Schlaeger Judith M, Takakura Nobuari, Yajima Hiroyoshi, Takayama Miho, Steffen Alana D, Gabzdyl Elizabeth M, Nisi Robyn A, McGowan Gruber Kathleen, Bussell Jason M, Wilkie Diana J
1Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, 845 S. Damen (M/C 802), Chicago, IL 60612 USA.
2Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan.
Pilot Feasibility Stud. 2018 Apr 13;4:72. doi: 10.1186/s40814-018-0265-9. eCollection 2018.
Efficacy of acupuncture is difficult to demonstrate without a feasible double-blind milieu. Double-blind acupuncture needles have been validated in single session protocols with one or two needles but not been tested in a protocol requiring many needles and repeated sessions.
We determined the feasibility of a 13-needle, 10-session study protocol. Feasibility focused on (1) enrolling and retaining participants; (2) two acupuncturists accurately implementing a double-blind, multi-needle, multi-session protocol; (3) participants completing measures; and (4) protocol acceptability to participants. In this double-blind randomized controlled pilot study, participants were randomized 1:1 to a penetrating needle group or a skin-touch placebo control group.
Six women with vulvodynia (mean age 31.5 ± 8 years; five white, non-Latina, one black/African American) met the eligibility requirements, consented to participation, and were enrolled. All six participants (100%) completed the 10-session study protocol in 5 weeks without missing any treatment sessions. Per observed checklist documented technique, two acupuncturists flawlessly administered the 13-needle, 10-session acupuncture protocol; no needles malfunctioned. Six participants attended all sessions and completed 99% of measurement items. One participant did not like acupuncture (60% acceptability score) and five liked acupuncture (100% acceptability scores); the mean acceptability score was 93.3%.
Study feasibility was supported. This protocol can be used in a double-blind efficacy trial of acupuncture for vulvodynia.
ClinicalTrials.gov, NCT02704234. Registered 30 November 2015.
在缺乏可行的双盲环境的情况下，针灸的疗效很难得到证实。双盲针灸针已在单疗程使用一到两根针的方案中得到验证，但尚未在需要多根针和重复疗程的方案中进行测试。
我们确定了一项使用13根针、进行10个疗程的研究方案的可行性。可行性集中在以下几个方面：（1）招募并留住参与者；（2）两名针灸师准确实施双盲、多针、多疗程方案；（3）参与者完成各项测量；（4）方案对参与者的可接受性。在这项双盲随机对照试验性研究中，参与者按1:1随机分为透刺针组或皮肤接触安慰剂对照组。
六名患有外阴痛的女性（平均年龄31.5±8岁；五名白人、非拉丁裔，一名黑人/非裔美国人）符合入选标准，同意参与并被纳入研究。所有六名参与者（100%）在5周内完成了10个疗程的研究方案，没有错过任何一次治疗。根据观察到的核对表记录的技术，两名针灸师完美地实施了13根针、10个疗程的针灸方案；没有针出现故障。六名参与者参加了所有疗程，完成了99%的测量项目。一名参与者不喜欢针灸（可接受性评分为60%），五名参与者喜欢针灸（可接受性评分为100%）；平均可接受性评分为93.3%。
研究的可行性得到了支持。该方案可用于针灸治疗外阴痛的双盲疗效试验。
ClinicalTrials.gov，NCT02704234。于2015年11月30日注册。
