Cabano Rita, Al-Abdallat Haneen, Hamamreh Rawan, Soll Greg, Oei Ju Lee, Schmölzer Georg M, Bruschettini Matteo
Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
School of Medicine, The University of Jordan, Amman, Jordan.
Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015894. doi: 10.1002/14651858.CD015894.pub2.
Procedural pain management in newborns, particularly those in neonatal intensive care units (NICUs), presents challenges due to limited safe and effective options. Acupuncture, a Traditional Chinese Medicine practice, has emerged as a potential alternative for pain relief in this population.
To assess the benefits and harms of acupuncture in newborn infants undergoing painful procedures.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, and clinical trial registries up to August 2023. We checked the references of included studies and related systematic reviews.
We included parallel and cross-over randomized controlled trials (RCTs) comparing acupuncture with no treatment or sham treatment; any non-pharmacological treatment; any pharmacological treatment; or one type of acupuncture compared to another type of acupuncture.
Our outcomes were: pain scores; harms; parental, family, and caregiver satisfaction with the intervention; use of additional pharmacological intervention for pain relief; episodes of bradycardia/apnea/desaturation; neonatal mortality; mortality during initial hospitalization; intraventricular hemorrhage; late-onset sepsis; duration of hospital stay; major neurodevelopmental disability.
We used Cochrane's RoB 1 tool for RCTs.
We conducted meta-analyses using fixed-effect models to calculate risk ratios (RR) and risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardized mean difference (SMD, when combining different pain scales) and standard deviation for continuous outcomes. We summarized the certainty of evidence according to the GRADE approach.
We included 11 RCTs enrolling 852 infants. Five studies compared acupuncture to no treatment or sham treatment; four studies to non-pharmacological treatment (oral sucrose or glucose); and two studies compared acupuncture to other types of Traditional Chinese Medicine treatments, which we refer to as 'type B acupuncture,' such as foot massage or reflexology. No studies compared acupuncture to any pharmacological treatment. We identified four ongoing studies.
We have listed outcomes reported in at least one study. Acupuncture compared to no treatment or sham treatment Acupuncture may reduce pain assessed during the procedure with any validated scale compared to no intervention (SMD -0.56, 95% CI -0.75 to -0.37; 7 studies, 471 infants; low-certainty evidence). It may result in little to no difference in any harms compared to no intervention (RR 0.35, 95% CI 0.01 to 8.31; 2 studies, 138 infants; low-certainty evidence). Acupuncture compared to any non-pharmacological treatment The evidence is very uncertain about the effect of acupuncture on pain assessed with a validated scale during the procedure compared to non-pharmacological intervention (SMD 0.29, 95% CI 0.04 to 0.54; 4 studies, 267 infants; very low-certainty evidence). Acupuncture may result in little to no difference in any harms compared to non-pharmacological treatment (RR not estimable, RD 0.00, 95% CI -0.03 to 0.03; 3 studies, 247 infants; low-certainty evidence). Acupuncture type A (e.g. penetration of the skin with a needle) compared to acupuncture type B (e.g. foot massage or reflexology) The evidence is very uncertain about the effect of acupressure on pain assessed with any validated scale during the procedure compared to foot massage (SMD 0.05, 95% CI -0.26 to 0.36; 2 studies, 163 infants; very low-certainty evidence).
AUTHORS' CONCLUSIONS: Acupuncture may reduce pain assessed with different scales during the procedure, with little to no difference in any harms, when compared to no intervention. The evidence is very uncertain about the effect of acupuncture on pain assessed with different scales during the procedure when compared to any non-pharmacological treatment; acupuncture may result in little to no difference in any harms. The evidence is very uncertain about the effect of acupressure on pain assessed during the procedure when compared to foot massage or reflexology.
This Cochrane review had no dedicated funding.
Protocol (2023): doi.org/10.1002/14651858.CD015894.
新生儿尤其是新生儿重症监护病房（NICU）中的新生儿的程序性疼痛管理面临挑战，因为安全有效的选择有限。针灸作为一种传统中医疗法，已成为该人群缓解疼痛的一种潜在替代方法。
评估针灸对接受疼痛性操作的新生儿的益处和危害。
我们检索了截至2023年8月的Cochrane对照试验中央注册库（CENTRAL）、PubMed、Embase和临床试验注册库。我们检查了纳入研究和相关系统评价的参考文献。
我们纳入了将针灸与不治疗或假治疗进行比较的平行和交叉随机对照试验（RCT）；任何非药物治疗；任何药物治疗；或一种针灸与另一种针灸进行比较。
我们的结局指标包括：疼痛评分；危害；父母、家庭和护理人员对干预措施的满意度；用于缓解疼痛的额外药物干预的使用情况；心动过缓/呼吸暂停/血氧饱和度下降的发作次数；新生儿死亡率；初次住院期间的死亡率；脑室内出血；晚发性败血症；住院时间；主要神经发育障碍。
我们对RCT使用Cochrane的RoB 1工具。
我们使用固定效应模型进行荟萃分析，以计算二分结局的风险比（RR）和风险差（RD）及其95%置信区间（CI），对于连续结局计算均值差（MD）或标准化均值差（SMD，当合并不同疼痛量表时）以及标准差。我们根据GRADE方法总结证据的确定性。
我们纳入了11项RCT，共852名婴儿。5项研究将针灸与不治疗或假治疗进行比较；4项研究将针灸与非药物治疗（口服蔗糖或葡萄糖）进行比较；2项研究将针灸与其他类型的传统中医疗法（我们称为“B型针灸”），如足部按摩或反射疗法进行比较。没有研究将针灸与任何药物治疗进行比较。我们确定了4项正在进行的研究。
我们列出了至少一项研究报告的结局。针灸与不治疗或假治疗相比与不干预相比，针灸可能会降低使用任何有效量表评估的操作过程中的疼痛（SMD -0.56，95%CI -0.75至-0.37；7项研究，471名婴儿；低确定性证据）。与不干预相比，其在任何危害方面可能几乎没有差异（RR 0.35，95%CI 0.01至8.31；2项研究，138名婴儿；低确定性证据）。针灸与任何非药物治疗相比与非药物干预相比，关于针灸对操作过程中使用有效量表评估的疼痛的影响，证据非常不确定（SMD 0.29，95%CI 0.04至0.54；4项研究，267名婴儿；极低确定性证据）。与非药物治疗相比，针灸在任何危害方面可能几乎没有差异（RR无法估计，RD 0.00，95%CI -0.03至0.03；3项研究，247名婴儿；低确定性证据）。A型针灸（如用针刺入皮肤）与B型针灸（如足部按摩或反射疗法）相比与足部按摩相比，关于指压对操作过程中使用任何有效量表评估的疼痛的影响，证据非常不确定（SMD 0.05，95%CI -0.26至0.36；2项研究，163名婴儿；极低确定性证据）。
与不干预相比，针灸可能会降低操作过程中使用不同量表评估的疼痛，且在任何危害方面几乎没有差异。与任何非药物治疗相比，关于针灸对操作过程中使用不同量表评估的疼痛的影响，证据非常不确定；针灸在任何危害方面可能几乎没有差异。与足部按摩或反射疗法相比，关于指压对操作过程中评估的疼痛的影响，证据非常不确定。
本Cochrane综述没有专项资助。
方案（2023）：doi.org/10.1002/14651858.CD015894
