Baby helmets and misinformation

Update BMJ May 2014: a further randomised controlled trial showing baby helmets’ aren’t necessary and make no difference 

 

Inside Health tonight had a piece about about baby helmets for so-called ‘flattened head’ syndrome. I think the evidence of benefit for these helmets – costing 2K upwards – simply isn’t there, and I think parents are being misled. My complaint – with all components upheld – with the ASA is here. The ASA point out that the aggressive marketing tactics may put off parents going to their GP, and that there isn’t RCT evidence of benefit. This is crucial because most children will develop a less flattened skull as they get older anyway – so without comparing children using helmets with ones who don’t, we don’t know they are any good.

Some of the references I used are here

RCT that the head shape improved with time and that devices to improve head shape aren’t needed

Review saying helmets aren’t needed

Natural history of head shape study

It’s worth pointing out that synostosis can also cause a misshapen baby’s head – but this is very rare, and should be diagnosed and treated through medical specialists, not via commercial baby helmets.

63 Responses to “Baby helmets and misinformation”

  1. steve September 26, 2012 at 8:08 am #

    Spot on!

    • Samantha Wright July 11, 2014 at 4:52 am #

      I am 20 and have struggled all through life with having the back of my head flatter than everyone else’s. I was born in 1995, and have two older sisters without this problem. My mother was one of those moms who really instilled the “baby must sleep on back” thing when I came around, she had also smoked the entire time she was pregnant.
      Sociology classes and just reality in general has shown me I can spot out people with flat heads like mine no problem. They usually have a lower-social class, not as popular. I have one ear higher than the other, and a lazy eye which causes me to be mostly blind in that eye. I have scoliosis in a mild form. I believe EVERY baby should start off life with the helmet.
      I see no wrong-doing in the use of the helmet, the only benefit in reality is preventing injury or deformation of a new child’s soft skull.
      For me, I NEED someone to preform a new study because flat-head-syndrome is so common, in my eyes from my personal experience.
      I am pregnant with my first child and I dont want my son growing up crying that he looks different, that he has positional/deformation issues with his head. I don’t want him to constantly ask me why his head is so flat. My moms only answer was that she tossed me into a ceiling fan on accident.

      I want to set up my son for success, because no matter how pretty your face is, a flat-head is honestly one of those things people judge, just like everything else. Because HAIR does not cover a flat spot!

  2. Lesley Hodgson September 27, 2012 at 9:56 pm #

    My 9.5 month old daughter has been in a band for 3 months. At 7 months she had not rolled, not sat and lay flat on her back. She was a late developer and her flat head was rapidly getting worse, not better. We therefore put her in an orthotic band.

    I agree that, happily, in most cases, positional plagiocephaly will correct naturally, as you said. The key word there is ‘most’. I don’t care if there has been a randomised study or not. The facts are out there to see. I have two friends with older children with uncorrected Brachycephaly. Their deformity is unsightly, and has never corrected. My son has uncorrected plagiocephaly – and most of the males in both our families went bald in their 20s, so the usual GP reasoning that ‘the hair will cover it’ , is somewhat laughable. I know two other older children with uncorrected plagiocephaly – they have eye asymmetry and misaligned ears. No amount of hair can cover that. We could begin to see much more of this, post the ‘back to sleep campaign’ as the tiny babies put on their backs grow up to be adults over the next decades.

    I have never met a parent who regretted helmeting – as it always has corrected the deformity. My daughter has never minded wearing her helmet and it is entirely comfortable. Our clinic never pressured us into taking a helmet and never once suggested doing it sooner rather than later. They asked if we wanted to go away and try repositioning for a few months. This was when our daughter was six months old. They even suggested a trip to the GP. They merely took her measurements and presented us with the facts. She had severe brachycephaly – the cephalic ratio proved that. She has worn the band for three months and it has already corrected. This was the right decision for us. We should have done the same three years ago for our son, and he would not now have plagiocephaly, which he may find extremely distressing when he goes bald in his 20s.

    In the UK we use orthodontic braces, we pin ears back. Using these bands is something we can do to correct unsightly deformities, and everything I have experienced from the clinics thus far has been extremely caring, non-pressured and balanced. I cannot say the same of the GPs I have spoken to. They won’t even accept that physio, repositioning and playtime pillows can assist the reduction of flat head. They simply say that it is ‘not an issue, will correct naturally, and the hair will cover it’. Two UK health authorities (Bristol and Leeds) offer NHS bands to severe plagiocephaly cases, so clearly they admit it works. I’m not expecting this to be offered to everyone, but surely at the very least the GPs can admit that flat head exists and offer parents the support and impartial advice regarding early natural correction. they are creating a problem by refusing to acknowledge it.

    Please remember the minority of families for whom this can be an important service. Yes they are unnecessary from a health point of view – but what about the emotional development of our children and our teenagers?

  3. Chris Hiley September 30, 2012 at 7:12 pm #

    A long time ago, mid nineties if I recall (See BMJ for me, plus CJMorley, for pubs.) I did a PhD looking at cot death and the Back to Sleep campaign, to reduce the risk of cot death occuring. One of the background things I did was look at various obscure sources in the medical literature. It became obvious that head shape was one of the drivers for medical advice to change infants’ sleeping postion to the FRONT. Very very bad advice, we now know, killing thousands of babies worldwide. Totally unevidenced. [It’s just struck me, sleeping postion was a cosmetic ‘proceedure’ which killed babies. Bloody hell.]

    I found medical ‘evidence’ (well, the old fashioned ‘respected medcial opinion’ which isn’t the same thing at all) against ALL sleeping postions. My favourite was the risk of mould spores dropping into the eyes of babies sleeping on their backs…. How much mouldy eye do you see in primary care Margaret? Vastly more since Back to Sleep? I guess not.

    Short of bringing up baby in a weightless environment I have no idea how some degree of asymetry in a baby’s head can be anything other than normal. There’s so much cultural clutter we bring to baby care we in the West may be equating ‘normal’ with symmetry and perfection – so anything less is in need of fixing.

    One of the ways the problem with front sleeping was spotted was through cultural comparisons. Some cultures simply never put babies to sleep on their fronts and had almost no cot deaths – the Hong Kong Chinese spring to mind. A British paediatrican noted the cot deaths there tended to be British ex-pats…..-the Chinese never had rates of cot death to match the western world’s. So with all their expereince of infants on their backs do they use helmets too? Or do they have an entirely different ‘take’ on headshape? Wonky headshape does mostly settle down or become inconspicuous. Mine did. I’m definitely asymetric. I have no helpful observations where this doesn’t happen, but it must be uncommon. From my experience toddling around London, behind hundreds of people who stop dead in front of me, earning a stare at the back of their heads, I see variety but no heads so wonky I’m secretly glad they aren’t mine. After a couple of decades of infants who slept on their backs I should surely, if there was a real cosmetic emergency?

    I wonder how much wonky headshape and the drive to helmets are a cultural phenomenon?

  4. Steve Mottram October 4, 2012 at 4:02 pm #

    I am one of the helmet providers and have serious problems with this blog.

    1. The RCT (randomised control trial) that she is using as evidence that repositioning has he same effect as using a helmet is not what it seems. It actually compares repositioning with a sleep positioning device / wrap, not a helmet. The chart in this study also shows that many infants continued to have a severely deformed head shape both with and without repositioning. How then do you support this as a valid study to illustrate the use of a cranial remoulding helmet and to say that the helmets do not work as we predict they do? It can not be used to justify your argument.

    I’m sure that you are aware that this same doctor has also undertaken two other studies of a prospective group of infants from birth to age 4 and this illustrates that at 4 years of age 4% (one in 25) continue to have a severe head shape deformity.

    2. The review quoted, (by Singh and Wacogne) is based on opinion not on research. This is no more valid than the oposing view, that helmet treatment for plagiocephaly does actually work. This advice is based on a biased view.

    3. The natural history head shape study is from 1997 and is most out of date. There are many reputable, well researched peer reviewed studies which have been produced since this which disprove the content of this article.

    As always, research can be used or misused to ‘prove’ an opinion. In this case I believe that there has been a misuse to support a previously held view and it is designed to discourage parents from making their own choices based on sound and complete advice.

    You mention synostosis and yes this must always be treated as a real issue by the medical community only. Sadly, we regularly see infants who have been disregarded and left undiagnosed by their health visitor or G.P. When we send them back for further investigations, their parents find great difficulties in gaining an appropriate referral to a craniofacial surgeon or paediatric neurosurgical specialist.

    Finally, we have been involved in this area of expertise for over 9 years now and I will happily share our experience with you. We do not treat 20% of the babies that come to us because they do not require treatment. We have very strict protocols and ONLY treat babies that have a severe bracycephaly, plagiocepahly or a combination of the two.

    We always achieve a positive result and the parents that we see are happy with the changes that we can bring about. Can I prove that this would not happen naturally? No, but I suspect that it wouldn’t and this is backed up by the many contacts that we receive from parents of older children and young adults who wish that they could have done something when the window of opportunity was open. Can you prove that it would have improved without our help? I doubt it.

    We would like to share our clinical experience with you and we will be happy to try to bridge the clinical gulf by meeting.

    Kind regards

    Steve Mottram
    ..

  5. Margaret McCartney
    margaretmccartney October 4, 2012 at 6:23 pm #

    Hi Steve
    I agree that the studies are not perfect. However you are offering an expensive intervention, and I have never heard of any medical intervention with a 100% success rate. I am afraid that the necessity for proving efficacy rests with the suppliers and manufacturers of these products. You are right; on current evidence you cannot prove that your helmets are necessary. best wishes, mgt

  6. Matt hodgson October 4, 2012 at 7:29 pm #

    Ms MacCartney. By the same rationale then, you certainly can’t cite that research as evidence that bands don’t work. Why does it appear to be such a huge issue to provide the balanced unbiased advice that parents both require and deserve? As there appears to be insufficient evidence to fully discount either argument, surely the rational approach is to provide all available information and allow parents to decide for themselves? Unless you think parents aren’t equipped to make those decisions?

