Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised  parallel-group trial

Metaxas, Corina; Mathis, Déborah; Jeger, Cyrill; Hersberger, Kurt E.; Arnet, Isabelle; Walter, Philipp

doi:10.4414/smw.2017.14421

Cited by 9 publications

(2 citation statements)

References 35 publications

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“…5 Patients' preferences can be a decisive factor for determining the administration route. In this trial, similar to previous studies, 17 there was a clear preference for the oral route, especially among the patients assigned to this group.…”

Section: Discussionsupporting

confidence: 76%

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

et al. 2020

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ObjectivesTo compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency.DesignPragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).Participants283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.InterventionsThe IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52.Main outcomesSerum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.ResultsThe follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.ConclusionsOral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.Trial registration numbersNCT 01476007; EUDRACT (2010-024129-20).

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Section: Discussionsupporting

confidence: 76%

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

et al. 2020

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“…The authors conducted a prospective study on long-term oral vitamin B 12 supplementation with 26 patients after total gastrectomy, which is one of the causes for the widespread cobalamin deficiency [2]. Some clear findings advocate for oral supplementation, such as its equivalence with intramuscular administration in cobalamin deficiency [3], its preference by patients compared to intramuscular injections [3, 4], and its lower costs [5]. …”

mentioning

confidence: 99%

Comment on “Efficacy of Long-Term Oral Vitamin B<sub>12</sub> Supplementation after Total Gastrectomy: Results from a Prospective Study”

Rothen¹,

Hersberger²,

Arnet³

2019

GE Port J Gastroenterol

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Oral vitamin B₁₂versus intramuscular vitamin B₁₂for vitamin B₁₂deficiency

Wang

Qin

et al. 2018

Cochrane Database of Systematic Reviews

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Low quality evidence shows oral and IM vitamin B having similar effects in terms of normalising serum vitamin B levels, but oral treatment costs less. We found very low-quality evidence that oral vitamin B appears as safe as IM vitamin B. Further trials should conduct better randomisation and blinding procedures, recruit more participants, and provide adequate reporting. Future trials should also measure important outcomes such as the clinical signs and symptoms of vitamin B deficiency, health related-quality of life, socioeconomic effects, and report adverse events adequately, preferably in a primary care setting.

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Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial

Cited by 9 publications

References 35 publications

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

Comment on “Efficacy of Long-Term Oral Vitamin B<sub>12</sub> Supplementation after Total Gastrectomy: Results from a Prospective Study”

Oral vitamin B₁₂versus intramuscular vitamin B₁₂for vitamin B₁₂deficiency

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Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial

Cited by 9 publications

References 35 publications

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)

Comment on “Efficacy of Long-Term Oral Vitamin B<sub>12</sub> Supplementation after Total Gastrectomy: Results from a Prospective Study”

Oral vitamin B12versus intramuscular vitamin B12for vitamin B12deficiency

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Oral vitamin B₁₂versus intramuscular vitamin B₁₂for vitamin B₁₂deficiency