How
we wish to be cited:
Björkegren K. Advice for assessors - how to read context and
content of the Roth-Orija paper [evaluation].
Rondel 2009; 29. URL:
http://www.rondellen.net
Advice
for assessors
How to read context and content of the Roth-Orija paper
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Summary The Roth-Orija trial is a cohort study. Patients with proven deficiency of vitamin B12 (n=60) were treated with injections for four years (mean value), which corresponds to remission treatment and maintenance treatment. Then the patients were converted to oral treatment and monitored for three years (mean value). Two of the patients were not able to comply with the oral regimen. Otherwise, the two regimens appeared to be equally efficient (Table 1). Dr Karin Björkegren, family physician, defended her theses on vitamin B12 deficiency in a commune setting in 2003 (link).
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Setting and shape
The paper of Roth and Orija (1) was published in March 2004 as a letter to the editor, a comment on the Nyholm paper from England (2) and the discussion on oral therapy with vitamin B12 versus the conventional injection therapy.
The Roth-Orija paper is from Cleveland, Ohio. One background of the paper was that 90% of the internists of the neighbour city Minneapolis (Minnesota) believed that vitamin B12 could not be adequately absorbed without intrinsic factor (1).
The Roth-Orija study was performed in a health maintenance organisation in order to demonstrate the utility of oral vitamin B12 in a community setting (1). They evaluated retrospectively 60 patients with established B12 deficiency and converted them from injection therapy to oral therapy (Table 1). The mean age of the cohort was 69 years, + 12. The mean duration of parenteral B12 was 4 years versus 3 years for oral treatment.
Results
The results of the Roth-Orija study are shown in Table 1. It is evident that the patients had proven deficiency of vitamin B12 at the time of diagnosis; the haemoglobin value of the cohort was at the border of overt anaemia, the mean corpuscular volume slightly raised, the serum vitamin B12 values definitely in the deficiency range.
The parameters mentioned (Table 1) were rectified by vitamin B12 injections. The conversion of the patients to oral vitamin B12 therapy maintained the remission induced by parenteral treatment. However, two out of the 60 patients were not able to comply with the oral regimen, as revealed by their serum vitamin B12 values.
Discussion
The Roth-Orija study provides a textbook case of sound clinical practice; they deemed that 60 patients were eligible for a conversion from injection therapy with vitamin B12 to oral therapy. They monitored their patients and found that two of them were not able to comply and returned them to injection therapy.
Although Roth and Orija do not present any formal test for equivalence or non-inferiority between injection therapy and oral therapy, most experienced physicians would be inclined to accept their conclusion that oral therapy in their hands was as good as injection therapy in suitable patients.
It should also be emphasised that the efficacy of parenteral therapy with vitamin B12 has never been adequately compared with previous therapy traditions such as purified liver extracts, crude liver extracts, crude yeast extracts, and raw liver preparations (3).
It is still difficult to make adequate controlled studies on parenteral vitamin B12 therapy versus oral therapy (4,5). At present, both regimens appear to be safe in the hands of experienced clinicians (3,6). The chief contribution of the Roth-Orija study (1) is that it extends the experience of the Nyholm study (2) to a larger patient material monitored over a longer period of time.
Conclusion
The Both-Orija study comprises 60 patients with a confirmed diagnosis of vitamin B12 deficiency. The patients had remission treatment and maintenance treatment with injections of vitamin B12 for the first years. Then they were converted to oral treatment. Two of the patients failed to comply with the oral regime. Otherwise, the two regimes appeared to be equally efficacious in this patient cohort.
Karin Björkegren
MD, assistant professor
Department of Public Health and Caring Science
Family Medicine, Uppsala University
Uppsala Science Park
SE-751 85 Uppsala, Sweden
References
Roth M, Orija I. Oral vitamin B12 therapy in vitamin B12 deficiency Amer J Med 2004; 116:358
Nyholm E, Turpin P, Swain D, Cunningham B, Daly S, Nightinggale P, Fegan C. Oral vitamin B12 can change our practice. Postgrad Med J 2003; 79:218:209
Lee GR, Bitchell TC, Forster J, Athens JW, Lukens JN, eds. Wintrobe´s Clinical Hematology, Ed 9. Philadelphia : Lea & Febiger. 1993;777-80
Nilsson M. Advice for assessors – how to read context and content of the Kuzminski paper [evaluation]. Rondel 2008; 28. URL: http://www.rondellen.net/evaluation28_eng.htm
Lökk J. Advice for assessors – how to read context and content of the Bolaman paper [debate]. Rondel 2008; 28. URL: http://www.rondellen.net/debate28_eng.htm
Norberg B. Deficiency of vitamin B12 and folate – the branded generic for optimal oral therapy [editorial]. Rondel 2008; 28. URL: http://www.rondellen.net/publisher28_eng.htm
Published February 15, 2009