It seems as though I inspired not just one but two blog posts by eminent skeptic Professor Edzard Ernst in 2018. What an honour! One was about what open-mindedness means; the other about my ‘irresponsible and unethical’ recommendation of acupuncture as an option for babies with colic. I feel I should take the time to respond, concentrating mainly on the colic post.
Professor Ernst has long been waging a war against complementary and alternative medicine, and I have dipped in and out of his admirably persistent and prolific blog for several years. In some ways I applaud and welcome this campaign - I’ve found some of the more intelligent exchanges in the comments section stimulating and challenging, for which I’m grateful. He also makes various important points about the pitfalls of CAM (Complementary and Alternative Medicine).
However, to my mind at least, the tactics he employs are often sensationalist, and even tabloid-like. Perhaps he feels this is the best way to grab the attention of as many people as possible? I’d argue that he often undermines his own credibility by so obviously painting only part of the picture, as I believe is the case with his depiction of acupuncture for infant colic. I’d like to present a different perspective here, and readers can make their own minds up on where they stand.
Binary thinking vs shades of grey?
As I’ve tried to argue on Prof. Ernst’s site, I believe it’s quite possible to approach any given situation - or indeed any set of data - and arrive at different rational conclusions. Prof. Ernst and his friends read this paper and focus, it seems, only on the conclusion that ‘percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis’. This then apparently leads them to the conclusion that anyone who chooses to try acupuncture for their colicky baby is irresponsible at best, and is even guilty of ‘child abuse’ or ‘immolation’ (child sacrifice). To some people, this is an entirely logical and reasonable reaction - if the best available evidence doesn’t explicitly endorse any given treatment, it should not only be avoided, but anyone who decides otherwise is acting unethically or even criminally.
Personally, I see rather more shades of grey in the question, and indeed in life in general. Whilst clinical trials are undoubtedly useful and important, they are not the only form of evidence worth considering, and they are very often far from conclusive. Moreover, even though the figures are sometimes exaggerated by CAM advocates, it’s worth remembering that a significant proportion of conventional medical treatments are given without solid evidence. This doesn’t mean ‘anything goes’ in conventional medicine, nor does it mean care shouldn’t be taken when choosing a therapeutic approach, especially when it’s on the behalf of a baby. But taking time to at least explore beyond the negative headlines is surely justified.
How much less does a baby WITH COLIC have to cry for it to be ‘relevant’?
With the above in mind, I think it’s worth delving a little deeper into the systematic review in question to see what shades of grey there might be. The authors found just 3 RCTs (randomised controlled trials) worth including, with data from 307 participants. The full conclusion was:
‘Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.’
I certainly agree that caution should be exercised. Acupuncture can’t be seen as an option ‘proven’ to be beneficial at this stage. For one thing, as stated, ‘the analysis is made on small samples of individuals’. In other words, whether the conclusion was positive or negative, it can’t be seen as decisive, and more trials are needed.
But an important issue is that of ‘clinically relevant effects’. As the authors discuss, they did not find any papers which attempted to establish guidelines on clinically relevant changes or minimal important differences in trials on pain or crying in infants. Therefore, they somewhat arbitrarily came up with the figure of 30 minutes average reduction in crying time per day (between treatment and control groups) as a yardstick. In other words, unless the babies who received the acupuncture treatments cried on average 30 minutes less per day than those who didn’t, the treatment would be considered ineffective.
The actual results showed a reduction of nearly 25 minutes per day mid-treatment, 11 minutes per day at the end of the treatment, and 12 minutes per day at the long-term follow-up. The mid-treatment figure dropped to about 14 minutes per day when one trial was removed in a ‘sensitivity analysis’, as the parents who were making the judgements in that trial were apparently unblinded (meaning they might have been biased towards reporting more favourable outcomes).
Are there different types of crying?
I would argue that while we can’t directly ask babies what they consider ‘relevant’, parents can certainly give an opinion. Both my own children had episodes of colic, and as I imagine most parents in this situation would agree, it is horrible watching your helpless child suffer. Colicky crying is quite different from normal crying, and far more stressful for all concerned. So would parents (and babies) consider 11-14 minutes per day reduction in crying ‘relevant’? Consider that we’re talking about a 1-month follow-up period, which means an average reduction in crying of about 10 hours over the duration of the longest included trial. When put this way, as a parent I would at least want to know more about the treatment in question.
