Bisht Babita, Darling Warren G, Grossmann Ruth E, Shivapour E Torage, Lutgendorf Susan K, Snetselaar Linda G, Hall Michael J, Zimmerman M Bridget, Wahls Terry L
1 Department of Health and Human Physiology, University of Iowa College of Liberal Arts and Sciences , University of Iowa, Iowa City, IA.
J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.
Multiple sclerosis is an autoimmune disease influenced by environmental factors.
The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed.
DESIGN/SETTING: This was a single-arm, open-label intervention study in an outpatient setting.
A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used.
Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12.
Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months.
In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.
多发性硬化症是一种受环境因素影响的自身免疫性疾病。
评估多模式干预对继发进展型多发性硬化症患者感知疲劳的可行性及其效果。
设计/地点：这是一项在门诊环境中进行的单臂、开放标签干预研究。
采用多模式干预，包括改良的旧石器时代饮食并补充营养、伸展运动、对躯干和下肢肌肉进行电刺激的强化锻炼、冥想和按摩。
使用每日日志计算对干预各组成部分的依从性。通过每月问卷调查和血液分析评估副作用。使用疲劳严重程度量表（FSS）评估疲劳情况。在基线以及第1、2、3、6、9和12个月收集数据。
13名参加为期2周导入期的受试者中有10名符合条件可继续参加为期12个月的主要研究。在这10名受试者中，8名完成了研究，6名受试者在12个月内完全坚持了研究干预。在12个月期间，饮食的平均依从天数超过90%，运动/肌肉刺激的平均依从天数超过75%。营养补充剂的摄入量在受试者之间和受试者内部各不相同。小组每日冥想平均时长为13.3分钟，按摩平均时长为7.2分钟。未报告不良副作用。小组FSS平均得分从基线时的5.7降至12个月时的3.32（p=0.0008）。
在这项小型、非对照的试点研究中，完成研究的患者疲劳情况有显著改善。鉴于样本量小和完成率低，有必要对这种多模式疗法进行进一步评估。
