Chinese Evidence-based Medicine Center and Cochrane China Center, West China Hospital, Sichuan University, Chengdu, China.
NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China.
Acupunct Med. 2022 Dec;40(6):524-537. doi: 10.1177/09645284221117848. Epub 2022 Aug 30.
Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture.
We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment.
Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = -0.15, 95% confidence interval: -0.91 to 0.62).
Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control.
干预措施的规范和对照的选择是成功进行针刺试验的两个方法学决定因素。然而，目前对于这两个决定因素的实践并不完全清楚。因此，我们进行了一项横断面调查，以检查已发表的针刺随机对照试验（RCT）中干预措施的规范和对照的选择。
我们在核心临床期刊和补充与替代医学（CAM）期刊上从 2010 年 1 月至 2019 年 12 月（10 年）的 PubMed 中搜索了针灸 RCTs，并纳入了评估针刺与任何类型对照治疗效果的 RCTs。我们使用网络荟萃分析来探索在使用假针刺作为对照时，慢性疼痛患者是否存在不同的治疗效果，而不是使用等待名单或不治疗。
319 项合格 RCT 中有大多数都很好地规范了针刺的方式（86.8%）、传统的穴位位置（96.2%）、针刺激类型（90.3%）和针留时间（85.6%）。然而，其他针刺细节的规范较少，包括寻求的反应（65.5%）、针刺操作（50.5%）、针刺次数（21.9%）、针刺角度和方向（31.3%）、患者姿势（32.3%）和辅助干预（22.9%）。假针刺（41.4%）是最常用的对照，其次是等待名单或不治疗（32.9%）。使用假针刺与等待名单/不治疗作为对照时，治疗效果没有差异（标准化均数差= -0.15，95%置信区间：-0.91 至 0.62）。
在过去的十年研究实践中，针刺干预措施的规范仍存在重要差距，包括寻求的反应、针刺操作和辅助干预。虽然假针刺已被广泛使用，但等待名单或不治疗也可以被认为是一种合适的对照。
