PP‐12 EFFICACY OF A STANDARDIZED EXTRACT OF MATRICARIAE CHAMOMILLA L., MELISSA OFFICINALIS L. AND TYNDALLIZED LACTOBACILLUS ACIDOPHILUS (H122) COMPARED WITH LACTOBACILLUS REUTERI (DSM 17938) AND WITH SIMETHICONE FOR THE TREATMENT OF INFANTILE COLIC

Abstract

Background and Aim:Infant colic is a prevalent physiological event of healthy children under 3 months of age, which can disrupt the child's home environment. Despite its benign natural history, sometimes it requires a therapeutic approach. There is limited evidence supporting the use of complementary and alternative treatments. The aim of this study was to investigate the effectiveness of a mixture of standardized extract of matricariae Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122) compared with Lactobacillus Reuteri (DSM 17938) and with simethicone for the treatment of infantile colic.Patients and Methods:A multicenter prospective, randomized comparative study was conducted involving 133 infants with colic, according to Rome III criteria, who were assigned at random to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) (Group A; n = 45), L reuteri DSM 17938 (108 CFU) (Group B; n = 45) or simethicone (Group C; n = 43). Treatment was given to subjects for 21 days and they were followed for 4 weeks. Treatment success was assessed at the end of study period. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.Results: Treatment success was observed in 30 out of 45 patients (66.7%) of infants in Group A, while it was seen in 31 out of 45 patients (68.9%) of Group B and in 19 out of 43 (44.2%) of subjects of Group C (χ2: 6.8; p = 0.03). Mean daily crying time was more significantly reduced (from 211.3 ± 40 min/day to 69.6 ± 59 min/day) in the Group A and in Group B (from 201.6 ± 32.5 min/day to 58.1 ± 48.9 min/day) when compared with Group C (from 199.5 ± 32 min/day to 106 ± 56.5 min/day) (p < 0.01, p = 0.006 respectively). No significant difference was observed comparing Group A and B (p = 0.4). No adverse events were reported in any group.Conclusions:This study suggests that administration of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) and L reuteri DSM 17938 are significantly more effective than simethicone in improving colic symptoms. Therefore, the use of herbal supplements may represent a new therapeutic strategy in the management of colicky infants.