  7. Margaret McCartney
    margaretmccartney October 4, 2012 at 11:45 pm #

    study 1) “A randomized controlled trial of positioning treatments in infants with positional head shape deformities”
    RCT of positioning (normal care) versus headwrap – Children’s headshape improved over the course of time
    2) Review of evidence in answer to question “what is the role of helmet therapy in positional plagiocephaly?’ – conclusion
    “There is no good evidence that for the average infant presenting with a moderate degree of plagiocephaly, helmet therapy will result in a better outcome, when compared with either active repositioning or no therapy. This is particularly of concern given the number of parents placing themselves under significant financial hardship to self-fund this treatment on such paucity of evidence. A good randomised trial is needed.” It’s not a biased review, it’s a review saying that there is no evidence that the helmets are useful.
    3) What is the natural history of plagiocephaly: physiotherapy/positioning was as good as helmets and again, most children’s head shape improved naturally.

    You need to show that you have evidence of efficacy before you can claim to have a treatment that works. Can I suggest you read Testing Treatments for many good reasons as to why this is; essentially, when people assume that a sensible sounding idea is useful, it often isn’t the case, and harm is done in the process.

    Essentially, there is no RCT evidence that these helmets are useful. They cost a lot of money, and necessitate a helmet worn 23/24 hours a day. The natural course is for most children’s head shape to improve, and because of this, you would need to compare children who used the helmets with those who just did physio and repositioning. RCTs are needed to prove something works; it’s not good enough to say that I have to prove it doesn’t. Proving a negative is somewhat impossible anyway, as I am sure you understand.

  8. Steve Mottram October 5, 2012 at 1:05 pm #

    I’m sorry, but the RTC that you are quoting has nothing to do with a headband, helmet or headwrap. It’s a sleep positioner (http://www.safetsleep.com/) and is in no way comparable to using a cranial remoulding orthosis (helmet). The results data also shows that infants using either method continue to have what Dr Hutchison regards as severe or very severe headshape. I’m sure that you know that this doctor has also undertaken two prospective studies of infants from birth to 2 and then to 4 years of age and these both show that 4% of infants remain to have a severe head shape deformity. These are the ones that ned our help.
    Item 2. The babies that are brought to us are not the ‘average infant presenting with a moderate degree of plagiocephaly’, the head shapes that we see are really severe and are truly awful. They will never have time to come back to anything approaching normality in the time that is available to them. Can I prove it? No. Would I like to be able to? Yes. If I were to undertake a study would you rank it? No because you’d say that it was commercially sponsored so not valid. I know what we can do and I know the timeframe that we can achieve this in. I also know that many parents come to us in distress after having waited beyond the time when we can help them.
    Item 3. We would never treat an infant with as small an asymmetry as 10mm which this study investigates. Typically, we see infants with 17mm + asymmetry and 99%+ head width (normal = 78%), both of which Dr Hutchison regard as severe +.Where is the second phase of their study which looks at moderate to severe infants?
    This treatment can be equated to teeth bracing, the price is similar and both bring about correction. We don’t treat if we don’t expect to see any appreciable change and in fact turn away approximately 20% of those that we see because they are not severe enough and time will naturally bring about correction. We don’t treat these because it’s not ethical and yes we always achieve a verifiable improvement in the head shape of the infants that we do treat.
    I can’t make up my mind about whether you are against this treatment because of cost, you think that parents should not make up their own minds about treatment but follow the NHS line, the fact that babies need to wear them for most of the time for a few months (as they would if they were wearing casts or harnesses if they had hip dysplasia or talipes) or for some other reason. Whichever it is, we know what we can do for parents and their babies and we believe that we are helping these children to a better future.

    • Brooke June 10, 2014 at 1:29 pm #

      As per what Steve said, my sons orthotist was absolutely against giving my son a helmet until he measured 19 mm out! I noticed my son developing a flat spot at 3 weeks old and took him straight to a childrens physiotherapist – the same pt that helped my 1st sons plagio due to torticollis! We discovered my 2nd didn’t have torticollis, he just favoured one side. It didnt matter how much position therapy we did he always moved his head straight back. He now turns to the opposite side with no issues but I would rather try the helmet for 3 months than have my son unhappy with his heads shape – I’m not taking a risk on fixing it naturally when there’s no guarantee it will happen, especially when I read other mums regrets for not doing it! Also, my orthotist told me about the studies and told me to do my own research before making up my mind on getting a helmet.

  9. JILL DENTON October 5, 2012 at 1:50 pm #

    My Daughter is 37 weeks old and has positional plagiocephly, which i first noticed at 2 weeks, my health visitor told me it would be fine not to worry, but i did worry, I raised it at her 6 week check up and again at her 12 check up and to the pediatrician she was under due to her silent reflux, in all case’s i was told to reposition her and it will get better and dont worry her hair will grow if it doesnt. Like most parents this was simply not good enough after I had gone down every NHS route I turned to the internet where I found these helmets, I didnt want her to have one, but she was now 5mths old and I was watching it get worse, her ears and eyes were both out of line. Not once did they ask “does she turn her head” the answer would have been yes she does but not much and she didnt move in her sleep. So I made an appointment for a band. Whilst waiting for the appoitment I was discusing her head to a chriopractor friend who suggested I take her to see one of her colleague’s, which I did. It turned out that my daughter had a tight muscle in her neck which was stopping her from turning normaly, and after 2 weeks there was already an imrpovement, she was feeding better, had started to roll and her head was filling out, but i had already gone down the helmet route. Helmet day arrived and all i did was cry, it was awful but i consoled myslef that it would be worth it, she would thank me in the long run, but i wasnt happy. I didnt like how it sat and seemed to move, the company assured me that it was correct, I rang them daily, but the first day she had it on for 11.5hrs I took it off and to my horror it was worse. The helmet had rubbed her head so she had sore spots and had moved in to the wrong place and so made the flat part flatter, there was also a point on her skull, needless to say the company got the backlash of a very angry mummy and I was back to crying myself to sleep at night becuase i had made it worse, the hemlet never went back on and I got my money back. The chiropractor was lovely and with her help I am happy to say that my daughters head is getting there, her eyes,ears and the roof of her mouth are now level and the back is filling out, and she now is all over her cot, it may never be what we deem as 100% normal but then who under their hair has a perfect skull??? i dont, trust me I look at everyone’s head these days. Try everything including a chiropractor before putting a helmet on, my next baby will be there at 2 weeks old for a check up!

  10. A father October 5, 2012 at 1:51 pm #

    Margaret,
    My 12 month old son was ‘diagnosed’ with flat head syndrome after we had visited the very kind and helpful people at the clinic in which Steve Mottram works. To use the term ‘aggressive marketing’ is very unfair. They were nothing but supportive and re-assuring from the beginning.
    We had of course been to see our GP and also consult with our health visitor when we first noticed that our son had a ‘problem’ with his head (which Steve’s clinic later classed as severe). When we asked about these special helmets, our GP looked at us as though we’d just told him we were from Mars. The health visitor also told us that this would correct itself in time.
    The point is though Margaret, is that based on the extensive research that my wife & I had done, were we prepared to take this risk that our son’s head would be severely disfigured for the rest of his life? I’m not sure if you have children, but if you do, try and put yourself in our position when faced with this dilemma.
    Our son has now been wearing his helmet for 8 months and the improvement is dramatic. He still now does not have a completely rounded head, but I assume from the NHS and your own point of view that when he eventually stops wearing the helmet, his head will ‘continue’ to correctly form? If it doesn’t, can I sue the NHS for giving my family wrong information? (the evidence will be there if my son’s head does not completely ‘correct’ itself). For other parents who have this dilemma, it is obviously your choice and if you have the funds to pay for such treatment, but I have nothing but praise for Steve & Sandy from Technology in Motion. Unless you have been through this experience yourself Margaret or have personally carried out extensive research, I’m not sure you’re qualified enough to comment on this subject and ‘advise’ parents on the matter. Your choice to post this comment or respond if you want to.

  11. Fiona Fletcher October 5, 2012 at 1:55 pm #

    HI, just wanted to share my experience.

    When my daughter was around 4 months old we discovered she had torticollis and plagiocephally (flat head syndrome) and we worked to correct the torticollis in hope of that helping reduce the flat spot on the back of her head. We were referred to an NHS consultant and they gave her x-rays, told us her head shape would fix itself and asked that we come back in six months. When we returned the consultant said that her head shape hadn’t improved and it was unlikely to improve now, and as she was a girl she could cover the shape with long hair!.

    When our son was born (6 years later) we were determined not to let the same thing happen again, so he spent very little time on his back to reduce the risk of a flat spot appearing, however at 4 weeks I saw the telltale signs of plagio. Although we went through the motions with the NHS (whose advice had shockingly remained unchanged in the six years) we decided to invest in a helmet and contacted Ossur (now Technology in Motion) and were told we should try re-positioning and physio first and re-contact them, if the re-positioning didn’t help, when he was 4 months old. (NO HARD SELL). Unfortunately re-positioning and physio didn’t work (not that I expected it to) and we visit the clinic in Glasgow to be told that our son would benefit from a helmet and that we should take some time to consider what was best for us before committing (AGAIN NO HARD SELL). We invested in a helmet and after 6 months of treatment are delighted with the results.

    MY ONLY REGRET….is that I don’t have a time machine so I can go back in time and get a helmet for my daughter, I am dreading the conversation I will have to have with her in the future.

    I believe my kids can be used as an example of the two opposing results and would opt for the helmet every time!!

