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      Systematic Review and Pragmatic Clinical Approach to Oral and Nasal Vitamin B12 (Cobalamin) Treatment in Patients with Vitamin B12 Deficiency Related to Gastrointestinal Disorders

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          Abstract

          The objective of this review is to provide an update on the effectiveness of oral and nasal vitamin B12 (cobalamin) treatment in gastrointestinal (GI) disorders. Relevant articles were identified by PubMed and Google Scholar systematic search, from January 2010 and June 2018, and through hand search of relevant reference articles. Additional studies were obtained from references of identified studies, the Cochrane Library and the ISI Web of Knowledge. Data gleaned from reference textbooks and international meetings were also used, as was information gleaned from commercial sites on the web and data from CARE B12 research group. For oral vitamin B12 treatment, 4 randomized controlled trials (vs. intramuscular), 4 narrative and 4 systematic reviews, and 13 prospective studies fulfilled our inclusion criteria. These studies concerned patients with vitamin B12 deficiency related to: food-cobalamin malabsorption ( n = 6), Biermer’s disease ( n = 3), veganism or vegetarianism ( n = 1), total gastrectomy after Roux-en-Y gastric bypass ( n = 2) and Crohn’s disease ( n = 1). Four prospective studies include patients with vitamin B12 deficiency related to the aforementioned etiologies, except veganism or vegetarianism. The systematic present review documents that oral vitamin B12 replacement, at a daily dose of 1000 μg (1 mg), was adequate to normalize serum vitamin B12 levels and cure main clinical manifestations related to vitamin B12 deficiency, in GI disorders, and thus, with safety profile. For nasal vitamin B12 treatment, only one preliminary study was available. We conclude that oral vitamin B12 is an effective alternative to intramuscular vitamin B12 (except in patients presenting with severe neurological manifestations). Oral vitamin B12 treatment avoids the discomfort, contraindication (in patients with anticoagulation), and cost of monthly injections.

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          Effective treatment of cobalamin deficiency with oral cobalamin.

          J Lindenbaum, A Kuźmiński, S Stabler … (1998)
          Because cobalamin deficiency is routinely treated with parenteral cobalamin, we investigated the efficacy of oral therapy. We randomly assigned 38 newly diagnosed cobalamin deficient patients to receive cyanocobalamin as either 1 mg intramuscularly on days 1, 3, 7, 10, 14, 21, 30, 60, and 90 or 2 mg orally on a daily basis for 120 days. Therapeutic effectiveness was evaluated by measuring hematologic and neurologic improvement and changes in serum levels of cobalamin (normal, 200 to 900 pg/mL) methylmalonic acid (normal, 73 to 271 nmol/L), and homocysteine (normal, 5.1 to 13.9 micromol/L). Five patients were subsequently found to have folate deficiency, which left 18 evaluable patients in the oral group and 15 in the parenteral group. Correction of hematologic and neurologic abnormalities was prompt and indistinguishable between the 2 groups. The mean pretreatment values for serum cobalamin, methylmalonic acid, and homocysteine were, respectively, 93 pg/mL, 3,850 nmol/L, and 37. 2 micromol/L in the oral group and 95 pg/mL, 3,630 nmol/L, and 40.0 micromol/L in the parenteral therapy group. After 4 months of therapy, the respective mean values were 1,005 pg/mL, 169 nmol/L, and 10.6 micromol/L in the oral group and 325 pg/mL, 265 nmol/L, and 12.2 micromol/L in the parenteral group. The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant, with P < .0005 and P < .05, respectively. In cobalamin deficiency, 2 mg of cyanocobalamin administered orally on a daily basis was as effective as 1 mg administered intramuscularly on a monthly basis and may be superior. Copyright 1998 by The American Society of Hematology.
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            Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency: a systematic review of randomized controlled trials.

