Chua Kenneth W De, Huang Xiaoting, Koh Xuan H, Soh Joshua F J Y, Barrera Vivian C, Anaikatti Poongkulali, Jing Deng, Moh Shirlene, Yeo Miko, Yuen Heng W, Low David, Rosario Barbara H
Department of Otorhinolaryngology-Head and Neck Surgery, Changi General Hospital, Singapore.
Department of Geriatric Medicine, Singapore General Hospital, Singapore.
Otolaryngol Head Neck Surg. 2025 Jan;172(1):127-136. doi: 10.1002/ohn.954. Epub 2024 Aug 28.
To determine if the recurrence rates of BPPV in older adults were lower in the vitamin D-treated group as compared to placebo groups.
Double-blinded randomized control placebo trial.
A single-centre study.
Double-blinded randomized controlled trial design with 12 months follow-up. Vitamin D3 deplete participants were randomized into treatment (Group A) or placebo groups (Group B). Treatment group received 13 weeks of 2000 IU vitamin D3 followed by 1000 IU for the next 13 weeks. Patients who were replete were allocated to a control group (Group C) for observation and follow up. All groups had dietary interventions for vitamin D3 and calcium.
Results showed an 87% reduction in recurrence rates of BPPV in the treatment group (Group A), with 0.75 fewer clinical episodes per 1 person-year as compared to placebo (Group B). Time to first recurrence was also significantly longer in Group A. There was no statistically significant difference between Group A and C in both recurrence rates and dizziness handicap scores.
This clinical trial has laid the foundation to expand the investigation of vitamin D as standard of care treatment in BPPV patients in future phase IIb and III studies.
A reduction in BPPV episodes in older adults has implications on fall risk, as dizziness from BPPV may cause falls. With fewer BPPV episodes and longer time to recurrence, seniors may have better postural stability and hence reduced risk of falls.
确定与安慰剂组相比,维生素D治疗组老年成人良性阵发性位置性眩晕(BPPV)的复发率是否更低。
双盲随机对照安慰剂试验。
单中心研究。
采用双盲随机对照试验设计,随访12个月。将维生素D缺乏的参与者随机分为治疗组(A组)或安慰剂组(B组)。治疗组接受13周2000国际单位维生素D3治疗,随后13周接受1000国际单位治疗。维生素D充足的患者被分配到对照组(C组)进行观察和随访。所有组均进行了维生素D3和钙的饮食干预。
结果显示治疗组(A组)BPPV复发率降低了87%,与安慰剂组(B组)相比,每人每年临床发作次数减少0.75次。A组首次复发时间也显著更长。A组和C组在复发率和头晕障碍评分方面均无统计学显著差异。
该临床试验为在未来的IIb期和III期研究中扩大对维生素D作为BPPV患者标准治疗方法的研究奠定了基础。
老年成人BPPV发作次数减少对跌倒风险有影响,因为BPPV引起的头晕可能导致跌倒。BPPV发作次数减少且复发时间延长,老年人可能具有更好的姿势稳定性,从而降低跌倒风险。