Oral versus intramuscular cobalamin treatment in megaloblastic anemia: A single-center, prospective, randomized, open-label study

doi:10.1016/S0149-2918(03)90096-8

Clinical Therapeutics

Volume 25, Issue 12, December 2003, Pages 3124-3134

https://doi.org/10.1016/S0149-2918(03)90096-8 Get rights and content

Abstract

Background: Cobalamin (vitamin B₁₂) deficiency, the most common cause of mega-loblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (PO) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost.

Objective: This study assessed the effects and cost of PO versus IM cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency.

Methods: This was a 90-day, prospective, randomized, open-label study conducted at the Division of Hematology, Department of Internal Medicine, Adnan Menderes University Research and Practice Hospital (Aydin, Turkey). Patients aged ≥ 16 years with megaloblastic anemia due to cobalamin deficiency were randomized to receive 1000-μg cobalamin PO once daily for 10 days (PO group) or 1000-μg cobalamin IM once daily for 10 days (IM group). After 10 days, both treatments were administered once a week for 4 weeks, and after that, once a month for life. Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected. Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0, 10, 30, and 90 and serum vitamin B₁₂ concentration on days 0 and 90. The Mini-Mental State Examination was used before and after the B₁₂ therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing. Neurologic sensory assessment, including soft-touch and pinprick examinations, was used to identify neuropathy at baseline and study end. Tolerability was assessed using laboratory tests and patient interview. Cost was assessed using the cost of the study drug and of the injection.

Results: Sixty patientss completed the study 26 in the PO group (16 men, 10 women; mean [SD] age, 60 [15] years) and 34 in the IM group (17 men, 17 women; mean [SD] age, 64 [10] years). Reticulocytosis was observed in all patients. In the PO group, at days 30 and 90, all hematologic parameters changed signiificantly versus day 0 (mean hemoglobin levels increased [both P < 0.001]; mean corpuscular volume decreased [both P < 0.001]; mean white blood cell count increased [day 30, P < 0.01; day 90, P < 0.001]; and mean platelet count increased [both P < 0.001]). The mean serum vitamin B₁₂ concentration incerased significantly from day 0 to 90 (P < 0.001). These hematologic parameters and the recovery patterns were similar between the 2 groups. Neurologic findings included sensitive peripheral neuropathy in 9 patients (15.0%), alteration of cognitive function (loss of memory, impaired concentration) in 7 patients (11.7%), and loss of sense of vibration in 5 patients (8.3%). Neurologic improvement was detected in 7 of 9 patients (77.8%) in the PO group and 9 of 12 patients (75.0%) in the IM group at day 30.

Conclusions: In this study of patients with megaloblastic anemia due to cobalamin deficiency, PO cobalamin treatment was as effective as IM cobalamin treatment. PO treatment also was better tolerated and less expensive compared with IM treatment. However, because of the small sample size and the short term of this study, further long-term studies are needed to determine the efficacy of PO cobalamin treatment.

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  La deficiencia de vitamina B₁₂ se puede tratar por vía parenteral o por vía oral.
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  En pacientes con una deficiencia grave y presencia de sintomatología se recomienda utilizar la vía parenteral. Una vez corregido el déficit se puede valorar utilizar la vía oral como tratamiento de mantenimiento.
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  La administración de vitamina B₁₂ por vía oral a dosis altas (1000 μg/día) es suficiente para cubrir los requerimientos diarios.
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  En pacientes con problemas de absorción, una terapia a dosis altas de vitamina B₁₂ (1000-2000 μg/día) se considera efectiva.
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  En pacientes con deficiencia dietética (veganas, vegetarianas, niños en lactancia exclusiva materna de madres con deficiencia) se recomienda utilizar la vía oral.
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  En el momento de seleccionar una vía de administración u otra, se deben tener en cuenta otro tipo de factores como la adherencia, las características de los pacientes (personas ancianas, con problemas de absorción o deglución, anticoaguladas, etc.) y también el coste y las preferencias de los pacientes.
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Original researchOral versus intramuscular cobalamin treatment in megaloblastic anemia: A single-center, prospective, randomized, open-label study

Abstract

Am J Clin Nutr

Lancet

Blood

J Pediatr

J Psychiatr Res

Am J Med

Am J Med

Lancet

Screening the older population for cobalamin (vitamin B12) deficiency

J Am Geriatr Soc

High prevalence of cobalamin deficiency in elderly outpatients

J Am Geriatr Soc

Vitamin B12

Vitamin B12 deficiency