Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency

Haiyan Wang; Linyi Li; Ling Ling Qin; Yanan Song; Josep Vidal‐Alaball; Tong Hua Liu

doi:10.1002/14651858.CD004655.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies (blank cells indicate that the particular outcome was not measured in some studies).

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study (blank cells indicate that the study did not measure that particular outcome).

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 1 Serum vitamin B12 levels.

Analysis 1.1

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 1 Serum vitamin B₁₂ levels.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 2 Number of participants with normalisation of serum vitamin B12 deficiency.

Analysis 1.2

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 2 Number of participants with normalisation of serum vitamin B₁₂ deficiency.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 3 Adverse events.

Analysis 1.3

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 3 Adverse events.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 4 Haemoglobin.

Analysis 1.4

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 4 Haemoglobin.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 5 Mean corpuscular volume.

Analysis 1.5

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 5 Mean corpuscular volume.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 6 Total homocysteine.

Analysis 1.6

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 6 Total homocysteine.

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Comparison 1 Oral versus intramuscular vitamin B12, Outcome 7 Serum methylmalonic acid.

Analysis 1.7

Comparison 1 Oral versus intramuscular vitamin B₁₂, Outcome 7 Serum methylmalonic acid.

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Summary of findings for the main comparison. Oral versus intramuscular vitamin B12 for vitamin B12 deficiency

Oral versus intramuscular vitamin B₁₂ for vitamin B₁₂ deficiency
Patient: people with vitamin B₁₂ deficiency Setting: outpatients Intervention: oral versus IM vitamin B₁₂
Outcomes	IM vitamin B₁₂	Oral vitamin B₁₂	Relative effect (95% CI)	No. of participants (trials)	Quality of the evidence (GRADE)	Comments
Serum vitamin B₁₂ levels Normal value: > 300 pg/mL (> 221 pmol/L) Follow‐up: 90 days and 4 months	See comment	See comment	Not estimable	153 (3)	⊕⊕⊝⊝ low^a	1 trial (60 participants) used 1000 μg/day oral or IM vitamin B₁₂ (total dose 15 mg): MD was ‐11.7 pg/mL (95% CI ‐29.5 to 6.1) (Bolaman 2003). 1 trial (33 participants) used 2000 μg/day vitamin B₁₂ (total dose 240 mg) or 1000 μg/day IM vitamin B₁₂ (total dose 9 mg): MD was 680 pg/mL (95% CI 392.7 to 967.3) in favour of oral vitamin B₁₂ (Kuzminski 1998). 1 trial (60 participants) (using 1000 μg/day oral or IM vitamin B₁₂ (total dose 90 mg and 15 mg, oral and IM respectively) reported that 27/30 in the IM vitamin B₁₂ group (90%) and 20/30 in the oral vitamin B₁₂ group (66.7%) achieved normalisation of serum vitamin B₁₂, defined as ≥ 200 pg/mL (Saraswathy 2012).
Clinical signs and symptoms	Not reported
Adverse events Follow‐up: 90 days and 3 months	See comment	See comment	Not estimable	120 (2)	⊕⊝⊝⊝ very low^b	Bolaman 2003 reported no treatment‐related adverse events in both the oral and IM vitamin B₁₂ groups. Saraswathy 2012 reported that 2/30 participants (6.7%) in the oral vitamin B₁₂ group left the trial early due to adverse events.
Health‐related quality of life	Not reported
Acceptability	Not reported
Socioeconomic effects Follow‐up: 90 days	See comment	See comment	Not estimable	60 (1)	⊕⊕⊝⊝ low^c	Only 1 trial reported data for this outcome (Bolaman 2003). The costs per treatment were USD 80 per person in the oral vitamin B₁₂ group compared with USD 220 per person in the IM group.
CI: confidence interval; IM: intramuscular; MD: mean difference
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aDowngraded by two levels due to serious imprecision (low numbers of trials and participants); see Appendix 12. ^bDowngraded by three levels due to risk of bias (performance bias, detection bias) and serious imprecision (low numbers of trials and participants); see Appendix 12. ^cDowngraded by two levels due to serious imprecision (low numbers of trials and participants); see Appendix 12.

Summary of findings for the main comparison. Oral versus intramuscular vitamin B12 for vitamin B12 deficiency

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Table 1. Overview of trial populations

	Intervention(s) and comparator(s)	Description of power and sample size calculation	Screened/eligible (N)	Randomised (N)	Analysed (N)	Finishing trial (N)	Randomised finishing trial (%)	Follow‐up (extended follow‐up)^a
Bolaman 2003 (parallel RCT)	I: 1000 µg oral vitamin B₁₂	—	—	26	26	26	100	90 days (none)
	C: 1000 µg IM vitamin B₁₂	—	—	34	34	34	100
	Total:			60^b	60	60	100
Kuzminski 1998 (parallel RCT)	I: 2000 µg oral vitamin B₁₂	—	138	18	18	18	100	4 months (none)
	C: 1000 µg IM vitamin B₁₂	—	138	15	15	15	100
	Total:			33^c	33	33	100
Saraswathy 2012 (parallel RCT)	I: 1000 μg oral vitamin B₁₂	"Sample size was estimated to be 23 in each study arm, assuming equal response of 90% and non inferiority margin of 25% /alpha = 0.25, 1‐beta = 80%)"	—	30	22	22	73	3 months (none)
	C: 1000 μg IM vitamin B₁₂		—	30	27	27	90
	Total:			60	49	49	82
*Grand total*	*All interventions*			74		66
	*All comparators*			79		76
	*All interventions and comparators*			*153*		*142*
— denotes not reported C: comparator; I: intervention; IM: intramuscular; RCT: randomised controlled trial ^aFollow‐up under randomised conditions until end of trial (= duration of intervention + follow‐up postintervention or identical to duration of intervention); extended follow‐up refers to follow‐up of participants once the original trial was terminated as specified in the power calculation. ^bOf 70 participants enrolled in the trial, 10 were excluded because of failure to appear for follow‐up after 10 days of treatment. ^c38 participants were randomised; after completion of the trial 5 participants were judged to have primary folate deficiency rather than vitamin B₁₂ deficiency and were excluded from the final analysis.

Table 1. Overview of trial populations

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Comparison 1. Oral versus intramuscular vitamin B12

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Serum vitamin B₁₂ levels Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Totals not selected

2 Number of participants with normalisation of serum vitamin B₁₂ deficiency Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4 Haemoglobin Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

5 Mean corpuscular volume Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

6 Total homocysteine Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

7 Serum methylmalonic acid Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

Comparison 1. Oral versus intramuscular vitamin B12

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