Before You Try Infacol, Try This Blog...

According to their webpage Infacol is:

"Clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic."

Music to the ears of any new parent with a distressed bundle right?  It seems so as their site claims they are "Britain's number 1 infant colic remedy"!

I'm guessing that's pretty profitable, heck they even provide a phone app to help you identify if your baby has "colic". 

Now perhaps I'm naive, but as colic is only defined as frequent persistent periods of unexplained crying (often in the evening), I'm pretty sure that parents know whether this is happening without an app to tell them?

It seems others agree as two reviewers wrote:

"Easy to use, navigate and understand but felt too engineered to get you to the end and say 'Use Infacol!'"

and

"It basically tells you what you already know and then says buy infacol."

Shock horror.

For those who aren't familiar the active ingredient in Infacol is Simethicone; and it's not just colic Infacol claims to work for:

"Unfortunately, wind can sometimes get trapped which can cause your baby discomfort. Infacol can gently help to bring up wind as its active ingredient- simeticone- helps the little trapped gas bubbles join into bigger bubbles which your baby can easily bring up as wind. - helping to relieve the pain.  Infacol can be used from birth onwards, unlike gripe waters, which can only be given to babies 1 month old and over"

 Wow wind and colic right, and suitable from birth.

Perhaps this is why so many doctors, midwives and health visitors prescribe or recommend parents try it?  And given how many do, it must be pretty solid "clinically proven" evidence right?

Er no.

A BMJ paper published in 2007 reviewing treatment of colic examined the evidence :

"One poor-quality randomised controlled trial (RCT) found limited evidence that simethicone reduced the number of crying attacks on days 4–7 of treatment compared with placebo."

By poor quality the BMJ clarify that there were only 26 infants aged 1-12 weeks in the study and no reported details on how cases of colic were defined.

Oh that's disappointing.  But surely GP's and all these other health professionals aren't suggesting or prescribing infacol on the basis of a "poor quality" small study of 26 babies?  A study that doesn't define nor claim to ease colic, but refers to "crying attacks" which could potentially have any cause or be of any frequency?

The BMJ discuss two other trials that do define colic, perhaps these are more compelling.

First is a double-blind, crossover of 83 infants aged 2–8 weeks, comparing 0.3 mL of simethicone versus placebo for a week before feeds.

"It found no significant difference in colic (using the standard colic definition), when rated by carers, between simethicone and placebo (28% improved with simethicone v 37% with placebo v 20% with simethicone plus placebo.)"

So a study three times the size of the first, found Infacol was actually 9% LESS effective than a placebo at helping colic?

Let's try again.

The second study (double-blind, crossover trial, 27 infants aged 2–8 weeks) found no significant difference between simethicone and placebo (10 drops before meals, duration of treatment 24 hours) in improvement as rated by parental interview, 24-hour diary, or behavioural observation.

In fact the BMJ conclude:

"Further trials are not considered to be of clinical importance and are unlikely to be undertaken. According to the available evidence, there is no reason to use simethicone in the treatment of infantile colic."

Yet the NHS website states:

"This medicine helps relieve griping pains and colic in babies and infants which may be caused by swallowing air."

Does it NHS?  Says who?  Infacol themselves with their "clinically proven" claims?  The BMJ disagrees!

What about reasons not to?

Let's look at the other ingredients in Infacol besides Simethicone.

• Purified Water
• Hypromellose
• Orange Flavour
• Saccharin Sodium
• Methyl Hydroxybenzoate (E218)
• Propyl Hydroxybenzoate (E216)

Obviously these ingredients have been approved for use in this product, but when weighing up whether to use or take a medicine, we typically consider the benefits that can be obtained, versus any risks or downsides.

The literature surrounding infacol states that Simethicone is not absorbed into the body and thus is unlikely to cause harm (although some parents do report perceived side effects and some more here), but some do warn that Methyl and propyl hydroxybenzoates (E218, E216) may cause allergic reactions (possibly delayed)

Furthermore E216 and E218 are parabens considered controversial by some and even taking this out of the equation,  has anyone considered the potential the impact to the baby's gut flora of putting a product containing fungicide, combined with artificial sweetener and a dollop of orange flavour in his digestive system several times per day for weeks at a time?

All for something that evidence suggests doesn't work?

What's also interesting is that there is a mounting body of evidence that probiotics may be an effective tool in reducing infant crying, including a trial that directly compared them to Simethicone:

"Eighty-three infants completed the trial: 41 in the probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline.
On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group.

And it's not an isolated study, a second study highlights effectiveness of probiotics for colic here and a third here.

So why then aren't GP's, health visitors and midwives prescribing and recommending them instead of something seemingly no more effective than a placebo?

Like Calpol, it seems to me Infacol has just via clever marketing become recognised as a default turn to product for many parents.  But as the antibiotic popping for every ailment generation age,  more parents are becoming aware of the implications of what we put into our bodies, more cynical about marketing and more holistic (and thus less keen to simply medicate symptoms without looking for a cause).  Perhaps gradually we will see a change.

1.  Effectiveness of treatments for infantile colic: systematic review, BMJ 1998;316:1563