Aim: This study investigated if a maternally reported, immediate improvement in breastfeeding following division of tongue-tie is due to a placebo effect.
Methods: This randomized controlled trial was conducted at Southampton General Hospital, Southampton, UK, in 2003-2004. Sixty breastfed babies 5-115 days old (mean, 32 days; median, 23 days) were randomized to division (Group A) or non-division (Group B). The mother and a trained observer were blinded and assessed breastfeeding before the intervention. Fifty-seven babies were analyzed because blinding failed in three of the babies in Group A. Following the intervention, the mother's and observer's views were noted, and then those infants allocated to non-division had their tongue-tie divided.
Results: Seventy-eight percent (21 of 27) of mothers in Group A reported an immediate improvement in feeding following the intervention, compared with 47% (14 of 30) in Group B (two-tailed χ(2) p<0.02; 95% confidence interval, 6-51%). At 1-day follow-up, 90% (54 of 60) reported improved feeding following division. At 3-month follow-up, 92% (54 of 59) still reported improved feeding, with 51% (30 of 59) continuing to breastfeed.
Conclusions: There is a real, immediate improvement in breastfeeding, detectable by the mother, which is sustained and does not appear to be due to a placebo effect.