This is a multicenter, randomized, placebo controlled, double-blind phase III trial with four parallel groups studying studying the feasibility of RCT in primary care as well as the effectiveness of treatment with prednisolone and/or vitamin B1/6/12 for PC19S.

Start Date11 Nov 2022

Sponsor / Collaborator

Wuerzburg University Hospital

[+2]

NCT05619328 / CompletedPhase 3

A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Product Vitamins B1 (100mg), B6 (100 mg), Plus B12 (5 mg) in Tablets in Subjects With Clinically Diagnosed PerIpheral Sensory polyNeuropathy of Different etiologieS (PINS Study)

This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo.

Start Date06 Sep 2022

Sponsor / Collaborator

Procter & Gamble, Inc.

100 Clinical Results associated with Cyanocobalamin/Vitamin B6/Thiamine Chloride Hydrochloride

100 Translational Medicine associated with Cyanocobalamin/Vitamin B6/Thiamine Chloride Hydrochloride

100 Patents (Medical) associated with Cyanocobalamin/Vitamin B6/Thiamine Chloride Hydrochloride

Literatures (Medical) associated with Cyanocobalamin/Vitamin B6/Thiamine Chloride Hydrochloride

01 Jun 2024·BJOG: An International Journal of Obstetrics & Gynaecology

The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green‐top Guideline No. 69)

Review

Author: Shehmar, Manjeet ; Nelson-Piercy, Catherine ; Hodson, Kenneth ; Gadsby, Roger ; Dean, Caitlin ; Nana, Melanie ; O'Hara, Margaret

Key recommendations

An objective and validated index of nausea and vomiting such as the Pregnancy‐Unique Quantification of Emesis (PUQE) and HyperEmesis Level Prediction (HELP) tools can be used to classify the severity of NVP and HG. [Grade C]

Ketonuria is not an indicator of dehydration and should not be used to assess severity. [Grade A]

There are safety and efficacy data for first line antiemetics such as anti (H1) histamines, phenothiazines and doxylamine/pyridoxine (Xonvea®) and they should be prescribed initially when required for NVP and HG (Appendix III). [Grade A]

There is evidence that ondansetron is safe and effective. Its use as a second line antiemetic should not be discouraged if first line antiemetics are ineffective. Women can be reassured regarding a very small increase in the absolute risk of orofacial clefting with ondansetron use in the first trimester, which should be balanced with the risks of poorly managed HG. [Grade B]

Metoclopramide is safe and effective and can be used alone or in combination with other antiemetics. [Grade B]

Because of the risk of extrapyramidal effects metoclopramide should be used as second‐line therapy. Intravenous doses should be administered by slow bolus injection over at least 3 minutes to help minimise these. [Grade C]

Women should be asked about previous adverse reactions to antiemetic therapies. If adverse reactions occur, there should be prompt cessation of the medications. [GPP]

Normal saline (0.9% NaCl) with additional potassium chloride in each bag, with administration guided by daily monitoring of electrolytes, is the most appropriate intravenous hydration. [Grade C]

Combinations of different drugs should be used in women who do not respond to a single antiemetic. Suggested antiemetics for UK use are given in Appendix III. [GPP]

Thiamine supplementation (either oral 100 mg tds or intravenous as part of vitamin B complex (Pabrinex®)) should be given to all women admitted with vomiting, or severely reduced dietary intake, especially before administration of dextrose or parenteral nutrition. [Grade D]

All therapeutic measures should have been tried before considering termination of pregnancy. [Grade C]

01 Dec 2020·Systematic ReviewsQ4 · MEDICINE

Parenteral thiamine for prevention and treatment of delirium in critically ill adults: a systematic review protocol

Q4 · MEDICINE

ArticleOA

Author: Page, Valerie J ; Taylor, David ; McAuley, Daniel F ; Spronk, Peter E ; Ostermann, Marlies ; McKenzie, Cathrine A ; Blackwood, Bronagh ; Strain, W David

