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Understanding and Treating Colic

Parenting an infant can be totally overwhelming. One of the earliest challenge many face is learning to deal with periods of intractable crying. I often speak with sleep deprived parents when they’re looking for something — anything — to stop their baby from crying. They’ve typically been told by friends of family that their baby must have “colic” and they’ve come to the pharmacy, looking for a treatment. Colic is common, affecting up to 40% of babies in the few months of life.

While distressing, colic is a diagnosis of exclusion — that it, it is given only after other causes have been ruled out (hunger, pain, fatigue, etc.). The most common definition for colic is fussing or crying for more than 3 hours per day, more than 3 days per week, for more than 3 weeks. These criteria, first proposed by Morris Wessel in 1954, continue to be used today. However, scientific evidence to explain the cause is lacking. Ideas proposed include:

  • changes in gastrointestinal bacteria/flora
  • food allergies
  • lactose intolerance
  • excess gas in stomach
  • cramping or indigestion
  • intolerance to substances in the breast milk
  • behavioural issues secondary to parenting factors

Despite its intensity, colic resolves on its own with no interventions. By three months of age, colic has resolved in 60% of infants. By four months, it’s 90%. It sounds harmless and short-lived, but colic’s ability to induce stress in parents cannot be overstated. Parents may be angry, frustrated, depressed, exhausted, or just feel guilty, ascribing their baby’s cries to some parenting fault.

Given our lack of understanding of the true cause of colic, there’s no shortage of cures that have been proposed. From drugs, to supplements, to manual therapies, everyone has their preferred intervention. As a pharmacist, I’m usually asked about drug and non-drug treatments. In particular, I’m often asked about gripe water — a cocktail of different ingredients, involving some combination of herbs, sodium bicarbonate, sugar, and alcohol. Invented by pharmacist William Woodward in the 1800′s, gripe water was originally develop to treat the fevers of malaria. Over time, it was felt to be helpful for babies with colic — though no rigorous evaluation has ever been conducted [PDF].

So what does work for colic? My usual advice to parents starts with reassurance. It’s not bad parenting, and it will pass, given enough time. But the lack of a clear cause and simple solution is not satisfying to many that I speak with. A discussion of stress management, dietary changes, or feeding changes (all usually recommended as first-line approaches) leaves few satisfied. Some are determined to leave the pharmacy with something. “What about this?” they’ll say, gesturing to a product on the shelf. “Will this help?” And that’s when it’s time to distill the evidence. Nicely, we have two new complementary (I don’t mean that in the CAM sense) systematic reviews published in 2011 that, together, cover most of the common treatments. The first review, Infantile colic: A systematic review of medical and conventional therapies by Belinda Hall and associates in Victoria, Australia, looked at “conventional” treatments — drugs, behavioural therapy, and dietary changes. The second, Nutritional Supplements and Other complementary medicines for infantile colic: A systematic review, is from Rachel Perry, Katherine Hunt, and Edzard Ernst. It looked at CAM therapies — supplements, nutritional products, and manual therapies. The two reviews overlapped with respect to nutritional products. Both papers are behind paywalls — I’ll summarize the highlights of both reviews.

The Hall paper was published the Journal of Pediatrics and Child Health earlier this year. A systematic review, it sought to examine all randomized interventions, cohort studies, and quasi-experimental studies for colic. Despite the ubiquity of colic, there have been few proper evaluations done. In a 30-year search of the literature, only 19 published trials were identified: five on drug treatments, ten on nutritional interventions, and four on behavioural interventions. All studies of drug products had significant quality limitations, including a lack of blinding and randomization information, unclear statisitical analyses, and in one case, no comparison of baseline demographics.

  • Simethicone is an “anti-foaming” agent believe to help consolidate air bubbles, leading to their expulsion. It’s found in dozens of products. Two trials compared crying duration — neither showed any significant effect. Overall, there’s fairly good evidence to suggest it is ineffective.
  • Dicyclomine is an old drug, now used most frequently (with limited success) to treat irritable bowel syndrome. Again, like simethicone, there are two trials, neither of which suggest there’s any meaningful effects. In addition, it has a nasty side effect profile. On balance, the risk-benefit profile suggests it should be avoided.
  • Cimetropium is backed by a single study noting a significant decrease in individual colic episodes, but reported side effects of increased drowsiness. That’s not surprising, given it’s a derivative of belladona. Cimetropium does not appear to be available in North America, the UK, or Australia, however. And in the absence of studies reproducing the effects, and a better evaluation of the toxicity, I’d be hesitant to recommend it anyway.

