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The effect of vitamin B12 on idiopathic tinnitus.

  • 2024-01
  • American journal of otolaryngology 45(1)
    • Mohammadhossein Dadgarnia
    • Mohammad Mandegari
    • Vahid Zand
    • Sedighe Vaziribozorg
    • Hadi Zare-Zardini
    • Kimia Mousaviyazdi
    • Mohammadali Kheradmandi

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 140
Population
140 patients with idiopathic tinnitus
Methods
double-blind clinical trial, divided into two groups, receiving vitamin B12 or placebo for a month; assessments at baseline, one month, and three months using THI and VAS questionnaires
Blinding
Double-blind
Duration
one month
  • Large Human Trial

Introduction

Tinnitus is one of the most important challenges in the field of ear, nose and throat diseases. The aim of this study was to evaluate the effect of vitamin B12 on idiopathic tinnitus.

Material and methods

In this double-blind clinical trial study, 140 patients with idiopathic tinnitus were divided into two groups, the group receiving vitamin B12 and the group receiving placebo. The first group received vitamin B12 for a month and the other group received placebo. All patients filled a THI questionnaire before the participation, one month and three months after the participation. VAS evaluation questionnaires were also filled for the patients before the participation, one month and three months after the participation. The effect of vitamin B12 on tinnitus was also assessed according to hearing loss status. The two groups were also compared regarding the side effects.

Results

There was no significant differences between two groups regarding age (p.value = 0.523), gender (females (p.value = 0.810) and males (p.value = 0.789), and hearing loss status (p value = 0.651). According to VAS score, there was no significant statistical differences in tinnitus severity in each group (B12 group, p.value = 0.851 and placebo group, p.value = 0.386). There was no significant statistical differences in tinnitus severity based on VAS score between two groups before the participation (p.value = 0.560), one month (p.value = 0.485) and three months (p.value = 0.254) after the participation. According to THI criterion, there was no significant statistical differences in tinnitus severity in each group (B12 group, p.value = 0.259 and placebo group, p.value = 0.521). There was no significant statistical differences in tinnitus severity based on THI score between two groups before the participation (p.value = 0.651), one month (p.value = 0.125) and three months (p.value = 0.089) after the participation. None of the patients of the two groups had any noticeable side effects. The mean of VAS and THI also had no statistically significant difference before and after the intervention in term of hearing loss status (p.value>0.05). These results were not significantly different between the two groups in term of hearing loss status (p value>0.05).

Conclusion

The result of this study indicated that vitamin B12 has no distinctive effect on reducing tinnitus severity.

Research Insights

  • Vitamin B12→Reduced Tinnitus Severity

    According to VAS score, there was no significant statistical differences in tinnitus severity in each group (B12 group, p.value = 0.851 and placebo group, p.value = 0.386). There was no significant statistical differences in tinnitus severity based on VAS score between two groups before the participation (p.value = 0.560), one month (p.value = 0.485) and three months (p.value = 0.254) after the participation. According to THI criterion, there was no significant statistical differences in tinnitus severity in each group (B12 group, p.value = 0.259 and placebo group, p.value = 0.521). There was no significant statistical differences in tinnitus severity based on THI score between two groups before the participation (p.value = 0.651), one month (p.value = 0.125) and three months (p.value = 0.089) after the participation.

    Effect
    Neutral
    Effect size
    Small

Adverse Events Reported

  • Vitamin B12→Overall tolerability

    None of the patients of the two groups had any noticeable side effects.

    Finding
    Reported
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