Shinto Lynne, Calabrese Carlo, Morris Cynthia, Yadav Vijayshree, Griffith Debbie, Frank Rachel, Oken Barry S, Baldauf-Wagner Sara, Bourdette Dennis
Department of Neurology, Oregon Health & Science University, Portland, OR 97239-3098, USA.
J Altern Complement Med. 2008 Jun;14(5):489-96. doi: 10.1089/acm.2007.0757.
Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS.
To assess quality of life in MS subjects who received interventions designed to "model" the "whole practice" of naturopathy.
A pilot, randomized, controlled study with a 6-month intervention period.
Participants who met criteria for clinically definite MS.
The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care.
The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety.
Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes.
Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.
多发性硬化症(MS)患者对补充和替代医学(CAM)的使用率很高,但关于CAM在MS中的安全性和有效性的报道有限。自然疗法涵盖了广泛的CAM模式,可能改善MS患者的生活质量。
评估接受旨在“模拟”自然疗法“整体实践”干预的MS受试者的生活质量。
一项为期6个月干预期的试点随机对照研究。
符合临床确诊MS标准的参与者。
3个干预组分别为常规护理、自然疗法加常规护理、MS教育加常规护理。
主要结果指标是生活质量(36项简短健康调查[SF-36])。次要结果指标包括疲劳(改良疲劳影响量表);抑郁(贝克抑郁量表);认知测试组合(斯特鲁普测试和听觉连续加法测试3),以及神经功能障碍(扩展残疾状态量表[EDSS]和多发性硬化症功能综合评分)。通过不良事件报告和实验室检测来评估安全性。
45名参与者(每组15名)被随机分组,所有参与者均完成了6个月的干预。在任何结果指标上,各组之间均无显著差异。在SF-36的总体健康子量表(p = 0.11)、定时步行(p = 0.11)和神经功能障碍(EDSS)(p = 0.07)方面,有倾向于自然疗法组的趋势。在斯特鲁普注意力测试中,有倾向于教育组的趋势(p = 0.07)。各组在不良事件或实验室指标变化方面无差异。
自然疗法联合MS常规护理在SF-36的总体健康子量表、定时步行和神经功能障碍方面显示出改善趋势。作为一种多模式疗法,对自然疗法的评估值得进一步研究。