维生素 K2 治疗夜间腿部抽筋:随机临床试验

IF 22.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Jing Tan, Rui Zhu, Ying Li, Li Wang, Shigeng Liao, Lin Cheng, LingXiu Mao, Dan Jing
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引用次数: 0

摘要

重要性:目前,尚无经证实安全有效的夜间腿部抽筋(NLCs)治疗方法。寻求安全有效的方法来控制夜间腿抽筋至关重要:目的:确定维生素 K2 在治疗 NLCs 方面是否优于安慰剂:这项多中心、双盲、安慰剂对照随机临床试验于 2022 年 9 月至 2023 年 12 月在中国进行。该研究使用的志愿者样本包括在两周筛查期间有 2 次或 2 次以上 NLC 发作记录的 65 岁及以上社区居民。研究人员对通过广告从社区招募的候选人进行了病史和体格筛查,符合条件的参与者按1:1的比例随机接受维生素K2或安慰剂治疗,为期8周:患者每天口服含有 180 μg 维生素 K2(甲萘醌 7)的胶囊或外观相似的安慰剂,连续服用 8 周。研究产品是定制生产的,包装完全相同,胶囊的外观和辅料完全相同,口感和重量也相似:主要结果是维生素 K2 组和安慰剂组每周 NLC 的平均次数。次要结果包括肌肉痉挛持续时间(以分钟为单位)和肌肉痉挛严重程度(用 1 到 10 的模拟量表进行评估):在 310 名参与者中,有 111 人被排除在外。在 199 名参加者中,108 人(54.3%)为女性,平均年龄(标准差)为 72.3(5.5)岁。共有 103 名患者(51.8%)被随机分配接受维生素 K2 治疗,96 名患者(48.2%)被分配接受安慰剂治疗。维生素 K2 组(2.60 [0.81])和安慰剂组(2.71 [0.80])每周抽筋频率的平均值(标度)基线相当。在为期 8 周的干预期间,维生素 K2 组的平均(标度)每周抽筋频率降至 0.96 (1.41)。与此同时,安慰剂组的平均(标度)每周抽筋频率保持在 3.63(2.20)次。组间差异具有统计学意义(差异,-2.67;95% CI,-2.86 至 -2.49;P 结论及相关性:这项随机临床试验表明,在老年人群中补充维生素 K2 能显著降低 NLC 的频率、强度和持续时间,且安全性良好:试验注册:ClinicalTrials.gov Identifier:NCT05547750。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Vitamin K2 in Managing Nocturnal Leg Cramps: A Randomized Clinical Trial.

Importance: Currently, there are no treatments for nocturnal leg cramps (NLCs) that have been proven to be both safe and effective. Seeking safe and effective approaches for managing NLCs is of crucial importance.

Objective: To determine whether vitamin K2 is better than placebo in managing NLCs.

Design, setting, and participants: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted in China between September 2022 and December 2023. This study used a volunteer sample comprising community-dwelling individuals 65 years and older with 2 or more documented episodes of NLCs during 2 weeks of screening. Researchers performed a history and physical screening of candidates recruited from the community through advertisements, and eligible participants were randomized in a 1:1 ratio to receive vitamin K2 or a placebo for 8 weeks.

Interventions: Patients orally took capsules containing either vitamin K2 (menaquinone 7), 180 μg, or a similar-looking placebo every day for 8 weeks. The study products were custom manufactured to have identical packaging and for the capsules to have matching appearance and identical excipients that shared similar taste and weight.

Main outcomes and measures: The primary outcome was the mean number of NLCs per week between the vitamin K2 and the placebo group. Secondary outcomes included the duration of muscle cramps measured in minutes and the severity of muscle cramps assessed using an analog scale ranging from 1 to 10.

Results: Among the 310 participants, 111 participants were excluded. Of the 199 enrolled individuals, 108 (54.3%) were female, and the mean (SD) age was 72.3 (5.5) years. A total of 103 patients (51.8%) were randomly assigned to receive vitamin K2 and 96 (48.2%) were assigned to placebo. The mean (SD) baseline weekly frequency of cramps was comparable in both the vitamin K2 group (2.60 [0.81]) and the placebo group (2.71 [0.80]). During the 8-week intervention, the vitamin K2 group experienced a reduction in the mean (SD) weekly frequency of cramps to 0.96 (1.41). Meanwhile, the placebo group maintained mean (SD) weekly frequency of cramps at 3.63 (2.20). The between-group difference was statistically significant (difference, -2.67; 95% CI, -2.86 to -2.49; P < .001). The vitamin K2 group had a more significant mean (SD) reduction in NLC severity (-2.55 [2.12] points) compared with the placebo group (-1.24 [1.16] points). The vitamin K2 group exhibited a more pronounced mean (SD) decrease in the duration of NLCs (-0.90 [0.88] minutes) than the placebo group (-0.32 [0.78] minutes). No adverse events related to vitamin K2 use were identified.

Conclusions and relevance: This randomized clinical trial showed that vitamin K2 supplementation significantly reduced the frequency, intensity, and duration of NLCs in an older population with good safety.

Trial registration: ClinicalTrials.gov Identifier: NCT05547750.

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来源期刊
JAMA Internal Medicine
JAMA Internal Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
43.50
自引率
1.30%
发文量
371
期刊介绍: JAMA Internal Medicine is an international, peer-reviewed journal committed to advancing the field of internal medicine worldwide. With a focus on four core priorities—clinical relevance, clinical practice change, credibility, and effective communication—the journal aims to provide indispensable and trustworthy peer-reviewed evidence. Catering to academics, clinicians, educators, researchers, and trainees across the entire spectrum of internal medicine, including general internal medicine and subspecialties, JAMA Internal Medicine publishes innovative and clinically relevant research. The journal strives to deliver stimulating articles that educate and inform readers with the latest research findings, driving positive change in healthcare systems and patient care delivery. As a member of the JAMA Network, a consortium of peer-reviewed medical publications, JAMA Internal Medicine plays a pivotal role in shaping the discourse and advancing patient care in internal medicine.
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