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Mama Natural, the nickname of college graduate Genevieve Howland, runs an extremely successful “natural parenting” brand with a large online presence reaching millions of people every month. Her website, a wretched hive of quackery and advertising, contains articles on a wide variety of pediatric medical topics and frequently makes specific recommendations based on anecdotes and flimsy evidence. She often uses emotionally charged language designed to denigrate medical interventions, such as the safe, and lifesaving, newborn dose of intramuscular vitamin K.

Howland writes with an unearned air of expertise and her website should be scuttled, but she’s not what I’m going to focus on today. But the website, specifically an article she penned on “natural ways to treat jaundice in newborn babies” did serve as a conduit through which I discovered a very interesting, and thoroughly bogus, treatment for the common and potentially dangerous condition. It also pointed the way to a real paper written by actual pediatricians that is an excellent example of how not to design, implement, and interpret a study.

So you don’t need to read Howland’s article unless you really are just asking to be annoyed. It does get a few things right, but overall it’s awful and even manages to go out of its way to imply that the newborn vitamin K dose might be harmful. Save the time and a bit of your sanity by just checking out the part that caught my attention:

As odd as it may sound, researchers found that barley seed flour sifted over a baby’s skin along with light exposure improved jaundice in newborn babies. The barley flour helps decrease indirect bilirubin levels and functions as an antioxidant. This traditional Iranian remedy probably won’t be effective on its own, but it can boost the effects of light therapy.

Odd is an understatement. It’s a baby, not a fritter. Howland actually recommends that parents take barley flour and sift it over a baby as an adjunct to using “light therapy”. That’s a bold claim and thankfully Howland does provide a link to the “research” backing it up.

She doesn’t specify what she means by light therapy but based on the linked study I’m fairly confident that she means conventional phototherapy rather than merely placing a baby in sunlight, which she does also recommend despite it being extremely problematic. I discuss the use of sunlight in the management of newborn jaundice in a 2014 post:

We know that sunlight lowers bilirubin levels, but that isn’t the issue. The problem is that in order to achieve that end, a child would need to be placed naked in direct sunlight for hours. This would place a baby at risk for hypothermia and/or sunburn. It also may only make the skin appear less jaundiced while not necessarily lowering the level of bilirubin in the blood appreciably, giving a false sense of security and potentially delaying care.

Most newborn jaundice doesn’t require any treatment and goes away as feeding improves and the ability of a baby to process (liver) and remove (pee and poop, mostly poop) the chemical that causes it (indirect or unconjugated bilirubin) ramps up. But when needed, phototherapy is extremely safe and effective in the treatment of severe jaundice and can prevent permanent brain damage. Although intriguing, my initial assessment of the use of topical barley flour along with phototherapy was that it sounded extremely implausible, although perhaps not homeopathy level impossible.

Is topical barley flour a plausible treatment option for newborn jaundice?

The first question I wanted to answer, before even looking at the study, was why barley flour? Why any topical treatment for that matter? I’m not aware of any topical therapy for lowering the amount of any toxin in the blood.

According to the Mama Natural article, barley flour is a traditional Iranian treatment. I was able to confirm that it appears to have originated in western Iran’s Lorestan Province, where it is used to treat a variety of ailments, but I was unable to find any information on when and why it became a part of the traditional medicine in that region. A Google search pretty much just resulted with more Mama Natural style articles and the one study she linked to.

I know that prescientific therapies often amount to arbitrary associations based on flawed anecdotal observations, but I couldn’t completely dismiss barley flour out of hand. After all, the concept of phototherapy was initially discovered in the 1950s when some British nurses happened to notice that babies placed in front of a window tended to be less jaundiced than those who weren’t. So I allowed my mind to remain just a bit ajar.

It seems more than a little far-fetched, but there could be some scenario, perhaps involving the children of bakers, where an astute observer noticed an improvement in jaundice. And yes, I’m being extremely charitable here. But there is more to plausibility than that anyway. A lot more.

How would a layer of barley flour theoretically improve the effectiveness of phototherapy, as claimed in the Mama Natural article and concluded in the study that I promise I will eventually get to? It wouldn’t increase the amount of exposed body surface area. It wouldn’t increase the spectral irradiance, which is largely based on the distance of the light from the patient. If anything, if there were a layer of something on the child’s skin it might block some of the light.

Maybe some component of the flour is being absorbed and then it interacts with bilirubin molecules in the bloodstream. Or perhaps it might stabilize red blood cell membranes and extend their life span. Baby RBCs have a shorter lifespan than adult versions, you see, and higher bilirubin levels are a result of the subsequent increased heme metabolism. The theoretical mystery chemical could increase albumin mediated transport of unconjugated bilirubin to the liver, or improve the conjugating capacity of the liver, either of which would help lower levels. But then why would barley flour only be recommended as an adjunct to phototherapy and not as a standalone preventative or treatment measure? I’m pretty sure that I know the reason, but I’ll save it for my conclusion.

Regardless of the potential mechanism of action, based on the natural course of newborn jaundice and challenges with how we measure bilirubin levels, any study looking into this would have to be well designed. You will likely not be surprised to learn, however, that this study was not well designed. It’s a bit of a mess in fact.

