Intro

All content of this blog is my own opinion only. It does not represent the views of any organisation or association I may work for, or be associated with. Nothing within this blog should be considered as medical advice and you should always consult your Doctor.

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."


"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

19 comments:

  1. This is a really enlightening article. Can you possibly share what the probiotic product was? I'd be grateful to know of one suitable for babies they seem hard to come across yet they are so helpful for children and adults that it would be good to take a look at the option for babies? Many thanks

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  2. Hi Nicola, if you check the article the studies mentioned are text links, it's L Reuteri
    AA

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  3. I agree, very enlightening! I would also be interested to know more about probiotics.....more reading for me tonight!

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  4. My son would've been considered "colicky". He had screaming fits, usually at night. It wasn't "colic" - he was born with gallstones.

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  5. I read something a long time ago that Infacol was LESS effective than skin-to-skin contact for 'colicky' babies. Damn, wish I could remember when/where I read it...... Meh.

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  6. I think it depends on the cause of the colic. My son had a dreadful latch due to tongue tie. This wasn't corrected until he was 3 months old, so from 4 weeks old he had colic bouts lasting 2-3 hours due to all the air he swallowed and had been unable to burp up. I wore him about 80% of my awake time, breastfed on demand and he had loads of skin-to-skin, but still the awful colic. It was very distressing. I started Infacol and he started burping and farting like a trooper. No more colic attacks on days when I used infacol after each feed. He would have a bout without fail on days that I forgot it or treated after some feeds only. So anecdotally, it worked for us, but I think that was because we had a very mechanical reason for his colic. If the cause is more chemical, I.e digestive, then I agree that pre/probiotics, or changes in maternal diet if BFing make more sense. I think simethicone has its place, but should be used in certain cases, not willy-nilly.

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  7. I would also like to know about the prebiotic products so that as a midwife I can recommend the best for the babies in my care. Great article.

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  8. Ive been using solgar childrens probiotic powder & its worked wonders id really reccomend it. Quite expensive but well worth it for the comfort of my baby.also dairy free diet for me & him as still bfeed & thats helped to.

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  9. Hello- thank You for these articles. Helpful to question these things. I'm also very interested in what pre-/probiotics you used. Many thanks.

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  10. Hi Nicola, if you check the article the studies mentioned are text links, it's L Reuteri
    AA

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  11. Have you seen the Breastfeeding Network Document entitled "Assessing the Evidence: Treatments for colic". http://www.breastfeedingnetwork.org.uk/pdfs/Colic.pdf
    Very interesting.

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  12. Two questions-
    1. Isn't breastmilk a probiotic? Is there such thing as overkill on probiotics?
    2. I gave my son infacol for gas and then later learned about the virgin gut, etc. Does infacol interfere with this?

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    1. " 1. Isn't breastmilk a probiotic? Is there such thing as overkill on probiotics?"

      It is, but levels may also depend on mum's levels. Furthermore things like antibiotics, sections etc also impact on colonisation.

      Does infacol interfere with gut flora? Given it's antifungal characteristics, sugar content etc I wouldn't be surprised but as I say in the piece I doubt anyone has/will explore this.

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  13. Infacol impacted negatively on early breastfeeding for us: it made baby's mouth/tongue much more slippery & that made it difficult to achieve a good, long-lasting latch. DD was constantly slipping off at the beginning of a feed, until there was less Infacol in her mouth.

    I've seen this mentioned a lot anecdotally in chat forums etc as well, so other parents have experience this effect too!

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  14. Just a few thoughts I've had: In the ideal research study, it would be useful to compare the treatments, both probiotic and Infacol, with placebo and maybe a fourth group receiving nothing except breastfeeding as even the placebo could interfere with the virgin gut. However, this would lead to removal of 'blindness' for the research study, a category which is so useful in determining how true the results are. Because of this I would be sceptical of probiotics on the basis of these research studies as well as Infacol from the research mentioned above.

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  15. Thank you for this. My 3rd baby (currently 2 weeks old) gets attacks of colic every evening and i decided to read up on if infacol would be a help to her. After reading this, i have definately decided it's a no, i will not be giving it to her. Also, i am shocked and apalled it contains artificial sweeteners. These are so dangerous! My middle daughter (aged 2) has a very bad reaction to them, so her baby sister will be going nowhere near them! Thanks again!

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  16. http://www.nhs.uk/news/2014/04April/Pages/Probiotics-no-good-at-treating-infant-colic.aspx I was just googling probiotics for babies and found this article.

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  17. Thank you in terms of summary of the evidence. This is the first website i found not just shouting out unsupported statements.

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