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

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Abstract
Abstract.  Hvas A‐M, Juul S, Nexø E, Ellegaard J (Aarhus University Hospital, Aarhus, Denmark). 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. J Intern Med 2003; 253: 146–152.Objective.  To examine the hypothesis that treatment with vitamin B‐12 improves health‐related quality of life (HRQOL) in individuals with biochemical signs of vitamin B‐12 deficiency.Design.  A randomized placebo‐controlled study.Setting.  Municipality of Aarhus, Denmark.Subjects.  Nonhospitalized individuals (n = 140) with a modest increase in plasma methylmalonic acid (0.40–2.00 μmol L−1) not previously treated with vitamin B‐12.Intervention.  The participants were randomized to vitamin B‐12 injection treatment or placebo weekly for 4 weeks and re‐examined 3 months later. The investigator and the participants were blinded to the intervention.Main outcome measure.  Change in HRQOL assessed by the SF‐36 questionnaire from baseline to follow‐up examination 3 months later.Results.  The participants reported a significantly worser HRQOL than the age‐ and sex‐matched Danish general population (P < 0.001). However, no change was observed after treatment with vitamin B‐12 for seven of eight health dimensions. A significant improvement was found only in general health when compared with the placebo group (P = 0.03).Conclusions.  Vitamin B‐12 treatment influenced only one of eight dimensions of HRQOL amongst participants with biochemical signs of vitamin B‐12 deficiency. We therefore question the benefit of vitamin B‐12 treatment amongst elderly with a modestly increased plasma methylmalonic acid as the only sign of vitamin B‐12 deficiency.