AbstractBackgroundDelirium is an acute confusional state, common in critical illness and associated with cognitive decline. There is no effective pharmacotherapy to prevent or treat delirium, although it is scientifically plausible that thiamine could be effective. Thiamine studies in dementia patients are inconclusive. Aside from small numbers, all used oral administration: bioavailability of thiamine is poor; parenteral thiamine bypasses this. In the UK, parenteral thiamine is administered as a compound vitamin B and C solution (Pabrinex®). The aim of this review is to evaluate the effectiveness of parenteral thiamine (alone or in a compound solution) in preventing or treating delirium in critical illness.MethodsWe will search for studies in electronic databases (MEDLINE (Pro-Quest), EMBASE, CINAHL, LILACS, CNKI, AMED, and Cochrane CENTRAL), clinical trials registries (WHO International Clinical Trials Registry, ClinicalTrials.gov, and Controlled-trials.com), and grey literature (Google Scholar, conference proceedings, and Index to Theses). We will perform complementary searches of reference lists of included studies, relevant reviews, clinical practice guidelines, or other pertinent documents (e.g. official documents and government reports). We will consider quasi-randomised or randomised controlled trials in critically ill adults. We will include studies that evaluate parenteral thiamine versus standard of care, placebo, or any other non-pharmacological or pharmacological interventions. The primary outcomes will be the delirium core outcome set, including incidence and severity of delirium and cognition. Secondary outcomes are adapted from the ventilation core outcome set: duration of mechanical ventilation, length of stay, and adverse events incidence. Screening, data extraction, and risk of bias assessment will be undertaken independently by two reviewers. If data permits, we will conduct meta-analyses using a random effects model and, where appropriate, sensitivity and subgroup analyses to explore sources of heterogeneity.DiscussionThis review will provide evidence for the effectiveness of parental thiamine in the prevention or treatment of delirium in critical care. Findings will contribute to establishing the need for a multicentre study of parenteral thiamine in the prevention and treatment of critical care delirium.Systematic review registrationPROSPERO CRD42019118808

01 Dec 2019·Alcohol and AlcoholismQ3 · MEDICINE

Incidence of Adverse Reactions to Parenteral Thiamine in the Treatment of Wernicke’s Encephalopathy, and Recommendations

Q3 · MEDICINE

Review

Author: Guerrini, Irene ; Marshall, Elizabeth Jane ; Thomson, Allan

AbstractAimTo offer an estimate of the incidence of anaphylactic reactions to parenteral products containing thiamine used in the treatment of Wernicke’s encephalopathy (WE) and make recommendations.MethodReview of previously released data on some older products and parenteral thiamine use in some other countries; analysis of sales and adverse incident data on anaphylaxis for a contemporary parenteral product used in the UK, Pabrinex.ResultsIt was difficult to estimate the incidence of related anaphylactic reactions to Pabrinex in the UK because the number of doses given is unknown. Sales data are only an approximation to doses given because for products with a limited shelf life not all product sold is administered. However, available data indicate that there have been 10 anaphylactic reactions to Pabrinex from between 5,431,235–6,651,947 patient-days (14,880–16,080 years) of treatment.ConclusionIt is reasonable to assume that the risk of anaphylaxis is low, and lower than for many other drugs. The risk-benefit ratio for administration is favourable given the potential severity of brain damage in Wernicke–Korsakoff (WK) syndrome. There is a need for international agreement on the reporting of anaphylaxis and on the optimum thiamine therapy for the treatment of WK syndrome. We make recommendations on how this might be achieved.

100 Deals associated with Cyanocobalamin/Vitamin B6/Thiamine Chloride Hydrochloride

External Link

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R&D Status

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Indication	Country/Location	Organization	Date
Vitamin B 12 Deficiency	PL	Aflofarm Farmacja Polska SP zoo	13 Jan 2016
Vitamin B 6 Deficiency	PL	Aflofarm Farmacja Polska SP zoo	13 Jan 2016
Thiamine Deficiency	PL	Aflofarm Farmacja Polska SP zoo	03 Jan 2016

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