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Infant colic is common in newborns, and it is associated with increased crying and family distress, increased risk of post-partum depression and early cessation of breastfeeding. Despite the high prevalence of this condition, there is not a definitive therapy to treat infant colic. Simethicone based products are commonly used, although evidence concerning their efficacy is limited and mixed.
In our study, we performed a multicenter, retrospective evaluation of medical records of 63 patients aged between 2 and 6 weeks who underwent a 14-days treatment with an oral formulation (Rilefast ACE drops, PJ Pharma) containing simethicone and silica dioxide. Neonatal Infant Pain Scale (NIPS) after lactation was assessed at baseline and after treatment.
NIPS after lactation significantly reduced after the 14-days treatment period (5.03 ±¬ 1.36 vs. 1.22 ±¬ 1.45, p<0.001). A positive correlation was found between NIPS difference and pre-treatment NIPS (beta=0.88, p=0.001), weight at birth (beta=2.39, p=0.009), and weight at baseline (beta=1.58, p=0.026), and a negative correlation between formula feeding and NIPS improvement (beta=- 2.04, p=0.015) was observed.
The results of the present study showed a significant improvement in the symptoms of infant colic in a cohort of infants treated with a combination of simethicone and silicon dioxide in an oil emulsion. An independent factor associated with the decrease in the NIPS value after treatment was the NIPS value baseline, showing an effective reduction in symptoms even in infants with greater distress. In contrast, feeding artificial feeding was negatively associated with symptom improvement.