The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study.
BACKGROUND
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.


OBJECTIVE
To determine the effectiveness of fennel seed oil emulsion in infantile colic.


METHODS
Randomized placebo-controlled trial.


METHODS
Two large multi-specialty clinics.


METHODS
125 infants, 2 to 12 weeks of age, who met definition of colic.


METHODS
Fennel seed oil emulsion compared with placebo.


METHODS
Relief of colic symptoms, which was defined as decrease of cumulative crying to less than 9 hours per week.


RESULTS
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.


CONCLUSIONS
Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.
Alexandrovich
Irina
I
Department of Pediatrics, St. Petersburg Medical Academy of Postdoctoral Education, St. Petersburg, Kirochnaya, Russia.
Rakovitskaya
Olga
O
Kolmo
Elena
E
Sidorova
Tatyana
T
Shushunov
Sergei
S
D003085:Colic / Q000188:drug therapy* / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D030001:Foeniculum; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008517:Phytotherapy / Q000379:methods; D010938:Plant Oils / Q000627:therapeutic use*; D010946:Plants, Medicinal; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D010938:Plant Oils