  12. Lucy October 5, 2012 at 2:17 pm #

    My 2 year old daughter had her helmet when she was 5 months old. It was the best decision my husband and I made. My daughter had plagiocephally, brachycephally and a bulging forehead. She was also starting to have one ear being pushed onto her face by the plagiocephally. After talking things through with many GP’s and health visitors we were always told the same…that it would correct itself. After knowing families who have gone through the same and NOT taken the helmet because they followed the GP’s advice, they have been left regretting their decision ever since. We, as parents couldn’t do this and given the chance and choice, we persued the helmet treatment. Within weeks we noticed a great difference in our daughters head shape and not only this but she went from being very grumpy and uncomfortable laying down, caused by the pressure, to a happy, content baby. Even with the teething problems we had when the helmet was first fitted, there is not a day that goes by that I regret my daughter having her helmet. I am very grateful for the team (including Steve) for treating my daughter and giving her the beautiful head shape she has now.

  13. Mark H October 5, 2012 at 3:11 pm #

    Our son was born 7 weeks premature and spent the first 2 weeks of his life being fed through a tube and with limited holding time, so he spent a lot of time lying flat in a cot, he developed a flat head to one side very early on, and we listened to the health visitors and doctors that said it would correct itself and we should just re-position him, because of course when you re-position a 4 months old head, he doesn’t just move it straight back again!… we took him several times to the Dr, and we mentioned it frequently to health visitors, as the flattening got worse and worse, the flatter it became the harder it was for our son to move his head, or for us to re-position it as it would naturally roll onto the flat side and stay put.

    Eventually a Dr reluctantly referred him to a physio, the physio said there was nothing wrong with his neck movement but that it was the worse flat head she had seen… she then went away for a few minutes, and when she returned she slipped us a piece of paper, as if she was slipping us some illegal drug… on the piece of paper was the name Steve Mottram and his website and phone number.

    We emailed Steve pictures of our son’s head and he recommended we made an appointment with one of his clinics so he could be properly measured, we also made appointments with the other providers, Ahead4babies and London Orthotics.

    All of them confirmed the same thing, that he had severe plagiocephaly and recommended treatment with a helmet, none of them were at all pushy and none of them claimed there was any evidence that it would not correct itself, but we knew, having seen it only getting worse and worse by the month that it was not going to correct itself. For a ‘non-commercial’ opinion we also made contact with a surgeon at Bristol hospital who had done a lot of study on the subject and actually offered a helmet treatment on the NHS from his clinic, and from the photos he also suggested it looked severe enough that it was unlikely to correct itself.

    It was obvious to us that if it did not improve that there would be practical effects of not being able to wear safety helmets for sport activity or wear glasses straight etc when older…

    We decided to go for a StarBand helmet treatment with Technology in Motion (Steve Mottrams clinic) and although it was a tough 6 months, not because our son had any trouble with the helmet, he showed no signs of knowing it was even there, but because we were constantly worrying about if we were doing the right thing.

    We also received comments from people we thought of as friends telling us we were vain, and based their opinion purely on ‘if it was needed it would be available on the NHS wouldn’t it?”

    Our son’s head shape dramatically improved after wearing the helmet for 6 months, it did not correct it 100% but it was enough that you now can’t notice it, the only time we notice now (he is now 4 years old) is when he puts on his cycle helmet and the peak points slightly to one-side…

    We have never since doubted the decision we made.

    When our daughter was born a year ago, we purchased a Swedish infant pillow for her that she used from Birth and she never showed any signs of a flat head.

    Thanks,

    Mark

  14. Shelley October 5, 2012 at 8:38 pm #

    This has made me very angry. ‘Experts’ shouldn’t comment unless they are fully aware of all of the facts and have done their research (like all of us anxious and worried parents do when we notice such a drastic difference in our baby’s head shape). There needs to be more awareness of the condition and for it not to be confused with a slight misshaping or flat spot which sometimes does correct itself. My son started to look like a completely different child with not only severe bracycephaly but a very noticeable dent in the back of his head. Do you risk leaving it when repositioning has not made any difference and there are other parents who unfortunately didn’t have a helmet and have seen no improvement. You always wonder if you are making the right decision but when you see the results there is no question! Luckily we had the help of family to be able to afford the helmet but not everyone is in the same fortunate situation. Technology in Motion were our lifeline when no other professional medical person would even acknowledge that there was anything wrong.

  15. Claire Bardon October 5, 2012 at 10:12 pm #

    Margaret, your blog disgusts me. Our little boy’s head started becoming extremely flat from about the age of 6 weeks. Health advisors and GPs gave us the usual robotic spiell ” it will correct itself” blah blah blah. We tried repositioning (impossible when your baby only ever sleeps with his head on the right) ,we tried baby pillows, but the damage was already done. Lots of research on the internet and the bounty forum led us to Technology in Motion when our baby boy was 5months old. By this time his brachycephaly and plagiocephaly were so severe they were off the measurement scale (thanks for your advice GPs). I do not think any loving parent would sit back and leave this to self correct. Leaving him with such a deformity would be like leaving a baby with a squint because you don’t want your baby to wear glasses. There are so many cosmetic procedures available on the NHS- boob reductions/enlargements (yes I know of someone who had a boob job on the NHS after having a baby, purely for cosmetic reasons), squint surgery, orthodontic braces etc. But I digress, this isn’t my arguament. You are very wrongly saying these helmets don’t work and that parents are being ripped off. Now there are a few problems with your feeble arguament….

    1) They do work. Yes, not all babies with flat heads will need one, and most will rectify. But, in severe cases, as with our child,it never would. By 5 months the condition was getting worse. He got the 1st helmet at exactly 6months of age (yes this will offend you, he was so bad he needed 2 helmets)- within a week of wearing the helmet his head was physically rounding out (we caught him at a growth spurt and you could see the changes with the naked eye)- in fact we got a 7mm improvement in 1 week. After 3 months our little boy had grown out of his first helmet and moved from off the chart , down to severe (past very severe). We were delighted. Now we had a 3 week wait in between helmets, and you know what hapened during that time? Absoloutely nothing. Yes, no improvement, no worsening. Funny that! We are now 2-3 months into the 2nd helmet and change is much slower since he is now 13months old and growing much slower, but things are still improving. For anyone that knows anything about plagiocephaly (which you clearly don’t) we started at 35mm plagio and 105% bracchy; we are now down to 13mm and 87% with a few more months to go. I know things would not have changed without the helmet, otherwise I wouldn’t have got one (and I am quite the neurotic so didn’t go down this path on a whim without doing my research). I work in the medical profession myself and recently saw a patient aged 7 who had such a severe flat head- it was exactly the shape our son’s was before treatment. If that poor little boy had worn the helmet as a baby his head would not have looked that way. Someone commented about people striving for perfection nowadays. There’s model looks, and there’s deformity. Not everyone can look perfect but it is unfair to allow such deformity in the world we live in today.

    Obviously the back to sleep campaign is an important one. But look at Sweden- a SIDS rate less than the UK but their babies sleep on baby pillows from birth- addressing SIDS and flat head syndrome (there is nothing so-called about it- it exists). It appears that the NHS is finally addressing the problem though- their protocol now mentions helmet therapy for severe cases.

    2) Aggressive marketing?????? I have never come across and advert for an orthotic helmet on tv/newspapers/magazines/social media? Not very agressive, they’ve hardly got the prime spot during Coronation Street have they. Oh, they have a website, with information, and success stories? Very aggressive.

    3) The price. People seem to think the price is far too high. Yes £2k is a lot to pay for anyone (we had £4k to pay but managed to fundraise) but the money pays for expertise, equipment (which I expect will be in the tens of thousands), overheads; and it’s hardly common, high street stuff. Optics is the same- people moan about the price of glasses (in fact there is indeed a huge markup) but it’s the same thing- professional fees need to be paid, equipment covered, and who would pay £150 for a sight test?!

    Technology in Motion have been amazing for us. Without them our little boy would have a severly flat head, a protruding forehead, possibly a squint, jaw misalignment, psychological issues, the list goes on. But since we didn’t listen to people like you his head looks amazing, he is perfectly beautiful and I can sleep at night knowing we did the right thing. I would advise anyone in the same boat to have the helmet if their baby has obvious flat head syndrome-in fact 2 worried mums have already spoken to me about it in supermarkets after seeing my little boy wearing his helmet and I have advised TIM- knowing they are an ethical company. I expect there are probably a few companies out there more interested in lining their pockets, but this is not the case here- which is clear from their recommendations online.

    Rant over.

  16. Tom October 5, 2012 at 10:53 pm #

    My child has to wear such a helmet. The results have been amazing and I do not regret having gone down this route.
    The question for me isn’t ‘Would this improvement have been seen without wearing the helmet?’ (which personally I don’t feel it would have been; change was drastic and immediate in the period when my boy started wearing his helmet). The question for me is ‘Is my childs future wellbeing worth £2000 in the hope that his head shape will improve?’. And for me it is. I would much rather pay that money ten fold and have no improvement than follow the NHS advice, do nothing and see no improvement. At least in that scenario I could look my child in the eyes in 20 years time and explained that we as parents tried every available avenue to improve the situation.
    However this is all hypothetical as the evidence I have seen is that the helmet is magnificently effective in rectifying these issues. You may disagree and ask for proof, but surely the medical community should be taking steps to provide that proof rather than not acknowledging this method as an option to parents desperately seeking assistance for what is a very upsetting condition.
    Finally I would like to say that we felt absolutely no pressure to buy this helmet. Steve and his team were the least sales orientated commerical venture I have ever dealt with in any capacity. The very fact that my wife has been in contact with individuals who have been turned away from treatment because they aren’t considered severe enough to warrant treatment is testament to that.

    Perhaps this might be an opportunity to review your style of argument; a more objective approach to reviewing these ‘unproven’ methods might well enable you to appreciate that sometimes trying anything positive is better than trying nothing, regardless of results.

