Amendolara Alfred, Sheppert Alexander, Powers Ryan, Payne Andrew, Stacey Stephen, Sant David
Department of Biomedical Science, Noorda College of Osteopathic Medicine, Provo, UT, United States.
Federated Department of Biological Science, New Jersey Institute of Technology, Newark, NJ, United States.
Front Med (Lausanne). 2024 Oct 3;11:1452465. doi: 10.3389/fmed.2024.1452465. eCollection 2024.
Craniosacral osteopathic manipulative medicine-also known as craniosacral therapy (CST)-is a widely taught and used component of osteopathic medicine. This paper seeks to systematically review and conduct a meta-analysis of randomized controlled trials assessing the clinical effectiveness of CST compared to standard care, sham treatment, or no treatment in adults and children.
A search of Embase, PubMed, and Scopus was conducted on 10/29/2023 and updated on 5/8/2024. There was no restriction placed on the date of publication. A Google Scholar search was conducted to capture grey literature. Backward citation searching was also implemented. All randomized controlled trials employing CST for any clinical outcome were included. Studies not available in English as well as studies that did not report adequate data were excluded. Multiple reviewers were used to assess for inclusions, disagreements were settled by consensus. PRISMA guidelines were followed in the reporting of this meta-analysis. Cochrane's Risk of Bias 2 tool was used to assess for risk of bias. All data were extracted by multiple independent observers. Effect sizes were calculated using a Hedge's G value (standardized mean difference) and aggregated using random effects models. The GRADE system was used to assess quality of evidence.
The primary study outcome was the effectiveness of CST for selected outcomes as applied to non-healthy adults or children and measured by standardized mean difference effect size. Twenty-four RCTs were included in the final meta-analysis with a total of 1,613 participants. When subgroup analyses were performed by primary outcome only, no significant effects were found. When secondary outcomes were included in subgroup analyses, results showed that only ( = 0.66, [0.30; 1.02], [-0.73; 2.05]) and ( = 0.34, [0.18; 0.50], [-0.41; 1.09]) show reliable, statistically significant effect. However, these should not be interpreted as positive results as wide prediction intervals, high bias, and statistical limitations temper the real-world implications of this finding.
CST demonstrated no significant effects in this meta-analysis, indicating a lack of usefulness in patient care for any of the studied indications.Pre-registration available at https://doi.org/10.17605/OSF.IO/54K6G.
颅骶骨整骨疗法——也称为颅骶疗法（CST）——是整骨医学中广泛传授和使用的一个组成部分。本文旨在系统回顾并对随机对照试验进行荟萃分析，以评估与标准护理、假治疗或不治疗相比，CST在成人和儿童中的临床疗效。
于2023年10月29日对Embase、PubMed和Scopus进行检索，并于2024年5月8日更新。对出版日期没有限制。进行谷歌学术搜索以获取灰色文献。还实施了反向引文搜索。纳入所有采用CST治疗任何临床结局的随机对照试验。排除非英文的研究以及未报告足够数据的研究。由多名评审员评估纳入情况，分歧通过协商解决。本荟萃分析的报告遵循PRISMA指南。使用Cochrane偏倚风险2工具评估偏倚风险。所有数据由多名独立观察员提取。效应量使用Hedge's G值（标准化平均差）计算，并使用随机效应模型汇总。采用GRADE系统评估证据质量。
主要研究结局是CST对应用于非健康成人或儿童的选定结局的有效性，通过标准化平均差效应量来衡量。最终的荟萃分析纳入了24项随机对照试验，共有1613名参与者。仅按主要结局进行亚组分析时，未发现显著效果。当亚组分析纳入次要结局时，结果显示只有[此处原文缺失具体内容]（=0.66，[0.30；1.02]，[-0.73；2.05]）和[此处原文缺失具体内容]（=0.34，[0.18；0.50]，[-0.41；1.09]）显示出可靠的、具有统计学意义的效果。然而，由于预测区间宽泛、高偏倚和统计局限性，不应将这些结果解释为积极结果，这限制了这一发现对现实世界的影响。
在本荟萃分析中，CST未显示出显著效果，表明其在任何所研究适应症的患者护理中均无用。预注册网址为https://doi.org/10.17605/OSF.IO/54K6G。
