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

Starting Formula Doesn't Have To Mean Stopping Breastfeeding...

We hear lots of different reasons mums choose to introduce formula when breastfeeding; pain, a very unsettled, hungry (or perceived to be) baby, feeling overwhelmed at being the sole person responsible for nourishing their new bundle (who perhaps may be growing slower than health professionals are happy with), returning to work or fear over feeding in public are a few of the common ones.

Society has researched, surveyed and tried to explore these reasons, in the hope barriers to success can be broken down.  But something I don't see examined with such scrutiny, is why mums so often "switch to" formula.

What I mean is why does it have to be a straight swap from 100% of one to 100% of another?   Why does it have to be all or nothing? 

Of course if a mum has damaged/sore nipples wanting to rest them is natural, but if we consider all the other reasons mothers change to exclusive formula feeding, why is it so often assumed once formula is regularly used one might as well switch 100%?

If we think of the breast purely as food, it perhaps seems logical.  If baby is getting adequate nutrition from another source, why continue any feeds at the breast?

But it's not.

Breastfeeding is about so much more!  Hormones, antibodies, bonding and comfort, often a "go to sleep" switch for all involved, to name just a few from a long list.

The problem is how often does a new mum know all this?

Whilst mums often hear oodles of tales about cracked nipples and mastitis, how often does someone who has breastfed successfully for longer than a few months, sit at a baby group regaling others with tales of all the upsides?  Er no, that's the definition of smug, judgy breastfeeding mum is it not?

For women who have never breastfed, have no family or friends that can share their insight into what lays beyond the early days, the sad thing is most don't even know what they're missing.

Of course the norm should be that all mothers get fast, effective help to resolve their problems; that all should be supported to exclusively breastfeed for as long as they wish.  But at the moment this isn't the reality.   For those who haven't managed to resolve problems and are about to switch 100%, don't they deserve to know they have other options?

To be supported to even share one breastfeed per day?  To know they can put the baby to the breast before or after the bottle (a baby causing lots of nipple damage may be more patient in adjustments and suck less strongly when he's not as hungry) at every feed, at some feeds or even for just one if that's all mum feels she can manage.

Once nipples have healed, mum may then choose to increase this if desired.  If we remember babies who  (for whatever reason) are not able to transfer milk as effectively as they need, may consistently feed for very long stretches or very frequently, and that baby is most likely not transferring well because of shallow attachment - the combination of the two can quickly cause cracking or bruising to the nipple.  Once this has healed mum may find combination feeding doesn't permit frequent enough feeding for trauma to reoccur.

I think mums also deserve to know that even if baby's main source of nutrition is formula, that doesn't mean they must also switch to an artificial pacifier; mum can continue to use the inbuilt original aka her breast should she wish to do so.  I've known babies suckle at breasts with barely any milk supply, which surely only confirms that to them, it's definitely not always just about feeling full.

Using some formula doesn't mean mum has to also miss the special little moments; baby pulling from the breast smiling, milk running down his chin.  The instant soothing of a teething pain, learning to sit bump, or 3am fussies with a simple lift of her shirt?

Some mums who feel baby just wasn't getting enough at the breast might choose to supplement feeds during the day and breastfeed only overnight.  If we think calories over a 24 hour period, if low intake was the issue (and increasing supply isn't an option) the extra milk can be given during waking hours, giving the ease and convenience of being able to roll over and feed baby instantly without either party fully waking.

For mums returning to work with younger babies and not wanting to express, you can continue to breastfeed your baby when you're with them.  Yes supply may drop compared to exclusive feeding, but if the alternative is a complete swap, then any feeds are a bonus right?  If baby drains the breast well when you do feed, and this happens with any regularity, supply is unlikely to dwindle altogether.

Even if baby isn't drinking lots of milk when at the breast and supply does reduce, it is likely to happen more gradually; this reduces the chance of mum suffering blockages or mastitis.  As supply reduces the breast begins a process called "involution", and milk gradually reverts to a more colostrum like substance to give the weaning nursling a boost of antibodies.

We could go through lots of scenarios to show how breastfeeding can work in different situations, and it is worth noting there is the potential for a baby finding breastfeeding difficult to become increasingly fussy or refuse the breast once nutritional needs are met elsewhere.  But if the alternative is no breastmilk anyway, some may feel they want to give it a try.

Lastly, and perhaps a key reason to not jump feet first, is that it leaves a window open for a change of heart.  Mums often choose to stop breastfeeding when emotionally at their lowest; tiredness may be overwhelming and she's aching for the situation to stop, never wanting to breastfeed again!  But a few days down the line feelings can change, if partners go back to work the realisation of just how much of a faff formula is (not to mention the ongoing cost) can hit. If not, mix feeding may feel more doable, but if mum does want to stop entirely that option is still there.  At least then the decision has been made rationally and not because things are so unbearable mum feels she has no choice.

I think we have to recognise that whilst there are such gaping holes in the support mothers receive, and a culture still so pro alternatives, any continued breastfeeding should be celebrated as one small step for mothers.  Perhaps instead of focusing on what we can't or don't do, we need to look more closely at what we can.  Celebrating every single feed as one more than might have been; after all every day matters.