Alexandrovich Irina, Rakovitskaya Olga, Kolmo Elena, Sidorova Tatyana, Shushunov Sergei
Department of Pediatrics, St. Petersburg Medical Academy of Postdoctoral Education, St. Petersburg, Kirochnaya, Russia.
Altern Ther Health Med. 2003 Jul-Aug;9(4):58-61.
Despite its benign, natural course, colic is a significant problem in infants and imparts a psychological, emotional, and physical burden to parents. Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective. Unfortunately, 5% of infants treated with dicyclomine hydrochloride develop serious side effects, including death. Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine. However, there have not been any clinical studies of its effectiveness.
To determine the effectiveness of fennel seed oil emulsion in infantile colic.
Randomized placebo-controlled trial.
Two large multi-specialty clinics.
125 infants, 2 to 12 weeks of age, who met definition of colic.
Fennel seed oil emulsion compared with placebo.
Relief of colic symptoms, which was defined as decrease of cumulative crying to less than 9 hours per week.
The use of fennel oil emulsion eliminated colic, according to the Wessel criteria, in 65% (40/62) of infants in the treatment group, which was significantly better than 23.7% (14/59) of infants in the control group (P < 0.01). There was a significant improvement of colic in the treatment group compared with the control group [Absolute Risk Reduction (ARR) = 41% (95% CI 25 to 57), Number Needed to Treat (NNT) = 2 (95% CI 2 to 4)]. Side effects were not reported for infants in either group during the trial.
Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.
尽管婴儿腹绞痛病程自然且一般为良性，但仍是婴幼儿的一个重大问题，给家长带来心理、情感和身体负担。盐酸双环胺是唯一一直有效的婴儿腹绞痛药物治疗方法。不幸的是，接受盐酸双环胺治疗的婴儿中有5%会出现严重副作用，包括死亡。茴芹籽油已被证明可减少肠道痉挛并增加小肠蠕动。然而，尚未有关于其有效性的临床研究。
确定茴芹籽油乳剂治疗婴儿腹绞痛的有效性。
随机安慰剂对照试验。
两家大型多专科诊所。
125名年龄在2至12周、符合腹绞痛定义的婴儿。
将茴芹籽油乳剂与安慰剂进行比较。
腹绞痛症状缓解，定义为累计哭闹时间减少至每周少于9小时。
根据韦塞尔标准，治疗组65%（40/62）的婴儿使用茴芹籽油乳剂后腹绞痛消失，显著优于对照组的23.7%（14/59）（P<0.01）。与对照组相比，治疗组的腹绞痛有显著改善[绝对风险降低率（ARR）=41%（95%CI 25至57），需治疗人数（NNT）=2（95%CI 2至4）]。试验期间两组婴儿均未报告有副作用。
我们的研究表明，茴芹籽油乳剂在减轻婴儿腹绞痛强度方面优于安慰剂。
