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, Year Topic Sample Outcome Measures Results Quality of Evidence Adverse Events Reported Designed studies RCT, Herzhaft, 2017 OMT vs sham OMT for biomechanical sucking dysfunction 97 infants, <6 wk of age LATCHa tool Latching improved after one OMT treatment High None reported Cohort, Vallone, 2004 Evaluation and treatment of musculoskeletal dysfunction in infants demonstrating difficulty breastfeeding 35 infants Doctor observation Neonates with nursing dysfunction had more MSK issues than those without Low N/A Pilot, Fraval, 1998 OMT for infants with sucking dysfunction 6 infants > 3wk and <6 mo of age Creamatocritb immediately pre-/posttreatment Breast milk fat content increased in all, significantly (normalized) in 4/6. Not rated Not stated Large case series >12c Miller, 2009 SMT for infants with suboptimal breastfeeding diagnosed by physician or lactation consultant 114 infants, mean age = 3 wk Exclusive breastfeeding All improved; 78% (89/114) exclusively breast fed after 2-5 treatments
over 2 wkNot rated None reported Vallone, 2004 SMT and CM for infants with MSK and nursing dysfunction 25 infants, mean age = 3 wk Improved latch by mother report and doctor observation 80% (23/25) improved after mean of 3 treatments (range 1-12) Not ratedd Not stated Stewart, 2012 SMT for infants with MSK and nursing dysfunction 19 infants Questionnaire on specific infant actions and overall stress while nursing Improved in all aspects assessed on questionnaire by mother report Not rated Not stated Summary of small case series (<12)c 5 case series SMT and CM for infants with MSK and nursing dysfunction 12 treated, 11 observed only Mother report and provider observation Favorable outcomes in treated cases Not rated Not stated Summary of case reportsc 20 case reports SMT and CM for infants with MSK and nursing dysfunction 20 infants Mother report and provider observation Favorable outcomes Not rated Not 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.