Do colic drops work?
Avoid — Not recommended in the UK or Ireland. Where a clinician suggests a trial, agree a fixed review point rather than continuing indefinitely
NICE guidance tells UK clinicians not to recommend simeticone or lactase drops for infant crying. Reviewed trials of simeticone found no difference in crying duration against placebo, in small studies at high risk of bias, and the evidence for lactase drops is inconsistent. The NHS says the same: not recommended, no evidence they help.
The verdict
The evidence says no, and UK guidance says so out loud. NICE Clinical Knowledge Summaries includes simeticone drops and lactase drops in a list of management strategies clinicians are told not to recommend for infant crying.
That is unusual language. Most guidance about unproven products says there is insufficient evidence. NICE goes further here because the trials have been done, and they came back negative.
What the trials found
Simeticone
Simeticone, spelled simethicone in the United States, is an antifoaming agent. The theory is that it merges small gas bubbles in the gut into larger ones that are easier to pass. It is not absorbed, which is why it has a very good safety record: it goes in and comes out.
The theory is plausible and the trials do not support it. NICE reports that a systematic review of two randomised trials found conflicting results and no difference in the reduction of colic episodes compared with placebo. A Cochrane systematic review of three small studies comparing simeticone with placebo found no difference in the reported duration of crying between the treatment and placebo groups, and NICE notes those studies were at high risk of bias. A further systematic review found moderate-to-low quality evidence of no benefit or negative effect.
Three separate reviews, no benefit found in any of them. That is why NICE moved from insufficient evidence to do not recommend.
Lactase drops
Lactase drops add the enzyme that breaks down lactose, on the theory that some colicky babies are struggling to digest it. NICE reports that the recommendation not to use them is based on expert opinion stating there is inconsistent and conflicting evidence of benefit, supported by a systematic review of treatments that also found no evidence of benefit.
There is a deeper problem with the premise. True lactose intolerance is rare in babies. The NHS says so directly in its guidance on formula types. So a treatment for lactose intolerance is being marketed to the parents of a very large number of babies who almost certainly do not have it.
Why they seem to work anyway
Three things happen at once, and they are hard to separate without a placebo group, which is exactly why the placebo-controlled trials matter so much.
First, colic resolves on its own. Crying peaks at around six weeks and declines to an hour or two a day by three to four months. Anything started at the peak is followed by improvement.
Second, giving drops is an intervention with its own soothing content: the baby is picked up, held upright, given a syringe or dropper to suck on, and attended to closely by a calm adult who now has something to do.
Third, parental report is the outcome measure. A parent who has just done something to help is a parent measuring the next hour differently. That is not a criticism; it is human, and it is why blinding exists in trials.
Are they harmful?
Mostly not, and it is worth being fair about that. Simeticone is not absorbed from the gut and has a benign side effect profile. Lactase drops are an enzyme. Neither is dangerous in the way that, say, teething gels or unregulated herbal preparations can be.
The costs are different in kind. There is money, spent repeatedly over weeks. There is the sugar and the excipients in some formulations, given several times a day to a newborn. And there is the opportunity cost, which is the real one: weeks spent working through the remedy shelf are weeks not spent getting an unsettled baby properly assessed, and a proportion of babies labelled colicky have cows' milk protein allergy, reflux with complications, feeding problems, tongue tie or, occasionally, something else entirely.
Where guidance differs
The UK is the strictest: NICE tells clinicians not to recommend these drops, and the NHS says they are not recommended and there is no evidence they help.
Ireland does not address the drops by name but applies the same scepticism to the products marketed alongside them, saying of comfort milks that there is no evidence that they work.
Australia keeps the focus on comfort measures, and says there is no evidence that reflux medicine reduces crying and fussing, with medicine framed as less effective and more harmful than settling.
The United States allows a supervised trial. The AAP says gas drops may be worth a try if discussed with a paediatrician first, and separately that these are not always helpful. That is a concession to reality rather than an endorsement.
If you are in the US and want to try them, the AAP's framing is the sensible one: with a paediatrician, and knowing the trials found no difference against placebo.
What actually helps
The interventions with the best support are the unglamorous ones, and they are the ones every authority lists.
Hold your baby through crying bouts. Use motion: walking, rocking, a pram, a sling. Use sound: white noise, a fan, a vacuum in the next room. Reduce light and stimulation. Wind before, during and after feeds, and keep your baby upright afterwards. Try a dummy. Consider paced bottle feeding if bottles are being taken fast.
Look after yourself, because this is where the actual danger lies. If you are at the end of your rope, put the baby down on their back in a safe place, leave the room, and take a few minutes. A baby must never be shaken.
When to get it assessed
Crying that is accompanied by poor weight gain, feed refusal, forceful vomiting, blood or mucus in the stool, worsening eczema, fever, unusual floppiness or sleepiness, or a baby who seems unwell rather than distressed, is not colic and should be seen.
Crying that starts after four months, or that is getting worse rather than better after the six-week peak, also deserves a look. Colic has a shape, and a baby whose crying does not follow it is telling you something.
NICE Clinical Knowledge Summaries instructs clinicians not to recommend simeticone drops or lactase drops for infant crying. On simeticone, it reports that a systematic review of two randomised trials found conflicting results and no difference in the reduction of colic episodes compared with placebo, that a Cochrane systematic review of three small studies found no difference in the reported duration of crying between treatment and placebo groups and that the studies were at high risk of bias, and that a further review found moderate-to-low quality evidence of no benefit or negative effect. On lactase drops it reports inconsistent and conflicting evidence of benefit, and a systematic review of treatments that found no evidence of benefit. The NHS states that anti-colic drops are not recommended and there is no evidence they help colic.
Showing guidance from NICE CKS and NHS — read the source.
The HSE applies the same scepticism to the products marketed alongside colic drops. Of comfort milks it says the labels often say they are made to help medical conditions such as colic or constipation, but there is no evidence that they work, and that some contain ingredients that can damage a baby's developing teeth and could lead to higher than normal weight gain. It asks parents to talk to their public health nurse or GP before changing a baby's formula rather than working through the speciality shelf.
Showing guidance from HSE Ireland — read the source.
The American Academy of Pediatrics permits a supervised trial without claiming benefit. Its guidance on infant abdominal pain says that probiotics, gripe water or gas drops may be worth a try, but discuss it with your pediatrician first, and elsewhere that you can talk with your baby's pediatrician about trying gas drops and probiotics, but these are not always helpful. Simethicone, the active ingredient in US gas drops, is the same compound the UK calls simeticone.
Showing guidance from AAP — read the source.
Australian guidance emphasises comfort over medicine. The Raising Children Network says that although many babies who have colic also have reflux symptoms, there's no evidence that reflux medicine reduces crying and fussing, and that doctors don't recommend naturopathic or homeopathic mixtures to treat colic because there's no evidence to say they work or are safe for young babies. Its conclusion is that making a baby comfortable and helping them settle is likely to be more effective and less harmful than giving them medicine.
Showing guidance from Raising Children Network — read the source.
Sources
- Infantile colic: Management — NICE Clinical Knowledge Summaries, accessed
- Colic — NHS, accessed
- Abdominal Pain in Infants: 8 Possible Reasons Your Baby's Tummy Hurts — American Academy of Pediatrics, accessed
- Colic — Raising Children Network (Australia), accessed
- Types of infant formula — HSE Ireland, accessed
- Types of formula — NHS, accessed