Nordic Institute of Chiropractic and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark.
Research Unit of General Practice in Odense, Department of Public Health, University of Southern Denmark, J.B. Winsløws vej 9A, DK-5000, Odense C, Denmark.
Chiropr Man Therap. 2021 Apr 19;29(1):16. doi: 10.1186/s12998-021-00373-6.
A recent trial identified large variation in effect of chiropractic care for infantile colic. Thus, identification of possible effect modifiers could potentially enhance the clinical reasoning to select infants with excessive crying for chiropractic care. Therefore, the aim of this study is to identify potential treatment effect modifiers which might influence the effect of chiropractic care for excessive crying in infancy.
Design: Prespecified secondary analyses of data from a randomised controlled trial. The analyses are partly confirmative and partly exploratory.
Four chiropractic clinics in Denmark.
Infants aged 2-14 weeks with unexplained excessive crying. Of the 200 infants randomised (1:1), 103 were assigned to a chiropractic care group and 97 to a control group.
Infants in the intervention group received chiropractic care for 2 weeks, while the control group was not treated. Main analyses: The outcome was change in daily hours of crying. Fifteen baseline variables and 6 general variables were selected as potential effect modifiers, and indices based on these were constructed. Factor analyses, latent class analyses and prognosis were used to construct other potentially modifying variables. Finally, an attempt at defining a new index aiming at optimal prediction of the treatment effect was made. The predictive value for all resulting variables were examined by considering the difference in mean change in crying time between the two treatment groups, stratified by the values of the candidate variables, i.e. interaction analyses.
None of the predefined items or indices were shown to be useful in identifying colicky infants with potentially larger gain from manual therapy. However, more baseline hours of crying (p = 0.029), short duration of symptoms (p = 0.061) and young age (p = 0.089) were all associated with an increased effect on the outcome of hours of crying.
Musculoskeletal indicators were not shown to be predictive of an increased benefit for colicky infants from chiropractic treatment. However, increased benefit was associated with early treatment and a high level of baseline crying, suggesting that the most severely affected infants have the greatest potential of benefiting from manual therapy. This finding requires validation by future studies.
Clinical Trials NCT02595515 , registered 2 November 2015.
最近的一项试验表明，针对婴儿绞痛的脊骨疗法的效果存在较大差异。因此，确定可能的疗效修饰因子可能有助于增强临床推理，以便为接受脊骨疗法治疗的过度哭闹婴儿进行选择。因此，本研究的目的是确定可能影响婴儿过度哭闹的脊骨疗法效果的潜在治疗效果修饰因子。
设计：对一项随机对照试验数据的预设二次分析。该分析既有证实性的部分，也有探索性的部分。
丹麦的四家脊骨疗法诊所。
2-14 周龄、原因不明的过度哭闹的婴儿。200 名随机分组的婴儿（1:1）中，103 名被分配到脊骨疗法组，97 名被分配到对照组。
干预组婴儿接受为期 2 周的脊骨疗法治疗，而对照组则不进行治疗。主要分析：结局是每日哭泣时间的变化。选择 15 个基线变量和 6 个一般变量作为潜在的疗效修饰因子，并构建基于这些因子的指标。采用因子分析、潜在类别分析和预后分析构建其他潜在的修饰变量。最后，尝试构建一个新的指数，旨在优化治疗效果的预测。通过考虑候选变量值分层后两组之间哭泣时间的平均变化差异，对所有产生的变量的预测价值进行了检验，即交互分析。
未发现任何预设项目或指标有助于识别出可能从手法治疗中获得更大收益的绞痛婴儿。然而，更多的基线哭泣时间（p=0.029）、较短的症状持续时间（p=0.061）和较小的年龄（p=0.089）均与哭泣时间结局的效果增加相关。
肌肉骨骼指标并未显示出对接受脊骨治疗的绞痛婴儿有增加的益处。然而，早期治疗和基线哭泣水平较高与较高的益处相关，这表明病情最严重的婴儿最有可能从手法治疗中受益。这一发现需要未来的研究加以验证。
临床试验 NCT02595515，于 2015 年 11 月 2 日注册。
