Khoshnevisasl Parisa, Sadeghzadeh Mansour, Kamali Koorosh, Hasanlo Masoumeh
Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.
Department of Pediatrics, Zanjan University of Medical Sciences, Zanjan, Iran.
J Res Med Sci. 2022 May 30;27:42. doi: 10.4103/jrms.jrms_128_21. eCollection 2022.
This study aims to evaluate the effect of symbiotic (Pedilact) on the treatment of infantile colic.
In this randomized clinical trial in Zanjan, Iran, 76 infants with infantile colic were assigned to two groups of 38 cases using block randomization. The intervention group received 5 drops of Pedilact, a symbiotic containing and simethicone (20 mg twice daily), and the control group received placebo in addition to simethicone for 4 weeks. Daily crying time, number of crying attacks per day, and sleep duration were recorded on days 1, 7, 14, 21, and 28, and the results were compared.
Thirty-three infants in the intervention group and 35 infants in the control group were enrolled. There was no significant difference between the two groups in terms of age, gender, gestational age, maternal age, type of delivery, type of feeding, and weight at the beginning and the end of the study (all > 0.05). Daily crying time in the control and intervention groups decreased from 240 and 210 min/day, respectively, to 0 min/day in both the groups. Daily crying attacks decreased from 5 and 4/day in the control and intervention groups, respectively, to 0/day. Sleep duration in both the groups increased from 720 to 840 and 930 min/day in the control and intervention groups, respectively, but the changes were not significant ( = 0.56, = 0.52, and = 0.13, respectively).
We did not find a significant improvement in colic symptoms in infants receiving symbiotic compared to placebo.
本研究旨在评估共生菌剂（培迪拉克）对婴儿腹绞痛的治疗效果。
在伊朗赞詹进行的这项随机临床试验中，76例婴儿腹绞痛患儿采用区组随机化方法被分为两组，每组38例。干预组接受5滴培迪拉克（一种含有 和西甲硅油的共生菌剂，西甲硅油20毫克，每日两次），对照组除西甲硅油外还接受安慰剂治疗，为期4周。在第1、7、14、21和28天记录每日哭闹时间、每日哭闹发作次数和睡眠时间，并对结果进行比较。
干预组纳入33例婴儿，对照组纳入35例婴儿。两组在年龄、性别、胎龄、母亲年龄、分娩方式、喂养方式以及研究开始和结束时的体重方面均无显著差异（均P>0.05）。对照组和干预组的每日哭闹时间分别从240分钟/天和210分钟/天降至两组均为0分钟/天。每日哭闹发作次数分别从对照组的5次/天和干预组的4次/天降至0次/天。两组的睡眠时间分别从对照组的720分钟/天增加到840分钟/天，干预组从720分钟/天增加到930分钟/天，但变化不显著（P分别为0.56、0.52和0.13）。
与安慰剂相比，我们未发现接受共生菌剂的婴儿腹绞痛症状有显著改善。
