Hoekman Daniël R, Zeevenhooven Judith, van Etten-Jamaludin Faridi S, Douwes Dekker Iuke, Benninga Marc A, Tabbers Merit M, Vlieger Arine M
Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
Medical Library, Academic Medical Center, Amsterdam, the Netherlands.
J Pediatr. 2017 Mar;182:155-163.e7. doi: 10.1016/j.jpeds.2016.12.022. Epub 2017 Jan 9.
To investigate the magnitude and determinants of the placebo response in studies with pediatric abdominal pain-related functional gastrointestinal disorders.
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL were searched for systematic reviews and randomized placebo-controlled trials concerning children 4-18 years of age with an abdominal pain-related functional gastrointestinal disorder. The primary outcome was the pooled proportion of subjects assigned to placebo with improvement as defined by the authors. The effect of trial characteristics on the magnitude of the placebo response was investigated using univariate meta-regression analysis.
Twenty-one trials were identified. The pooled proportion of subjects with improvement was 41% (95% CI, 34%-49%; 17 studies) and with no pain was 17% (95% CI, 8%-32%; 7 studies). The pooled standardized mean difference on the Faces Pain Scales compared with baseline was -0.73 (95% CI, -1.04 to -0.42; 8 studies). There was significant heterogeneity across studies with respect to both outcomes. Lower dosing frequency (P = .04), positive study (P = .03), longer duration of treatment (P < .001), and higher placebo dropout (P < .001) were associated with higher report of no pain. Response on Faces Pain Scales was greater in studies conducted in the Middle East (P = .002), in studies that did not report the randomization schedule (P = .02), and in studies with a higher percentage of females (P = .04).
Approximately 41% of children with abdominal pain-related functional gastrointestinal disorders improve on placebo. Several trial characteristics are correlated significantly with the proportion of patients with no pain on placebo and with the magnitude of the placebo response on Faces Pain Scales. These data could be valuable for the design of future studies.
探讨儿科腹痛相关功能性胃肠疾病研究中安慰剂反应的程度及决定因素。
检索Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE和护理学与健康领域数据库（CINAHL），查找有关4-18岁腹痛相关功能性胃肠疾病儿童的系统评价和随机安慰剂对照试验。主要结局是作者定义的分配至安慰剂组且病情改善的受试者合并比例。采用单变量Meta回归分析研究试验特征对安慰剂反应程度的影响。
共纳入21项试验。病情改善的受试者合并比例为41%（95%CI，34%-49%；17项研究），无痛的受试者合并比例为17%（95%CI，8%-32%；7项研究）。与基线相比，面部疼痛量表的合并标准化均差为-0.73（95%CI，-1.04至-0.42；8项研究）。两项结局在各研究间均存在显著异质性。较低的给药频率（P = 0.04）、阳性研究（P = 0.03）、较长的治疗持续时间（P < 0.001）和较高的安慰剂脱落率（P < 0.001）与无痛报告率较高相关。在中东地区开展的研究（P = 0.002）、未报告随机化方案的研究（P = 0.02）以及女性比例较高的研究（P = 0.04）中，面部疼痛量表的反应更大。
约41%的腹痛相关功能性胃肠疾病儿童服用安慰剂后病情改善。多项试验特征与服用安慰剂后无痛患者比例以及面部疼痛量表上的安慰剂反应程度显著相关。这些数据对未来研究的设计可能具有重要价值。