            Rebecca Cannings-John, Alexandra Papaioannou, Andrew McCaddon … (2006)
            Vitamin B(12) deficiency is common, increasing with age. Most people are treated in primary care with intramuscular vitamin B(12). Several studies have reported equal efficacy of oral administration of vitamin B(12). We set out to identify randomized controlled trial (RCT) evidence for the effectiveness of oral versus intramuscular vitamin B(12) to treat vitamin B(12) deficiency. We conducted a systematic review searching databases for relevant RCTs. Outcomes included levels of serum vitamin B(12), total serum homocysteine and methylmalonic acid, haemoglobin and signs and symptoms of vitamin B(12) deficiency. Two RCTs comparing oral with intramuscular administration of vitamin B(12) met our inclusion criteria. The trials recruited a total of 108 participants and followed up 93 of these from 90 days to 4 months. In one of the studies, mean serum vitamin B(12) levels were significantly higher in the oral (643 +/- 328 pg/ml; n = 18) compared with the intramuscular group (306 +/- 118 pg/ml; n = 15) at 2 months (P < 0.001) and 4 months (1005 +/- 595 versus 325 +/- 165 pg/ml; P < 0.0005) and both groups had neurological responses. In the other study, serum vitamin B(12) levels increased significantly in those receiving oral vitamin B(12) and intramuscular vitamin B(12) (P < 0.001). The evidence derived from these limited studies suggests that 2000 microg doses of oral vitamin B(12) daily and 1000 microg doses initially daily and thereafter weekly and then monthly may be as effective as intramuscular administration in obtaining short-term haematological and neurological responses in vitamin B(12)-deficient patients.
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              Oral cyanocobalamin supplementation in older people with vitamin B12 deficiency: a dose-finding trial.

              Simone J. P. M. Eussen, Friso W. A. Hoefnagels, Robert Clarke … (2005)
              Supplementation with high doses of oral cobalamin is as effective as cobalamin administered by intramuscular injection to correct plasma markers of vitamin B(12) deficiency, but the effects of lower oral doses of cobalamin on such markers are uncertain. We conducted a randomized, parallel-group, double-blind, dose-finding trial to determine the lowest oral dose of cyanocobalamin required to normalize biochemical markers of vitamin B(12) deficiency in older people with mild vitamin B(12) deficiency, defined as a serum vitamin B(12) level of 100 to 300 pmol/L (135-406 pg/mL) and a methylmalonic acid level of 0.26 mumol/L or greater. We assessed the effects of daily oral doses of 2.5, 100, 250, 500, and 1000 mug of cyanocobalamin administered for 16 weeks on biochemical markers of vitamin B(12) deficiency in 120 people. The main outcome measure was the dose of oral cyanocobalamin that produced 80% to 90% of the estimated maximal reduction in the plasma methylmalonic acid concentration. Supplementation with cyanocobalamin in daily oral doses of 2.5, 100, 250, 500, and 1000 mug was associated with mean reductions in plasma methylmalonic acid concentrations of 16%, 16%, 23%, 33%, and 33%, respectively. Daily doses of 647 to 1032 mug of cyanocobalamin were associated with 80% to 90% of the estimated maximum reduction in the plasma methylmalonic acid concentration. The lowest dose of oral cyanocobalamin required to normalize mild vitamin B(12) deficiency is more than 200 times greater than the recommended dietary allowance, which is approximately 3 mug daily.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Med
                Journal ID (iso-abbrev): J Clin Med
                Journal ID (publisher-id): jcm
                Title: Journal of Clinical Medicine
                Publisher: MDPI
                ISSN (Electronic): 2077-0383
                Publication date (Electronic): 26 September 2018
                Publication date Collection: October 2018
                Volume: 7
                Issue: 10
                Electronic Location Identifier: 304
                Affiliations
                [1 ]Department of Internal Medicine, Diabetes and Metabolic Diseases, Hôpitaux Universitaires de Strasbourg, 67091 Strasbourg, France
                [2 ]Department of Geriatrics, CHRU de Rouen, 76000 Rouen, France; abzulfiqar@ 123456gmail.com
                [3 ]Department of Internal Medicine, CHRU, d’Oujda 60049, Morocco; serrajkhalid@ 123456yahoo.fr
                [4 ]Department of Geriatrics and Internal Medicine, Hôpitaux Universitaires de Strasbourg, 67091 Strasbourg, France; thomas.vogel@ 123456chru-strasbourg.fr (T.V.); georges.kaltenbach@ 123456chru-strasbourg.fr (G.K.)
                Author notes
                [* ]Correspondence: emmanuel.andres@ 123456chru-strasbourg.fr ; Tel.: +3-33-8811-5066; Fax: +3-33-8811-6262
                Article
                Publisher ID: jcm-07-00304
                DOI: 10.3390/jcm7100304
                PMC ID: 6210286
                PubMed ID: 30261596
                SO-VID: 5be1d721-ccd4-4098-bf0d-172da465f288
                Copyright © © 2018 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 24 August 2018
                Date accepted : 23 September 2018
                Categories
                Subject: Article

                Keywords: vitamin b12,cobalamin,oral vitamin b12 treatment,nasal vitamin b12 treatment,biermer’s disease,food-cobalamin malabsorption
                Data availability:
                Keywords: vitamin b12, cobalamin, oral vitamin b12 treatment, nasal vitamin b12 treatment, biermer’s disease, food-cobalamin malabsorption

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