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• Oral versus parenteral vitamin B12
  Elizabeth S Nyholm
  Published on: 11 June 2003
• Is oral vitamin B12 a prefect replacement for its parenteral form in all clinical situations?
  Sudhir Kumar
  Published on: 5 June 2003

• Published on: 11 June 2003

  Oral versus parenteral vitamin B12

  • Elizabeth S Nyholm, General Practitioner

  Dear Editor

  Your correspondent (Sudhir Kumar 5 June 2003) makes some constructive comments.[1] Our study group represented a normal range of patients with vitamin B12 deficiency in a UK inner city general practice. Previous studies [2,3] satisfied us that we could treat this group with mixed aetiologies for their vitamin B12 deficiency in the same way using oral vitamin B12 1000mg tablets as replacement therapy....

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  Dear Editor

  Your correspondent (Sudhir Kumar 5 June 2003) makes some constructive comments.[1] Our study group represented a normal range of patients with vitamin B12 deficiency in a UK inner city general practice. Previous studies [2,3] satisfied us that we could treat this group with mixed aetiologies for their vitamin B12 deficiency in the same way using oral vitamin B12 1000mg tablets as replacement therapy.

  The ten excluded patients were representative of the group as a whole (2/10 intrinsic factor positive, 1/10 gastrointestinal surgery related, 7/10 intrinsic factor negative compared with 10/50, 9/50 and 31/50 respectively) and this does not affect interpretation of the results.

  To reflect the long periods of time that vitamin B12 is stored in the liver, patients did not enter the oral arm of the study until their serum levels had fallen to the lower 25th centile (418pg/ml) in all cases. With respect to follow up, we now have unpublished data for a further 12 month period which confirms the effectiveness of the oral vitamin B12 - no patients required transfer back to injection treatment and maintained levels above the lower 25th centile.

  The issue of compliance is always a matter for concern. It is our experience as general practitioners that patients on long term therapy always require close monitoring and it is the responsibility of both the patient and the doctor to ensure compliance. Such monitoring is successfully carried out in patients on thyroid replacement therapy and treatment for vitamin B12 deficiency is no different in this respect. Patients need recall and active intervention to maintain injection therapies as they do for oral treatments. Where an individual is non compliant with oral medication, then it is easy to revert to injection therapy but with continued recall and monitoring.

  We agree that any savings from an oral preparation of vitamin B12 will relate to the cost of the tablets – the 1000 mcg preparation is not currently licensed in the UK. However, such preparations are easily available from the US by post with costs of about US$ 39.95 for 500 tablets. It is highly likely that our costing analysis [4] will effect savings in NHS staff costs.

  The place of oral B12 therapy in the UK has yet to be decided and it is important to stimulate debate as to its role. This study showed that patients prefer an oral to an injection treatment and we should reflect that in our management. The knowledge that we have an effective and safe preparation to use as replacement therapy for vitamin B12 deficiency surely means that we must offer our patients the choice.

  References

  (1) Kumar S. Is oral vitamin B12 a prefect replacement for its parenteral form in all clinical situations? [electronic response to Nyholm E et al. Oral vitamin B12 can change our practice] postgradmedj.com 2003 http://pmj.bmjjournals.com/cgi/eletters/79/930/218#38

  (2) Berlin H, Berlin R, Brante G. Oral treatment of pernicious anaemia with high doses of vitamin B12 without intrinsic factor. Acta Med Scand 1968; 184:247-258.

  (3) Kuzminski AM, Del Giacco EJ, Allen RH, Stabler SP, Lindenbaum J. Effective treatment of cobalamin deficiency with oral cobalamin. Blood 1998;92:1191-98.

  (4) Nyholm E. Oral or parenteral therapy for B12 deficiency. Correspondence Lancet 1999;353:411.

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  Conflict of Interest:
  None declared.

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• Published on: 5 June 2003

  Is oral vitamin B12 a prefect replacement for its parenteral form in all clinical situations?

  • Sudhir Kumar, Consultant Neurologist, Neurology Unit

  Dear Editor

  I read with interest the recent article by Nyholm E et al.[1] It is indeed an exciting prospect to be able to safely and effectively switch over from the traditional parenteral form of vitamin B12 to the oral form. However, I would like to make certain observations.

  The group of patients included in this study is highly heterogeneous with majority of them (almost two-thirds) being neg...

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  Dear Editor

  I read with interest the recent article by Nyholm E et al.[1] It is indeed an exciting prospect to be able to safely and effectively switch over from the traditional parenteral form of vitamin B12 to the oral form. However, I would like to make certain observations.

  The group of patients included in this study is highly heterogeneous with majority of them (almost two-thirds) being negative of intrinsic factor antibody. The group of prime interest to us- intrinsic-factor antibody positive and post-gastrointestinal surgery- had only 19 patients. It is well known that vitamin B 12 absorption is grossly reduced in the two groups of patients mentioned above.[2] Hence, the results obtained in this study may not be applicable uniformly to the whole group.

  Secondly, ten patients were excluded from the final analysis. It is not clear whether they were intrinsic factor antibody-positive or negative. If they belonged to the antibody-positive group, it could make a major difference in the interpretation of results of this study.

  All patients received a parenteral dose at the beginning of the study. We know that vitamin B12 can be stored in the liver for a prolonged period of time and hence finding a normal serum vitamin B12 level at variable periods of follow up may be due to the initial injection rather than the subsequent oral tablets. Also, the follow up of the patients has not been long enough in this study. No patients were followed up for two years and only 11 were followed up for 18 months. It would have been interesting to see if the serum vitamin B12 levels declined with longer periods of follow up.

  A concern has been raised earlier regarding the problem of drug compliance [3] with the oral preparation, as it needs to be taken on a daily basis for longer periods including for a lifetime. Compliance with long-term medications is generally poorer and it may be more of a problem in B12-deficient patients with cognitive deficits.

  Authors talk about saving money with oral treatment. However, money saved on the injection procedure may be offset by the total cost of tablets. Tablets need to be taken daily as compared to injections that need to be taken monthly or even less frequently. The cost with oral therapy may go even higher if there is a need to check serum B12 levels periodically. There is no such need after starting parenteral B12 therapy.

  Oral B12 therapy may take longer to replenish the body stores and hence, it may not be suitable for sicker patients with severe anaemia or neuropsychiatric deficits. Lastly, authors have not discussed other routes of administration of vitamin B12 such as intranasal route. 500 micrograms intranasal vitamin B12 weekly has been found to be an easy and effective alternative to parenteral therapy, which can be administered by the patient also.[4]

  In conclusion, based on the data presented, oral vitamin B12 therapy can not be recommended for all cases of B12 deficiency, though it may be an effective option in a selected group of vitamin B12-deficient patients.

  References

  (1) Nyholm E, Turpin P, Swain D, et al. Oral vitamin B 12 can change our practice. Postgrad Med J 2003;79:218-9.

  (2) Dharmarajan TS, Norkus EP. Approaches to vitamin B12 deficiency. Early treatment may prevent devastating complications. Postgrad Med 2001;110:99-105.

  (3) Elia M. Oral or parenteral therapy for B 12 deficiency. Lancet 1998;352: 1721-2.

  (4) Swain R. An update of vitamin B 12 metabolism and deficiency states. J Fam Pract 1995;41:595-600.

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  Conflict of Interest:
  None declared.

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