Cerritelli Francesco, Pizzolorusso Gianfranco, Renzetti Cinzia, Cozzolino Vincenzo, D'Orazio Marianna, Lupacchini Mariacristina, Marinelli Benedetta, Accorsi Alessandro, Lucci Chiara, Lancellotti Jenny, Ballabio Silvia, Castelli Carola, Molteni Daniela, Besana Roberto, Tubaldi Lucia, Perri Francesco Paolo, Fusilli Paola, D'Incecco Carmine, Barlafante Gina
Clinical-based Human Research Department, Centre for Osteopathic Medicine-C.O.ME. Collaboration, Pescara, Italy; Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.
The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups.
A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention.
Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.
尽管有一些初步证据，但整骨手法治疗是否能改善早产临床结局在很大程度上仍不清楚。
本多中心随机单盲平行组临床试验纳入了来自3个不同公共新生儿重症监护病房、符合孕龄29至37周标准且无任何先天性并发症的新生儿。早产婴儿被随机分配至常规产前护理组（对照组）或整骨手法治疗组（研究组）。主要结局是两组之间住院时间的平均差异。
共有695名新生儿被随机分配至研究组（n = 352）或对照组（n = 343）。两组在主要结局方面观察到统计学显著差异（研究组和对照组分别为13.8天和17.5天，p < 0.001，效应大小：0.31）。多变量分析显示住院时间缩短了3.9天（95%可信区间 -5.5至 -2.3，p < 0.001）。此外，与常规护理相比，治疗在成本方面有显著降低（研究组和对照组之间的差异：1,586.01欧元；95%可信区间1,087.18至6,277.28；p < 0.001），但在每日体重增加方面没有差异。该干预未出现并发症。
整骨治疗显著减少了住院天数，并且在一大群早产婴儿中具有成本效益。
