Schnyer Rosa N, Iuliano Diane, Kay Joseph, Shields Monica, Wayne Peter
New England School of Acupuncture, Watertown, MA, USA.
J Altern Complement Med. 2008 Jun;14(5):515-22. doi: 10.1089/acm.2007.0826.
Very little research has been conducted in the West to evaluate the clinical efficacy of Japanese acupuncture (JA). The characteristics that define and differentiate JA from Chinese acupuncture styles add specific challenges to the operationalization of treatment protocols for use in clinical trials.
To develop an ecologically valid and viable multimodal treatment intervention, including active and sham protocols, for use in a pilot randomized sham-controlled trial of a style of JA in treating endometriosis-related chronic pelvic pain in adolescents and young women.
A focus group format was used to systematize the diagnostic framework, operationalize the intake, design the treatment protocols, and develop a viable and effective sham acupuncture intervention using the Streitberger device and sham moxibustion. Implementation of the treatment protocol employed the manualization process to provide flexibility of treatment while assuring replicability and standardization.
The Japanese Acupuncture Department at the New England School of Acupuncture in Newton, MA.
Completed study visit forms indicated good compliance of study practitioners with active and sham treatment protocols. The specific JA protocols used in our pilot study were well tolerated by the adolescent girls who participated in the trial. No serious adverse events were reported by any participants. Our protocols were successful in maintaining patient blinding and minimizing differences in outcome expectations between treatment groups.
Manualization provided a viable method for conforming to the interactive nature of JA treatments, yet facilitated compliance with a replicable treatment protocol. Sham controls of complex, multicomponent JA interventions pose unique challenges. The modified Streitberger needle in conjunction with sham moxibustion showed promise as a viable control in clinical trails of JA; both components of this sham protocol require further validation.
在西方，针对日本针灸（JA）临床疗效的研究非常少。JA与中国针灸风格在定义和区分上的特点给用于临床试验的治疗方案实施带来了特殊挑战。
开发一种生态有效且可行的多模式治疗干预措施，包括主动和假治疗方案，用于一项针对青少年和年轻女性子宫内膜异位症相关慢性盆腔疼痛的JA风格试点随机假对照试验。
采用焦点小组形式来系统化诊断框架、实施初诊流程、设计治疗方案，并使用 Streitberger 装置和假艾灸开发一种可行且有效的假针灸干预措施。治疗方案的实施采用手册化流程，以在确保可重复性和标准化的同时提供治疗灵活性。
马萨诸塞州牛顿市新英格兰针灸学校的日本针灸科。
完整的研究访视表格表明研究从业者对主动和假治疗方案的依从性良好。参与试验的少女对我们试点研究中使用的特定JA方案耐受性良好。没有参与者报告严重不良事件。我们的方案成功地保持了患者的盲态，并最大限度地减少了治疗组之间结果预期的差异。
手册化提供了一种可行的方法，既能符合JA治疗的交互性质，又便于遵循可重复的治疗方案。复杂的多成分JA干预措施的假对照带来了独特挑战。改良的 Streitberger 针结合假艾灸在JA临床试验中显示出作为可行对照的前景；该假治疗方案的两个组成部分都需要进一步验证。