Nutritional interventions suffer from the same methodological limitations as the drug studies. A lack of proper blinding was the most common bias. Other deficiencies included a lack of baseline characteristics, and unclear definitions of colic. Keeping this in mind, the data look somewhat more promising than drugs. There are mixed results with low-allergenic formulas, with some trials showing modest effects, and others showing no improvements. Promising results were found in breastfed infants who were switched to casein hydrosylate formulas, reducing colic from over 7 hrs/day to just under 3 hrs/day. This finding seems consistent with other studies, but comparisons are complicated by different designs and products used. Low-allergen maternal diets have also been associated with improvements in several studies, though they all are subject to bias due to a lack of blinding. Bottom line: promising but unproven. At least these interventions have minimal risk.

What doesn’t work? High-fibre diets had no effect when evaluated. Nor does lactase (Lactaid). Behavioural interventions have not been shown to suggest any meaningful effects. Examples include modified parent-child interaction, contingent music, and that old standby, “car ride simulation”.

“Alternative” Treatments

From a science-based perspective, “alternative” medicine is a misnomer: when clinical evidence emerge to demonstrate unproven therapies are effective, they become accepted as part of medicine. In short, effective treatment is “medicine,” while ineffective or unproven treatments are not medicine. Yet many are used in the absence of evidence, under monikers like “alternative”, “complementary”, and more recently, “integrative”. In the second review, the authors also conducted a systematic review, identifying randomized controlled trials of children diagnosed with colic, and treated with any form complementary or alternative medicine. Trials needed some form of control (placebo, no treatment, etc.) and needed to measure an outcome like severity, quality-of-life, physiologic parameters, or a reduction in the need of medication or other consequence of treatment. Fifteen trials met inclusion criteria — and were too different to permit meta-analysis. About half were deemed to be of good methodologic quality. Few collected or reported safety data: reinforcing the erroneous assumption that that natural products are inherently safe.

Spinal manipulation — Four studies were found, with three showing results that were statistically significant, yet all three positive trials were noted to have multiple methodologic issues (lack of blinding, etc). The highest quality trial was the only double-blind, placebo-controlled study conducted. It showed no effect in outcomes according to parent reports or crying diaries. (As most of you are aware, Simon Singh has made the lack of evidence of chiropractic for colic quite well known.)

A double-blind comparison of Colimil (fennel, lemon balm, and German chamomile) was evaluated to be more effective than placebo. Again, methodologic problems and a lack of duplicative studies makes an evaluation difficult. Another small trial of fennel tea suggested a beneficial effect, too.

I’ve blogged previously how sugar solutions can provide analgesic effects to reduce vaccination distress. They’ve also been evaluated for colic. Like other interventions, some promising results are watered down by methodologic issues.

Is it a lack of beneficial bacteria in the gastrointestinal tract? Probiotic studies have reported positive effects, albiet with quality issues that included a lack of blinding. This paper also looked at nutritional studies, and flagged the same issues that the other review identified.

In a study of massage, both massage and a vibrating bed were reported to have beneficial effects. The improvement over the duration of the trial may have been due simply to the natural course of the condition. A single reflexology trial had problems with entry criteria and so many flaws it was not possible to drawn conclusions beyond the possible beneficial effects of touch alone.

Conclusion

It’s easy to give the TL;DR version of both reviews: Nothing has been convincingly demonstrated to be effective. And that shouldn’t be surprising. Given we don’t know the actual cause of colic (if there even is a single cause), our interventions are simply shots in the dark, meaning there’s little prior probability — and the data that emerge from these isolated trials becomes much less persuasive. With weak study designs, the probability of publication bias, and the lack of confirmatory data for most treatments, we’re left with some promising areas that require further study – and that’s about it.