  17. Claire October 5, 2012 at 11:06 pm #

    PS. I think GPs need to be careful We live in a culture where people want to claim compensation for anything (something I don’t agree with). I wonder how long it will be before a doctor is up in court because they told a parent their child’s head will correct itself…..it doesn’t and is left severe; that child suffers bullying and the mum decides to sue- their arguament “we weren’t told about these helmets, if I’d known about them I would have tried helmet therapy”. . GPs should be mentioning these helmets, fair enough advise they are expensive, but they cannot just brush it under the carpet because what it boils down to is do nothing and risk nothing happening, or put your baby in a risk-free helmet with a high chance of success! Patients need to be able to make educated choices- they need informing of their options and the latest technology- and arrive at their own decisions. Such old school, one-sided thought processes in the NHS aren’t good enough.

  18. Ruth October 6, 2012 at 11:21 am #

    As a grandmother of a baby boy who develeloped severe bracycephaly within a few months of his birth, I fully support the work of Technology in Motion. His head was VERY flat at the back but he now looks a different boy altogether. I am so glad that his parents were able to take the courageous desision to allow him to receive the treatment. Everyone very quickly became use to seeing him in his smart blue helmet and he does not mind wearing it at all.

  19. steve October 6, 2012 at 8:09 pm #

    Hi Claire – forgive my pedantry BUT no GP will end up in Court IF they are following established NHS advice such as that issued by GOSH which states that most cases correct with time and the value or otherwise of helmets remains unclear. They also point out that this is an entirely cosmetic issue. That is not to under-estimate the risk of significant future psychological issues that might arise as a consequence of persisting severe deformity.
    As a working GP with over 20 years experience I can only say that I refer all severe cases of plagiocephaly for a paediatric opinion.
    As parents we all make cosmetic decisions for our kids. Sometimes that says more about societal attitudes than our own (e.g. a lot of dental braces) and I for one find that quite sad.
    Anyway as parents we have to what we think is best for our kids and provided we do no harm I am not going to criticise anyone.
    Do these helmets cause harm? I am not aware of anything that says they do (apart from to you bank balance!). But I don’t think that was the crux of what Margaret was trying to say. Rather she felt (and the ASA agreed) that this technique was being over-promoted and was simply calling for better evidence for the claims being made. Sadly in the medical and scientific context anecdote is not enough, real though it is for the people affected by it. We demand something more rigorous. And that’s as it should be especially if anyone wants the tax payer to pay for it.
    If only we could demand the same level of evidence from our politicians when they decide to meddle with the NHS as they constantly do.
    I am glad your wee boy is doing well. Twenty odd years ago one of my wee ones had a degree of plagiocephaly which I opted to leave alone. They still have perhaps a slight mis-shape but only I could possibly tell and they themselves are unaware and they are a well-adjusted medical student (if that’s not too much of an oxymoron!).
    Don’t be too disgusted by Margaret – she works very hard to cut out all the bull that fuddles our lives and I for one am grateful for that.

  20. Margaret McCartney
    margaretmccartney October 7, 2012 at 4:35 pm #

    hello, again
    if an intervention is being offered it is important that it is tested to ensure that it is 1) necessary/useful 2) not harmful 3) better than doing nothing at all. It has taken medicine a long term to learn this, and people have been harmed in the process.
    Anecdotes are very powerful. But we seldom hear from people who have been disappointed by the use of these helmets, who found that they caused upset with their child. who gave up with them and thought them a waste of money, who ended up in financial difficulties because of them, or who didn’t need them at all – of course, because it is seldom obvious, without doing a trial, when treatment is unnecessary. This isn’t because these stories don’t exist. But for many reasons, people don’t feel as comfortable speaking out about them.

    The bias caused by anecdotes is is why we need fair trials. You can read more about this here http://www.testingtreatments.org/.

    The ASA found that advertising for these helmets in one clinic was unfair. Please read the judgement and see why.

    • Tom October 16, 2014 at 4:43 am #

      Margaret,

      I was going to write that you’re a worthless imbecile, but I’ve reconsidered. I believe it’s actually very helpful to the world that you are maintaining this website. You typify the misguided fools in this world who are against helmet treatment. On the other hand, effectively all of whom disagree passionately with you, come off as sincere, sensible, and truly knowledgeable. Anyone who reads the contents of the various messages on this site will surely come away with the strong impression that helmet treatment is effective and there is no basis in the arguments made against its use.

      Unfortunately, I think I’ve waited too long for my son… He’s 12.5 months old already. Our pediatrician had always just brushed us off. We had tried using pillows designed to help his head round out. Over the last few months, we oscillated between acceptance and denial. Then things got very busy in our lives. Now the child is over a year old. I feel so sad…

  21. Claire October 7, 2012 at 10:28 pm #

    Steve: I am sure if your son’s plagio had been as bad as ours you would not have sat back and done nothing. I would be happy to send you copies of the scans taken of our son’s head before treatment and after the 1st helmet – I think even you would have to agree it wouldn’t have rectified on its own. I think for very severe cases of plagio/bracchy these helmets need at least a mention from a gp. For a gp to fob them off or not mention them at all is unfair to their patients. Interestingly the final gp we saw about our son’s head shape said straight away it wouldn’t sort itself out without a helmet but that they weren’t available on the nhs. She was a young gp. You might have 20years experience but she is clearly a gp with modern views whom I respect. She was open, honest and up to date with her knowledge. She also referred us to paeds to rule out torticollis hence doing a very thorough job, something you may all learn from!

    Margaret, if NICE or some other governing body were to invest into some research into plagio/brachy via questionnaires, measurements of head shapes before and after helmet therapy or before and after no treatment, I am sure you would be shocked (perhaps saddened even) to see that the helmets do work, and the severe untreated cases are still severe (but they have hair so it’s all rosy. Until they suffer from alopecia due to all the bullying, or go bald in their 20s!).

  22. Allison Kimura October 8, 2012 at 2:31 am #

    Numerous studies are out that misshapen heads are not a cosmetic issue. Eye, ear, jaw and mandible asymmetry are leading to various problems when left untreated. I am a practitioner in the States and there is not one private insurance company that will state that deformational plagiocephaly/brachycephaly is a cosmetic issue. They may choose not to provide coverage, but it is not for the condition being cosmetic.

    I can say that helmets are effective on every single infant I have treated. I, like Steve Mottram see many infants that do not require helmet treatment. They are monitored for a few months to ensure that their plagio/brachy doesn’t get worse.

    “You need to show that you have evidence of efficacy before you can claim to have a treatment that works”. I can say with absolute confidence every infant that I, and Steve and his lot have treated, are evidence of the efficacy and necessity of orthotic intervention.

  23. Steve Mottram October 8, 2012 at 9:33 am #

    There must be a reason why there are few reports from parents who have been disappointed with treatment. That’s because we monitor and hlep thm throughout treatment to make sure that we achieve a positive result.

    The UK medical community has little to no experience of this treatment, yet it’s in regular use in other countries and we have very successfully treated thousands of infants for just on ten years now, always with success. Do you believe that UK babies are different in some way that they will react other than how those in other countries do? As Alison Kimura says, look across the pond to see what’s happening in the USA where this is a well researched, documented and recognised treatment. The same goes for the Netherlands and Germany. We’ll happily colllaborate in a UK study.

    Yes, you made a complaint to the ASA and they found that one clinic (not Technology in Motion) wa advertising improperly. However, you have still not answered the question of the RCT that you are quoting as evidence to support your argument? This has nothing at all to do with using a helmet but only compares simple repositioning advice against a repositioning wrap with both proving to offer minimal result as far as head shape is concerned, leaving many infants with a severe deformity. Will you correct this?

    Baby helmets and misinformation is your title. It sits well with your argument.

  24. Lesley Hodgson October 8, 2012 at 9:45 am #

    The very fact that within one family, ie ours, one child with plagiocephaly had no helmet treatment, and he still 3 years later has plagiocephaly; then the other child had severe brachycephaly, has had helmet treatment – and it has corrected within 3 months – THIS is evidence for me that it works. I feel dreadful for not offering the same treatment to my son, who will go bald.
    £2000 is a fair price for the future of my children, for the incredible bespoke helmet she wears, for the appointments every 1-2-3 weeks she recieves to adjust the helmet, for the caring expertise of the orthotists, for the technology which allows her to have a laser scan rather than be sedated for a scan (as on the NHS). Do you feel as strongly about our friends who paid £3000 to have their child’s ears pinned back? That is a cosmetic issue, also with implications on future emotional health. Do you feel as strongly about the 5 teeth braces I wore between 9-14 years of age, each of which actually hurt for days when they tightened them? My daughter’s helmet never hurts her, ever. She slept 7-7 at night pre-helmet. And she sleeps 7-7 at night in the helmet, and wakes up smiling.
    I feel sorry for you when the studies are finally done and it is proven that orthotic banding does make a difference in severe cases. And you have to think about all the children, now adults, whose parents you advised not to bother.

    Regardless, all I personally want is NOT for these bands to be available on the NHS. I just want the helmet providers to be left alone to do the great job that they do. And I want our gps and health visitors to be less ignorant of the distress that plagio and brachy cause parents and children, and to offer worried parents the unbiased information regarding repositioning, playtime pillows, specialist mattresses, and tummy time. Send parents away with this knowledge and we may never suffer with plagio and brachy. Don’t say ‘don’t worry all children get this, most correct naturally and anyway- if not the hair will cover it anyway’. To dismiss a parent’s concern in this manner is simply negligent. And if, after several months, the repositioning hasn’t worked, and the same parent revisits you – I then want them to know that they don’t just have to sit back and worry. I want them to know that they have options. That there are private helmet companies who can solve the problem and safeguard their child’s psychological future.
    I’m not asking the NHS for money, or more time. I’m just asking them to provide more health information from educated health professionals.

