Ont Health Technol Assess Ser. Preliminary therapeutic trial [Deficience en vitamine B12 et etat dementiel: etude epidemiologique multicentrique et therapeutique. Intramuscular vitamin B12 can be administered in two different forms: cyanocobalamin and hydroxocobalamin. selection bias - a) was the randomisation procedure adequate? Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. FOIA The process resulted in agreement in the pre-selection stage, the quality of the assessment, and in the data extraction phase. People who have a rare blood disorder (polycythemia vera) may rarely have symptoms related to this disorder while taking hydroxocobalamin. Discuss the risks and benefits with your doctor. Without enough red blood cells, your tissues and organs don't get enough oxygen. Proper Use. Nygard O, Nordrehaug JE, Refsum H, Ueland PM, Farstad M, Vollset SE. Keep all medical and lab appointments. It was agreed that if during our search we identified any additional key words of relevance, we would adapt our strategy accordingly and re-run the search. Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm . Do not start, stop, or change the dosage of any medicines without your doctor's approval. Current clinical practice in UK and in most countries is to prescribe vitamin B12 in the intramuscular form for the treatment of vitamin B12 deficiency. Cochrane Database Syst Rev. Most people with vitamin B12 deficiency are treated in primary care with intramuscular vitamin B12 which is a considerable source of work for health care professionals. Tell your doctor if you are on a vegetarian diet. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. For self-injection purposes, we normally recommend to inject in the stomach (around the belly button, see the picture above). Hydrochloric acid and/or sodium hydroxide may have . Berlin H, Berlin R, Brante G. Oral treatment of pernicious anemia with high doses of vitamin B12 without intrinsic factor. This video shows you how to give your partner (or family member) a B12 injection into the deltoid muscle. This was difficult to ascertain because in the trials numbers are small, follow up short and trials did not include patients with common conditions that might interfere with absorption in the terminal ileum such as Crohn’s disease, coeliac disease or ulcerative colitis. If you cannot absorb vitamin B12 from food, Dr. Ralph Caramel, author of a 2008 article on vitamin B12 in the journal "Blood," suggests an initial injection cycle of 8 to 10 administrations over the first two to three months, then injections once a month thereafter. Conley C, Krevans J. Eine Überdosierung an Vitamin B12 ist aber möglich bei: Lebermetastasen. Normal daily requirements of vitamin B12 vary according to age. Costs were reported in one of the included trials (Bolaman 2003). Fraser RC, Farooqi A, Sorrie R. Use of vitamin B-12 in Leicestershire practices: a single topic audit led by a medical audit advisory group. However the samples were judged valid for assay of serum metabolites. Slot WB, Merkus FW, Van Deventer SJ, Tytgat GN. This vitamin is needed to make red blood cells, which carry oxygen to all parts of your body. Retention of cyanocobalamin, hydroxocobalamin, and coenzyme B12 after parenteral administration. Avoid touching the needle on the glass bottom of the vial, because it might dull its sharpness. When uncertainty arose, or when there were differences between these reviewers, we obtained and reviewed the hard copies of papers and made decisions by consensus. Daily requirements are age-related; the recommended dietary amounts for adults and infants are 1,5 mcg and 0.4 mcg respectively ( FAO/WHO 1988, DH 1991 ). Randomised controlled trials (RCTs) examining the use of oral or intramuscular vitamin B12 to treat vitamin B12 deficiency. No additional studies were identified in this way. Properly discard this product when it is expired or no longer needed. Insert needle at a 90-degree right angle. The methodological quality of the included studies were independently assessed by two researchers (CCB and RCJ) and disagreements brought back to the whole group for discussion. Hydroxocobalamin. Searches were undertaken of The Cochrane Library, MEDLINE, EMBASE and Lilacs in early 2005. Normalization of plasma vitamin B12 concentration by intranasal hydroxocobalamin in vitamin B12-deficient patients. van Walraven C, Naylor CD. We searched the following databases: Our search strategy was based on the strategy described in the Cochrane Reviewers’ Handbook (Optimal Search Strategy for RCTs. Die Ernährung sollte - sowohl bei Veganern als auch bei Nicht . Vitamin B12 nasal gel. Kuzminski and colleagues (Kuzminski 1998) concluded that 2000 mcg daily of oral cyanocobalamin was as effective or even superior to 1000 mcg of the same medication administered intramuscularly every month. Brody EA. Evaluated outcomes were vitamin B12 levels (two RCTs) and normalization of vitamin B12 levels (two RCTs). Consult your doctor before breast-feeding. In some countries hydroxocobalamin has completely replaced cyanocobalamin as first choice for vitamin B12 therapy because it is retained in the body longer and can be administered at intervals of up to three months (BNF 2004). FOIA Common Vitamin B12 side effects may include: diarrhea; or. Two studies compared oral and intramuscular vitamin B12: Kuzminski and colleagues (Kuzminski 1998) reported neurologic and haematologic responses. Dosage of hydroxocobalamin for vitamin B12 deficiency [Dosering af hydroksokobalamin (Vibeden)]. Tell your doctor right away if any of these serious side effects occur: muscle cramps, weakness, irregular heartbeat. