Table 4.

Summary of Strength of Evidence Based on Included Clinical Studies (Including Case Series and Case Reports Reported in Included Narrative Reviews).

Study Type, First Author, YearTopicSampleOutcome MeasuresResultsQuality of EvidenceAdverse Events Reported
Designed studies

 RCT, Herzhaft, 2017OMT vs sham OMT for biomechanical sucking dysfunction97 infants, <6 wk of ageLATCHa toolLatching improved after one OMT treatmentHighNone reported

 Cohort, Vallone, 2004Evaluation and treatment of musculoskeletal dysfunction in infants demonstrating difficulty breastfeeding35 infantsDoctor observationNeonates with nursing dysfunction had more MSK issues than those withoutLowN/A

 Pilot, Fraval, 1998OMT for infants with sucking dysfunction6 infants > 3wk and <6 mo of ageCreamatocritb immediately pre-/posttreatmentBreast milk fat content increased in all, significantly (normalized) in 4/6.Not ratedNot stated

Large case series >12c

 Miller, 2009SMT for infants with suboptimal breastfeeding diagnosed by physician or lactation consultant114 infants, mean age = 3 wkExclusive breastfeedingAll improved; 78% (89/114) exclusively breast fed after 2-5 treatments
over 2 wk
Not ratedNone reported

 Vallone, 2004SMT and CM for infants with MSK and nursing dysfunction25 infants, mean age = 3 wkImproved latch by mother report and doctor observation80% (23/25) improved after mean of 3 treatments (range 1-12)Not ratedd Not stated

 Stewart, 2012SMT for infants with MSK and nursing dysfunction19 infantsQuestionnaire on specific infant actions and overall stress while nursingImproved in all aspects assessed on questionnaire by mother reportNot ratedNot stated

Summary of small case series (<12)c

 5 case seriesSMT and CM for infants with MSK and nursing dysfunction12 treated, 11 observed onlyMother report and provider observationFavorable outcomes in treated casesNot ratedNot stated

Summary of case reportsc

 20 case reportsSMT and CM for infants with MSK and nursing dysfunction20 infantsMother report and provider observationFavorable outcomesNot ratedNot stated

Abbreviations: RCT, randomized controlled trial; OMT, osteopathic manipulative therapy; CM, cranial manipulation; CS, case series; CR, case report (1 case); N/A, not applicable; MSK, musculoskeletal; SMT, spinal manipulative therapy.

a LATCH is a trained observer-reported instrument measuring latching ability: Latch, Audible swallowing, Type of nipple, Comfort, Hold.

b Creamatocrit is the fat content in breast milk measured via a standardized process in a hematocrit centrifuge.

c Cases are detailed in Table 5.

d Vallone case series was nested within cohort study cited above but was not rated.