Metcalf T J, Irons T G, Sher L D, Young P C
Willow Creek Pediatrics, Salt Lake City, UT.
Pediatrics. 1994 Jul;94(1):29-34.
To determine the efficacy of simethicone in the treatment of infant colic.
Randomized, double blind, placebo-controlled.
Three general pediatric practices in distinct geographic regions.
Eighty-three infants between 2 and 8 weeks of age with infant colic.
Treatment with simethicone and placebo in double blind crossover fashion.
A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.
Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.
确定西甲硅油治疗婴儿腹绞痛的疗效。
随机、双盲、安慰剂对照试验。
不同地理区域的三家普通儿科诊所。
83名年龄在2至8周的患有婴儿腹绞痛的婴儿。
采用双盲交叉方式使用西甲硅油和安慰剂进行治疗。
对83名婴儿共166个疗程（3至10天）进行了评估。与基线相比，54%的疗程报告症状改善，22%报告症状恶化，24%无变化。无论婴儿接受的是安慰剂还是西甲硅油，被评为症状改善、恶化或无变化的疗程可能性相同。28%的婴儿仅对西甲硅油有反应，37%仅对安慰剂有反应，20%对两者均有反应。这三组有反应的婴儿之间未发现统计学上的显著差异。即使将有“与气体相关症状”（根据家长报告）的婴儿作为一组单独分析，也未显示出差异。
尽管两者都能使症状得到改善，但西甲硅油在治疗婴儿腹绞痛方面并不比安慰剂更有效。