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency . Wie kann unsere Evidenz zu Gesundheitsthemen Ihnen helfen. = to substitute for one or no characters; tw = text word; pt = publication type; sh = MeSH: Medical subject heading (Medline medical index term); adj = adjacency. A crucial aspect our study addresses is whether or not patients with conditions that might cause malabsorption may be safely treated with oral vitamin B12 in primary care. None of the studies was conducted in Primary Care where most of the patients with vitamin B12 deficiencies are treated; this makes the generalisability of the results more difficult. Vitamin B12 wird von Ärzten eher in Form von Injektionen in den Muskel (intramuskuläre Injektion) verabreicht, da sie möglicherweise die Option Vitamin B12 oral zu verabreichen nicht kennen oder Bedenken hinsichtlich deren Wirksamkeit haben. detection bias - were outcome assessors adequately blinded to the intervention patients received? Oral vitamin B12 without intrinsic factor in the treatment of pernicious anemia. Eine Vielzahl von Anzeichen und Symptomen können auftreten, insbesondere eine Blutarmut und neurologische Störungen.. Für die Aufnahme von Vitamin B 12 ist im Magen ein Protein notwendig, der Intrinsische Faktor.Fehlt dieser z. official website and that any information you provide is encrypted Andres E, Kaltenbach G, Noel E, Noblet-Dick M, Perrin AE. Comprehensive Approach to Medical Nutrition Therapy in Patients with Type 2 Diabetes Mellitus: From Diet to Bioactive Compounds. http://food.gov.uk/multimedia/pdfs/EVM/00/20/P. Vitamin B12 (cobalamin) is necessary for the development of red blood cells, growth, and nervous system maintenance. BMC Public Health. We planned to report serum concentrations of vitamin B12, homocysteine and methylmalonic acid and sources of clinical outcome of both routes of administration, oral and parenteral, giving mean differences and confidence intervals. Archie Cochrane, working in South Wales, was one of the first to identify that substantial financial savings could be made from more evidence-based prescribing of vitamin B12. Intention to treat analysis and blinding was not performed or mentioned in any of the studies. Possible reasons for doctors not prescribing oral formulations include unawareness of this option or concerns regarding unpredictable absorption (Lederle 1991; Lederle 1998). Journal of the American Medical Association. Hydroxocobalamin. We identified many studies assessing the effectiveness of oral vitamin B12, but they were not randomised. This tends to be the best B12 injection site for many people, because this area tends to have . We consider this as insufficient because of the long biological half-life of body stores of vitamin B12. Everybody involved in the administration of Vitamin B12 Injections sho. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. See: Characteristics of included studies; Characteristics of excluded studies. However, in two patients in each group the response was not optimal. The only dietary sources of vitamin B12 are animal products, such as eggs, fish and meats. US residents can call their local poison control center at 1-800-222-1222. Report of a Joint FAO/WHO Expert Consultation. The most common cause of vitamin B12 deficiency is autoimmune pernicious anaemia, a condition that carries an increased risk of gastric cancer. Dr Andrew McCaddon is a Scientific Consultant for, and shareholder of, COBALZ LIMITED - a private company developing ’glutathionylcobalamin’ as an alternative orally available form of vitamin B12. Four of the eighteen participants randomised to receive oral vitamin B12 and four of the fifteen randomised to receive intramuscular vitamin B12 had a neurological response with a marked improvement or clearing of paresthesias, ataxia, or memory loss. Accessibility Kaltenbach G, Noblet-Dick M, Andres E, Barnier-Figue G, Noel E, Vogel T, et al. 73426-1/Canadian Institutes of Health Research/Canada. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. In zwei Studien wurden 1000 μg Vitamin B12 /Tag oral verabreicht. Naurath HJ, Joosten E, Riezler R, Stabler SP, Allen RH, Lindenbaum J. You may report side effects to the FDA at 1-800-FDA-1088. McIntyre PAHR, Masters JM, Krevans JR. In the UK, oral vitamin B12 is not currently available on NHS prescription in high dose formulations. This is estimated to be more than 30 month (Basu 1996). This medicine is given as a shot into a muscle. Consult your pharmacist or local waste disposal company. Differences in the Formation of Reactive Oxygen Species and Their Cytotoxicity between Thiols Combined with Aqua- and Cyanocobalamins. Ricerca clinica in doppio cieco]. The aim of the present study was to compare the efficacy of SL versus the standard IM administration of VB12 in restoring B12 levels. The difference was even greater at four months (1,005 +/− 595 vs. 325 +/− 165 pg/mL; P< 0.0005). Es sollten