Data_Sheet_1_Effectiveness of osteopathic craniosacral techniques: a meta-analysis.PDF

BackgroundCraniosacral 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.MethodsA 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.ResultsThe 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 Neonate health, structure (g = 0.66, 95% CI [0.30; 1.02], Prediction Interval [−0.73; 2.05]) and Pain, chronic somatic (g = 0.34, 95% CI [0.18; 0.50], Prediction Interval [−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.Conclusions and relevanceCST 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.Systematic Review Registrationhttps://osf.io/54k6g.

背景：颅骶骨整骨医学，亦称颅骶疗法（CST），是整骨医学中广泛教授和应用的组成部分。本文旨在对随机对照试验进行系统综述和荟萃分析，评估与标准治疗、安慰剂治疗或无治疗相比，CST在成人和儿童中的临床有效性。方法：于2023年10月29日对Embase、PubMed和Scopus进行了检索，并于2024年5月8日更新。未对出版日期设定限制。通过Google Scholar进行检索以捕获灰色文献。同时实施逆向文献检索。纳入所有采用CST评估任何临床结果的随机对照试验。排除非英语文献以及未报告足够数据的文献。采用多位评审员评估纳入标准，通过共识解决分歧。遵循PRISMA指南报告本荟萃分析。使用Cochrane偏倚风险评估2工具评估偏倚风险。所有数据均由多位独立观察者提取。使用Hedge的G值（标准化平均差异）计算效应量，并使用随机效应模型进行汇总。使用GRADE系统评估证据质量。结果：主要研究结果是CST对非健康成人或儿童所选结果的疗效，通过标准化平均差异效应量进行衡量。最终荟萃分析中包括24项RCT，共1,613名参与者。仅当按主要结果进行亚组分析时，未发现显著效应。当将次要结果纳入亚组分析时，结果显示，仅新生儿健康、结构（g=0.66，95%CI[0.30；1.02]，预测区间[−0.73；2.05]）和慢性躯体疼痛（g=0.34，95%CI[0.18；0.50]，预测区间[−0.41；1.09]）显示出可靠的、具有统计学意义的效应。然而，这些结果不应被视为积极结果，因为广泛的预测区间、较高的偏倚和统计局限性削弱了这一发现的现实世界意义。结论与相关性：CST在本荟萃分析中未显示出显著效应，表明对于所研究的任何适应症，其在患者护理中均缺乏实用性。预注册信息可在https://doi.org/10.17605/OSF.IO/54K6G获得。系统综述注册信息：https://osf.io/54k6g。