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.
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.


CONCLUSIONS
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.
Savino
Francesco
F
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. Francesco.savino@unito.it
Cresi
Francesco
F
Castagno
Emanuele
E
Silvestro
Leandra
L
Oggero
Roberto
R
D000284:Administration, Oral; D001942:Breast Feeding; D003085:Colic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D030001:Foeniculum; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D031334:Melissa; D010147:Pain Measurement; D010276:Parasympatholytics / Q000008:administration & dosage / Q000627:therapeutic use*; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D010946:Plants, Medicinal; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D010276:Parasympatholytics; D010936:Plant Extracts