Colic Aid EZ (Simethicone) for Infantile Colic
Simethicone is not recommended for the treatment of infantile colic, as it has been proven no more effective than placebo in multiple high-quality studies. 1, 2
Evidence Against Simethicone
A randomized, double-blind, placebo-controlled multicenter trial of 83 infants found that simethicone showed no statistically significant difference from placebo in improving colic symptoms, with 28% responding only to simethicone, 37% only to placebo, and 20% responding to both 1
A Cochrane systematic review of pain-relieving agents for infantile colic concluded there is no evidence to support the use of simethicone as a treatment, finding no difference in daily crying hours or number of responders compared to placebo 2
Even when infants with "gas-related symptoms" were analyzed as a separate subgroup, simethicone showed no benefit over placebo 1
A 2019 study comparing simethicone to a homeopathic complex found simethicone significantly less effective in reducing colic symptoms 3
What Actually Works: Evidence-Based Alternatives
For Breastfed Infants
First-line approach: Maternal dietary elimination 4, 5
- Implement a strict 2-4 week maternal elimination diet removing all dairy products and eggs, as cow's milk protein expressed in breast milk commonly triggers or exacerbates colic 4, 5
- Monitor infant response closely during this trial period for reduction in crying duration and frequency 5
Second-line approach: Probiotic supplementation 4, 5
- Lactobacillus reuteri (strain DSM 17938) reduces crying time by approximately 65 minutes per day at 21 days in exclusively breastfed infants 4, 5
- Evidence is strongest for breastfed infants; effectiveness in formula-fed infants remains uncertain 4
For Formula-Fed Infants
- Switch to extensively hydrolyzed protein or amino acid-based formula if cow's milk protein intolerance is suspected 4, 6
- Avoid empiric formula switching without evidence of milk protein allergy 6, 5
Supportive Measures (Implement Concurrently)
- Reduce feeding volume while increasing feeding frequency to minimize gastric distension 6, 5
- Use proper burping techniques after each feeding with patting or gentle tapping rather than rubbing 6, 5
- Keep the infant completely upright when awake and for 10-20 minutes after feeding 6, 5
- Avoid seated positions (car seats, infant carriers) after feeding, as these exacerbate reflux 6, 5
Behavioral Management
- Use gentle motion and rhythmic movement to calm the overstimulated infant 4
- Provide white noise for consistent auditory input without overstimulation 4
- Avoid excessive tactile, visual, auditory, and kinesthetic stimuli 4
Critical Safety Considerations
This is the peak age for abusive head trauma risk 4
- Crying is the most common trigger for abusive head trauma, with incidence paralleling the normal developmental crying curve that peaks at 2-4 months 4
- Almost 6% of parents of 6-month-old infants admit to smothering, slapping, or shaking their infant at least once because of crying 4
- Explicitly counsel parents that it's safe to put the baby down in a safe place and take a break if overwhelmed 4
Red Flags Requiring Immediate Evaluation
Evaluate immediately for the following concerning features 4, 6:
- Bilious vomiting
- Gastrointestinal bleeding
- Consistently forceful vomiting
- Fever
- Lethargy
- Hepatosplenomegaly
- Abdominal tenderness or distension
Monitoring and Follow-Up
- Monitor weight gain closely to ensure the infant is thriving despite colic symptoms 6, 5
- Reassess at 2 weeks—if no improvement occurs with dietary interventions, consider other diagnoses or refer to pediatric gastroenterology 6, 5
Common Pitfalls to Avoid
- Do not use proton pump inhibitors—they are ineffective and carry risks including pneumonia and gastroenteritis 4
- Avoid overdiagnosis and overtreatment with medications before trying conservative measures 6
- Do not use dicyclomine—it is contraindicated due to serious adverse effects including prolonged sleep, drowsiness, and wide-eyed states 7, 2