  25. Lesley Hodgson October 8, 2012 at 10:03 am #

    Oh yes and please – as mr mottram said – correct the ridiculous inclusion of the RCT which has no relevance to the use of helmets (except in fact to back up our argument, in that the re-positioned infants are left with severe disfigurement)
    Also – you say they cost £2k upwards. No they don’t. They cost £2k full stop. At every clinic. In fact ours was £1950
    Also – on the radio 4 programme it was said they are banded at 3-4 months. I have never known of a baby banded at 3 months.
    Also – you said parents are being misled. We are only being misled by our gps. Not the helmet clinics. I have only had honesty from them. And our helmet has worked!!

  26. Lesley Hodgson October 8, 2012 at 10:14 am #

    Two final comments from me. You may be delighted that your complaints were upheld by the ASA. Fair enough – one clinic advertised unfairly. BUT that does NOT change the fact that even that clinic does brilliant work with helmets (and no I don’t use that clinic). Their only mistake was bad wording in an advert. Their children are still going away with corrected plagio and brachy.

    And – I am trying to decide what to write to the BBC. It is my understanding that the BBC is supposed to give unbiased reporting. That inside health programme was not unbiased. It was smugly indicating to listeners that you believe helmets don’t work. The craniofacial surgeon did not provide balance. Dr mark porter should have included either a helmet provider or a parent who has used a helmet, to give the other side of the story. How easy it was for you to sit there and say that helmets don’t work, unchallenged by anyone. I am thoroughly disappointed in the BBC.

  27. Claire October 8, 2012 at 12:42 pm #

    Hear hear L Hodgson!! I would be up for taking this complaint to the BBC also!!!

  28. Claire October 8, 2012 at 12:43 pm #

    Hear hear L. Hodgson!! I would be up for taking this complaint to the BBC also!!!

  29. Margaret McCartney
    margaretmccartney October 8, 2012 at 8:17 pm #

    Steve, I have altered the wording in the text above. This was my fault and an error.
    Comments are welcome but rudeness and nasty personal comments are not, as are the very unpleasant emails I’ve received. Please don’t do that.
    I think you should be arguing about evidence; the fact is that the ASA considered the clinic I complained about to be advertising wrongly and have been stopped for doing so. The ASA are independent: read what they have to say about the evidence and the lack of RCTs and .
    http://www.asa.org.uk/Rulings/Adjudications/2012/9/RSL-Steeper/SHP_ADJ_154343.aspx
    If there was good quality evidence that these helmets helped children I would be recommending them as would NICE/SIGN. I’m concerned that there seems no appreciation of overtreatment or unnecessary treatment or the importance of RCTs. I have no reason to disbelieve the people who have told me what their helmets cost, or who thought they needed them, sought a second opinion from a paediatrician, didn’t buy one, and their child is fine.

  30. Margaret McCartney
    margaretmccartney October 8, 2012 at 8:20 pm #

    and Alison
    “You need to show that you have evidence of efficacy before you can claim to have a treatment that works”. I can say with absolute confidence every infant that I, and Steve and his lot have treated, are evidence of the efficacy and necessity of orthotic intervention.”
    – this isn’t an RCT, and produces numerous types of bias. Please read Testing Treatments which contains numerous examples of why RCTs in this situation are very important and why personal experience can be very misleading.
    http://www.testingtreatments.org/

  31. Vicky October 8, 2012 at 10:53 pm #

    Having read your post about the “misinformation” surrounding baby helmets I couldn’t not reply. I have been through helmet treatment twice so I feel I have some relevant experience in this area to share with other parents who may read this post. Having read the conclusion you come to, I can only assume you haven’t actually done any real research and spoken to experts in the field or parents of babies who have undergone treatment.

    My son Arthur (aged 13 months) has just finished helmet treatment at the Technology in Motion (TiM) clinic in Leeds, where he was diagnosed as a severe plagiocephaly and brachycephaly case. My daughter Lily was treated in 2010 for very severe plagiocephaly and brachycephaly. Lily’s head-shape was awful prior to treatment, it looked like one side of her head was missing, and her head was they same width as it was front to back. Arthur’s was very flat – his head just went up and up to a point, and from the front it was very wide and looked huge. The idea that their hair would cover the deformity was laughable, not least because fine hair and bald men run in our family. We were very concerned that they would be bullied as they grew up, which would no doubt have a devastating effect on their self-esteem.

    You make a few points which I would like to address as follows:

    You say the helmet treatment costs “£2K upwards”. This is not correct. The full cost for treatment for Lily and Arthur at the Leeds TiM clinic (no price increase despite inflation between 2010 and 2012) was just under £2000. You suggest here that the base price is £2000 which is very misleading.

    Another point you make is that that so-called “aggressive marketing tactics may put off parents going to their GP”. Again, in my experience this was also not the case. In fact, it was our GP who recommended we look into helmet treatment as he had seen himself the outcome of successful treatment. If it hadn’t have been for the conversation we had with him, we’d never have known the clinics existed. Also, Technology in Motion (TiM) were in no way aggressive, and we never got anything like a “hard sell”. The initial consultation is free of charge with no obligation. Steve and Sandie (the clinicians) are two of the loveliest people you could ever hope to meet, and the consultation consists of them measuring the baby’s head and giving you the information you need to make an informed decision about whether to go ahead with treatment. You can decide there and then or go away and think about it. If your baby is very young, you can go back again free of charge when they are a bit older to see if there has been any improvement from repositioning. The clinic is entirely ethical – they will only treat a severe or very severe case and I have had friends with concerns who TiM have refused to treat because the case was not severe enough. By quoting the report from another clinic, you are making a giant leap to conclude that all clinics that offer this treatment are the same, with absolutely no evidence or research to back up these claims.

    Your statement “most children will develop a less flattened skull as they get older” is true, but the cases treated at the TiM clinic are not “most children”. The babies have severe or very severe cases, not mild or moderate ones. Also “less flattened” gives no indication as to just how much improvement would be seen. My daughter’s head ratio for the front-back and side-side measurement was 100%, and her asymmetry was 13mm. She may have seen some improvement without helmet treatment, but there’s no way it would have got anywhere near the result we saw with the helmet (88% and 6mm at the end of treatment). I make this claim based on the facts that before treatment her head got worse and worse and we saw NO improvement from repositioning. The only time we saw any improvement at all in either child was during the time they were wearing the helmet. The improvement was very fast at first and as parents we could see a difference within a few days of full-time helmet use. The improvement was continuous while the treatment continued, and as you would expect as the babies got older the improvement slowed as their heads were not growing as fast at the end as they were at the start. My son finished treatment being classed as “mild” he had no asymmetry at all, and his head no longer looked like an alien’s.

    A very important point I would like to make on the issue of self correction is that my daughter’s head (she is now 3) is the exact same shape as it was the day her helmet came off. This means that her head has not improved at all on its own. This was confirmed when we took her with us for one of Arthur’s appointments and her head was remeasured. The asymmetry was still 6mm – the exact same as it was on her last appointment two years previously. Your post makes the point that because there is no research on helmet treatment, “we don’t know they are any good.” There was a time, before the right research was done, that we didn’t know penicillin was any good. It is only through study that the helmets will be proven to work.

    Finally, I would like to make the point that by discounting the use of helmet treatment, you are basically telling parents whose children have severely deformed skulls to cross their fingers and hope it gets better on its own. The problem with this is that there is a fairly small window in which the treatment will work (which is why TiM will not treat a child over 14 months). My husband and I discussed Lily’s head-shape at length and decided that we would rather risk looking back in the years to come and thinking we spent some money we didn’t need to, than look back and wish we’d treated her because her head was still deformed, she was being bullied and was self conscious, and there was nothing we could do about it (For Arthur it was a no-brainer, we knew the treatment would work so as soon as we knew his measurements we didn’t even have to think about it). Also, having had the treatment and seen the results we have I wholeheartedly believe the latter situation would be the one we’d be stuck with. I will be eternally grateful for what Steve and Sandie at TiM did for my family – the children now no longer have deformed heads, and I won’t spend the rest of my life wondering “what if” and worrying that I should have had the treatment when I didn’t.

  32. Margaret McCartney
    margaretmccartney October 8, 2012 at 11:12 pm #

    Vicky
    please read the ASA statement about the clinic which I’ve linked to. I wasn’t discussing the clinic or costs that you went to in your description. I have never mentioned the clinic that you name.
    You are mistaking and misrepresenting what I’ve said; I have not said that parents should ‘cross their fingers’. I have said that there is no quality evidence the helmets work. You may feel happy with your experience, but not everyone does.
    I would support quality RCTs, and there is often a recommendation made that an intervention is done ‘only in research’, which is how I think this kind of intervention should have been done. The history of clinical trials is well made in Testing Treatments. You will find a long litany of interventions which people used thinking they were necessary when they were not, or had unintended consequences.

  33. Claire October 9, 2012 at 12:42 pm #

    Margaret, you keep going on about RCTs but who actually wants to be the placebo when their baby has severe flat head syndrome? I think the fact that nothing changes when the helmet is off is enough evidence that they work. Having had to have 2 helmets with 3 weeks of no change in between (we have always had regular improvement during helmet use) is enough evidence to vouch for that, as is a prior post stating their child is exactly the same now 2years post treatment. I think you have angered many people and set yourself up to be critisised (which shouldn’t be getting nasty I have to add) by disregarding helmet therapy- as do the majority of GPs. I hope the comments you have received on here may make you, and other professionals actually consider the severe cases and actually provide your patients with non biased information ie actually mention banding. You shouldn’t be just ignoring it and saying hope for the best. That is a personal biased opinion. You actually cause a lot of anxiety by saying severe cases will improve on their own- who wants to wait until it’s too late for nothing to happen when you can do something proactive. There are too many comments on here for helmet therapy to disregard it .