die Auswirkungen von oral eingenommenem Vitamin B12 im Vergleich zu intramuskulär injiziertem Vitamin B12 bei Vitamin-B12-Mangel untersucht werden. Essai preliminaire]. Skouby AP. Each vial also contains Sodium Chloride, 0.9%. Rickes EL, Brink NG, Koniuszy FR, Wood TR, Folkers K. Crystalline vitamin B12. Studio controllato]. The studies, dating from the early 50’s to recently, were mainly before and after studies and all show that patients with vitamin B12 deficiency respond to oral vitamin B12 replacement therapy in clinical and/or laboratory terms (Andres 2001; Andres 2003a; Berlin 1968; Brody 1959; Chalmers 1958; Conley 1952; Conley 1955; Hemsted 1958; Kondo 1998 ; McIntyre 1960; Reisner 1955; Spies 1949; Unglaud 1955; Ungley 1950; Verhaeverbeke 1997; Waife 1963). When a difference between reviewers arose, we obtained and reviewed a hard copy of the papers and made decisions by consensus. Study participants with low serum vitamin B12 levels, meeting criteria for vitamin B12 replacement therapy. Comparison of hydroxocobalamin and cyanocobalamin in the treatment of pernicious anaemia. Plasma homocysteine levels and mortality in patients with coronary artery disease. Characteristics of these studies are shown in Characteristics of included studies. Methylcobalamin has a higher bioavailability (absorption . European Review for Medical & Pharmacological Sciences. Vitamin B12 deficiency and dementia: A multicenter epidemiologic and therapeutic study. We could have included more studies if we had considered participants with normal vitamin B12 levels at study entry but the objective of the review was to look at the use of vitamin B12 for the treatment of vitamin B12 deficiency. Consult the product instructions and your pharmacist for storage details. Conley C, Green T, Hartmann R, Krevans J. Prolongued Treatment of Pernicious Anemia with Vitamin B12. The methodological quality of the included studies was independently assessed by two researchers and disagreements were brought back to the whole group and resolved by consensus. The corresponding percentage after an injection of 1000 mcg of hydroxocobalamin was 27% (Glass 1961). sharing sensitive information, make sure you’re on a federal A very serious allergic reaction to this drug is rare. The trials recruited a total of 108 participants and followed up 93 of these from 90 days to four months. Boddy K, King P, Mervyn L, Macleod A, Adams JF. Does Hydro B12 Solution interact with other drugs you are taking? A major consideration was heterogeneity of oral treatment regimes and diverse eligibility for study entry. Portions of this document last updated: May 01, 2023. Doctors may not be prescribing oral formulations because they are unaware of this option or have concerns regarding effectiveness. swelling anywhere in your body. British Medical Journal Clinical Research Ed. Higgins JP, Thompson SG. The intramuscular treatment regimen was 1 mg per day of cyanocobalamin on alternate days for two weeks, then 1 mg per week during weeks 3 to 8, and 1 mg per month during weeks 9 to 52. Chalmers JN, Shinton NK. ANDREW GORINGE: Haematological advice. No evidence that patients were vitamin B12 deficient, Review of treatments of diabetes. All rights reserved. However, in another non-randomised control trial, researchers attempted to convert patients in primary care from intramuscular to oral vitamin B12 replacement but only half agreed to participate in the study (Nyholm 2003). Laut einer Studie wurden in keiner der beiden Gruppen (orale oder IM-Vitamin-B12unerwünschte, behandlungsbedingte Ereignisse beobachtet. CHRISTOPHER C BUTLER: Formulation of study question, searching, protocol writing, data extraction, piloting form for data extraction, study quality assessment, interpretation of data, report writing. Behandlungsfrequenz und tägliche Dosis des verabreichten Vitamin B12 variierte zwischen den einzelnen Studien. van Asselt DZ, Pasman JW, van Lier HJ, Vingerhoets DM, Poels PJ, Kuin Y, et al. However, adherence and monitoring will remain important considerations, regardless of route of administration. b) was the allocation concealment adequate? This is not a complete list of possible side effects. Ungley CC. Blood levels and urinary excretion of vitamin B12 in man after a single parenteral dose of aqueous hydroxocobalamin, aqueous cyanocobalamin and cyanocobalamin zinc-tannate complex. We have not received any commercial sponsorship for this review. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue. Neuropsychiatric disorders caused by cobalamin deficiency in the absence of anemia or macrocytosis. Prevalence figures between 1.5% and 15% have been reported (Clarke 2004; Figlin 2003; Pennypacker 1992; Rajan 2002; van Walraven 1999). Vitamin B12 and folate deficiency in later life. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Short-term oral cobalamin therapy for food-related cobalamin malabsorption. Glass GB, Skeggs HR, Lee DH. Hvas A-M, Juul S, Nexo E, Ellegaard J. Vitamin B-12 treatment has limited effect on health-related quality of life among individuals with elevated plasma methylmalonic acid: A randomized placebo-controlled study. It was not possible to investigate heterogeneity or to do subgroup analysis as the four studies differed markedly in terms of interventions.