Here we go.

A double-blind, randomized, and controlled waste of time

The study, “Phytotherapy with Hordeum Vulgare: A Randomized Controlled Trial on Infants with Jaundice”, was published in March of 2017 in the Journal of Clinical Diagnostic Research. It is a double-blind, randomized, and controlled trial involving 70 infants admitted to a hospital for treatment of jaundice at Hajar Hospital of Shahrekord in Southwest Iran from July to December of 2014. These babies were all full term, “over three-days-old”, breastfed, and healthy, meaning that they did not have any significant pathological risk factors for severe jaundice.

There are already potential issues. When it comes to bilirubin clearance in the newborn, you can’t just lump all term babies together. Newborns that have just completed a 38th week of gestation and those that have completed 41 weeks are all full term, but they don’t necessarily have an equal ability to remove unconjugated bilirubin from the systemic circulation. So if this wasn’t accounted for in the analysis of the study’s results, it calls any interpretation into question. A similar issue applies to a baby’s age. A five-day-old term infant, even without treatment, is likely already at a point where serum bilirubin levels are stable or even dropping. They would likely still be rising on day 3.

Although it doesn’t apply to this particular study, the age of a baby is also important in determining when to treat them. When interpreting a bilirubin level and assessing the need for initiating phototherapy, we look the hour of age not the day. A three-day-old baby can be anywhere from just over 48 hours old to 72 hours old depending on the time of birth, and it can make a huge difference in the ability of a baby’s blood-brain barrier to keep neurotoxic bilirubin from causing damage. For a healthy term baby at 48 hours of life, the cutoff for starting lights is 2.4 mg/dl lower than it would be for the same baby at 72 hours.

34 of the newborn subjects were allocated to a control group that would receive phototherapy. 36 subjects received phototherapy plus topical barley seed flour three times a day. This involved applying 150 grams of sieved flour to the body excluding the head, face, and area around the umbilical cord. That’s because of infection risk. Barley flour wouldn’t be sterile and omphalitis, infection of the umbilical stump, is a rare but very serious problem in newborns. We also recommend keeping the stump dry, and the flour was rinsed off after each application.

The primary outcome being measured in this study was indirect bilirubin at hospital discharge. After statistical analysis, they found that the treatment group had a lower mean indirect level at discharge, with a p value of 0.009, thus deeming it statistically significant. The authors concluded that topical barley flour was an effective means of lowering indirect bilirubin levels when used along with phototherapy and implied that it might help prevent severe complications of newborn jaundice.

They go on to postulate that the flour works through the absorption of antioxidants that then enhance liver function. But, and stop me if you’ve heard this before, it is generally a good idea to make sure if something happened before worrying about how it happened. In this case, the evidence provided doesn’t at all support the claim that topical barley flour does anything at all.

A few limitations of the present study

The study authors list only two limitations to their study. They were unable to extract the effective compounds of barley flour and they did not investigate the mechanism of action. I’m not sure that they understand what a study limitation is. I’m here to help.

  1. They didn’t take into account when phototherapy was started. If babies in the treatment group were older, even by less than a day, they might clear bilirubin faster than babies in the control group.
  2. They didn’t take into account how feeding was going. They state that the babies were all breastfed, but not how breastfeeding was going, if formula supplementation was given, and what the average weight loss compared to birth weight was. Even small amounts of formula can significantly improve bilirubin clearance from the gut.
  3. They didn’t take into account duration of time under phototherapy. Because time under the lights is largely parent driven in the hospital, it isn’t uncommon for babies to be kept out of the lights for periods of time longer than we recommend. It’s easy for a 20-30 minute feed to turn into an hour long snuggle session.
  4. They didn’t take into account the error bars of serum indirect bilirubin values, which are notoriously inaccurate. You can run the same sample ten times and get ten different results, with higher levels showing larger variation. The variation for bilirubin levels in the range documented in this study would be larger than the difference they found between the treatment and control groups. This issue alone renders the study virtually meaningless.
  5. They claim double-blinding but don’t describe how it was done. Who applied and rinsed off the flour? It is easy to imagine that caregivers or physicians might find remaining small clumps of flour in a babies nooks and/or crannies. This could result in changes in care, such as keeping a baby under the lights longer, or medical decision making, such as when to stop phototherapy and discharge a baby.
  6. Speaking of discharging the babies, another tidbit that practically invalidates this whole study is that the treatment group didn’t get home any sooner. So clinically there was no real difference whatsoever.

Conclusion: Flour is for baking, not babies

Ultimately this study is an answer to a question that nobody was asking. We already have safe and effective treatments for newborn jaundice, which often consists merely of breastfeeding support, strategic use of formula supplementation, and sometimes phototherapy. But the study was done and I gave it a fair assessment. It’s worthless, and it doesn’t leave me confident that the pediatricians who ran it know much about study design, jaundice, or babies.

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Posted by Clay Jones

Clay Jones, M.D. is a pediatrician and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @SBMPediatrics and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey. The comments expressed by Dr. Jones are his own and do not represent the views or opinions of Newton-Wellesley Hospital or its administration.