Simethicone Less Effective Than Placebo for Infant Colic!

Simethicone Less Effective Than Placebo for Infant Colic!

Although scientific studies repeatedly proved simethicone is less effective than placebo the website promoting products containing simeticone claims they are “Britain’s number 1 infant colic remedy” and that it is supposed to be “clinically proven to significantly reduce the frequency and severity of crying attacks associated with colic.”

On the other hand a BMJ paper published in 2007 reviewing treatment of colic stated that, “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.”

After that the BMJ scientific article continues and discloses the results of two other studies stating that the first one, “found no significant difference in colic between simethicone and placebo (28% improved with simethicone v 37% with placebo v 20% with simethicone plus placebo.)” It means that according to this study (which was three times the size of the first), found simethicone was actually almost 10% less effective than a placebo in treating colic!

And since also the second study repeated the same results and found no difference between simethicone and placebo the author of the BMJ article wrote the following shocking conclusion:

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.

However, the NHS website doesn’t seem to accept that as it still maintains on its website that simethicone “helps relieve griping pains and colic in babies and infants which may be caused by swallowing air.”

At the same time NHS is eager to promote a small study which misguide people by suggesting probiotics do not work, although it was repeatedly demonstrated by proper studies that they are effective >

Why NHS does not quote the mentioned above studies that proved simethicone is less effective than placebo and that at the same time probiotics formulas with Lactobacillus reuteri strein are much more effective?

In addition, unlike it is in case of probiotics there are some other ingredients in simethicone containing formulas which are not needed in the body of an infant or a baby and which might be even harmful and may cause allergic reactions (possibly delayed) especially Methyl Hydroxybenzoate (E218) and Propyl Hydroxybenzoate (E216) which are parabens. Other three ingredients are Saccharin Sodium, Hypromellose, and Orange Flavour.

The question therefore is, why on earth NHS still promotes simeticone knowing that it is less effective than placebo and in spite of the fact that there is so much evidence that probiotics are effective in reducing infant colic and crying time. Three studies even compared probiotics to Simethicone and all three again proved the same story. In one of them 83 infants participated in the experiment: 41 were on probiotics and 42 on simethicone. The infants were similar regarding gestational age, birth weight, gender, and crying time. On day 28, thirty nine infants (95%) experienced relief as a result of receiving probiotic bacteria while only 3 (7%) were responders in the simethicone group!

So what is the reason GP’s, health visitors or midwives still prescribe and recommend less effective than placebo simethicone instead of probiotics containing Lactobacillus reuteri which proved they actually work?


–  Lactobacillus reuteri is superior to simethicone in the treatment of infantile colic > 

– Peppermint is at least as effective as the drug simethicone in the treatment of infantile colic >


– Metcalf, T., Irons, T., Sher, L. and Young, P. (1994) ‘Simethicone in the treatment of infant colic: A randomized, placebo-controlled, multicenter trial’, Pediatrics., 94(1), pp. 29–34.

– Savino, F., Pelle, E., Palumeri, E., Oggero, R. and Miniero, R. (2007) ‘Lactobacillus reuteri (American type culture collection strain 55730) versus Simethicone in the treatment of infantile Colic: A prospective Randomized study’, Article, 119(1), pp. 124–130. doi: 10.1542/peds.2006-1222.

– Assendelft, W.J.J., Gubbels, J.W., van Geldrop, W.J. and Neven, K.A. (1998) ‘Effectiveness of treatments for infantile colic: Systematic review’, Paper, 316(7144), pp. 1563–1568. doi: 10.1136/bmj.316.7144.1563.


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