Formula milk trials “not reliable”, study finds
Greater transparency is needed
A systematic review of international trials of baby formula published in the British Medical Journal suggests the findings were not reliable, and the studies may even have discouraged the women taking part from continuing to breastfeed.
Dr Zhaoli Joy Dai-Keller, an epidemiologist at the Australian Institute of Health Innovation at Macquarie University, was part of the Australian research team for the paper, contributing to the study design and critically reviewing the evidence.
The study evaluated the conduct and reporting of 307 infant formula trials between 2006 and 2020, with a detailed analysis of 125 trials between 2015 and 2020.
More than four out of five of the trials were found to have received support from the formula milk industry. Findings were almost always reported as favourable, and there was little transparency about the aims of the trial or the reporting of results.
The trials were also found to not be protecting breastfeeding in their participants. Just one of 38 trials in partially breastfed infants reported adequate support for breastfeeding, and out of 87 trials in non-breastfed infants, only 14 confirmed the decision not to breastfeed had been firmly established before enrolment in the trial.
Dr Dai-Keller said the findings supported the need for a substantial change in the conduct and reporting of formula trials to ensure participants were being protected from harm and consumers shielded from misleading information.
The release of the findings coincides with the health talk series for Nutrition for Growth Summit organised by the World Health Organisation and UNICEF earlier this month.
Formula feeding is common globally for children under the age of three, and it has been increasing in recent years. It has been associated with a range of health risks compared to breastmilk, including colic, constipation, various infections, and fatal diarrhoea in developed and developing nations.
Read the journal article here or request a copy:
Helfer B, Leonardi-Bee J, Mundell A, Parr C, Ierodiakonou D, Garcia-Larsen V, Kroeher CM, Dai Z, Man A, Jobson J, Dewji F, Kunc M, Bero L, Boyle RJ. Conduct and reporting of formula milk trials: systematic review BMJ 2021; 375 :n2202 doi:10.1136/bmj.n2202
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