Harle Lindsey, Brown Todd, Laheru Daniel, Dobs Adrian S
University of Texas Medical Branch, Galveston, TX, USA.
J Altern Complement Med. 2005 Dec;11(6):1039-46. doi: 10.1089/acm.2005.11.1039.
Complementary and alternative medicine (CAM) is increasingly popular, despite the limited evidence of the efficacy and safety of some forms of CAM. Cancer patients often turn to CAM therapies for the relief of treatment- induced side-effects and comorbidities. Cancer-associated weight loss commonly results in decreased functional status, life expectancy, and quality of life. Despite the high morbidity and mortality associated with cancer cachexia, mainstream treatments do not sustain weight. Although nutritional supplements are commonly used, many of these have not been tested in clinical trials. The issues faced in dietary supplement research differ from those in pharmaceutical drug trials. These include problems with standardization, contamination, and compliance documentation. A double-blind, randomized, placebo-controlled trial is proposed to evaluate the efficacy and safety of fish oil supplementation for the treatment of cachexia in pancreatic cancer patients. The primary outcome measure will be lean body mass; secondary outcomes include functional status and quality of life. The methodology of the clinical trial is reviewed here and the unique problems faced by investigators in designing studies of dietary supplements are discussed.
补充和替代医学（CAM）越来越受欢迎，尽管某些形式的补充和替代医学的疗效和安全性证据有限。癌症患者常常求助于补充和替代医学疗法来缓解治疗引起的副作用和合并症。癌症相关的体重减轻通常会导致功能状态、预期寿命和生活质量下降。尽管癌症恶病质具有高发病率和死亡率，但主流治疗方法并不能维持体重。虽然营养补充剂被普遍使用，但其中许多尚未在临床试验中进行测试。膳食补充剂研究中面临的问题与药物试验中的问题不同。这些问题包括标准化、污染和依从性记录方面的问题。拟进行一项双盲、随机、安慰剂对照试验，以评估补充鱼油治疗胰腺癌患者恶病质的疗效和安全性。主要结局指标将是去脂体重；次要结局包括功能状态和生活质量。本文回顾了该临床试验的方法，并讨论了研究人员在设计膳食补充剂研究时面临的独特问题。
