Herbs and plantsInfant colic — is fennel tea really safe?
- Henryk Różański — Owoc kopru – Fructus Foeniculi i olejek koperkowy – Oleum Foeniculi w medycynie
- Europejska Agencja Leków (EMA) — Owoc kopru włoskiego (odmiana słodka) — streszczenie EMA dla pacjentów
- Infant Colic-What works: A Systematic Review of Interventions for Breast-fed Infants. · J Pediatr Gastroenterol Nutr 2016
- The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. · Altern Ther Health Med 2003
- A randomized double-blind placebo-controlled trial of a standardized extract of Matricariae recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants. · Phytother Res 2005
- Nutritional supplements and other complementary medicines for infantile colic: a systematic review. · Pediatrics 2011
- An overview of systematic reviews of complementary and alternative therapies for infantile colic. · Syst Rev 2019
Henryk Różański quotes Rudolf Franck’s recommendation: 0.2–2 g of fennel fruit several times a day, or an infusion made from 5–15 g of crushed fruit in 100 ml of boiling water.
- Różański says that in the 19th century fennel was used, among other things, to prevent colic and relieve bloating.
- The European Medicines Agency does not recommend medicines made from sweet fennel fruit for children under 4 because there is not enough information about their safe use in this age group.
- The EMA recommendation applies to medicines made from sweet fennel fruit.
What the authors write
Henryk Różański quotes Rudolf Franck’s recommendation, which advised using fennel fruit for bloating, even in young children.
The historical recommendation quoted gives a dose of 0.2–2 g of fruit several times a day, or an infusion made from 5–15 g of crushed fruit in 100 ml of boiling water.
Henryk Różański says that in the 19th century fennel fruit was used, among other things, to prevent colic and relieve bloating.
The EMA does not recommend medicines made from sweet fennel fruit for children under 4 because there is not enough information about their safe use in this age group.
The EMA says that medicines made from sweet fennel fruit are usually taken three or four times a day, for no longer than 1–2 weeks.
The EMA lists allergic reactions affecting the skin or respiratory system and advises people who are allergic to sweet fennel not to use these medicines.
Research from PubMed · Europe PMC
We selected 5 studies with the best, positive results. This is a selection, not a full review of all research.
Total number of studies on this topic in PubMed: 15.
A review suggests that preparations containing fennel oil may shorten crying time in infants with colic, although the authors point out that the evidence has limitations.
Aim of the study: To determine the strength of evidence for commonly used interventions for colic in breast-fed and mixed-fed infants younger than 6 months.
Results: A total of 17 articles met the inclusion criteria for this review. The 6 studies included in the subgroup meta-analysis of probiotic treatment, particularly Lactobacillus reuteri, showed that probiotics appear to be an effective treatment, with an overall mean difference in crying time on day 21 of -55.8 min/day (95% CI -64.4 to -47.3, P = 0.001). The 3 studies included in the subgroup meta-analysis of preparations containing fennel suggest that they are effective, with an overall mean difference of -72.1 min/day (95% CI -126.4 to -17.7, P < 0.001). Probiotics, particularly L. reuteri, and preparations containing fennel oil appear effective in reducing colic, although these findings have limitations. Evidence for maternal dietary changes, lactase, sucrose, glucose and simethicone is weak. Further well-designed clinical trials are needed to strengthen the evidence for all these interventions.
“Not stated” does not mean nobody paid — the database does not always record it.
In the study, an emulsion of fennel seed oil resolved colic in a greater proportion of infants than placebo.
Aim of the study: Despite its benign, natural course, colic is a significant problem in infants and places a psychological, emotional and physical burden on parents. Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has consistently been effective. Unfortunately, 5% of infants treated with dicyclomine hydrochloride develop serious side effects, including death.
Results: Fennel oil emulsion eliminated colic, according to the Wessel criteria, in 65% (40/62) of infants in the treatment group, significantly more than the 23.7% (14/59) in the control group (P < 0.01). Colic improved significantly more in the treatment group than in the control group [Absolute Risk Reduction (ARR) = 41% (95% CI 25 to 57), Number Needed to Treat (NNT) = 2 (95% CI 2 to 4)]. No side effects were reported in either group during the trial. Our study suggests that fennel seed oil emulsion is superior to placebo in reducing the intensity of infantile colic.
“Not stated” does not mean nobody paid — the database does not always record it.
A preparation containing fennel, chamomile and lemon balm was associated with a greater reduction in crying time in infants than placebo.
Aim of the study: The aim of this randomized, double-blind, placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent containing Matricariae recutita, Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic.
Results: A total of 88 infants completed the trial: 41 in the PA group and 47 in the control group. The average daily crying time in the PA group was 201.2 min/day (SD 18.3) at baseline and 76.9 min/day (SD 23.5) at the end of the study; in the placebo group, it was 198.7 min/day (SD 16.9) and 169.9 min/day (SD 23.1) (p < 0.005). Crying time decreased in 85.4% of subjects in the PA group and 48.9% of subjects in the placebo group (p < 0.005). No side effects were reported. This study shows that colic in breastfed infants improves within 1 week of treatment with an extract based on Matricariae recutita, Foeniculum vulgare and Melissa officinalis.
“Not stated” does not mean nobody paid — the database does not always record it.
The review reports encouraging results from studies of fennel extract and herbal mixtures, but highlights their limitations.
Aim of the study: Complementary and alternative medicines are often recommended for infantile colic, yet the evidence has not been synthesized to guide current practice on their use. To critically evaluate all randomized clinical trials of nutritional supplements and other complementary and alternative medicines as treatments for infantile colic.
Results: Fifteen randomized clinical trials met the inclusion criteria and were included. Thirteen studies were placebo-controlled. Eight were of good methodological quality. Eleven trials reported a significant result in favor of complementary and alternative medicines. However, none of these randomized clinical trials was without flaws. Most approaches lacked independent replication. Some encouraging results were found for fennel extract, mixed herbal tea and sugar solutions, although it must be stressed that all the trials had major limitations. Therefore, the evidence from the included randomized clinical trials does not currently support the claim that any form of complementary and alternative medicine is effective for infantile colic. Further replications are needed before firm conclusions can be drawn.
“Not stated” does not mean nobody paid — the database does not always record it.
The review suggests that fennel extract may relieve colic symptoms, although some concerns about the evidence remain.
Aim of the study: Infantile colic is a distressing condition characterized by excessive crying during the first few months of life. This research aimed to update the synthesis of evidence from the literature on complementary and alternative medicine (CAM) for infantile colic and establish what evidence is currently available.
Results: Sixteen systematic reviews were identified. Probiotics, fennel extract and spinal manipulation show promise in relieving colic symptoms, although some concerns remain. Acupuncture and soy are not currently recommended. Most of the reviews were assessed as having a high or unclear risk of bias and low confidence in their findings. There is a clear need for larger and methodologically stronger RCTs on the effectiveness of some CAM therapies for infantile colic. Particular attention to probiotics in non-breastfed infants is warranted.
“Not stated” does not mean nobody paid — the database does not always record it.
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