Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials

<b>Objective:</b> Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic. <b>Design:</b> A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents]. <b>Eligibility criteria and data sources:</b> We included randomised controlled trials of acupuncture treatments of infantile colic. Systematic searches were conducted in Cochrane CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, and in the Chinese language databases CNKI, VIP, Wang fang, SinoMed and Chinese Clinical Trial Registry. <b>Results:</b> We included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was −24.9 min [95% confidence interval, CI −46.2 to −3.6; three trials] at mid-treatment, −11.4 min [95% CI −31.8 to 9.0; three trials] at the end of treatment and −11.8 min [95% CI −62.9 to 39.2; one trial] at the 4-week follow-up. The corresponding standardised mean differences [SMDs] were −0.23 [95% CI −0.42 to −0.06], −0.10 [95% CI −0.29 to 0.08] and −0.09 [95% CI −0.48 to 0.30]. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD −13.8 min [95%CI −37.5 to 9.9] and SMD −0.13 [95%CI −0.35 to 0.09]. The registration of crying during treatment suggested more crying during acupuncture [odds ratio 7.7; 95% CI 2.7–20.6; one trial]. <b>GRADE-</b>Moderate quality evidence. <b>Conclusions:</b> Percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis. <b>Systematic review registration:</b> PROSPERO 2015:CRD42015023253Key pointsThe role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results.There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials.The data indicate that acupuncture induces some treatment pain in many of the children.The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis. The role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results. There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials. The data indicate that acupuncture induces some treatment pain in many of the children. The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis.

**研究目的：** 小儿针刺疗法在西医中已获得一定认可，但该疗法存在争议，因婴幼儿无法自主同意接受治疗。本研究旨在评估其治疗婴儿肠绞痛（infantile colic）的临床疗效。
**研究设计：** 本研究为基于随机对照试验（randomised controlled trial, RCT）个体患者数据（individual patient data, IPD）的系统综述与盲法验证研究。主要结局指标为治疗中期、治疗结束时及1个月随访时的啼哭时长。将针刺组与对照组间啼哭时长的30分钟平均差（mean difference, MD）预先设定为具有临床意义的差异。采用Pearson卡方检验及James与Bang指数对结局评估者（家长）的盲法实施效果进行检验。
**纳入标准与数据来源：** 本研究纳入针对婴儿肠绞痛行针刺治疗的随机对照试验。系统检索了Cochrane CENTRAL、MEDLINE、EMBASE、CINAHL、AMED，以及中国知网（CNKI）、维普（VIP）、万方（Wang Fang）、中国生物医学文献服务系统（SinoMed）和中国临床试验注册中心（Chinese Clinical Trial Registry）等中英文数据库。
**研究结果：** 本研究共纳入3项随机对照试验，涉及307名受试者。仅1项纳入研究成功实现了针刺组与对照组结局评估者的盲法。治疗中期，针刺组与非针刺对照组的啼哭时长平均差为-24.9分钟[95%置信区间（confidence interval, CI）：-46.2至-3.6；3项试验]；治疗结束时为-11.4分钟[95%CI：-31.8至9.0；3项试验]；4周随访时为-11.8分钟[95%CI：-62.9至39.2；1项试验]。对应的标准化均差（standardised mean difference, SMD）分别为-0.23[95%CI：-0.42至-0.06]、-0.10[95%CI：-0.29至0.08]及-0.09[95%CI：-0.48至0.30]。所有分析的异质性均可忽略。敏感性分析中排除该未盲化研究后，治疗中期的统计学显著性结果消失：MD为-13.8分钟[95%CI：-37.5至9.9]，SMD为-0.13[95%CI：-0.35至0.09]。某一项试验的治疗期间啼哭登记数据显示，针刺组儿童啼哭更多[优势比（odds ratio, OR）：7.7；95%CI：2.7至20.6]。
**GRADE证据质量：** 中等质量证据。
**研究结论：** 目前不推荐将经皮针刺疗法常规用于婴儿肠绞痛的治疗。
**系统综述注册信息：** PROSPERO 2015:CRD42015023253
**核心要点：** 针刺疗法在婴儿肠绞痛治疗中的作用尚存争议。现有试验样本量较小且结果存在矛盾。本项基于随机对照试验个体患者数据的Meta分析显示，接受针刺治疗与未接受针刺治疗的婴儿之间不存在具有临床意义的差异。数据表明，针刺疗法在多数儿童中会引发一定程度的治疗相关性疼痛。本研究结果提示，不应常规推荐经皮针刺疗法用于婴儿肠绞痛的治疗。