But we can draw some conclusions of exclusion: There’s little evidence that conventional drug treatments are safe or effective. There’s also no evidence to suggest behavioural interventions, or manual therapies like chiropractic and massage have any effect. Dietary interventions appear to be the most promising type of treatment, followed by sugar solutions, and remotely, herbal products like fennel tea. While there are significant data quality issues with all trials, at least dietary interventions and sugar solutions have little risk. So for parents determined to try something, these interventions seem to offer the best risk/benefit perspective.  But the best, most effective intervention for colic remains the passage of time. Colic will pass. Reassurance is probably the best advice of all.


References

ResearchBlogging.org
Hall B, Chesters J, & Robinson A (2011). Infantile colic: A systematic review of medical and conventional therapies. Journal of paediatrics and child health PMID: 21470331
Perry R, Hunt K, & Ernst E (2011). Nutritional supplements and other complementary medicines for infantile colic: a systematic review. Pediatrics, 127 (4), 720-33 PMID: 21444591

Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

Leave a Comment (28) ↓

28 thoughts on “Understanding and Treating Colic

  1. windriven says:

    Apparently cimetropium bromide is a common colic treatment in Italy.

    J Pediatr Gastroenterol Nutr. 2002 Apr;34(4):417-9
    Cimetropium bromide in the treatment of crisis in infantile colic.

    Dosage was 1.2 mg/kg. From the results:

    “The average duration of crying for each crisis was 17.3 +/- 12.6 minutes in the cimetropium bromide group and 47.5 +/- 28.5 minutes in the placebo group (P < 0.005). Response to cimetropium bromide was 74%. Response to placebo was 33% (P < 0.05). Side effects did not differ significantly between the two groups, except sleepiness, which increased in the infants treated with cimetropium bromide."

    As Scott noted cimetropium bromide does not appear in the US Pharmacopeia. Ciao Italia!

  2. This was by far the worst part of early parenting for us. Our son had nightly episodes of intractable crying for the first seven months of his life, and about three nights per week for the next month after that. Nothing we tried worked, and we tried everything legal. Anything I write about what a hell this was for an unsure, child-inexperienced first-time parent would be understatement.

    The best advice anyone ever gave me was that it will pass and it is NOT because of bad parenting that your baby has colic. If only I could go back in time and tell my younger self that earlier!

  3. LovleAnjel says:

    It might be possible that colic itself has multiple causes, with different effective treatments. Since we can’t isolate any specific cause(s), it would be difficult to design a study which adequately tests a treatment. some of these might actually work, but only for some cases and not others.

  4. weing says:

    When my kids were going through the colic phase, I read in Barnett’s Pediatrics about a technique that I tried out and found effective. I don’t know of any studies, and I don’t have the edition around any longer. It consisted of Q-tips and vaseline. You dip one end of a Q-tip in the vaseline and then gently insert it into the anus, while twirling the Q-tip. They would expel gas or gas + stool and immediately quiet down.

  5. Ash says:

    My 2nd child had colic; my (anecdotal) experience showed that nothing really worked, including gripe water, dietary changes and a prescription medicine (I can’t remember what one exactly). There were things that made it worse; if my wife drank alcohol we would have a screaming baby after the next feeding every time. In the end we just had to wait for it to pass (took about 6 months in our case). I can understand why parents would try anything though – it’s hell going through it.

  6. icewings27 says:

    Is it possible that colic is not a bad thing? I know that it is distressing and annoying for parents, but from the baby’s perspective, if there’s nothing actually wrong, is it possible that the long crying bouts could be adaptive, or beneficial, in some way?

    Maybe trying to “cure” colic is the wrong tack. Maybe we should be trying to change the parents attitude toward it instead?

  7. @icewings27, or possibly the parents responding with distress to their child’s hours of crying is adaptive or beneficial in some way.

