizing neonate, (2) recognize the importance of checking a glucose level in a seizing neonate, (3) demonstrate understanding of antiepileptic medications and dosing, and (4) identify status epilepticus and initiate pyridoxine once initial seizure management has failed. The goals of this simulation are for residents to treat a seizing infant in an emergency department setting, identify status epilepticus, develop a differential diagnosis that includes vitamin B6 deficiency, and correctly administer pyridoxine. Requirements of this simulation include a high-fidelity patient simulator, medical supplies, a patient simulator operator, and one actor.
RESULTS
This simulation case was performed at the simulation lab at the State University of New York Upstate Medical University with emergency medicine and pediatric residents. Feedback evaluations for the case showed that it improved resident education and clinical skills.
DISCUSSION
This simulation case was well received and helped residents develop a systematic approach to seizure management of a newborn. Residents reported increased confidence in treating a seizing neonate and increased comprehension of pyridoxine-dependent epilepsy.
Topics: Clinical Competence; Emergency Medicine; Epilepsy; High Fidelity Simulation Training; Humans; Infant; Infant, Newborn; New York; Pediatric Emergency Medicine; Pyridoxine; Seizures; Vitamin B Complex
PubMed: 30800953
DOI: 10.15766/mep_2374-8265.10753 -
Paediatric Drugs Jun 2014Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for... (Review)
Review
Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Unfortunately, many women receive either no pharmacological treatment or are recommended therapies for which fetal safety and efficacy have not been established. First-line treatment of NVP, as recommended by several leading healthcare and professional organizations, is the combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed-release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 under the brand name Diclegis(®), and has been on the Canadian market since 1979, currently under the brand name Diclectin(®). The efficacy of Diclegis(®)/Diclectin(®) has been demonstrated in several clinical trials, and, more importantly, studies on more than 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy have demonstrated no increased fetal risk for congenital malformations and other adverse pregnancy outcomes. The present review aims to present the scientific evidence on the effectiveness and fetal safety of Diclegis(®)/Diclectin(®) for the treatment of NVP to justify its use as first-line treatment for NVP.
Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pregnancy; Pregnancy Complications; Pyridoxine; Treatment Outcome; Vomiting
PubMed: 24574047
DOI: 10.1007/s40272-014-0065-5 -
Frontiers in Cellular and Infection... 2023B vitamins are essential micro-organic compounds for the development of humans and animals. Vitamin B6 comprises a group of components including pyridoxine, pyridoxal,...
B vitamins are essential micro-organic compounds for the development of humans and animals. Vitamin B6 comprises a group of components including pyridoxine, pyridoxal, and pyridoxamine. In addition, vitamin B6 acts as the coenzymes in amino acid biosynthesis, decarboxylation, racemic reactions, and other biological processes. In this study, we found that the expressions of a gene encoding pyridoxine biosynthesis protein () were significantly upregulated in the early infectious stages in . Furthermore, deletion of slowed vegetative growth on different media, especially on MM media, and the growth defect was rescued when MoPdx1-protein was expressed in mutants strains and when commercial VB6 (pyridoxine) was added exogenously. However, VB6 content in different strains cultured in CM media has no significant difference, suggested that MoPdx1 was involved in VB6 biosynthesis not in uptake process, and VB6 regulates the vegetative growth of . The Δ mutants presented abnormal appressorium turgor, slowed invasive growth and reduced virulence on rice seedlings and sheath cells. MoPdx1 was located in the cytoplasm and present in spore and germ tubes at 14 hours post inoculation (hpi) and then transferred into the appressorium at 24 hpi. Addition of VB6 in the conidial suspentions could rescue the defects of appressorium turgor pressure at 14 hpi or 24 hpi, invasive growth and pathogenicity of the deletion mutants. Indicated that MoPdx1 affected the appressorium turgor pressure, invasive growth and virulence mainly depended on VB6, and VB6 was biosynthesized in conidia, then transported into the appressorium, which play important roles in substances transportation from conidia to appressorium thus to regulate the appressorium turgor pressure. However, deletion of did not affect the ability that scavenge ROS produced by rice cells, and the mutant strains were unable to activate host defense responses. In addition, co-immunoprecipitation (Co-IP) assays investigating potential MoPdx1-interacting proteins suggested that MoPdx1 might take part in multiple pathways, especially in the ribosome and in biosynthesis of some substances. These results indicate that vitamins are involved in the development and pathogenicity of .
Topics: Humans; Virulence; Pyridoxine; Fungal Proteins; Magnaporthe; Oryza; Plant Diseases; Spores, Fungal; Gene Expression Regulation, Fungal
PubMed: 36824685
DOI: 10.3389/fcimb.2023.1099967 -
Cellular Physiology and Biochemistry :... Jun 2022Besides their physiological properties, vitamins, such as vitamin C (ascorbic acid) and B (pyridoxine), ameliorate the symptoms of allergic disorders. Because exocytosis...
BACKGROUND/AIMS
Besides their physiological properties, vitamins, such as vitamin C (ascorbic acid) and B (pyridoxine), ameliorate the symptoms of allergic disorders. Because exocytosis in mast cells can be detected electrophysiologically by the changes in the membrane capacitance (Cm), its continuous monitoring in the presence of these vitamins would determine their mast cell-stabilizing, anti-allergic properties.
METHODS
Employing the whole-cell patch-clamp technique in rat peritoneal mast cells, we examined the effects of ascorbic acid and pyridoxine on the degranulation of mast cells and the increase in the Cm during exocytosis.
