SynthesisBMJ (Clinical research ed.)2021
Conduct and reporting of formula milk trials: systematic review.
Synthesis in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Topical Anti-Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta-Analysis.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2024Pooled it
- Trial
- Operation Stork Speed represents an opportunity to reform infant formula clinical trials.Nature food · 2026Article
- Programming the Infant Gut: How Maternal and Early Life Nutrition Shape the Infant Microbiome and Long-term Health-A Narrative Review.Molecular nutrition & food research · 2026Review
- Commercial influences on infant and young child feeding.Future healthcare journal · 2025Article
- The urgent need to end sponsorship of healthcare professional associations by the commercial milk formula industry.Future healthcare journal · 2025Article
- How trustworthy and applicable is the evidence from systematic reviews of depression treatments: Protocol for systematic examination.PloS one · 2025Article
- Article
- The Commercial Determinants of Health and Evidence Synthesis (CODES): methodological guidance for systematic reviews and other evidence syntheses.Systematic reviews · 2023Article
- Health and nutrition claims for infant formula: international cross sectional survey.BMJ (Clinical research ed.) · 2023Article
- Soy-Based Infant Formula Feeding and Uterine Fibroid Development in a Prospective Ultrasound Study of Black/African-American Women.Environmental health perspectives · 2023Article
- Exploring Infant Caregivers' Provision of Modified Formulas: Potential Demographic Differences and Reasons for Provisions.Frontiers in nutrition · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo systematically review the conduct and reporting of formula trials.
designSystematic review. DATA SOURCES: Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1 January 2006 to 31 December 2020. REVIEW
methodsIntervention trials comparing at least two formula products in children less than three years of age were included, but not trials of human breast milk or fortifiers of breast milk. Data were extracted in duplicate and primary outcome data were synthesised for meta-analysis with a random effects model weighted by the inverse variance method. Risk of bias was evaluated with Cochrane risk of bias version 2.0, and risk of undermining breastfeeding was evaluated according to published consensus guidance. Primary outcomes of the trials included in the systematic review were identified from clinical trial registries, protocols, or trial publications.
results22 201 titles were screened and 307 trials were identified that were published between 2006 and 2020, of which 73 (24%) trials in 13 197 children were prospectively registered. Another 111 unpublished but registered trials in 17 411 children were identified. Detailed analysis was undertaken for 125 trials (23 757 children) published since 2015. Seventeen (14%) of these recently published trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and primary outcome, and authors or sponsors shared prospective protocols for 11 (9%) trials. Risk of bias was low in five (4%) and high in 100 (80%) recently published trials, mainly because of inappropriate exclusions from analysis and selective reporting. For 68 recently published superiority trials, a pooled standardised mean difference of 0.51 (range -0.43 to 3.29) was calculated with an asymmetrical funnel plot (Egger's test P<0.001), which reduced to 0.19 after correction for asymmetry. Primary outcomes were reported by authors as favourable in 86 (69%) trials, and 115 (92%) abstract conclusions were favourable. One of 38 (3%) trials in partially breastfed infants reported adequate support for breastfeeding and 14 of 87 (16%) trials in non-breastfed infants confirmed the decision not to breastfeed was firmly established before enrolment in the trial.
conclusionsThe results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2018 CRD42018091928.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.