  34. Margaret McCartney
    margaretmccartney October 9, 2012 at 1:51 pm #

    Dear Claire
    please read this section on bias in trials
    http://www.testingtreatments.org/tt-main-text/
    and why RCTs are reliable when case studies are not reliable ways to make decisions.
    Children with severe deformities are usually seen at hospital outpatient clinics for assessment by experts including physiotherapists and neurosurgeons. I believe that doctors for decades have caused unnecessary harms and sufferings because they used all kinds of treatments based on what they thought was right rather than what was proven to be useful. If you think that makes me ‘biased’ I think that’s unfair and misleading.
    The ASA are independent. Have you read the ASA statement on the current evidence? You seem to think they are wrong. Have you challenged them?

  35. Vicky October 9, 2012 at 9:52 pm #

    Margaret

    Thank you for your response. I am aware that the ASA statement was about a different clinic to the one my children were treated at, but nowhere do you mention that it is only some particular clinics that you feel may mislead parents, or that some clinics cost less than £2k for treatment. Your statement makes it sound like the whole industry is misleading people.

    My children are living proof that helmet treatment works. The change in head-shape for both of them was dramatic and only occurred while the helmets were in use. The comments on this blog from parents are overwhelmingly in favor of helmet treatment, in fact there is only one parent to respond who did not have a positive experience.

    I know you didn’t actually use the phrase “cross their fingers” but you seem to imply that parents shouldn’t have helmet treatment because there is no proof that it works (a point which I argue against). This is essentially the same thing just worded differently, surely a parent choosing not to put their child through treatment would hope that the head will self-correct?

    You say there is no evidence that the helmets are any good. I ask you then where is the evidence that they are ineffective? Where is the evidence to prove that severe cases self-correct to a satisfactory level, or one in line with the improvements seen during helmet treatment? Until there is a proper RCT to answer all of the above questions there is just no way to tell whether a child’s head will self-correct. In that case, I would chose every time to ensure that the deformity was corrected in childhood with helmet treatment. Why gamble with your child’s future wellbeing?

    I am sure that if you took Steve Mottram up on his offer to meet and see the work that TiM do you would be amazed at the difference the helmets make in just a few months. I think TiM have a clinic in Glasgow so you wouldn’t even have to travel far. The notice boards at the clinic in Leeds are overwhelmed with cards thanking Steve and Sandie for their help and I’m sure that lots of parents would be happy to share their experiences with you. I know the results TiM and their babies can show you do not count as an RCT, but the problem with that is it would take years and years to complete (until the children were fully grown) and what parent would choose to potentially leave their child with a deformity for life just for a clinical trial?

  36. Margaret McCartney
    margaretmccartney October 9, 2012 at 10:14 pm #

    I am not sure if you have read the links I gave you about the need for RCTs? Or about why they are so important especially if, as the research I pointed you to shows, the trend is for improvement earlier? There are many parents of children who have spoken to paediatricians and physiotherapists and made decisions not to have helmets and who are happy with the outcomes. You say ‘just’ a clinical trial. Clinical trials are the only way to fairly judge interventions – and to ensure you are not wasting time and resources, or causing unintended harm. There is a gamble either way. I can understand why parents feel they must do everything possible to protect their child. I can also understand that this was the emotion which led many people not to give their children MMR – and which has caused subsequent harm. That’s why as a doctor I have a responsibility to turn to quality evidence to inform decision making. In truth I don’t understand why RCTs were not done at the time these helmets were first thought of; if they had, the uncertainty would have been resolved long ago.

  37. Claire October 10, 2012 at 1:10 pm #

    Margaret, I am not wasting my time complaining to the ASA. You have not achieved anything by complaining to the ASA about one helmet providor. All that has hapened is that providor has to change the wording of a paragraph!!!!

    You seem to be annoyed that patents are preferring to seek help from helmet providers instead of GPs. Maybe that’s because most GPs do nothing, as do paedetritions. Yes, rare problems such as the skull fusing need ruling out-TIM asked if we’d been referred- but severe cases of plagio need correcting not leaving.

    You are obviously not going to change your opinion. Medicine has advanced over the years with testing and trials helping along the way. But, for any drug, vigourous trials will have taken place and side effects docummented. Let me tell you this, just because it has been tested doesn’t mean it is safe for everyone. You mentioned the MMR vaccine, something which has nothing to do with helmet therapy but since you have mentioned it- my brother had the whooping vaccine 32 years ago- a live vaccine like the MMR one. He was born perfectly normal and suffered a severr reaction to the jab resulting in severe brain damage- something doctors blamed on the vaccine and advised my mum against having any further children vaccinted. My son has not had the 5 in 1 or the MMR. My point? Most things in medicine are not entirely safe despite the trials. In most cases it works, but not all, there can be severe reactions to drugs, deaths during routine operations, all of which have been tried and tested. Choosing to use a helmet is totally risk free. Fair enough it isn’t clinically proven to work, but from the opinion of people who have experience at using them, they do work. So maybe you should consider recommending them with the safe knowledge that children aren’t going to die/suffer brain damage/anaphalyctic shock from using them, there’s a huge chance that they might work and the only downside is the expense (which can be covered via fundraising/charities set up to help low earners).

    Amen

  38. Tracey October 10, 2012 at 1:12 pm #

    My grandson needed treatment and whereas the NHS are all too willing to diognosised it they aren’t willing to treat it. After having open heart surgery at 6 weeks old it became apparent there was a problem. It isn’t just cosmetics we’re talking about, he couldn’t hold his head up straight or look left at 5 months old and his physio said he wouldnt until he had the helmet treatment which she knew we were funding. Now after just 2 weeks of wearing his helmet he is starting to hold his head better and today I saw my grandson for the first time at 5 months old turn his head left fully. This treatment is working, his head looks better already, I don’t need any test studies I just look at my grandson. Thank God we his family all pulled together to fund this.

  39. Malvolio October 10, 2012 at 6:31 pm #

    Margaret would do well to remember the recently updated Cochrane review of clinical trials into the effectiveness and safety of the MMR vaccine …

    http://www.ncbi.nlm.nih.gov/pubmed/22336803

    … and its conclusion that, “the design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    MMR is safe? I wonder what quality evidence Margaret turns to to inform her decision about the safety of that particular vaccine.

    PS. Well said, Claire … and Tracey too.

  40. Tom October 10, 2012 at 10:38 pm #

    Margaret

    Sorry if this is very dim but I don’t understand why no RCTs have taken place? As a matter of interest is there historical
    precedence of a RCT being incorrect, e.g. drugs trials being shown to have positive effects in the first instance but then shown to be less or entirely ineffective at a latter stage? Are RCTs an infallible test of effectiveness?
    I think that someone made the point above that whilst there was no proven effectiveness equally there is no proven ineffectiveness. Thus the advice given by medical professionals should surely be ‘we don’t it works, we don’t know it doesn’t, give it a go if you feel the need’ rather than saying ‘it doesn’t work, don’t do it’ or not even informing a patient as to its existence as a treatment.
    You say that you don’t feel the evidence of benefit exists and so parents are being misled…well if you were to apply your own logic surely you need evidence of none benefit before you can actively advise against the use of the helmet?
    I’m sorry you feel like people have launched a personal tirade against you following your comments. It does highlight however how much impact these helmets have had on peoples lives.

  41. Margaret McCartney
    margaretmccartney October 10, 2012 at 11:58 pm #

    hello Tom
    I’m happy to have debate, and I don’t mind criticism (although it’s worth pointing out that several people who as parents would have liked to post an alternative view have declined because of the tone of some of the responses and worries about how they might respond to that) – it would be far far easier for me to simply agree, and tell parents – well, they might help, these people think they help, so why don’t you try them. The reason I don’t is not because I like to be unpopular, but because medical history is rich with harm and damage being done by well intentioned people who hadn’t done fair tests of treatments.
    I don’t know why RCTs weren’t done when the helmets were introduced. They should have been. RCTs are not always appropriate, but for a treatment like this, they should be done because otherwise you don’t know whether they are needed or whether they cause unintended side effects. (I think you will like the Testing Treatments book and website.
    http://www.testingtreatments.org/, where there is much more information about this.) This has meant that there has been more uncertainty than is needed about them. Because the vast majority of children’s head shape will change over time, it’s very hard to say whether say at 1 year the head shape of a helmet treated child will be different from a non treated child. It would be easy to think that because the helmets seem to work, it’s the helmet, and not the natural course over time, that is making the shape appear more ‘normal’.
    Many things in orthodox medicine have not been adequately or fairly tested or treated or offered to patients – it’s something I write about a lot.
    Outside the NHS, there are many organisations who offer all kinds of treatments and interventions – I’ve just seen an advert for a device which offers to cure multiple problems for 2.5K and which uses anecdotes rather than RCTs to promote it. The anecdotes are sincere and make the device sound amazing. Stories are very powerful. But there is no scientific credibility for the device, and the people who are buying it are being misled.
    The conclusion from Testing Treatments is that when we presume we know what’s best (and indeed, when we look and see what’s happening and feel that the outcomes are good) we can still be badly misled – and do much harm – without fair tests of treatments.

  42. Lesley Hodgson October 11, 2012 at 7:31 am #

    I am curious- why do you think helmets ARE available on the NHS, when you are so certain they are unlikely to make a difference?
    Please see the following exchange with a consultant at Frenchay:
    http://plagiocephalyuk.blogspot.co.uk/2012/01/frenchay-hosptial.html?m=1

    You can also there see the cost of a more basic helmet than we recieve at the clinics. On the NHS the children are sedated to make the scan (this does not happen privately so the child is put through zero unpleasantness) and they are adjusted less frequently on the NHS.

  43. Claire October 11, 2012 at 1:22 pm #

    Margaret, I see you didn’t acknowledge the vaccine comment! Interesting how you recommend something so strongly that isn’t 100% safe but fob off something safe but not 100% proven!! Anyway, my last comment on this subject matter is you keep quoting “most children”. Most children are mild and not in need of a helmet. Severe cases do require treatment. It is a good job these helmet clinics exist- I am entitel y grateful to them for all their help and support. This therapy is here to stay, you will never succeed in getting rid of such clinics. I expect one day they will be proven clinically- a sad day for you!!

