Effects of brief early exposure to partially hydrolyzed and whole cow milk proteins

Partially Hydrolyzed Whey Infant Formula: Literature Review on Effects on Growth and the Risk of Developing Atopic Dermatitis in Infants from the General Population

“…When randomized, the use of random sequence generation or allocation concealment is not described, suggesting a medium-to-high risk of selection bias in these studies overall. Only 3 studies [14,16,18] were clearly mentioned as double-blinded, but in these, the data on growth or AD were not available from the publication. One study was single-blinded [17], one was a retrospective observational study [15], and the others did not report on the blinding of the participants or health care practitioners.…”

“…When present, negative data are only cited as non-significant, limiting access to the numerical data. However, out of the studies that fall in the category of data not being reported, Moran [18] and Schmitz et al [16] did not look at the outcome due to not being powered enough or not finding any significant effect, while Hartman et al [14] mentioned a significant protective effect of the pHF-W over the CMF.…”

“…material). Out of these 8 studies, 7 used the same infant formula, a 100% pHF-W from Nestlé: Akimoto et al [10,11], Exl et al [7,12], Fukushima et al [13], Hartman et al [14], Ngamphaiboon [15], Schmitz et al [16], and Wen et al [17]. The eighth, performed by Moran [18], used a mix of pHF-W/casein (60/40) (Mead Johnson) and could not be summarized due to the lack of documentation on allergy-related parameters (only milkspecific IgG in the serum was reported); the authors also mentioned that the study was not powered to look at AD.…”

“…In addition, despite a significant reduction of the rate of allergic manifestations for the pHF-W groups compared to the CMF group after 4 months of age, the study did not provide frequency data to allow for recalculating the effect [14]. The second, by Schmitz et al [16], involved a very short intervention limited to the first 5 days of life, and did not provide sufficient numerical data for AD.…”

“…Moran [18] Schmitz et al [16] Hartmann et al [14] Iikura et al [11] Akimoto et al [10] Fukushima et al [13] Exl et al [7] Ngamphaiboon [15] Wen et al [17] High risk Medium or unknown risk Low risk I n d i v i d u a l r a n d o m s e q u e n c e g e n e r a t i o n a n d a l l o c a t i o n c o n c e a l m e n t ( s e l e c t i o n b i a s ) B l i n d i n g o f p a r t i c i p a n t s a n d As far as other biases are concerned, such as concomitant nutritional recommendations other than the tested formula, the absence of peer-reviewed publication in an international journal, or the sponsorship provided by the company manufacturing the formula, all but 2 of the studies were identified as having a higher risk of bias.…”