RESULTS
Both ascorbic acid and pyridoxine dose-dependently suppressed the GTP-γ-S-induced increase in the Cm and inhibited the degranulation from mast cells. Surprisingly enough, relatively low concentrations of pyridoxine (1, 2 mM) synergistically enhanced the suppressive effect of 2 mM ascorbic acid on mast cell degranulation.
CONCLUSION
These results provided electrophysiological evidence for the first time that ascorbic acid and pyridoxine inhibited the process of exocytosis in a dose-dependent manner. At relatively lower concentrations, these vitamins were not enough to stabilize mast cells. However, such concentrations of pyridoxine synergistically potentiated the mast cell-stabilizing property of ascorbic acid.
Topics: Animals; Ascorbic Acid; Exocytosis; Mast Cells; Pyridoxine; Rats; Vitamins
PubMed: 35781358
DOI: 10.33594/000000534 -
Cleveland Clinic Journal of Medicine 1989
Review
Topics: Adrenocorticotropic Hormone; Anticonvulsants; Humans; Infant; Pyridoxine; Spasms, Infantile
PubMed: 2541944
DOI: No ID Found -
Experimental and Clinical... May 2021This prospective study aimed to compare changes in serum thiamine and pyridoxine levels of patients who underwent liver transplant or living donor hepatectomy.
OBJECTIVES
This prospective study aimed to compare changes in serum thiamine and pyridoxine levels of patients who underwent liver transplant or living donor hepatectomy.
MATERIALS AND METHODS
Between January 2013 and November 2013, 35 patients with chronic liver disease who underwent liver transplant (the recipient group) and 30 healthy individuals who underwent living donor hepatectomy (the control group) during the same period were prospectively compared in terms of both preoperative and postoperative serum thiamine and pyridoxine levels. The groups were also subjected to intragroup analysis of preoperative and postoperative changes in serum vitamin levels to determine how a major surgical procedure affected serum vitamin levels. Mann-Whitney U test and Wilcoxon signed-rank test were used for intergroup comparisons and intragroup repeated measurements, respectively.
RESULTS
The intergroup comparisons revealed significant differences in favor of the control group with respect to preoperative thiamine (P < .026) and postoperative thiamine (P < .017) levels, whereas there were statistically significant differences in favor of the recipient group with respect to the preoperative pyridoxine (P < .006) and postoperative pyridoxine (P < .001) levels. The intragroup comparisons showed significant increases in serum thiamine (P < .001) and pyridoxine (P < .031) levels compared with the preoperative serum levels of both vitamins at postoperative day 5 in the recipient group. In the control group, serum thiamine level (P < .001) at postoperative day 5 was significantly different from the preoperative level. On the other hand, a drop in serum pyridoxine level was detected at postoperative day 5, although this was not statistically significant (P < .21).
CONCLUSIONS
This study showed a lower serum thiamine level but a higher serum pyridoxine level in patients with chronic liver disease versus healthy controls. This difference persisted into the early postoperative period. This study also showed significant increases in thiamine and pyridoxine levels after transplant surgery.
Topics: Case-Control Studies; Hepatectomy; Humans; Liver Transplantation; Living Donors; Prospective Studies; Pyridoxine; Thiamine; Vitamins
PubMed: 29292683
DOI: 10.6002/ect.2017.0102 -
Rhode Island Medical Journal (2013) Mar 2022Pediatric seizures are a common reason for emergency department visits. The highest risk of seizures in children is during the neonatal period. A low index of suspicion... (Review)
Review
Pediatric seizures are a common reason for emergency department visits. The highest risk of seizures in children is during the neonatal period. A low index of suspicion is important to facilitate the early assessment, workup, and treatment of inborn errors of metabolism to optimize developmental outcomes. We present the rare case of a 9-day-old with seizures refractory to multiple anticonvulsant medications who was diagnosed with pyridoxine-dependent epilepsy. We review differences in the management of neonatal seizures from older patients, the utility of a trial of pyridoxine in refractory neonatal seizures, and the importance of preparing for emergent airway management given pyridoxine's ability to cause apnea and central nervous system depression.
Topics: Epilepsy; Humans; Infant, Newborn; Pyridoxine; Seizures
PubMed: 35211704
DOI: No ID Found -
British Medical Journal Dec 1961
Topics: Anemia; Anemia, Hypochromic; Anemia, Sideroblastic; Genetic Diseases, X-Linked; Pyridoxine; Vitamin B 6; beta-Thalassemia
PubMed: 13905463
DOI: 10.1136/bmj.2.5269.1756 -
Molecules (Basel, Switzerland) Mar 2022Described in this paper are studies on the preparation of three classes of dimethylpyridinols derived from pyridoxine fused with aminooxazole, aminoimidazole, and...
Described in this paper are studies on the preparation of three classes of dimethylpyridinols derived from pyridoxine fused with aminooxazole, aminoimidazole, and aminopyrrole. The key feature of this synthetic strategy is the manipulation of hydroxymethyl moiety of C(5)-position of the pyridoxine starting material along with the installation of an amino group at C(6)-position. Efficient and practical synthesis for the oxazole- and imidazole-fused targets was accomplished, while the instability of the pyrrole-fused one was observed.
Topics: Oxazoles; Pyridoxine; Pyrroles
PubMed: 35408475
DOI: 10.3390/molecules27072075