Department of Epidemiology, School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands.
Department of Epidemiology, School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands.
Gastroenterology. 2017 Jan;152(1):82-91. doi: 10.1053/j.gastro.2016.09.015. Epub 2016 Sep 17.
BACKGROUND & AIMS: Functional constipation (FC) is a common childhood problem often related to pelvic floor muscle dysfunction. We compared the effectiveness of pelvic physiotherapy (PPT) vs standard medical care (SMC) in children with FC.
We performed a multicenter randomized controlled trial of 53 children (age, 5-16 y) with FC according to the Rome III criteria, at hospitals in The Netherlands from December 2009 to May 2014. Group allocation was concealed using a central computer system. SMC consisted of education, toilet training, and laxatives (n = 26), whereas PPT included SMC plus specific physiotherapeutic interventions (n = 27). Results were obtained from written reports from the subjects' pediatricians and parents. The primary outcome was absence of FC, according to Rome III criteria, after a 6-month follow-up period. Secondary outcomes were global perceived effect (range, 1-9; success was defined as a score ≥ 8), numeric rating scales assessing quality of life (parent and child; scale, 1-10), and the strengths and difficulties questionnaire (SDQ).
Treatment was effective for 92.3% of the children receiving PPT and for 63.0% of the children receiving SMC (adjusted odds ratio for success of PPT, 11.7; 95% confidence interval, 1.8-78.3) (P = .011). Significantly more children undergoing PPT stopped using laxatives (adjusted odds ratio, 6.5; 95% confidence interval, 1.6-26.4) (P = .009). Treatment success (based on global perceived effect) was achieved for 88.5% of subjects receiving PPT vs 33.3% of subjects receiving SMC) (P < .001). PPT also produced larger adjusted mean differences, before vs after treatment, in numeric rating scales to assess quality of life: an increase of 1.8 points for parents (P = .047) and 2.0 points for children (P = .028). Results from the SDQ did not differ significantly between groups (P = .78).
In a randomized controlled trial of children with FC, PPT was more effective than SMC on all outcomes measured, with the exception of findings from the SDQ. PPT should be considered as a treatment option for FC in children 5-16 years old. Dutch Clinical Trial Registration no: NL30551.068.09.
功能性便秘(FC)是一种常见的儿童问题,常与盆底肌肉功能障碍有关。我们比较了盆底物理疗法(PPT)与标准医疗护理(SMC)在 FC 患儿中的疗效。
我们在荷兰的多家医院进行了一项多中心随机对照试验,纳入了 53 名符合罗马 III 标准的 FC 患儿(年龄 5-16 岁),研究时间为 2009 年 12 月至 2014 年 5 月。使用中央计算机系统对患儿进行分组隐藏。SMC 包括教育、如厕训练和泻药(n=26),而 PPT 包括 SMC 加特定的物理治疗干预(n=27)。结果由患儿儿科医生和家长的书面报告得出。主要结局是在 6 个月的随访期后,根据罗马 III 标准,FC 消失。次要结局是总体感知效果(范围 1-9;成功定义为评分≥8)、生活质量的数字评分量表(家长和儿童;评分 1-10)和《长处和困难问卷》(SDQ)。
PPT 组 92.3%的患儿治疗有效,SMC 组 63.0%的患儿治疗有效(PPT 成功的调整后优势比为 11.7;95%置信区间,1.8-78.3)(P=0.011)。接受 PPT 治疗的患儿中,停止使用泻药的比例明显更高(调整后优势比,6.5;95%置信区间,1.6-26.4)(P=0.009)。接受 PPT 治疗的患儿中,88.5%的患儿治疗成功(基于总体感知效果),而接受 SMC 治疗的患儿中,33.3%的患儿治疗成功(P<0.001)。PPT 治疗前后的生活质量数字评分量表也有更大的调整平均差异:父母增加 1.8 分(P=0.047),儿童增加 2.0 分(P=0.028)。两组间 SDQ 的结果差异无统计学意义(P=0.78)。
在一项 FC 患儿的随机对照试验中,与 SMC 相比,PPT 在所有测量结果上均更有效,除了 SDQ 的结果。对于 5-16 岁的 FC 患儿,PPT 应被视为一种治疗选择。荷兰临床试验注册号:NL30551.068.09。