The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study
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Published on: September 20, 2019
Irina Alexandrovich1, Olga Rakovitskaya, Elena Kolmo
1Department of Pediatrics, St. Petersburg Medical Academy of Postdoctoral Education, St. Petersburg, Kirochnaya, Russia.
Insights
Fennel seed oil emulsion effectively reduced infantile colic symptoms compared to placebo. This natural treatment offers a safe alternative for managing colic in infants, with significant improvements observed in crying duration.
Area of Science:
- Pediatrics
- Gastroenterology
- Pharmacology
Background:
- Infantile colic causes significant parental distress despite its benign course.
- Dicyclomine hydrochloride is effective but carries risks of serious side effects.
- Fennel seed oil shows potential for reducing intestinal spasms, but clinical data were lacking.
Purpose of the Study:
- To evaluate the efficacy of fennel seed oil emulsion in treating infantile colic.
Main Methods:
- A randomized, placebo-controlled trial was conducted in two multi-specialty clinics.
- 125 infants aged 2-12 weeks meeting colic criteria received either fennel seed oil emulsion or placebo.
- Colic symptom relief was measured by a decrease in cumulative crying to under 9 hours per week.
Main Results:
- Fennel oil emulsion resolved colic in 65% of infants, significantly higher than the 23.7% in the placebo group (P < 0.01).
- The treatment showed a significant improvement with an Absolute Risk Reduction of 41% and Number Needed to Treat of 2.
- No side effects were reported in either the treatment or placebo groups.
Conclusions:
- Fennel seed oil emulsion is a superior treatment to placebo for reducing the intensity of infantile colic.
- This natural remedy presents a safe and effective option for infantile colic management.
Context:
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.
Objectives:
To determine the effectiveness of fennel seed oil emulsion in infantile colic.
Design:
Randomized placebo-controlled trial.
Settings:
Two large multi-specialty clinics.
Subjects:
125 infants, 2 to 12 weeks of age, who met definition of colic.
Intervention:
Fennel seed oil emulsion compared with placebo.
Outcome Measure:
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.
Conclusion:
Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.
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