Ai A L, Peterson C, Gillespie B, Bolling S F, Jessup M G, Behling B A, Pierce F
University of Michigan's Complementary and Alternative Medicine Research Center for Cadiovascular Diseases, Ann Arbor, Mich, USA.
Altern Ther Health Med. 2001 Jul-Aug;7(4):83-90.
Demand for energy healing is growing rapidly in the United States. Until recently, however, few clinical trials have been conducted to investigate its clinical efficacy, risks, and cost-effectiveness. This article discusses principles underlying the research design of clinical trials on energy healing, based on the experience of an interdisciplinary team conducting a large-sample clinical study on qigong funded by the National Institutes of Health. The first part overviews the background and contemporary practice of qigong therapy. The second addresses some difficulties and unique issues to be considered in designing a clinical trial on energy healing. These issues include research emphasis on outcome versus mechanism, randomization, control, expectations/placebo effects, staff and practitioner bias/conflict of interest, patients' belief, selection bias, intent-to-treat analysis, ethics, informed consent, sample size, and outcome report. The ultimate goal is to promote more scholarly and clinical discussion on the evaluation of energy healing.
在美国，对能量疗法的需求正在迅速增长。然而，直到最近，很少有临床试验来研究其临床疗效、风险和成本效益。本文基于一个跨学科团队在美国国立卫生研究院资助下开展的一项关于气功的大样本临床研究的经验，探讨能量疗法临床试验研究设计的基本原则。第一部分概述了气功疗法的背景和当代实践。第二部分阐述了在设计能量疗法临床试验时需要考虑的一些困难和独特问题。这些问题包括研究对结果与机制的侧重点、随机化、对照、期望/安慰剂效应、工作人员和从业者的偏见/利益冲突、患者的信念、选择偏倚、意向性分析、伦理、知情同意、样本量和结果报告。最终目标是促进关于能量疗法评估的更多学术和临床讨论。
