Effectiveness of Vitamin B12 in Treating Recurrent Aphthous Stomatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Article Figures & Data

Table 1.

Sociodemographic and Basic Clinical Characteristics of Population

	Intervention Group (n = 31) (n [%])	Control Group (n = 27) (n [%])	P
Gender
Male	16 (51.6)	13 (48.1)	.5
Female	15 (48.4)	14 (51.9)
Age (years)
Mean ± SD	33.10 ± 9.57	29.15 ± 6.61	.077
Median	33	29
Range	21–62	18–47
Marital status
Single	6 (19.4)	8 (29.6)	.272
Married	25 (80.6)	19 (70.4)
Country of Birth
Israel	26 (83.9)	26 (96.3)	.13
Other	5 (16.1)	1 (3.7)
Education
Primary School	4 (12.9)	3 (11.1)	.108
High school	5 (16.1)	11 (40.7)
Academic	22 (71.0)	13 (48.1)
Initial level of vitamin B₁₂ (pg/mL)
150–250	6 (19.4)	4 (14.8)	.459
>250	25 (80.6)	23 (85.2)
Number of years suffering from RAS
Mean ± SD	10.45 ± 9.00	9.74 ± 6.50	.735
Median	8	10
Range	1–5	1–25
Average duration of RAS episode during last year (days)
Mean ± SD	11.02 ± 7.5	8.68 ± 5.98	.203
Median	9.7	7
Range	1.17–29	2.5–28

Table 2.

Changes of the 3 Main Study Measurements for Treatment Effectiveness During the 6 Months of the Study

Measurement	χ²	df	P
Average duration of RAS episode (days)
Intervention group	30.68	5	.000
Control group	7.32	5	.198
Average level of pain
Intervention group	29.25	5	.000
Control group	9.16	5	.103
RAS outbreaks per month (n)
Intervention group	32.97	5	.000
Control group	7.37	5	.194

Table 3.

Patients Achieving Recovery ("No Aphthous Ulcers Status") By the Time of Examination

Time	Intervention Group (n = 31) (n [%])	Control Group (n = 27) (n [%])	P
After 6 months of treatment
No aphthous ulcers status	20 (74.1)	8 (32.0)	.0023
Other	7 (25.9)	17 (68.0)
Total	27 (mis = 4)	25 (mis = 2)
After 5 months of treatment
No aphthous ulcers status	15 (55.6)	4 (16.0)	.003
Other	12 (44.4)	21 (84.0)
Total	27 (mis = 4)	25 (mis = 2)
After 4 months of treatment
No aphthous ulcers status	8 (29.6)	3 (12.0)	.11
Other	19 (70.4)	22 (88.0)
Total	27 (mis = 4)	25 (mis = 2)