  8. Harriet Hall says:

    A pediatrician I once worked with described good pediatrics as “benign neglect of children and support of parents.” If nothing works, if they’re going to cry no matter what you do, you might as well accept the crying and do nothing. Colicky babies grow up just as healthy as non-colicky babies. When I was in practice, I didn’t treat babies with colic; I treated the parents – with reassurance and advice about minimizing stress. I would suggest things like mini-vacations: leaving the baby with another caretaker and doing something pleasurable for themselves, if only for an hour.

  9. Ed Whitney says:

    I have not had time to look for studies, but it seems plausible that babies with colic would be at increased risk of non-accidental trauma. Anyone know offhand?

  10. Angora Rabbit says:

    The Gripe Water link on Wiki also mentions a 3.6% alcohol content. As an alcohol researcher, that made me wince. 3.6% is certainly enough to affect the infant’s neurochemistry, often a sedating effect (but sometimes stimulatory, as per the above anecdote). A growing data base documents that alcohol, nicotine, and drugs of addiction have more potent and persistent effects on developing postnatal brain, well into adolescence.

    So while the alcohol could have a real biological effect, it’s also a very bad idea! Yet I am still seeing and hearing reports that some physicians and pediatricians recommend it to promote infant sleep. Yipes.

  11. PharmScep says:

    “The best advice anyone ever gave me was that it will pass and it is NOT because of bad parenting that your baby has colic. If only I could go back in time and tell my younger self that earlier!”

    That is a powerful anectdote…and with my now 1 year old son, he had 1-2 months of colic and my pediatrician’s office had pretty much done what Harriet Hall said about “benign neglect of children and support of parents.”….indeed for a new parent the worst is the thought that you are missing something, that you yourself are not being a good parent to this new little person….

    A colleague (fellow pharmacists with two children) had given me her anectdote about gripe water…”it worked for me”…luckily the nurses at the doctors office did such a fantastic job of simply re-assuring us that it would pass, and once we realized that this was no one’s fault…we coped with it much better (albeit it did not last for 7 months) and I never tried the gripe water .

    PS – mother in laws and other family do not help this point about “benign neglect”….they are all pseudo pediatricians ready to tell you all the ways you should be fixing of colic with such authority….errrrrrgggg….

  12. PharmScep says:

    I got into a VERY long back and forth on fb with two guys from high school that are now chiros…we got on the subject of colic and I pointed out the research….ahh but there anectdotes are so darn convincing…..btw did you all know that oncologists cause cancer, pediatricians poison babies, tylenol causes asthma, and medical doctors are the 2nd leading cause of death in the USA….????

  13. Harriet Hall —

    “Colicky babies grow up just as healthy as non-colicky babies.”

    Can you possibly link me to research on that? I am curious and have been searching publications after reading this article and haven’t had any luck. I am probably not using the right search terms.

    Thanks!

  14. jpmd says:

    I commonly recommend the techniques in “Happiest Baby on the Block” and find good results. Some babies really respond well the swaddling.

  15. Harriet Hall says:

    @nobodyyouknow,

    Although colic can impact the family, most references on colic say there are no short- or long-term adverse effects on the child’s health. For instance, one website says “Long-term studies have examined the possible relationships between colic and later childhood, including temperament, sleep patterns, family functioning, asthma, and cognitive development. However, no significant relationship between colic and these features of later childhood have been proven.” http://www.uptodate.com/contents/patient-information-colic-excessive-crying-in-infants They don’t link to any of those studies.
    I did find a few studies suggesting that colic might be an early sign of some later abnormality, but I didn’t find them very convincing. I didn’t find any evidence that treating colic made any difference compared to letting it run its course – except for a poorly designed chiropractic study claiming to show that spinal manipulation resulted in better outcomes.

    So I don’t really have any direct evidence that colicky babies grow up just as healthy, but there is no good evidence that they don’t.

  16. BiteSizeTherapy says:

    I think the work of Dr. Marc Weissbluth provides the best insight into colic behavior.He uses the term “extreme fussiness” and I think this is a better description. It is Dr. Weissbluth’s idea that all babies can be fussy, but that ‘colic’ is on the extreme end of the continuum. His research suggests that about 20% of infants 0-4 months have colic. These babies may be difficult to soothe or require a great deal of soothing in order to sleep.

