Hammerschlag R
Yo San University of Traditional Chinese Medicine, Santa Monica, California 90401, USA.
J Altern Complement Med. 1998 Summer;4(2):159-71. doi: 10.1089/acm.1998.4.159.
In this review, controlled clinical trials of acupuncture are placed into five categories on the basis of the treatment with which acupuncture is compared. Methodological and ethical issues relevant to each category are discussed. Wait list (or no treatment) controls, which are ethically acceptable for stable, chronic conditions, assess the efficacy of acupuncture relative to the natural history of the condition but do not control for nonspecific treatment effects. Placebo controls, defined here as noninvasive procedures such as inactive transcutaneous electrical nerve stimulation (TENS) or mock needling, assess whether acupuncture has an effect beyond that of the therapeutic milieu. Sham controls, defined as invasive but inappropriate procedures such as shallow needling at nonacupoint sites, assess whether acupuncture efficacy depends on the style and location of needling. Standard care comparisons assess whether acupuncture performs at least as well as a medication, medical device, or physiotherapy. Adjunctive care comparisons assess the efficacy of acupuncture plus standard care relative to standard care alone. From an ethical perspective, active debate surrounds placebo and sham controls. Those who argue against these procedures consider withholding treatment to be improper. They favor the wait list and both standard care designs in which all patients receive treatment. Others argue that testing a treatment prior to demonstrating its efficacy against a placebo is equally improper. From a methodological perspective, it should also be considered that most clinical trials of acupuncture have assessed its efficacy by administering a fixed course of treatment based on biomedical diagnosis. The challenge for future trials is to design conditions that more closely mimic the delivery of acupuncture in clinical practice, as individualized treatment informed by its own diagnostic traditions.
在本综述中，针灸对照临床试验根据与之比较的治疗方法分为五类。讨论了与每类相关的方法学和伦理问题。等待列表（或无治疗）对照对于稳定的慢性疾病在伦理上是可接受的，它评估针灸相对于疾病自然病程的疗效，但不能控制非特异性治疗效果。安慰剂对照在此定义为非侵入性程序，如无效的经皮电刺激神经疗法（TENS）或假针刺，评估针灸是否具有超出治疗环境的效果。假对照定义为侵入性但不适当的程序，如在非穴位部位浅刺，评估针灸疗效是否取决于针刺方式和部位。标准治疗对照评估针灸是否至少与药物、医疗器械或物理治疗效果相当。辅助治疗对照评估针灸加标准治疗相对于单纯标准治疗的疗效。从伦理角度来看，围绕安慰剂和假对照存在激烈争论。反对这些程序的人认为不给予治疗是不恰当的。他们倾向于等待列表对照以及所有患者都接受治疗的标准治疗设计。其他人则认为在证明一种治疗方法对安慰剂有效之前对其进行测试同样不恰当。从方法学角度来看，还应考虑到大多数针灸临床试验是通过基于生物医学诊断给予固定疗程的治疗来评估其疗效的。未来试验面临的挑战是设计出更接近临床实践中针灸实施情况的条件，即基于其自身诊断传统的个体化治疗。
