FDA-approved specialty baby formulas don’t work; previous studies were faulty or had conflicts of interest according to recent research

Infant formulas with proteins that have been hydrolyzed are said to reduce a child’s risk of developing eczema by at least 33 percent. Nevertheless, that assertion has come into question, as a study that was published in The BMJ shows the results of 37 different trials into hydrolyzed formula.

There is an idea that a certain type of baby formula — the kind that has been hydrolyzed in order to break down the milk proteins — can be given to children who are at risk of getting allergies or eczema in order to reduce the risk levels. The new research shows that this may be completely untrue.

Statistically insignificant

According to the team from Imperial College London, who conducted the research, there was “no statistically significant reduction” in risk levels for milk allergies or eczema among babies that were given hydrolyzed formula instead of the standard variety. The authors also said that there were conflicts of interest in many of the older studies conducted, mainly due to financial links with makers of baby formula.

“Despite parents being advised [that] these hydrolyzed milk formulas may reduce the risk of conditions such as milk allergy and eczema, we found no evidence to support these claims,” says Dr. Robert Boyle, senior author of the study from the Imperial College London‘s Department of Medicine.

These findings invalidate what many now think to be common knowledge when it comes to baby formula and health.

“Not only did we find no evidence of reduced risk from hydrolyzed formula, but we found very few studies which were methodologically sound and without a conflict of interest,” explains Boyle. “For instance, in some of the studies all babies were started on the formula at birth, or a few days after. This raises questions about whether enough was done to promote breastfeeding to the mothers in those studies.”

The results of this study are quite the revelation. At some point in the past, the U.S. Food and Drug Administration (FDA) actually approved a manufacturer’s claim that partially hydrolyzed formula could reduce risk of eczema in some babies. Meanwhile, a Cochrane review in 2006 found “limited evidence” that feeding hydrolyzed formula to babies or children could reduce the risk of milk allergies.

According to Professor Jo Leonardi-Bee, senior statistician on the study from University of Nottingham‘s Division of Epidemiology and Public Health, the results may not be representative of all studies conducted in its area. “Our research suggests that there was evidence of publication bias, where some studies that showed formula milk didn’t actually reduce allergies may not have been published,” says Leonardi-Bee.

Implications of the study

During the course of the research, the team analyzed other studies that included over 19,000 participants. As such, this new effort is considered to be the most complete and robust assessment of all the evidence to date, according to Boyle. It’s so expansive that it even counts the trials that looked into the risks of other ailments like Type 1 diabetes.

The main focus of the study was investigating whether hydrolyzed milk formula could actually reduce the risk or eczema or milk allergies. This mostly meant that the baby had a known first-hand relative, like a sibling or a parent, with the ailments. The researchers compared the hydrolyzed formula with the standard one, and some trials even compared them with breast milk.

In the end, the researchers say that further studies into baby milk formula will be necessary, and that they will need to be even more robust. Professor Leonardi-Bee in particular says that future studies need to be carefully designed in order to make sure that guidance to parents is based on reliable evidence.

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