    The other thing that is interesting is that colic infants have been shown to have shorter sleep durations than non-colic infants. Dr. Weissbluth has also shown that their nap rhythms are slower to develop. Colic is very misunderstood; I suspect it is more behavioral/sleep related than anything to do with gastrointestinal issues.

  17. lizditz says:

    Bryan Vartabedian MD, a pediatric gastroenterologist, published Colic Solved in 2007. The Amazon page (linked) has a pretty complete summary of the book’s theses.

    While he’s now mostly blogging about health care and social media at 33 Files, his archive of posts on colic is still available.

  18. HH”When I was in practice, I didn’t treat babies with colic; I treated the parents – with reassurance and advice about minimizing stress. I would suggest things like mini-vacations: leaving the baby with another caretaker and doing something pleasurable for themselves, if only for an hour.”

    This sounds like good advice. I didn’t have to deal with colic with my children, but I did have a period of months with intense daily tantrums. I would add one suggestion to that list. Try to have a friend, spouse or family member available to call, someone who will reliably talk you down off the ledge and reassure you when you feel like a complete failure.

  19. Simmerja says:

    When we were a very young couple, one of the older ladies from our church would stop by every so often just to check up on us. I still remember how, just a few weeks after our first daughter was born, she pulled my wife aside and said “And sweetie, sometimes babies just cry, and it doesn’t mean your doing anything wrong. And sometimes you just need to put that baby down and step out of the room for awhile before you go nuts – and that’s ok too!”

    Sound advice, and we’ve been passing it on ever since; good to see it validated!

  20. daeve says:

    I was just reading the article on homeopathy, when I came to the homepage and saw this article on colic.

    I went surfing in Puerto Rico in 1978 with my wife and son who was into his third month of bouts with colic. At home I used to put him in the car and go for a ride or place him on my stomach and pat him to sleep.

    We did not have a car on the island and after several nites of him screaming I went the the local Pharmacy, explained the issue and the Pharmacist said “no problema” and he brought me to this rack and gave me some Hylands homeopathic medicine specific for colic. I stood there looking at this little bottle thinking how it this going to do anything.

    That nite when my son started crying we gave him son and it worked right away. We were just amazed it was like day and nite for us. Anyways that was the end of having a colicky baby which was great because I was able to sleep and get early for the surf which was just great that year.

  21. jmilan says:

    @jpmd and @Harriet Hall,

    I also read “The Happiest Baby on the Block” by Harvey Karp, MD and was quite astonished with the results when I tried the techniques on my incessantly crying first-born.

    I am curious on whether you are familiar with that book and I what your thoughts are. It seems that, as was mentioned in the post, it is a vague term and that was part of what the book addressed. Thanks!

  22. BillyJoe says:

    Is there a genetic link?

    I ask this because we have four children and none of them cried when they were babies (except for when they were hungry or tired and then the solution was both obvious and immediate).

    I always attributed this to my wife’s calm, matter of fact way of handling the children. But was that cause or effect? Maybe we were lucky enough to pass on the right genes to all four. Or perhaps neither of us had the wrong genes to pass on.

    1. Harriet Hall says:

      @BillyJoe,
      Any nurse in the newborn nursery can tell you babies are different from birth. Some are calmer, some are more irritable and cry a lot. You were lucky.

  23. BillyJoe says:

    …btw, nice lateral thinking Harriet. :)

  24. PharmScep says:

    @Daeve

    We have anectdotal stories for most any proposted treatment…people who had cancer and supposedly cured by herbal pills or chiropractors. People who have prayed away their cancer. As a pharmacists I have heard sooooo many people have similar stories about many herbal pills or remedies that have failed to prove any distinguishable effect as compared to placebo.

    Being a scientist and being a skeptic means questioning uncontrolled observations in a more rigorous manner in order to conclude that your anectdote is worth taking as important to anyone else…

    If alls we required was anectdotes we would all being taking homeopathic medications, herbal pills, doing faith healing, or sacrificing animals, etc, etc…all because “it worked for me”….

    Speaking of, please read this as it relates to your point of “it worked for me”…..

    http://theness.com/neurologicablog/index.php/well-it-worked-for-me/

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