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Pickle Juice Intervention for Cirrhotic Cramps Reduction: The PICCLES Randomized Controlled Trial.
The American Journal of Gastroenterology ( IF 9.8 ) Pub Date : 2022-04-13 , DOI: 10.14309/ajg.0000000000001781
Elliot B Tapper 1 , Najat Salim 1 , Jad Baki 1 , Zhe Zhao 1 , Vinay Sundaram 2 , Vilas Patwardhan 3 , Samantha J Nikirk 1
Affiliation  

INTRODUCTION Muscle cramps are common among persons with cirrhosis and associated with poor health-related quality of life. Treatment options are limited. We sought to determine whether pickle juice can improve muscle cramp severity. METHODS We enrolled 82 patients with cirrhosis and a history of >4 muscle cramps in the previous month from December 2020 to December 2021. Patients were randomized 1:1 to sips of pickle juice vs tap water at cramp onset. Our primary outcome assessed at 28 days was the change in cramp severity measured by the visual analog scale for cramps (VAS-cramps, scaled 0-10). Cramps were assessed 10 times over 28 days using interactive text messages. Secondary outcomes included the proportion of days with VAS-cramps <5, change in sleep quality, and global health-related quality of life measured using the EQ-5D. RESULTS Overall, 74 patients completed the trial, aged 56.6 ± 11.5 years, 54% male, 41% with ascites, 38% with encephalopathy, and model for end-stage liver disease-sodium score 11.2 ± 4.9. Many patients were receiving other cramp therapies at baseline. The baseline VAS for cramps was 4.2 ± 3.4, the EQ-5D was 0.80 ± 0.10, and 43% rated sleep as poor. At trial completion, the respective values for the pickle juice and control arms were -2.25 ± 3.61 points on the VAS for cramps, compared with control tap water (-0.36 ± 2.87), P = 0.03; a proportion of cramp-days with VAS-cramps <5 were 46% vs 35% (P = 0.2); and the change in sleep quality was not different (P = 0.1). The end-of-trial EQ-5D was 0.78 ± 0.10 vs 0.80 ± 0.10 (P = 0.3). No differences in weight change were observed for those with and without ascites. DISCUSSION In a randomized trial, sips of pickle brine consumed at cramp onset improve cramp severity without adverse events.

中文翻译:

减少肝硬化痉挛的泡菜汁干预:PICCLES 随机对照试验。

引言 肌肉痉挛在肝硬化患者中很常见,并且与健康相关的生活质量差有关。治疗选择有限。我们试图确定泡菜汁是否可以改善肌肉痉挛的严重程度。方法 我们招募了 82 名肝硬化患者,在 2020 年 12 月至 2021 年 12 月的前一个月内有超过 4 次肌肉痉挛病史。患者在痉挛发作时以 1:1 的比例随机分配到泡菜汁和自来水。我们在 28 天评估的主要结果是通过视觉模拟痉挛量表(VAS-痉挛,0-10 级)测量的痉挛严重程度的变化。使用交互式短信在 28 天内对抽筋进行了 10 次评估。次要结果包括 VAS 痉挛 <5 天的比例、睡眠质量的变化以及使用 EQ-5D 测量的全球健康相关生活质量。结果 总体而言,74 名患者完成了试验,年龄 56.6 ± 11.5 岁,54% 为男性,41% 患有腹水,38% 患有脑病,终末期肝病模型钠评分为 11.2 ± 4.9。许多患者在基线时正在接受其他痉挛疗法。抽筋的基线 VAS 为 4.2 ± 3.4,EQ-5D 为 0.80 ± 0.10,43% 的人认为睡眠不佳。试验完成时,泡菜汁和对照组抽筋的 VAS 值分别为 -2.25 ± 3.61 分,与对照自来水相比(-0.36 ± 2.87),P = 0.03;VAS 痉挛 <5 的痉挛天比例分别为 46% 和 35%(P = 0.2);睡眠质量的变化没有差异(P = 0.1)。试验结束的 EQ-5D 为 0.78 ± 0.10 vs 0.80 ± 0.10 (P = 0.3)。对于有腹水和没有腹水的人,没有观察到体重变化的差异。讨论 在一项随机试验中,
更新日期:2022-04-13
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