Surgery and Medical Surgical Specialities Department, Faculty of Medicine and Health Sciences, University of Oviedo, Oviedo, Asturias, Spain.
Paediatric Gastroenterology and Nutrition Unit, Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain.
J Altern Complement Med. 2020 Jul;26(7):620-627. doi: 10.1089/acm.2020.0047. Epub 2020 Jun 16.
Make a preliminary assessment of the efficacy of manual physical therapy (MPT) compared to conventional pharmacologic treatment (CPT) in chronic pediatric functional constipation (CPC). A pilot randomized and controlled trial was conducted. Subjects were recruited in a tertiary university hospital in the north of Spain. Forty-seven children (2-14 years) were included. Participants were assessed by Pediatric Gastroenterologist. They were recruited in a tertiary university hospital. Subjects were randomly allocated. MPT was performed in a private clinic. Control group (CG) received CPT and intervention group (IG) received MPT, consisting in nine sessions of MPT with a 45-min initial session and 30 min for the rest of sessions distributed weekly during the first and second months and biweekly in the third month. At times 0-1-3 months and 5 years, results obtained were checked and compared, according to the defecatory pattern ("Symptom Severity Score" SSS), quality of life (Pediatric Quality of Life Inventory Scale), Bristol Stool Form Scale (BSFS), and the defecation frequency (DF). Results from SSS, BSFS, and DF revealed no statistically significant differences between groups in median values at any follow-up. However, there were significant changes over time. The full sample median for SSS was reduced from baseline 24 (interquartile range 20-27) to 11 (6-13) at month 1, 7 (3-13) at month 3, (8 CG; 5 IG), and 5 (1-12) at year 5. The BSFS scale increased from 2 (1-3) at baseline to 4 (3-4) at month 1 and year 5. DF increases progressively from 1 per week to 5 in the fifth year. Higher rates of quality of life were observed at month 3 in IG for the total, physical, and emotional functioning scores and at fifth year for total, emotional, social, and school functioning scores. This study gives preliminary evidence of no difference between MPT and CPT for improvement in measures of CPC, although there was some advantage for MPT in quality of life. Study results justify the conduct of a full-scale efficacy trial of MPT, as well as a noninferiority trial comparing MPT and CPT.
初步评估手法物理治疗（MPT）与常规药物治疗（CPT）在慢性儿科功能性便秘（CPC）中的疗效。进行了一项随机对照试验。研究对象招募于西班牙北部的一家三级大学医院。共纳入 47 名（2-14 岁）儿童。由儿科胃肠病学家对参与者进行评估。他们在一家三级大学医院被招募。参与者被随机分配。MPT 在一家私人诊所进行。对照组（CG）接受 CPT，干预组（IG）接受 MPT，包括 9 次 MPT，初始 45 分钟，其余时间每周在第一个和第二个月内分 30 分钟进行，第三个月每两周进行一次。在 0-1-3 个月和 5 年内，检查并比较了获得的结果，根据排便模式（“症状严重程度评分”SSS）、生活质量（儿科生活质量量表）、布里斯托粪便形态量表（BSFS）和排便频率（DF）。在任何随访中，SSS、BSFS 和 DF 的中位数结果均未显示组间存在统计学差异。然而，随着时间的推移发生了显著变化。SSS 的全样本中位数从基线的 24（四分位距 20-27）降至 1 个月时的 11（6-13）、3 个月时的 7（3-13）（8 例 CG；5 例 IG）和 5 岁时的 5（1-12）。BSFS 量表从基线时的 2（1-3）增加到 1 个月和 5 岁时的 4。DF 每周逐渐增加到第 5 年的 5。IG 在第 3 个月时在总、生理和情绪功能评分以及第 5 年时在总、情绪、社会和学校功能评分方面的生活质量评分较高。这项研究初步表明 MPT 和 CPT 在改善 CPC 测量方面没有差异，尽管 MPT 在生活质量方面有一些优势。研究结果证明有必要进行 MPT 的全面疗效试验，以及 MPT 和 CPT 的非劣效性试验。
