Scientific Article Review:

Effectiveness of Vitamin B12 in Treating Recurrent Aphthous Stomatitis

Published In: Journal of the American Board of Family Medicine (JABFM)

Publication Year: 2009

Study Design

Randomized, Double-Blind, Placebo-Controlled Trial

Funding Sources

The study received partial funding from Solgar Pharmaceutical Company. However, Solgar did not participate in planning, implementing, analyzing, or writing the manuscript.

PICO Framework - what was studied and how?

Population

• Adults aged 18+ with recurrent aphthous stomatitis (RAS) lasting over a year and with outbreaks at least once every two months.

Intervention

• Sublingual vitamin B12 tablets (1000 mcg daily) administered for six months.

Comparison

• Placebo tablets without vitamin B12.

Outcomes

1. Average duration of RAS episodes (days).
2. Average number of RAS ulcers per month.
3. Subjective pain levels measured using the Numerical Rating Scale (NRS).
4. Percentage of participants achieving “no aphthous ulcers status.”

In Paragraph Form
This trial investigated the effects of daily sublingual vitamin B12 (1000 mcg) over six months in adults with recurrent aphthous stomatitis (RAS). The intervention group was compared to a placebo group to evaluate improvements in episode duration, ulcer frequency, pain levels, and the attainment of ulcer-free status.

Inclusion and Exclusion Criteria

Inclusion Criteria

• Adults over 18 years with RAS for at least one year.
• Outbreak frequency of at least once every two months.

Exclusion Criteria

• Systemic illnesses associated with oral lesions (e.g., Behçet disease, lupus).
• Pregnancy or breastfeeding.
• Recent treatment with vitamin B12 (within the last year).
• Known vitamin B12 deficiency.

Demographics and Study Design

• Total Participants: 58 (31 intervention, 27 control).
• Age Range: 18–62 years.
• Gender Distribution: Roughly equal between groups.
• Initial Vitamin B12 Levels: All participants had levels above 150 pg/mL.
• Study Period: March 2006 – December 2007.

Primary Outcome Variables and Results

Results Summary

1. Duration of RAS Episodes:

   • Intervention group reduced from 11 days (baseline) to 1.98 days at six months.
   • Control group saw a lesser reduction, ending at 4.84 days.
   • Statistical Significance: P < .05.

2. Number of Ulcers:

   • Intervention group ulcers decreased significantly by month six (3.88 ulcers/month vs. 13.39 in the control group).
   • Statistical Significance: P < .05.

3. Pain Levels (NRS):

   • Pain levels in the intervention group reduced from 3.1 to 0.64, compared to a modest decline in the control group.
   • Statistical Significance: P < .01.

4. No Aphthous Ulcers Status:

   • Achieved by 74.1% of the intervention group compared to 32.0% of the control group by the sixth month (P = .01).

Conclusions

Vitamin B12, regardless of serum levels, significantly reduced the duration, frequency, and pain of RAS episodes. This simple, cost-effective, and safe intervention also increased the likelihood of achieving ulcer-free status.

Discussion

Strengths

• Double-blind design minimized bias.
• Clear and objective outcome measures.
• Treatment was accessible and non-invasive.

Limitations

• Small sample size may limit generalizability.
• Delay in response (observed at 4+ months) suggests further studies are needed to optimize dosage.
• Lack of biochemical markers to evaluate functional vitamin B12 deficiency.

Citation

Volkov I, et al. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: A randomized, double-blind, placebo-controlled trial. J Am Board Fam Med. 2009;22(1):9–16. PubMed

Visual Aids

Simple Chart: Outcome Improvements