  44. steve October 11, 2012 at 6:41 pm #

    Sadly Claire this type of comment merely displays a lack of understanding of science and evidence based medicine. No true scientist is “sad” when new evidence contradicts their previously held view. Rather they will feel enlightened by such evidence.
    In calling for better evidence Margaret is merely seeking such enlightenment. As she is trying to point out when we just deal in anecdote no one’s anecdote carries any more weight or validity than anyone else’s.
    No vaccine is 100% safe or 100% effective but given the potential alternatives – nasty, potentially fatal diseases – and the relative safety of current recommended vaccines it’s a no brainer as far as far I’m concerned. But, again, parents have the right to decide for their own child. But you cannot have rights without responsibility and, in my humble opinion, if you chose not to vaccinate, you should be responsible for the costs of caring for your child should they go on to develop one of the diseases they should have been vaccinated against.

  45. Margaret McCartney
    margaretmccartney October 11, 2012 at 9:41 pm #

    Dear Claire
    Why on earth would I be ‘sad’ about a properly conducted RCT result? Part of medicine is change according to the evidence. If something is shown to be harmful, we should stop doing it. If something is proven to be useful, then we should use it. If we don’t know then we should be admitting that and reducing uncertainty – indeed, the GMC stipulates that doctors must work to reduce uncertainties in healthcare.

    I am not aware of any intervention in medicine which comes with a ‘100%’ guarantee of success. I had hoped that readers would recognise the MMR scenario as one where it could be difficult to disentangle one’s wish to protect one’s child and do their very best for them, with the scientific evidence. I really don’t want to waste time on (another) MMR debate, I’ve written about it extensively, and there is nothing new to say. Other than that I don’t personally know any doctor who hasn’t given it to his or her children.

  46. Tom October 11, 2012 at 11:25 pm #

    Hi Margaret

    I’m your reply to my earlier post you said that don’t know why an RCT wasnt undertaken when these helmets where first introduced. Is there any reason why an RCT cant be undertaken now? Is that the responsibility of the company offering it a treatment or of some central medical governance organisation? Surely it would be best to get some evidence gathered to clear up what is obviously perceived as very muddy water? As a parent with a child who had undergone this treatment, and would recommend it to others, I strongly feel that presenting a clearer picture can only help other parents and the decision makers in the NHS as to the effectiveness of this treatment.

  47. john fulton October 12, 2012 at 4:07 pm #

    my son is nearly 2half years old, he has flat head at the back of his head, me & my partner got told this would sort it self out when our son would be 18months, but it hasent , it just looks the same, my partner took our son back to the doctors today 12/10/12 we have to wait on refferall to go see specialist. question am asking is can our son still get help with hime being 2half years old?

  48. steve October 13, 2012 at 5:38 pm #

    Hi Tom – thank you for posting a reasoned and reasonable post which deserves a reasoned and reasonable reply. In the absense of Margaret I hope I will do! However, I should point out that I am not an expert on clinical trials so if what follows sounds like gobbledy gook (or, conversely, if I am teaching you to suck eggs) please forgive me.

    The reason RCTs are so important is clearly set out in Testing Treatments which anyone one with a genuine interest in medicine and healthcare should read. Here’s a link to it:

    http://www.amazon.co.uk/Testing-Treatments-Better-Research-Healthcare/dp/1905177488/ref=sr_1_1?s=books&ie=UTF8&qid=1350142890&sr=1-1

    What well-conducted RCTs allow us to do is find objective evidence for the value or otherwise of any kind of medical drug or device. When a new drug or device is developed the onus is most definitely on the developers to prove that it’s better than the current existing treatment(s) for that condition or, alternatively, just as good as current treatment(s) but with fewer side effects. If there is no current treatment then they have to prove that their new drug/device is better than a “dummy pill” (placebo) or not using the device.

    The great thing about a good RCT is that it can be repeated many times and the results will be the same. The fewer RCTs you see for something in medicine the more suspicious you should be.

    You ask if the results of RCTs are ever over-turned. What is actually more likely to happen is that Big Pharma or device manufacturers may actually bury data which shows that their drug or device is not effective or not safe or both. This is a major problem beautifully outlined in Ben Goldacre’s new book Big Pharma – again a book which should be regarded as essesntial reading for anyone with an interest in medicine or healthcare:

    http://www.amazon.co.uk/Bad-Pharma-companies-mislead-patients/dp/0007350740/ref=sr_1_1?s=books&ie=UTF8&qid=1350143347&sr=1-1

    Another way in which Big Pharma manipulates the system is to carry out RCTs comparing their new drug to placebo instead of to existing drugs in the same class/group. So, for example, say there is an established drug for treating heart failure. We’ll call it Feelalot. Along comes a rival company to the one which produces Feelalot with a similar product for the same indication (a so-called “me too” drug). This rival wants a slice of the lucrative Feelalot market and have come up with Healalot. Now the legitimate way for them to proceed would be to carry out an RCT that compares their new drug Healalot to the existing treatment Feelalot to prove that either Healalot is more effective than Feelalot or that is is just as effective but with fewer adverse effects.

    Instead what Big Pharma do increasingly is try to subvert this logic by comparing their new drug to placebo then touting it as being better than placebo and therefore of value. But if Healalot turns out to be better than placebo that really is of little use to us because it takes us no further forward when what we really want to know is is Healalot more effective than Feelalot and/or is it safer?

    Any drug or device manufacturer that genuinely believed they had developed a wonder product should be rushing out to perform a RCT with their product – they should but they don’t.

    Instead they may resort to an old trick which is anecdote or personal testimony. This is easy to do particularly if your treatment or device has no real discernible unpleasant side effects and you are marketing it for self-limiting and spontaneously resolving problems. So if you give a sugar pill for, say, the common cold and the person gets better then the natural human response is to put it down to the sugar pill, especially when you are told that the sugar pill in fact contains an electro-magnetic memory of something that used to be in it or some other fancy pseudo-science/natural philosophy and especially if the practitioner delivering it is friendly, kind, warm, patient, a good listener, etc. and you are paying for thier time! But, of course, even the simplest of logic would tell you that you simply cannot say it was the pill that did it. But that doesn’t matter because after a while you have built up a huge bank of personal testimony, positive anecdote and good will that swears your sugar pill was the wonder cure.

    The problem with devices (as opposed to pills) is that it would be essentially impossible to “blind” both the clinicians and the patients as to who was getting the intervention and who wasn’t. Of course that then means a whole load of bias is introduced in both clinicians and patients which will undoubtedtly skew the results (almost certainly in favour of the device unless it had unpleasant side effects).

    So in the case of baby helmets it would be difficult to construct a good RCT to see if they were more effective than the alternative (i.e. doing nothing other than positional work) – difficult but not beyond the realms of possibility. So you could assign kids to helmet or no helmet randomly (assuming that all the kids would otherwise have been considered suitable for helmeting) and observe what happens after 3 or 6 months or whatever and then determine whether any noted change was significant (and I don’t just mean in terms of physical appearance but also clinically). You would then need to follow up these kids for a number of years to see if any perceived benefit of treatment (or adverse effect of non-treatment) was sustained at 1 year, 3 years, 5 years, 10 years, etc.

    So you need to throw your question back to the device manufacturers. Have they done these trials? Have they repeated them more than once and come up with the same results each time? Have they submitted these trials for publication in a peer-reviewed journal and, if so, were they subsequently published?

    Do helmets work? I hope so but I have no objective way of knowing for sure (as opposed to the clearly heart-felt anecdotal testimonies above). If they do work is that clinically (as opposed to cosmetically) significant? I hope so but I have no objective way of knowing for sure. And, if it is clinically significant, does that carry with it a sustained and presisting measurable clinical or psychological benefit? I hope so but I have no objective way of knowing for sure.

    If Steve Morttram and the other good people at TiM have the type of evidence I am looking for I would be glad to see it and if it is of good quality I will be the first to recommend that the NHS funds this therapy and that all GPs, health visitors and paediatricans working in the NHS are aware of the treatment and have access to it.

    Phew! Hope that helps a bit Tom.

  49. caroline October 14, 2012 at 5:22 pm #

    My son has plagiocephaly and started wearing a helmet from 5 months, and like the other parents I too noticed a dramatic difference in head shape shortly after treatment started. However, I would have loved it if there was randomised controlled trial evidence that wearing the helmet was an effective treatment before embarking on treatment. As a parent you feel anxious about either course of action – are you causing unnecessary distress to your baby (in my case my baby has tolerated the helmet extremely well) or are you missing an opportunity for treatment that will save your child bullying taunts in years to come. Steve – you say that any such trial would be dismissed as industry sponsored. It would not be dismissed if you involved independent collaborators and signed up to making the results publically available whatever the outcome. If you believe your treatment works, then a properly designed RCT will silence the doubters like Margaret once and for all, and may lead to this treatment being available on the NHS.

  50. Lesley Hodgson October 14, 2012 at 7:33 pm #

    Whilst paediatric rcts are more common nowadays than they used to be, I’m guessing an RCT of this nature would not get past the ethics committee, as it would be nearly impossible to do a fairly and truly random trial. And extremely distressing for the families involved. However there are some countries which do childrens rcts as a matter of course so perhaps it will happen elsewhere.
    I myself would not put my child forward for such an RCT, and as such I am happy to trust the very persuasive anecdotal evidence. My son did not correct naturally. We has nothing to lose with my daughter as it is risk and pain-free.