A vital consideration when looking at this meta-analysis is that they only considered total crying time, and didn’t differentiate colicky crying. Unfortunately, the 2013 trial (the only negative one) didn’t use a validated symptom diary, and therefore didn’t record this information. The authors of the 2017 trial put it this way:
‘Even though the reduction in minutes may seem modest, significantly more infants who received acupuncture cried for <3 hours/day, with significantly less time spent colicky crying, which is the most intense form of crying. This reduction in crying is arguably the difference between having a baby with colic versus one without, and therefore is clinically relevant for parents.’
The fact is that all 3 included trials in this systematic review showed a reduction in total crying in the acupuncture group when compared to the control groups, and it seems to me that whether these reductions are classed as significant or not depends largely on your perspective.
How good were the treatments given in these trials?
One of the first things I do when I come across a new trial of acupuncture is to look at what constitutes the ‘real’ treatment. I understand that it is very complicated to allow fully individualised treatments in clinical trials, and that standardised protocols fit much more neatly into this realm, even if they don’t really reflect real-world practice. Personally, I feel colic is a condition which can generally be treated with a standard protocol, partly because you can’t ask a baby for feedback.
But what should that protocol be? Personally, I tend to minimally needle the acupuncture points LI-4, ST-36, and use moxa (a warming technique) at REN-12. Kasja Landrgen (one of the authors of the 2010 and 2017 trials) contacted 24 pediatric acupuncture specialists to find out the most commonly used approaches. It turns out that LI-4 (an acupuncture point in the hand) was the most commonly used point of all, and it was used in both the 2010 and 2017 trials, both of which had positive conclusions. However, it wasn’t used in the 2013 trial. This trial also allocated fewer treatments to the babies, which may be another important factor. Although total crying time in the 2013 trial was lower in the acupuncture group, the results weren’t significant and therefore the conclusion was negative.
So is it possible LI-4 is more effective for colic than ST-36? Or is a combination of points more effective than a single point? Should the choice of points be tailored to the individual baby? Does moxa add to the effects? How many treatments are needed? These are all important questions that would take high-powered trials (i.e. lots of participants) to answer, so we can only speculate at this point. But LI-4 is apparently the most important point according to experts, so it seems reasonable to include it in standardised treatments.
How painful is acupuncture for babies?
This is of course an important question. When the effects of acupuncture for colic can’t be described as ‘proven’, whether or not it should be considered must be weighed against any risk of injury or discomfort. The authors of the 3 included trials stated the following:
‘...fussing/crying lasted for <10 s in most cases. On one occasion one infant cried for more than a minute after the acupuncture treatment but none cried for more than 2 min, indicating that this light acupuncture treatment was well tolerated by the infants.’ (2010)
‘Acupuncture treatment in children is considered a safe intervention, which was confirmed in the present trial. Adverse reactions were few and insignificant.’ (2013)
‘In 52% of the treatments (200/388) the infant did not cry at all, and only 8% of the treatments (31 of 388) triggered crying that lasted ≥ 1 min. Thus, if the treatment reduces excessive crying, it may be considered ethically acceptable.’ (2017)
You will see from the video I made of an acupuncture session with my daughter (see below) that there are no signs of distress at all - in fact, quite the opposite (and I didn’t edit out any outbursts!). The above conclusions are in line with my own experience of treating babies.
What are the alternatives?
When weighing up whether or not any treatment is worth trying, it’s important to consider what other options are available. The NHS website advises trying the following:
hold or cuddle your baby when they're crying a lot
sit or hold your baby upright during feeding to stop them swallowing air
wind your baby after feeds
gently rock your baby over your shoulder
gently rock your baby in their Moses basket or crib, or push them in their pram
bath your baby in a warm bath
have some gentle noise in the background to distract them
keep feeding your baby as usual
They also mention cow’s milk allergy as a possible cause.
I would certainly agree these should all be tried. But if symptoms are severe and don’t respond well to the above, should you just wait it out?
Conclusion
Is the small risk of inducing a minute or so of crying in the hope of reducing colicky crying in the longer run ethically acceptable? All three of the trials included in this meta-analysis showed a reduction in overall crying time, especially those that included the point LI-4. The results were more significant when colicky crying was differentiated from ‘normal’ crying, and when more treatments were given. I personally feel that whilst acupuncture isn’t yet ‘proven’ to be effective for colic, a reasonable conclusion based on the current evidence (and my own experience) is that the potential benefits seem to outweigh the risks, especially when alternative options are lacking.
The problem of course is that babies can’t make that judgement for themselves - my comment in the video above about my daughter being a ‘willing volunteer’ was obviously tongue-in-cheek! So until we have more well designed, large-scale trials to consider, perhaps parents are best placed to make this judgement. I encourage people to read these papers for themselves, and weigh up whether they want to wait it out, or try a few sessions with a qualified acupuncturist.