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.
RCT Entities:
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.
Authors: Paulo D Picon; Rafael V Picon; Andry F Costa; Guilherme B Sander; Karine M Amaral; Ana L Aboy; Amélia T Henriques Journal: BMC Complement Altern Med Date: 2010-04-30 Impact factor: 3.659
Authors: Clara Lia Costa Brandelli; Raquel Brandt Giordani; Geraldo Attilio De Carli; Tiana Tasca Journal: Parasitol Res Date: 2009-01-20 Impact factor: 2.289