  51. Margaret McCartney
    margaretmccartney October 14, 2012 at 7:48 pm #

    hello Lesley
    there is a trial ongoing in the Netherlands
    http://www.trialsjournal.com/content/pdf/1745-6215-13-108.pdf

  52. Radio 4 listener November 4, 2012 at 11:51 pm #

    Whilst the comments from a few people may side with emotion, lacking the formal scientific logic of argument the medical professionals come to rely on I think there are many valid points raised. Having engaged with these clinics I, as many others, can completely dispel the ‘hard sell’ and ‘aggressive’ nature that the owner of this blog raised with the ASA. You were very self congratulatory of you achievements in getting a paragraph of text changed but surely if you really want to make a difference you’d use the education, that either you or your family invested in for your future, to make a difference to people’s lives.

    Firstly, returning to the comment about balanced reporting by the BBC and reiterate that this was not in keeping with their ethos to provide balanced independent reporting as there was only the comment from this owner of this blog in the negative for these helmets, inconclusive comment from a Dr but where was the pro helmet argument? I’m sure you can see that from any debating perspective there was clearly a empty seat that lead to the delivery of a skewed perspective on the matter.

    We can then draw on medical results from across the globe, the fact this type of working has been going on since 1979, the number of success stories and the lack of any negative cases. Whilst you represent yourself on this blog, and in this case Radio 4, you have adopted an opinion that is purely representative of your education and that of your peers who I’m sure you’ll agree represent a small proportion of society, so would not stand up to the random sampling measures required by any study. Now be it the mean, medium or the mode the results stand for them selves in the favour of this work. If we were to in fact take the recommendations from the majority who are in this case pro helmet treatment your point would therefore in a random sampling be moot.

    If you have studied any of the medical litigation in the USA you will note that if the slightest issues is picked up there will be huge financial ramifications. The fact that insurance companies, who under pin medical care in the US are covering this is testament to their success. I’m sure you’ll be aware that insurance companies make a business out of not paying out unless it’s in there favour.

    In addition to this would be the adoption of the technique by other well developed countries demonstrating that on an international playing field your point, even though some what focused on advertising, cost and lack of controlled research are like our crumbling NHS infrastructure considered, to say the least, to be weak.

    Relying on medical studies that have been categorised by the NICE as being poorly undertaken, look at some of the scientific results, measurements, durations and improvements that are all factors in recommending treatments you’ll likely come to the same conclusion that many NHS trusts have. Simply that since the successful Back to Sleep campaign the number of case of “flat head syndrome” have dramatically increased and “Most clinicians believed the demand for treatment would grow and could have a major impact on the NHS” (this statement was made back in 2007).

    I’m sure you felt that your moral outrage would be well received by the people suffering the turmoil of raising funds, courageously dealing with on lookers and the lack of some physical contact with their child’s head, but you should have stopped to consider the bottled up emotions these people deal with. The back lash I have read on this website is of your own doing and if you want to stand on the soap box that is Radio 4, then I’m sure you were ready for this type of reaction. You probably felt you had people’s best interests at heart though unfortunately you did not conduct your own random sample research into the audience/demographic you were addressing.

    Taking a step back into the reality of life, you can see that this is people simply opting out of the NHS (as with many cosmetic treatments but this is just a much early intervention), private undermining the publicly available services (lets not look at the education model as this will only further emphasise the points being raise).

  53. Radio 4 listener November 5, 2012 at 12:06 am #

    Aside from emotion, debate, moral outrage and everything else expressed in these comments the bottom line will be:

    HEADS will be the first study to present data on the effectiveness of helmet therapy. Outcomes will be important for parents and their children, health care professionals and future treatment policies. They will likely influence the reimbursement of health insurance companies.

    If only you had clearly lead with this argument, as it dates back to July, rather than the outdated studies and ASA complaints I think you would have had more people’s ear.

  54. Margaret McCartney
    margaretmccartney November 5, 2012 at 7:05 pm #

    hello
    the bottom line is that people are currently being advertised expensive unproven interventions for a condition which spontaneously improves in the vast majority. There are many people who have ended up paying for treatment which their child did not need and who were given inadequate information about the evidence based for the helmets. Your experience may not be of ‘hard sell’, but it is not the case for all people. It is not sufficient to use anecdotal evidence in situations like this, mainly because of bias, but also because it is not good enough to work out what works and what doesn’t.
    I recommend this book http://www.jameslindlibrary.org/testing-treatments.html which clearly outlines why fair trials are needed and the problems when they are not. Please read the ASA judgement about the clinic in question.
    I don’t mind criticism, at all, it’s healthy, but I don’t think personal attack is necessary and it detracts from the issues. Once again can I point out that there are people who hold differing views (and who have given me permission to say) that they have had bad experiences but are afraid of talking about it because of the hostility shown to them.

  55. Radio 4 listener November 6, 2012 at 11:59 pm #

    I thank you for your response, you’ll note I raised points about the way in which you presented the argument and the unbalance nature in which it was portrayed focusing on the commercials / advertising. I did not personally attack you just your methods of argument and delivery, which you have accepted is healthy. If you perceived the the point about investing in your future as this you may have missed the subcontext, the fact by undertaking this private treatment parents feel they are investing in their children’s future and doing what they can. The point about using your education to make a difference in people’s lives was highlighting if this is such a difficult matter for you then don’t complain to the ASA, lobby professional health bodies to get the research undertaken, or use your skills to do so yourself.

    It’s very easy to take the moral high ground by quoting books people should read to support your argument, I could refer you to literature that form the foundation of such modern methods of research upon which all formal logic of argument is equated but that would detract from the issue.

    The points I raised were counter / challenging to the points you had made on Radio 4 and those discussed in earlier comments. I out lined a bottom line in my later statement that agreed the HEADS research would be a line in the sand, and you have clearly made you professional standpoint. I hope if the results of this research conflict with your opinions broadcast on Radio 4 you will be bold enough to step forward and go back on the show to follow up on the statements you made. To let people know this research has been conducted and your opinions previously stated were incorrect , in that these were not just people trying to take money from worried parents. You might then ask the NHS trusts to re-assess their reports on helmets based on the new scientific research. The demand for the helmets will then drive down the cost of production and as such people on low incomes can now be able to benefit from the treatment.

    Once again can I point out that there are people who hold differing views and who have expressed them on your website as the argument delivered on Radio 4 was biased. Your evidence was as much hearsay as would that of a helmet provider have been and in your own words this anecdotal evidence can not be taken in to account.

    As mentioned in my last comment if you had mentioned this new research being undertaken or worked with the producer of the show closely to make sure it delivered a fair argument unbiased argument, you may not have had so many comments on this thread. I’m sure if the points in this blog were formally raised with OFCOM in a clear and concise manner it would have similar success to that you had with the ASA. However, I’m sure you may again view this as personal attack rather than just a cross examination of the of the arguments you put forward. Which whilst may feel uncomfortable it’s not personally vindictive, just the counter comment to the opinions broadcast.

  56. Margaret McCartney
    margaretmccartney November 7, 2012 at 9:27 pm #

    I don’t think there is anything of the ‘moral high ground’ in wanting to explain how fair tests of healthcare interventions should be done. I think it’s essential if there is to be useful debate. I’m not sure what literature you want to refer me to, but if you feel it trumps the need for fair tests of treatments, let me know. In terms of regulation, the private healthcare sector is one that I’ve written about lots before – not just baby helmets, but cosmetic surgery, nutritionists, homeopaths, doctors providing expensive, evidence free interventions for conditions without a cure – and the recurring theme is the lack of effective regulation ensuring fair information about evidence. See all the blogposts about lifeline screening for example. I wonder why you think the ASA upheld the complaints. Describing the lack of RCTs and the overselling of this intervention was hardly hearsay.

  57. Lesley hodgson November 11, 2012 at 12:57 am #

    You keep mentioning this condition which ‘spontaneously improves in the vast majority’. Once again, we are not denying that it improves on the vast majority, and neither are the helmet providers! This treatment is only for the small minority. And you should not try to deny them a treatment which works. It effectively treated my daughters deformity. She is now not deformed. It worked. She is the small minority.

  58. Zoya April 15, 2016 at 6:53 pm #

    Good post.

  59. Alex Hawley July 28, 2016 at 2:58 pm #

    If anyone is still reading this thread, you might be interested to know the findings of the Netherlands-based RCT referred to above by Dr McCartney. It published in the BMJ in 2014 (http://www.bmj.com/content/348/bmj.g2741), and found no difference in outcome between the helmet therapy and natural course therapy. The authors concluded that “Based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.”

  60. Helen July 28, 2016 at 10:35 pm #

    Please disregard this report. It was based on testing only mild cases.

    My second son is having treatment as did my first and when in clinic a couple of weeks ago, I met a mum whose first son was a year older than my eldest. He had his head closely shaved, and you could see that it was still very flatten at the top back part of the skull. The bottom back, his mother said had rounded out to some degree. However, it was still quite flat also. They had listened to the advice that a helmet would make little difference to leaving the skull to naturally round out. She was not doing it again with their second child. She was quite upset to meet my son as she felt guilty. You can only make a difference to the skull shape up to 18 months old and most companies might not start treatment after 14 months. They are not in it to take your money, but to responsibly advise parents if the treatment will do any good and if there is enough time left for the parents to see enough results for the investment.

    My first son’s head was badly mishappen and now looks normal. My second son is rounding out very well and quickly.

    Please do not take a chance, 5% of babies will need and benefit from the helmet treatment and 1%, as both mine are, will fall into the severely mishappen despite all precautions you can take. My sons have very soft skull bones until they fuse, it runs in my husband’s family. Severely mishappen will lead to problems with blindness, hearing, being able to wear safety hats and no hair cut could hide coning up on the one side as my first son became before he was old enough to wear the helmet.

    Helmets work, repositioning naturally will not work as well and nothing works after 18 months. Do not take a chance. Has enough research been done to prove things like autism spectrum conditions that appear higher in children with flattened heads is not effected or caused by the brain growing in a mishappen skull? 4 the more severe cases, parents might wish to be cautious and opt for the certainty in results with the helmet.

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