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

Authors

  • Francesco Savino,

    Corresponding author
    1. Dipartimento di Scienze Pediatriche e dell'Adolescenza-Università di Torino, Ospedale Infantile Regina Margherita, Azienda Ospedaliera OIRM S. ANNA, Piazza Polonia, 94, 10126 Torino, Italy
    • Dipartimento di Scienze Pediatriche e dell'Adolescenza, Università di Torino, Ospedale Infantile Regina Margherita, Piazza Polonia, 94, 10126 Torino, Italy.
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  • Francesco Cresi,

    1. Dipartimento di Scienze Pediatriche e dell'Adolescenza-Università di Torino, Ospedale Infantile Regina Margherita, Azienda Ospedaliera OIRM S. ANNA, Piazza Polonia, 94, 10126 Torino, Italy
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  • Emanuele Castagno,

    1. Dipartimento di Scienze Pediatriche e dell'Adolescenza-Università di Torino, Ospedale Infantile Regina Margherita, Azienda Ospedaliera OIRM S. ANNA, Piazza Polonia, 94, 10126 Torino, Italy
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  • Leandra Silvestro,

    1. Dipartimento di Scienze Pediatriche e dell'Adolescenza-Università di Torino, Ospedale Infantile Regina Margherita, Azienda Ospedaliera OIRM S. ANNA, Piazza Polonia, 94, 10126 Torino, Italy
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  • Roberto Oggero

    1. Dipartimento di Scienze Pediatriche e dell'Adolescenza-Università di Torino, Ospedale Infantile Regina Margherita, Azienda Ospedaliera OIRM S. ANNA, Piazza Polonia, 94, 10126 Torino, Italy
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Abstract

Objective: The aim of this randomized, double-blind, placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita, Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic.

Methods: 93 breastfed colicky infants were enrolled, the diagnosis was made according to Wessel's criteria. After a 3 day observation period, the infants were randomly divided into two groups, one treated with phytotherapeutic agent (PA) and the other with placebo twice a day for 1 week. Crying time and side effects were recorded. Results: 88 infants completed the trial: 41 in the PA group and 47 in the control. The daily average crying time for the PA was 201.2 min/day (SD 18.3) at the baseline and 76.9 min/day (SD 23.5) at the end of the study; for the placebo it was 198.7 min/day (SD 16.9) and 169.9 min/day (SD 23.1) (p < 0.005). Crying time reduction was observed in 85.4% subjects for the PA and in 48.9% subjects for the placebo (p < 0.005). No side effects were reported.

Conclusion: The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita, Foeniculum vulgare and Melissa officinalis. Copyright © 2005 John Wiley & Sons, Ltd.

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